[27 Pa.B. 3609]
[Continued from previous Web Page] § 205.74. [Linen] (Reserved).
[(a) The facility shall have available at all times a quantity of linens essential for proper care and comfort of patients. The facility shall have available at least three changes of linen per patient per day.
(b) Each bed shall have clean linen.]
§ 205.75. Supplies.
Adequate supplies shall be available at all times to meet the [patients'] residents' needs.
CHAPTER 207. HOUSEKEEPING AND MAINTENANCE STANDARDS FOR LONG TERM CARE NURSING FACILITIES
HOUSEKEEPING AND MAINTENANCE § 207.1. [Environmental safety] (Reserved).
[(a) Housekeeping and maintenance services shall be provided to maintain a sanitary, comfortable environment and to help prevent the development and transmission of infection.
(b) The facility shall be kept free from insects, rodents and vermin through operation of a pest control program.
(c) The grounds shall be free from accumulated rubbish and other health hazards of similar nature.]
§ 207.2. Administrator's responsibility.
* * * * * (b) [The administrator shall designate a full-time employe to be responsible for these functions and for the training and supervision of personnel.] Nursing personnel may not be assigned housekeeping duties that are normally assigned to housekeeping personnel.
[(c) In a facility that has a contract with an outside resource for housekeeping services, the administrator shall ensure that the services provided under the contract meet the requirements of this chapter.]
§ 207.3. [Housekeeping] (Reserved).
[(a) The interior and exterior of the building shall be maintained in a clean, safe and orderly manner by accepted practices and procedures of good institutional housekeeping.
(b) Provisions shall be made for the disposal of soiled dressings and similar items in a safe and sanitary manner.
(c) Light and light fixtures shall be kept clean.
(d) Refuse containers provided for an area shall have tight-fitting covers.
(e) Ashes from furnaces or incinerators shall be placed in metal containers.]
§ 207.4. Ice containers and storage.
[(a)] * * *
[(b) Ice used for any purpose shall be made from water which comes from a safe and sanitary source, and shall be used only if it has been manufactured, stored, transported and handled in a sanitary manner.
(c) Ice shall meet the bacteriological and chemical standards for drinking water.
(d) The ice scoop shall be handled in a safe and sanitary manner.]
§ 207.5. [Maintenance of equipment and building] (Reserved).
[(a) The facility shall establish a written, preventive maintenance program to ensure that equipment is operative and that the interior and exterior of the building is clean, orderly and attractive.
(b) Buildings shall be maintained in good repair and free from hazards such as loose handrails, loose or broken window glass, loose or cracked floor coverings or other conditions of similar nature.
(c) Electrical and mechanical equipment used shall be maintained in good repair and safe operating condition.
(d) Patient care equipment for personal care and treatment shall be maintained in a safe and sanitary condition.
(e) Sterile equipment shall be provided where necessary.]
CHAPTER 209. FIRE PROTECTION AND SAFETY PROGRAMS FOR LONG TERM CARE NURSING FACILITIES
FIRE PROTECTION AND SAFETY § 209.1. Fire department service.
[(a)] * * *
[(b) A nursing facility located in a rural area shall have by each telephone the telephone number of at least two fire departments located nearest to the facility.]
§ 209.2. Hazardous areas.
Exposed heating pipes, hot water pipes or radiators in rooms and areas used by [patients] residents and within reach of the [patients] residents shall be covered or protected to prevent injury or burn to [patients] residents.
§ 209.3. Smoking.
(a) Policies regarding smoking shall be adopted. The policies shall include provisions for the protection of the rights of the nonsmoking [patients] residents. The smoking policies shall be posted in a conspicuous place where [patients] residents, visitors and staff can see them.
* * * * * [(c) Smoking by patients classified as not responsible is prohibited, except under supervision.
(d) Smoking by patients in bed is prohibited unless the patient 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) Metal containers with self-closing covers shall be provided in areas where smoking is permitted.]
§ 209.4. [Fire extinguishers] (Reserved).
[(a) Fire extinguishers shall be of an approved type and installed under State regulations and local codes.
(b) Fire extinguishers shall be inspected and tested as often as required by State and local regulations.
(c) Personnel shall be instructed in the operation of the various types of fire extinguishers used in the facility.]
§ 209.5. [Emergency lighting system] (Reserved).
[(a) Emergency lighting shall be in good functioning condition.
(b) Emergency lighting shall be checked weekly and a written record maintained showing date checked, by whom checked and whether or not the system was operative.]
§ 209.6. [Fire alarm] (Reserved).
