reglab/statecodes huggingface dataset:
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart E - Birth Centers › Chapter 501 - BIRTH CENTERS › OPERATIONS › Section 501.71 - Midwifery services

Current through Register Vol. 54, No. 28, July 13, 2024
Midwifery services provided at the birth center shall be
						in compliance with applicable Federal, State and local statutes, and shall
						include, but not be limited to, the following:
(1) Midwifery services shall be under the
					 supervision of the Director of Midwifery Services.
(2) Each midwife shall be licensed to
					 practice midwifery in this Commonwealth. The license shall be current and
					 displayed in the birth center.
(3)
					 Midwifery services at the birth center shall be provided within the scope of
					 written medical and midwifery protocols, approved by the Director of Midwifery
					 Services and the Physician Director of Medical Affairs. These shall be
					 reviewed, revised, signed and dated by both, on an annual basis.
(4) Policies, procedures and service delivery
					 protocols, shall be developed to assure comprehensive quality care for the
					 patient and newborn infant.
(5)
					 Inservice training for professional staff shall be provided on a regular basis.
					 The training shall include the areas of medication, patient education, as well
					 as normal patterns and complications of pregnancy.
(6) Adequate health supervision of mother and
					 newborn at the time of referral or discharge from the birth center services
					 shall be provided.
(7) A certified
					 midwife or physician shall be physically present, at all times, when a mother
					 is laboring in the birth center.
This section cited in 28 Pa. Code §
													501.74 (relating to pharmaceutical
						  services).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart E - Birth Centers › Chapter 501 - BIRTH CENTERS › OPERATIONS › Section 501.72 - Birth center services

Current through Register Vol. 54, No. 28, July 13, 2024
(a) There shall
					 be a Physician Director of Medical Affairs who is a licensed
					 physician.
(b) A Physician Director
					 of Medical Affairs, who is not certified as an obstetrician or pediatrician,
					 shall have developed consultant services in these specialties for the birth
					 center by contractual arrangement.
(c) The Physician Director of Medical Affairs
					 shall insure that the following services are provided:
(1) Immediate availability of physician
					 services through direct communication, by radio, telephone or
					 telecommunications.
(2) An
					 agreement with a Board certified obstetrician and Board certified pediatrician,
					 including arrangements for hospital admission of mother and newborn infant, in
					 order to ensure effective care in life threatening situations.
(3) Review, by the Physician Director of
					 Medical Affairs and Director of Midwifery Services on a semiannual basis, of
					 records of mothers and newborn infants discharged or transferred from the birth
					 center during that 6 month period.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart E - Birth Centers › Chapter 501 - BIRTH CENTERS › OPERATIONS › Section 501.73 - Nursing services

Current through Register Vol. 54, No. 28, July 13, 2024
(a) Nursing
					 services at the birth center shall be under the supervision of the Director of
					 Midwifery Services.
(b) Nursing
					 staff shall be provided with orientation and in-service training on a regular
					 basis by the Physician Director of Medical Affairs and Director of Midwifery
					 Services. Opportunities for out-service training shall be offered to licensed
					 and professional staff members.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart E - Birth Centers › Chapter 501 - BIRTH CENTERS › OPERATIONS › Section 501.74 - Pharmaceutical services

Current through Register Vol. 54, No. 28, July 13, 2024
(a) There shall
					 be a listing of all drugs and biologicals, including intravenous solutions,
					 which are to be retained for emergency use in the birth center, which is
					 consistent with the midwifery and medical protocols as required in §
											501.71(3) 
					 (relating to midwifery services). The listing shall be developed and approved
					 by the Physician Director of Medical Affairs. The listing shall include the
					 identity of birth center staff who are authorized to administer the drugs,
					 biologicals, or intravenous solutions. The purchase and use of drugs shall be
					 done under the direction of the Physician Director of Medical Affairs or
					 supervising physician.
(b) If a
					 drug, biological, or intravenous solution is obtained on an emergency basis, it
					 shall only be done upon an order, written or oral, by a physician, and it must
					 be noted in the current list.
(c)
					 Drugs and biologicals must be secured in an appropriate cabinet, or when
					 refrigeration is necessary, must be stored in a separate refrigerator located
					 in a controlled area for staff use only or in a locked stationary container, if
					 stored in a refrigerator to which the public has access.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart E - Birth Centers › Chapter 501 - BIRTH CENTERS › OPERATIONS › Section 501.75 - Laboratory services

