CHAPTER 101. GENERAL INFORMATION

§ 101.1. Legal base.

 (a)  This subpart implements the powers and duties of the Department contained in Chapter 8 of the act of July 19, 1979 (P. L. 130, No. 48) added by the act of July 12, 1980 (P. L. 655, No. 136) (35 P. S. § §  448.801—448.821) known as the Health Care Facilities Act and contained in article II of the act (62 P. S. § §  201—209), as transferred to the Department in Reorganization Plan No. 5 of 1973 (71 P. S. §  755-5).

 (b)  This subpart establishes standards which the Department hereby brings to the attention of the officers or other persons having the management of licensed general and special hospitals and which, it is the duty of such officers or such other persons to adopt and to put into practice, pursuant to sections 803 and 806 of the act (35 P. S. § §  448.803 and 448.806).

 (c)  This subpart establishes the rules and regulations for visitation, examination, and inspection of all licensed general and special hospitals, pursuant to sections 810 and 813 of the act (35 P. S. § §  448.810 and 448.813).

 (d)  This subpart establishes provisions for minimum standards in the construction, maintenance, and operation of hospitals and for the issuance of licenses for general and special hospitals pursuant to sections 803 and 806 of the act.

   The provisions of this §  101.1 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)); and under 803 of the Health Care Facilities Act (35 P. S. §  448.803).

 This subpart establishes minimum standards with which licensed hospitals must comply. This subpart is subject to revision and reasonable interpretation by the Department in accordance with the changing needs for health services in this Commonwealth.

   The provisions of this §  101.2 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)); and under 803 of the Health Care Facilities Act (35 P. S. §  448.803).

 This subpart shall apply to all general and special hospitals within this Commonwealth except those hospitals operated by the United States.

   The provisions of this §  101.3 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)); and under 803 of the Health Care Facilities Act (35 P. S. §  448.803).

 The following words and terms, when used in this subpart, have the following meanings, unless the context clearly indicates otherwise:

   Act—Health Care Facilities Act (35 P. S. § §  448.101—448.904).

   Advanced life support—The invasive prehospital and interhospital emergency medical care of serious illness or injury by trained health professional and allied health professional personnel under the medical command of a physician.

   Anesthetist—A generic term used to identify anesthesiologists, other qualified physician anesthetists, or qualified nurse or dentist anesthetists.

   Authenticate—To verify authorship, for example, by written signature, identifiable initials, or computer key; the use of rubber stamp signatures shall be acceptable under the following strict conditions:

     (i)   The practitioner whose signature the rubber stamp represents is the only one who has possession of the stamp and is the only one who uses it.

     (ii)   The hospital maintains in its administrative offices a signed statement by the practitioner to the effect that he is the only person who possesses the stamp and is the only one who will use it.

   Certified medical records practitioner—Either an Accredited Records Technician or a Registered Records Administrator, approved by the American Medical Records Association.

   Chairman, chief—The director of a medical, clinical service; the term always connotes a physician unless otherwise stated.

   Chief executive officer—A job descriptive term used to identify the individual appointed by the governing body to act in its behalf in the overall management of the hospital.

   Clinical privileges—Permission to render medical care in the granting institution rendered pursuant to Chapter 107 (relating to medical staff).

   Compliance directive—A directive issued by the Department citing deficiencies which have come to the attention of the Department through the survey process or by on-site inspection and directing the hospital to take corrective action as the Department directs or to submit a plan of correction.

   Consultant—One who provides professional advice or services on request.

   Deficiency—Any condition which exists contrary to, in violation of, or in noncompliance with this subpart.

   Department—The Department of Health of the Commonwealth. Where a provision of this subpart confers powers or imposes duties upon the Department, which under a statute may be exercised by or imposed on only the Secretary, the reference to the Department shall be construed to mean the Department acting by and through the Secretary, or the person for the time being acting as the Secretary, personally.

   Dietetic assistant—A person who has completed a program in food service administration and nutritional care which meets the training standards established by the American Dietetic Association and provides at least 90 clock hours of coursework.

   Dietetic technician—A person who has completed an associate degree program which meets the educational standards established by the American Dietitian Association; this person works under the direction of a qualified dietitian.

   Direction—Authoritative policy or procedural guidance for the accomplishment of a function or activity.

   Director—An individual with administrative responsibility for the direction of a division or service of the hospital. When this term is used in connection with a medical, clinical service, it is synonymous with chairman and does not necessarily imply a salaried or otherwise remunerated individual.

