[27 Pa.B. 3609]
[Continued from previous Web Page] (1) Deficiencies are, individually and in combined effect, of a minor nature so that neither the deficiencies [nor] or efforts toward their correction will not do one of the following:
* * * * * (iii) Exceed the assigned classification of the ASF.
* * * * * § 551.83. Provisional license.
* * * * * [(d) A provisional license will not be issued to services or facilities, or parts of facilities, which are subject to Certificate of Need review, if the review has not been completed.]
REFUSAL OR REVOCATION § 551.91. Grounds.
(a) The Department may refuse to issue a license for [any] one or more of the following reasons:
* * * * * [(5) A Certificate of Need, if necessary, has not been issued.]
(b) The Department may refuse to renew a license, or may suspend or revoke or limit a license for all or a portion of an ASF, or for a particular service offered by an ASF, or may suspend admissions for any of the following reasons:
* * * * * (10) Providing services exceeding the scope of the classification assigned in the license.
[(c) Failure to obtain a Certificate of Need will necessitate a licensure modification to exclude the areas lacking certificate of need approval.]
§ 551.93. Notice.
(a) If the Department proposes to revoke, modify, limit or refuse to issue or renew a license or to issue a provisional license, or to suspend admissions or to levy a civil penalty against the ASF, it will give written notice to the ASF by certified mail.
(b) Written notice will specify the reasons for the proposed action of the Department and will notify the ASF of its right to a hearing. The order will specify the time within which a request of the ASF for a hearing shall be filed with the [State Health Facility Hearing Board] Health Policy Board.
HEARINGS § 551.111. Hearings relating to licensure.
Hearings relating to licensure, including the issuance of a provisional license, or the suspension of admissions, will be conducted by the [State Health Facility Hearing] Health Policy Board, 37 Pa. Code Chapter 197 (relating to practice and procedure).
[CIVIL RIGHTS] § 551.121. [Principle] (Reserved).
[An ASF shall comply with the Pennsylvania Human Relations Act (43 P. S. §§ 951--963) and 16 Pa. Code Part II, Subpart A (relating to Human Relations Commission).]
§ 551.122. [Civil rights compliance] (Reserved).
[Civil rights compliance shall be a condition required for the issuance of a license. The Department may make on-site visits to verify the civil rights compliance status of the ASF.]
§ 551.123. [Civil rights compliance records] (Reserved).
[The following records shall be maintained to indicate that no person is excluded from participation in, is denied the benefits of, or is otherwise subjected to discrimination in the provision of care or services on the ground of age, race, creed, color, sex, national origin, religion, handicap or disability.
(1) A signed and dated copy of the policies of the ASF pertaining to the admission of patients and visitors. The date the policies were adopted shall also be indicated. The policies shall set forth in clear terms nondiscriminatory practices with regard to age, race, creed, color, religion, national origin, sex, handicap or disability.
(2) Other records or reports as may be required by the Department, to determine compliance with the Pennsylvania Human Relations Act (43 P. S. §§ 951--963).]
CHAPTER 553. OWNERSHIP, GOVERNANCE AND MANAGEMENT
GOVERNING BODY § 553.2. Ownership.
(a) The owner of the ASF may be an individual, partnership, association, a corporation or a combination thereof. [The following rules apply to ASFs according to the mode of ownership:]
[(1) Individual ownership.] (b) A complete list of the names and addresses of owners [and of the persons in charge] , directors, officers and managers shall be submitted with the application. [When a sole owner of an ASF dies, the executor or administrator of the estate may apply for, and the Department may, after review, approve the transfer of the license for the ASF.
(2) Partnerships. A complete list of names and addresses of the persons in charge and partners shall be submitted with the application. If a license is issued to a partnership and one or more of the partners dies, the executor or administrator of the deceased's estate, together with the surviving partners may apply for a license. After review, the Department may transfer the license.
(3) Association or corporation. A complete list of names and addresses of the officers and directors, of the corporate owner and of the parent corporation, if applicable, and of the persons in charge, who are responsible for the management of the ASF, shall be submitted with the application.
(4) Stockholders with 5% ownership interest. A facility shall list persons who have a direct or indirect ownership interest of 5% or more in the ASF, including, for example, stockholders.
