PROPOSED RULEMAKING

DEPARTMENT OF HEALTH

[28 PA. CODE CHS. 201, 207, 209 AND 211]

Long-Term Care Nursing Facilities

[52 Pa.B. 3070]
[Saturday, May 28, 2022]

 The Department of Health (Department), after consultation with the Health Policy Board, proposes to amend §§ 201.18—201.21, 201.24, 201.26, 201.29, 211.2—211.10, 211.12, 211.16 and 211.17 and delete §§ 201.25, 201.30, 201.31, 207.2, 209.3, 211.11 and 211.15 to read as set forth in Annex A.

 The Department initially decided to submit proposed amendments to Part IV, Subpart C (relating to long-term care facilities) in five separate packages. The Department has since decided, in response to concerns raised during the public comment period for the previous packages, to reduce the number of proposed packages from five to four by combining what it intended to propose in its fourth and fifth packages. Therefore, this is the fourth, and last, set of amendments to be proposed to Part IV, Subpart C.

 The Department will begin drafting the corresponding four final-form rulemaking packages after the public has had the opportunity, through the separate public comment periods provided for in each package, to review and comment on all four proposed rulemaking packages. The Department is also planning to hold meetings with stakeholders after each public comment period has ended. The first of these meetings, to discuss proposed groups 1 and 2, took place on December 15, 2021. Additional meetings will be scheduled to discuss proposed groups 3 and 4 after the public comment period has ended for each of those groups. The Department intends to submit all four final-form regulatory packages to the House Health Committee, Senate Health and Human Services Committee and the Independent Regulatory Review Commission (IRRC) together on the same day, so that all four final-form regulatory packages can be reviewed together as a whole.

 The contents for this fourth, and last, proposed rulemaking are as follows:

Proposed Rulemaking 4

§ 201.18. Management.

§ 201.19. Personnel records.

§ 201.20. Staff development.

§ 201.21. Use of outside resources.

§ 201.24. Admission policy.

§ 201.25. Discharge policy.

§ 201.26. Power of attorney.

§ 201.29. Resident rights.

§ 201.30. Access requirements.

§ 201.31. Transfer agreement.

§ 207.2. Administrator's responsibility.

§ 209.3. Smoking.

§ 211.2. Physician services.

§ 211.3. Oral and telephone orders.

§ 211.4. Procedure in event of death.

§ 211.5. Clinical records.

§ 211.6. Dietary services.

§ 211.7. Physician assistants and certified registered nurse practitioners.

§ 211.8. Use of restraints.

§ 211.9. Pharmacy services.

§ 211.10. Resident care policies.

§ 211.11. Resident care plan.

§ 211.12. Nursing services.

§ 211.15. Dental services.

§ 211.16. Social services.

§ 211.17. Pet therapy.

 The contents for the previously submitted proposed rulemakings are as follows:

Proposed Rulemaking 1

§ 201.1. Applicability.

§ 201.2. Requirements.

§ 201.3. Definitions.

§ 211.12(i). Nursing Services.

Proposed Rulemaking 2

§ 201.23. Closure of facility.

Chapter 203. Application of Life Safety Code for Long-Term Care Nursing Facilities.

Chapter 204. Physical Environment and Equipment Standards for Alteration, Renovation or Construction of Long-Term Care Nursing Facilities.

Chapter 205. Physical Environment and Equipment Standards for Long-Term Care Nursing Facilities.

§ 207.4. Ice containers and storage.

Proposed Rulemaking 3

§ 201.12. Application for license of a new facility or change in ownership.

§ 201.12a. Evaluation of application for license of a new facility or change in ownership. (new)

§ 201.12b. Opportunity for public comment.

§ 201.13. Issuance of license for a new facility or change in ownership.

§ 201.13a. License renewal.

§ 201.14. Responsibility of licensee.

§ 201.15. Restrictions on license.

§ 201.17. Location.

§ 201.22. Prevention, control and surveillance of tuberculosis (TB).

§ 209.1. Fire department service.

§ 209.7. Disaster preparedness.

§ 209.8. Fire drills.

§ 211.1. Reportable diseases.

Background and Need for Amendments

 The percentage of adults 65 years of age or older in this Commonwealth is increasing. In 2010, approximately 15% of Pennsylvanians were aged 65 or older. In 2017, this number increased to 17.8%. This Commonwealth also has a higher percentage of older adults when compared to other states. In 2017, this Commonwealth ranked fifth in the Nation in the number (2.2 million) of older adults and seventh in percentage (17.8%). The increase in older Pennsylvanians is expected to continue. It has been estimated that by 2030, there will be 38 older Pennsylvanians (65 years of age or older) for every 100-working age Pennsylvanians (15 years of age to 64 years of age). Penn State Harrisburg, Pennsylvania State Data Center. (July 2018). Population Characteristics and Change: 2010 to 2017 (Research Brief). Retrieved from https://pasdc.hbg.psu.edu/data/research-briefs/pa-population-estimates. As the number of older Pennsylvanians increases, the number of those needing long-term care nursing will also increase. It has been estimated that an individual turning 65 years of age today has an almost 70% chance of needing some type of long-term nursing care during the remainder of their lifetime. Administration for Community Living. (February 2020). How Much Care Will You Need? Retrieved from https://acl.gov/ltc/basic-needs/how-much-care-will-you-need. Currently, there are approximately 73,000 Pennsylvanians residing in 689 long-term care nursing facilities licensed by the Department.

 The Department's long-term care nursing facilities regulations have not been updated since 1999, with the last significant update occurring in 1997 after the 1996 amendment to the Health Care Facilities Act (the HCFA or act) (35 P.S. §§ 448.101—448.904b). Since that time, there have been substantial changes in the means of delivering care and providing a safe environment for residents in long-term care nursing facilities. This proposed rulemaking is necessary to improve the quality of care delivered to residents, increase resident safety and minimize procedural burdens on health care practitioners who provide care to residents in long-term care nursing facilities.

 The Department began the process of updating the current long-term care regulations in late 2017. The Department sought review, assistance and advice from members of a long-term care work group (LTC Work Group) consisting of relevant stakeholders. The members of the LTC Work Group were drawn from a diverse background and included representatives from urban and rural long-term care facilities and various stakeholder organizations and consumer groups that work in the area of resident care and delivery of services. The LTC Work Group members consisted of representatives from the following organizations: American Institute of Financial Gerontology; Baker Tilly Virchow Krause, LLP; Berks Heim and Rehabilitation; Fulton County Medical Center; Garden Spot Community; HCR ManorCare; Inglis House; Landis Communities; Leading Age; Legg Consulting Services; LIFE Pittsburgh; Luzerne County Community College; The Meadows at Blue Ridge; Mennonite Home, Lutheran Senior Life Passavant Community; PA Coalition of Affiliated Healthcare and Living Communities; Pennsylvania Home Care Association; University of Pittsburgh; and Valley View Nursing Home. The following State agencies participated: Department of Aging; the Department of Human Services (DHS); and the Department of Military and Veteran's Affairs (DMVA).

 The members of the LTC Work Group met regularly during 2018 with the LTC Work Group's primary focus being the simplification and modernization of the existing long-term care regulations. Upon completion of the LTC Work Group's discussions, the Department conducted an internal review of the recommended changes. While the Department accepted most of the language and substantive changes proposed by the LTC Work Group and attempted to incorporate them in this proposed rulemaking, the Department is proposing additional changes to language and additional substantive changes, as well.

 During 2019 and 2020, the Department conferred with other agencies that would be potentially affected by the proposed regulatory changes, to seek their input on provisions within their substantive expertise. These agencies included the Department of Aging, DHS and the DMVA. The Department received recommendations from these agencies regarding the draft proposed regulations and made additional changes to the proposed regulations to enhance resident safety and quality of care.

 The Department in its first and second proposed rulemakings addressed inconsistencies between Federal and State requirements for long-term care nursing facilities licensed in this Commonwealth. In the first proposed rulemaking, the Department proposed to expand the adoption of the Federal requirements to include all of the requirements set forth in 42 CFR Part 483, Subpart B (relating to requirements for long-term care facilities). The purpose of that amendment was to create consistency in the application of Federal and State requirements to long-term care nursing facilities in this Commonwealth. In the second proposed rulemaking, the Department proposed to amend existing regulations pertaining to the closure of a long-term care nursing facility to eliminate duplication between existing State requirements and Federal requirements. The Department also proposed in that rulemaking to update requirements for alterations, renovations or construction of long-term care nursing facilities.

 In the third proposed rulemaking, the Department shifted its focus to the requirements that a long-term care nursing facility must meet for licensure, as well as safety requirements and requirements for infection prevention and control. The amendments in that proposed rulemaking included: eliminating provisions that are duplicative of the Federal requirements, and updating requirements for the application for licensure of new facilities and changes in ownership for existing facilities.

 In this fourth, and last, proposed rulemaking, the Department proposes amendments to the remaining sections of regulations pertaining to long-term care nursing facilities. These proposed amendments include additional elimination of provisions that are duplicative and that conflict with the Federal requirements. Other proposed amendments include increasing the number of registered nurses (RN), licensed practical nurses (LPN) and nurse aides required under § 211.12 (relating to nursing services), adding a requirement that facilities have a full-time qualified social worker regardless of the size of the facility, requiring facilities to have admissions policies and procedures that include introductions and orientation for new residents to key personnel and services, and adding an anti-discrimination provision.

Description of Proposed Amendments

§ 201.18. Management

Subsection (a)

 The Department proposes to delete this subsection to eliminate duplication and avoid conflict with the Federal requirements for long-term care nursing facilities. Under 42 CFR 483.70(d) (relating to administration), a facility is required to have a governing body, or designated persons functioning as a governing body, that is legally responsible for establishing and implementing policies regarding the management and operation of a facility.

Subsection (b)

 The Department proposes to add language at the beginning of this subsection to clarify that the requirements in this subsection are in addition to the Federal requirements at 42 CFR 483.70(d). The Department also proposes to add the words ''of a facility'' after ''governing body'' to make it clear that the governing body of a long-term care nursing facility shall perform the tasks delineated in paragraphs (1) through (3) of subsection (b).

Subsection (c)

 The Department proposes to replace ''provide the information required in § 201.12 (relating to application for license) and prompt reports of changes which would affect the accuracy of the information required'' with ''report to the Department within 30 days changes to the information that was submitted with the facility's application for licensure under § 201.12 (relating to application for license of a new facility or change in ownership)'' to clarify the governing body's responsibility with respect to the information submitted under § 201.12. It is a prospective owner's responsibility to submit the information required under § 201.12 for the application for licensure, rather than the governing body. Once an application for licensure is approved, the governing body becomes responsible for reporting to the Department any changes to the information that was submitted with the application for licensure. The Department is proposing to require that changes be reported within 30 days to align with § 51.4 (relating to change in ownership; change in management), which requires notification to the Department at least 30 days prior to a transfer involving 5% or more of stock or equity, a change in ownership and a change in management.

Subsection (d)

 The Department proposes to delete the first sentence in subsection (d) to eliminate duplication and avoid conflict with the Federal requirements. Under 42 CFR 483.70(d)(1), a facility is required to have a governing body that is legally responsible for establishing and implementing policies regarding the management and operation of the facility. In the second sentence of subsection (d), the Department proposes to add a cross-reference to the requirement in 42 CFR 483.70(d)(1) for clarity. The Department also proposes to delete the phrase ''shall be made available to the members of the governing body, which shall ensure that they are operational.'' This phrase is unnecessary and redundant given that the governing body is responsible for establishing and implementing policies for the management and operation of the facility, under the Federal requirements. In the third sentence, the Department proposes to replace the term ''responsible persons'' with the term ''resident representatives.'' The term ''responsible person'' is an outdated term that is no longer used and has been replaced, throughout the regulations, with the term ''resident representative'' to describe the types of individuals who may act on behalf of a resident. The term ''resident representative'' is defined in the Federal requirements at 42 CFR 483.5 (relating to definitions) and encompasses not only individuals who are authorized by law to act on behalf of a resident but also other individuals who may be chosen by residents to act on their behalf.

Subsection (d.1)

 This subsection is proposed to be added. The Department proposes to move the requirement from the first sentence of existing subsection (e) to this new subsection with some minor changes. The Department proposes to replace language requiring the governing body to appoint an administrator with a cross-reference to that requirement in 42 CFR 483.70(d)(2) of the Federal requirements. The Department proposes to retain the requirement that the administrator be currently licensed and registered in this Commonwealth and that the administrator be employed full time. The Department is proposing to remove the requirement in existing subsection (e) that a facility, with 25 beds or less, seek an exception to share an administrator with another facility. The Department proposes new language, in subsection (d.1), to permit a facility with 25 beds or less to share an administrator provided that the Department is informed of this arrangement, there is a plan in the event of an emergency when the administrator is not working, and there is a readily available method for residents to contact the administrator should they find it necessary. The existing language limiting the sharing of an administrator to two facilities is moved from subsection (e) to this subsection.

 The Department has received multiple requests for exception under existing subsection (e), particularly from facilities that provide transitional care, have few residents, and a lot of resident turnover. In these cases, the facilities would like to share an administrator with other facilities within their network to save money. Permitting facilities with 25 beds or less to share an administrator addresses these concerns and will provide flexibility for those facilities that do not have a need for a full-time administrator. Adding the requirements in paragraphs (1) through (4), that is, requiring the Department to be informed, having a plan in the event of an emergency when the administrator is not working, having a readily available method of contacting the administrator and requiring the director of nursing to have sufficient knowledge and experience to compensate for the time that the administrator is not in the facility, will ensure the health and safety of residents when a facility chooses to employ a part-time administrator.

Subsection (d.2)

 This subsection is proposed to be added. The Department proposes to move the requirement in the fourth sentence of subsection (e) into this subsection with no substantive changes. The Department proposes to move this requirement to its own subsection for clarity and ease of readability.

Subsection (e)

 As noted previously, the Department proposes to delete the requirement in the first sentence of this subsection and move it to proposed subsection (d.1), with amendments. The Department proposes to delete the next two sentences. The ability of a facility to share an administrator is contemplated through the addition of the language in proposed subsection (d.1) which will permit facilities with 25 beds or less to have a part-time administrator if the requirements in subsection (d.1)(1) through (4) are met. As noted previously, the Department also proposes to delete the requirement in the fourth sentence and move it into subsection (d.2).

 The Department proposes to retain the last sentence in subsection (e), as well as paragraphs (1) through (7). The Department proposes to add new paragraph (2.1). The Department proposes to move into paragraph (2.1) the existing language from § 207.2(a) (relating to administrator's responsibility), requiring an administrator to ensure satisfactory housekeeping and maintenance of the buildings and grounds. The Department is proposing this amendment so that the responsibilities of the administrator are all together in one place in the regulations. In paragraph (5), the Department proposes to replace the term ''employe'' with the term ''employee'' for correct usage and spelling of that term. The Department does not propose any amendments to paragraphs (1), (2), (3), (4), (6) or (7).