   Division—An organizational division in the hospital.

   Drug administration—An act in which a single dose of an identified drug is given to a patient.

   Drug dispensing—The issuance of floor stocks or of one or more doses of a prescribed medication in containers that are correctly labeled to indicate the name of the patient, the contents of the container, and all other vital information needed to facilitate correct patient usage and drug administration.

   Emergency contraception—

     (i)   A drug, drug regime or device approved by the Food and Drug Administration that is used after sexual intercourse to inhibit or prevent ovulation or fertilization.

     (ii)   The term also includes a drug, drug regime or device approved by the Food and Drug Administration that is used after sexual intercourse to inhibit or prevent the implantation of a fertilized ovum within the uterus.

   Existing hospital—A facility erected or remodeled for use as a hospital prior to the effective date of this subpart.

   Ex officio—Position by virtue of or because of an office, with no reference to specific voting power.

   Facilities—Buildings, equipment, and supplies necessary for implementation of hospital services by personnel.

   Full-time—The normal or standard working period established by the hospital.

   General hospital—A hospital equipped and staffed for the treatment of medical or surgical conditions, or both, in the acute or chronic stages, on an inpatient basis of 24 or more hours.

   Graduate nurse—A graduate of an approved program of professional nursing practicing his profession pursuant to and in accordance with The Professional Nursing Law (63 P. S. § §  211—225).

   Graduate social worker—A person qualified by a graduate degree from a school of social work accredited by the Council on Social Work Education.

   Hospital—A facility having an organized medical staff and providing equipment and services primarily for inpatient care to persons who require definitive diagnosis or treatment, or both, for injury, illness, pregnancy, or other disability.

   House staff/House staff officers—Physicians in training whose clinical privileges are delineated pursuant to Chapter 107.

   Licensed practical nurse—A person licensed to practice practical nursing pursuant to The Practical Nurse Law (63 P. S. § §  651—667).

   May—A term used to indicate an acceptable but not mandatory standard, method, process, or result.

   Medical—Of, pertaining to, or dealing with the healing art and the science of medicine or osteopathy.

   Must—Synonymous with shall.

   New construction—New buildings, additions to existing buildings, conversion of existing buildings or portions thereof, or portions of buildings undergoing alterations other than repair.

   Nuclear medicine—The scientific and clinical discipline concerned with diagnostic, therapeutic-exclusive of sealed radium sources, and investigative use of radionuclides.

   Nursing care unit—An organized jurisdiction of nursing service in which nursing services are provided on a continuous basis.

   Nursing service—Patient care services pertaining to the curative, restorative, and preventative aspects of nursing that are performed or supervised by a registered nurse pursuant to the medical care plan of the practitioner and the nursing care plan.

   Nursing station—The physical area within a patient care unit from which nursing services are provided and where nursing records and supplies are maintained.

   Organized—Administratively and functionally structured.

   Organized medical staff—A formal organization of physicians, and dentists with the delegated responsibility and authority to maintain proper standards for medical care.

   Outpatient service—An organizational unit of the hospital which is designed to support the provision of nonemergency health care services to patients who do not remain in the hospital overnight; the term includes a short-term procedure unit when applicable.

   Paramedic—An emergency medical technician specifically trained in an advanced program of emergency cardiac and noncardiac care and certified by the Department as qualified to render the services enumerated in section 3 of the act of November 30, 1976 (P. L. 1205, No. 264) (35 P. S. §  6803) otherwise known as an emergency medical technician—paramedic or EMT—paramedic.

   Patient care unit—A designated area of the hospital where nursing services are provided on a continuous basis.

   Pharmacy—Any place where the practice of pharmacy is conducted pursuant to the Pharmacy Act (63 P. S. § §  390-1—390-13).

   Physician—A person licensed to practice medicine or osteopathy. The term is more fully defined in 1 Pa.C.S. §  991.

   Policy—A heading designating a section of this subpart which is a duty or responsibility only of the Department. Policy regulations carry the force of law when applied to the Department but do not apply to hospitals under this subpart.

   Practice privileges—Synonymous with clinical privileges.

   Practitioner—A licensed physician, dentist, or podiatrist.

   Principle—A term used to indicate the general approach or objective to be accomplished by meeting the standards or other regulations appearing after the stated principle.

   Professional nurse/registered professional nurse—A person licensed to practice professional nursing pursuant to The Professional Nursing Law (63 P. S. § §  211—225).

