RULES AND REGULATIONS
Title 28--HEALTH
AND SAFETY
DEPARTMENT OF HEALTH
[28 PA. CODE CHS. 201, 203, 205, 207,
209 AND 211]
Long-Term Care Nursing Facilities
[29 Pa.B. 3999] Scope and Purpose
This final rulemaking amends Part IV (relating to health facilities) by amending Subpart C (relating to long-term care facilities), Chapters 201, 203, 205, 207, 209 and 211, to read as set forth in Annex A.
The Health Care Facilities Act (act) (35 P. S. §§ 448.101--448.904) provides that, to be issued a license as a health care facility, an applicant shall show that: 1) it is a responsible entity; 2) the place to be used as a health care facility is adequately constructed, equipped and maintained, and safely and efficiently operated; 3) it will provide safe and efficient services adequate for the care and treatment of patients or residents; and 4) it is in substantial compliance with the rules and regulations of the Department of Health (Department). See section 808(a) of the act (35 P. S. § 448.808(a)).
The vast majority of long-term care nursing facilities (facilities) in this Commonwealth participate in the Federal Medicare and Medicaid programs. The Department is the State survey agency for the Health Care Financing Administration (HCFA) and, as such, surveys facilities for Federal certification as well as State licensure purposes. Facilities which participate in the Medicare and Medical Assistance (MA) Programs must comply with the Federal certification regulations in 42 CFR 483.1--483.75 (relating to requirements for long-term care facilities), as well as the State licensure regulations in Part IV, Subpart C.
The Federal regulations address many of the same areas addressed by the facility licensure regulations in Part IV, Subpart C. In certain instances the State licensure and Federal certification regulations are duplicative. In other cases, the two sets of regulations conflict. In an effort to resolve the inconsistencies and unnecessary duplication, the Department is adopting many of the Federal regulatory provisions and incorporating them into its State licensure regulations. Further, the Department has deleted those State licensure regulations which were overly prescriptive, but has kept those regulations which the Federal certification regulations either do not address or are less specific than the licensure regulations.
The Department felt it necessary, for public protection purposes, to keep certain State licensure regulations which are not addressed in the Federal certification regulations. For example, there is no Federal counterpart to the State licensure regulation in § 211.1 (relating to reportable diseases), requiring the reporting of specific diseases, or to § 201.22 (relating to prevention, control and surveillance of tuberculosis (TB)), pertaining to the protocols for tuberculosis control.
There are a few amendments to current regulations which are stricter in some respects than the corresponding Federal regulations. For example, the Federal regulation in 42 CFR 483.13(a) (relating to resident behavior and facility practices) states that a restraint may not be applied for discipline or convenience. The State licensure regulation pertaining to restraints in § 211.8 (relating to use of restraints) has always been more specific than the Federal regulation. The Department has now added a requirement that the need for a restraint be reviewed every 30 days by an interdisciplinary team as defined in § 201.3 (relating to definitions). Another amendment in § 201.3 revises the definition of ''restraint'' to include chemical as well as physical restraints. This follows the Federal regulations.
The State licensure regulation in § 201.14 (relating to responsibility of licensee) lists various incidents that must be reported to the appropriate Division of Nursing Care Facility field office. The proposed amendments add deaths due to sepsis as a reportable incident and require notification within 24 hours.
With regard to transfers and discharges, both State and Federal regulations provide that they shall be appropriate and may occur only after adequate prior notice. However, the amendment in § 201.29(d) (relating to resident's rights) specifically places the responsibility for appropriate placement on the facility.
The regulations will provide consistency for the majority of facilities that participate in the Federal reimbursement programs and will offer additional protection to residents of this Commonwealth by retaining important State licensure provisions that are not fully addressed by the Federal certification regulations.
Public Comments
Notice of proposed rulemaking was published at 27 Pa.B. 3609 (July 19, 1997) with an invitation to submit written comments within 30 days. Within the 30 day comment period, the Department received letters with comments from 36 individuals or organizations having an interest in long-term care. The Department also received comments from Senator Allen Kukovich and former Senator Hardy Williams, and Representatives Mike Veon, Patricia Vance, Keith McCall and James Casorio. The Department of Aging and Department of Public Welfare submitted comments as well. Finally, the Independent Regulatory Review Commission (IRRC) provided the Department with comments to the proposed rulemaking.
The following is a discussion of the comments received and the Department's response to those comments:
Chapter 201. Applicability, Definitions, Ownership and General Operation of Long-Term Care Nursing Facilities
Section 201.2. Requirements.
The Department received various comments with respect to the proposed amendment of this section to incorporate Subpart B of the Federal long-term care certification regulations, 42 CFR 483.1--483.75, into the State licensure regulations, with certain specific exceptions. In light of comments received, the Department has removed several exceptions in the proposed regulations. The exceptions which the Department has decided to not incorporate primarily reference the Medicare and Medicaid programs and are thus applicable to the facilities which participate in those programs only and not suitable as general licensure regulations.
