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

[Continued from previous Web Page]

Annex A

TITLE 28. HEALTH AND SAFETY

PART IV. HEALTH FACILITIES

Subpart C. LONG-TERM CARE FACILITIES

CHAPTER 201. APPLICABILITY, DEFINITIONS, OWNERSHIP AND GENERAL OPERATION OF LONG-TERM CARE NURSING FACILITIES.

OWNERSHIP AND MANAGEMENT

§ 201.18. Management.

 (a) [The facility shall have an effective governing body or designated person functioning with full legal authority and responsibility for the operation of the facility.] (Reserved).

 (b) [The] In addition to the requirements under 42 CFR 483.70(d) (relating to administration), the governing body of a facility shall adopt and enforce rules relative to:

 (1) The health care and safety of the residents.

 (2) Protection of personal and property rights of the residents, while in the facility, and upon discharge or after death.

 (3) The general operation of the facility.

 (c) The governing body shall [provide the information required in § 201.12 (relating to application for license) and prompt reports of changes which would affect the current accuracy of the information required] 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).

 (d) [The governing body shall adopt effective administrative and resident care policies and bylaws governing the operation of the facility in accordance with legal requirements.] The administrative and resident care policies and bylaws, established and implemented by the governing body under 42 CFR 483.70(d)(1), shall be in writing; shall be dated; [shall be made available to the members of the governing body, which shall ensure that they are operational;] and shall be reviewed and revised, in writing, as necessary. The policies and bylaws shall be available upon request, to residents, [responsible persons] resident representatives and for review by members of the public.

 (d.1) The administrator appointed by the governing body under 42 CFR 483.70(d)(2) shall be currently licensed and registered in this Commonwealth and shall be employed full-time in facilities that have more than 25 beds. Facilities with 25 beds or less may share an administrator provided that all of the following apply:

 (1) The Department is informed of this arrangement.

 (2) There is a plan in the event of an emergency when the administrator is not working.

 (3) There is a readily available method for residents to contact the administrator should they find it necessary.

 (4) The director of nursing services has adequate knowledge and experience to compensate for the time the administrator is not in the building.

 (5) The sharing of an administrator shall be limited to two facilities.

 (d.2) The administrator's schedule shall be publicly posted in the facility.

 (e) [The governing body shall appoint a full-time administrator who is currently licensed and registered in this Commonwealth and who is responsible for the overall management of the facility. The Department may, by exception, permit a long-term care facility of 25 beds or less to share the services of an administrator in keeping with section 3(b) of the Nursing Home Administrators License Act (63 P.S. § 1103(b)). The sharing of an administrator shall be limited to two facilities. The schedule of the currently licensed administrator shall be publicly posted in each facility.] The administrator's responsibilities shall include the following:

 (1) Enforcing the regulations relative to the level of health care and safety of residents and to the protection of their personal and property rights.

 (2) Planning, organizing and directing responsibilities obligated to the administrator by the governing body.

 (2.1) Ensuring satisfactory housekeeping in the facility and maintenance of the building and grounds.

 (3) Maintaining an ongoing relationship with the governing body, medical and nursing staff and other professional and supervisory staff through meetings and periodic reports.

 (4) Studying and acting upon recommendations made by committees.

 (5) Appointing, in writing and in concurrence with the governing body, a responsible [employe] employee to act on the administrator's behalf during temporary absences.

 (6) Assuring that appropriate and adequate relief personnel are utilized for those necessary positions vacated either on a temporary or permanent basis.

 (7) Developing a written plan to assure the continuity of resident care and services in the event of a strike in a unionized facility.

 (f) A written record shall be maintained on a current basis for each resident with written receipts for personal possessions [and funds] received or deposited with the facility [and for expenditures and disbursements made on behalf of the resident]. The record shall be available for review by the resident or [resident's responsible person] resident representative upon request.

 (g) The governing body shall disclose, upon request, to be made available to the public, the licensee's current daily reimbursement under Medical Assistance and Medicare as well as the average daily charge to other insured and noninsured private pay residents.

 (h) When the facility accepts the responsibility for the resident's financial affairs, the resident or [resident's responsible person] resident representative shall designate, in writing, the transfer of the responsibility. [The facility shall provide the residents with access to their money within 3 bank business days of the request and in the form—cash or check—requested by the resident.] The facility shall provide cash, if requested, within 1 day of the request or a check, if requested, within 3 days of the request.

§ 201.19. Personnel [policies and procedures] records.

 Personnel records shall be kept current and available for each [employe] facility employee and contain [sufficient] all of the following information [to support placement in the position to which assigned.]:

 (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, as of the employee's start date, is free from the 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 assigned 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.

 (9) In the event of a conviction prior to or following employment, a determination by the facility of the employee's suitability for initial or continued employment in the position to which the employee is assigned.

§ 201.20. Staff development.

 (a) There shall be an ongoing coordinated educational program which is planned and conducted for the development and improvement of skills of the facility's personnel, including [training related to problems, needs and rights of the residents], at a minimum, annual in-service training on the topics outlined in 42 CFR 483.95 (relating to training requirements) in addition to the following topics:

 (1) Accident prevention.