[(a) The alarm system and its equipment shall be of the standard, approved type suitable for the purpose for which installed.
(b) The alarm system shall be under the supervision of a responsible person.
(c) The fire alarm system shall be in good functioning condition.
(d) The system shall be checked at least weekly.
(e) A written record shall be maintained showing date checked, by whom checked and whether or not the system was operative.
(f) Personnel shall be instructed in the operation of the fire alarm system.]
§ 209.7. Disaster preparedness.
(a) [The facility shall have a comprehensive written plan, periodically rehearsed, with procedures to be followed in an internal or external disaster. The plan shall also have procedures for the care of casualties--patients and personnel--arising from potential or actual disasters such as fires, explosions, floods, nuclear incidences or other natural or man-made disasters.
(b)] The facility shall have a comprehensive written disaster plan which shall be developed and maintained with the assistance of qualified fire, safety and other appropriate experts. It shall include procedures for prompt transfer of casualties and records, instructions regarding the location and use of alarm systems and signals and fire fighting equipment, information regarding methods of containing fire, procedures for notification of appropriate persons and specifications of evacuation routes and procedures. The written plan shall be made available to personnel, and it shall be available at each nursing station and in each department. The plan shall be reviewed periodically to determine its effectiveness.
[(c)] (b) A diagram of each floor showing corridors, line of travel, exit doors and location of the fire extinguishers and pull signals shall be posted on each floor in view of [patients] residents and personnel.
(c) Personnel shall be instructed in the operation of the various types of fire extinguishers used in the facility.
§ 209.8. Fire drills.
* * * * * (b) A written report shall be maintained of each fire drill which includes date, time required for evacuation or relocation, number of [patients] residents evacuated or moved to another location and number of personnel participating in a fire drill.
CHAPTER 211. PROGRAM STANDARDS FOR LONG TERM CARE NURSING FACILITIES § 211.1. [Infection control] Reportable diseases.
(a) [The facility shall establish an active Infection Control Committee composed of members of the medical and nursing staffs, administration, and dietetic, pharmacy, housekeeping, maintenance and other services charged with responsibility for overall infection control.
(b) The Infection Control Committee shall establish written policies and procedures for investigating, controlling and preventing infections in the facility, and for identifying patients with reportable diseases.
(c) The written policies and procedures in aseptic and isolation techniques shall be followed by personnel. If the facility does not have the capability of caring for a patient with an infectious disease, the written policies shall include provisions for handling isolation cases until arrangements can be made to have the patient transferred to a facility capable of caring for the patient and the needs related to the specific organism.
(d) The Infection Control Committee shall monitor staff performance to ensure that policies and procedures are executed.
(e) Procedures shall be reviewed and revised for effectiveness and improvement at least annually or more frequently as necessary.
(f) Minutes shall be maintained for Committee meetings.
(g) A patient who develops a communicable disease after admission shall be medically isolated from other patients if ordered by the physician. If the patient cannot or should not be managed in the facility, arrangements shall be made by the attending physician for the transfer of the patient to an appropriate facility at the earliest practical time.
(h)] When a [patient] resident develops a reportable disease, the administrator shall report the information to the appropriate health agencies and [Long Term Care Field Office] appropriate Division of Nursing Care Facilities field office. Reportable diseases and conditions are:
* * * * * Chlamydia Trachomatous Infections
[Cancer]
* * * * * [Guillain] Guillian-Barre Syndrome
* * * * * [(i) The following conditions shall be reported when diagnosis is confirmed by laboratory findings:
Amebiasis
Anthrax
Botulism
Brucellosis
Campylobacteriosis
Cholera
Diphtheria infections
Giardiasis
Gonococcal infections
Haemophilus influenzae type b disease
Hepatitis, viral, including types A and B
Hypothroidism in infant up to 24 months
Histoplasmosis
Lead poisoning
Legionnaires' disease
Leptospirosis
Lyme disease
Lymphogranuloma venereum
Malaria
Meningococcal isolations
Phenylketonuria
Plague
Psittacosis (ornithosis)
Rabies
Rickettsial infection including Rocky Mountain Spotted Fever
Salmonella isolations
Shigella isolations
Syphilis
Trichinosis
Tuberculosis
Tularemia
Typhoid isolations
Viral infections
Vaccine-preventable diseases
Arboviruses
Respiratory viruses
(j) If a communicable disease develops, adequate steps shall be taken to determine the source and degree of dissemination of the disease.