Several commentators, including the Pennsylvania Association of Non Profit Homes for the Aging (PANPHA), the Pennsylvania Health Care Association (PHCA), the Pennsylvania Association of County Homes Affiliated Homes (PACAH), former Senator Williams and IRRC, suggested that the Department should adopt the Federal nurse aide training requirement in 42 CFR 483.75(e) (relating to administration), which provides for each state to operate a nurse aide registry and requires a state approved training and competency evaluation for nurse aides that meets the requirements of 42 CFR 483.151--483.154.
The Department currently operates the nurse aide registry for the Commonwealth. The majority of facilities require Federal certification and thus must use the registry and trained nurse aides. However, the Department agrees with the commentators that it should adopt the Federal regulation as a State requirement as well, to ensure that facilities in this Commonwealth, including those that do not participate in the Medicare or MA Programs, hire only trained nurse aides who have passed a competency evaluation and are in good standing on the registry. Therefore, the Department has adopted the Federal regulation in 42 CFR § 483.75(e) as a requirement of State licensure, by excluding it from the proposed list of exceptions.
The PANPHA asked why the Department was not adopting the Minimum Data Set (MDS) required by the Federal regulation in 42 CFR 483.20(b)(1)(i) (relating to resident assessment). Following the implementation of the case-mix reimbursement system, the Department added a new Pennsylvania-specific section to the MDS. Therefore, the Department has determined that it should adopt the MDS requirement for state licensure purposes as a quality improvement initiative. It has excluded that regulatory requirement from the proposed list of exceptions.
The Department agrees with a comment from former Senator Williams that it should adopt the Federal regulation in 42 CFR 483.10(c)(3)(i) (relating to level A requirement: Resident rights), which requires a facility to deposit residents' personal funds in excess of $50 in an interest bearing account separate from the facility's operating accounts. Although the current licensure regulation in § 201.18 (relating to management) does not require that resident funds be placed in an interest bearing account, the Department concludes that this should be a requirement for all Commonwealth facilities. Therefore, the Department has decided it will adopt 42 CFR 483.10(c)(3) so that all facilities in this Commonwealth, and not just those which participate in the Medicare or MA Programs, will be required to place residents' funds in excess of $50 in an interest bearing account. However, the Department has determined that it will not adopt the surety bond requirement in 42 CFR 483.10(c)(7) as a State licensure requirement.
The PANPHA and former Senator Williams questioned why the Department was not adopting the Federal regulatory requirement in 42 CFR 483.70(d)(1)(iv) (relating to physical environment) requiring full visual privacy. The exception in § 201.2 (relating to exceptions) in the proposed regulations was a typographical error. It is now corrected to read 42 CFR 483.70(d)(1)(v), which requires privacy curtains only in facilities initially certified after March 3, 1992. The Department interprets the requirement of full visual privacy to mean all beds shall have privacy curtains.
Several commentators, including the Department of Aging and former Senator Williams, expressed concern regarding the format of the regulations and expressed their desire to see the text of the Federal regulations adopted rather than the regulatory citation alone. The Department does not consider it necessary to include the specific Federal language for purposes of official legal publication in the Pennsylvania Bulletin and the Pennsylvania Code. The Department currently provides regulation manuals upon request. It will ensure that those manuals integrate the Federal regulatory sections being adopted, and it will make them available to providers and the public in a user-friendly format.
The Department had proposed to revise the exception provision in former § 201.2 and move it to the general administrative Chapter 51 (relating to general information). Several commentators did not realize that this was the case and expressed concern that the exception provision had been deleted. The exception provisions are now applicable to all health care facilities and appear in §§ 51.33 and 51.34 (relating to requests for exceptions; and revocation of exceptions).
Section 201.3. Definitions.
Abuse
Section 201.3 is amended to include a new definition of ''abuse.'' The definition is taken from the guidelines to the Federal regulations. This is also the definition of ''abuse'' which is used by the Department when adjudicating appeals by nurse aides who have had a finding of abuse entered against them in the nurse aide registry. The Department kept that portion of the former definition which now appears under the subheading of ''neglect.''
IRRC, the PANPHA and PACAH commented that the Department should adopt the definition of abuse in the Older Adults Protective Services Act (35 P. S. §§ 10225.101--10225.5102) (Act 79), rather than the language in the federal guidelines. The definition of abuse in Act 79 is included in the language proposed by the Department except that the definition of sexual abuse in Act 79 refers to the definition of sexual abuse in the Protection From Abuse Act (PFA). The Department felt that the definition of sexual abuse in the PFA deals more with sexual abuse among family members and was not as relevant as the description of what constitutes sexual abuse in the Federal abuse guidelines.
IRRC also commented that the Department should include the statutory definition of ''abandonment.'' The Department has decided not to include a separate definition of abandonment as the definition of ''neglect'' covers that concept. This definition states that neglect includes deprivation by a caretaker of goods or services which are necessary to maintain physical or mental health.