 (2) Restorative nursing techniques.

 (3) Emergency preparedness in accordance with 42 CFR 483.73(d) (relating to emergency preparedness).

 (4) Fire prevention and safety in accordance with 42 CFR 483.90 (relating to physical environment).

 (b) An [employe] employee shall receive appropriate orientation to the facility, its policies and to the position and duties. [The orientation shall include training on the prevention of resident abuse and the reporting of the abuse.]

 (c) [There shall be at least annual in service training which includes at least infection prevention and control, fire prevention and safety, accident prevention, disaster preparedness, resident confidential information, resident psychosocial needs, restorative nursing techniques and resident rights, including personal property rights, privacy, preservation of dignity and the prevention and reporting of resident abuse.] (Reserved).

 (d) Written records shall be maintained which indicate the content of and attendance at [the] staff development programs.

§ 201.21. Use of outside resources.

 (a) [The facility is responsible for insuring that personnel and services provided by outside resources meet all necessary licensure and certification requirements, including those of the Bureau of Professional and Occupational Affairs in the Department of State, as well as requirements of this subpart.] (Reserved).

 (b) [If the facility does not employ a qualified professional person to render a specific service to be provided by the facility, it shall make arrangements to have the service provided by an outside resource, a person or agency that will render direct service to residents or act as a consultant to the facility.] (Reserved).

 (c) [The responsibilities, functions and objectives and the terms of agreement, including financial arrangements and charges of the outside resource shall be delineated in writing and signed and dated by an authorized representative of the facility and the person or agency providing the service.] (Reserved).

 (d) [Outside resources supplying temporary employes to a facility shall provide the facility with documentation of an employe's health status as required under § 201.22 (c)—(j) and (l)—(m) (relating to prevention, control and surveillance of tuberculosis (TB)).] (Reserved).

 (e) 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 (relating to restrictions on health care practitioners) and are physically able to perform their assigned duties.

§ 201.24. Admission policy.

 (a) [The resident may be permitted to name a responsible person. The resident is not required to name a responsible person if the resident is capable of managing the resident's own affairs.] (Reserved).

 (b) [A facility may not obtain from or on behalf of residents a release from liabilities or duties imposed by law or this subpart except as part of formal settlement in litigation.] (Reserved).

 (c) A facility shall admit only residents whose nursing care and physical needs can be provided by the staff and facility.

 (d) A resident with a disease in the communicable stage may not be admitted to the facility unless it is deemed advisable by the attending physician—medical director, if applicable—and administrator and unless the facility has the capability to care for the needs of the resident.

 (e) The governing body of a facility shall establish written policies for the admissions process for residents, and through the administrator, shall be responsible for the development of and adherence to procedures implementing the policies. The policies and procedures shall include all of the following:

 (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. Prior to introductions, the professional nursing and direct care staff shall review the orders of the physician or other health care practitioner for the resident's immediate care.

 (2) Orientation of the resident to the facility and location of essential services and key personnel, including the dining room, nurses' workstations and offices for the facility's social worker and grievance or complaint officer.

 (3) A description of facility routines, including 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).

 (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.

 (f) The coordination of introductions, orientation and discussions, under subsection (e), shall be the responsibility of the facility's social worker, or a delegee designated by the governing body, and shall occur within 2 hours of a resident's admission.

§ 201.25. [Discharge policy] (Reserved).

 [There shall be a centralized coordinated discharge plan for each resident to ensure that the resident has a program of continuing care after discharge from the facility. The discharge plan shall be in accordance with each resident's needs.]

§ 201.26. [Power of attorney] Resident representative.

 [Power of attorney may not be assumed for a resident by the] A resident representative may not be a licensee, [owner/operator] owner, operator, members of the governing body, an [employe] employee or anyone [having] with a financial interest in the facility unless ordered by a court of competent jurisdiction, except that a resident's family member who is employed in the facility may serve as a resident representative so long as there is no conflict of interest.

§ 201.29. Resident rights.

 (a) The governing body of the facility shall establish written policies regarding the rights and responsibilities of residents and, through the administrator, shall be responsible for development of and adherence to procedures implementing the policies. The written policies shall 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.

 (b) Policies and procedures regarding rights and responsibilities of residents shall be available to residents and members of the public.

 (c) Policies of the facility shall be available to staff, residents, consumer groups and the interested public, including a written outline of the facility's objectives and a statement of the rights of its residents. The policies shall set forth the rights of the resident and prohibit mistreatment and abuse of the resident.

 (d) [The staff of the facility shall be trained and involved in the implementation of the policies and procedures.] (Reserved).

 (e) [The resident or if the resident is not competent, the resident's responsible person, shall be informed verbally and in writing prior to, or at the time of admission, of services available in the facility and of charges covered and not covered by the per diem rate of the facility. If changes in the charges occur during the resident's stay, the resident shall be advised verbally and in writing reasonably in advance of the change. ''Reasonably in advance'' shall be interpreted to be 30 days unless circumstances dictate otherwise. If a facility requires a security deposit, the written procedure or contract that is given to the resident or resident's responsible person shall indicate how the deposit will be used and the terms for the return of the money. A security deposit is not permitted for a resident receiving Medical Assistance (MA).] (Reserved).