Subsection (f)

 The Department proposes to delete the words ''and funds'' and the phrase ''and for expenditures and disbursements made on behalf of the resident'' to eliminate duplication and avoid conflict with the Federal requirements. A facility's responsibility for resident funds is addressed in the Federal requirements at 42 CFR 483.10(f)(10) and (11) (relating to resident rights). The Department also proposes to replace the term ''responsible person'' with the term ''resident representative'' for consistency in the use of that term throughout the regulations.

Subsection (g)

 The Department does not propose any amendments to this subsection.

Subsection (h)

 The Department proposes to replace the term ''resident's responsible person'' with ''resident representative'' for consistency in the use of that term throughout the regulations. The Department proposes to delete the last sentence requiring a facility to provide residents with access to their money within 3 business days in the form requested, cash or check, by the resident. The Department proposes to replace this sentence with a requirement that a facility provide the resident with cash, if requested, within 1 day of the request, or with a check, if requested, within 3 days of the request. The proposed requirement that a facility provide a resident with cash, if requested, within 1 day is new. Based on discussions with the LTC Work Group, the Department believes that facilities typically have enough cash on hand, or have the ability to obtain cash quickly, and therefore, should be able to provide a resident with cash, if requested, within 1 day. The Department proposes no amendment to the existing requirement that a check be provided, if requested, within 3 days because specific personnel are often needed to process a check and these personnel may not be onsite every day.

§ 201.19. Personnel records

 The Department proposes to amend the name of this section from ''personnel policies and procedures'' to ''personnel records.'' This section requires a facility to maintain certain types of personnel records, not to create policies and procedures for personnel records. Therefore, the term ''personnel records'' more accurately describes the requirements of this section.

 The Department also proposes to replace the term ''employe'' with the term ''employee'' to reflect the current usage and spelling of that term. The Department proposes to add the word ''facility'' before the word ''employee'' to clarify that this section applies to employees of the facility and not, for example, employees of another agency that the facility may utilize to provide care or services to residents. The Department proposes to replace the word ''sufficient'' with the words ''the following'' and to delete ''to support placement in the position to which assigned'' after the word ''information.'' The Department proposes these amendments to accommodate the addition of several new proposed requirements in paragraphs (1) through (9) of this section.

 The Department proposes in paragraphs (1) through (9) to require a facility to keep in its personnel records, for each facility employee: (1) the employee's job description, educational background and employment history; (2) employee performance evaluations; (3) documentation of current certification, registration or licensure, if applicable, for the position to which the employee is assigned; (4) a determination by a health care practitioner that the employee is free from communicable diseases or conditions listed in § 27.155 (relating to restrictions on health care practitioners); (5) records of the pre-employment health examinations and of subsequent health services rendered to the facility's employees as are necessary to ensure that all employees are physically able to perform their duties; (6) documentation of the employee's orientation to the facility and the employee's position prior to or within 1 week of the employee's start date; (7) documentation of the employee's completion of required trainings; (8) a criminal history record; and (9) in the event of a conviction, a determination of the employee's suitability for employment in the position to which the employee is assigned. Proposed paragraphs (1) through (4), (6) and (7) are currently in the Department's interpretive guidelines for § 201.19 (relating to personnel records). Facilities, therefore, are already maintaining this information. Nonetheless, the Department is proposing to include these guidelines in regulation to make it clear that facilities are expected to include these items in employee personnel records. Department of Health. Interpretive Guidelines. Retrieved from: https://www.health.pa.gov/topics/Documents/Laws%20and%20Regulations/interpretive_guidelines_for_state_regs.pdf.

 Proposed paragraph (5) is an expansion of the Department's inclusion of ''health status'' that is currently in the previously-referenced guidance. Because the use of the term ''health status'' is vague, the Department is proposing to clarify in regulation that a facility is required to maintain records of pre-employment health examinations and subsequent health services rendered to the facility's employees as are necessary to ensure that all employees are physically able to perform their duties. This requirement mirrors a requirement that exists for hospitals in § 103.36 (relating to personnel records). For this requirement, the Department is not concerned with what specific conditions an employee may have but is only looking to see if the facility is maintaining this information. It is not the Department's intent to determine who can and cannot perform certain duties due to a medical condition or health condition. Rather, it is up to each individual facility to determine what to do with this information, for example, provide restrictions for the employee or limit contact with residents, depending on specific circumstances and in accordance with applicable laws. Requiring a facility to maintain the types of records identified in paragraphs (1) through (7) will assist both the facility and the Department if a concern arises regarding an employee at the facility.

 The Department is proposing to add paragraph (8) to align with section 502 of the Older Adult Protective Services Act (OAPSA) (35 P.S. § 10225.502), which requires a criminal history background check for individuals applying for employment in a long-term care nursing facility. The Department is proposing to add paragraph (9) to require, in the event that an employee has a conviction, that a facility include in the employee's personnel record a determination of the employee's suitability for employment in the position to which the employee is assigned. The Department recognizes that hiring decisions should be made on a case-by-case basis, and are dependent upon individual circumstances, but proposes to require that a facility document its determination, where an employee has a conviction, to demonstrate that the employee's background was considered should a concern arise regarding the employee's suitability for employment.

§ 201.20. Staff development

Subsection (a)

 The Department proposes to delete ''training related to problems, needs and rights of the residents.'' The Department proposes to move the requirement that a facility provide, at a minimum, annual in-service training from subsection (c), to add a cross-reference to the Federal training requirements in 42 CFR 483.95 (relating to training requirements), and to include from existing subsection (c) accident prevention, restorative nursing techniques, emergency preparedness and fire prevention and safety as additional training topics. The Department proposes to delete from subsection (c) those requirements that are duplicative of the Federal requirements in 42 CFR 483.95, and to move from subsection (c) those topics that are not covered under 42 CFR 483.95. For additional clarity and ease of readability, the Department proposes to place these training topics into an enumerated list.

 The topics proposed for deletion from subsection (c) include infection prevention and control, residents' confidential information, residents' psychosocial needs and resident rights, as these are required as part of the training requirements in 42 CFR 483.95. The Department proposes to retain and move into subsection (a), accident prevention and restorative nursing techniques, as these two topics are not covered within the training requirements in 42 CFR 483.95. The Department proposes to retain these two training requirements to ensure the health and safety of residents. The Department also proposes to retain and move into subsection (a), emergency preparedness and fire prevention and safety as training topics, as they are not covered within 42 CFR 483.95. These topics are covered elsewhere in the Federal requirements, but because they are not covered specifically in 42 CFR 483.95, the Department proposes to retain them in this subsection with cross-references for clarity. Disaster preparedness is covered under 42 CFR 483.73(d) (relating to emergency preparedness), which requires facilities to develop and maintain an emergency preparedness training and testing program that is based on their emergency plan. Fire prevention and safety training is required by the National Fire Protection Association's Life Safety Code (NFPA 101 Life Safety Code), which has been adopted in the Federal requirements in 42 CFR 483.90(a) (relating to physical environment). Under sections 18.7.2.3.1 and 19.7.2.3.1 of the NFPA 101 Life Safety Code, all facility personnel are to be instructed in their role in the use of and response to fire alarms.

Subsection (b)

 The Department proposes to replace the term ''employe'' with the term ''employee'' for current usage and spelling of that term. The Department proposes to delete the second sentence of this subsection because training on the prevention of resident abuse and reporting of abuse is covered under the Federal requirements at 42 CFR 483.95(c).

Subsection (c)

 The Department proposes to delete this subsection in light of the proposed amendments to subsection (a), as described previously.

Subsection (d)

 The Department proposes one minor, grammatical amendment to this subsection. The Department proposes to delete the word ''the'' between the words ''at'' and ''staff development programs.''

§ 201.21. Use of outside resources

Subsection (a)

 The Department proposes to delete this subsection to eliminate duplication and to avoid conflict with the Federal requirements. Under 42 CFR 483.70(g)(2)(i), an arrangement or agreement for the use of outside resources must specify in writing that the facility assumes responsibility for obtaining services that meet professional standards and principles that apply to professionals providing services in the facility.

Subsection (b)

 The Department proposes to delete this subsection to eliminate duplication and to avoid conflict with the Federal requirements. Under 42 CFR 483.70(g)(1), a facility is required to have services furnished to residents by a person or agency outside the facility if the facility does not employ a qualified professional person to furnish that service.

Subsection (c)

 The Department proposes to delete this subsection to eliminate duplication and avoid conflict with the Federal requirements. Under 42 CFR 483.70(g)(2), the arrangement or agreement for outside services must be in writing.

Subsection (d)

 The Department proposes to delete this subsection and replace it with subsection (e), described as follows.

Subsection (e)

 Proposed subsection (e) will replace the requirement in existing subsection (d) regarding outside resources that supply temporary employees to a facility. The Department proposes to require in this new subsection that if a facility acquires employees from outside resources, the facility shall obtain confirmation from the outside resource that the employees are free from the communicable diseases and conditions listed in § 27.155 and that the employees are physically able to perform their assigned duties. The Department is proposing this amendment to ensure that employees obtained from outside resources, such as agency staff, are able to care for residents. As with proposed § 201.19(4) and (5), the Department is not concerned with what specific conditions an employee may have but is only checking to see if the facility has obtained confirmation from an outside resource that the employees being provided are able to work with residents. It would be up to the outside agency to comply with applicable laws pertaining to the sharing of personal information.

§ 201.24. Admission policy

Subsection (a)

 The Department proposes to delete this subsection to eliminate duplication and to avoid conflict with the Federal requirements. As discussed previously, the term ''responsible person'' is an outdated term that is no longer used and has been replaced with the term ''resident representative'' to describe the types of individuals who may act on behalf of a resident. The term ''resident representative'' is defined in the Federal requirements in 42 CFR 483.5 and encompasses not only individuals who are authorized by law to act on behalf of a resident but also other individuals who may be chosen by residents to act on their behalf. The ability of a resident representative to exercise the rights of a resident are addressed in 42 CFR 483.10(b). Under 42 CFR 483.10(b), a residentrepresentative has the right to exercise a resident's rights to the extent those rights are delegated to the resident representative, either by the resident or by law.

Subsection (b)

 The Department proposes to delete this subsection to eliminate duplication and avoid conflict with the Federal requirements. Under 42 CFR 483.15(a)(2)(i) (relating to admission, transfer, and discharge rights), a facility must not request or require residents or potential residents from waiving their rights under the Federal requirements, or applicable State, Federal or local licensing or certification laws. Under 42 CFR 483.15(a)(2)(iii), a facility must not request or require residents or potential residents to waive facility liability for losses of personal property.

Subsections (c) and (d)

 The Department does not propose any amendments to subsections (c) or (d).

Subsection (e)

 This subsection is proposed to be added and goes above and beyond the Federal requirements in 42 CFR 483.15(a) by requiring that the governing body of a facility establish written policies and procedures for the admissions process for residents, and through the administrator, to develop and adhere to procedures implementing those policies. The Department proposes to require a facility to include the following in its policies and procedures: (1) introduction of residents to at least one member of the professional nursing staff for the unit where the resident will be living and to direct care staff who have been assigned to care for the resident; (2) orientation of the resident to the facility and location of essential services and key personnel to include the dining room, nurses' workstations, and offices for the social worker and grievance or compliance officer; (3) a description of facility routines to include nursing shifts, mealtimes and posting of menus; (4) discussion and documentation of the resident's customary routines and preferences to be included in the care plan developed for the resident under 42 CFR 483.21 (relating to comprehensive person-centered care planning); and (5) assistance to the resident, if needed, in creating a homelike environment and settling personal possessions in the room to which the resident has been assigned. The Department, under section 803 of the act (35 P.S. § 448.803), has the authority to promulgate rules and regulations necessary to carry out the purposes and provisions of the act. One of the stated purposes of section 102 of the act (35 P.S. § 448.102), is to assure that citizens receive humane, courteous and dignified treatment. The Department has been made aware of residents being left on their own for hours and even up to a day after admission to a facility, without receiving any information or services, which can be confusing or disorienting to a resident. Requiring a facility to have in place policies and procedures to introduce and orient a resident to a facility will ensure that residents are provided with essential information concerning their stay at the facility, at the time of admission when they are likely to feel the most vulnerable.

Subsection (f)

 This subsection is proposed to be added and will require that the coordination of introductions, orientation and discussions, required under proposed subsection (e), be the responsibility of the facility's social worker, or other delegee designated by the governing body. Social workers play a vital role in assisting residents with their psychosocial needs, and thus, are ideally suited for performing these types of tasks. The Department proposes to permit another individual, identified by the governing body, to stand in the shoes of the facility's social worker to perform these tasks as the social worker may not always be available at the time of a resident's admission. The Department also proposes to require that the coordination of introductions, orientation and discussions occur within 2 hours of a resident's admission to further ensure that residents are not left on their own for too long after being admitted to a facility.

§ 201.25. Discharge policy

 The Department proposes to delete this section to eliminate duplication and avoid confusion with the Federal requirements. Under 42 CFR 483.21(c), a facility is required to develop and implement a discharge plan and a post-discharge plan of care. The requirements of these plans include, among other things, ensuring that the discharge needs of the resident are identified and arrangements for the resident's care following discharge.

§ 201.26. Resident representative

 The Department proposes to replace the words ''power of attorney'' in the title and body of this section. The term ''resident representative'' encompasses not only a power of attorney relationship, but also other types of individuals who are authorized to act on behalf of a resident. The Department proposes to delete the slash mark and replace it with a comma to make ''owner'' and ''operator'' two words for stylistic reasons. The Department proposes to replace the word ''employe'' with ''employee'' for current usage and spelling of that term. The Department proposes another grammatical change by replacing the word ''having'' with the word ''with'' for ease of readability. The Department also proposes to add to the end of this section an exception for family members of residents who are employed in the facility. The Department proposes to allow family members who are employed in the facility to serve as resident representatives, so long as there is no conflict of interest. This amendment was proposed by the LTC Work Group, and the Department agrees that a resident should have the best person acting on their behalf, regardless of that person's employment within the facility. The addition of ''so long as there is no conflict of interest'' is proposed to ensure that residents are protected from possible financial exploitation from having a family member employee serve as their resident representative.

§ 201.29. Resident's rights

Subsection (a)

 The Department proposes to add a sentence requiring that the written policies established by the governing body include a mechanism for the inclusion of residents in the development, implementation and review of the policies and procedures regarding the rights and responsibilities of residents. The Department proposes this requirement as part of its efforts to promote more resident-centered environments in long-term care nursing facilities. The residents of a facility live there and are subject to the policies and procedures of the facility. Therefore, they should be allowed to have some say in how the facility operates. Including residents in the development and implementation of policies and procedures regarding resident rights will provide residents with this ability.

Subsections (b) and (c)

 The Department proposes no amendments to subsections (b) and (c).

Subsection (d)

 The Department proposes to delete this subsection to eliminate duplication and avoid conflict with the Federal requirements. Under 42 CFR 483.95(b), a facility must ensure that staff members are educated on the rights of residents and the responsibilities of the facility to properly care for residents, as set forth in 42 CFR 483.10.