(b) The Department shall be notified in writing within 30 days after a change has taken place in the officers, directors, stockholders with 5.0% or more ownership interest or persons in charge of an ASF.]
(c) [The Department shall be notified in writing at least 90 days before a change in ownership or the form of ownership or name of the facility takes place. The license is transferable upon approval by the Department] Owners shall be considered any person who has a direct or indirect equity interest in the facility of 5% or more, including, shareholders and partners.
* * * * * § 553.3. Governing body responsibilities.
Governing body responsibilities include[, but are not limited to]:
* * * * * (8) Establishing personnel policies and practices which adequately support sound patient care to include[, but not be limited to,] the following:
(i) Require the employment of personnel with qualifications commensurate with a job's responsibilities and authority, including appropriate licensure and certification.
[(i)] (ii) ***
[(ii)] (iii) * * *
[(iii) An employe shall be determined to be physically able to perform duties. Reasonable precautions shall be taken to assure the absence of detectable active communicable disease.]
(iv) Compliance with Occupational Safety and Health Administration (OSHA) Universal Precautions for prevention of transmission of diseases.
[(iv)] (v) ***
(vi) Compliance with Federal and State regulations including, The Americans with Disabilities Act of 1990 (42 U.S.C.A. §§ 12101--12213), civil rights and OSHA regulations.
* * * * * (13) Approving major contracts or arrangements affecting the medical care provided under its auspices, including, [but not limited to,] those concerning:
(i) The employment [of practitioners] for contractual arrangements with practitioners and others providing direct patient care.
(ii) The provision of all treatment related services including, radiology, medical laboratory, pathology, anesthesia and pharmaceutical services.
(iii) The provision of care by other health care organizations[, such as hospitals under § 555.24(d)--(f) (relating to post-operative care)].
* * * * * (16) Assuring that at least one medical professional [working staff person] in the [surgical suite] facility is [certified] currently and on an ongoing basis certified in advanced cardiac life support, or its successor.
(17) Assuring that all ASF personnel wear identification tags which include the person's name and professional designation.
§ 553.4. Other functions.
* * * * * (c) If [a majority of its members are practitioners,] 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 [of the practitioners]--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 [of the practitioner]--initial appointments, reappointments and assignment or curtailment of clinical privileges of the practitioners.
* * * * * (g) The governing body shall ensure that [the following disclosure requirements are met:] the licensee provides to the Department, the documents under § 551.53 (relating to presurvey preparation).
[(1) The licensee provides to the appropriate health systems agency information that the health systems agency is required to collect under section 1512(b) of the National Health Planning and Resources Development Act (42 U.S.C.A. § 3001-1(b)).
(2) The licensee makes available to the public and the Department upon request the licensee's current reimbursement under Blue Shield, Blue Cross, Medical Assistance, Medicare and other third-party payment arrangements for a service, as well as the average usual and customary charge for a service to noninsured private pay patients.]
(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.
ADMISSION, TRANSFER AND DISCHARGE § 553.21. Principle.
* * * * * (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 his usual level considering limitations imposed by the surgical procedure.
(3) Mental status. The patient is awake, alert or functions at his 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.
* * * * * (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.
* * * * * (b) Privileges granted shall reflect the results of peer review or utilization review programs, or both, specific to ambulatory surgery.
[(b)] (c) ***
[(c)] (d) ***
(1) A written record of the application, which [include] includes the scope of privileges sought and granted. The delineation ''clinical privileges'' shall address the administration of anesthesia.
* * * * * [(d)] (e) ***
(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 nurse practitioners.
* * * * * (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). 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 Boards of Medicine and Nursing.
* * * * *
MEDICAL ORDERS § 555.12. Oral orders.
[Orders given orally for drugs and biologicals shall be followed by a written order, signed by the prescribing practitioner, within 24 hours of the order] 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 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 24 hours of the order. If the practitioner is not the attending physician, the practitioner must be authorized by the attending physician and shall be knowledgeable about the patient's condition.
§ 555.13. Administration of drugs.
Drugs shall be administered only upon the proper order of a practitioner acting within the scope of his 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. 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, on an annual basis, upon the recommendation of the medical staff and congruent with ASF classification as stated on their 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 [physician's] 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 [7] 30 days prior to date of surgery.