 (f) [The resident shall be transferred or discharged only for medical reasons, for his welfare or that of other residents or for nonpayment of stay if the facility has demonstrated reasonable effort to collect the debt. Except in an emergency, a resident may not be transferred or discharged from the facility without prior notification. The resident and the resident's responsible person shall receive written notification in reasonable advance of the impending transfer or discharge. Reasonable advance notice shall be interpreted to mean 30 days unless appropriate plans which are acceptable to the resident can be implemented sooner. The facility shall inform the resident of its bed-hold policy, if applicable, prior to discharge. The actions shall be documented on the resident record. Suitable clinical records describing the resident's needs, including list of orders and medications as directed by the attending physician shall accompany the resident if the resident is sent to another medical facility.] (Reserved).

 (g) [Unless the discharge is initiated by the resident or resident's responsible person, the facility is responsible to assure that appropriate arrangements are made for a safe and orderly transfer and that the resident is transferred to an appropriate place that is capable of meeting the resident's needs.] Prior to transfer, the facility shall inform the resident or the [resident's responsible person] resident representative as to whether the facility where the resident is being transferred is certified to participate in the Medicare and [MA] Medical Assistance reimbursement programs.

 (h) [It is not necessary to transfer a resident whose condition had changed within or between health care facilities when, in the opinion of the attending physician, the transfer may be harmful to the physical or mental health of the resident. The physician shall document the situation accordingly on the resident's record.] (Reserved).

 (i) [The resident shall be encouraged and assisted throughout the period of stay to exercise rights as a resident and as a citizen and may voice grievances and recommend changes in policies and services to the facility staff or to outside representatives of the resident's choice. The resident or resident's responsible person shall be made aware of the Department's Hot Line (800) 254-5164, the telephone number of the Long-Term Care Ombudsman Program located within the Local Area Agency on Aging, and the telephone number of the local Legal Services Program to which the resident may address grievances. A facility is required to post this information in a prominent location and in a large print easy to read format.] (Reserved).

 (j) [The resident shall be treated with consideration, respect and full recognition of dignity and individuality, including privacy in treatment and in care for the necessary personal and social needs.] (Reserved).

 (k) [The resident shall be permitted to retain and use personal clothing and possessions as space permits unless to do so would infringe upon rights of other residents and unless medically contraindicated, as documented by his physician in the medical record. Reasonable provisions shall be made for the proper handling of personal clothing and possessions that are retained in the facility. The resident shall have access and use of these belongings.] (Reserved).

 (l) [The resident's rights devolve to the resident's responsible person as follows:

 (1) When the resident is adjudicated incapacitated by a court.

 (2) As Pennsylvania law otherwise authorizes.] (Reserved).

 (m) [The resident rights in this section shall be reflected in the policies and procedures of the facility.] (Reserved).

 (n) The facility shall post in a conspicuous place near the entrances and on each floor of the facility a notice which sets forth the list of resident's rights. [The facility shall on admission provide a resident or resident's responsible person with a personal copy of the notice. In the case of a resident who cannot read, write or understand English, arrangements shall be made to ensure that this policy is fully communicated to the resident.] A certificate of the provision of personal notice as required in this section shall be entered in the resident's [clinical] medical record.

 (o) Experimental research or treatment in a [nursing home] facility may not be carried out without the approval of the Department and without the written approval and informed consent of the resident [after full disclosure.], or resident representative, obtained prior to participation and initiation of the experimental research or treatment. The resident, or resident representative, shall be fully informed of the nature of the experimental research or treatment and the possible consequences of participating. The resident, or resident representative, shall be given the opportunity to refuse to participate both before and during the experimental research or treatment. For the purposes of this subsection, ''experimental research'' [means an experimental treatment or procedure that is one of the following:

 (1) Not a generally accepted practice in the medical community.

 (2) Exposes the resident to pain, injury, invasion of privacy or asks the resident to surrender autonomy, such as a drug study.] refers to 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 or medical community as effective and conforming to medical practice.

 (p) 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.

§ 201.30. [Access requirements] (Reserved).

 [(a) The facility may limit access to a resident when the interdisciplinary care team has determined it may be a detriment to the care and well-being of the resident in the facility. The facility may not restrict the right of the resident to have legal representation or to visit with the representatives of the Department of Aging Ombudsman Program. A facility may not question an attorney representing the resident or representatives of the Department, or the Department of Aging Ombudsman Program, as to the reason for visiting or otherwise communicating with the resident.

 (b) A person entering a facility who has not been invited by a resident or a resident's responsible persons shall promptly advise the administrator or other available agent of the facility of that person's presence. The person may not enter the living area of a resident without identifying himself to the resident and without receiving the resident's permission to enter.]

§ 201.31. [Transfer agreement] (Reserved).