The Department concludes that the definition of ''abuse'' in the Federal abuse guidelines is more explicit and includes most of the definition in Act 79. Also, the Department's definition of ''abuse'' specifically states that it applies to all residents, including those who are not necessarily competent or conscious. Further, to remain consistent with its investigations and prosecutions of nurse aides accused of abusing residents, the Department feels it is important to adopt the language in the Federal guidelines.
The proposed rulemaking would have added the requirement that the abuse be ''willful.'' The Department has removed this term since this is not part of the Federal language. The Department agrees with recommendations from IRRC and Cedarbrook Nursing Homes that this qualifier be removed as it would make it much more difficult to prosecute an alleged abuser.
The PHCA and Extendicare expressed their concern that the definitions of ''abuse'' and ''neglect'' do not take into consideration the fact that services may be withheld at the request of a resident such as in an advance directive. They recommended that this be clarified in the definitions. A living will or other advance directive would be part of a resident's clinical record and as such would be readily available for review by surveyors if a question would arise as to whether withholding particular care or therapy constituted neglect. The Department, therefore, does not choose to incorporate this exception into the definitions.
Activities Coordinator
In response to a comment by the PANPHA, pointing out that § 211.17 (relating to patient activities) would be deleted with the exception of the provisions dealing with pet therapy, the Department has deleted the definition of ''activities coordinator.'' This term will no longer appear in the regulations.
Charge nurse
The definition of ''charge nurse'' was revised as proposed. The Department received a comment from the PNA that this term was outdated in the health care industry. However, as it is used in many nursing facilities, the Department has not changed the heading of charge nurse. It has, however, updated the requirements for being a charge nurse.
Clinical records
The PANPHA and IRRC commented that the proposed definition of ''clinical records'' was too broad and could require the release of more than just the resident's medical record. The proposed definition was based on the Federal interpretation of the term. However, in response to the comment, the Department deleted the portion of the proposed definition that included records dealing with social records and resident fund accounts.
Dietitian
The proposed rulemaking included a revised definition of ''dietitian'' to require that a person who would serve as a dietitian would have either registration by the Commission on Dietetic Registration of the American Dietetic Association, or appropriate education, training or experience. A dietitian and IRRC suggested that the Department specify what appropriate education, training or experience is. Therefore, the Department has revised the definition to specifically include those requirements which make one eligible for registration by the Commission.
Dietetic service supervisor
In response to a suggestion by the PANPHA the Department deleted the word ''qualified'' before ''dietitian'' in the definition of ''dietetic service supervisor'' as the qualifications for a dietitian are in the definition of that term.
Elopement
The Department is adding a definition of ''elopement'' in this section and taking the definition out of § 201.14 (relating to responsibility of licensee). The PACAH had raised a specific comment with regard to the requirement of reporting elopements in § 201.14, arguing that elopement should be limited to incapacitated residents who are missing from the facility for over 1 hour. The PANPHA suggested a definition that would limit elopements to residents who have wandered off the facility's premises and whose whereabouts are unknown. The Department rejected this recommendation. It determined that the definition of ''elopement'' should apply to all residents who are missing and not be limited to those who have wandered off the premises. Further, the Department does not believe the reporting requirement should be triggered by a specific period of time that the resident is missing.
The facility's premises could encompass many acres of surrounding land owned by the facility. Residents who elope are at risk of injury or death. There have been instances of these occurrences in the past. Therefore, the Department is more comfortable with a comprehensive definition which would require reporting when a resident leaves the facility itself without the facility's knowledge. This strict definition is not intended, however, to restrict the freedom of movement of those residents who are competent and generally permitted outside on facility grounds.
Existing facility
IRRC, the PANPHA and PHCA commented that the Department should revise this definition to reflect that an existing facility is a facility constructed and licensed before the effective date of these regulations. The Department agrees.
Experimental Drug
The Department agrees with a suggestion made by IRRC that it delete the definition of ''experimental drug'' as it is deleting § 211.9(p)(relating pharmaceutical services) where the term is used.
Facility
The Department is amending this definition by referring to the definition of ''long-term care nursing facility'' in section 802.1 of the act (35 P. S. § 448.802a). The previous definition was identical to the definition of ''long-term care nursing facility'' in the act. The Department of Aging had suggested that the Department define ''facility'' as an entity that includes housing and comprehensive medical services. However, the definition of ''facility'' in the regulations must be the same as a long-term care nursing facility, which is the licensed entity that the act authorizes the Department to regulate.
Interdisciplinary team
A definition is now included for the term ''interdisciplinary team.'' This definition has been taken from the Federal regulation at 42 CFR 483.20(d)(2)(ii), which lists the professionals who must take part in the preparation of residents' care plans. IRRC and the PANPHA feel that the words ''the participation of'' should be deleted from the proposed definition to ensure that the resident or family member will be included.