Subsection (e)

 The Department proposes to delete this subsection to eliminate duplication and avoid conflict with the Federal requirements. Under 42 CFR 483.10(g)(18), a facility is required to inform a resident, before or at the time of admission, and periodically during the resident's stay, of services available in the facility and of charges for those services, including charges for services not covered by Medicare or Medical Assistance (MA), or by the per diem rate of the facility. A facility is also required under 42 CFR 483.10(g)(18)(i) and (ii), to provide notice when changes in coverage are made to items and services covered by Medicare or MA, and at least 60 days prior to the implementation of changes to charges for other items and services offered by the facility. The 60-day notice under the Federal requirements is more stringent and thus, is more protective of residents than the language that currently exists in subsection (e). The return of security deposits is covered by 42 CFR 483.10(g)(18)(iii), which requires a facility to refund any deposit or charges already paid, less the facility per diem rate, for the days the resident actually resided or reserved or retained a bed in the facility, regardless of any minimum stay or discharge requirements. Facility requirements for the handling of resident funds are also addressed in 42 CFR 483.10(f)(10) and (11).

Subsection (f)

 The Department proposes to delete this subsection to eliminate duplication and to avoid conflict with the Federal requirements. The requirements pertaining to the transfer and discharge of residents are in 42 CFR 483.15. The first sentence of existing subsection (f) is addressed in 42 CFR 483.15(c)(1). Under 42 CFR 483.15(c)(1), a facility must permit each resident to remain in the facility and not transfer or discharge the resident from the facility unless the transfer or discharge is necessary for the resident's welfare and the resident's needs cannot be met in the facility; the resident's health has improved sufficiently so that the resident no longer needs services provided by the facility; the health and safety of individuals is endangered; the resident has failed after reasonable and appropriate notice to pay for staying at the facility; or the facility ceases to operate.

 The notification requirements contained in the second, third and fourth sentences of existing subsection (f) are covered in 42 CFR 483.15(c)(3) and (4). Under 42 CFR 483.15(c)(3) and (4), a facility must notify a resident and the resident's representative of the transfer or discharge in writing and in a language and manner they understand, at least 30 days before the transfer or discharge, except where an immediate transfer or discharge is required, where the health and safety of individuals at the facility would be endangered, or when a resident has not resided in the facility for 30 days. A facility's bed-hold policy is covered by 42 CFR 483.15(d), which requires written notice regarding the duration of its bed-hold policy to a resident, or the resident representative. Although existing subsection (f) refers to the bed-hold policy in terms of discharge, and the Federal requirements refer to a bed-hold in the context of a transfer, the Department considers the term ''discharge'' to be synonymous with ''transfer'' in this context because conceptually, a bed-hold is only necessary in the case of a temporary absence. The last two sentences of subsection (f), pertaining to documentation, are addressed in 42 CFR 483.15(c)(2), which requires documentation of the transfer or discharge in the resident's medical record and that appropriate information regarding the resident be communicated to the receiving health care institution or provider.

Subsection (g)

 The Department proposes to delete the first sentence of this subsection to eliminate duplication and avoid conflict with the Federal requirements. The Federal requirements pertaining to the transfer and discharge of residents are in 42 CFR 483.15. Under 42 CFR 483.15(c)(7), a facility must provide and document preparation and orientation to residents to ensure a safe and orderly transfer or discharge from the facility. Under 42 CFR 483.15(c)(2), a facility is required to document the transfer or discharge in the resident's medical record and communicate appropriate information regarding the resident to the receiving health care institution or provider, including all necessary information to ensure a safe and effective transition of care. Where a transfer occurs because the facility cannot meet the needs of the resident, the facility must document its attempts to meet the resident's needs and the service that is available at the receiving facility to meet the resident's needs. The Department proposes to retain the second sentence in this subsection, with minor amendments. Specifically, the Department proposes to replace the term ''resident's responsible person'' with ''resident representative'' for consistency in the use of that term throughout the regulations. The Department also proposes to replace ''MA'' with ''Medical Assistance'' for clarity.

Subsection (h)

 The Department proposes to delete this subsection to eliminate duplication and to avoid conflict with the Federal requirements. The Federal requirements pertaining to the transfer of residents are in 42 CFR 483.15. Under 42 CFR 483.15(c), a facility is only permitted to transfer a resident under certain circumstances. These circumstances do not contemplate the ability to transfer a resident where the transfer would be harmful to the physical or mental health of the resident being transferred. Because the Department is proposing to adopt the Federal requirements, and a facility would be prohibited under 42 CFR 483.15(c) from transferring a resident where the transfer would be harmful to that resident, there is no need to include this requirement in State regulation.

Subsection (i)

 The Department proposes to delete this subsection to eliminate duplication and to avoid conflict with the Federal requirements. Under 42 CFR 483.10(b), a resident has the right to exercise their rights as a resident of the facility and as a citizen or resident of the United States. Under 42 CFR 483.10(g)(4) and (5), a resident has the right to receive notices orally and in writing in a format and a language that they understand. The notices required under 42 CFR 483.10(g)(4) include contact information for all pertinent State regulatory and informational agencies, advocacy groups, the State Long-Term Care Ombudsman and others. A facility is also required to provide information for filing grievances or complaints. Under 42 CFR 483.10(g)(5), a facility is required to post this information, in a form and manner that is accessible and understandable to residents and resident representatives. In addition, under 42 CFR 483.10(j), a resident has the right to voice grievances to the facility or to an agency or entity that hears grievances without discrimination or reprisal or fear of discrimination or reprisal. A facility is also required under 42 CFR 483.10(j)(4) to establish a grievance policy which meets certain minimum requirements, and under 42 CFR 483.10(j)(3), make available information on how to file a grievance or complaint.

Subsection (j)

 The Department proposes to delete subsection to eliminate duplication and to avoid this conflict with the Federal requirements. Under 42 CFR 483.10(a)(1), a facility is required to treat each resident with respect and dignity and to care for each resident in a manner and in an environment that promotes maintenance or enhancement of quality of life, while recognizing each resident's individuality. Under 42 CFR 483.10(h), a resident has a right to personal privacy and confidentiality of personal and medical records. The right to personal privacy encompasses accommodations, medical treatment, communications (oral, written and telephone), personal care, and visits and meetings with family and resident groups.

Subsection (k)

 The Department proposes to delete this subsection to eliminate duplication and to avoid conflict with the Federal requirements. Under 42 CFR 483.10(e)(2), a resident has the right to retain and use personal possessions, including clothing and furnishings, as space permits, unless to do so would infringe upon the rights or health and safety of other residents. Under 42 CFR 483.10(i), a facility must provide residents with a safe, clean, comfortable and homelike environment, and allow residents to use their personal belongings to the extent possible. This includes the provision of private closet space in each resident's room.

Subsection (l)

 The Department proposes to delete this subsection to eliminate duplication and to avoid conflict with the Federal requirements. The ability of a resident representative to exercise the rights of a resident are addressed in 42 CFR 483.10(b). Under that subsection, a resident representative has the right to exercise a resident's rights to the extent those rights are delegated to the resident representative, either by the resident or by law.

Subsection (m)

 The Department proposes to delete this subsection. Existing subsection (a), which the Department proposes to retain, addresses the requirement that a facility have policies and procedures related to resident rights. Thus, there is no need to retain this subsection.

Subsection (n)

 The Department proposes no amendments to the first sentence of this subsection. The Department proposes to delete the second sentence in this subsection to eliminate duplication and to avoid conflict with the Federal requirements. Under 42 CFR 483.10(g)(16), a facility must provide a notice of rights and services to residents prior to or upon admission and also, during the residents' stay. A facility must inform a resident of their rights and all rules and regulations governing resident conduct and responsibilities during their stay in the facility, both orally and in writing in a language that the resident understands. The Department proposes to replace the word ''clinical'' with the word ''medical'' in the last sentence for consistency in the use of the term ''medical record'' throughout the regulations to describe a resident's medical record.

Subsection (o)

 The Department proposes to replace the term ''nursing home'' with the term ''facility'' for consistency in the use of that term throughout this subpart, and as defined in § 201.3 (relating to definitions). The remaining amendments proposed by the Department, to this subsection, align with the Federal requirements and Federal guidance found in Appendix PP—Guidance to Surveyors for Long-Term Care Facilities from the Centers of Medicare & Medicaid Services (CMS) State Operations Manual. Under 42 CFR 483.10(c)(6), a resident has the right to participate in or refuse to participate in experimental research. Appendix PP expands upon this as follows:

The resident has the right to refuse to participate in experimental research. A resident being considered for participation in experimental research must be fully informed of the nature of the experimental research (for example, medication or other treatment) and the possible consequences of participating. The resident must provide informed consent prior to participation and initiation of experimental research. If the resident is incapable of understanding the situation and of realizing the risks and benefits of the proposed research, but a resident representative gives consent, facility staff have a responsibility to ensure that the consent is properly obtained and that essential measures are taken to protect the resident from harm or mistreatment. The resident (or his or her representative if the resident lacks health care decision-making capacity) must have the opportunity to refuse to participate both before and during the experimental research activity.

 Appendix PP defines experimental research as the development, testing and use of a clinical treatment, such as an investigational drug or therapy that has not yet been approved by the United States Food and Drug Administration (FDA) or medical community as effective and conforming to accepted medical practice. Commentators and IRRC, requested in prior proposed rulemakings that the Department expressly add into regulation any guidance that it wishes to adopt from Appendix PP. The Department proposes to expressly add the previous guidance from Appendix PP into regulation because it provides greater protection to residents than the Federal requirement alone. This protection is necessary as residents who are being considered for experimental research are already vulnerable and need to be fully informed of the nature of the research and the possible consequences for participating in the research to make a decision.

Subsection (p)

 The Department proposes to add this subsection to make it clear that a resident has the right to care without discrimination based upon race, color, familial status, religious creed, ancestry, age, sex, gender, sexual orientation, gender identity or expression, national origin, ability to pay, handicap or disability, use of guide or support animals because of the blindness, deafness or physical handicap of the resident or because the resident is a handler or trainer of support or guide animals. The Department's proposal to include race, color, familial status, religious creed, ancestry, age, sex, national origin, handicap or disability, use of guide or support animals because of the blindness, deafness or physical handicap of the user or because the user is a handler or trainer of support or guide animals in this subsection mirrors existing protections under the Pennsylvania Human Relations Act (PHRA) (43 P.S. §§ 951—963). Section 5(i) of the PHRA (43 P.S. § 955(i)) prohibits places of public accommodation from discriminating against individuals on the basis of race, color, familial status, religious creed, ancestry, age, sex, national origin, handicap or disability, use of guide or support animals because of the blindness, deafness or physical handicap of the user or because the user is a handler or trainer of support or guide animals.

 Further, the Department is proposing to clarify that discrimination in the provision of health care based on sexual orientation, gender identity and expression is also prohibited. Currently, Federal and State law do not specifically prohibit discrimination based on sexual orientation or gender identity, though the Federal requirements for long-term care nursing facilities do provide some protections for same-sex spouses and residents based on sexual orientation and gender identity. See 42 CFR 483.10(b)(3); 42 CFR 483.10(f)(4)(vi)(B) and (C). In 2018, the Pennsylvania Human Relations Commission (PHRC), the entity charged with enforcing the PHRA, released guidance stating that its interpretation of the term ''sex'' in the PHRA ''may refer to sex assigned at birth, sexual orientation, transgender identity, gender transition, gender identity, and/or gender expression.'' PHRC. Pennsylvania Human Relations Commission Guidance on Discrimination on the Basis of Sex under the Pennsylvania Human Relations Act. Retrieved from https://www.phrc.pa.gov/AboutUs/Documents/APPROVED %20Sex%20Discrimination%20Guidance%20PHRA.pdf. The result of that guidance is that the PHRC will accept filing of complaints arising out of discrimination based on sex assigned at birth, sexual orientation, transgender identity, gender transition, gender identity or gender expression in places of public accommodation. As mentioned, long-term care nursing facilities are places of public accommodation under both Federal and State law and therefore, would be subject to the PHRC guidance.

 Further, the Department's proposal in subsection (p) is consistent with its duty and authority under section 102 of the act to ensure that ''all citizens receive humane, courteous, and dignified treatment.'' That duty cannot be met if the Department allows or remains silent on discrimination against any class of persons, especially persons that otherwise have not been afforded clear protections under the law. Section 804 of the act (35 P.S. § 448.804), further prohibits any provider from discriminating on the basis of sex. Consistent with the PHRC guidance, discrimination on the basis of ''sex'' would include discrimination based on sex assigned at birth, sexual orientation, transgender identity, gender transition, gender identity or gender expression. The Department is proposing to make clear to long-term care nursing facilities the Department's interpretation of this statutory provision, which is consistent with the text of the statute and the intent and purpose of the act.

§ 201.30. Access requirements

 The Department proposes to delete this section to eliminate duplication and avoid conflict with the Federal requirements at 42 CFR 483.10(f). Under 42 CFR 483.10(f)(4), a resident has a right to receive visitors of their choosing at the time of their choosing. A facility must provide immediate access to certain individuals, subject to the resident's right to deny visitation. A facility must provide reasonable access to any entity or individual that provides health, social, legal or other services to the resident, subject to the resident's right to deny visitation. A facility must have written policies and procedures regarding visitation rights, including any clinically necessary or reasonable restriction or limitation or safety restriction or limitation the facility may need to place on these rights. These policies and procedures must include the reasons for the restriction or limitation.

§ 201.31. Transfer agreement

 The Department proposes to delete this section to eliminate duplication and avoid conflict with the Federal requirements at 42 CFR 483.70(j). Under 42 CFR 483.70(j), a facility is required to have in effect a written transfer agreement with one or more hospitals that are approved for participation under Medicare or Medical Assistance. The transfer agreement must reasonably assure that residents will be transferred to the hospital with timely admission to the hospital when transfer is medically appropriate and that all medical and other information needed for the care and treatment of residents will be exchanged between the providers. The facility is also required to attempt in good faith to enter into an agreement with a hospital sufficiently close to the facility to make transfer feasible.

§ 207.2. Administrator's responsibility

 The Department proposes to delete this section. As discussed previously, the Department proposes to move the requirement in existing subsection (a), pertaining to the administrator's responsibility for housekeeping and maintenance, to § 201.18(e)(2.a) (relating to management). Thus, there is no need to retain this requirement here. The Department proposes to delete subsection (b) as this provision is outdated. In recent years, there has been a shift in the long-term care nursing environment to providing residents with a more homelike environment. Residents being cared for at home would not typically have services provided by multiple people. Prohibiting nursing services personnel from performing any housekeeping duties can contribute to residents feeling as though they are institutionalized regardless of what their environment looks like. Properly trained staff should be allowed to provide primary care for residents that covers a broad range of tasks.

§ 209.3. Smoking

 The Department proposes to delete this section to eliminate duplication and avoid conflict with the Federal requirements. Under 42 CFR 483.90(i)(5), a facility is required to establish policies, in accordance with applicable Federal, State and local laws and regulations, regarding smoking, smoking areas and smoking safety that also take into account non-smoking residents. The NFPA 101 Life Safety Code, which has been adopted in the Federal requirements in 42 CFR 483.90(a), also addresses requirements for smoking policies at 18.7.4 and 19.7.4.