 [(a) The facility shall have in effect a transfer agreement with one or more hospitals, located reasonably close by, which provides the basis for effective working arrangements between the two health care facilities. Under the agreement, inpatient hospital care or other hospital services shall be promptly available to the facility's residents when needed.

 (b) A transfer agreement between a hospital and a facility shall be in writing and specifically provide for the exchange of medical and other information necessary to the appropriate care and treatment of the residents to be transferred. The agreement shall further provide for the transfer of residents' personal effects, particularly money and valuables, as well as the transfer of information related to these items when necessary.]

CHAPTER 207. HOUSEKEEPING AND MAINTENANCE STANDARDS FOR LONG-TERM CARE NURSING FACILITIES

HOUSEKEEPING AND MAINTENANCE

§ 207.2. [Administrator's responsibility] (Reserved).

 [(a) The administrator shall be responsible for satisfactory housekeeping and maintenance of the buildings and grounds.

 (b) Nursing personnel may not be assigned housekeeping duties that are normally assigned to housekeeping personnel.]

CHAPTER 209. FIRE PROTECTION AND SAFETY PROGRAMS FOR LONG-TERM CARE NURSING FACILITIES

FIRE PROTECTION AND SAFETY

§ 209.3. [Smoking] (Reserved).

 [(a) Policies regarding smoking shall be adopted. The policies shall include provisions for the protection of the rights of the nonsmoking residents. The smoking policies shall be posted in a conspicuous place and in a legible format so that they may be easily read by residents, visitors and staff.

 (b) Proper safeguards shall be taken against the fire hazards involved in smoking.

 (c) Adequate supervision while smoking shall be provided for those residents who require it.

 (d) Smoking by residents in bed is prohibited unless the resident is under direct observation.

 (e) Smoking is prohibited in a room, ward or compartment where flammable liquids, combustible gases or oxygen is used or stored, and in other hazardous locations. The areas shall be posted with ''NO SMOKING'' signs.

 (f) Ash trays of noncombustible material and safe design shall be provided in areas where smoking is permitted.

 (g) Noncombustible containers with self-closing covers shall be provided in areas where smoking is permitted.]

CHAPTER 211. PROGRAM STANDARDS FOR LONG-TERM CARE NURSING FACILITIES

§ 211.2. [Physician services] Medical director.

 (a) [The attending physician shall be responsible for the medical evaluation of the resident and shall prescribe a planned regimen of total resident care.] (Reserved).

 (b) [The facility shall have available, prior to or at the time of admission, resident information which includes current medical findings, diagnoses and orders from a physician for immediate care of the resident. The resident's initial medical assessment shall be conducted no later than 14 days after admission and include a summary of the prior treatment as well as the resident's rehabilitation potential.] (Reserved).

 (c) [A facility shall have a medical director who is] In addition to the requirements of 42 CFR 483.70(h) (relating to administration), the medical director of a facility shall be licensed as a physician in this Commonwealth [and who is responsible for the overall coordination of the medical care in the facility to ensure the adequacy and appropriateness of the medical services provided to the residents] and shall complete at least four hours annually of continuing medical education (CME) pertinent to the field of medical direction or post-acute and long-term care medicine. The medical director may [serve on a full- or part-time basis depending on the needs of the residents and the facility and may] be designated for single or multiple facilities. There shall be a written agreement between the physician and the facility.

 (d) [The medical director's responsibilities shall include at least the following:

 (1) Review of incidents and accidents that occur on the premises and addressing the health and safety hazards of the facility. The administrator shall be given appropriate information from the medical director to help insure a safe and sanitary environment for residents and personnel.

 (2) Development of written policies which are approved by the governing body that delineate the responsibilities of attending physicians.] (Reserved).

§ 211.3. [Oral] Verbal and telephone orders.

 (a) [A physician's oral] Verbal and telephone orders shall be given to a registered nurse, physician or other individual authorized by appropriate statutes and the State Boards in the Bureau of Professional and Occupational Affairs and shall immediately be recorded on the resident's clinical record by the person receiving the order. The entry shall be signed and dated by the person receiving the order. [Written orders may be by fax.]

 (b) [A physician's oral] Verbal and telephone orders for care [and treatments], treatment or medication, shall be dated and countersigned with the original signature of the physician, or physician's delegee authorized under 42 CFR 483.30(e) (relating to physician services), within [7 days] 48 hours of receipt of the order. [If the physician is not the attending physician, he shall be authorized and the facility so informed by the attending physician and shall be knowledgeable about the resident's condition.]

 (c) [A physician's telephone and oral orders for medications shall be dated and countersigned by the prescribing practitioner within 48 hours. Oral orders for Schedule II drugs are permitted only in a bona fide emergency.] (Reserved).

 (d) [Oral] Verbal orders for [medication or treatment] care, treatment or medication shall be accepted only under circumstances where it is impractical for the orders to be given in a written manner by the [responsible practitioner] physician, or physician's delegee authorized under 42 CFR 483.30(e). An initial written order as well as a countersignature may be [received] sent by a fax or secure electronic transmission which includes the practitioner's signature.