PANPHA expressed a concern that the definition did not fully relay the fact that the resident and the resident's family are an integral part of the team. The Department of Aging pointed out that the resident may not have family, and recommended that the team should include the responsible person. The Department has revised the definition to address both concerns.
The Department concludes that the Federal requirement adequately protects the resident's interests. The Federal language requires the facility to use its best efforts to include the resident or the resident's representative, but allows for some flexibility for those limited situations where it is not possible to do so, such as where a resident is incapacitated and has no representative or family members to participate.
Locked restraint
PACAH and the Philadelphia Geriatric Center recommended deleting the definition of ''locked restraint'' as it is no longer used. The Department does not agree that the definition should be deleted at this time.
Long term care nursing facility
The definition of a ''long-term care nursing facility'' has been deleted as it is referred to in the revised definition of ''facility.''
Mantoux tuberculin skin test
The Department has deleted this definition as it is now referred to as an ''intradermal skin test'' and defined in § 201.22(d) (relating to notification of change in patient status).
Medical record practitioner
The Department agrees with comments from IRRC, an accredited record technician and the Pennsylvania Health Information Management Association (PHIMA) that the definition relates to the clinical record keeping requirements in § 211.5 (relating to clinical records) and should specify criteria for personnel in charge of these records. The Department recognizes that the issues surrounding medical record keeping have become more complex, has reconsidered its proposal to delete the definition, and has updated the definition to reflect the present requirements of the American Health Information Management Association (AHIMA).
Nurse aide
After considering comments by the Department of Public Welfare, the Pennsylvania Nurses Association (PNA) and IRRC, the Department has amended the definition of ''nurse aide'' to reflect the Federal language and to require that the person be in good standing on the Pennsylvania nurse aide registry. This will require all facilities, including those that do not participate in the Medicare or MA Programs, to hire nurse aides who have received or are in the process of receiving required training and evaluation.
Resident
The term ''resident'' has been added to the definitions and replaces the term ''patient'' throughout the regulations. This change has been made in order to be consistent with Federal terminology and to reflect the fact that for the most part individuals in long-term care nursing facilities are residing there.
Restraint
The definition of ''restraint'' has been revised in accordance with the guidelines to the Federal certification regulations and now specifically includes chemical restraints. Further, the definition now includes devices which are adjacent to a resident in addition to those which are applied to a resident and, depending on the situation, could include side rails. This is also consistent with the Federal view of what constitutes a restraint.
Serious violation
The Department has deleted the definition of ''serious violation'' as it is defined in section 811 of the act (35 P. S. § 448.811 (1)).
Skilled or intermediate nursing care
The Department is deleting the definition of ''intermediate care'' and including a new definition of ''skilled or intermediate care'' which is in keeping with the elimination of the distinction between these two levels of care since the implementation of the case-mix reimbursement system. The new definition reflects a range of care, rather than two separate levels of care, which may be provided in a nursing facility.
The PANPHA and the Department of Aging support the integration of the levels of care, however, the PANPHA and Presbyterian Senior Care suggested that the Department delete the portion of the definition that states the care is that which is provided to ''an individual not in need of hospitalization'' and ''above the level of room and board.'' The Department did not delete these provisions as it believes it is necessary to identify the appropriate level of care to be provided in the facility and to distinguish this level of care from personal care or acute care provided in hospitals.
The PHCA would like to see the term ''intermediate'' deleted and the Department of Public Welfare suggested that the Department just define ''nursing care'' instead of ''skilled or intermediate care.'' The Department is bound by the definition of ''long-term care nursing facility'' in the act which specifically references ''skilled or intermediate care.''
IRRC expressed concerns that, due to differing usage in other regulations pertaining to provision and payment of services in long-term care facilities, the use of the word ''daily'' may cause confusion. The Department intends this word to be interpreted according to common usage, that is, these services must be available 7 days each week to the residents of the facility.
Social worker
Although one comment was received that opposed the proposed revised definition, the Department has adopted the Federal definition of a qualified social worker, as proposed, which requires a bachelor's degree in a human service field and one year of experience. The comment objected to the former requirement that the individual be a graduate of a school of social work accredited by the Council on Social Work or have 1 year of experience in a health setting. The revised definition is more strict in that it requires a degree as well as experience in a health care setting.
Therapeutic recreation specialists
The Department deleted the definition of ''therapeutic recreation specialists,'' as it has adopted the Federal regulation in 42 CFR 483.15(f) (relating to quality of life). The Federal provision provides that resident activities must be directed by a qualified therapeutic recreation specialist and includes the requirements for these individuals.
Section 201.12. Application for license.
Former subsection (b), requiring the issuance of a Certificate of Need (CON) as a condition of licensure, has been deleted.
Section 201.13. Issuance of license.
This section sets forth licensure fees and has been revised to reflect the statutory increase in fees which have been in effect since 1992, following amendments to the act.