(k)] (b) Cases of scabies and lice shall be reported to the [Long Term Care Field Office] appropriate Division of Nursing Care Facilities field office.
(c) Cases of Methicillin Resistant S. Aureus (MRSA), vancomycin-resistant Staphylococcus Aureus (VRSA), vancomycin-resistant enterococci (VRE) and vancomycin-resistant S. epidermidis (VRSE) shall be reported to the appropriate Division of Nursing Care Facilities field office.
§ 211.2. [Medical] Physician services.
(a) [The facility shall have or make provisions for a physician who shall be responsible for attending to the medical needs of the patients.
(b) A patient shall be under the current care of a physician. A skilled care patient shall be seen by the attending physician at least every 30 days and an intermediate care patient at least every 60 days, or more often as necessary.
(c) A patient's total program of care, including medications, care and treatments, shall be reviewed during a visit by the attending physician at least once every 30 days for a skilled care patient and every 60 days for an intermediate care patient. Revisions shall be made as necessary. The physician shall indicate on the patient's medical record that the review has been made. Entries made by the physician on the medical record shall be dated and signed with the original signature of the physician. A physician's orders shall be renewed at least once every 30 days for skilled care patients and every 60 days for intermediate care patients.
(d) The facility shall have written procedures available at each nurses station that provide for a physician to be available to furnish necessary medical care in case of emergency. The procedures shall be reviewed periodically to determine their effectiveness.
(e)] The attending physician shall be responsible for the medical evaluation of the [patient] resident and shall prescribe a planned regimen of total [patient] resident care. [This regimen shall incorporate all of the components of the patient's care and shall designate the patient's appropriate level of care.
(f) The facility shall have available, prior to or at the time of admission, patient information which includes current medical findings, diagnoses and orders from a physician for immediate care of the patient. Information shall also be available at the time of admission or within 48 hours thereafter, on the patient's rehabilitation potential and a summary of the course of prior treatment.
(g) The admission requirements shall include a report of physical examination, chest X-ray, complete blood count and urinalysis. These shall be done within 1 week prior to, or within 48 hours after admission. A chest X-ray taken within 60 days prior to admission will fulfill the admission requirement for a chest X-ray. When the patient is admitted to the facility directly from a hospital, the hospital report of these examinations and tests accompanying the patient shall be considered to meet this requirement, if the attending physician in the facility documents, in the patient record, that these reports are acceptable. When a patient is admitted to another level of care within a facility, or to another licensed nursing facility, the medical reports transferred with the patient shall be considered to meet this requirement, if the attending physician in the facility documents, in the patient's record, that these reports are acceptable.
(h) Annually thereafter, there shall be a physical examination, complete blood count and urinalysis completed for each patient. The results of the tests shall be available on the patient chart.
(i) A progress note shall be written or typed and signed and dated by the physician on the day the patient is seen.
(j) A physician's orders shall be dated and signed with the original signature of the physician.
(k) A facility shall have a medical director who is 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 patients. The medical director may serve on a full- or part-time basis depending on the needs of the patients and the facility and may be designated for single or multiple facilities. There shall be a written agreement between the physician and the facility.
(l)] (b) The medical director's responsibilities shall include at least the following:
(1) [Coordination of care of patients provided by attending physicians and ensurance of compliance with the facility's written bylaws and rules which delineate responsibilities.
(2)] 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 [patients] residents and personnel.
[(3) Execution of patient care policies as they relate to the patient's total plan of care.
(4)] (2) * * *
[(m) The requirement for a medical director may be waived by the Department for an appropriate period of time depending on the following:
(1) The facility is located in an area where the supply of physicians is not sufficient to permit compliance with this requirement without seriously reducing the availability of physician services within the area.
(2) The facility has made continuous efforts in good faith to recruit a medical director but has not been able to hire a physician due to the unavailability of physicians.]
§ 211.3. Oral and telephone orders.
(a) A physician's oral and telephone orders shall be given to a licensed 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 [patient's] resident's medical record by the person receiving the order. The entry shall be signed and dated by the person receiving the order.
(b) A physician's oral and telephone orders for care and treatments, exclusive of medication orders--see § 211.9(h) (relating to pharmaceutical services)--shall be dated and countersigned with the original signature of the physician within 7 days 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 [patient's] resident's condition.
§ 211.4. Procedure in event of death.
(a) [The patient's physician or the physician's designee shall be notified immediately of the apparent death of a patient. Documentation shall be on the patient's medical record of this notification or attempt to notify the physician.
(b) Written and dated documentation by the physician shall be on the patient's medical record that death has occurred.