 (e) The facility shall establish policies identifying the types of situations for which [oral] verbal orders may be accepted and the appropriate protocols for the taking and transcribing of [oral] verbal orders in these situations, which shall include:

 (1) Identification of all treatments or medications which may not be prescribed or dispensed by way of [an oral] a verbal order, but which instead require written orders.

 (2) A requirement that all [oral] verbal orders be stated clearly, repeated by the issuing [practitioner] physician, or physician's delegee authorized under 42 CFR 483.30(e), and be read back in their entirety by personnel authorized to take the [oral] verbal order.

 (3) Identification of all personnel authorized to take and transcribe [oral] verbal orders.

 (4) The policy on fax or secure electronic transmissions.

§ 211.4. Procedure in event of death.

 (a) Written postmortem procedures shall be available [at each nursing station] to all personnel.

 (b) Documentation shall be on the resident's clinical record that the next of kin, guardian or [responsible party] resident representative has been notified of the resident's death. The name of the notified party shall be written on the resident's clinical record.

§ 211.5. [Clinical] Medical records.

 (a) [Clinical records shall be available to, but not be limited to, representatives of the Department of Aging Ombudsman Program.] (Reserved).

 (b) [Information contained in the resident's record shall be privileged and confidential. Written consent of the resident, or of a designated responsible agent acting on the resident's behalf, is required for release of information. Written consent is not necessary for authorized representatives of the State and Federal government during the conduct of their official duties.] (Reserved).

 (c) [Records shall be retained for a minimum of 7 years following a resident's discharge or death.] (Reserved).

 (d) Records of discharged residents shall be completed within 30 days of discharge. [Clinical] Medical information pertaining to a resident's stay shall be centralized in the resident's record.

 (e) When a facility closes, resident [clinical] medical records may be transferred with the resident if the resident is transferred to another health care facility. Otherwise, the owners of the facility shall make provisions for the safekeeping and confidentiality of resident medical records and shall [notify the Department of how the records may be obtained] 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.

 (f) [At a minimum, the] In addition to the items required under 42 CFR 483.70(i)(5) (relating to administration), a resident's [clinical] medical record shall include [physicians' orders, observation and progress notes, nurses' notes, medical and nursing history and physical examination reports; identification information, admission data, documented evidence of assessment of a resident's needs, establishment of an appropriate treatment plan and plans of care and services provided; hospital diagnoses authentication—discharge summary, report from attending physician or transfer form—diagnostic and therapeutic orders, reports of treatments, clinical findings, medication records and discharge summary including final diagnosis and prognosis or cause of death. The information contained in the record shall be sufficient to justify the diagnosis and treatment, identify the resident and show accurately documented information.] at a minimum:

 (i) Physicians' orders.

 (ii) Observation and progress notes.

 (iii) Nurses' notes.

 (iv) Medical and nursing history and physical examination reports.

 (v) Admission data.

 (vi) Hospital diagnoses authentication.

 (vii) Report from attending physician or transfer form.

 (vii) Diagnostic and therapeutic orders.

 (viii) Reports of treatments.

 (ix) Clinical findings.

 (x) Medication records.

 (xi) Discharge summary, including final diagnosis and prognosis or cause of death.

 (g) [Symptoms and other indications of illness or injury, including the date, time and action taken shall be recorded.] (Reserved).

 (h) [Each professional discipline shall enter the appropriate historical and progress notes in a timely fashion in accordance with the individual needs of a resident.] (Reserved).

 (i) The facility shall assign overall supervisory responsibility for the [clinical] medical record service to a medical records practitioner. Consultative services may be utilized[,]; however, the facility shall employ sufficient personnel competent to carry out the functions of the medical record service.

§ 211.6. Dietary services.

 (a) Menus shall be planned and posted in the facility or distributed to residents at least 2 weeks in advance. Records of menus of foods actually served shall be retained for 30 days. When changes in the menu are necessary, substitutions shall provide equal nutritive value.

 (b) [Sufficient food to meet the nutritional needs of residents shall be prepared as planned for each meal. There shall be at least 3 days' supply of food available in storage in the facility at all times.] (Reserved).

 (c) [Overall supervisory responsibility for the dietary services shall be assigned to a full-time qualified dietary services supervisor.] (Reserved).

 (d) [If consultant dietary services are used, the consultant's visits shall be at appropriate times and of sufficient duration and frequency to provide continuing liaison with medical and nursing staff, advice to the administrator, resident counseling, guidance to the supervisor and staff of the dietary services, approval of menus, and participation in development or revision of dietary policies and procedures and in planning and conducting inservice education and programs.] (Reserved).

 (e) [A current therapeutic diet manual approved jointly by the dietitian and medical director shall be readily available to attending physicians and nursing and dietetic service personnel.] (Reserved).

 (f) Dietary personnel shall practice hygienic food handling techniques. [An employe] Employees shall wear clean outer garments, maintain a high degree of personal cleanliness and conform to hygienic practices while on duty. [Employes] Employees shall wash their hands thoroughly with soap and water before starting work, after visiting the toilet room and as often as necessary to remove soil and contamination.