Section 201.14. Responsibility of licensee.
The Department received a number of comments to the proposed revisions of this section. It has been revised in the final version so as not to duplicate provisions in the publication in June of 1998 of Chapter 51, which includes general provisions applicable to all health care facilities, including required incident reporting. The Department has revised this section to cover those situations that are not completely addressed in § 51.3 (relating to notification). Subsection (e) will now require the reporting of serious incidents within 24 hours. Subsection (d) will add a requirement that facilities report deaths occurring in the facility or following a hospital admission due to sepsis.
Incidents such as temporary disruptions of services, deaths due to injuries, accidents or suicide, elopements and complaints of resident abuse, which are covered in § 51.3 have been deleted from this section.
The PHCA commented that the phrase ''following a hospital admission'' should be deleted from subsection (d)(1), as the facility should not be responsible for reporting deaths that occur in the hospital. The PANPHA expressed some uncertainty as to whether the facility must track a resident who is admitted to a hospital for a lengthy stay. As all health care facilities are required to report deaths due to malnutrition, dehydration or sepsis under § 51.3, if the resident is transferred to the hospital and subsequently dies of one of these causes, the hospital will be responsible for reporting the death. Therefore, the Department has deleted the provision in the proposed regulations which would have required nursing facilities to report these deaths following a hospital admission.
The PACAH also questioned why the Department is requiring reporting on transfers as well as subsequent admissions to hospitals as a result of accidents and injuries. The Department believes it is important to be notified of accidents and injuries that require a resident to be sent to the hospital, even if there is no need for subsequent admission.
Several commentators, including the PANPHA and PHCA, questioned why the proposed regulations require facilities to report hospitalizations due to sepsis. The proposal would also require that deaths occurring in the facility or following a hospital admission due to malnutrition or dehydration be reported by the facility. The Department has reevaluated this requirement and deleted the subsection in light of the regulation at § 51.3(g), which requires all licensed health care facilities to report resident or patient deaths due to malnutrition, dehydration or sepsis. Therefore, a death due to malnutrition, dehydration or sepsis would be reported by the facility where the resident or patient expired.
The PACAH felt that the current 24 hour time frame for reporting in subsection (e) is insufficient time to allow the facility to fully investigate the incident being reported. The PHCA suggested the time frame be within 24 hours of the first working day after the incident. The Department considers the 24 hour time frame to be important. An investigation does not have to be completed within the 24 hour period for initial reporting of an incident. Facilities may report emergencies by the Department's hot line after hours or on weekends and holidays.
Section 201.15. Restrictions on license.
The Department has deleted subsection (c), as the language defining a ''serious violation'' is part of the act. Former subsection (d), which is now subsection (c), has been amended to reflect that an appeal from an order of the Department is to the Health Policy Board. This is consistent with an amendment to The Administrative Code of 1929 (71 P. S. § 2102(n)), in 1996, which transferred the duties of the former State Health Facilities Hearing Board to the Health Policy Board.
Section 201.16. Change in ownership, structure or name.
The requirements in this section have been addressed in § 51.4 (relating to change in ownership; change in management). Therefore, this section is being repealed.
Section 201.17. Location.
The PANPHA and PACAH questioned whether the Department was proposing to delete this section. The Department did not address this section in the proposed rulemaking and has not deleted or amended this section.
Section 201.18. Management.
Former subsection (j) is now subsection (h). It requires facilities which accept responsibility for residents' financial affairs to provide residents with access to their money within 3 bank business days from the date of request. The regulation had provided for 7 days.
IRRC and St. Mary's Home of Erie commented that subsection (e)(7), which requires a strike plan, should only be applicable to unionized facilities. As the Department has applied this requirement to unionized facilities only, it agrees and has clarified this in the subsection.
Section 201.19. Personnel policies and procedures.
This section has been revised to delete all subsections except for former subsection (b). The subsections which have been deleted are either covered by the Federal regulations which have been adopted or are included in other sections of these regulations.
The University of Pennsylvania Health System's Institute on Aging raised a question with regard to former subsection (i), which required employes to have a chest X-ray within the previous 60 days if the intradermal tuberculin skin test was positive. The question was whether a chest X-ray taken more than 60 days prior to the skin test would be satisfactory. Revised § 201.22 (relating to prevention, control and surveillance of tuberculosis (TB)) addresses tuberculosis protocols and provides that an employe or resident whose skin test is positive shall be referred for further diagnostic testing and treatment in accordance with current standards of practice.
Section 201.20. Staff development.
Subsection (c) has been revised to require annual in-service training on resident rights.
Section 201.21. Use of outside resources.
In response to a comment by the PANPHA, the Department has revised subsection (a) to require facilities to ensure that personnel and services provided by outside resources meet all necessary licensure and certification requirements.
Section 201.22. Prevention, control and surveillance of tuberculosis (TB).
