reglab/statecodes huggingface dataset:
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 555 - MEDICAL STAFF › MEDICAL STAFF › Section 555.3 - Requirements for membership and privileges

Current through Register Vol. 54, No. 28, July 13, 2024
(a) To receive favorable recommendation for
					 appointment, or reappointment, members of the medical staff shall always act in
					 a manner consistent with the highest ethical standards and levels of
					 professional competence.
(b)
					 Privileges granted shall reflect the results of peer review or utilization
					 review programs, or both, specific to ambulatory surgery.
(c) Privileges granted shall be commensurate
					 with an individual's qualifications, experience and present
					 capabilities.
(d) Granting of
					 clinical privileges shall follow established policies and procedures in the
					 bylaws or similar rules and regulations. The procedures shall provide the
					 following:
(1) A written record of the
					 application, which includes the scope of privileges sought and granted. The
					 delineation "clinical privileges" shall address the administration of
					 anesthesia.
(2) A review,
					 summarized on record with appropriate documentation, of the qualifications of
					 the applicant.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 555 - MEDICAL STAFF › MEDICAL STAFF › Section 555.4 - Clinical activities and duties of physician assistants and certified registered nurse practitioners

Current through Register Vol. 54, No. 28, July 13, 2024
(a) If
					 the ASF assigns patient care responsibilities to physician assistants and nurse
					 practitioners, the medical staff shall have established policies and procedures
					 approved by the governing body, for overseeing and evaluating their clinical
					 activities. The training, experience and demonstrated current competence of
					 physician assistants and nurse practitioners shall be commensurate with their
					 duties and responsibilities.
(b)
					 Physician assistants shall perform within the limits established by the medical
					 staff and consistent with the Medical Practice Act of 1985 (63 P. S.
					 §§
												422.1-422.45) and the
					 Osteopathic Medical Practice Act (63 P. S. §§
												261-271). Certified registered nurse
					 practitioners shall perform within the limits established by the medical staff
					 and consistent with the Professional Nursing Law (63 P. S. §§
												211-225.5) and the joint regulations of the
					 State Boards of Medicine and Nursing.
(c) Physician assistants and nurse
					 practitioners shall be licensed or certified as applicable.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 555 - MEDICAL STAFF › MEDICAL ORDERS › Section 555.11 - Written orders

Current through Register Vol. 54, No. 28, July 13, 2024
(a) Medication
					 or treatment shall be administered by authorized persons to administer drugs
					 and medications only upon written and signed orders of a practitioner acting
					 within the scope of the practitioner's license.
(b) Physician assistants and certified
					 registered nurse practitioners may write orders for medication or treatment in
					 accordance with their legally authorized scope of practice and policies and
					 procedures of the ASF.
(c) Written
					 orders may be issued by facsimile transmission.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 555 - MEDICAL STAFF › MEDICAL ORDERS › Section 555.12 - Oral orders

Current through Register Vol. 54, No. 28, July 13, 2024
Oral orders for medication or treatment shall be accepted
						only under urgent circumstances when it is impractical for the orders to be
						given in written manner by the responsible practitioner. Oral orders shall be
						administered in accordance with §
											555.13 (relating to administration
						of drugs) only by personnel qualified by their professional license or
						certification issued by the Commonwealth and according to medical staff bylaws
						or rules, who shall document the orders in the proper place in the medical
						record of the patient. The order shall include the date, time and full
						signature of the person taking the order and shall be countersigned by a
						practitioner within 48 hours of the order. If the practitioner is not the
						attending physician, the practitioner shall be authorized by the attending
						physician and shall be knowledgeable about the patient's condition.
						Countersignatures may be received by facsimile transmission.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 555 - MEDICAL STAFF › MEDICAL ORDERS › Section 555.13 - Administration of drugs

Current through Register Vol. 54, No. 28, July 13, 2024
Drugs shall be administered only upon the proper order of
						a practitioner acting within the scope of the practitioner's license and
						authorized according to medical staff bylaws, rules and regulations. Drugs
						shall be administered directly by a practitioner qualified according to medical
						staff bylaws, rules and regulations or by a professional nurse or by a licensed
						practical nurse with pharmacy training. Physician assistants and certified
						registered nurse practitioners shall be permitted to administer drugs within
						their authorized scope of practice. Further policies on the administration of
						drugs shall be established by the medical staff in conjunction with
						pharmaceutical services or personnel.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 555 - MEDICAL STAFF › SURGICAL SERVICES › Section 555.21 - Surgical procedures