[(2) If it is a referred evaluation, a physician] 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 [surgeon] practitioner, and signed by the patient, or responsible person, for the performance of the specific [surgical procedure] 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 shall participate in the surgery.
(c) Written instructions for [pre-operative] preoperative procedures, which have been approved by the medical staff, shall be given to the patient or responsible person, and shall include [, but not be limited to]:
* * * * * (5) [The requirement that, upon] Upon discharge of a patient who has received sedation or general anesthesia, a responsible person shall be available to escort the patient home. [A medical decision shall be made as to whether another patient needs a responsible person to escort him home.]
(d) [Pre-operative] Preoperative diagnostic studies, if performed, shall be evaluated, annotated, signed and entered into the patient's medical record before surgery.
(e) [After the patient has been placed on the operating table] 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 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 his defined specific practice privileges. Physician assistants and 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.
* * * * * (e) The ASF shall have a written transfer agreement with a hospital which has emergency and surgical services available, [or] and physicians performing surgery in the ASF shall have admitting privileges at a hospital in close proximity to the ASF.
* * * * * § 555.24. [Post-operative] 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 nurse practitioner performed part of the operation, [he shall accurately record] the findings and techniques of the procedure shall be accurately recorded. This description shall become a part of the patient's medical record.
(b) [Patients who have had general anesthesia, or local anesthesia with sedation,] A patient who has received anesthesia shall be observed in the facility by a registered nurse or a practitioner for a period of time which is sufficient to ensure that no immediate [post-operative] postoperative complications are present.
* * * * * (d) [An anesthesiologist or another physician qualified in resuscitative techniques] 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 or IV sedation, the anesthetist who provides the anesthesia or sedation shall remain present until that patient has been discharged from the facility.
[(e) Patients who have received sedation or general anesthesia shall be examined by a physician prior to discharge, after recovery from anesthesia.]
[(f)] (e) ***
[(g)] (f) Protocols approved by the medical staff shall be established for instructing patients in self-care after surgery [. Written] including written instructions which, at a minimum, shall include the following:
* * * * * (2) An explanation of prescribed drug regime [. Directions] including directions for use [on the medical label are adequate to fulfill this requirement] of any medications.
(3) The limitations and restrictions on activities of the patient, if necessary.
* * * * * [(h)] (g) Patients shall be discharged only on the written signed order of a [physician] 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 [or its designee shall determine the extent of anesthesia services and] shall define the degree of supervision required and the scope of responsibilities delegated to anesthesiologists and nurse 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 qualified practitioners, as defined in § 551.3 (relating to definitions).
(b) If a nonphysician administers the anesthesia, the anesthetist shall be under the medical direction of an anesthesiologist or a qualified 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 medical direction of the anesthetist.
§ 555.33. Anesthesia policies and procedures.
* * * * * (b) In ASFs where there is no anesthesiologist, the governing body shall designate a qualified 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.
[(b)] (d) Anesthesia procedures shall provide at least the following:
(1) A patient requiring anesthesia shall have a pre-anesthesia evaluation by a [physician] qualified 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 pre-anesthesia medications.
* * * * * (4) Following the procedure for which anesthesia was administered, the anesthetist [or a designee] shall remain with the patient as long as necessary to insure [that the patient has recovered. Personnel] safe transport to the recovery area and shall advise personnel responsible for [post-anesthetic] postanesthetic care [shall be advised as to specific problems presented by] of the condition of the patient.
* * * * * (6) Intraoperative physiologic monitoring shall include the following at a minimum:
(i) The use of pulse oximeter.
(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.
[(6)] (8) Before discharge from the ASF, a patient shall be evaluated for proper anesthesia recovery by the person who administered the anesthesia, operating room surgeon, anesthesiologist or dentist. Depending on the type of anesthesia and length of surgery, the [post-operative] postoperative check shall include at least the following:
* * * * * (v) [Patient color] Pulse oximeter.
§ 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. The 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 [which is] 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) [Clinical] Peer-based review of clinical performance of individuals with clinical privileges.
* * * * * (d) The plan shall [define] include participation of [physicians] 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.