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The birth
					 center shall provide laboratory services directly or by arrangement with a
					 licensed provider.
(b) If the
					 service is provided directly, the facility must be licensed and approved by the
					 Department to perform the necessary tests under the Clinical Laboratory Act
					 (35
					 P. S. §§
												2151-2165) and Chapter 5
					 (relating to clinical laboratories).
(c) If the service is provided by
					 arrangement, the written agreement shall meet the requirements of §
											501.43 (relating to agreements)
					 and shall be available for review.
(d) If services are provided by arrangement
					 with, or referral to, an outside provider of services, the original copy of the
					 signed and dated report shall become a part of the mother's permanent
					 record.
(e) Tests completed at the
					 birth center shall be entered, dated, and signed in the mother's record by the
					 individual who performed the test. Abnormal test findings shall be promptly
					 referred to the consulting physician.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart E - Birth Centers › Chapter 501 - BIRTH CENTERS › ENVIRONMENTAL SERVICES › Section 501.82 - Physical environment

Current through Register Vol. 54, No. 28, July 13, 2024
(a) At a
					 minimum, each birth room shall have a toilet and sink with hot and cold running
					 water in the room or convenient access to it. The bathroom shall not be shared
					 by more than two patients, support persons, and family. Toilet facilities for
					 staff members shall be separate from birth room toilet facilities.
(b) If a kitchen is available for birth room
					 occupants and their family members or support persons, the kitchen shall be
					 maintained in a safe and sanitary manner and should contain a refrigerator,
					 sink, stove, and oven.
(c) The
					 birth center shall adequately meet the comfort and privacy needs of the
					 laboring woman and her family or support persons through the provision of:
(1) Comfortable chairs for
					 laboring.
(2) An interview room
					 with facilities for assured privacy.
(3) Consultation and examining rooms to meet
					 the needs of the patient, consultant, and family.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart E - Birth Centers › Chapter 501 - BIRTH CENTERS › ENVIRONMENTAL SERVICES › Section 501.83 - Infection control

Current through Register Vol. 54, No. 28, July 13, 2024
The birth center shall develop infection control policies
						and procedures to minimize and control possibilities of infection, which shall
						include, but not be limited to, the following:
(1) Handwashing techniques for adequate
					 protection of the mother or newborn infant from infection and other
					 contamination.
(2) Contagious
					 disease control measures for staff personnel, carrier or suspected carrier,
					 spouse, or support persons.
(3)
					 Sterilization methods and procedures.
(4) Infection control measures, including
					 birth room cleaning policies and birth room waste disposal policies and
					 procedures.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart E - Birth Centers › Chapter 501 - BIRTH CENTERS › ENVIRONMENTAL SERVICES › Section 501.84 - Disposal of placenta

Current through Register Vol. 54, No. 28, July 13, 2024
Pathological and bacteriological waste, surgical and
						obstetrical wastes, contaminated wastes, and similar materials shall be
						incinerated on the premises or disposed of by a method approved by the
						Department of Environmental Resources and in compliance with local
						regulations.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart E - Birth Centers › Chapter 501 - BIRTH CENTERS › ENVIRONMENTAL SERVICES › Section 501.85 - Water supply

Current through Register Vol. 54, No. 28, July 13, 2024
If the water supply is from an individual well source, a
						water sample testing report shall be obtained annually from a testing
						laboratory, and a report of the findings shall be made available to the
						Department.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 551 - GENERAL INFORMATION › GENERAL PROVISIONS › Section 551.1 - Legal base

Current through Register Vol. 54, No. 28, July 13, 2024
(a) This subpart is
					 promulgated by the Department under Chapter 8 of the act (35 P. S. §§
												448.801-448.820), and section 2102(a) and (g)
					 of The Administrative Code of 1929 (71 P. S. §
												532(a) and (g)).
(b) The Department has the duty to promulgate
					 regulations necessary to implement Chapter 8 of the act and to assure that its
					 regulations and the act are enforced.
(c) The purpose of this subpart is to protect
					 and promote the public health and welfare through the establishment and
					 enforcement of regulations setting minimum standards in the construction,
					 maintenance and operation of ASFs. The standards are intended to assure safe,
					 adequate and efficient facilities and services, and to promote the health,
					 safety and adequate care of the patients of the facilities. It is also the
					 purpose of this subpart to assure quality health care through appropriate and
					 nonduplicative review and inspection, with regard to the protection of the
					 health and rights of privacy of the patients and without unreasonably
					 interfering with the operation of the ambulatory surgical facility.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 551 - GENERAL INFORMATION › GENERAL PROVISIONS › Section 551.2 - Affected institutions