   Provider—An individual; a trust or estate; a partnership; a corporation including associations, joint stock companies, and insurance companies; and the Commonwealth or a political subdivision or instrumentality thereof including a municipal corporation or authority that operates a health care facility.

   Qualified dietitian—A person who:

     (i)   Is registered or eligible for registration by the Commission on Dietetic Registration and has at least one year of experience in clinical dietetics and nutrition; or

     (ii)   Has a baccalaureate degree or advanced degree with major studies in food or nutrition of dietetics and who has at least one year of clinical experience.

   Qualified nurse anesthetist—A nurse who has been certified as a nurse anesthetist by the American Association of Nurse Anesthetists or who has the equivalent training and experience.

   Qualified records administrator—Either an Accredited Records Technician or a Registered Records Administrator, approved by the American Medical Records Association.

   Radiologic technologist—An individual who is a graduate of a program in radiologic technology approved by the Council on Medical Education of the American Medical Association or who has the equivalent of such education and training.

   Rape crisis center—An office, institution or center that offers assistance to a sexual assault victim or the victim’s family through crisis intervention, medical and legal accompaniment and follow-up counseling.

   Reportable communicable disease—Any disease for which reports are required pursuant to the provisions of the Disease Prevention and Control Law of 1955 (35 P. S. § §  521.1—521.21). Reference should also be made to Chapter 27, Subchapters B, E and F (relating to selected procedures for preventing disease transmission; and miscellaneous provisions).

   Respiratory therapy—The provision of ventilatory support and associated services to patients.

   Secretary—The Secretary of the Department.

   Service—Used to indicate a functional division of the hospital or of the nursing or medical staff; also used to indicate the delivery of care.

   Sexual assault—Any offense specified in 18 Pa.C.S. Chapter 31, Subchapter B (relating to definition of offenses), except that the term does not include indecent exposure as defined in 18 Pa.C.S. §  3127 (relating to indecent exposure) or sexual intercourse with an animal as defined in 18 Pa.C.S. §  3129 (relating to sexual intercourse with animal).

   Sexual assault counselor—A person who is engaged or employed by a rape crisis center that arranges for the provision of services to a sexual assault victim, who has undergone at least 40 hours of sexual assault training and is under the control of a direct services supervisor of a rape crisis center, whose primary purpose is the rendering of advice, counseling or assistance to victims of sexual assault.

   Sexual assault emergency services—A medical examination, forensic examination, or other procedure or service provided by a hospital to a sexual assault victim because of a sexual assault.

   Sexual assault victim or victim—A person who has been sexually assaulted.

   Short-term procedure unit—A unit organized for the delivery of nonemergency surgical services to patients who do not remain in the hospital overnight.

   Small hospital—A hospital maintaining 100 beds or less, as licensed by the Department.

   Special care unit—An appropriately equipped area of the hospital where provision has been made for a concentration of physicians, nurses, and others who have special skills and experiences to provide medical care for critically ill patients.

   Special hospital—A hospital equipped and staffed for the treatment of disorders within the scope of specific medical specialties or for the treatment of limited classifications of diseases in their acute or chronic stages on an inpatient basis of 24 or more hours.

   Survey—The process of evaluation or reevaluation of the compliance of a hospital with this subpart.

   Undergraduate social worker—A person qualified by a bachelor’s degree from an undergraduate program in social work accredited by the Council on Social Work Education.

   Unit—A functional facility of the hospital.

   The provisions of this §  101.4 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)); and under 803 of the Health Care Facilities Act (35 P. S. §  448.803); amended under sections 102, 201(12), 801.1 and 803(2) of the Health Care Facilities Act (35 P. S. § §  448.102, 448.201(12), 448,801a and 448.803(2)); and under section 2102(a) and (g) of The Administrative Code of 1929 (71 P. S. §  532(a) and (g)).

§ 101.6. Contact person.

 Any person having questions or comments concerning this subpart may address those questions or comments to:

   Bureau of Quality Assurance

   Pennsylvania Department of Health

   Post Office Box 90

   Harrisburg, Pennsylvania 17108

   The provisions of this §  101.6 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)); and under 803 of the Health Care Facilities Act (35 P. S. §  448.803).

   The provisions of this §  101.6 adopted December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129.

EXCEPTIONS

§ 101.11. Principle.