§ 211.2. Medical director

 As explained as follows, the Department proposes to delete subsections from this section, pertaining to physicians, to eliminate duplication and to avoid confusion with the Federal requirements. The Department proposes to retain and amend subsections of this section that pertain to the medical director. As a result of these amendments, the Department proposes to amend the title of this section from ''physician services'' to ''medical director'' to reflect the proposed contents of this section more accurately.

Subsection (a)

 The Department proposes to delete this subsection to eliminate duplication and avoid conflict with the Federal requirements for facilities. Under 42 CFR 483.30 (relating to physician services), a physician is required to approve in writing an individual's admission to a facility, and each resident in a facility must remain under the care of a physician. Under 42 CFR 483.21(b), a facility is required to develop and implement a comprehensive person-centered care plan for each resident. This care plan is prepared by an interdisciplinary care team, that includes the attending physician, the resident and resident representative, and others who are involved in the resident's care.

Subsection (b)

 The Department proposes to delete this subsection to eliminate duplication and avoid conflict with the Federal requirements. Under 42 CFR 483.20(a) (relating to resident assessment), a facility is required to have, at the time of admission, a physician's orders for the resident's immediate care. Under 42 CFR 483.21 (relating to comprehensive person-centered care planning), a facility is required to develop and implement, within 48 hours of admission, a baseline care plan for each resident. The baseline care plan must include the minimum healthcare information necessary to properly care for a resident, including physician orders. A facility is also required, under 42 CFR 483.20(b), to conduct a comprehensive assessment of a resident's needs, strengths, goals, life history and preferences, using a resident assessment instrument. Under 42 CFR 483.20(b)(2)(i), this assessment must be conducted within 14 days after admission.

Subsection (c)

 The Department proposes to amend the first sentence of subsection (c), to delete language that is duplicative of the Federal requirements for the provision of a medical director and to include a cross-reference to the Federal requirements for a medical director at 42 CFR 483.70(h). Under 42 CFR 483.70(h), a facility is required to designate a physician to serve as medical director. The medical director is responsible for implementation of resident care policies and the coordination of medical care in the facility. The Department proposes to retain the requirement that the medical director be licensed as a physician in this Commonwealth, as that is not specifically indicated in the Federal requirements for a medical director.

 The Department also proposes to add, at the request of stakeholders, a requirement that the medical director complete at least 4 hours annually of continuing medical education (CME) pertinent to the field of medical direction or post-acute and long-term care medicine. The Department has determined that this addition, which is not included in the Federal requirements, is necessary to ensure that the medical director of a facility remains current in the field. Having a knowledgeable medical director is critical to the provision of quality care. Additionally, requiring 4 hours of CME pertinent to the field of medical direction or post-acute and long-term care medicine will not present a burden for medical directors as these hours would count towards the 100 minimum CME hours required annually for physicians to maintain their licensure in this Commonwealth. In the second sentence, the Department proposes to delete the ability of a facility to have a medical director serve on a full or part time basis. Under 42 CFR 483.70(f), a facility is required to have professional staff on a full-time, part-time or consultant basis as needed. This would extend to the medical director.

Subsection (d)

 The Department proposes to delete this subsection to eliminate duplication and avoid conflict with the Federal requirements. Paragraph (1) is covered by 42 CFR 483.75(g)(1) (relating to quality assurance and performance improvement), which requires a facility to maintain a quality assessment and assurance committee. The medical director or the medical director's designee serves on this committee. Paragraph (2) is covered under 42 CFR 483.70(h)(2). Under 42 CFR 483.70(h)(2), the medical director is responsible for the implementation of resident care policies and the coordination of medical care in the facility. This includes oversight of the responsibilities of attending physicians.

§ 211.3. Verbal and telephone orders

 The Department proposes to replace the word ''oral'' with the word ''verbal'' in the title of this section, as the word ''verbal'' is more commonly used now in the long-term care nursing environment to describe nonwritten communications.

Subsection (a)

 The Department proposes to replace ''a physician's oral'' with the word ''verbal'' at the beginning of this subsection. The amendment from ''oral'' to ''verbal'' is made for consistency in the use of terminology. The Department proposes the deletion of the word ''physician'' because physicians are not the only individuals permitted to issue orders under the scope of practice standards. Under 42 CFR 483.30(e), a physician may delegate tasks to a physician assistant, nurse practitioner or clinical nurse specialist acting within the scope of their practice as defined by State law. The scope of practice for physician assistants, including supervision by a physician, is set forth in section 13 of the Medical Practice Act of 1985 (63 P.S. § 422.13) and in regulation at 49 Pa. Code Chapter 18, Subchapter D (relating to physician assistants). The scope of practice for certified registered nurse practitioners is set forth in section 8.2 of the Professional Nursing Law (63 P.S. § 218.2) and in regulation at 49 Pa. Code Chapter 21, Subchapter C (relating to certified registered nurse practitioners). The scope of practice for clinical nurse specialists set forth in section 8.6 of the Professional Nursing Law (63 P.S. § 218.6) and in regulation at 49 Pa. Code Chapter 21, Subchapter H (relating to clinical nurse specialists). The Department proposes to delete the last sentence allowing written orders to be faxed, as this is duplicative of existing language in subsection (d), which the Department proposes to keep with amendments, as described as follows.

Subsection (b)

 The Department proposes to replace ''a physician's oral'' with the word ''verbal'' for consistency with the proposed amendments to subsection (a). The Department proposes to replace ''and treatments'' with ''treatment or medication'' to clarify that this subsection applies to medication orders as well as orders for care or treatment. The Department proposes to add ''or physician's delegee authorized under 42 CFR 483.30(e) (relating to physician services)'' after the word ''physician'' to clarify which individuals are permitted to issue verbal orders. The Department proposes to delete the requirement that verbal and telephone orders be dated and countersigned with the original signature of the physician or physician's delegee within 7 days and replace this with the requirement, currently in subsection (c), that verbal and telephone orders be dated and countersigned within 48 hours. The Department proposes this amendment as it is imperative that orders be signed within 48 hours to ensure that the orders are correct, especially in cases where the medical issue that is being addressed is urgent.

Subsection (c)

 The Department proposes to delete this subsection. As noted previously, the Department proposes to move the 48-hour requirement from the first sentence of this subsection into subsection (b). The Department proposes to delete the second sentence of this subsection, pertaining to Schedule II medications. Dispensation of controlled substances is covered under Federal law. See 21 CFR 1306.11 (relating to requirement of prescription).

Subsection (d)

 The Department proposes to replace the word ''oral'' with the word ''verbal'' for consistency in terminology. The Department proposes to replace ''medication or treatment'' with ''care, treatment or medication'' for consistency with the proposed amendments to subsection (b), as described previously. The Department proposes to replace the term ''responsible practitioner'' with ''physician, or physician's delegee authorized under 42 CFR 483.30(e)'' as well for consistency with the proposed amendments in subsection (b). The Department proposes to replace the word ''received'' with the word ''sent'' for grammatical reasons. The Department also proposes to add ''or secure electronic transmission'' after the word ''fax'' to account for the use of electronic health record systems, as well as other electronic mechanisms, such as e-mail or text, that are used to enter orders.

Subsection (e)

 The Department proposes, throughout this subsection, to replace the words ''an oral'' with the words ''a verbal'' for consistency in terminology. In paragraph (2), the Department proposes to replace ''practitioner'' with ''physician, or physician's delegee authorized under 42 CFR 483.30(e)'' for consistency in terminology. In paragraph (4), the Department proposes to add the words ''or secure electronic'' between the word ''fax'' and the word ''transmissions'' for consistency with the use of this term as proposed in subsection (d).

§ 211.4. Procedure in event of death

Subsection (a)

 The Department proposes to replace the words ''at each nursing station'' with the words ''to all personnel.'' The long-term care nursing industry has begun to shift away from terms such as ''nurses' station'' and ''nursing station'' towards terms that focus more on resident-centered care. The term ''all personnel'' is more specific and more accurately reflects who should have access to written postmortem procedures.

Subsection (b)

 The Department proposes only one amendment to this subsection. The Department proposes to replace the term ''responsible party'' with the term ''resident representative'' for consistency in the use of that term throughout the regulations.

§ 211.5. Medical records

 The Department proposes to amend the title of this section from ''clinical records'' to ''medical records.'' The Department proposes this amendment to align with the use of this term in the Federal requirements throughout 42 CFR Part 483, Subpart B, to refer to a resident's medical records.

Subsection (a)

 The Department proposes to delete subsection (a) to eliminate duplication and to avoid conflict with the Federal requirements at 42 CFR 483.10(h)(3)(ii). Under 42 CFR 483.10(h)(3)(ii), a facility must allow representatives of the Office of the State Long-Term Care Ombudsman to examine a resident's medical, social and administrative records in accordance with State law.

Subsection (b)

 The Department proposes to delete this subsection to eliminate duplication and to avoid conflict with the Federal requirements. Under 42 CFR 483.10(h)(3), a resident has the right to secure and confidential personal and medical records, and under 42 CFR 483.10(h)(3)(i), has the right to refuse the release of personal and medical records except as provided under 42 CFR 483.70(i)(2) or other applicable Federal or State laws. Under 42 CFR 483.70(i)(2), a facility is required to keep information contained in a resident's medical records confidential except when the records are released to the resident or resident representative, for treatment, payment or health care operations, for public health activities or as required by law.

Subsection (c)

 The Department proposes to delete this subsection to eliminate conflict with the Federal requirements at 42 CFR 483.70(i)(4), which requires medical records to be retained for the period of time required by State law or for 5 years from the date of discharge when there is no State law requirement, or in the case of a minor, for 3 years after the resident reaches legal age under State law.

Subsection (d)

 The Department proposes one minor amendment in this subsection. The Department proposes to replace the word ''clinical'' with ''medical'' for consistency in terminology.

Subsection (e)

 The Department proposes to replace the word ''clinical'' with the word ''medical'' before the word ''records'' for consistency in the use of the term ''medical records.'' In the second sentence, the Department proposes to add the word ''resident'' before medical records for clarity. The Department also proposes to replace the phrase, ''notify the Department of how the records may be obtained'' with ''provide to the Department, within 30 days of providing notice of closure under § 201.23 (relating to closure of facility), a plan for the storage and retrieval of medical records.'' When a facility closes, it is often difficult to determine where medical records have been stored as there is no longer a point of contact for the facility. Requiring a facility to have a plan for storage and retrieval and to provide the Department with that plan, will ensure that residents will be able to access their medical records after the facility closes.

Subsection (f)

 The Department proposes to replace the word ''clinical'' with the word ''medical'' for consistency in the use of the term ''medical record.'' The Department proposes to delete the words ''at a minimum, the'' at the beginning of this subsection and add a cross-reference to 42 CFR 483.70(i)(5) to clarify that the items listed in this subsection are required in addition to the items in the Federal requirements. The Department also proposes to replace the language after the word ''include'' with a delineated list that includes the items that are presently in subsection (f). The Department proposes this amendment for clarity and ease of readability.

Subsection (g)

 The Department proposes to delete this subsection to eliminate duplication and avoid conflict with the Federal requirements. Under 42 CFR 483.70(i)(1), a facility must maintain medical records in accordance with accepted professional standards and practices. Medical records must contain sufficient information to identify the resident, a record of the resident's assessments, a comprehensive plan of care and services provided, the results of any preadmission screening and resident review evaluations and determinations conducted by the State, progress notes from physicians, nurses and other licensed professionals, and laboratory, radiology and other diagnostic services reports.

Subsection (h)

 The Department proposes to delete this subsection to eliminate duplication and avoid conflict with the Federal requirements. Under 42 CFR 483.70(i)(5)(v), a resident's medical record must contain progress notes from physicians, nurses and other licensed professionals.

Subsection (i)

 The Department proposes to replace the word ''clinical'' with the word ''medical'' for consistency in the use of the term ''medical record.'' The Department also proposes one minor grammatical change by replacing the comma following the word ''utilized'' with a semi-colon.

§ 211.6. Dietary services

Subsection (a)

 The Department proposes to add language to this subsection to require that menus not only be planned but also posted in the facility or distributed to residents at least 2 weeks in advance. This requirement goes above and beyond the Federal requirements for facilities under 42 CFR 483.60 (relating to food and nutrition services). The Department proposes this requirement as part of its efforts to promote more resident-centered environments in long-term care nursing facilities. Requiring that menus be posted or distributed to residents contributes to a more resident-centered environment by allowing residents and their visitors to view and plan meals in advance.

Subsection (b)

 The Department proposes to delete this subsection to eliminate duplication and avoid conflict with the Federal requirements. Under 42 CFR 483.60, a facility must provide each resident with a nourishing, palatable, well-balanced diet that meets the resident's daily nutritional and special dietary needs, taking into consideration the resident's preferences. Facilities should utilize the emergency plan developed under 42 CFR 483.73 to determine how much food is needed in the event of an emergency. Each facility's needs will be different in terms of facility size and the amount of time they need to shelter in place. Requiring a facility to have food on hand for a specific number of days could result in a cost and waste to the facility. Instead, facilities should utilize the emergency plan developed under 42 CFR 483.73 to determine how much food is needed in the event of an emergency.

Subsection (c)

 The Department proposes to delete this subsection to eliminate duplication and avoid conflict with the Federal requirements. Under 42 CFR 483.60(a)(1), a facility is required to employ sufficient staff with the appropriate competencies and skills necessary to carry out the functions of the food and nutrition service, taking into account resident assessments, individual plans of care, and the number, acuity and diagnoses of the resident population in accordance with the facility assessment. In addition to providing sufficient support personnel to safely carry out the functions of the food and nutrition service, a facility must employ a qualified dietitian or other clinically qualified nutrition professional on either a full-time, part-time or on a consultant basis. This individual must meet the requirements of 42 CFR 483.60(a)(1)(i)—(iv). If a qualified dietician or other clinically qualified nutrition professional is not employed full-time, the facility must designate a director of food and nutrition services, who meets the requirements set forth in 42 CFR 483.60(a)(2)(i)—(iii).

Subsection (d)

 The Department proposes to delete this subsection to eliminate duplication and avoid conflict with the Federal requirements. A facility must employ sufficient dietary staff that meet the requirements in 42 CFR 483.60(a) to carry out the functions of the food and nutrition service, as described in 42 CFR 483.60.

Subsection (e)

 The Department proposes to delete this subsection to eliminate duplication and avoid conflict with the Federal requirements. Under 42 CFR 483.60(b), a member of the food and nutrition services staff must participate on the interdisciplinary team as required by 42 CFR 483.21(b)(2)(ii). The Federal requirements are also quite extensive regarding the requirements for menus and food and nutrition for residents. Menu requirements are addressed in 42 CFR 483.60(c), food and drink requirements are addressed in 42 CFR 483.60(d), therapeutic diets are addressed in 42 CFR 483.60(e), meal frequency requirements are addressed in 42 CFR 483.60(f), and equipment and utensils are addressed in 42 CFR 483.60(g).