§ 211.7. Physician assistants and certified registered nurse practitioners.

 (a) [Physician assistants and certified registered nurse practitioners may be utilized in facilities, in accordance with their training and experience and the requirements in statutes and regulations governing their respective practice.] (Reserved).

 (b) If the facility utilizes the services of physician assistants or certified registered nurse practitioners, the following apply:

 (1) [There shall be written policies indicating the manner in which the physician assistants and certified registered nurse practitioners shall be used and the responsibilities of the supervising physician.] (Reserved).

 (2) There shall be a list posted at each [nursing station] workstation of the names of the supervising physician and the persons, and titles, whom they supervise.

 (3) A copy of the supervising physician's registration from the State Board of Medicine or State Board of Osteopathic Medicine and the physician assistant's or certified registered nurse practitioner's certificate shall be available in the facility.

 (4) A notice plainly visible to residents shall be posted in prominent places in the institution explaining the meaning of the terms ''physician assistant'' and ''certified registered nurse practitioner.''

 (c) [Physician assistants' documentation on the resident's record shall be countersigned by the supervising physician within 7 days with an original signature and date by the licensed physician. This includes progress notes, physical examination reports, treatments, medications and any other notation made by the physician assistant.] (Reserved).

 (d) [Physicians shall countersign and date their verbal orders to physician assistants or certified registered nurse practitioners within 7 days.] (Reserved).

 (e) [This section may not be construed to relieve the individual physician, group of physicians, physician assistant or certified registered nurse practitioner of responsibility imposed by statute or regulation.] (Reserved).

§ 211.8. Use of restraints.

 (a) [Restraints may not be used in lieu of staff effort. Locked restraints may not be used.] (Reserved).

 (b) [Restraints may not be used or applied in a manner which causes injury to the resident.] (Reserved).

 (c) [Physical restraints shall be removed at least 10 minutes out of every 2 hours during the normal waking hours to allow the resident an opportunity to move and exercise. Except during the usual sleeping hours, the resident's position shall be changed at least every 2 hours. During sleeping hours, the position shall be changed as indicated by the resident's needs.] (Reserved).

 (c.1) If restraints are used, a facility shall ensure that appropriate interventions are in place to safely and adequately respond to resident needs.

 (d) [A signed, dated, written physician] An order from a physician, or physician's delegee authorized under 42 CFR 483.30(e) (relating to physician services), shall be required for a restraint. [This includes the use of chest, waist, wrist, ankle, drug or other form of restraint. The order shall include the type of restraint to be used.]

 (e) The physician, or physician's delegee authorized under 42 CFR 483.30(e), shall document the reason for the initial restraint order and shall review the continued need for the use of the restraint order by evaluating the resident. If the order is to be continued, the order shall be renewed by the physician, or physician's delegee authorized under 42 CFR 483.30(e), in accordance with the resident's total program of care.

 (f) Every 30 days, or sooner if necessary, the interdisciplinary team shall review and reevaluate the use of all restraints ordered by physicians.

§ 211.9. Pharmacy services.

 (a) Facility policies shall ensure that:

 (1) Facility staff involved in the administration of resident care shall be knowledgeable of the policies and procedures regarding pharmacy services including medication administration.

 (2) [Only licensed pharmacists shall dispense medications for residents. Licensed physicians may dispense medications to the residents who are in their care.] (Reserved).

 (b) [Medications shall be] Facility policies shall ensure that medications are administered by authorized persons as indicated in § 201.3 (relating to definitions).

 (c) Medications and biologicals shall be administered by the same licensed person who prepared the dose for administration and shall be given as soon as possible after the dose is prepared.

 (d) Medications, both prescription and non-prescription, shall be administered under the [written] orders of the attending physician, or the physician's delegee authorized under 42 CFR 483.30(e) (relating to physician services).

 (e) [Each resident shall have a written physician's order for each medication received. This includes both proprietary and nonproprietary medications.] (Reserved).

 (f) Residents shall be permitted to purchase prescribed medications from the pharmacy of their choice. If the resident does not use the pharmacy that usually services the facility, the resident is responsible for securing the medications and for assuring that applicable pharmacy regulations and facility policies are met. The facility:

 (1) Shall notify the resident or the [resident's responsible person] resident representative, at admission and as necessary throughout the resident's stay in the facility, of the right to purchase medications from a pharmacy of the resident's choice as well as the resident's and pharmacy's responsibility to comply with the facility's policies and State and Federal laws regarding packaging and labeling requirements.

*  *  *  *  *

 (g) [If over-the-counter drugs are maintained in the facility, they shall bear the original label and shall have the name of the resident on the label of the container. The charge nurse may record the resident's name on the nonprescription label. The use of nonprescription drugs shall be limited by quantity and category according to the needs of the resident. Facility policies shall indicate the procedure for handling and billing of nonprescription drugs.] (Reserved).