Current through Register Vol. 54, No. 28, July 13, 2024
(a) This
					 subpart applies to ASFs, 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.
(b) 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 ASFs.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 551 - GENERAL INFORMATION › INTERPRETATIONS › Section 551.21 - Criteria for ambulatory surgery

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
					 Ambulatory surgical procedures are limited to those that do not exceed:
(1) A total of 4 hours of operating
					 time.
(2) A total of 4 hours
					 directly supervised recovery.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 551 - GENERAL INFORMATION › INTERPRETATIONS › Section 551.22 - Criteria for performance of ambulatory surgery on pediatric patients

Current through Register Vol. 54, No. 28, July 13, 2024
In addition to the criteria in §
											551.21 (relating to criteria for
						ambulatory surgery), the following criteria apply to the performance of
						ambulatory surgery on children under 18 years of age:
(1) A child under 6 months of age may not be
					 treated in an ASF.
(2) The medical
					 record shall include documentation that the child's primary care provider was
					 notified by the surgeon in advance of the performance of a procedure in an ASF
					 and that an opinion was sought from the primary care provider regarding the
					 appropriateness of the use of the facility for the proposed procedure. When an
					 opinion from the child's primary care provider is not obtainable, the medical
					 record shall include documentation which explains why an opinion could not be
					 obtained.
(3) Surgical procedures
					 on persons older than 6 months and younger than 18 years of age shall be
					 performed only under the following conditions:
(i) Anesthesia services shall be provided by
					 an anesthesiologist who is a graduate of an anesthesiology residency program
					 accredited by the accreditation council for graduate medical education or its
					 equivalent, or by a certified registered nurse anesthetist trained in pediatric
					 anesthesia, either of whom shall have documented demonstrated historical and
					 continuous competence in the care of these patients.
(ii) The practitioner performing the surgery
					 shall be either board certified by or have obtained preboard certification
					 status with the American Board of Medical Specialties, the American Osteopathic
					 Board of Surgery, the American Board of Podiatric Surgery or the American Board
					 of Oral and Maxillofacial Surgery.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 551 - GENERAL INFORMATION › APPLICATION AND AUTHORIZATION TO OPERATE AN ASF › Section 551.31 - Licensure

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A Class A ASF
					 shall meet the following criteria:
(1) A
					 license is not required for the operation of a Class A ASF. The facility shall
					 be accredited by the Accreditation Association for Ambulatory Health Care, the
					 Joint Commission on the Accreditation of Health Care Organizations, the
					 American Association for the Accreditation of Ambulatory Surgical Facilities or
					 another Nationally recognized accrediting agency acknowledged by the Medicare
					 Program in order to be identified as providing ambulatory surgery.
(2) A Class A ASF shall register with the
					 Department and shall forward a copy of its accreditation survery to the
					 Department.
(3) The Class A
					 registration form shall request the following information, which shall also be
					 provided to the Department by the Class A ASF on an annual basis.
(i) A list of operative procedures proposed
					 to be performed at the facility and the ages of the patients to be
					 served.
(ii) The type of anesthetic
					 proposed to be used for each operative procedure.
(iii) The facility's current accreditation
					 survey and the designation of accreditation status by the Nationally recognized
					 accrediting agency.
(iv) Other
					 information the Department deems pertinent to registration
					 requirements.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 551 - GENERAL INFORMATION › APPLICATION AND AUTHORIZATION TO OPERATE AN ASF › Section 551.33 - Survey

Current through Register Vol. 54, No. 28, July 13, 2024
The Department will conduct a survey to insure that the
						applicant is in compliance with this subpart. The survey will include an 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.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 551 - GENERAL INFORMATION › APPLICATION AND AUTHORIZATION TO OPERATE AN ASF › Section 551.34 - Licensure process