This section addresses the testing of residents and personnel for tuberculosis. The Department has revised this section, including its title.
The proposed criteria were based on National standards, including CDC protocols. The Pennsylvania Medical Society (PMS) expressed its approval of the Department's inclusion of National guidelines and standards, including those of the CDC.
A fellow with the University of Pennsylvania Health System's Institute on Aging suggested that the regulations address the situation where a resident or a responsible person refuses the required testing. Another commentator suggested that terminally ill residents not be tested. The Department believes that these situations will need to be reviewed on a case by case basis. If necessary, exceptions can be granted in individual situations.
The Hospital and Health System Association of Pennsylvania (HAP) commented that SNFs in hospitals should be granted automatic exceptions to subsection (c)'s requirement of baseline TB testing on residents. The Department does not believe it would be appropriate to grant a blanket exception to hospital-based SNFs. Instead, it believes that any exceptions should be requested on a case by case basis. The regulations do not require that the 2-step test be complete before a resident is admitted. However, the facility must obtain a base line TB status on each resident.
The PANPHA questioned the requirement in proposed subsection (h) which required volunteers having 10 or more hours per week of contact with residents to be tested along with employes having the same contact. The Department recognized the difficulty facilities would face if forced to test volunteers and, therefore, has deleted the reference to volunteers.
Several commentators, including the University of Pennsylvania Health System's Institute of Aging, the PACAH and PANPHA, asked whether the TB testing of personnel must be preemployment. Another commentator questioned whether an employe who has a new positive reaction to the skin test may continue to work in the facility pending the results of a chest X-ray. Subsections (j) and (m) provide that testing and results are to be preemployment. Therefore, an employe having a new positive reaction would not be permitted to have contact with residents until the facility had chest X-ray results indicating the employe did not have TB. Subsection (j) has been revised to clarify that the 2-step intradermal skin test must be administered to employes prior to employment.
Two commentators felt the section was unclear as to what was meant by ''previous positive reaction'' in subsection (l). The Department is referring to those residents or employes who have prior history of a positive skin reaction but have no diagnosis of active TB.
The PANPHA and the United Church of Christ Homes suggested that the criteria in subsection (n) is too strict and that a facility should be permitted to admit a resident with infectious tuberculosis if the facility has a negative pressure room and is otherwise able to handle the resident's condition. The Department recognizes that subsection (n) is strict, but concludes that the criteria for admission of residents with diagnoses of TB are necessary to adequately safeguard other residents.
Section 201.24. Admission policy.
The Department proposed to delete this section in its entirety, but in light of comments received, including comments from the Department of Aging, the Pennsylvania Health Law Project and Community Legal Services, has decided to keep subsections (a)--(d). The commentators felt that it was important to state that a resident does not have to name a responsible person if the resident chooses not to do so. In response to a comment from the Department of Aging, the provision in subsection (a) which allowed facilities to name a resident's responsible person as a third-party financial guarantor if the agreement was in writing, has now been deleted to reflect the Federal regulations which prohibit third-party guarantees.
The Pennsylvania Health Law Project and Community Legal Services suggested it was important to keep subsection (b) to prohibit an express waiver of liability or of certain resident rights in an admission agreement.
Subsection (e) has been deleted as it is dealt with more specifically in § 201.22(n) (relating to prevention, control and surveillance of tuberculosis (TB)).
Section 201.25. Discharge policy.
It was proposed that this section was to be deleted in its entirety. However, the Department agrees with a comment by Community Legal Services that subsection (a) should be retained as the Federal regulation at 42 CFR 483.12(a)(7) (relating to admission, transfer and discharge) only requires ''sufficient preparation and orientation'' prior to discharge and does not specifically address the need for coordinated discharge planning. It is important that a resident have a single coordinated discharge plan rather than separate plans from various disciplines.
Additional language has been added to § 201.29(e) and (f) (relating to resident rights) regarding the facility's responsibilities with regard to transfer and discharge of residents. The new language clarifies that 30 days advance notice must be given prior to discharge and that the facility is responsible for assuring that the resident is appropriately placed.
Section 201.26. Power of attorney.
The PANPHA had requested that the Department expand this section to address situations where a resident has no power of attorney for health care and is unable to make his wishes known. The Department is unable to regulate in this area. Facilities are bound by current State law surrounding power of attorney, advance directives and guardianship.
Although the Department recognizes the difficulties facilities face in these situations, guidance in this area must come from the legislature or the courts. The Department notes that facilities which participate in MA are to provide the summary of State law concerning advance directives to residents upon admission. All facilities should offer residents the opportunity to draft a living will if they are competent and wish to do so.
Section 201.27. Advertisement of special services.
In response to a comment from the Pennsylvania Association of Rehabilitation Facilities (PARF), the Department decided to retain this section. It provides that facilities may not advertise special services such as rehabilitation or physical therapy unless the service is provided by specifically trained personnel.
Section 201.28. Nondiscriminatory policy.