 (h) [If a unit of use or multiuse systems are used, applicable statutes shall be met. Unit of use dispensing containers or multiuse cards shall be properly labeled. Individually wrapped doses shall be stored in the original container from which they were dispensed.] (Reserved).

 (i) [At least quarterly, outdated, deteriorated or recalled medications shall be identified and returned to the dispensing pharmacy for disposal in accordance with acceptable professional practices. Written documentation shall be made regarding the disposition of these medications.] (Reserved).

 (j) [Disposition of discontinued and unused medications and medications of discharged or deceased residents shall be handled by facility policy which shall be developed in cooperation with the consultant pharmacist. The method of disposition and quantity of the drugs shall be documented on the respective resident's chart. The disposition procedures shall be done at least quarterly under Commonwealth and Federal statutes.] (Reserved).

 (j.1) The facility shall have written policies and procedures for the disposition of medications that address all of 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.

 (5) A method of disposition to prevent diversion or accidental exposure consistent with applicable Federal and State requirements, local ordinances and standards of practice.

 (k) The oversight of pharmaceutical services shall be the responsibility of the quality assurance committee. Arrangements shall be made for the pharmacist responsible for the adequacy and accuracy of the services to have committee input. The quality assurance committee, with input from the pharmacist, shall develop written policies and procedures for drug therapy, distribution, administration, control, accountability and use.

 (l) A facility shall have at least one emergency medication kit that is readily available to staff. The kit used in the facility shall be governed by the following:

 (1) The facility shall have written policies and procedures pertaining to the use, content, storage [and], security, refill of and inventory tracking for the kits.

 (2) The quantity and categories of medications and equipment in the kits shall be [kept to a minimum and shall be] based on the immediate needs of the facility and criteria for the contents of the emergency medication kit shall be reviewed not less than annually.

 (3) The emergency medication kits shall be under the control of a practitioner authorized to dispense or [pre-scribe] prescribe medications under the Pharmacy Act [(63 P.S. §§ 390.1—390.13)] (63 P.S. §§ 390-1—390-13).

 (4) [The kits shall be kept readily available to staff and shall have a breakaway lock which shall be replaced after each use.] (Reserved).

§ 211.10. Resident care policies.

 (a) Resident care policies shall be available to admitting physicians, sponsoring agencies, residents and the public, shall reflect an awareness of, and provision for, meeting the total medical and psychosocial needs of residents. [The needs include admission, transfer and discharge planning.]

 (b) The policies shall be reviewed at least annually and updated as necessary.

 (c) The policies shall be designed and implemented to ensure that each resident receives treatments, medications, diets and rehabilitative nursing care as prescribed.

 (d) The policies shall be designed and implemented to ensure that the resident receives proper care to prevent pressure sores and deformities; that the resident is kept comfortable, clean and well-groomed; that the resident is protected from accident, injury and infection; and that the resident is encouraged, assisted and trained in self-care and group activities.

§ 211.11. [Resident care plan] (Reserved).

 [(a) The facility shall designate an individual to be responsible for the coordination and implementation of a written resident care plan. This responsibility shall be included as part of the individual's job description.

 (b) The individual responsible for the coordination and implementation of the resident care plan shall be part of the interdisciplinary team.

 (c) A registered nurse shall be responsible for developing the nursing assessment portion of the resident care plan.

 (d) The resident care plan shall be available for use by personnel caring for the resident.

 (e) The resident, when able, shall participate in the development and review of the care plan.]

§ 211.12. Nursing services.

 (a) [The facility shall provide services by sufficient numbers of personnel on a 24-hour basis to provide nursing care to meet the needs of all residents.] (Reserved).

 (b) [There shall be a full-time director of nursing services who shall be a qualified licensed registered nurse.] (Reserved).

 (c) The director of nursing services shall have, in writing, administrative authority, responsibility and accountability for the functions and activities of the nursing services [staff,] personnel and shall serve only one facility in this capacity.

 (d) The director of nursing services shall be responsible for:

 (1) Standards of accepted nursing practice.

 (2) Nursing policy and procedure manuals.

 (3) Methods for coordination of nursing services with other resident services.

 (4) Recommendations for the number and levels of nursing services personnel to be employed.

 (5) General supervision, guidance and assistance for a resident in implementing the resident's personal health program to assure that preventive measures, treatments, medications, diet and other health services prescribed are properly carried out and recorded.

 (e) [The facility shall designate a registered nurse who is responsible for overseeing total nursing activities within the facility on each tour of duty each day of the week.] (Reserved).

 (f) [In addition to the director of nursing services, the following daily professional staff shall be available.

 (1) The following minimum nursing staff ratios are required:

Census	Day	Evening	Night
59 and under	1 RN	1 RN	1 RN or 1 LPN
60/150	1 RN	1 RN	1 RN
151/250	1 RN and 1 LPN	1 RN and 1 LPN	1 RN and 1 LPN
251/500	2 RNs	2 RNs	2 RNs
501/1,000	4 RNs	3 RNs	3 RNs
1,001/Upward	8 RNs	6 RNs	6 RNs

 (2) When the facility designates an LPN as a nurse who is responsible for overseeing total nursing activities within the facility on the night tour of duty in facilities with a census of 59 or under, a registered nurse shall be on call and located within a 30-minute drive of the facility.] (Reserved).

