[29 Pa.B. 5583]
[Continued from previous Web Page] (b) If the governing body elects, appoints or employs officers and administrators to carry out its directives, the authority, responsibility and functions of the positions shall be defined.
(c) If the governing body is comprised of two or more members, and if the majority of those members are practitioners, the governing body, either directly or by delegation, shall make--based on evidence of the education, training and current competence--initial appointments, reappointments and assignment or curtailment of clinical privileges of the practitioners.
(d) If the governing body is comprised of only one member, or if a majority of the members of the governing body are not practitioners, the ASF bylaws or similar rules and regulations shall specify a procedure for establishing medical review by practitioners for the purpose of recommending to the governing body for its approval based on evidence of the education, training and current competence--initial appointments, reappointments and assignment or curtailment of clinical privileges of the practitioners.
(e) If students and postgraduate trainees are present in the facility, their role and functions shall be defined.
(f) The governing body shall ensure that personnel are provided with continuing education which is relevant to their responsibilities within the organization.
(g) The governing body shall ensure that the licensee provides to the Department, the documents under § 551.53 (relating to presurvey preparation).
(h) The governing body shall appoint a medical director who shall be board certified by an American Board of Medical Specialties recognized board or the dental, podiatric or osteopathic equivalent. The governing body may appoint an interim director during the period of time between the departure of a director and the selection of a new director.
(1) The interim director shall be a physician who is able to demonstrate qualifications acceptable to the medical staff of the ASF and to the Department.
(2) If the interim director is not board certified, the Department will specify the maximum period of time for which the interim director may serve.
ADMISSION, TRANSFER AND DISCHARGE § 553.21. Principle.
(a) The ASF shall have written policies for the admission, discharge, transfer and proper referral of patients.
(b) The ASF may not provide beds or other accommodations for an overnight stay of patients.
(c) A patient shall be discharged in a conscious and coherent condition and able to maintain vital life functions or shall be transferred to a hospital.
(d) A patient shall be discharged only with appropriate discharge instructions under § 555.24 (relating to postoperative care).
§ 553.22. Admission criteria.
The governing body, with the advice of and in conjunction with the medical staff, shall establish medical criteria for admissions under § 555.22(a) (relating to preoperative care). Medical criteria shall be congruent with the assigned ASF class level stated on the facility license.
§ 553.25. Discharge criteria.
A patient may only be discharged from an ASF if the following physical status criteria are met:
(1) Vital signs. Blood pressure, heart rate, temperature and respiratory rate are within the normal range for the patient's age or at preoperative levels for that patient.
(2) Activity. The patient has regained preoperative mobility without assistance or syncope, or function at the patient's usual level considering limitations imposed by the surgical procedure.
(3) Mental status. The patient is awake, alert or functions at the patient's preoperative mental status.
(4) Pain. The patient's pain can be effectively controlled with medication.
(5) Bleeding. Bleeding is controlled and consistent with that expected from the surgical procedure.
(6) Nausea/vomiting. Minimal nausea or vomiting is controlled and consistent with that expected from the surgical procedure.
MANAGEMENT AND ADMINISTRATION OF OPERATIONS § 553.31. Administrative responsibilities.
(a) A full time person in charge shall be appointed who has authority and responsibility for the operation of the ASF at all times. Qualifications, authority, responsibilities and duties of the person in charge shall be defined in a written statement adopted by the governing body.
(b) Administrative policies, procedures and controls shall be established, documented and implemented to assure the orderly and efficient management of the ASF.
CHAPTER 555. MEDICAL STAFF
MEDICAL STAFF § 555.3. Requirements for membership and privileges.
(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.
(e) Reappraisal and reappointment shall be required of every member of the medical staff at regular intervals no longer than every 2 years.
(f) The governing body shall request and consider reports from the National Practitioner Data Bank on each practitioner who requests privileges.
§ 555.4. Clinical activities and duties of physician assistants and certified registered nurse practitioners.
(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.
MEDICAL ORDERS § 555.11. Written orders.
(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.
§ 555.12. Oral orders.
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.
§ 555.13. Administration of drugs.
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.
SURGICAL SERVICES § 555.21. Surgical procedures.
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.
§ 555.22. Preoperative care.
(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.