This section has been repealed. The subject matter is now addressed in §§ 51.11--51.12 (relating to civil rights compliance and nondiscriminatory policy) in the general administrative chapter which applies to all health care facilities.
Section 201.29. Resident rights.
The Department proposed to delete subsections (a)--(c), as the Federal regulations address resident rights. These subsections provided that facilities are to have written policies regarding the rights and responsibilities of residents and are to make them available to residents, staff and consumer groups.
In response to comments from Community Legal Services and the PANPHA, the Department has decided not to delete subsection (a) and to revise subsection (b) by adding a provision which requires that resident rights policies be available to residents and members of the public. Subsection (c) is also retained.
In light of a comment from the PACAH, the Department has clarified the language in subsection (e) to ensure that information regarding available services and charges which are covered by the facility's per diem rate is first provided to the resident, if competent, and to the resident's responsible person if the resident is not competent.
Former subsection (h) is now subsection (f) and includes subject matter previously dealt with in former § 201.25 (b) (relating to discharge policy) which provided for reasonable advance notice of 30 days prior to a transfer or discharge of the resident. HAP had suggested that the Department include a provision automatically exempting hospital-based SNFs from the 30-day notice provision, as many residents are not in these units that long. The Department does not see the need to include a specific exception in the regulation, as there is a provision that the transfer or discharge may be implemented in less than 30 days if the plans are suitable to the resident.
In response to a comment from the Department of Aging, language has been added to subsection (f) which requires the transferring facility to inform the resident of its bed-hold policy prior to transfer.
The PACAH commented that amended subsections (f) and (g), which provide that the facility is responsible for a safe and orderly transfer, are covered by the Federal regulations in 42 CFR 483.12 and should be deleted. Although 42 CFR 483.12 does address the transfer and discharge issue, the Department believes that the language in amended subsections (f) and (g), as revised, is more specific than the Federal language in that it provides that the transfer or discharge without 30-days advance notice must be acceptable to the resident. Further, subsection (g) specifically states that the receiving facility must be capable of meeting the resident's needs. In response to a suggestion from the Department of Aging, the Department added language to subsection (g), requiring transferring or discharging facilities to inform the resident as to whether the receiving facility participates in the Medicare or MA programs, or both.
As proposed, subsection (f) had stated reasonable advance notice was to be interpreted as 30 days ''unless appropriate plans could be implemented.'' The Department agreed with the assessment of St. Mary's Home of Erie that this was unclear. Therefore, it has clarified the phrase by adding the word ''sooner'' after ''implemented.'' Also, the Department, in response to comments by the PANPHA, has further clarified the provision by specifying that transfer or discharge plans executed with less than 30 days notice, must be acceptable to the resident. The subsection was further clarified by adding language requiring that suitable clinical records, in addition to a list of medications and treatments, accompany the resident being transferred.
The Department added subject matter to subsection (g) which had been addressed in former § 201.25(g), which provided that it is not necessary to transfer a resident between or within a facility if in the opinion of the attending physician such a transfer would be harmful to the resident.
The Department had proposed to delete subsection (i), but has accepted the recommendation of Community Legal Services that it be retained. The PACAH had supported the deletion of the subsection, as Federal regulations address the provision of advocacy information to residents, but encouraged the retention of language giving hot line numbers and requiring that this information be provided to residents. Subsection (h) contains information that is specific to Pennsylvania and therefore appropriate to retain.
The Department deleted former subsections (j)--(n), as the same subject matter is addressed by the Federal regulations. Community Legal Services requested that former subsection (j) be retained. However, the Department feels that this subsection is fully addressed in 42 CFR 483.10(a)(2).
The Pennsylvania Health Law Project and Community Legal Services requested that the Department retain former subsection (l), which provided that where a facility is responsible for a resident's funds, the facility must maintain written policies that assure the resident receives a quarterly accounting and prohibit the facility from commingling the resident's funds with its own. The Federal regulation in 42 CFR 483.10(c)(4)(i) and (ii), prohibits commingling of resident and facility funds and requires that the resident be provided with financial statements each quarter and upon request. Although the Federal regulation does not specifically require written policies, it does require the facility to have a system to assure full, complete and separate accounting. The Department would cite a facility whose system is inadequate. Therefore, the Department believes that the Federal regulation fully addresses the provisions of former subsection (l).
In response to a comment from Community Legal Services, the Department is retaining former subsection (o), which provides that the resident is to be treated with consideration, respect and in full recognition of dignity. Although the Federal regulations are similar, subsection (o), now subsection (j), is broader. The commentator further complimented the Department on its interpretive guidelines to this subsection.
Former subsections (p)--(s) and (u), which addressed the resident's right to associate freely with members of the resident's family and the community, have been deleted as they are covered by Federal regulations which have been adopted. Although former subsection (p), which prohibited a resident from performing services for the facility, is not specifically dealt with in the Federal regulations, subsection (j) of the revised licensure regulations, which requires a resident to be treated with dignity, would prohibit this.