 (a)  Any exception granted under this chapter may be revoked by the Department for any justifiable 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 hospital to come into compliance with the applicable regulations. Failure by the hospital to comply after the specified date may result in enforcement proceedings under this chapter.

 (c)  If a hospital wishes to request a reconsideration of a denial or revocation of an exception, it must 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.

   The provisions of this §  101.14 issued under 67 Pa.C.S. § §  6101—6104 (Repealed); and Reorganization Plan No. 2 of 1973 (71 P. S. §  755-2) (Renumbered).

   The provisions of this §  101.14 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial page (37757).

CLASSIFICATION OF HOSPITALS

§ 101.21. Classification.

 Every hospital licensed under this subpart shall be designated as either a general or special hospital, and this classification shall be noted on its license.

   The provisions of this §  101.21 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)); and section 803 of the Health Care Facilities Act (35 P. S. §  448.803).

   The provisions of this §  101.21 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (66821).

HOSPITAL REQUIREMENTS

§ 101.31. Hospital requirements.

 A hospital shall have all of the following:

   (1)  An organized governing body.

   (2)  A chief executive officer.

   (3)  An organized medical staff.

   (4)  An organized nursing staff.

   (5)  Medical services, continuous.

   (6)  Nursing services, continuous.

   (7)  Permanent on-site facilities for the care of patients 24 hours a day.

   (8)  A hospital-wide infection control program.

   (9)  Minimum on-site clinical provisions as follows:

     (i)   Inpatient care areas equipped with hospital furnishings.

     (ii)   Nursing care units.

     (iii)   Diagnostic and treatment areas.

     (iv)   Supplies and equipment to meet the medical and nursing needs of the patients within the scope of the services provided.

     (v)   Pharmaceutical services in compliance with Chapter 113 (relating to pharmacy services).

     (vi)   Facilities for the sterilization of equipment and supplies.

     (vii)   Treatment equipment for drug, blood, and parenteral fluid administration and for performance of medical or surgical nursing procedures.

     (viii)   Treatment equipment for the management of common medical or surgical, or both, emergencies, including facilities for cardio-pulmonary resuscitation.

     (ix)   Medical records services.

     (x)   Provision for medical social work services in compliance with Chapter 121 (relating to social work services).

     (xi)   Professional library services in compliance with Chapter 145 (relating to professional library services).

     (xii)   Provision for therapeutic diets.

   (10)  Minimum supportive capabilities or facilities as follows:

     (i)   A safe, structurally sound, habitable, sanitary, fire-resistant physical plant designed and equipped specifically for the delivery of contemporary forms of hospital care.

     (ii)   Facilities to provide adequate heat, light, ventilation, potable water, sewage disposal, electrical power, internal and external communications, and emergency utility services.

     (iii)   Sanitary garbage, trash, and waste disposal.

     (iv)   Internal and external environmental sanitation services.

     (v)   Sanitary laundry services for hospital garments and linens.

     (vi)   Sanitary hospital dietary services.

     (vii)   An internal fire and disaster plan, fire alarm system and evacuation plan.

     (viii)   Scheduled general and preventive maintenance services for building, services and biomedical equipment.

     (ix)   Participation with community agencies in the establishment of the role of the hospital in event of external disasters.

     (x)   Capability for obtaining police and fire protection, emergency transportation, grounds-keeping and snow removal.

     (xi)   Personnel recruitment, training and continuing education.

     (xii)   Business management capability.

     (xiii)   Short- and long-range planning capability.

     (xiv)   Fiscal services to assure continuity of operation under both normal and emergency conditions.

     (xv)   Comprehensive policies and standards for assuring the safety of patients, employes and visitors and for protection against malpractice and negligence.

   The provisions of this §  101.31 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)); and section 803 of the Health Care Facilities Act (35 P. S. §  448.803).

   The provisions of this §  101.31 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (66822).

   This section cited in 55 Pa. Code §  1181.2 (relating to definitions); and 55 Pa. Code §  1187.2 (relating to definitions).

INITIAL APPLICATION AND AUTHORIZATION TO
OPERATE A HOSPITAL

§ 101.41. Principle.

 The Department will grant the initial license to operate a new hospital after a survey conducted by the Department indicates that the applicant is in compliance with applicable provisions of this subpart. Such survey shall include an on-site inspection and review of written approvals submitted to the Department by regulatory agencies responsible for building, electric, fire, and environmental safety.

   The provisions of this §  101.41 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)); and section 803 of the Health Care Facilities Act (35 P. S. §  448.803).