(b) A written statement indicating informed consent, obtained by the practitioner, and signed by the patient, or responsible person, for the performance of the specific procedures shall be procured and made part of the patient's clinical record. It shall contain a statement which evidences the appropriateness of the proposed surgery, as well as any alternative treatments discussed with the patient. It shall also identify any practitioner who will participate in the surgery.
(c) Written instructions for preoperative procedures, which have been approved by the medical staff, shall be given to the patient or responsible person, and shall include:
(1) Applicable restrictions upon food and drink before surgery.
(2) Special preparations to be made by the patient.
(3) The required proximity of the patient to the ASF for a specific time following surgery, if applicable.
(4) An understanding that the patient may require admission to the hospital in the event of medical need.
(5) Upon discharge of a patient who has received sedation or general anesthesia, a responsible person shall be available to escort the patient home. With respect to patients who receive local or regional anesthesia, a medical decision shall be made regarding whether these patients require a responsible person to escort them home.
(d) Preoperative diagnostic studies, if performed, shall be evaluated, annotated, signed and entered into the patient's medical record before surgery.
(e) Prior to the administration of anesthesia, it is the responsibility of the primary operating surgeon and the person administering anesthesia to properly identify the patient and the procedure to be performed and to document this identification in the patient's medical record. This procedure shall be in written policies designating the mechanism to be used to identify each surgical patient.
§ 555.23. Operative care.
(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.
§ 555.24. Postoperative care.
(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.
(g) Patients shall be discharged only on the written signed order of a practitioner.
ANESTHESIA SERVICES § 555.31. Principle.
(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.
§ 555.32. Administration of anesthesia.
(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.
§ 555.33. Anesthesia policies and procedures.
(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.
(d) Anesthesia procedures shall provide at least the following:
(1) A patient requiring anesthesia shall have a pre-anesthesia evaluation by a practitioner, with appropriate documentation of pertinent information regarding the choice of anesthesia.
(2) A review and documentation shall be made of the condition of the patient immediately prior to induction of anesthesia, including pertinent laboratory findings, time of administration and dosage of preanesthesia medications.
(3) Prior to beginning the administration of anesthesia, the anesthetist shall check equipment to be used in administration of anesthetic agents. An anesthetic gas machine in anesthetising areas shall have a pin-index safety system.
(4) Following the procedure for which anesthesia was administered, the anesthetist shall remain with the patient as long as necessary to insure safe transport to the recovery area and shall advise personnel responsible for postanesthetic care of the condition of the patient.
(5) A patient receiving anesthesia shall have an anesthetic record maintained. This shall include a record of vital signs and all events taking place during the induction of, maintenance of and emergence from anesthesia, including the dosage and duration of anesthetic agents, other drugs and intravenous fluids.
(6) Intraoperative physiologic monitoring shall include the following at a minimum:
(i) The use of oxygen saturation by pulse oximetry.
(ii) The use of End Tidal CO2 monitoring during endotracheal anesthesia.
(iii) The use of EKG monitoring.
(iv) The use of blood pressure monitoring.
(7) A patient may not receive general anesthesia unless one or more additional health care professionals besides the one performing the surgery, are present, one of whom is trained in the administration of anesthesia.
(8) Before discharge from the ASF, a patient shall be evaluated for proper anesthesia recovery by an anesthetist, the operating room surgeon, anesthesiologist or dentist. Depending on the type of anesthesia and length of surgery, the postoperative check shall include at least the following:
(i) Level of activity.
(ii) Respirations.
(iii) Blood pressure.
(iv) Level of consciousness.
(v) Oxygen saturation by pulse oximetry.
§ 555.35. Safety regulations.
(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.
CHAPTER 557. QUALITY ASSURANCE AND IMPROVEMENT § 557.1. Policy.
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.
§ 557.2. Plan.
(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.
(2) Anesthesia services.
(3) Nursing services.
(4) Pharmaceutical services.
(5) Pathology and radiology services.
(6) Infection control procedures.
(7) Procedures performed in the ASF and their necessity.
(8) Reports of accidents, injuries and safety hazards.
(d) The plan shall include participation of practitioners and other health care personnel.
§ 557.3. The quality assurance and improvement program.
(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.