In response to comments from the Pennsylvania Health Law Project and Community Legal Services, the Department is retaining former subsection (t), now subsection (k), which permits residents to retain personal clothing and possessions and mandates that facilities make provisions for the proper handling of these items.
The Department proposed to delete former subsection (v), which listed rights which devolve to a resident's responsible person in situations where the resident is adjudicated incapacitated, found by their attending physician to be incapable of understanding their rights, or unable to communicate.
Comments were received from the Pennsylvania Medical Directors Association, the PMS, the Pennsylvania Health Law Project and Community Legal Services, urging the Department to retain this section, as they felt the Department should address surrogate decision making through regulation.
Although the Department recognizes the need for providers to have guidance on treatment issues for incapacitated residents, it has reservations as to whether Pennsylvania law actually permits a responsible person to make certain decisions concerning their treatment in situations where the resident has not been adjudicated incapacitated. Even in situations where there is a durable power of attorney for health care, it is not clear whether a responsible person is authorized under Pennsylvania law to exercise certain residents' rights such as the right to refuse or discontinue life sustaining treatment. A responsible party would need a valid advance directive specifically authorizing such a refusal or appointing that individual as the surrogate decision maker.
The Department has addressed these competing concerns by redesignating former subsection (v) as subsection (l) and revising it to allow for a resident's right to devolve to a responsible person where the resident has been adjudicated incapacitated or ''as Pennsylvania law otherwise authorizes.'' This permits decisions on a case-by-case basis and allows for changes in the law of surrogate decision-making. Facilities may wish to obtain legal guidance in developing procedures and protocols in this area.
In response to comments from Community Legal Services, the Department is retaining former subsections (x) and (y), now subsections (n) and (o). These subsections require resident rights to be posted and fully explained to residents who cannot read and/or who do not understand English. Further, they prohibit experimental treatment or research without Department approval and full disclosure to residents. The Pennsylvania Long-Term Care Pharmacist's Coalition disagreed with the requirement that facilities must obtain Department approval prior to implementing experimental research such as clinical drug trials using residents. Rather they felt these procedures should instead be run past an institutional review board. The Department's requirement that experimental research be approved is simply to ensure that the resident is fully informed of the risks, if any. The facility still needs to obtain any further requisite approvals regarding clinical validity of the treatment or trials from the appropriate regulatory agencies such as the FDA.
Section 201.30. Access requirements.
The Department had proposed to delete this section with the exception of former subsection (f), now subsection (b), which provides that a person entering a facility shall identify himself and receive permission from the resident to enter the resident's room. The PACAH suggested that the deletion of former subsection (e), now subsection (a), which permits facilities to limit access, would tie the hands of facilities charged with the responsibility for the resident. The Department is retaining this subsection, but has adopted the PACAH's suggestion that access be limited only in those situations where the interdisciplinary care team has determined that access would be detrimental to the resident's health. Any complaints from residents, family or friends regarding access restrictions will be swiftly and thoroughly reviewed by the Department.
The Pennsylvania Health Law Project urged the Department to prohibit facility personnel from questioning attorneys as to the reason for visiting the resident. The Department incorporated a provision to this effect and expanded the prohibition to cover the Department of Aging ombudsman as well as any representative of the Department who may wish to speak directly with a resident.
Former subsection (h) has been deleted as its subject matter is now addressed in § 201.29 (relating to resident rights).
Section 201.31. Transfer agreement.
The Department proposed to delete subsection (a). The Department has decided that the subsection is necessary, but has revised subsection (b) to state that a transfer agreement must provide for the interchange of necessary medical information as well as the transfer of residents' personal effects.
Former subsection (c), which dealt with facilities not having a transfer agreement with a hospital, has been deleted.
Section 201.32. Room placements.
This section has been repealed. The Department believes it is obvious that a married couple may share a room if they so desire and that such a directive by way of a regulation is not necessary. Furthermore, the Federal regulations in 42 CFR § 483.10(m), which is part of the section on resident rights being adopted by the Department, provides for this right.
Chapter 203. Application of Life Safety Code for Long-Term Care Nursing Facilities.
The Department has revised § 203.1 (relating to application of the Life Safety Code) to state that facilities are to comply with the applicable edition of the Life Safety Code that has been adopted by the Department.
Former § 203.2 (relating to restrictions) required long-term care facilities to comply with certain Life Safety Code standards. As all long-term care facilities are currently required to meet Life Safety Code construction and sprinkler requirements, this section is duplicative. The Department has repealed this section.
Chapter 205. Physical Plant and Equipment Standards for Long-Term Care Nursing Facilities.
Buildings and Grounds
Section 205.3 Building approval.
This section has been deleted. Its requirements that no new constructions or alterations may be occupied until the Department has authorized occupancy, appear at § 51.5 (relating to building occupancy).
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