Current through Register Vol. 54, No. 28, July 13, 2024
Procedures performed in the ASF are limited to procedures
						that are approved by the governing body, upon the recommendation of the medical
						staff and congruent with ASF classification as stated on its ASF
						license.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 555 - MEDICAL STAFF › SURGICAL SERVICES › Section 555.22 - Preoperative care

Current through Register Vol. 54, No. 28, July 13, 2024
(a) Pertinent
					 medical histories and physical examinations, and supplemental information
					 regarding drug sensitivities shall be documented the day of surgery or one of
					 the following:
(1) If medical evaluation,
					 examination and referral are made from a private practitioner's office,
					 hospital or clinic, pertinent records thereof shall be available and made part
					 of the patient's clinical record at the time the patient is registered and
					 admitted to the ASF. This information is considered valid only if the
					 evaluation was performed no more than 30 days prior to date of
					 surgery.
(2) A practitioner shall
					 examine the patient immediately before surgery to evaluate the risk of
					 anesthesia and of the procedure to be performed. The information shall be
					 clearly documented in the medical record.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 555 - MEDICAL STAFF › SURGICAL SERVICES › Section 555.23 - Operative care

Current through Register Vol. 54, No. 28, July 13, 2024
(a) Approved
					 surgical procedures shall be performed only by a qualified physician, dentist
					 or podiatrist within the limits of the practitioner's defined specific practice
					 privileges. Physician assistants and certified registered nurse practitioners
					 may be permitted to assist in the performance of surgical procedures in
					 accordance with their legally authorized scope of practice and the policies and
					 procedures of the ASF.
(b) Tissues
					 and exudates removed during a surgical procedure shall be properly labeled and
					 sent to a laboratory for examination by a pathologist. The specimen shall be
					 accompanied by pertinent clinical information, including its source and the
					 preoperative and postoperative surgical diagnosis. The pathologist's signed
					 report of the examination shall be made a part of the patient's medical record.
					 Certain tissues and exudates may be exempt from laboratory examination. The
					 exemptions shall be those that are consistent with current medical practices
					 and are in writing and approved by the governing body.
(c) An ASF shall be prepared to initiate
					 immediate onsite resuscitation or other appropriate response to an emergency
					 which may be associated with procedures performed there.
(d) The ASF shall have an effective procedure
					 for the immediate transfer to a hospital of patients requiring emergency
					 medical care beyond the capabilities of the ASF.
(e) The ASF shall have a written transfer
					 agreement with a hospital which has emergency and surgical services available,
					 or physicians performing surgery in the ASF shall have admitting privileges at
					 a hospital in close proximity to the ASF, to which patients may be
					 transferred.
(f) There shall be a
					 written agreement in effect with an ambulance service staffed by certified EMT
					 personnel, for the safe transfer of a patient to a hospital in an emergency
					 situation, or as the need arises.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 555 - MEDICAL STAFF › SURGICAL SERVICES › Section 555.24 - Postoperative care

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The findings
					 and techniques of an operation shall be accurately and completely written or
					 dictated immediately after the procedure by the practitioner medical staff
					 member who performed the operation. If a physician assistant or certified
					 registered nurse practitioner performed part of the operation, the findings and
					 techniques of the procedure shall be accurately recorded and the report shall
					 be countersigned by the medical staff member. This description shall become a
					 part of the patient's medical record.
(b) A patient who has received anesthesia
					 shall be observed in the facility by a registered nurse, physician assistant or
					 a practitioner for a period of time which is sufficient to ensure that no
					 immediate postoperative complications are present.
(c) Patients in whom a complication is known
					 or suspected to have occurred during or after the performance of a surgical
					 procedure shall be informed of the condition and arrangements made for
					 treatment of the complication. In the event of admission to an inpatient
					 facility, a summary of care given in the ASF concerning the suspected
					 complication shall accompany the patient.
(d) A medical professional certified in
					 advanced cardiac life support shall be present until patients operated on that
					 day have been discharged from the facility. If a patient receives general
					 anesthesia, regional anesthesia or IV sedation, an anesthetist shall remain
					 present until that patient has been discharged from the facility.
(e) Patients shall be discharged in the
					 company of a responsible person, if one is deemed to be necessary under §
											555.22(c)(5)
					 (relating to preoperative care).
(f) Protocols approved by the medical staff
					 shall be established for instructing patients in self-care after surgery
					 including written instructions which, at a minimum, include the following:
(1) The symptoms of complications associated
					 with procedures performed.
(2) An
					 explanation of prescribed drug regime including directions for use of
					 medications.
(3) The limitations
					 and restrictions on activities of the patient, if necessary.
(4) A specific telephone number to be used by
					 the patient, if a complication or question arises.
(5) A date for follow-up or return visit
					 after the performance of the surgical procedure.
(6) Instructions on the care of dressing and
					 wounds.
(7) Instructions on dietary
					 limitations.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 555 - MEDICAL STAFF › ANESTHESIA SERVICES › Section 555.31 - Principle