(e) The program shall include a mechanism to assure that activities are documented and reports of the quality assurance activities are brought to the attention of the governing body. There shall be a periodic reappraisal of the program.
(f) The quality assurance program shall include the establishment of a quality assurance committee.
§ 557.4. Quality assurance and improvement committee.
(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.
(b) Committee functions shall include:
(1) Evaluating data submitted as part of the quality assurance program.
(2) Reviewing credentials.
(3) Reviewing tissue examination reports.
(4) Reviewing infection control program.
(5) Reviewing the standards of practice in all specific areas of the ASF.
(c) Committee records of the activities shall include:
(1) Reports made to the governing body.
(2) Minutes of committee meetings including date, time, persons attending, description and results of cases reviewed and recommendations made by the committee.
(3) Corrective actions taken including appropriate orientation, training or education programs necessary to correct deficiencies which are uncovered as a result of the quality assurance program.
CHAPTER 559. NURSING SERVICES § 559.2. Director of nursing.
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.
§ 559.3. Nursing personnel.
(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.
CHAPTER 561. PHARMACEUTICAL SERVICES
GENERAL PROVISIONS § 561.1. Drugs and biologicals.
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 licensed 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).
§ 561.2. Pharmaceutical service.
(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.
PHARMACEUTICAL FACILITIES § 561.13. Storage.
The area in the ASF where drugs are stored shall be periodically checked by the responsible pharmacist or practitioner and proper logs maintained.
POLICIES AND PROCEDURES § 561.21. Principle.
The scope of the pharmaceutical service shall be consistent with the medication needs of the patients and congruent with the licensed 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.
§ 561.23. Use of controlled substances and other drugs.
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.
CHAPTER 563. MEDICAL RECORDS § 563.8. Automation or computerization of medical records.
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.
§ 563.12. Form and content of record.
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.
§ 563.13. Entries.
(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.
CHAPTER 565. LABORATORY AND RADIOLOGY SERVICES
RADIOLOGY SERVICES § 565.12. Radiology service policy.
(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.
§ 565.13. Organization and staffing.
(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.
§ 565.15. Records.
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.
CHAPTER 567. ENVIRONMENTAL SERVICES
INFECTION CONTROL § 567.1. Principle.
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.
§ 567.3. Policies and procedures.
(a) Only authorized persons, who are properly attired, shall be allowed in the surgical area.
(b) Current written policies and procedures to assure definite and valid infection control shall include the following:
(1) Medical asepsis.
(2) Surgical asepsis.
(3) Sterilization and disinfection, including suitable equipment for routine and rapid sterilization.
(4) Sterilized materials are packaged, labeled and dated in a consistent manner.
(5) Housekeeping.
(6) Cleaning of surgical suites prior to each operation.
(7) Clean and soiled linen and utility rooms.
(8) Linen.
(9) Traffic flow patterns.
(10) Isolation protocols.
(11) Staff health status requirements.
(12) Infection control in-service education for personnel.
(13) Recording and reporting of potential infection.
(14) Bacteriological testing of potential infections, recording results and reporting to the quality assurance committee.
(15) Admission criteria for patients with specific or suspected infections.
(16) Patient postdischarge investigation.
(17) Reporting of communicable diseases as required by § 27.2 (relating to reportable diseases).
SUPPLIES § 567.11. Operating suite equipment.
The operating suite shall be adequately equipped with age appropriate equipment for the types of procedures to be performed and the recovery area shall be adequately equipped for the proper care of postanesthesia recovery of surgical patients. All equipment and supplies shall be age and size appropriate for the patients treated. The following equipment shall be available in the operating suite and recovery area.
(1) Suitable surgical instruments customarily available for the planned surgical procedure.
(2) Emergency call system.
(3) Airways, breathing bag and device for the provision of positive pressure rescue breathing.
(4) Cardio-pulmonary drugs and intubation equipment.
(5) Cardiac monitor and defibrillator.
(6) Resuscitator including oxygen and suction equipment.
(7) Tracheostomy and necessary pulmonary reexpansion supplies.
HOUSEKEEPING SERVICES § 567.32. Policies and procedures.
Procedures shall be developed for cleaning and care of equipment, for establishment of cleaning schedules, for cleaning methods and for proper use of cleaning supplies and disposal of waste. Suitable equipment shall be provided to facilitate cleaning.