Subsection (f)

 The Department proposes only minor amendments to this subsection. Specifically, the Department proposes to replace ''an employe'' with ''employees'' and ''employes'' with ''employees.'' The Department proposes these two amendments for grammatical reasons and for consistency in the usage and spelling of the term ''employees.''

§ 211.7. Physician assistants and certified registered nurse practitioners

 The Department proposes to delete subsections (a), (b)(1), (c), (d) and (e) to eliminate duplication and avoid conflict with the Federal requirements and State scope of practice standards. Under 42 CFR 483.30, each resident must remain under the care of a physician. The circumstances under which a physician may delegate tasks to a physician assistant, nurse practitioner or clinical nurse specialist are delineated in 42 CFR 483.30(e) and (f), and includes the requirement that the physician assistant, nurse practitioner or clinical nurse specialist be acting within the scope of their practice as defined by State law. The scope of practice for physician assistants, including supervision by a physician, is set forth in statute in section 13 of the Medical Practice Act of 1985 and in regulation at 49 Pa. Code Chapter 18, Subchapter D. The scope of practice for certified registered nurse practitioners is set forth in statute in section 8.2 of the Professional Nursing Law and in regulation at 49 Pa. Code Chapter 21, Subchapter C. The scope of practice for clinical nurse specialists is set forth in statute in section 8.6 of the Professional Nursing Law and in regulation at 49 Pa. Code Chapter 21, Subchapter H.

 The Department proposes to retain the requirements in subsection (b)(2) through (4) as the Federal requirements do not cover posting and notification requirements for supervising physicians. The Department proposes one minor amendment to subsection (b)(2). The Department proposes to replace the term ''nursing station'' with the term ''workstation.'' As noted in the Department's other proposed long-term care nursing regulatory packages, the long-term care nursing industry has begun to shift away from the use of the term ''nurses' station'' in favor of terms such as ''workstations'' that focus more on person centered care.

§ 211.8. Use of restraints

Subsection (a)

 The Department proposes to delete this subsection to eliminate duplication and avoid conflict with the Federal requirements. Under 42 CFR 483.10(e)(1), a resident has the right to be free from any physical or chemical restraints imposed for the purposes of discipline or convenience and not required to treat the resident's medical symptoms. A facility, under 42 CFR 483.12(a)(2) (relating to freedom from abuse, neglect, and exploitation), is required to ensure that residents are free from physical or chemical restraints imposed for discipline or convenience and that are not required to treat a resident's medical symptoms. When the use of restraints is indicated, the facility must use the least restrictive alternative for the least amount of time and document ongoing re-evaluation of the need for restraints.

Subsection (b)

 The Department proposes to delete this subsection. As noted previously, under 42 CFR 483.12(a)(2), when restraints are used, a facility must use the least restrictive alternative for the least amount of time. In addition, any restraint to a resident that results in injury to the resident would be considered to be abuse as defined in the Federal requirements at 42 CFR 483.5 and prohibited by 42 CFR 483.12(a)(1).

Subsection (c)

 The Department proposes to delete this subsection, which requires removal of restraints for a specified time period. The Department is concerned that setting forth a requirement in regulation for the removal of restraints for a specified period of time could result in a facility only complying with the minimum standard for removal, rather than considering the health and safety of the particular individual that is being restrained. The Department proposes to delete subsection (c) and replace it with new language in subsection (c.1) as follows.

Subsection (c.1)

 The Department proposes this new subsection as a replacement for existing subsection (c) to require that, if restraints are used, a facility ensure that appropriate interventions are in place to safely and adequately respond to resident needs. Physical or chemical restraints are permitted by the Federal requirements, but only in limited circumstances. When used, the facility must use the least restrictive alternative for the least amount of time and document ongoing re-evaluation of the need for restraints. The Department is proposing to add the language in subsection (c.1) to clarify that a facility is required to have appropriate interventions in place, when restraints are used, to protect the health and safety of residents. Depending on the type of restraint, these interventions would include, for example, turning and repositioning residents, providing distractions while the resident is in restraints, checking the skin of the resident underneath the restraint, and supervising the resident to ensure that the resident is not harmed while in restraints.

Subsection (d)

 The Department proposes to delete the words ''a signed, dated, written'' because orders for restraints may be either written or verbal. The Department also proposes to replace the word ''physician'' with the phrase ''from a physician, or physician's delegee authorized under 42 CFR 483.30(e) (relating to physician services)'' for consistency in the use of terminology to describe the type of individual who may provide medical orders. The Department proposes to delete the last two sentences of this subsection. As noted previously, physical or chemical restraints are permitted by the Federal requirements, but only in limited circumstances. When used, the facility must use the least restrictive alternative for the least amount of time and document ongoing re-evaluation of the need for restraints.

Subsection (e)

 The Department proposes to add ''or physician's delegee authorized under 42 CFR 483.30(e)'' after the word ''physician'' for consistency in the use of terminology as described previously.

Subsection (f)

 The Department proposes no amendments to this subsection.

§ 211.9. Pharmacy services

Subsection (a)

 The Department proposes to retain the requirement in paragraph (1) with minor stylistic amendments. The Department proposes to delete paragraph (2) because in practice, medications are dispensed by pharmacies to facilities, not directly to the residents. Medications are administered to residents by authorized persons to administer drugs and medication, as defined in § 201.3.

Subsection (b)

 The Department proposes to amend subsection (b) by replacing ''medications shall be'' with ''facility policies shall ensure that medications are'' before ''administered by authorized persons.'' This amendment is made to clarify that a facility is required to have policies in place to ensure that medications are administered by authorized persons to administer drugs and medications.

Subsection (c)

 The Department proposes no amendments to this subsection.

Subsection (d)

 The Department proposes to add the words ''both prescription and non-prescription'' after the word ''medications'' to make it clear that a written order is required for both prescription and non-prescription medications. An order is necessary for both prescription and non-prescription medications so as to maintain a resident's continuity of care. Requiring an order for both prescription and non-prescription medications will enable a facility to monitor and track all medications that a resident receives, to ensure that there are no contraindications or interactions between medications, and to help prevent accidental overdoses from residents self-administering non-prescription medications. The Department proposes to delete the word ''written'' before the word ''orders'' because orders may be written or verbal. The Department also proposes to add ''or the physician's delegee authorized under 42 CFR 483.30(e)'' for consistency in the use of this term throughout the regulation, and because these individuals may also provide medication orders.

Subsection (e)

 The Department proposes to delete this subsection. It is not necessary to retain this requirement given the proposed amendment to subsection (d), to require a written order for both prescription and non-prescription medications.

Subsection (f)

 The Department proposes only one amendment to this subsection. In paragraph (1), the Department proposes to replace the term ''resident's responsible person'' with the term ''resident representative'' for consistency in the use of that term throughout the regulations.

Subsections (g) and (h)

 The Department proposes to delete subsections (g) and (h) to eliminate duplication and avoid conflict with the Federal requirements. Pharmacy services requirements for facilities are located at 42 CFR 483.45 (relating to pharmacy services). Under 42 CFR 483.45(a), a facility is required to provide pharmaceutical services, including procedures that assure accurate acquiring, receiving, dispensing and administering of all medications, to meet the needs of each resident. The Federal requirements further require that a facility employ a pharmacist and outline the responsibilities of the pharmacist, which include providing consultation on all aspects of the provision of pharmacy services. The pharmacist is to conduct a review of the medication regiment for each resident at least once a month and must report any irregularities to the attending physician, the medical director and the director of nursing. Other requirements in 42 CFR 483.45 address unnecessary medications, psychotropic medications, labeling and storage.

Subsections (i) and (j)

 The Department proposes to delete subsections (i) and (j) and add subsection (j.1), pertaining to the disposition of medications, as described as follows.

Subsection (j.1)

 The Federal requirements for pharmacy services do not directly address the disposition of medications. The Department, therefore, proposes to add subsection (j.1) to require a long-term care nursing facility to have written policies and procedures for the disposition of medications. The Department also proposes to require that a facility's policies and procedures address: (1) timely identification and removal of medications for disposition; (2) identification of storage methods for medications awaiting final disposition; (3) control and accountability of medications awaiting final disposition consistent with standards of practice; (4) documentation of actual disposition of medications to include the name of the individual disposing of the medication, the name of the resident, the name of the medication, the strength of the medication, the prescription number if applicable, the quantity of medication and the date of disposition; and (5) a method of disposition to prevent diversion or accidental exposure consistent with applicable Federal and State requirements, local ordinances and standards of practice. These requirements align with Federal guidance found in section F755 of Appendix PP. Commentators, and IRRC, requested in prior proposed rulemakings that the Department expressly add into regulation any guidance that it wishes to adopt from Appendix PP. The Department proposes to expressly add the previous guidance from Appendix PP into regulation because it provides greater protection to residents than the Federal requirement. Proper procedures for the disposition of medications are vital for the health and safety of residents.

Subsection (k)

 The Department proposes no amendments to this subsection.

Subsection (l)

 The Department proposes to move the requirement that an emergency medication kit be ''readily available to staff'' from paragraph (4) to the first sentence in this subsection. Moving this requirement to the beginning of the subsection adds clarity to the requirement that a facility have at least one medication kit. In paragraph (1), the Department proposes to add ''security'' and ''inventory tracking'' to the policies and procedures that a facility is required to have for the emergency medication kit. The Department proposes this addition to prevent diversion and to protect the integrity of the contents of the emergency medication kit to ensure that the medications within it are available in the event of an emergency. In paragraph (2), the Department proposes to delete the phrase ''kept to a minimum and shall be'' because this language is unclear and unnecessary. It is more important that the medications within the emergency kit meet the needs of the residents than to be kept at a minimum. The Department also proposes, in paragraph (2), to require that the criteria for the contents of the emergency medication kit be reviewed not less than annually. This requirement will ensure that the emergency medication kits are tailored to the needs of the facility's current resident population. In paragraph (3), the Department proposes a grammatical change from the word ''pre-scribe'' to ''prescribe.'' The Department also proposes to correct the citation to the Pharmacy Act from (63 P.S. §§ 390.1—390.13) to (63 P.S. §§ 390-1—390-13).

 The Department proposes to delete paragraph (4). As noted, the Department proposes to move the phrase ''readily available to staff'' to the first sentence of this subsection. The Department proposes to delete the requirement that an emergency medical kit have a breakaway lock that is replaced after each use because this requirement is outdated. When the regulations were promulgated, facilities used tackle boxes with locks for emergency medication kits. A breakaway lock was required to ensure quick access in an emergency. Due to technological advances, many emergency medication kits now can be locked electronically, with the use of a code. Thus, the requirement for a breakaway lock is no longer necessary. Instead, the Department proposes to require, in paragraph (1), that the facility have policies and procedures that address the security of the emergency medication kits. In this way, the facility will have discretion to determine the best way to secure the medication.

§ 211.10. Resident care policies

Subsection (a)

 The Department proposes to delete the last sentence in this subsection to eliminate duplication and to avoid conflict with the Federal requirements. A facility is required to establish and implement an admissions policy under 42 CFR 483.15(a). Transfers and discharges are covered in 42 CFR 483.15(c). Admission, transfer and discharge planning are also part of the resident's comprehensive care plan and are covered in 42 CFR 483.21(b) and (c). The Department proposes to retain the first sentence in subsection (a) because even though the Federal requirements address what is required for resident care planning, the requirements do not require a facility to have resident care policies, and the Department considers resident care policies to be an integral part of resident care planning.

Subsections (b) through (d)

 The Department proposes no amendments to subsections (b) through (d).

§ 211.11. Resident care plan

 The Department proposes to delete this section to eliminate duplication and to avoid conflict with the Federal requirements. Under 42 CFR 483.21(b), a facility is required to develop and implement a comprehensive person-centered care plan for each resident. This care plan is prepared by an interdisciplinary care team, that includes the attending physician, an RN and nurse aide with responsibility for the resident, a member of the food and nutrition services staff, the resident and resident representative and others who are involved in the resident's care. Nursing services personnel are responsible, under 42 CFR 483.35(a)(4) (relating to nursing services), for assessing, evaluating, planning and implementing resident care plans.

§ 211.12. Nursing services

Subsection (a)

 The Department proposes to delete this subsection to eliminate duplication and to avoid conflict with the Federal requirements. Under 42 CFR 483.35(a)(1), a facility is required to provide services by sufficient numbers of personnel on a 24-hour basis to provide nursing care to all residents in accordance with resident care plans.

Subsection (b)

 The Department proposes to delete this subsection to eliminate duplication and to avoid conflict with the Federal requirements. Under 42 CFR 483.35(b)(2), except when waived, a facility is required to designate an RN to serve as the director of nursing on a full-time basis.

Subsection (c)

 The Department proposes only one amendment to this subsection. The Department proposes to replace the word ''staff'' with the word ''personnel'' for consistency in the use of the term ''nursing services personnel'' throughout the regulations.

Subsection (d)

 The Department proposes only one amendment to this subsection. The Department proposes to add the word ''services'' between the words ''nursing'' and ''personnel'' for consistency in the use of the term ''nursing services personnel'' throughout the regulations.

Subsection (e)

 The Department proposes to delete this subsection to eliminate duplication and to avoid conflict with the Federal requirements. Charge nurses are responsible for overseeing nursing activities within the facility. Under 42 CFR 483.35(a)(2), unless waived, a facility is required to designate a licensed nurse to serve as a charge nurse on each tour of duty.

Subsection (f)

 The Department proposes to delete this subsection. The Department proposes new minimum staffing ratios, to replace the requirements in paragraph (1). These new staffing ratios are outlined in proposed subsection (f.1). The new proposed staffing ratios also render paragraph (2) obsolete, as the Department's proposal does not contemplate an LPN being responsible for overseeing total nursing activities within a facility on the night tour of duty. The Department is proposing to require one RN instead of an LPN during the night shift because there should always be an RN on duty to provide care to residents. Residents do not stop needing the higher level of care provided by an RN during the night. An LPN does not have the same level of education or training as an RN, and the scope of practice for an RN is more extensive than an LPN. For example, an LPN cannot complete an assessment of a resident. If someone were to fall in the middle of the night shift, an RN would have to be called in or the resident would have to wait until the next shift for an assessment to be performed. Requiring an RN at all times ensures resident safety.

Subsection (f.1)

 This subsection is proposed to be added. The Department proposes to move the requirements in subsections (g) to proposed paragraph (3), subsection (h) to proposed paragraph (2), and subsection (j) to new proposed paragraph (1) to this subsection for clarity and ease of readability. The Department proposes in paragraph (4) to require a minimum of 1 nurse aide per 10 residents during the day, 1 nurse aide per 10 residents during the evening and 1 nurse aide per 15 residents overnight. This requirement is being proposed to clarify the expected distribution of nurse aides over the course of three shifts, to ensure that the same level of nurse aide coverage is provided to residents during the day and evening, and to ensure that adequate staffing is being provided throughout the course of a 24-hour period. Adding this requirement will also improve the ability of residents and their families to determine whether the regulations are being followed.