Current through Register Vol. 54, No. 28, July 13, 2024
(a) Anesthesia
					 services provided in the facility are limited to those techniques that are
					 approved by the governing body upon the recommendation of qualified medical
					 staff. They shall be limited to those techniques appropriate to the assigned
					 classification per ASF license.
(b)
					 The governing body shall define the degree of supervision required and the
					 scope of responsibilities delegated to anesthesiologists, certified registered
					 nurse anesthetists and dentist anesthetists, as well as the corresponding
					 responsibilities of supervising physicians.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 555 - MEDICAL STAFF › ANESTHESIA SERVICES › Section 555.32 - Administration of anesthesia

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
					 Anesthetics shall be administered by anesthesiologists and certified registered
					 nurse anesthetists and dentist anesthetists, or practitioners as defined in
					 § 551.3 (relating to definitions).
(b) If a nonphysician administers the
					 anesthesia, the anesthetist shall be under the overall direction of an
					 anesthesiologist or a physician or dentist who is present in the ASF.
(c) The Director of Anesthesia Services shall
					 be responsible for designating the physician or dentist who will be responsible
					 for the overall direction of the anesthetist.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 555 - MEDICAL STAFF › ANESTHESIA SERVICES › Section 555.33 - Anesthesia policies and procedures

Current through Register Vol. 54, No. 28, July 13, 2024
(a) In ASFs where an anesthesiologist is
					 present, the anesthesiologist shall be designated the Director of Anesthesia
					 Services and shall be responsible for directing the anesthesia services and
					 establishing the general policies and procedures for the administration of
					 anesthesia in the ASF which shall be approved by the governing body.
(b) In ASFs where there is no
					 anesthesiologist, the governing body shall designate a physician or dentist to
					 function as the Director of Anesthesia Services, who shall be responsible for
					 directing the anesthesia services and establishing the general policies and
					 procedures for the administration of anesthesia in the ASF which shall be
					 approved by the governing body.
(c)
					 Policies and procedures shall be developed for anesthesia services and shall
					 include the following:
(1) Education,
					 training and supervision of personnel.
(2) Responsibilities of nonphysician
					 anesthetists.
(3) Responsibilities
					 of supervising physicians or dentists.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 555 - MEDICAL STAFF › ANESTHESIA SERVICES › Section 555.34 - Development and review of safety regulations

Current through Register Vol. 54, No. 28, July 13, 2024
Regulations governing procedures to assure the safety of
						anesthetics and other medical gases shall be developed, approved and reviewed
						by appropriate representatives of the medical staff and of the governing
						body.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 555 - MEDICAL STAFF › ANESTHESIA SERVICES › Section 555.35 - Safety regulations

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
					 Appropriate precautions shall be taken to ensure the safe administration of
					 anesthetic and other medical gas agents, in accordance with the latest edition
					 of NFPA Code 56G, and other applicable NFPA Codes as required.
(b) The machines used for anesthesia shall
					 have at least one annual function testing by technicians with appropriate
					 training and a log of this testing and outcomes shall be maintained.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 557 - QUALITY ASSURANCE AND IMPROVEMENT › Section 557.1 - Policy

Current through Register Vol. 54, No. 28, July 13, 2024
The ASF, with active participation of the medical and
					 nursing staff, shall conduct an ongoing quality assurance and improvement
					 program designed to objectively and systematically monitor and evaluate the
					 quality and appropriateness of patient care, pursue opportunities to improve
					 patient care and resolve identified problems.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 557 - QUALITY ASSURANCE AND IMPROVEMENT › Section 557.2 - Plan