 (f.1) In addition to the director of nursing services, a facility shall provide all of the following:

 (1) Nursing services personnel on each resident floor.

 (2) A minimum of two nursing services personnel on duty at all times.

 (3) A minimum of 1 nursing services personnel on duty, per 20 residents.

 (4) 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.

 (5) 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, as follows:

Census	Day	Evening	Night
1—60	2 RNs and 1 LPN	1 RN and 1 LPN	1 RN
61—120	4 RNs and 2 LPNs	2 RNs and 2 LPNs	2 RNs
121—180	6 RNs and 3 LPNs	3 RNs and 3 LPNs	3 RNs
181—240	8 RNs and 4 LPNs	4 RNs and 4 LPNs	4 RNs
241—300	10 RNs and 5 LPNs	5 RNs and 5 LPNs	5 RNs
301—360	12 RNs and 6 LPNs	6 RNs and 6 LPNs	6 RNs
361—420	14 RNs and 7 LPNs	7 RNs and 7 LPNs	7 RNs
421—480	16 RNs and 8 LPNs	8 RNs and 8 LPNs	8 RNs
481—540	18 RNs and 9 LPNs	9 RNs and 9 LPNs	9 RNs

Facilities with more than 540 residents shall calculate and provide additional nursing services personnel in accordance with the ratios provided under this subsection.

 (f.2) A facility may substitute a nurse aide with an LPN or RN and an LPN with an RN, but may not substitute an RN with a nurse aide or an LPN, to meet the requirements of subsection (f.1).

 (g) [There shall be at least one nursing staff employe on duty per 20 residents.] (Reserved).

 (h) [At least two nursing service personnel shall be on duty.] (Reserved).

 (Editor's Note: The text or subsection (i) is printed as it currently appears in the Pennsylvania Code. This subsection is proposed to be amended as set forth in the proposed rulemaking published at 51 Pa.B. 4074 (July 31, 2021)).

 (i) A minimum number of general nursing care hours shall be provided for each 24-hour period. The total number of hours of general nursing care provided in each 24-hour period shall, when totaled for the entire facility, be a minimum of 2.7 hours of direct resident care for each resident.

 (i.1) Only direct resident care provided by nursing service personnel may be counted towards the total number of hours of general nursing care required under subsection (i).

 (j) [Nursing personnel shall be provided on each resident floor.] (Reserved).

 (k) [Weekly time schedules shall be maintained and shall indicate the number and classification of nursing personnel, including relief personnel, who worked on each tour of duty on each nursing unit.] (Reserved).

 (l) [The Department may require an increase in the number of nursing personnel from the minimum requirements if specific situations in the facility—including, but not limited to, the physical or mental condition of residents, quality of nursing care administered, the location of residents, the location of the nursing station and location of the facility—indicate the departures as necessary for the welfare, health and safety of the residents.] (Reserved).

§ 211.15. [Dental services] (Reserved).

 [(a) The facility shall assist residents in obtaining routine and 24-hour emergency dental care.

 (b) The facility shall make provisions to assure that resident dentures are retained by the resident. Dentures shall be marked for each resident.]

§ 211.16. Social services.

 (a) [The facility shall provide social services designed to promote preservation of the resident's physical and mental health and to prevent the occurrence or progression of personal and social problems. Facilities with a resident census of more than 120 residents] A facility shall employ a qualified social worker on a full-time basis.

 (b) [In facilities with 120 beds or less that do not employ a full-time social worker, social work consultation by a qualified social worker shall be provided and documented on a regular basis.] (Reserved).

§ 211.17. Pet therapy.

 If pet therapy is utilized, [the following standards apply] a facility shall have written policies and procedures to ensure all of the following:

 (1) Animals are not permitted in the kitchen or other food service areas, dining rooms when meals are being served, utility rooms and rooms of residents who do not want animals in their rooms.

 (2) Careful selection of types of animals [shall be] is made so [they] the animals are not harmful or annoying to residents.

 (3) The number and types of pets [shall be] are restricted according to the layout of the building, type of residents, staff and animals.

 (4) [Pets shall be] Animals are carefully selected to meet the needs of the residents involved in the pet therapy program.

 (5) [The facility shall have written procedures established which will address the physical and health needs of the animals. Rabies shots shall be given to animals who are potential victims of the disease. Care of the pets may not be imposed on anyone who does not wish to be involved.] (Reserved).

 (5.1) Animals are up to date on vaccinations, are in good health and do not pose a risk to the health and safety of residents.

 (6) [Pets] Animals and places where they reside [shall be] or visit are kept clean and sanitary.

 (7) Infection prevention and control measures, such as hand hygiene, are followed by residents and personnel when handling animals.

[Pa.B. Doc. No. 22-775. Filed for public inspection May 27, 2022, 9:00 a.m.]

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