(c) Death certificates shall be completed and signed by the physician under Article V of the Vital Statistics Law of 1953 (35 P. S. §§ 450.501--450.506).
(d)] Written postmortem procedures shall be available at each nursing station.
[(e)] (b) Documentation shall be on the [patient's] resident's medical record that the next of kin, guardian or responsible party has been notified of the [patient's] resident's death. The name of the notified party shall be written on the [patient's] resident's medical record.
§ 211.5. [Medical] Clinical records.
(a) [The facility shall maintain, in accordance with accepted professional standards and practices, an organized patient record system. These records shall be available to professional and other staff directly involved with the patient and to authorized representatives of the State and Federal government. Records] Clinical records shall be available to, but not be limited to, representatives of the Department of Aging Ombudsman Program.
(b) [The medical record service shall have sufficient staff, facilities and equipment to provide medical records that are documented completely and accurately, readily accessible and systematically organized to facilitate retrieving and compiling information.
(c)] Information contained in the [patient's] resident's record shall be privileged and confidential. Written consent of the [patient] resident, or of a designated responsible agent acting on the [patient's] 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.
[(d) The facility shall provide the patient or the patient's designee, upon request, access to information contained in the patient's medical records unless medically contraindicated. If the patient or patient designee wants a copy of the medical record, the facility shall provide the copy and may charge a reasonable fee for reproducing copies.
(e) If requested, after the death of a patient, the facility shall make the patient's medical record available to the deceased patient's executor or administrator of the decedent's estate or to the person who is responsible for the disposition of the body. If a copy of the medical record is requested, the facility shall provide one copy and may charge a reasonable fee for reproducing copies.
(f) Records shall be adequately safeguarded against destruction, fire, loss or unauthorized use.
(g) The facility shall maintain adequate facilities and equipment, which are conveniently located, in order to provide efficient processing of medical records.
(h)] (c) Records shall be retained for a minimum of 7 years following a [patient's] resident's discharge or death.
[(i) Medical records] (d) Records of discharged [patients] residents shall be completed within 30 days of discharge. Clinical information pertaining to a [patient's] resident's stay shall be centralized in the [patient's medical] resident's record.
[(j)] (e) When a facility closes, [patient] resident medical records may be transferred with the [patient] resident if the [patient] resident is transferred to another health care facility. Otherwise, the owners of the facility shall make provisions for the safekeeping and confidentiality of medical records and shall notify the Department of how the records may be obtained.
[(k)] (f) At a minimum, the [patient] resident 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 [patient's] 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 [patient] resident and show accurately documented information.
[(l)] (g) * * *
[(m)] (h) Each professional discipline shall enter the appropriate historical and progress notes in a timely fashion in accordance with the individual needs of a [patient] resident.
[(n)] (i) Overall supervisory responsibility for the medical record service shall be [assigned to a full-time employe of the facility. If the person is not a qualified medical records administrator, this person functions with consultation from a person so qualified] performed by qualified personnel competent to carry out the functions of the medical record service. The facility shall also employ sufficient supportive personnel competent to carry out the functions of the medical record service.
[(o) The following information shall be incorporated by members of the nursing staff into the nurses' notes section of the medical record:
(1) Drugs or treatment administered to patients shall be recorded daily on the proper record.
(2) Observations made concerning the condition of critically or acutely ill patients shall be recorded daily on the proper record on each tour of duty.
(3) Observations made concerning the condition of patients who are not critically or acutely ill shall be recorded in summary at least once each month for each tour of duty.
(4) Nurses' notes shall be written in chronological order and shall be signed and dated by the person making the entry. Nurses' notes include, but are not limited to, observations made concerning the general condition of the patient, change in the physical or mental condition, an incident or accident and significant items of care.]
§ 211.6. Dietary services.
(a) [The facility shall provide a hygienic dietetic service that meets the daily nutritional needs of patients, ensures that special dietary needs are met and provides palatable and attractive meals. A facility that has a contract with an outside food management company may be found to be in compliance with this section if the facility or company, or both, meets the standards listed in this section.
(b) Menus shall be planned and followed to meet nutritional needs of patients under physician's orders and, to the extent medically possible, under the recommended dietary allowances of the Food and Nutrition Board, National Research Council--National Academy of Sciences.
(c)] * * *
[(d)] (b) Sufficient food to meet the nutritional needs of [patients] 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.
[(e) At least three meals or their equivalent shall be served daily at regular times with not more than a 14-hour span between a substantial evening meal and breakfast. If not medically contraindicated, bedtime nourishments shall be offered routinely to patients.
