[27 Pa.B. 3609]
[Continued from previous Web Page] (p) No drug intended solely for study or experimental use may be administered unless authorized by 21 CFR (relating to food and drugs) and then, only with the written consent of the patient or the legal guardian.
(q) Written policies and procedures shall be established in conjunction with the consulting pharmacist or Pharmaceutical Services Committee regarding the proper storage and maintenance of drugs and biologicals. The storage policies shall ensure that:
(1) Drugs and biologicals, including those that require refrigeration, shall be stored in locked compartments and properly maintained. Only authorized personnel shall have access to the keys.
(2) Separately locked, permanently affixed compartments shall be provided for storage of controlled substances listed in Schedule II in section 4(2) of The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. § 780-104(2)) and § 25.72(c) (relating to schedules of controlled substances), and other drugs subject to abuse.
(3) If mobile medication carts are used, they shall:
(i) Have a double locked box within the cart for storage of controlled Schedule II substances.
(ii) Be secured in an acceptable fashion if not in use to insure security control.
(iii) Be stored away from corridors when not in use.
(4) Internal and external medications shall be stored separately in locked compartments.
(r) A Pharmaceutical Services Committee shall perform the following:] (k) The oversight of pharmaceutical services shall be the responsibility of the quality assurance committee. Arrangements shall be made for the pharmacist responsible for the adequacy and accuracy of the services to have committee input.
[(1) Develop] The quality assurance committee shall develop written policies and procedures for drug therapy, distribution, administration, control and use.
[(2) Develop procedures for control and accountability for drugs and biologicals in the facility.
(3) Be comprised of at least a registered pharmacist, director of nursing, administrator and one licensed physician.
(4) Oversee the pharmaceutical services in the facility, make recommendations for improvement, monitor the service to ensure accuracy and adequacy and make provisions for annual inservice training programs for facility staff.
(5) Meet at least quarterly and document in writing its activities, findings and recommendations.
(6) Assure that the drug regimen of each patient is reviewed at least monthly by a registered pharmacist and that the pharmacist documents the findings of the review on each patient's medical record.
(7) Review and approve the contents, storage and use of emergency medication kits.
(s)] (l) A facility shall have at least one emergency medication kit. The kit used in the facility shall be governed by the following:
(1) The facility shall have written policies and procedures pertaining to the use, content, storage and refill of the kits.
* * * * * (3) The emergency medication kits shall be under the control of a practitioner [licensed by statute] authorized to dispense or prescribe medications under the Pharmacy Act (63 P. S. §§ 390.1--390.13).
* * * * * § 211.10. [Patient] Resident care policies.
(a) [A facility shall have written policies to govern the continuing nursing care and related medical and other services provided. The policies shall reflect the philosophy of the facility.
(b) The facility shall have policies which are developed by the administrator and director of nurses with the advice of the medical director or the organized medical staff and of other professional personnel. The policies shall govern the nursing care and medical care or other related services it provides.
(c) The] Resident care policies [which] shall be available to admitting physicians, sponsoring agencies, [patients] residents and the public, shall reflect an awareness of, and provision for, meeting the total medical and psychosocial needs of [patients] residents. The needs include admission, transfer and discharge planning. [The range of services available to patients also includes the frequency of physician visits by each category of patients admitted.
(d) The policies shall include provisions to protect patients' personal and property rights.
(e) The medical records and minutes of staff and committee meetings shall reflect the rendering of patient care under the written patient care policies.
(f) The facility shall appoint in writing a physician or a registered nurse to be responsible for the execution of the policies. If the responsibility for day-to-day execution of patient care policies has been delegated to a registered nurse, the facility shall make available an advisory physician from whom medical guidance is received.
(g)] (b) * * *
[(h)] (c) The policies shall be designed and implemented to ensure that each [patient] resident receives treatments, medications, diets and rehabilitative nursing care as prescribed.
[(i)] (d) The policies shall be designed and implemented to ensure that the [patient] resident receives proper care to prevent [decubitus ulcers] pressure sores and deformities; that the [patient] resident is kept comfortable, clean and well-groomed; that the [patient] resident is protected from accident, injury and infection; and that the [patient] resident is encouraged, assisted and trained in self-care and group activities.