CHAPTER 569. FIRE AND SAFETY SERVICES
GENERAL PROVISIONS § 569.2. Fire safety standards.
(a) An ASF shall meet the applicable edition of National Fire Protection Association 101 Life Safety Code, which is currently adopted by the Department.
(b) An ASF previously in compliance with prior editions of the Life Safety Code, is deemed in compliance with subsequent Life Safety Codes, except renovation or new construction shall meet the current edition adopted by the Department.
INTERNAL DISASTER PLAN § 569.11. Firefighting service.
The person in charge of the ASF shall establish a workable plan with the nearest fire department for fire- fighting service. The ASF shall provide the fire department with a current floor plan of the building showing the location of firefighting equipment, exits, patient rooms, storage places of flammable and information that the fire department requires or as may be necessary.
EVACUATION DRILLS § 569.21. Fire drills.
(a) Fire, internal disaster and evacuation drills shall be held at least quarterly for ASF personnel and under varied conditions.
(b) The CEO shall:
(1) Ensure that all personnel are trained to perform assigned duties.
(2) Ensure that all personnel are familiar with the use and operation of the firefighting equipment in the ASF.
(3) Enable the chief executive officer to evaluate the effectiveness of the plan.
(c) A written report and evaluation of drills conducted since the last survey shall be kept on file.
(d) The actual evacuation of patients to safe areas during a drill is optional.
SAFETY PRECAUTIONS § 569.33. Smoking.
Smoking is not permitted in an ASF.
§ 569.35. General safety precautions.
The following safety precautions shall be met:
(1) Doorways, corridors and stairwells shall be properly lighted and free of obstructions.
(2) Doors into patient rooms may not be locked.
(3) Exit doors may not be locked from the inside while patients are in the ASF.
(4) Doors opening to shafts shall be equipped with self-closing devices and positive latches.
(5) Wastebaskets, cubicle curtains, window shades and drapes shall be rendered flame retardant.
(6) Call bells in the shower, tub room or water closet shall be easily accessible to patients.
(7) Only nonflammable agents may be present in a surgical suite.
CHAPTER 571. CONSTRUCTION STANDARDS
GENERAL PROVISIONS § 571.1. Minimum standards.
ASF construction shall be in accordance with the latest edition of the ''Guidelines for Design and Construction of Hospital and Health Care Facilities,'' as published by the American Institute of Architects/Academy of Architecture for Health including those guidelines established for various outpatient facilities. In the alternative, a facility shall meet the construction guidelines for specified types of surgical procedures as listed in Appendix A (relating to alternative construction guidelines). Where renovation or replacement work is performed within an existing facility, all new work or additions shall comply with the requirements for new construction.
§ 571.2. Modifications to HHS requirements.
(a) Life Safety Code means the standard as defined in § 569.2 (relating to fire safety standards).
(b) Adequate storage areas shall be provided to meet the needs of the facility.
(c) Patient privacy shall be provided in preoperative and postoperative areas.
(d) In multistory buildings, where the ASF may be provided on floors other than at grade level, at least one hospital type elevator shall be provided.
(e) Elevators shall conform to ''HHS Requirements'' and the latest edition of the ''American National Standard Safety Code for Elevators, Dumbwaiters, Escalators and Moving Stairs.''
(f) The Americans with Disabilities Act of 1990 (ADA) (42 U.S.C.A. §§ 12101--12213).
SUBMISSION OF PLANS § 571.11. Principle.
Plans and specifications shall be submitted to the Division of Safety Inspection of the Department for approval prior to construction of an ASF, in accordance with § 51.5 (relating to building occupancy). Submission shall be in three stages.
§ 571.13. (Reserved).
CHAPTER 573. (Reserved) § 573.1. (Reserved).
§ 573.2. (Reserved).
APPENDIX A. ALTERNATIVE CONSTRUCTION GUIDELINES
ENDOSCOPY 1) Office Endoscopy, edited by Bergein F. Overholt and Sarkis J. Chobanian.
2) Planning an Endoscopy Suite for Office and Hospital, by Jerome D. Waye and Martin E. Rich.
[Pa.B. Doc. No. 99-1827. Filed for public inspection October 22, 1999, 9:00 a.m.]
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