(f) Foods shall be prepared by methods that conserve nutritive value, flavor and appearance, and are attractively served at proper temperatures and in a form to meet individual needs.
(g) If a patient refuses food served, appropriate substitutions of similar nutritive value shall be offered.
(h) When necessary, individuals shall be provided special equipment, implements or utensils to assist them with eating.
(i) Food shall be procured from sources approved or considered satisfactory by Federal, State or local authorities. Food shall be stored, prepared, distributed and served under sanitary conditions. Waste shall be disposed of properly.
(j) Written reports of inspections by State and local health authorities shall be on file at the facility with notation made of action taken by the facility to comply with recommendations.
(k)] (c) * * *
[(l) If the dietary services supervisor is not a qualified dietitian, the supervisor shall function with frequent regularly scheduled consultation from a person who is qualified.
(m)] (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, [patient] 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.
[(n) The facility shall employ sufficient supportive persons who are competent to carry out the functions of the dietary services.
(o) Food service personnel shall be on duty over a period of 12 or more hours.
(p) Therapeutic diets shall be prescribed by the attending physician.
(q) Therapeutic menus shall be planned in writing. They shall be prepared and served as ordered under supervision or consultation from the dietetic supervisor and advice from the physician whenever necessary.
(r)] (e) * * *
[(s) Procedures shall be established and regularly followed which assure that the serving of meals to patients for whom special or restricted diets have been medically prescribed is supervised. Observation of the patient's eating habits shall be made and charted on the patient's medical record.
(t)] (f) * * *
§ 211.7. Physician assistants/nurse practitioners.
(a) Physician assistants/nurse practitioners may be utilized in long term care facilities, in accordance with their training and experience and the requirements [set forth] in statutes and regulations governing their respective practice. [They may not be used in lieu of licensed physicians, with respect to the requirements of § 211.2(b) and (c) (relating to medical services).]
(b) If the facility utilizes the services of physician assistants/nurse practitioners, the following apply:
* * * * * (4) A notice plainly visible to [patients] residents shall be posted in prominent places in the institution explaining the meaning of the terms ''physician assistant'' and ''nurse practitioner.''
(c) Physician assistants'/nurse practitioners' documentation on the [patient's] 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 and any other notation made by the physician assistant/nurse practitioner.
* * * * * § 211.8. Use of restraints.
(a) [Restraints shall be used to prevent injury to the patient or other patients only as necessary.] Restraints may not be used in lieu of staff effort. Locked restraints may not be used.
(b) [Restraints] Physical restraints may not be used or applied in a manner which causes injury to the [patient] resident.
(c) [Restraints] Physical restraints shall be removed at least 10 minutes out of every 2 hours during the normal waking hours to allow the [patient] resident an opportunity to move and exercise. Except during the usual sleeping hours, the [patient's] resident's position shall be changed at least every 2 hours. During sleeping hours, the position shall be changed as indicated by the [patient's] resident's needs.
(d) A signed, dated, written physician order shall be required for a physical or chemical restraint. This includes the use of [posey,] chest, waist, wrist, ankle or other form of restraint. The order shall include the type of restraint to be used.
(e) The physician 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 [patient] resident. Need for the continued use of a restraint shall be evaluated at least every 30 days by an interdisciplinary team. [If the order is to be continued, the order shall be renewed for at least every 30 days for skilled patients and every 60 days for intermediate care patients by the physician in accordance with the patient's total program of care.
(f) [A written order is not required for the use of a geriatric chair. If the patient is placed in a geriatric chair, the patient shall be removed from the chair and exercised at least every 2 hours.] Every 30 days, the interdisciplinary team shall review and reevaluate the use of all restraints ordered by physicians.
§ 211.9. [Pharmaceutical] Pharmacy services.
(a) [The facility shall have written policies and procedures which are used to ensure that all aspects of medication control and pharmaceutical services are acceptable practices and comply with applicable State, Federal and local statutes and regulations. The] Facility policies [and procedures] shall ensure that [the following are complied with:
(1) The identity of the patient shall be unquestionably established before medication is administered.
(2) The employe who administers medications to patients shall record and sign on the individual medication record of each patient the medication, dosage and time it was given. This shall be done as soon as possible after the medications have been given.
(3) Appropriate facility staff shall be knowledgeable of the policies and procedures.
(4) Only] only licensed pharmacists shall dispense medications for [patients] residents. Licensed physicians may dispense medications to the [patients] residents who are in their care.