§ 211.11. [Patient] Resident care plan.
[(a) A registered nurse on the staff of the facility shall be designated by the director of nursing services to be responsible for the coordination of a written patient care plan. This responsibility shall be in the nurse's job description.
(b) The patient care plan shall be developed upon admission and implemented as soon as possible thereafter.
(c) The patient care plan shall be reviewed, evaluated and updated, as necessary, by professionals involved in the care of the patient.
(d) The patient care plan shall be an interdisciplinary care plan that shall include input as appropriate but not limited to physicians services, nursing services, social services, rehabilitative services, dietary, pharmacy and activities service.
(e) The patient plan of care shall establish goals and define the approach to be utilized by each discipline toward achievement of the goals. Goals of care shall be set through the evaluation of the patient's present state of physical and emotional health, potential for improvement or potential to maintain the present level of functioning. Goals of the plans of care shall be set through the evaluation of the patient's present state of physical and emotional health, potential for improvement or potential to maintain the present level of functioning.
(f)] The [patient] resident care plan shall be available for use by personnel caring for the [patient] resident.
[(g) The patient, when able, shall participate in the development and review of the plan.]
§ 211.12. Nursing services.
(a) The facility shall provide [nursing to meet the needs of patients] services by sufficient numbers of personnel on a 24-hour basis to provide nursing care to all residents in accordance with resident care plans.
* * * * * (d) [If the director of nursing services has institutional responsibilities other than nursing responsibilities, a qualified registered nurse shall serve as an assistant and act in the absence so there is the equivalent of a full-time director of nursing services.
(e)] The director of nursing services shall be responsible for:
(1) [The development and maintenance of nursing service objectives.
(2)] Standards of [good] accepted nursing practice.
[(3)] (2) * * *
[(4) Written job descriptions for each level of nursing personnel.
(5)] (3) Methods for coordination of nursing services with other [patient] resident services.
[(6)] (4) * * *
[(7) Schedules of daily rounds to see patients. Rounds shall be made daily by the director of nursing services or a delegate.
(8) Nursing staff development.
(9)] (5) General supervision, guidance and assistance for a [patient] resident in implementing the [patient's] resident's personal health program to assure that preventive measures, treatments, medications, diet and other health services prescribed are properly carried out and recorded.
[(f) Until July 1, 1988, there shall be a qualified licensed nurse as the charge nurse who is responsible for supervising total nursing activities in the facility for each tour of duty in accordance with the following:
(1) There shall be a licensed registered nurse on the day tour of duty each day of the week and a registered nurse or licensed practical nurse on the evening and night tour of duty in a facility that has skilled patients.
(2) There shall be a registered nurse or licensed practical nurse on each tour of duty each day of the week in a facility that has only intermediate care patients.
(g) After July 1, 1988, there shall be] (e) The facility shall designate a registered nurse as the charge nurse who is responsible for supervising total nursing activities within the facility on each tour of duty each day of the week.
[(h)] (f) In addition to the director of nursing services, the following daily professional staff shall be available [except as provided in subsection (j).]:
(1) The following [is effective July 1, 1988] apply:
* * * * * (2) [If] When the facility designates an LPN [is in] as a charge nurse, a registered nurse shall be on call and located within a 30-minute drive of the facility.
[(i) The following requirement is effective until July 1, 1988, in a facility that has skilled care patients except as provided in subsection (j).
Census Day Evening Night 59 and under -- 1 RN or LPN 1 RN or LPN 60/150 1 RN 1 RN 1 RN 151/250 1 RN and 1 LPN 1 RN and 1 LPN 1 RN and 1 LPN 251/Upward 2 RNs 2 RNs 2 RNs
(j) The director of nursing services may also serve as the day professional staff nurse in a facility with an average daily census of 59 patients or less.
(k) The charge nurse shall delegate responsibility to nursing personnel for the direct nursing care of specific patients during each tour of duty on the basis of staff education qualifications, size and physical layout of the facility, characteristics of the patient load and the emotional, social and nursing care of patients.]