 The Department proposes in paragraph (5) to require a facility to provide a minimum of 2 RNs and 1 LPN during the day, 1 RN and 1 LPN during the evening and 1 RN overnight, per 60 residents. The Department proposes to add a chart with a breakdown for facilities with 1 to 540 residents to assist facilities in determining the actual number of RNs and LPNs required under paragraph (1). The Department proposes to add clarifying language for facilities with more than 540 residents to make it clear that those facilities will need to calculate and provide additional RNs and LPNs in accordance with the ratios established by this subsection.

 The Federal requirements do not specify a minimum number of direct care hours to be provided to residents, nor do the requirements specify a minimum number or type of nursing services personnel for resident care. CMS, however, in a 2001 study, found that a minimum of 4.1 hours of direct care per resident day would improve the quality of care provided to a resident, and that anything below that amount ''could result in harm and jeopardy to residents.'' Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities, 80 FR 42167, 42202 (July 16, 2015). In the Department's first proposed rulemaking published at 51 Pa.B. 4074 (July 31, 2021), the Department proposed, in subsection (i) to require a minimum of 4.1 direct care hours to align with the CMS study. In the 2001 study, CMS identified a pattern of incremental benefits in increased staffing until a threshold was reached, where no significant quality improvements were observed. This threshold occurred when 2.8 hours of care per resident day were provided by nurse aides, .75 hours of care per resident day were provided by RNs and .55 hours of care per resident day were provided by other licensed staff, that is, LPNs. Feuerberg, Marvin. CMS. (December 2001). Appropriateness of Minimum Nurse Staffing Ratios in Nursing Homes. Overview of the Phase II Report: Background, Study Approach, Findings, and Conclusions. Retrieved from: https://www.justice.gov/sites/default/files/elderjustice/legacy/2015/07/12/Appropriateness_of_Minimum_Nurse_ Staffing_Ratios_in_Nursing_Homes.pdf.

 The Department considered the breakdown of RNs, LPNs and nurse aides recommended by CMS, but ultimately determined that a somewhat lower breakdown is more feasible in this Commonwealth, given the funding concerns shared by facilities in response to the Department's first proposed rulemaking as well as the ongoing nurse staffing challenges and shortages in this Commonwealth and Nationally. The Department, therefore, is proposing to require fewer RNs and LPNs than those recommended by CMS, but to require more nurse aides, proportionally, to achieve the 4.1 hours of direct care per resident per day proposed in § 211.12(i) of the Department's first proposed rulemaking.

 Based on the experience and expertise of Department staff with first-hand knowledge of the administration of long-term care nursing facilities, the Department determined that the lowest acceptable level of nursing services personnel would be 2 RNs and 1 LPN per 60 residents during the day shift, 1 RN and 1 LPN per 60 residents during the evening shift, and 1 RN per 60 residents during the night shift, so that there is always an RN on duty. Therefore, per resident day, a minimum of 4 RNs and a minimum of 2 LPNs would be required per 60 residents, with nurse aides making up the remaining number of staff needed to meet the minimum 4.1 hours of direct care required by proposed § 211.12(i). By contrast, at the staffing levels recommended in the CMS study, a minimum of 6 RNs and 4 LPNs would be required per day, per 60 residents, with nurse aides making up the remaining number of nursing services personnel needed to meet the minimum 4.1 hours of direct care.¹

 It is important to note that, despite being somewhat lower than what was recommended by CMS, the nursing staff ratios proposed by the Department represent a significant increase from current minimum requirements, which the Department believes will result in improvements in resident care and reduced professional nurse staff workloads. Lower staffing levels have been associated with high turnover rates and burnout among professional nurse staff, which leads to a greater risk of resident safety errors, reduction in quality measures and adverse outcomes overall, ultimately increasing health care costs. This in turn leads to poor outcomes for residents. Kolonoski, Ann. (2021). ''A Call to the CMS: Mandate Adequate Professional Nurse Staffing in Nursing Homes.'' 121 The American Journal of Nursing 3.; Harrington, Charlene. (2016). ''The Need for Higher Minimum Staffing Standards in U.S. Nursing Homes.'' 9 Health Services Insights 13. Benefits of higher staffing ratios to residents include improved activity levels, lower mortality rates, fewer infections, less antibiotic use, fewer pressure ulcers and fewer catheterized residents, improved eating patterns and pain levels, and improved mental health. Shin, Juh Hyun and Bae, Sung-Heui. (2012). ''Nurse Staffing, Quality of Care, and Quality of Life in U.S. Nursing Homes, 1996—2011.'' 38 Journal of Gerontological Nursing 46. Requiring a proportionally higher rate of nurse aides, as proposed by the Department, will also ensure adequate time is devoted to attending residents' basic needs, as nurse aides are often the ones responsible for basic care, which includes assisting residents with toileting and dressing and psychosocial needs.

 In addition, the Department is proposing higher staffing ratios for RNs and LPNs during the day because residents are generally awake during the day, the majority of interactions with physicians, pharmacies and other healthcare professionals typically occur during the day, the majority of admissions and discharges take place during the day, most treatments and medications are administered during the day, residents receive visitors during the day and care planning typically occurs during the day. The Department is proposing a slightly lower ratio of nursing services personnel in the evening. Many of the activities listed previously take place during the evening, but to a lesser extent. The Department is proposing to require one RN instead of an LPN during the night shift because there should always be an RN on duty to provide care to residents. Residents do not stop needing the higher level of care provided by an RN during the night. An LPN does not have the same level of education or training as an RN, and the scope of practice for an RN is more extensive than an LPN. For example, an LPN cannot complete an assessment of a resident. If someone were to fall in the middle of the night shift, an RN would have to be called in or the resident would have to wait until the next shift for an assessment to be performed. Requiring an RN at all times ensures resident safety.

Subsection (f.2)

 The Department proposes in this subsection to add language that will prohibit a facility from substituting a nurse aide for an LPN or RN and substituting an LPN for an RN to meet the minimum nursing staff ratio. However, a facility may substitute an RN for a nurse aide or an LPN to meet the ratio. Nurse aides are not able to perform the work of an LPN or RN based on their education and training. Likewise, LPNs are not able to perform the work of an RN based on their education and training. However, LPNs and RNs can perform the work of a nurse aide and could be substituted for a nurse aide. Likewise, an RN can perform all of the work of an LPN based on their education and training, and thus, could be used as a substitute where an LPN is required to meet the minimum nursing staff ratio.

Subsection (g)

 As noted previously, the Department proposes to delete this subsection and to move the requirements of this subsection to proposed subsection (f.1).

Subsection (h)

 As noted previously, the Department proposes to delete this subsection and to move the requirements of this subsection to proposed subsection (f.1).

Subsection (i)

 Proposed amendments to subsection (i) were discussed and explained in the Department's first proposed rulemaking, which was published at 51 Pa.B. 4074. The Department is presently reviewing and considering public comments that were submitted in response to that proposed rulemaking to determine if further amendments are needed in the final-form rulemaking.

Subsection (i.1)

 This subsection is proposed to be added. The Department proposes to add a requirement that only direct resident care provided by nursing service personnel be counted towards the total number of hours of general nursing care required under subsection (i). Under this requirement, only direct care provided to residents by RNs, LPNs and nurse aides would count toward the 4.1 number of direct care hours that were proposed by the Department in subsection (i) in its first proposed rulemaking. Section (i.1) goes above and beyond the Federal requirements for direct care staffing, as the Federal requirements contemplate that direct care may be provided by additional individuals, including therapists. See 42 CFR 483.70(q)(2)(i). Direct care refers to assisting a resident, through interpersonal contact, with care and services that allow the resident to attain or maintain the highest practicable physical, mental and psychosocial well-being. 42 CFR 483.70(q)(1). Direct care typically involves assisting residents with tasks such as grooming and dressing themselves, exercise, eating, changing soiled clothing, repositioning and providing toileting assistance. RNs, LPNs and nurse aides are better positioned to provide this type of resident care based on their training and experience, than other types of professionals, such as physical therapists, who are primarily focused on providing residents with specialized care.

Subsection (j)

 As noted previously, the Department proposes to delete this subsection and to move the requirements of this subsection to proposed subsection (f.1).

Subsection (k)

 The Department proposes to delete this subsection to eliminate duplication and to avoid conflict with the Federal requirements. Under 42 CFR 483.35(g), a facility is required to post, on a daily basis and at the beginning of each shift, the total number and actual hours worked by RNs, LPNs and certified nurse aides.

Subsection (l)

 The Department proposes to delete this subsection. The Department proposed, in its first proposed rulemaking, to add language to subsection (i) requiring a facility to have, during each shift in each 24-hour period, a sufficient number of nursing staff with the appropriate competencies and skill sets to provide nursing care and related services to assure resident safety and to attain or maintain the highest practicable physical, mental and psychosocial well-being of each resident. It is therefore not necessary to retain the language in subsection (l).

§ 211.15. Dental services

 The Department proposes to delete this section to eliminate duplication and to avoid conflict with the Federal requirements. Under 42 CFR 483.55 (relating to dental services), a facility is required to provide or obtain from an outside resource routine and emergency dental services. A facility is required to assist residents in making dental appointments and arranging transportation to and from dental services locations. A facility is also required to have a policy to identify the circumstances in which the loss or damage of dentures is the facility's responsibility and to provide a referral for dental services for residents with lost or damaged dentures, within 3 days.

§ 211.16. Social services

Subsection (a)

 The Department proposes to delete the first sentence of this subsection and to replace the phrase ''facilities with a resident census of more than 120 residents'' with ''a facility.'' The effect of this proposed amendment will be to require that all facilities have a full-time qualified social worker, regardless of size. This exceeds the Federal requirements at 42 CFR 483.70(p) which only require a full-time qualified social worker for facilities with more than 120 beds. The Department, under section 803 of the act, has the authority to promulgate rules and regulations necessary to carry out the purposes and provisions of the act. One of the stated purposes of the act is to assure that citizens receive humane, courteous and dignified treatment. See 35 P.S. § 448.102. The Department believes strongly that all facilities need to have a full-time social worker on staff regardless of the size of the facility. Social workers have specialized education and training and are well-suited to assist residents and their families with all aspects of their stay in a long-term care nursing facility, including the social, emotional, financial, and psychological aspects, and preparing residents and their families for life post-discharge. In addition, over time, the condition of residents seeking care in the long-term care nursing environment has changed, and there has been an increase in the number of residents presenting with a wide range of psychosocial or behavioral issues. For example, facilities may have younger residents with mental health conditions, veterans with post-traumatic stress disorder or older residents with dementia. These residents require engaged social workers to assist with their care planning and to provide psychosocial support.

Subsection (b)

 The Department proposes to delete this subsection in light of the proposed changes to subsection (a) as described previously, which will require all facilities to have a full-time qualified social worker, regardless of size.

§ 211.17. Pet therapy

 The Department proposes to rephrase this section to require a facility to have written policies and procedures that incorporate the requirements that already exist in this section, with amendments, if pet therapy is utilized. The Department proposes grammatical changes to paragraphs (2)—(4) and (6) for ease of readability. In paragraphs (4) and (6), the Department proposes to amend the word ''pets'' to ''animals'' for consistency in the use of terms throughout this section. The Department proposes to delete paragraph (5) and replace it with proposed paragraph (5.1) to address the health of animals and the health and safety of residents by requiring that a facility have policies and procedures in place to ensure that animals are up to date on vaccinations, are in good health and do not pose a risk to the health and safety of residents. In paragraph (6), the Department proposes to add the words ''or visit'' to clarify that a facility shall have policies and procedures in place to ensure that animals and places where they visit, as well as where they reside, are kept clean and sanitary. Paragraph (7) is proposed to be added and will require a facility to have in place policies and procedures to ensure that infection prevention and control measures, such as hand hygiene, are followed by residents and personnel when handling animals, to reduce the risk of illness or infection that can sometimes occur when handling animals.

Fiscal Impact and Paperwork Requirements

Fiscal Impact

Commonwealth—Department

 The Department's surveyors perform the function of surveying and inspecting long-term care nursing facilities for compliance with both Federal and State regulations. The proposed elimination of sections, as described previously, that are duplicative of the Federal requirements will streamline the survey process for long-term care nursing facilities. This, in turn, will create consistency and eliminate confusion in the application of standards that apply to long-term care nursing facilities.

Commonwealth—DHS

 Cost to meet proposed nursing staff ratio

 The Department consulted with DHS to determine the effect of the proposed increase in § 211.12(f.1)(5) to the 20 county-owned facilities and the 594 privately-owned facilities, that are not operated by the DMVA, and to determine the effect on the MA program. The proposed increase in RNs and LPNs, as proposed by the Department in § 211.12(f.1)(5), will require the 20 county-owned facilities that participate in MA to employ an additional estimated 184 Full Time Equivalent (FTE) RNs but no LPNs. The average cost for an RN is projected to average $127,072, which is an increase of 28% from the average current cost report data provided by county owned facilities. This estimate for the increased cost includes wages and benefits and is based on the 75th percentile of Bureau of Labor Statistics (BLS) wage data reported for these professions across all industries in this Commonwealth. The wages were increased to reflect the most recent benefit cost percentage (28%) and trended for inflation to 2023 (5%). The 75th percentile wage was used as a proxy for expected wages in 2023 with consideration of increased demand from the 4.1-hour requirement along with trends in the labor market for RNs, LPNs and nurse aides and unchecked pressures on agency use and pricing. The total cost to county-owned facilities that participate in MA to add 184 RNs at the increased salary assumption is estimated to be $23,381,248. The affected county-owned facilities will also need to hire an estimated 539 FTE nurse aides in addition to the 184 RNs to meet the Department's proposal in the first rulemaking to require, in § 211.12(i), 4.1 direct resident care hours per resident per day. The average cost for a nurse aide, including wages and benefits, is projected to increase to $56,477 which is an increase of 23%, from the average salary paid as reported by facilities in the current cost report data reported to DHS. The cost to hire an additional 539 FTE nurse aides is projected to be $30,441,103. The total cost to meet the requirements of § 211.12(f.1)(5) and (i) therefore will be $53,822,351. According to data obtained from DHS, approximately 84.51% or $45,485,269 of this cost will be covered by the MA program. The Federal MA Program rate, estimated to be 52%, will apply to MA payments made to fund these costs, for an estimated Federal match of $23,652,340 and a State general fund investment of $21,832,929.