[(5) The records of receipt and disposition of controlled substances shall be maintained in sufficient detail to enable an accurate reconciliation.
(6) Drug records shall be in order and an account of controlled substances shall be maintained and reconciled.
(7) A drug formulary shall be available readily to medical and nursing staff to use as a cross reference if generic drugs are used.
(8) Self-administration of medications shall be allowed only with written permission of the attending physician.]
* * * * * (e) Each [patient] resident shall have a written physician's order for each medication received. This includes both proprietary and nonproprietary medications. [These physician's orders shall be on each patient's individual chart and shall be reviewed, renewed, signed and dated by the physician every 30 days for skilled patients and 60 days for intermediate care patients.
(f) Written medication orders which are not specifically limited to time or number of doses shall be controlled by automatic stop orders or other methods under written policies. The attending physician shall be notified of an automatic stop order prior to the last dose so that he may decide if the medication order is to be renewed.
(g) If a prescribed medication is not given, the reason shall be recorded on the patient's medical record, and the prescribing practitioner shall be notified of the information under acceptable medical and nursing practices.
(h)] (f) A physician's telephone and oral orders for medications shall be given only to a licensed nurse, pharmacist, physician or other individual as authorized by the appropriate statutes and the State Board in the Bureau of Professional and Occupational Affairs. Telephone and oral orders shall be recorded immediately on the [patient's] resident's medical record and dated and signed by the person receiving the order. Telephone and oral orders shall be countersigned by the prescribing practitioner/attending physician within 48 hours. Orders may be by facsimile transmission. Oral orders for Schedule II drugs are permitted only in a bona fide emergency.
[(i) A prescription container shall be labeled individually by the pharmacist for each patient. The label shall include the name of the prescribing practitioner, name of patient, Federal Drug Enforcement Administration number--if appropriate--name and address of the pharmacy, directions for use, required warnings, name and strength of the drug, prescription serial number, date originally dispensed, quantity of drug dispensed and initial or name of dispensing persons. The name of the manufacturer shall be on the label if generic drugs are used.
(j) Patients] (g) Residents shall be permitted to purchase prescribed medications from the pharmacy of their choice. If the [patient] resident does not use the pharmacy that usually services the facility, the [patient] resident is responsible for securing the medications and for assuring that applicable pharmacy regulations and facility policies are met.
[(k) If over-the-counter drugs are maintained in the facility, they shall bear the original label and shall have the name of the patient on the label of the container. The charge nurse may record the patient's name on the nonprescription label. The use of nonprescription drugs shall be limited by quantity and category according to the needs of the patient. Facility policies shall indicate the procedure for handling and billing of nonprescription drugs.
(l)] (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 [under subsection (i)]. Individually wrapped doses shall be stored in the original container from which they were dispensed.
[(m)] (i) At least quarterly, outdated, deteriorated or recalled medications shall be identified and [referred to the Pharmaceutical Services Committee or consultant pharmacist] returned to the dispensing pharmacy for disposal [under State and Federal statutes and regulations] in accordance with acceptable professional practices. Written documentation shall be made regarding the [disposal] disposition of these medications.
[(n)] (j) Disposition of discontinued and unused medications and medications of discharged or deceased [patients] residents shall be handled by facility policy which shall be developed in cooperation with the consultant pharmacist [or Pharmaceutical Services Committee]. The method of disposition and quantity of the drugs shall be documented on the respective [patient's] resident's chart. The disposition procedures shall be done at least quarterly under Commonwealth and Federal statutes.
[(o) The facility shall maintain written policies and procedures relating to medications and biologicals which provide the following:
(1) If the facility maintains a licensed pharmacy, a licensed pharmacist shall be in charge and present during the pharmacy's normal hours of operation.
(2) If the facility does not maintain a licensed pharmacy, it shall have arrangements with at least one licensed pharmacy to provide required services and consultation.
(3) Arrangments shall be made to assure that pharmaceutical services will be available on an emergency basis.
(4) The pharmacist, if not a full-time employe of the facility, shall devote a sufficient number of hours during a regularly scheduled visit to carry out the specified contractual responsibilities. Consultation shall be provided at least monthly on methods, procedures, storage, administration, disposal and recordkeeping of medications and biologicals and patient records. The consulting pharmacist shall submit a written monthly report on the status of the facility's pharmaceutical services and staff performance to the Pharmaceutical Services Committee.
(5) The Pharmaceutical Services Committee shall review medication errors and irregularities and shall document the review and corrective action plans in the minutes.
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