Current through Register Vol. 54, No. 28, July 13, 2024
(a) An
					 application for the appropriate license to operate an ASF shall be made in
					 accordance with section 807 of the act (35 P. S. §
												448.807).
(b) The application form for a license to
					 operate an ASF shall be obtained from the Department of Health, Division of
					 Acute and Ambulatory Care Facilities, Post Office Box 90, Harrisburg,
					 Pennsylvania 17108.
(c)
					 Applications for renewal of a license shall be made annually on forms obtained
					 from the Department.
(d)
					 Applications or renewal forms shall be accompanied by a fee of $250.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 551 - GENERAL INFORMATION › CONTINUING OPERATIONS › Section 551.41 - Policy

Current through Register Vol. 54, No. 28, July 13, 2024
The Department will issue a license valid for 1 year to
						an ASF which is in compliance with this subpart.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 551 - GENERAL INFORMATION › CONTINUING OPERATIONS › Section 551.43 - Void license

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The license
					 of an ASF becomes automatically void when one of the following occurs:
(1) The license term of 1 year
					 expires.
(2) The ASF substantially
					 changes its name or location, in which case a new license will be automatically
					 issued upon application by an ASF if the ASF is otherwise in compliance with
					 this subpart.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 551 - GENERAL INFORMATION › CONTINUING OPERATIONS › Section 551.44 - Display of license

Current through Register Vol. 54, No. 28, July 13, 2024
The current license shall be displayed in a public and
						conspicuous place in the ASF.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 551 - GENERAL INFORMATION › CONTINUING OPERATIONS › Section 551.45 - Licensure information/application

Current through Register Vol. 54, No. 28, July 13, 2024
Information regarding licensure shall be completed
						annually on forms supplied by the Department. Both the Annual ASF Questionnaire
						and the Application for Licensure and other data requested by the Department
						shall be completed each year.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 551 - GENERAL INFORMATION › INSPECTION AND SURVEY ACTIVITIES › Section 551.51 - Policy

Current through Register Vol. 54, No. 28, July 13, 2024
Representatives of the Department will annually conduct a
						survey of every ASF required to be licensed.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 551 - GENERAL INFORMATION › INSPECTION AND SURVEY ACTIVITIES › Section 551.52 - ASF responsibilities

Current through Register Vol. 54, No. 28, July 13, 2024
An ASF shall comply with applicable standards which are
						required by Federal, State and local authorities. This includes, but is not
						limited to, standards at 49 Pa. Code Chapters 17, 21 and 27 (relating to State
						Board of Medicine-medical doctors; State Board of Nursing; and State Board of
						Pharmacy) in addition to standards related to radiologic health, sanitation,
						food service, electric wiring and life safety code compliance. When the ASF has
						been inspected by another regulatory agency, it shall have available during the
						survey by the Department written confirmation of compliance as required by the
						other regulatory agency.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 551 - GENERAL INFORMATION › INSPECTION AND SURVEY ACTIVITIES › Section 551.53 - Presurvey preparation

Current through Register Vol. 54, No. 28, July 13, 2024
Prior to an annual 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.
This section cited in 28 Pa. Code §
													553.4 (relating to other
						  functions).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 551 - GENERAL INFORMATION › INSPECTION AND SURVEY ACTIVITIES › Section 551.54 - Access by the Department

Current through Register Vol. 54, No. 28, July 13, 2024
Upon presenting the official Department identification
						card to the ASF's person in charge, authorized agents of the Department will
						have access to the ASF to determine compliance with this subpart. The access
						shall include:
(1) Entry to the entire
					 ASF premises.
(2) Inspection and
					 examination of the facilities, records, documents and phases of operations,
					 including those relating to compliance with Chapter 553 (relating to ownership,
					 governance and management).
(3)
					 Interviews of staff, employes, members of the governing body and
					 patients.
(4) Examination of a
					 patient, with the patient's consent.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 551 - GENERAL INFORMATION › INSPECTION AND SURVEY ACTIVITIES › Section 551.55 - Site survey coverage

Current through Register Vol. 54, No. 28, July 13, 2024
The Department will survey on-site those aspects of the
						ASF as it deems necessary to fully and fairly assess the compliance of the ASF
						with this subpart.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 551 - GENERAL INFORMATION › INSPECTION AND SURVEY ACTIVITIES › Section 551.56 - Documentation

Current through Register Vol. 54, No. 28, July 13, 2024
The Department will document the extent of an ASF's
						compliance with this subpart in at least one of the following ways:
(1) The statement of a person in charge or
					 staff member.
(2) Documentary
					 evidence provided by the facility.
(3) Answers by the ASF to detailed questions
					 provided by the Department concerning the implementation of this subpart or
					 examples of the implementation which will enable a judgment about compliance to
					 be made.
(4) On-site observation by
					 surveyors.
(5) Interviews with
					 patients, employes or other persons or sources capable of providing reliable
					 information to the Department.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 551 - GENERAL INFORMATION › POST SURVEY PROCEDURES › Section 551.61 - Policy