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The ASF shall
				  have a written plan for the quality assurance and improvement program that
				  describes the program's objectives, organization, scope and mechanisms for
				  overseeing the effectiveness of monitoring, evaluation and problem solving
				  activities.
(b) The written plan
				  shall be endorsed by the governing body and the medical director who are
				  responsible for establishment and direction of the program and which indicates
				  the staff person responsible for implementation of the program.
(c) The plan shall emphasize the ongoing
				  nature of the quality assurance program and the comprehensiveness of the scope
				  of the program which shall include monitoring and evaluation of the following:
(1) Medical staff functions including:
(i) Peer-based review of clinical performance
				  of individuals with clinical privileges.
(ii) Surgical case and tissue
				  review.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 557 - QUALITY ASSURANCE AND IMPROVEMENT › Section 557.3 - Quality Assurance and Improvement Program

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The quality assurance program shall
				  include monitoring and evaluation of data collected, based on defined criteria
				  that reflect current knowledge and clinical experience and relate to the care
				  provided by the service. Sources of data include the medical records, incident
				  reports, infection control records and patient complaints. The medical record
				  shall contain sufficient data to support the diagnosis and determine that the
				  procedures are appropriate to the diagnosis. Facilities that treat pediatric
				  patients shall segregate data regarding these patients.
(b) The quality assurance program shall
				  provide for the identification of problems and actions taken-through the
				  monitoring and evaluation process-which improve the quality of patient
				  care.
(c) The frequency, severity
				  and source of suspected problems or concerns are evaluated by practitioners and
				  nurses.
(d) Measures shall be
				  implemented to resolve important problems or concerns identified. The results
				  of these corrective measures shall be monitored to assure that the problem has
				  been satisfactorily resolved. Measures which may be taken include:
(1) Changes in policies and
				  procedures.
(2) Staffing and
				  assignment changes.
(3) Appropriate
				  education and training.
(4)
				  Adjustments in clinical privileges.
(5) Changes in equipment or physical
				  plant.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 557 - QUALITY ASSURANCE AND IMPROVEMENT › Section 557.4 - Quality Assurance and Improvement Committee

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The Committee shall consist of the
				  following:
(1) A practitioner who is not an
				  owner.
(2) A representative of
				  administration.
(3) A registered
				  nurse.
(4) Other health care
				  personnel, as appropriate.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 559 - NURSING SERVICES › Section 559.1 - Nursing department

Current through Register Vol. 54, No. 28, July 13, 2024
The ASF shall have an organized nursing department under
					 the supervision of a registered nurse who has responsibility and accountability
					 for nursing services.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 559 - NURSING SERVICES › Section 559.2 - Director of nursing

Current through Register Vol. 54, No. 28, July 13, 2024
The director of nursing shall be currently licensed as a
					 registered nurse in this Commonwealth and be responsible and accountable to the
					 person in charge of the ASF for:
(1)
				  Delivery of nursing services to patients.
(2) Development and maintenance of nursing
				  service goals and objectives, standards of nursing practice, nursing policy and
				  procedure manuals and written job descriptions for each level of
				  personnel.
(3) Coordination of
				  nursing services with other patient services.
(4) Establishment of a means of assessing the
				  nursing care needs of patients and staffing to meet those needs.
(5) Staff development.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 559 - NURSING SERVICES › Section 559.3 - Nursing personnel

Current through Register Vol. 54, No. 28, July 13, 2024
(a) An adequate
				  number of licensed and assistive personnel shall be on duty to assure that
				  staffing levels meet the total nursing needs of patients based on the number of
				  patients in the facility and their individual nursing care needs. Class B and
				  Class C ASFS which provide surgical services to pediatric patients shall have
				  nursing staff with documented experience in the postoperative care of these
				  patients.
(b) At least one
				  registered nurse shall be in attendance during the hours patients are present.
				  Nursing personnel shall be assigned to duties consistent with their education,
				  training and experience.
(c)
				  Registered professional nurses or licensed practical nurses practicing at an
				  ASF shall be licensed to practice in this Commonwealth. There shall be a
				  procedure to verify the licensure status of the nurses.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 559 - NURSING SERVICES › Section 559.4 - Staffing schedules

Current through Register Vol. 54, No. 28, July 13, 2024
(a) There shall
				  be staffing schedules reflecting actual nursing personnel required for the ASF.
				  Staffing patterns should reflect consideration of nursing goals, standards of
				  nursing practice and the needs of the patients.
(b) Schedules which contain an indication of
				  personnel attendance by date, and time of actual attendance shall be kept on
				  file for a minimum of 1 year.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 559 - NURSING SERVICES › Section 559.5 - Nursing notes