 The proposed increase in RNs and LPNs, as proposed by the Department in § 211.12(f.1)(5), is projected to require the 594 privately-owned facilities that participate in MA to employ an additional 2,374 FTE RNs and 26 FTE LPNs. The average cost for an RN is projected at $127,072, which is an increase of 28% from the average current cost report data for privately owned facilities that participate in MA. The average cost for an LPN is projected at $67,395 which is an increase of 4% from the average current cost report data. This estimate of increased costs includes wages and benefits determined using the assumptions and data described in the county facility cost explanation. The total cost to facilities to add an estimated 2,374 FTE RNs is estimated to be $301,540,749. The total cost to facilities to add 26 FTE LPNs is estimated to be $1,752,277. The affected privately-owned facilities will also need to hire an estimated 5,988 FTE nurse aides in addition to the estimated 2,374 FTE RNs and estimated 26 FTE LPNs to meet the Department's proposal in the first rulemaking to require, in § 211.12(i), 4.1 direct resident care hours per resident per day. The average nurse aide salary is projected at $56,477 which is a 23% increase from the average current cost report data. The total estimated cost to add 5,988 FTE NAs is $338,128,429. The total increased cost to meet the requirements of § 211.12(f.1)(5) and (i) therefore will be $641,421,455. According to data obtained from DHS, approximately 75.82%, or $486,325,747, of this cost will be covered by the MA program. Applying the Federal share of approximately 52% to the total costs results in an estimated Federal match of $252,889,388 and a State general fund investment of $233,436,359.

 The Department's proposal in § 211.12(f.1)(4) to require 1 nurse aide per 10 residents during the day, 1 nurse aide per 10 residents during the evening and 1 nurse aide per 15 residents overnight will not result in any costs beyond those already delineated previously.

 Cost of proposal to add qualified social worker

 The Department estimates that the annual cost to employ one full-time social worker in the private sector, in the first year, will be approximately $73,216 on average, including wages and benefits. Assuming that the data provided to the Department in the 2019-2020 annual report remains unchanged, the Department estimates that the total cost to the 70 privately-owned MA facilities, with 120 beds or less, that do not employ either a full-time or part-time social worker, will be approximately $5,125,120 in the first year. According to data obtained from DHS, approximately 73%, or $3,741,338, of this cost will be covered by the MA program. Applying the Federal share of approximately 52% to the total costs results in an estimated Federal match of $1,945,496 and a State general fund investment of $1,795,842. The Department estimates a 5% increase in wages and benefits for each year thereafter.

 The Department estimates that it will cost facilities with 120 beds or less $36,608 each to staff up from a part-time social worker to a full-time social worker. This assumes that the part-time social workers, currently employed, are earning half the salary of a full-time social worker. The total cost to the ten MA facilities is estimated to be $329,472. According to data obtained from DHS, approximately 73%, or $240,515, of the cost to the ten MA facilities will be covered by the MA program. Applying the Federal share of approximately 52% to the total costs results in an estimated Federal match of $125,068 and a State general fund investment of $115,447. The Department estimates a 5% increase in wages and benefits for each year thereafter.

Commonwealth—DMVA

 Cost to meet proposed nursing staff ratio

 The DMVA operates six veterans' homes across the State with the capacity to serve 1,526 total residents and employs more than 2,000 clinical and professional staff. The proposed increase in RNs and LPNs, as proposed by the Department in § 211.12(f.1)(5) will require the DMVA to employ an additional 166 RNs and 83 LPNs. The average cost to the DMVA for an RN is $136,031.24 and for an LPN is $103,720.67. This estimate includes wages and benefits. The total cost to the DMVA to add 166 RNs will be $22,581,185.84 and to add 83 LPNs will be $8,608,815.61, for a total cost of $31,189,918.45. The DMVA will need to hire an additional 43 nurse aides in addition to the 166 RNs and 83 LPNs to meet the Department's proposal in the first proposed rulemaking to require, in § 211.12(i), 4.1 direct care resident hours, per day. The average cost to the DMVA for a nurse aide, including wages and benefits, is $75.871.34 for a total cost of $3,262,467.62. The total cost to the DMVA under the proposed amendments to meet the requirements of § 211.12(f.1)(5) and (i) will be $34,452,469.07. Based on the number of eligible MA residents, about 35% of the total cost, an estimated $12 million, will be covered by the MA program; therefore, the Federal MA Program rate, estimated to be 52%, will apply to these costs, for an estimated $6.2 million. Applying the Federal share of approximately $6.2 million to the total costs of approximately $34 million needed to staff up to the 4.1 ratio results in an estimated increase of approximately $28 million in State funding ($5.8 million State funds for the MA program and $22.2 million DMVA share non-MA eligible residents).

 Cost of proposal to add qualified social worker

 The DMVA operates six veterans' homes across the State with the capacity to serve 1,526 total residents and employs more than 2,000 clinical and professional staff. Six veterans' homes currently employ a licensed social worker on a full-time basis. Thus, the DMVA would not be impacted by the Department's proposal in § 211.16 (relating to social services) to require that a facility employ a qualified social worker on a full-time basis.

Regulated community

 Cost of proposal to adopt Federal requirements

 The Department anticipates little to no financial impact on the 689 licensed long-term care nursing facilities as a result of the proposed elimination of sections that are duplicative of the Federal requirements. All but 3 of the 689 long-term care nursing facilities participate in either Medicare or MA and thus, are required to comply with existing Federal requirements. The three long-term care nursing facilities that do not participate in Medicare or MA may be impacted if they do not already meet the minimum standards within the Federal requirements. However, any financial impact to the three facilities that do not participate in Medicare or MA is outweighed by the need for consistency in the application of standards to all long-term care nursing facilities, regardless of whether the facilities participate in Medicare or MA.

 Cost to meet proposed nursing staff ratio

 The Department consulted with the DMVA to determine the impact of the proposed increase to the nursing staff ratio in § 211.12(f.1)(5) as well as the proposed increase in the number of direct care nursing hours to 4.1 as proposed in the Department's first proposed rulemaking. The proposed increase in RNs and LPNs, as proposed by the Department in § 211.12(f.1)(5) will require the DMVA to employ an additional 166 RNs and 83 LPNs. The average cost to the DMVA for an RN is $136,031.24 and for an LPN is $103,720.67. This estimate includes wages and benefits. The total cost to the DMVA to add 166 RNs will be $22,581,185.84 and to add 83 LPNs will be $8,608,815.61, for a total cost of $31,189,918.45. The DMVA will need to hire an additional 43 nurse aides in addition to the 166 RNs and 83 LPNs to meet the Department's proposal in the first proposed rulemaking to require, in § 211.12(i), 4.1 direct care resident hours, per day. The average cost to the DMVA for a nurse aide, including wages and benefits, is $75,871.34 for a total cost of $3,262,467.62. The total cost to the DMVA under the proposed amendments to meet the requirements of § 211.12(f.1)(5) and (i) will be $34,452,469.07. Based on the number of eligible MA residents, about 35% of the total cost, an estimated $12 million, will be covered by the MA program; therefore, the Federal MA Program rate, estimated to be 52%, will apply to these costs for an estimated $6.2 million. Applying the Federal share of approximately $6.2 million to the total costs of approximately $34 million needed to staff up to the 4.1 ratio results in an estimated increase of approximately $28 million in State funding ($5.8 million State fund for the MA program and $22.2 million DMVA share non-MA eligible residents).

 The Department consulted with DHS to determine the impact of the proposed increase in § 211.12(f.1)(5) to the 20 county-owned facilities and the 594 privately-owned facilities, that are not operated by the DMVA. The proposed increase in RNs and LPNs, as proposed by the Department in § 211.12(f.1)(5), will require the 20 county-owned facilities, that participate in MA, to employ an additional estimated 184 FTE RNs but no LPNs. The average cost for an RN is projected to average $127,072, which is an increase of 28% from the average current cost report data. This estimate for the increased cost includes wages and benefits and is based on the 75th percentile of BLS wage data reported for these professions across all industries in this Commonwealth. The wages were increased to reflect the most recent benefit cost percentage (28%) and trended for inflation to 2023 (5%). The 75th percentile wage was used as a proxy for expected wages in 2023 with increased demand from the 4.1-hour requirement along with trends in the labor market for RNs, LPNs and nurse aides and unchecked pressures on agency use and pricing. The total cost to county-owned facilities that participate in MA, to add 184 RNs at the increased salary assumption is estimated to be $23,381,248. The affected county-owned facilities will also need to hire an estimated 539 FTE nurse aides in addition to the 184 RNs to meet the Department's proposal in the first rulemaking to require, in § 211.12(i), 4.1 direct resident care hours, per day. The average cost for a nurse aide, including wages and benefits, is projected to increase to $56,477, which is an increase of 23%, from the average salary paid as reported by facilities in the current cost report data reported to DHS. The cost to hire an additional 539 FTE nurse aides is projected to be $30,441,103. The total cost to meet the requirements of § 211.12(f.1)(5) and (i) therefore will be $53,822,351. According to data obtained from DHS, approximately 84.51%, or $45,485,269, of this cost will be covered by the MA program. The Federal MA Program rate, estimated to be 52%, will apply to MA payments made to fund these costs, for an estimated Federal match of $23,652,340 and a State general fund investment of $21,832,929.

 The proposed increase in RNs and LPNs, as proposed by the Department in § 211.12(f.1)(5), is projected to require the 594 privately-owned facilities that participate in MA to employ an additional 2,374 FTE RNs and 26 FTE LPNs. The average cost for an RN is projected at $127,072, which is an increase of 28% from the average current cost report data for privately owned facilities that participate in MA. The average cost for an LPN is projected at $67,395, which is an increase of 4% from the average current cost report data. This estimate of increased costs includes wages and benefits determined using the assumptions and data described in the county facility cost explanation. The total cost to facilities to add an estimated 2,374 FTE RNs is estimated to be $301,540,749. The total cost to facilities to add 26 FTE LPNs is estimated to be $1,752,277. The affected privately-owned facilities will also need to hire an estimated 5,988 FTE nurse aides in addition to the estimated 2,374 FTE RNs and estimated 26 FTE LPNs to meet the Department's proposal in the first rulemaking to require, in § 211.12(i), 4.1 direct resident care hours, per day. The average nurse aide salary is projected at $56,477, which is a 23% increase from the average current cost report data. The total estimated cost to add 5,988 FTE NAs is $338,128,429. The total increased cost to meet the requirements of § 211.12(f.1)(5) and (i) therefore will be $641,421,455. According to data obtained from DHS, approximately 75.82%, or $486,325,747, of this cost will be covered by the MA program. Applying the Federal share of approximately 52% to the total costs results in an estimated Federal match of $252,889,388 and a State general fund investment of $233,436,359.

 There are 62 facilities that participate only in Medicare. The proposed increase in RNs and LPNs, as proposed by the Department in § 211.12(f.1)(5), will require these 62 facilities, to employ an additional 258 FTE RNs and 3 FTE LPNs. This estimate is based on data obtained from the Department's 2019-2020 annual report. The average projected annual cost for an RN is $127,072 and the average projected annual cost for an LPN is $67,395. This estimate includes wages and benefits. The total cost to facilities to add approximately 258 FTE RNs, based on the same cost assumptions provided by DHS, will be approximately $32,784,576. The total cost to add three FTE LPNs will be approximately $202,186. The affected Medicare facilities will also need to hire 659 nurse aides in addition to the 258 RNs and 3 LPNs to meet the Department's proposal in the first rulemaking to require, in § 211.12(i), 4.1 direct resident care hours per resident per day. The average cost for a nurse aide, including wages and benefits, is $56,477. The total cost to add 659 nurse aides is approximately $37,218,412. The total cost for Medicare facilities to meet the requirements of both § 211.12(f.1)(5) and (i) therefore will be $70,205,174. The Department is not able to assess to what extent these costs will be offset by Medicare as Medicare is a Federally managed healthcare program and the Department does not have access to data regarding payment of Medicare to facilities.

 There are three private-pay facilities that do not participate in either Medicare or MA. The proposed increase in RNs and LPNs, as proposed by the Department in § 211.12(f.1)(5), will require the three privately-owned facilities to employ an additional three FTE RNs, but no LPNs. This estimate is based on data obtained from the Department's 2019-2020 annual report. The average projected annual cost for an RN is $127,072. This estimate includes wages and benefits. The total cost to facilities to add three RNs is estimated to be $381,216. The affected facilities will also need to hire eight nurse aides in addition to the three RNs to meet the Department's proposal in the first rulemaking to require, in § 211.12(i), 4.1 direct resident care hours, per day. The average cost for a nurse aide, including wages and benefits, is $56,477. The total cost to meet the requirements of § 211.12(f.1)(5) and (i), therefore, will be $833,031.

 The Department's proposal in § 211.12(f.1)(4) to require 1 nurse aide per 10 residents during the day, 1 nurse aide per 10 residents during the evening and 1 nurse aide per 15 residents overnight will not result in any costs beyond those already delineated previously.

Cost of proposal to add full-time qualified social worker

 Some long-term care nursing facilities will be affected by the Department's proposal, in § 211.16, to require all facilities to employ a full-time qualified social worker. Currently, a full-time social worker is only required for facilities with more than 120 beds. To estimate how many facilities will be impacted, the Department pulled data from the most recent, available annual report, for fiscal year 2019-2020. This report is available on the Department's web site. Department of Health. (2021). Nursing Home Reports. Retrieved from: https://www.health.pa.gov/topics/HealthStatistics/HealthFacilities/NursingHome Reports/Pages/nursing-home-reports.aspx. Data within the annual report is obtained through an annual survey of facilities. The data therefore is dependent on self-reporting from the facilities who complete the survey. Based on a review of the report, the Department estimates that the proposal in § 211.16 will impact 91 privately-owned facilities.² Out of these 91 facilities, 10 indicated that they only have a part-time social worker, and the remaining 81 reported that they do not have either a full-time or part-time social worker. Of the 81 facilities that reported they do not have either a full-time or part-time social worker, 70 participate in MA, 10 participate only in Medicare and 1 is private pay only. Of the ten facilities that have only a part-time social worker, nine participate in MA and one is private pay only.

 According to this Commonwealth's Center for Workforce Information & Analysis, the median annual wage for a healthcare social worker is $55,890. Center for Workforce Information & Analysis. (2021). Occupational Wages. Retrieved from: https://www.workstats.dli.pa.gov/Products/Occupational%20Wages/Pages/default.aspx. This does not include the cost of benefits. According to the United States Bureau of Labor Statistics, benefits make up approximately 31% of an employer's cost for compensation, in the private sector.

 The Department estimates, based on the previous, that the annual cost to employ one full-time social worker in the private sector, in the first year, will be approximately $73,216 on average, including wages and benefits. Assuming that the data provided to the Department in the 2019-2020 annual report remains unchanged, the Department estimates that the total cost to the 70 privately-owned MA facilities with 120 beds or less, that do not employ either a full-time or part-time social worker, will be approximately $5,125,120 in the first year. According to data obtained from DHS, approximately 73%, or $3,741,338, of this cost will be covered by the MA program. Applying the Federal share of approximately 52% to the total costs results in an estimated Federal match of $1,945,496 and a State general fund investment of $1,795,842. The total estimated cost to the ten Medicare-only facilities that do not employ either a full-time or part-time social worker is $73,216. The total estimated cost to the one private pay facility that does not employ either a full-time or part-time social worker is $73,216. The Department estimates a 5% increase in wages and benefits for each year thereafter.