Current through Register Vol. 54, No. 28, July 13, 2024
After completion of the site visit, the Department will
						evaluate relevant information gathered during the survey, formulate its
						compliance findings and determinations, and order the ASF to correct, within a
						specified period of time, deficiencies found.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 551 - GENERAL INFORMATION › POST SURVEY PROCEDURES › Section 551.62 - Compliance directive

Current through Register Vol. 54, No. 28, July 13, 2024
(a) If
					 there is noncompliance with this subpart, the Department will notify the ASF in
					 writing of deficiencies and will direct the officers governing or managing the
					 ASF to take corrective action as the Department directs or to submit a plan of
					 correction, or to do both, within the time specified by the Department. In its
					 compliance directive and request for plan of correction, the Department will
					 state its findings and the reasons for its determination.
(b) The ASF shall be presumed to be in
					 compliance with provisions of this subpart for which the compliance directive
					 does not cite a deficiency.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 551 - GENERAL INFORMATION › POST SURVEY PROCEDURES › Section 551.63 - Submission of plan of correction

Current through Register Vol. 54, No. 28, July 13, 2024
A plan of correction shall be submitted to the Department
						within 30 days of receipt of written notification by the Department. The plan
						shall be attested to by the signature of the chairman of the governing body or
						the person in charge. The plan of correction shall be submitted to the
						governing body as a whole for its review at its regular
						meeting.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 551 - GENERAL INFORMATION › POST SURVEY PROCEDURES › Section 551.64 - Content of plan of correction

Current through Register Vol. 54, No. 28, July 13, 2024
A plan of correction shall address deficiencies cited in
						the compliance directive of the Department. The plan shall state specifically
						what corrective action is to be taken, by whom and when.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 551 - GENERAL INFORMATION › POST SURVEY PROCEDURES › Section 551.65 - Public inspection of compliance documents

Current through Register Vol. 54, No. 28, July 13, 2024
Copies of compliance directives and plans of correction
						will be kept readily available by the Department in appropriate regional
						offices for the purpose of public inspection, examination and duplication at a
						reasonable cost. An ASF shall make available a current copy of these documents
						for inspection and examination.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 551 - GENERAL INFORMATION › CONTINUING SURVEILLANCE › Section 551.71 - Unannounced surveys

Current through Register Vol. 54, No. 28, July 13, 2024
Whenever the Department has received a complaint or has
						other reasonable grounds to believe that a deficiency exists, the Department
						may without notice to the ASF investigate, inspect or survey the facility, or
						portion of the ASF to which the alleged deficiency relates.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 551 - GENERAL INFORMATION › ISSUANCE OF LICENSE › Section 551.81 - Principle

Current through Register Vol. 54, No. 28, July 13, 2024
The Department will issue an ASF license to a facility
						which complies with this subpart. The license will reflect the regular,
						provisional or limited status and the classification assigned to the ASF. The
						license applies only to the designated facility.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 551 - GENERAL INFORMATION › ISSUANCE OF LICENSE › Section 551.82 - Regular license

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The
					 Department will issue a regular 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:
(1) Deficiencies are, individually and in
					 combined effect, of a minor nature so that neither the deficiencies nor efforts
					 toward their correction will do one of the following:
(i) Interfere with or adversely affect normal
					 ASF operations.
(ii) Adversely
					 affect a patient's health or safety.
(iii) Exceed the assigned classification of
					 the ASF.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 551 - GENERAL INFORMATION › ISSUANCE OF LICENSE › Section 551.83 - Provisional license

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The
					 Department may issue a provisional license if:
(1) There are numerous deficiencies or a
					 serious specific deficiency in compliance with applicable statutes, ordinances
					 or regulations.
(2) The ASF is
					 taking appropriate steps to correct the deficiencies in accordance with a plan
					 of correction submitted by the ASF and agreed upon by the Department.
(3) There is no cyclical pattern of
					 deficiencies over a period of 2 or more years. A cyclical pattern is one where
					 an ASF is alternately in and out of substantial or full compliance, which is
					 corrected only when actively supervised by the Department.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 551 - GENERAL INFORMATION › REFUSAL OR REVOCATION › Section 551.91 - Grounds