(l)] (g) There shall be at least one nursing staff employe per 20 [patients] residents on duty.
[(m)] (h) * * *
[(n)] (i) A minimum number of general nursing care hours shall be provided for each 24-hour period. The total number of hours of general nursing care provided in each 24-hour period shall, when totalled for the entire facility, be a minimum of [2.7] 2.3 hours of direct resident care for each [skilled care patient and a minimum of 2.3 hours of direct patient care for each intermediate care patient] resident. The total number of daily required hours shall be computed by multiplying the number of [intermediate care patients] residents by 2.3 hours [and by multiplying the number of skilled care patients by 2.7 hours. The two figures shall be added; the sum shall be the minimum total number of hours of general nursing provided in each 24-hour period for the entire facility.
(o)] (j) Nursing personnel shall be provided on each [patient] resident floor.
[(p)] (k) Weekly time schedules shall be maintained and shall indicate the number and classification of nursing personnel, including relief personnel, who worked on each tour of duty on each nursing unit.
[(q)] (l) The Department may require an increase in the number of nursing personnel from the minimum requirements if specific situations in the facility--including, but not limited to, the physical or mental condition of [patients] residents, the quality of nursing care administered, the location of [patients] residents, the location of the nursing station and location of the facility--indicate the departures as necessary for the welfare, health and safety of the [patients] residents.
[(r) Nursing personnel shall be aware of the nutritional needs and food and fluid intake of patients and assist promptly where necessary in the feeding of patients. A procedure shall be established to inform the dietetic service of physicians' diet orders and of patients' dietetic problems. Food and fluid intake of patients shall be observed, and deviations from normal shall be recorded and reported to the charge nurse and the physician.
(s) The facility shall have an active program of restorative care for patients who need the service. The service shall be an integral part of nursing service and shall be directed toward assisting a patient to achieve and maintain an optimal level of self-care and independence. Records shall be maintained when the services are performed.]
§ 211.13. [Rehabilitative services] (Reserved).
[(a) The facility shall maintain a specialized rehabilitative program for those patients who need the service. Either directly or through arrangements with qualified outside resources, the service is designed to preserve and improve abilities for independent function, to prevent progressive disability and to restore maximum function.
(b) Rehabilitative services are provided upon a physician's written order and with a written plan of care developed in conjunction with the attending physician and appropriate therapist and nursing service personnel.
(c) Information regarding rehabilitative services shall be recorded on the patient's record and shall be signed and dated. This includes the physician's written order and the progress note of the person providing the service.
(d) Safe and adequate space and equipment shall be available commensurate with the service offered.
(e) If the facility does not offer the services directly, it may not admit nor retain patients in need of rehabilitative care unless provision is made for the services under arrangement with qualified outside resources under which the facility assumes professional responsibility for the service rendered.
(f) The patient's progress shall be reviewed regularly by the physician and the therapist. They shall reevaluate the plan of rehabilitative services as necessary, but at least every 30 days for skilled patients and every 60 days for intermediate care patients.
(g) Specialized rehabilitative services shall be provided under accepted professional practices by qualified therapists, or by qualified assistants or other supportive personnel under the supervision of qualified therapists.
(h) Written administrative and patient care policies and procedures shall be developed for restorative services by appropriate therapists and representatives of the medical, administrative and nursing staffs.]
§ 211.14. [Diagnostic services] (Reserved).
[(a) The facility shall have provision for promptly obtaining required laboratory, X-ray and other diagnostic services.
(b) If the facility provides its own X-ray services, it shall be in compliance with 25 Pa. Code Part I, Subpart D, Article V (relating to radiological health). If the facility provides its own clinical laboratory services, it shall be in compliance with Chapter 5 (relating to clinical laboratories).
(c) If the facility does not provide diagnostic services, arrangements shall be made for obtaining the services from a physician's office, a hospital or facility, a portable X-ray supplier or independent laboratory which is approved by the necessary agencies to provide the services.
(d) Services shall be provided only on the orders of the attending physician who shall be notified promptly of the findings.