   The provisions of this §  101.41 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (66823).

 New construction, alterations, or renovations that provide space for patient services or patient rooms shall not be used or occupied until authorization for such occupancy has been received by the hospital from the Department. It is the responsibility of the hospital to request a preoccupancy survey at least two weeks prior to the anticipated occupancy of a hospital or any addition or remodeled part thereof. The Department will conduct an on-site survey of the new or remodeled portion of the hospital prior to granting approval for occupancy. The Department, acting through the Director of the Division of Hospitals, may give such authorization orally, either in person or by telephone. The Department will provide the hospital with written confirmation of such oral authorization within 30 days.

   The provisions of this §  101.42 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)); and section 803 of the Health Care Facilities Act (35 P. S. §  448.803), unless otherwise noted.

   The provisions of this §  101.42 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial pages (66823) and (52722).

 A hospital shall meet the edition of the National Fire Protection Association 101, Life Safety Code and all applicable appendices which are currently enforced by the Federal government. Hospitals previously in compliance with prior editions of the Life Safety Code will be deemed in compliance with any subsequent edition with the exception of any new renovation or construction, which shall meet the current standard.

   The provisions of this §  101.42a issued under section 803 of the Health Care Facilities Act (35 P. S. §  448.803); and section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)).

   The provisions of this §  101.42a adopted January 20, 1984, effective January 21, 1984, 14 Pa.B. 215.

 The Department will supply the necessary forms for application under § §  101.41, 101.42 and 101.42a (relating to principle; building occupancy; and code compliance).

   The provisions of this §  101.43 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)); and section 803 of the Health Care Facilities Act (35 P. S. §  448.803).

   The provisions of this §  101.43 amended January 20, 1984, effective January 21, 1984, 14 Pa.B. 215. Immediately preceding text appears at serial page (77204).

CONTINUING OPERATIONS

§ 101.51. Policy.

 The Department will issue a license valid for two years to any hospital which is in compliance with this subpart.

   The provisions of this §  101.51 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)); and section 803 of the Health Care Facilities Act (35 P. S. §  448.803).

 A hospital shall advise the Department no later than 90 days prior to an intended change of ownership or control of the hospital. No license shall be transferable to new owners or controlling parties except upon a finding by the Department that they are responsible persons.

   The provisions of this §  101.52 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)); and section 803 of the Health Care Facilities Act (35 P. S. §  448.803).

 The license of a hospital becomes automatically void when any or all of the following occur:

   (1)  The license term expires.

   (2)  The hospital substantially changes its name or location, in which case a new license will be automatically issued upon application by a hospital if the hospital is otherwise in compliance with the applicable provisions of this subpart.

   (3)  If the hospital locates or relocates services at a site other than the current, contiguous site, it shall notify the Department 30 days prior to such change in order that the Department may determine if a new license is necessary.

   The provisions of this §  101.53 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)); and section 803 of the Health Care Facilities Act (35 P. S. §  448.803).

 A license is issued for approved existing facilities and bed complement. A hospital shall notify the Department when increases in bed complement are scheduled according to the following guidelines:

   (1)  If the increased bed complement will increase the total number of beds by more than ten beds or by more than 10% of the total bed capacity, the hospital shall not utilize the increased capacity until approval is obtained from the Department.

   (2)  If the hospital increases the bed complement by not more than ten beds or 10% of the total bed capacity, whichever is less, during a period of a license, prior approval of the Department is not required, although notification of the change must still be made. A hospital must at all times meet the physical plant, staffing, and all other requirements, as defined by this chapter, if additional beds are added.

   The provisions of this §  101.54 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)); and section 803 of the Health Care Facilities Act (35 P. S. §  448.803).

 The current license shall be displayed in a public and conspicuous place in the hospital.

   The provisions of this §  101.55 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)); and section 803 of the Health Care Facilities Act (35 P. S. §  448.803).

 (a)  Information regarding licensure must be completed annually on forms supplied by the Department. The Annual Hospital Questionnaire shall be completed each year; the Application for Hospital Licensure shall be completed biennially.

 (b)  If a hospital operates any number or variety of separate or distinct clinical facilities and has been issued a single license, information requested on the questionnaire and application forms must be separate and distinct according to location of facilities listed.

   The provisions of this §  101.56 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)); and section 803 of the Health Care Facilities Act (35 P. S. §  448.803).