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The Department
					 may refuse to issue a license for one or more of the following reasons:
(1) The health care provider is not a
					 responsible person.
(2) The place
					 to be used as an ASF is not adequately constructed, equipped, maintained and
					 operated to safely and efficiently render the services offered.
(3) The ASF does not provide safe and
					 efficient services which are adequate for the care, treatment and comfort of
					 the patients or residents of the facility.
(4) There is not substantial compliance with
					 this subpart.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 551 - GENERAL INFORMATION › REFUSAL OR REVOCATION › Section 551.92 - Modification of license

Current through Register Vol. 54, No. 28, July 13, 2024
The Department may modify a license by substituting a
						provisional license for a regular license if the Department determines that the
						ASF is not in compliance or substantial compliance as defined in §
											551.82 (relating to regular
						license) but the ASF otherwise meets the requirements of §
											551.83 (relating to provisional
						license).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 551 - GENERAL INFORMATION › REFUSAL OR REVOCATION › Section 551.93 - Notice

Current through Register Vol. 54, No. 28, July 13, 2024
(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 Health
					 Policy Board.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 551 - GENERAL INFORMATION › CORRECTION OF DEFICIENCY › Section 551.101 - Policy

Current through Register Vol. 54, No. 28, July 13, 2024
If an ASF notifies the Department that it has completed a
						plan of correction and corrected its deficiencies, the Department will conduct
						a survey to ascertain completion of the plan of correction. Upon finding full
						or substantial compliance, as defined in §
											551.82(b)
						(relating to a regular license), the Department will issue a regular
						license.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 551 - GENERAL INFORMATION › HEARINGS › Section 551.111 - Hearings relating to licensure

Current through Register Vol. 54, No. 28, July 13, 2024
Hearings relating to licensure, including the issuance of
						a provisional license, or the suspension of admissions, will be conducted by
						the Health Policy Board, under 37 Pa. Code Chapter 197 (relating to practice
						and procedure).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 553 - OWNERSHIP, GOVERNANCE AND MANAGEMENT › GOVERNING BODY › Section 553.1 - Principle

Current through Register Vol. 54, No. 28, July 13, 2024
There shall be an organized governing body or designated
						person vested with ownership who shall assume the full legal authority and
						responsibility for the conduct of the ASF.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 553 - OWNERSHIP, GOVERNANCE AND MANAGEMENT › GOVERNING BODY › Section 553.2 - Ownership

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The owner of
					 the ASF may be an individual, partnership, association, a corporation or a
					 combination thereof.
(b) A complete
					 list of the names and addresses of owners, directors, officers and managers
					 shall be submitted with the application.
(c) 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.
(d) A physically noncontiguous branch of the
					 ASF shall meet the requirements for licensure and shall be independently
					 licensed.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 553 - OWNERSHIP, GOVERNANCE AND MANAGEMENT › GOVERNING BODY › Section 553.3 - Governing body responsibilities

Current through Register Vol. 54, No. 28, July 13, 2024
Governing body responsibilities include:
(1) Conforming to applicable Federal, State
					 and local law.
(2) Determining the
					 goals and objectives of the ASF.
(3) Assuring that facilities and personnel
					 are adequate and appropriate to carry out the goals and objectives.
(4) Establishing an organizational structure
					 and specifying functional relationships among the various components of the
					 ASF.
(5) Adopting bylaws or similar
					 rules and regulations for the orderly development and management of the ASF,
					 which:
(i) Describe the authority delegated to
					 the person in charge and to the medical staff.
(ii) Require the governing body to review and
					 approve the bylaws, or similar rules and regulations, of the medical
					 staff.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 553 - OWNERSHIP, GOVERNANCE AND MANAGEMENT › GOVERNING BODY › Section 553.4 - Other functions

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The
					 governing body shall meet at least annually and keep minutes or other records
					 necessary for the orderly conduct of the ASF.
(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.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 553 - OWNERSHIP, GOVERNANCE AND MANAGEMENT › PATIENT'S BILL OF RIGHTS › Section 553.11 - Purpose