(e) Signed and dated reports of a clinical laboratory, X-ray and other diagnostic services shall be reviewed by the physician and shall be filed with the patient's medical record.
(f) The facility shall assist the patient, if necessary, in arranging for transportation to and from the source of service.]
§ 211.15. Dental services.
(a) The facility shall [make satisfactory arrangements to assist patients in obtaining emergency and routine dental care on a regularly scheduled basis] assist residents in obtaining routine and 24-hour emergency dental care.
[(b) An advisory dentist or dental hygienist under the supervision of a dentist shall participate in the staff development program for nursing and other appropriate personnel, and shall recommend oral hygiene policies and practices for the care of patients.
(c) The facility shall have a cooperative agreement with a dental service, and shall maintain a list of dentists in the community for patients who do not have a private dentist.
(d) The facility shall assist the patient if necessary in arranging transportation to and from the dentist's office.
(e)] (b) The facility shall make provisions to assure that [patient] resident dentures are retained by the [patient] resident. [When possible, dentures] Dentures shall be marked [with the patient's name] for each resident.
§ 211.16. [Social services] (Reserved).
[(a) The facility shall provide social services designed to promote preservation of the patient's physical and mental health and to prevent the occurrence or progression of personal and social problems.
(b) In the absence of a qualified social worker on the staff who is a graduate of a school of social work accredited by the Council on Social Work Education, a designated staff member suited by training or experience shall be responsible for arranging for social services through health and welfare resources in the community, and for the integration of the social services with other elements of the patient's plan of care.
(c) Social work consultation by a qualified social worker consultant shall be provided and documented on a regular basis.
(d) The social work employe shall maintain a written record of the frequency and nature of the qualified social work consultation and services provided or obtained.
(e) There shall be an evaluation of each patient's social needs. The plan for providing care shall be formulated and recorded in the patient's record and periodically reevaluated in conjunction with the patient's total plan of care.
(f) Pertinent social data shall be collected upon admission for a patient or immediately prior to admission and the data shall be placed in the patient's medical record. The data shall include information about the personal and family problems related to the patient's illness and care, and of actions taken to meet the patient's needs. Pertinent social data shall be made available to the attending physician and other appropriate staff members. After the data is collected, an evaluation shall be made to determine if the patient needs continued social service.
(g) For patients receiving social services, there shall be a clearly defined plan prepared by qualified persons to assist a patient to adjust to the social and emotional aspects of the illness, treatment and stay in the facility. This plan shall be formulated in conjunction with the patient's total plan of care and shall be reevaluated periodically.
(h) Policies and procedures shall be established for ensuring the confidentiality of the patient's social information.]
§ 211.17. [Patient activities] Pet therapy.
[(a) The facility shall provide for an activities program appropriate to the needs and interests of a patient which shall encourage self-care, resumption of normal activities and maintenance of optimal self-functioning and contact with the environment.
(b) A full-time member of the facility's staff shall be designated as responsible for the patient activities program. If he is not a patient activities coordinator, he shall function with frequent regularly scheduled consultation from a person so qualified.
(c) Provision shall be made for an ongoing program of meaningful activities appropriate to the needs and interests of patients, designed to promote opportunities for engaging in normal pursuits, including religious activities of their choice. The activities shall be designed to promote the physical, social, religious and mental well being of the patients.
(d) A patient's activities plan shall be approved by the patient's attending physician to insure that it is not in conflict with the treatment plan. The activity plan shall be incorporated into the overall plan of care, and it shall be reviewed at least quarterly by the patient and appropriate staff. The plan shall be changed as needed.
(e) The facility shall make available adequate space and a variety of supplies and equipment to satisfy the individual interests of patients. If the space used is a multipurpose room, the activities program space may not interfere with other activities.
(f)] If pet therapy is utilized, the following standards apply:
(1) Animals are not permitted in the kitchen or other food service areas, dining rooms, utility rooms and rooms of [patients] residents who do not want animals in their rooms.
(2) Careful selection of types of animals shall be made so they are not harmful or annoying to [patients] residents.
(3) The number and types of pets shall be restricted according to the layout of the building, type of [patients] residents, staff and animals.