Current through Register Vol. 54, No. 28, July 13, 2024
Nursing notes shall be pertinent, accurate and concise so
					 that they contribute to the continuity of patient care. Nursing records and
					 reports shall become part of the patient's medical record.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 561 - PHARMACEUTICAL SERVICES › GENERAL PROVISIONS › Section 561.1 - Drugs and biologicals

Current through Register Vol. 54, No. 28, July 13, 2024
The ASF shall provide drugs and biologicals in a safe and
						effective manner to meet the needs of the patients and to adequately support
						the organization's clinical capabilities commensurate with their license
						classification, in accordance with accepted ethical and professional practice
						and applicable State and Federal law, including the Pharmacy Act (63 P. S.
						§§
												390.1-390.13), 49 Pa. Code
						Chapter 27 (relating to State Board of Pharmacy), The Controlled Substance,
						Drug, Device and Cosmetic Act (35 P. S. §§
												780-101-780-144) and Chapter 25 (relating to
						controlled substances, drugs, devices and cosmetics).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 561 - PHARMACEUTICAL SERVICES › GENERAL PROVISIONS › Section 561.2 - Pharmaceutical service

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
					 Pharmaceutical services shall be supervised by a physician or dentist who is
					 qualified to assume professional, organization and administrative
					 responsibility for the quality of services rendered. Practitioners may dispense
					 drugs only to the patients who are in their care.
(b) A pharmacy owned and operated by the ASF
					 shall be supervised by a licensed pharmacist.
(c) Contracted pharmaceutical services shall
					 be provided in accordance with the same ethical and professional practices and
					 legal requirements that would be required if these services are provided
					 directly by the organization.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 561 - PHARMACEUTICAL SERVICES › PHARMACEUTICAL FACILITIES › Section 561.11 - Principle

Current through Register Vol. 54, No. 28, July 13, 2024
The ASF shall provide equipment and supplies for the
						pharmaceutical service to implement its professional and administrative
						functions and to ensure patient safety through the proper storage and
						dispensing of drugs. Facilities shall be provided for the storage,
						safeguarding, preparation and dispensing of drugs.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 561 - PHARMACEUTICAL SERVICES › PHARMACEUTICAL FACILITIES › Section 561.12 - Supplies

Current through Register Vol. 54, No. 28, July 13, 2024
The pharmacist or practitioner in charge of the
						pharmaceutical service shall maintain a supply of drugs and devices adequate to
						meet the needs of the patients. Pharmacy supplies shall conform to 49 Pa. Code
						§
											27.14 (relating to
						supplies).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 561 - PHARMACEUTICAL SERVICES › PHARMACEUTICAL FACILITIES › Section 561.13 - Storage

Current through Register Vol. 54, No. 28, July 13, 2024
The area in the ASF where drugs are stored shall be
						periodically checked by the responsible pharmacist or practitioner and proper
						logs maintained.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 561 - PHARMACEUTICAL SERVICES › PHARMACEUTICAL FACILITIES › Section 561.14 - Space

Current through Register Vol. 54, No. 28, July 13, 2024
There shall be adequate space provided for pharmaceutical
						operations, and the storage of drugs at a satisfactory location provided with
						proper lighting. Ventilation and temperature controls shall be in accordance
						with 49 Pa. Code §§
											27.15 and
						27.16 (relating to sanitary
						standards; and construction requirements).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 561 - PHARMACEUTICAL SERVICES › PHARMACEUTICAL FACILITIES › Section 561.15 - Locked storage

Current through Register Vol. 54, No. 28, July 13, 2024
Special locked storage space shall be provided to meet
						requirements for storage of controlled substances, alcohol and other prescribed
						drugs as set forth in Chapter 25 (relating to controlled substances, drugs,
						devices and cosmetics) and 49 Pa. Code §§
											27.16(b)(4) and
						27.17 (relating to construction
						requirements; and security for Schedule II controlled
						substances).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 561 - PHARMACEUTICAL SERVICES › POLICIES AND PROCEDURES › Section 561.21 - Principle