(c) [Sources of data shall include, but not be limited to, 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.] The frequency, severity and source of suspected problems or concerns are evaluated by practitioners and nurses.
(d) [Corrective actions and the results] 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. [Actions] Measures which may be taken include[, but are not limited to]:
* * * * * § 557.4. Quality [Assurance Committee] assurance and improvement committee.
(a) The committee shall consist of the following:
(1) A [physician] practitioner who is not an owner.
* * * * * (c) Committee records of the activities shall include:
(1) Reports made to the governing [authority] body.
* * * * *
CHAPTER 559. NURSING SERVICES § 559.2. Director of nursing.
The director of nursing shall be [an employe] currently licensed as a registered nurse in this Commonwealth and be responsible and accountable to the person in charge of the ASF for:
* * * * * § 559.3. Nursing personnel.
(a) An adequate number of licensed and [ancillary nursing] unlicensed 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.
(b) At least one registered nurse shall be in [the facility] attendance during the hours [it is in operation, and available for emergency treatment] patients are present. Nursing personnel shall be assigned to duties consistent with their training and experience.
(c) [Persons employed and classified as registered] 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 [but not limited to] 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 pharmacy operated by the ASF shall be supervised by a licensed pharmacist. If the ASF does not operate a licensed pharmacy, a practitioner shall be appointed in charge of the pharmaceutical service and shall be responsible for maintaining an adequate supply of drugs. Practitioners may dispense drugs only to the patients who are in their care].
(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 shall be obtained.
§ 561.23. Use of [dangerous drugs] 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 [dangerous drugs] 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.
[(1) Dangerous drugs include controlled substances, sedatives, anticoagulants, antibiotics, oxytoxics and corticosteroids.
(2) Policies shall be established regarding written orders for appropriate dosage of dangerous drugs.]
CHAPTER 563. MEDICAL RECORDS § 563.8. Automation or computerization of medical records.
Nothing in this subpart [may be construed to prohibit] 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:
* * * * * (2) [Significant] Pertinent medical history and results of physical examination.
(3) [Pre-operative] Preoperative diagnostic studies--entered before surgery--if performed.
(4) [Allergies or abnormal] 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.
* * * * * (9) [Disposition] Written and verbal disposition recommendations and instructions given to the patient.
* * * * * § 563.13. Entries.
* * * * * (e) Necessary documentation on the patient's medical record as specified in § 563.12 (relating to form and content of record) shall be completed [on the day of surgery] within 24 hours.
CHAPTER 565. LABORATORY AND RADIOLOGY SERVICES
RADIOLOGY SERVICES § 565.12. Radiology service policy.
* * * * * (b) Applicable provisions of the Department of Environmental [Resources] Protection regulations at 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 at, 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.
* * * * * (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] within 24 hours.
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, [but not be limited to,] the following:
* * * * * (3) Sterilization and disinfection, including suitable equipment for routine and rapid sterilization.
(4) Sterilized materials are packaged, labeled and dated in a consistent manner.
[(4)] (5) ***
(6) Cleaning of surgical suites prior to each operation.
[(5)] (7) Clean and soiled linen and utility rooms.
[(6)] (8) ***
[(7)] (9) ***
[(8)] (10) Isolation [standards] protocols.
[(9) Strict and protective isolation of appropriate patients.]
[(10)] (11) ***
[(11)] (12) ***
[(12)] (13) ***
[(13)] (14) ***
[(14)] (15) ***
[(15)] (16) ***
[(16)] (17) ***
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 [post anesthesia] postanesthesia recovery of surgical patients. The following equipment shall be available in the operating suite and recovery area.
* * * * * (7) Tracheostomy [set] and necessary pulmonary reexpansion supplies.
[(8) Thoracotomy set.]
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
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 [fire fighting] firefighting equipment, exits, patient rooms, storage places of flammable and explosive [gases] substances and other information that the fire department requires or as may be necessary.
EVACUATION DRILLS § 569.21. Fire drills.
* * * * * (b) [If multiple shifts are employed, these drills shall be alternated to:] 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 [fire-fighting] firefighting equipment in the ASF.
* * * * * [(c) At least one ASF fire drill each year should be supervised by the local fire department.