(4) Pets shall be carefully selected to meet the needs of the [patients] residents involved in the pet therapy program.
* * * * *
Subpart [E] F. AMBULATORY SURGICAL FACILITIES
CHAPTER 551. GENERAL INFORMATION
GENERAL PROVISIONS § 551.1. Legal base.
* * * * * (b) The Department has the duty to promulgate[, after consultation with the Health Care Policy Board,] the regulations necessary to implement Chapter 8 of the act and to assure that its regulations and the act are enforced.
* * * * * § 551.2. Affected institutions.
This subpart applies to ambulatory surgical facilities, profit or nonprofit, operated within this Commonwealth. Only those facilities which are licensed under this subpart shall provide ambulatory surgery in this Commonwealth, except as provided in Class A facilities. This subpart does not apply to outpatient surgery performed at licensed hospitals, or to dentists' or oral surgeons' offices except to the extent the offices seek licensure as ambulatory surgical facilities.
§ 551.3. Definitions.
The following words and terms, when used in this subpart, have the following meanings, unless the context clearly indicates otherwise:
ASF--Ambulatory surgical facility [(ASF)--A facility which provides outpatient surgical treatment and is not located upon the premises of a hospital. The term does not include the office of an individual or group practice physician or dentist, unless the office has a distinct part used solely for outpatient surgical treatment on a regular and organized basis.] A facility or portion thereof not located upon the premises of a hospital which provides specialty or multispecialty outpatient surgical treatment. The term does not include individual or group practice offices of private practitioners unless the offices have a distinct part used solely for outpatient surgical treatment on a regular and organized basis.
* * * * * Ambulatory surgery--Surgery which is performed:
(i) On an outpatient basis in a facility which is not located in a hospital.
(ii) On patients who do not require hospitalization but who do require constant medical supervision following the surgical procedure performed and whose total length of stay does not exceed the standards in this subpart.
Anesthesia--The use of pharmaceutical agents to induce the loss of sensation. For the purpose of this chapter, the term applies when any patient, in any setting receives, for any purpose, by any routine one of the following:
(i) General, spinal or other regional anesthesia.
(ii) Sedation (with or without analgesia), for which there is a reasonable expectation that, in the manner used, will result in the loss of protective reflexes for a significant percentage of a group of patients.
* * * * * Authorized person to administer drugs and medications--In an ASF, the term includes the following:
(i) [Physicians and dentists] Practitioners who are currently licensed by the Bureau of Professional and Occupational Affairs, Department of State.
* * * * * Classification levels--ASFs shall be classified as follows:
(i) Class A--A private or group practice office of practitioners where procedures performed are limited to those requiring administration of either local or topical anesthesia, or no anesthesia at all. Class A enterprises shall receive ASF accreditation from a Nationally recognized accrediting body such as the Accreditation Association for Ambulatory Health Care (AAAHC), or the Joint Commission on the Accreditation of Health Care Organizations (JCAHO) to be identified as providing ambulatory surgery.
(ii) Class B--A single-specialty or multiple-specialty facility with a distinct part used solely for ambulatory surgical treatments involving administration of sedation analgesia or dissociative drugs wherein reflexes may be obtunded; and where patients are limited to Physical Status (PS) PS-I or PS-II patients, unless the patient's PS status would not be adversely affected or sought to be remedied by the surgery. A Class B ASF may be a distinct part of a private or group practice medical or dental office so long as the requirements of this subpart are met.
(iii) Class C--A single-specialty or multiple-specialty facility used exclusively for the purpose of providing ambulatory surgical treatments which involve the use of a spectrum of anesthetic agents, up to and including general anesthesia. PS-I, PS-II and PS-III patients may be treated at a Class C facility, within limitations imposed by regulations regarding anesthesia and recovery time, if the facility is freestanding.
Classification system--A process used to identify three levels of ambulatory surgical facilities (A, B and C) based on the procedure, patient status and anesthesia used. Only ASF's classified as a B or C facility are eligible for licensure.
* * * * * Distinct part--An area which is part of a practitioner's office which is physically identifiable and where surgery is performed on a regular and organized basis.