Current through Register Vol. 54, No. 28, July 13, 2024
The scope of the pharmaceutical service shall be
						consistent with the medication needs of the patients and congruent with the
						license classification of the ASF. The pharmaceutical policies shall include a
						program for the control and accountability of drug products throughout the ASF.
						If drugs are used for an experimental purpose, the use thereof shall be
						approved by an Institutional Review Board (IRB) or an IRB shall waive review
						and proper consent for use shall be obtained.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 561 - PHARMACEUTICAL SERVICES › POLICIES AND PROCEDURES › Section 561.22 - Records

Current through Register Vol. 54, No. 28, July 13, 2024
(a) Drug
					 transactions of the pharmaceutical service shall be recorded, and those records
					 shall be correlated with other ASF records. Records and security shall be
					 maintained to assure the control and safe dispensing of drugs and compliance
					 with Federal and Commonwealth statutes.
(b) Drugs ordered and administered to
					 patients shall be documented in the medical record of the patient.
(c) Oral orders for drugs for immediate
					 administration shall be followed by a written order, signed by the prescribing
					 practitioner, prior to the discharge of the patient.
(d) Adverse drug reactions and drug
					 sensitivities shall be recorded in the patient's medical record and copies
					 maintained for review by the quality assurance committee.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 561 - PHARMACEUTICAL SERVICES › POLICIES AND PROCEDURES › Section 561.23 - Use of controlled substances and other drugs

Current through Register Vol. 54, No. 28, July 13, 2024
There shall be policies and procedures developed and
						approved by the medical staff which establish controls governing the use of
						controlled substances and other drugs, including sedatives, anticoagulants,
						antibiotics, oxytoxics and corticosteroids. Policies shall be established
						regarding written orders for appropriate dosage of all drugs.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 561 - PHARMACEUTICAL SERVICES › POLICIES AND PROCEDURES › Section 561.24 - Emergency pharmaceutical services

Current through Register Vol. 54, No. 28, July 13, 2024
Provision shall be made for emergency pharmaceutical
						services. Emergency drugs shall be kept readily available and under the control
						of either the pharmacist or the practitioner in charge of pharmaceutical
						services.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 561 - PHARMACEUTICAL SERVICES › POLICIES AND PROCEDURES › Section 561.25 - Distressed drugs, devices and cosmetics

Current through Register Vol. 54, No. 28, July 13, 2024
Drugs, devices and cosmetics which are outdated, visibly
						deteriorated, unlabeled or inadequately labeled, recalled, discontinued or
						obsolete shall be identified by the licensed pharmacist or responsible
						practitioner and shall be disposed of in compliance with applicable
						Commonwealth and Federal regulations.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 561 - PHARMACEUTICAL SERVICES › POLICIES AND PROCEDURES › Section 561.26 - Mishandling of drugs

Current through Register Vol. 54, No. 28, July 13, 2024
If there is reason to suspect mishandling of scheduled or
						controlled drugs, the person in charge of the ASF shall contact the Bureau of
						Drug Control of the Office of Attorney General or State or local
						police.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 563 - MEDICAL RECORDS › Section 563.1 - Principle

Current through Register Vol. 54, No. 28, July 13, 2024
The ASF shall maintain complete, comprehensive and accurate
					 medical records for every patient to ensure adequate patient
					 care.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 563 - MEDICAL RECORDS › Section 563.2 - Organization and staffing

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The ASF
				  shall have a medical record service. It shall be directed, staffed and equipped
				  to ensure the accurate processing, indexing and filing of medical
				  records.
(b) At least one full-time
				  or part-time employe shall provide regular medical record service.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 563 - MEDICAL RECORDS › Section 563.3 - Facilities

Current through Register Vol. 54, No. 28, July 13, 2024
The medical record service shall be properly equipped to
					 enable its personnel to function in an effective manner and to maintain medical
					 records so that they are readily accessible and secure from unauthorized
					 use.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 563 - MEDICAL RECORDS › Section 563.4 - Identification and filing of medical records

Current through Register Vol. 54, No. 28, July 13, 2024
The medical record service shall maintain a system of
					 identification and filing to facilitate the prompt location of the medical
					 record of a patient.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 563 - MEDICAL RECORDS › Section 563.6 - Preservation of medical records