Current through Register Vol. 54, No. 28, July 13, 2024
The purpose of §§
											553.11-553.13 (relating to patient's bill
						of rights) is to promote the interests and well-being of the patients of
						ambulatory surgical facilities subject to this subpart even in those instances
						where the interests of the patients may be in opposition to the interests of
						the ASF. It is the policy of the Department that the interests of patients be
						protected by a patient's bill of rights. Nothing in §§
											553.11-553.13 is intended to serve as
						evidence of a standard of reasonable conduct for the purpose of determining
						civil liability between providers and consumers of health services. The ASF has
						the right to expect the patient to fulfill patient responsibilities as may be
						stated in the ASF's rules affecting patient care and conduct.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 553 - OWNERSHIP, GOVERNANCE AND MANAGEMENT › PATIENT'S BILL OF RIGHTS › Section 553.13 - Procedures for distribution

Current through Register Vol. 54, No. 28, July 13, 2024
The ASF shall develop procedures to inform each patient
						of his rights. Copies of the ASF's patient's bill of rights shall be made
						generally available through one of the following ways:
(1) Prominent displays in appropriate
					 locations in addition to copies available upon request.
(2) Provision of a copy to each patient or
					 responsible party upon admission.
This section cited in 28 Pa. Code §
													553.3 (relating to governing body
						  responsibilities); and 28 Pa. Code §
													553.11 (relating to
						  purpose).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 553 - OWNERSHIP, GOVERNANCE AND MANAGEMENT › ADMISSION, TRANSFER AND DISCHARGE › Section 553.21 - Principle

Current through Register Vol. 54, No. 28, July 13, 2024
(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).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 553 - OWNERSHIP, GOVERNANCE AND MANAGEMENT › ADMISSION, TRANSFER AND DISCHARGE › Section 553.22 - Admission criteria

Current through Register Vol. 54, No. 28, July 13, 2024
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.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 553 - OWNERSHIP, GOVERNANCE AND MANAGEMENT › ADMISSION, TRANSFER AND DISCHARGE › Section 553.23 - Discharge by transfer

Current through Register Vol. 54, No. 28, July 13, 2024
A patient may not be transferred to another medical
						facility unless prior arrangements for admission have been made. Clinical
						records of sufficient content to insure continuity of care shall accompany the
						patient.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 553 - OWNERSHIP, GOVERNANCE AND MANAGEMENT › ADMISSION, TRANSFER AND DISCHARGE › Section 553.24 - Discharge of a minor or incompetent patient

Current through Register Vol. 54, No. 28, July 13, 2024
An individual who cannot legally consent to his own care
						shall be discharged only to the custody of parents, legal guardian, person
						standing in loco parentis or another responsible party unless otherwise
						directed by the parent or guardian or court of competent jurisdiction. If the
						parent or guardian directs that discharge be made otherwise, he shall so state
						in writing, and the statement shall become a part of the permanent medical
						record of the patient.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 553 - OWNERSHIP, GOVERNANCE AND MANAGEMENT › ADMISSION, TRANSFER AND DISCHARGE › Section 553.25 - Discharge criteria

Current through Register Vol. 54, No. 28, July 13, 2024
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.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 553 - OWNERSHIP, GOVERNANCE AND MANAGEMENT › MANAGEMENT AND ADMINISTRATION OF OPERATIONS › Section 553.31 - Administrative responsibilities

Current through Register Vol. 54, No. 28, July 13, 2024
(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.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 555 - MEDICAL STAFF › MEDICAL STAFF › Section 555.1 - Principle

Current through Register Vol. 54, No. 28, July 13, 2024
There shall be an organized medical staff which is
						accountable to the governing body and which has responsibility for the quality
						of medical care provided to patients and for the ethical conduct and
						professional practice of its members and other practitioners who have been
						granted clinical privileges in the ASF.
This section cited in 28 Pa. Code §
													551.3 (relating to
						  definitions).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart F - Ambulatory Surgical Facilities › Chapter 555 - MEDICAL STAFF › MEDICAL STAFF › Section 555.2 - Medical staff membership

Current through Register Vol. 54, No. 28, July 13, 2024
A member of the medical staff shall be qualified for
						membership and the exercise of clinical privileges granted to him. The
						governing body of the ASF, after considering the recommendations of the medical
						staff, may grant clinical privileges to qualified, licensed practitioners in
						accordance with their training, experience and demonstrated competence and
						judgment. Members of the medical staff and others granted clinical privileges
						shall currently hold licenses to practice in this
						Commonwealth.
This section cited in 28 Pa. Code §
													551.3 (relating to
						  definitions).