   The provisions of this §  101.56 adopted December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129.

INSPECTION AND SURVEY OF ACTIVITIES

§ 101.61. Policy.

 Representatives of the Department will biennially conduct a survey of every hospital required to be licensed under this subpart or will conduct surveys in conjunction with representatives of accrediting agencies in Appendix A and in accordance with §  101.62 (relating to combined survey).

   The provisions of this §  101.61 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)); and section 803 of the Health Care Facilities Act (35 P. S. §  448.803).

 (a)  A provider may request that the Department consider, during the determination of the Department whether a particular hospital is in compliance with these regulations, the survey report of the Federal government or a nationally recognized accrediting agency if the provider has been issued a regular license covering the particular hospital to be surveyed for the last 3 years.

 (b)  If a provider requests to be licensed in accordance with subsection (a), it must submit to the Department a copy of the accrediting survey report of the agency within 7 days of receipt.

 (c)  If a provider requests to be licensed in accordance with subsection (a), it must comply with all requirements of this subpart. The requirements that are not covered by the standard survey of each approved accrediting agency are listed in Appendix B.

 (d)  The Department will have the sole authority to accept or reject, in whole or in part, the findings of the accrediting agency.

   (1)  If the accrediting findings of the agency are rejected, a full or partial survey at the discretion of the Department will be conducted by the surveyors of the Department to determine whether a license can be issued.

   (2)  If the accrediting agency denies accreditation to a provider, a full State survey will be conducted to determine whether a license can be issued.

   (3)  If a provider chooses not to apply for a license through the accrediting procedure even though qualified to do so under this section, a full State survey will be conducted to determine whether a license can be issued.

   (4)  For those portions of the accrediting agency survey report which the Department accepts as evidence that the provider is meeting the provisions of this subpart, the provider will be considered to be in full compliance with the corresponding provisions of this subpart.

   The provisions of this §  101.62 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)); and section 803 of the Health Care Facilities Act (35 P. S. §  448.803).

   The provisions of this §  101.62 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129 and 4281. Immediately preceding text appears at serial pages (52723) to (52724).

 The Department will provide the Department of Environmental Protection with its schedule for biennial hospital licensure inspections at a reasonable time in advance of such inspections. It will also be responsible for updating this schedule promptly as required in the event of any changes. The Department will exert every effort to coordinate and cooperate with DER in the exercise of their duties to enforce all applicable environmental, health, sanitation and safety standards under their jurisdiction.

   The provisions of this §  101.63 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)); and section 803 of the Health Care Facilities Act (35 P. S. §  448.803).

 The Department will give reasonable notice to a hospital of its intent to conduct the site visit component of the biennial survey.

   The provisions of this §  101.65 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)); and section 803 of the Health Care Facilities Act (35 P. S. §  448.803).

 Prior to a biennial survey site visit of a hospital by the Department, the Department may request from the hospital any documents, records, necessary consents to review the records of the hospital held by other organizations or agencies, or other information necessary for the Department to prepare for the site visit. The hospital shall provide any and all information or consents so requested.

   The provisions of this §  101.66 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)); and section 803 of the Health Care Facilities Act (35 P. S. §  448.803).

 (a)  Upon presenting the official Department of Health identification card to the hospital’s chief executive officer or his designee, authorized agents of the Department shall have access to the hospital to determine compliance with this subpart. Such access shall include:

   (1)  Entry to all hospital premises.

   (2)  Inspection and examination of all of the facilities, records, documents, and phases of operations, as permitted by law, including those relating to compliance with Chapter 103 (relating to governance and management).

   (3)  Interviewing of any staff, employes, members of the governing body and patients, subject to subsection (b).

   (4)  Examination of any patient, with his consent.

 The Department will document the extent of the compliance of a hospital with this subpart in at least one of the following ways:

   (1)  The statement of a responsible, authorized administrator or staff member.

   (2)  Documentary evidence provided by the facility.

   (3)  Answers by the hospital to detailed questions provided by the Department concerning the implementation of any provision of this subpart or examples of such 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.

   The provisions of this §  101.69 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)); and section 803 of the Health Care Facilities Act (35 P. S. §  448.803).

   The provisions of this §  101.69 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (37763).

POSTSURVEY PROCEDURES

§ 101.71. Policy.

 (a)  In the event of noncompliance with any provision of this subpart, the Department will notify the hospital, in writing, of any deficiencies and will direct the officers governing or managing the hospital to take such 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.