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The
				  facility shall have a written policy regarding the retention of records.
				  Medical records whether original, reproductions or microfilm, shall be kept on
				  file for a minimum of 7 years following the discharge of a patient.
(b) If the patient is a minor, records shall
				  be kept on file until his majority, and then, for 7 years or as long as the
				  records of adult patients are maintained.
(c) If an ASF discontinues operation, it
				  shall make known to the Department where its records are stored. Records are to
				  be stored in a facility offering retrieval services for at least 5 years after
				  the closure date. Prior to destruction, public notice shall be made to permit
				  former patients or their representatives to claim their own records. Public
				  notice shall be in at least two forms, legal notice and display advertisement
				  in a local newspaper of general circulation.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 563 - MEDICAL RECORDS › Section 563.7 - Microfilming medical records

Current through Register Vol. 54, No. 28, July 13, 2024
Medical records may be microfilmed at any time including
					 immediately after completion. Microfilming may be done on or off the premises.
					 If done off the premises, the ASF shall take precautions to assure the
					 confidentiality and safekeeping of the records. The original of microfilmed
					 medical records may not be destroyed until the medical records service has had
					 an opportunity to review the processed film for content.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 563 - MEDICAL RECORDS › Section 563.8 - Automation or computerization of medical records

Current through Register Vol. 54, No. 28, July 13, 2024
Nothing in this subpart prohibits the use of automation or
					 computerization in the medical records service, if the provisions in this
					 chapter are met and the information is readily available for use in patient
					 care. Innovations in medical record formats, compilation and data retrieval are
					 specifically encouraged.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 563 - MEDICAL RECORDS › Section 563.9 - Confidentiality of medical records

Current through Register Vol. 54, No. 28, July 13, 2024
Records shall be treated as confidential. Only authorized
					 personnel shall have access to the records. The written authorization of the
					 patient shall be presented and then maintained in the original record as
					 authority for release of medical information outside the ASF.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 563 - MEDICAL RECORDS › Section 563.10 - Ownership

Current through Register Vol. 54, No. 28, July 13, 2024
There shall be written policies and procedures which
					 specify who has access to medical records, under what conditions records may be
					 removed from the ASF, and under what conditions medical record information may
					 be released. Medical records are the property of the ASF, and they may not be
					 removed from the premises except for court purposes. Copies may be made
					 available for authorized appropriate purposes, such as insurance claims and
					 practitioner review.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 563 - MEDICAL RECORDS › Section 563.11 - Patient access

Current through Register Vol. 54, No. 28, July 13, 2024
Patients or patient designees shall be given access to or a
					 copy of their medical records, or both. The patient or the patient's designee
					 may be charged for the cost of reproducing the copies; however, the charges
					 shall be reasonably related to the cost of making the copy.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 563 - MEDICAL RECORDS › Section 563.12 - Form and content of record

Current through Register Vol. 54, No. 28, July 13, 2024
The ASF shall maintain a separate medical record for each
					 patient. Every record shall be accurate, legible and promptly completed.
					 Patient medical records shall be constructed to stand alone and be easily
					 identified as ASF records. Medical records shall include at least the
					 following:
(1) Patient
				  identification.
(2) Pertinent
				  medical history and results of physical examination.
(3) Preoperative diagnostic studies-entered
				  before surgery-if performed.
(4)
				  The presence or absence of allergies and untoward drug reactions recorded in a
				  prominent and uniform location in all patient charts on a current
				  basis.
(5) Documentation of
				  properly executed, informed patient consent.
(6) Entries related to anesthesia
				  administration.
(7) Findings and
				  techniques of the operation, including a pathologist report on tissue removed
				  during surgery.
(8) Notes by
				  authorized staff members and individuals who have been granted clinical
				  privileges, nurses' notes and entries by other professional
				  personnel.
(9) Written and verbal
				  disposition recommendations and instructions given to the patient.
(10) Significant medical advice given to a
				  patient by telephone.
(11)
				  Discharge summary including discharge diagnosis.
This section cited in 28 Pa. Code §
												563.13 (relating to
						entries).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 563 - MEDICAL RECORDS › Section 563.13 - Entries

Current through Register Vol. 54, No. 28, July 13, 2024
(a) Entries in the
				  record shall be dated and authenticated by the person making the
				  entry.
(b) Symbols and
				  abbreviations may be used only when they have been approved by the medical
				  staff and when a legend exists to explain them.
(c) A single signature on the fact sheet of a
				  record does not suffice to authenticate the entire record. Each entry shall be
				  individually authenticated.
(d)
				  Notation of unusual incidents shall be entered in the medical record.
(e) Necessary documentation on the patient's
				  medical record as specified in §
										563.12 (relating to form and
				  content of record) shall be completed in a timely manner not to exceed 30
				  days.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 565 - LABORATORY AND RADIOLOGY SERVICES › LABORATORY SERVICES › Section 565.1 - Principle