(d)] (c) ***
[(e)] (d) ***
SAFETY PRECAUTIONS § 569.33. Smoking.
[(a) The governing body shall adopt written rules governing smoking within the ASF, which shall be made known to ASF personnel, patients and the public.
(b) These rules shall include at least the following:
(1) Smoking shall be prohibited in an area where flammable liquid, combustible gas or oxygen is being used or stored, and in any other hazardous area of the ASF. The areas shall be posted with no smoking signs.
(2) Patients classified as not mentally or physically responsible for their actions shall be prohibited from smoking unless constant supervision is provided.]
Smoking is not permitted in an ASF.
§ 569.35. General safety precautions.
The following safety precautions shall be met:
* * * * * (7) Only nonflammable agents may be present in a surgical suite.
CHAPTER 571. CONSTRUCTION STANDARDS
GENERAL PROVISIONS § 571.2. Modifications to HHS requirements.
[The following provisions modify and supplement the HHS Requirements cited in § 571.1 (relating to minimum standards):
(1) An item in the HHS Requirements which refers to the]
(a) Life Safety Code [shall meet] means the standard as defined in § 569.2 (relating to fire safety standards).
[(2) A design of an ASF which constitutes a single enclosed cubicle or room for patients shall be a minimum of 100 square feet per cubicle or room, exclusive of equipment, toilet room, vestibule and furnishings.
(3)] (b) ***
[(4)] (c) ***
[(5) Modify Section 9.5 to read as follows:
(N) Elevators.
(1)] (d) In [multi-story] multistory buildings, where the ASF may be provided on floors other than at grade level, at least one hospital type elevator shall be provided.
[(2)] (e) Elevators shall conform to [Section 7.28 of the] ''HHS Requirements''[.] and
[(3) In Section 7.28 of the HHS Requirements, the reference made to ANSI A-17.1 is] 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 § 571.13. [Approval of plans] (Reserved).
[For practical reasons, construction drawing should not be submitted for final approval to the Division of Safety Inspection until a Certificate of Need (CON) has been obtained where necessary. Final approval of construction drawings will not be construed as a CON approval. See § 551.31 (relating to Certificate of Need).]
CHAPTER 573. [STATEMENT OF POLICY] (Reserved) § 573.1. [Criteria for ambulatory surgical facility] (Reserved).
[(a) A facility is considered an ASF if the surgical procedures performed are all of the following:
(1) Commonly performed on an inpatient basis in hospitals, but may be safely performed in an ASF.
(2) Not of the type that are commonly performed, or that may be safely performed in physicians' offices without a separate operating room or suite that is dedicated to the performance of surgery for a set period of time each week.
(3) Limited to those requiring a dedicated operating room--or suite as described in paragraph (2)--and generally requiring a post-operative recovery room or a short term (not overnight) convalescent room.
(b) A facility performing surgical procedures which appear on the list, published by the United States Department of Health and Human Services, of procedures which are reimbursed under Medicare at 47 Fed. Reg. 34099 (August 5, 1982) (relating to Medicare Program, List of Covered Surgical Procedures for Certain Ambulatory Surgical Services) or procedures which appear on the list, to be published by the Department of Public Welfare, of procedures which are reimbursed under Medical Assistance, may be considered an ASF, if the facility meets other criteria in this section.
(c) A physician's office may be considered an ASF if the following exist:
(1) The office has an area dedicated to performing surgery for a set period of time each week.
(2) The procedures performed are those described in this section.]
§ 573.2. [Criteria for ambulatory surgical procedures] (Reserved).
[(a) Surgical procedures are limited to those that do not generally exceed:
(1) A total of 90 minutes operating time.
(2) A total of 4 hours recovery or convalescent time.
(b) If the surgical procedures require anesthesia, the anesthesia shall be either of the following:
(1) Local or regional anesthesia.
(2) General anesthesia of 90 minutes or less duration.
(c) Surgical procedures may not be of a type that:
(1) Generally result in extensive blood loss.
(2) Require major or prolonged invasion of body cavities.
(3) Directly involve major blood vessels.
(4) Are generally emergency or life threatening in nature.]
[Pa.B. Doc. No. 97-1177. Filed for public inspection July 18, 1997, 9:00 a.m.]
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