* * * * * Governing body--The individuals, group or entity that has ultimate authority and responsibility for establishing policy, maintaining quality patient care and providing for organizational management and planning.
* * * * * Organized--Administratively and functionally structured to include the following:
(i) Governing body.
(ii) Medical staff.
(iii) Quality assurance.
(iv) Nursing services.
(v) Pharmacy services.
(vi) Medical record services.
(vii) Laboratory and radiology services.
(viii) Environmental services.
(ix) Fire and safety services.
* * * * * Physical status classifications--The evaluation of the patient's overall health as it would influence the conduct and outcome of anesthesia or surgery, or both. Physical status shall be defined within one of five assigned classes which are:
(i) Class 1 patients have no organic, physiologic, biochemical, metabolic or psychiatric disturbance. The operation to be performed is for a local pathologic process and has no systemic effect.
(ii) Class 2 patients have a systemic disturbance which may be of a mild to moderate degree but which is either controlled or has not changed in its severity for some time.
(iii) Class 3 patients suffer from significant systemic disturbance, although the degree to which it limits the patient's functioning or causes disability may not be quantifiable.
(iv) Class 4 patients suffer from severe systemic diseases that are already life-threatening and may or may not be correctable by surgery.
(v) Class 5 patients are moribund and not expected to survive without surgery.
* * * * * Surgery--The branch of medicine that diagnoses and treats diseases, disorders, malformations and injuries wholly or partially by operative procedures.
* * * * *
[EXCEPTIONS] § 551.11. [Principle] (Reserved).
[The Department may, within its discretion and for good reason, grant exceptions to this subpart when the policy and objectives of this subpart are otherwise met, or when compliance would create an unreasonable hardship, and when an exception would not impair the health, safety or welfare of a patient.]
§ 551.12. [Requests for exceptions] (Reserved).
[Requests for exceptions to this subpart shall be made in writing to the Department by the ASF. Requests, whether approved or not approved, will be documented and retained on file by the Department. Approved requests shall be retained on file by the ASF during the period the exception remains in effect.]
§ 551.13. [Revocation of exceptions] (Reserved).
[(a) An exception granted under this chapter may be revoked by the Department for a good reason. Notice of revocation will be in writing and will include the reason for the action of the Department and a specific date upon which the exception will be terminated.
(b) In revoking an exception, the Department will provide for a reasonable time between the date of written notice of revocation and the date of termination of an exception for the ASF to come into compliance with this subpart. Failure by the ASF to comply after the specified date may result in enforcement proceedings under this chapter.
(c) If an ASF wishes to request a reconsideration of a denial or revocation of an exception, it shall do so in writing to the Director of the Bureau of Quality Assurance of the Department within 30 days of receipt of the adverse notification.]
INTERPRETATIONS § 551.21. [Definition of] Criteria for ambulatory surgery.
(a) Ambulatory surgical procedures are limited to those that do not generally exceed:
(1) A total of 4 hours of operating time.
(2) A total of 4 hours directly supervised recovery.
(b) If the surgical procedures require anesthesia, the anesthesia shall be one of the following:
(1) Local or regional anesthesia.
(2) General anesthesia of 4 hours or less duration.
(c) Surgical procedures may not be of a type that:
(1) Generally associated with the risk of 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.
(5) Are performed on patients younger than 6 months of age or on low birth weight babies up to 1 year of age.
[(a)] (d) ***
[(b)] (e) ***
[(c)] (f) ***
APPLICATION AND AUTHORIZATION TO OPERATE AN AMBULATORY SURGICAL FACILITY § 551.31. [Certificate of Need] Licensure.
[A Certificate of Need shall be obtained under the act.]
(a) A license shall be obtained to operate a freestanding Class B or Class C ambulatory surgical facility.
(b) An ASF license shall designate the licensed facility as either Class B or Class C.
(c) An applicant for a license to operate an ASF request licensure by the Department by means of written communication which sets forth:
(1) A list of operative procedures proposed to be performed at the facility and the ages of the patients to be served.
(2) The highest level of anesthetic proposed to be used for each proposed operative procedure.