Current through Register Vol. 54, No. 28, July 13, 2024
The ASF shall have procedures for obtaining routine and
						emergency laboratory services to meet the needs of patients.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 565 - LABORATORY AND RADIOLOGY SERVICES › LABORATORY SERVICES › Section 565.2 - Laboratory service policy

Current through Register Vol. 54, No. 28, July 13, 2024
Laboratory services shall be provided under The Clinical
						Laboratory Act (35 P. S. §§
												2151-2165) and Chapter 5 (relating to
						clinical laboratories).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 565 - LABORATORY AND RADIOLOGY SERVICES › LABORATORY SERVICES › Section 565.3 - Functions

Current through Register Vol. 54, No. 28, July 13, 2024
Laboratory functions shall include:
(1) Performing tests in a timely
					 manner.
(2) Distributing test
					 results within 24 hours after completion of a test and maintaining a copy of
					 the results in the laboratory.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 565 - LABORATORY AND RADIOLOGY SERVICES › LABORATORY SERVICES › Section 565.4 - Records

Current through Register Vol. 54, No. 28, July 13, 2024
Dated reports of services performed shall be made a part
						of the patient's medical record.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 565 - LABORATORY AND RADIOLOGY SERVICES › RADIOLOGY SERVICES › Section 565.11 - Principle

Current through Register Vol. 54, No. 28, July 13, 2024
Radiology services provided or made available shall meet
						the needs of the patients and shall be provided in accordance with ethical and
						professional standards of the American Society of Radiologic Technologists and
						the American College of Radiology.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 565 - LABORATORY AND RADIOLOGY SERVICES › RADIOLOGY SERVICES › Section 565.12 - Radiology service policy

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The
					 service shall be provided by contract or directly by the ASF.
(b) Applicable provisions of the Department
					 of Environmental Protection regulations in 25 Pa. Code Chapters 221-233 and 25
					 Pa. Code §§
											235.1 and
					 235.11-235.15, and the United States
					 Nuclear Regulatory Commission regulations in 10 CFR Chapter I (relating to
					 Nuclear Regulatory Commission) shall be met by the ASF or its contracted
					 radiology service.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 565 - LABORATORY AND RADIOLOGY SERVICES › RADIOLOGY SERVICES › Section 565.13 - Organization and staffing

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
					 Radiology services provided by the ASF shall be directed by a person who is
					 qualified to assume professional, organizational and administrative
					 responsibility for the quality of services rendered.
(b) Sufficient adequately trained, certified
					 and experienced personnel shall be available to supervise and conduct the work
					 of the radiology services.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 565 - LABORATORY AND RADIOLOGY SERVICES › RADIOLOGY SERVICES › Section 565.14 - Policies

Current through Register Vol. 54, No. 28, July 13, 2024
(a) Policies shall
					 address the quality aspects of radiology services including, but not limited
					 to:
(1) Performing radiology services only
					 upon the written order of a practitioner, which shall be accompanied by a
					 concise statement of the reason for the examination.
(2) Limiting the use of radioactive sources
					 to qualified persons in the organization who have been granted privileges for
					 the use on the basis of their training, experience and current
					 competence.
(3) Storing and
					 retaining of films.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 565 - LABORATORY AND RADIOLOGY SERVICES › RADIOLOGY SERVICES › Section 565.15 - Records

Current through Register Vol. 54, No. 28, July 13, 2024
Authenticated, dated reports of services performed shall
						be made a part of the patient's medical record, in a timely manner not to
						exceed 30 days.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 565 - LABORATORY AND RADIOLOGY SERVICES › RADIOLOGY SERVICES › Section 565.16 - Facilities

Current through Register Vol. 54, No. 28, July 13, 2024
If radiology services are provided by the ASF, adequate
						space, equipment and supplies shall be provided to perform the volume of work
						with optimal accuracy, precision, efficiency and safety.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 567 - ENVIRONMENTAL SERVICES › INFECTION CONTROL › Section 567.1 - Principle

Current through Register Vol. 54, No. 28, July 13, 2024
The ASF shall have a sanitary environment, properly
						constructed, equipped and maintained to protect surgical patients and ASF
						personnel from cross-infection and to protect the health and safety of
						patients.