 The Department estimates that it will cost facilities with 120 beds or less $36,608 each to staff up from a part-time social worker to a full-time social worker. This assumes that the part-time social workers, currently employed, are earning half the salary of a full-time social worker. The total cost to the nine MA facilities is estimated to be $329,472. According to data obtained from DHS, approximately 73%, or $240,515, of the cost to the nine MA facilities will be covered by the MA program. Applying the Federal share of approximately 52% to the total costs results in an estimated Federal match of $125,068 and a State general fund investment of $115,447. The total estimated cost to the one private pay facility that needs to staff up from a part-time social worker to a full-time social worker is $36,608. The Department estimates a 5% increase in wages and benefits for each year thereafter.

 The Department believes that the costs to facilities to employ a full-time social worker is strongly outweighed by the need to have a full-time social worker on staff. Social workers have specialized education and training and are well-suited to assist residents and their families with all aspects of their stay in a long-term care nursing facility, including the social, emotional, financial, and psychological aspects, and preparing residents and their families for life post-discharge. In addition, over time, the condition of residents seeking care in the long-term care nursing environment has changed, and there has been an increase in the number of residents presenting with a wide range of psychosocial or behavioral issues. These residents require engaged social workers to assist with their care planning and to provide psychosocial support.

Local government

 Cost of proposal to adopt Federal requirements

 There are currently 20 county-owned long-term care nursing facilities which account for approximately 8% (8,706 beds) of long-term care nursing beds across this Commonwealth. Allegheny County owns four of the nursing homes; the remaining homes are in the following 16 counties: Berks, Bradford, Bucks, Chester, Clinton, Crawford, Cumberland, Delaware, Erie, Indiana, Lehigh, Monroe, Northampton, Philadelphia, Warren and Westmoreland. The county-owned long-term care nursing facilities participate in either Medicare or MA. Because these facilities are already required to comply with Federal requirements, they will not incur a cost as a result of the Department's proposed elimination of sections that are duplicative of the Federal requirements.

 Cost to meet proposed nursing staff ratio

 The Department consulted with DHS to determine the impact of the proposed increase in § 211.12(f.1)(5) to the 20 county-owned facilities. The proposed increase in RNs and LPNs, as proposed by the Department in § 211.12(f.1)(5), will require the 20 county-owned facilities that participate in MA to employ an additional estimated 184 FTE RNs but no LPNs. The average cost for an RN is projected to average $127,072, which is an increase of 28% from the average current cost report data. This estimate for the increased cost includes wages and benefits and is based on the 75th percentile of BLS wage data reported for these professions across all industries in this Commonwealth. The wages were increased to reflect the most recent benefit cost percentage (28%) and trended for inflation to 2023 (5%). The 75th percentile wage was used as a proxy for expected wages in 2023 with increased demand from the 4.1-hour requirement along with trends in the labor market for RNs, LPNs and nurse aides and unchecked pressures on agency use and pricing. The total cost to county-owned facilities that participate in MA, to add 184 RNs at the increased salary assumption is estimated to be $23,381,248. The affected county-owned facilities will also need to hire an estimated 539 FTE nurse aides in addition to the 184 RNs to meet the Department's proposal in the first rulemaking to require, in § 211.12(i), 4.1 direct resident care hours, per day. The average cost for a nurse aide, including wages and benefits, is projected to increase to $56,477 which is an increase of 23%, from the average salary paid as reported by facilities in the current cost report data reported to DHS. The cost to hire an additional 539 FTE nurse aides is projected to be $30,441,103. The total cost to meet the requirements of § 211.12(f.1)(5) and (i) therefore will be $53,822,351. According to data obtained from DHS, approximately 84.51% or $45,485,269 of this cost will be covered by the MA program. The Federal MA Program rate, estimated to be 52%, will apply to MA payments made to fund these costs, for an estimated Federal match of $23,652,340 and a State general fund investment of $21,832,929.

 Cost of proposal to add full-time qualified social worker

 There will be no cost to the county-owned long-term care nursing facilities as a result of the Department's proposal in § 211.16. Currently, a full-time social worker is only required for facilities with more than 120 beds. Out of the 20 county-owned facilities, 19 have more than 120 beds and thus, are already required to have a full-time social worker. The one county-owned facility with 120 or less beds reported having a full-time social worker in the 2019-2020 annual report. If this continues to be the case, there will be no impact to this facility.

General public and residents of long-term care nursing facilities

 There is expected to be no cost to the general public. More than 72,000 individuals reside in the 689 long-term care nursing facilities licensed by the Department and will be affected by the proposed regulations. These residents, and their family members, will benefit from the proposed adoption of the Federal requirements because the same standards will now apply to all long-term care nursing facilities, regardless of whether these facilities participate in Medicare or MA. It is also expected that those who currently reside in facilities, as well as those who may need long-term care nursing in the future, will benefit from improved quality of care and life due to the proposed increase in direct care hours provided by RNs, LPNs and nurse aides.

 The Department is not able to determine the extent to which residents may be financially affected by the proposed regulations. Various insurance options cover the costs residents pay for long-term nursing care, including Original Medicare, Medicare Supplement Insurance (Medigap), a Medicare Advantage Plan, long-term care insurance, MA and out-of-pocket.

 Most people with Medicare get their health care through Original Medicare, which is managed by the Federal government. For residents of long-term care nursing facilities, only short-term stays of up to 100 days are covered by Original Medicare. Original Medicare does not cover all services provided by a long-term care nursing facility. Original Medicare does not cover custodial care, such as assistance with getting in and out of bed, eating, bathing, dressing and using the bathroom, if that is the only kind of care that is needed. Centers for Medicare & Medicaid Services. (2019). Medicare Coverage of Skilled Nursing Facility Care. Retrieved from https://www.medicare.gov/Pubs/pdf/10153-Medicare-Skilled-Nursing-Facility-Care.pdf.

 Original Medicare will cover long-term nursing care if the resident has Medicare Part A, has had a qualifying hospital stay of 3 consecutive days or more and enters the facility within 30 days of leaving the hospital, the resident needs inpatient services which require the skill of professional personnel, and the resident needs skilled care on a daily basis and the services can only be given in a facility. Original Medicare pays the full cost of the first 20 days of a long-term care nursing facility stay. For days 21—100, Original Medicare pays all but a daily coinsurance, which is the resident's responsibility. In 2019, the coinsurance was up to $170.50 per day. For days beyond 100, Original Medicare pays nothing, and the resident is responsible for the full cost of covered services. Id.

 Covered services and costs in a long-term care nursing facility may be different if the resident has Medigap, a Medicare Advantage Plan, MA or long-term care insurance. Covered services and costs vary under these types of plans depending on the type of plan the resident has. Id. MA is managed by the state and provides benefits for residents with limited income and resources. The costs not covered by the previous resources would result in an out-of-pocket cost to the resident. Medicare.gov. How Can I Pay for Nursing Home Care? https://www.medicare.gov/what-medicare-covers/what-part-a-covers/how-can-i-pay-for-nursing-home-care.

 Because the circumstances of each resident are unique with respect to the types of insurance coverage they may have as well as to their length of stay and needs while in the facility, the Department is not able to estimate to what extent costs of a long-term care nursing stay, including costs for professional nursing staff, may be offset by Original Medicare, Medigap, a Medicare Advantage Plan, MA or long-term care insurance. The Department is also not able to estimate how much a resident may pay out-of-pocket for care, based on these variables.

Paperwork Requirements

 The Department's proposed amendment to § 201.19 will require a facility to maintain certain employee personnel records, as proposed in paragraphs (1) through (9). Proposed paragraphs (1) through (7) are currently in the Department's interpretive guidelines for § 201.19. Facilities, therefore, are already maintaining this information. Proposed paragraph (8), which requires a criminal background check, is already required by OAPSA. Proposed paragraph (9) would be a new paperwork requirement. Proposed paragraph (9) will require a facility, in the event that an employee has a conviction, to include in the employee's personnel record a determination of suitability for employment in the position to which the employee is assigned. The Department is not proposing any particular format for this determination and does not believe this requirement will be overburdensome to facilities. Indeed, a facility should benefit from having all of the information proposed in paragraphs (1) through (9) in the event that a question or concern arises regarding an employee at the facility.

 The Department's proposed amendment to § 201.24(e) (relating to admission policy) will require the governing body of a facility to establish written policies and procedures for the admission process for residents, and through the administrator, to develop and adhere to procedures implementing those policies. The Department is proposing that these policies and procedures include introductions and orientation for residents to the facility and key staff, discussion and documentation of resident routines and preferences to be included in their care plan, and assistance to residents in creating a homelike environment. The Department is not requiring any particular format for these policies and procedures and believes that many facilities may already have these policies and procedures in place or may only need to review and update their existing policies and procedures to ensure compliance with the proposed amendment.

 The Department's proposed amendment to § 211.5(e) (relating to medical records) will require a long-term care nursing facility to provide to the Department, within 30 days of closure, a plan for the storage and retrieval of medical records. A specific form will not be required for this plan, and thus, should not be overburdensome for facilities. In addition, this requirement will only affect a facility in the event of a closure. When a facility closes, it is often difficult to determine where medical records have been stored as there is no longer a point of contact for the facility. Requiring a facility to have a plan for storage and retrieval, and to provide the Department with that plan, will ensure that residents will be able to access their medical records after a facility closes.

 The Department's proposed addition of § 211.9(j.1) will require a facility to have written policies and procedures for the disposition of medications. The Department proposes that these policies and procedures align with Federal guidance found in Appendix PP and address the following: (1) timely identification and removal of medications for disposition; (2) identification of storage methods for medications awaiting final disposition; (3) control and accountability of medications awaiting final disposition consistent with standards of practice; (4) documentation of actual disposition of medications to include the name of the individual disposing of the medication, the name of the resident, the name of the medication, the strength of the medication, the prescription number if applicable, the quantity of medication and the date of disposition; and (5) a method of disposition to prevent diversion or accidental exposure consistent with applicable Federal and State requirements, local ordinances and standards of practice. This should not impose any burden on those facilities that participate in Medicare or MA as they are already following this guidance. In addition, existing § 211.9(i) and (j) already requires all facilities licensed by the Department, including those that do not participate in Medicare or MA, to have policies in place regarding the disposition of medications that are similar to those being proposed in § 211.9(j.1). Therefore, only a minor update to existing policies and procedures should be required for the three facilities that do not participate in Medicare or MA.

Statutory Authority

 Sections 601 of the HCFA (35 P.S. § 448.601) and section 803 of the HCFA authorize the Department to promulgate, after consultation with the Health Policy Board, regulations necessary to carry out the purposes and provisions of the HCFA. Section 801.1 of the HCFA (35 P.S. § 448.801a) seeks to promote the public health and welfare through the establishment of regulations setting minimum standards for the operation of health care facilities that includes long-term care nursing facilities. The minimum standards are to assure safe, adequate, and efficient facilities and services, and to promote the health, safety and adequate care of patients or residents of those facilities. In section 102 of the HCFA, the General Assembly has found that a purpose of the HCFA is, among other things, to assure that citizens receive humane, courteous and dignified treatment. Finally, section 201(12) of the HCFA (35 P.S. § 448.201(12)) provides the Department with explicit authority to enforce its rules and regulations promulgated under the HCFA.

 The Department also has the duty to protect the health of the people of this Commonwealth under section 2102(a) of the Administrative Code of 1929 (71 P.S. § 532(a)). The Department has general authority to promulgate regulations under section 2102(g) of the Administrative Code of 1929 (71 P.S. § 532(g)).

Effectiveness/Sunset Date

 This proposed rulemaking will become effective upon publication in the Pennsylvania Bulletin as a final-form rulemaking. A sunset date will not be imposed. The Department will monitor the regulations and update them as necessary.

Regulatory Review

 Under section 5(a) of the Regulatory Review Act (71 P.S. § 745.5(a)), on May 11, 2022, the Department submitted a copy of this proposed rulemaking and a copy of a Regulatory Analysis Form to IRRC and to the Chairpersons of the Senate Health and Human Services Committee and the House Health Committee. A copy of this material is available to the public upon request.

 Under section 5(g) of the Regulatory Review Act, IRRC may convey any comments, recommendations, or objections to the proposed rulemaking within 30 days of the close of the public comment period. The comments, recommendations or objections must specify the regulatory review criteria in section 5.2 of the Regulatory Review Act (71 P.S. § 745.5b) which have not been met. The Regulatory Review Act specifies detailed procedures for the review prior to final publication of the rulemaking by the Department, the General Assembly and the Governor.

Contact Person

 Interested persons are invited to submit comments, suggestions or objections to the proposed regulations within 30 days after publication of this notice in the Pennsylvania Bulletin. The Department prefers that comments, suggestions or objections be submitted by e-mail to RA-DHLTCRegs@pa.gov. Persons without access to e-mail may submit comments, suggestions or objections to Lori Gutierrez, Director, Office of Policy, 625 Forster Street, Room 814, Health and Welfare Building, Harrisburg, PA 17120, (717) 317-5426. Persons with a disability may submit questions in alternative format such as by audio tape, Braille or by using V/TT (717) 783-6514 or the Pennsylvania Hamilton Relay Service at (800) 654-5984 (TT). Persons who require an alternative format of this document may contact Lori Gutierrez at the previously listed e-mail, address or telephone number so that necessary arrangements can be made. Comments should be identified as pertaining to proposed rulemaking 10-224 (Long-term care nursing facilities, Proposed Rulemaking 4).

DR. DENISE A. JOHNSON, 
Acting Secretary

 Fiscal Note: 10-224. (1) General Fund;

 (7) DHS—MA—Community HealthChoices; (2) Implementing Year 2021-22 is $0; (3) 1st Succeeding Year 2022-23 is $60,889,000; 2nd Succeeding Year 2023-24 is $121,775,000; 3rd Succeeding Year 2024-25 is $127,864,000; 4th Succeeding Year 2025-26 is $134,257,000; 5th Succeeding Year 2026-27 is $140,970,000; (4) 2020-21 Program—$3,166,000; 2019-20 Program—$2,329,000; 2018-19 Program—$693,766,000;

 (7) DMVA—Veterans Homes; (2) Implementing Year 2021-22 is $0; (3) 1st Succeeding Year 2022-23 is $12,757,000; 2nd Succeeding Year 2023-24 is $25,513,000; 3rd Succeeding Year 2024-25 is $26,789,000; 4th Succeeding Year 2025-26 is $28,128,000; 5th Succeeding Year 2026-27 is $29,535,000; (4) 2020-21 Program—$76,167,000; 2019-20 Program—$80,914,000; 2018-19 Program—$82,863,000;

 (8) recommends adoption. Funds have been accounted for in the budget.

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¹  The Department reached this conclusion by multiplying the minimum proposed hours per resident day by 60 residents and dividing by 8 to represent 8-hour shifts. For example, for RNs, the Department multiplied .75 hours per resident day times 60 and divided by 8, to determine that the CMS staffing equivalent would be 6 RNs per resident day.

²  The DMVA indicated to the Department that the six veterans' homes that it operates will not be affected by the Department's proposal in § 211.16. In addition, out of the 20 county-owned facilities, 19 have more than 120 beds and thus, are already required to have a full-time social worker. The one county-owned facility with 120 or less beds reported having a full-time social worker in the 2019-2020 annual report. If this continues to be the case, there will be no impact to this facility.

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