(3) The highest PS patient level proposed to receive ambulatory surgery at the facility.
(4) A statement from the applicant which may be accompanied by a written opinion from a Nationally recognized accrediting body stating the most appropriate facility Class (A, B or C) or licensure ready.
(d) If a facility desires to change its classification level from a Class B enterprise to a Class C enterprise, the facility shall request and obtain a license prior to providing services to ASA Class III or PS-III patients.
§ 551.32. [Building occupancy] (Reserved).
[New construction, alterations or renovations that provide space for patient rooms may not be used or occupied until authorization for the occupancy has been received by the ASF from the Department.
(1) The Department will require at least one inspection during the construction phase of an ASF. The inspection shall take place at approximately 75% of the estimated time of completion of the facility.
(2) The Department shall be notified in writing when an ASF is at least 75% complete in construction, so arrangements may be made for inspection.
(3) It is the responsibility of the ASF to request a preoccupancy survey at least 2 weeks prior to the anticipated occupancy of an ASF or an addition or remodeled part thereof. The Department will conduct an on-site survey of the new or remodeled portion of the ASF prior to granting approval for occupancy. The Department, acting through the Director of the Division of Hospitals, may give the authorization orally, either in person or by telephone. The Department will provide the ASF with written confirmation of the oral authorization within 30 days.]
§ 551.33. Survey.
The Department will conduct a survey to insure that the applicant is in compliance with this subpart. The survey will include an [on-site] onsite inspection and review of written approvals submitted to the Department by regulatory agencies responsible for building, electric, fire and environmental safety. The Department may designate Nationally recognized accrediting agencies whose standards are at least as stringent as the Department's to perform some or all aspects of licensure surveys.
§ 551.34. Licensure process.
(a) An application for [a] the appropriate license to operate an ASF shall be made in accordance with section 807 of the act (35 P. S. § 448.807).
* * * * * (c) Applications for renewal of a license shall be made [annually] biannually on forms obtained from the Department of Health.
(d) Applications or renewal forms shall be accompanied by a fee of $ [50] 250.
CONTINUING OPERATIONS § 551.41. Policy.
The Department will issue a license valid for [1 year] 2 years to an ASF which is in compliance with this subpart.
§ 551.42. [Nontransfer of license] (Reserved).
[An ASF shall advise the Department no later than 90 days prior to an intended change of ownership or control of the ASF. A license is not transferable to new owners or controlling parties except upon a finding by the Department that they are responsible persons, and that other provisions of the act and this subpart have been met.
§ 551.43. Void license.
(a) The license of an ASF becomes automatically void when one of the following occurs:
(1) The license term of [1 year] 2 years expires.
* * * * * (b) If the ASF locates or relocates services at a site other than the current site or a site contiguous thereto, [it] the ASF shall notify the Department 30 days prior to the change [in order] so that the Department may determine if a new license [and certificate of need review are] is necessary.
INSPECTION AND SURVEY ACTIVITIES § 551.53. Presurvey preparation.
(a) Prior to [an annual] a biennial survey site visit of an ASF by the Department, the Department may request from the ASF documents or records of the ASF, or other information necessary for the Department to prepare for the site visit. The ASF shall provide the information requested, including a declarative statement that sets forth the information requested in § 551.31 (relating to licensure) as follows:
(1) A list of operative procedures proposed to be performed at the facility.
(2) The highest level of anesthetic proposed to be used for each proposed operative procedure.
(3) The highest PS patient level proposed to receive outpatient surgical treatments at the facility.
ISSUANCE OF LICENSE § 551.81. Principle.
The Department will issue an ASF [licenses] license to a facility which complies with this subpart. The license will reflect the regular [or], provisional or limited status [of] and the classification assigned to the ASF. The license applies only to [those facilities designated] the designated facility.
§ 551.82. Regular license.
(a) The Department will issue a regular [1] 2 year license to an ASF when that ASF is in compliance with section 808 of the act (35 P. S. § 448.808) and is in full or substantial compliance with this subpart.
(b) As used in subsection (a) ''substantial compliance'' means:
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