 Copies of compliance directives and plans of correction will be kept readily available by the Department’s Division of Hospitals or its successor in appropriate regional offices for the purpose of public inspection, examination, and duplication at a reasonable cost. Each hospital shall make available for inspection and examination by any person a current copy of these documents provided to it by the Department.

   The provisions of this §  101.75 issued under 67 Pa.C.S. § §  6101—6104 and Reorganization Plan No. 2 of 1973 (71 P. S. §  755-2).

   The provisions of this §  101.75 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial page (37764).

CONTINUING SURVEILLANCE

§ 101.81. Unannounced surveys.

 Whenever the Department has received any complaint or has other reasonable grounds to believe that a deficiency exists, the Department may without notice to the hospital, investigate, inspect or survey any service, facility, or portion of the hospital to which the alleged deficiency relates.

ISSUANCE OF LICENSE

§ 101.91. Principle.

 The Department will issue hospital licenses to qualified facilities. The license will reflect a regular or provisional status of the hospital. The license shall apply only to those facilities designated.

   The provisions of this §  101.91 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)); and section 808 of the Health Care Facilities Act (35 P. S. §  448.808).

 (a)  The Department will issue a regular 2-year license to a hospital when that hospital is in full compliance with section 808 of the act (35 P. S. §  448.808) and is in full or substantial compliance with the provisions of this subpart.

 (b)  As used in subsection (a), ‘‘full compliance’’ means total compliance; as used in subsection (a), ‘‘substantial compliance’’ means:

   (1)  That any deficiencies are, individually and in combined effect, of a minor nature such that neither the deficiencies nor efforts toward their correction will:

     (i)   Interfere with or adversely affect normal hospital operations; or

     (ii)   Adversely affect any patient’s health or safety; and

   (2)  That the hospital has adopted a plan of correction approved by the Department.

   The provisions of this §  101.92 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)); and section 808 of the Health Care Facilities Act (35 P. S. §  448.808).

   The provisions of this §  101.92 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial pages (52727) to (52728) and (37766).

 (a)  The Department may issue a provisional license, valid for a specified time period of no more than 6 months, when there are numerous deficiencies or a serious specific deficiency in compliance with applicable statutes, ordinances or regulations but when:

   (1)  The hospital is taking appropriate steps to correct the deficiencies in accordance with a timetable submitted by the hospital and agreed upon by the Department.

   (2)  There is no pattern of repeat deficiencies over a period of 2 or more years.

 (b)  A provisional license may be renewed no more than three times at the discretion of the Department.

 (c)  A provisional license may not be issued to allow services or facilities, or parts of facilities, which are subject to Certificate of Need review, but have not been submitted for such review, to be operated pending completion of Certificate of Need review.

   The provisions of this § §  101.93 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)); and section 808 of the Health Care Facilities Act (35 P. S. §  448.808).

   The provisions of this §  101.93 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (37766).

   This section cited in 28 Pa. Code §  101.101 (relating to grounds); and 28 Pa. Code §  101.102 (relating to modification of license).

REFUSAL OR REVOCATION

§ 101.101. Grounds.

 (a)  The Department may revoke or refuse to issue a license for any of the following reasons:

   (1)  Failure to comply with any compliance directive issued by the Department.

   (2)  Violation of or noncompliance with this subpart except when the hospital is in full compliance or substantial compliance as defined in §  101.92(b) (relating to regular license) or otherwise meets the conditions set forth in §  101.93 (relating to provisional license).

   (3)  Failure to correct any deficiency pursuant to a plan of correction, unless the Department approves an extension or modification of the plan of correction.

   (4)  Gross incompetence, negligence or misconduct in operating the hospital.

   (5)  Fraud, deceit, misrepresentation or bribery in obtaining or attempting to obtain a license.

   (6)  Lending, borrowing, or using the license of another hospital.

   (7)  Knowingly aiding or abetting in any way the improper granting of a license.

   (8)  Mistreating or abusing individuals cared for by the hospital.

   (9)  A pattern of continued noncompliance, in disregard of regulations, which is corrected only when actively supervised by the Department.

 (b)  Failure to obtain a Certificate of Need will necessitate a licensure modification to exclude the service lacking certificate of need approval.

   The provisions of this §  101.101 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)); and section 803 of the Health Care Facilities Act (35 P. S. §  448.803).

 The Department may modify a license by substituting a provisional license for a regular license whenever the Department determines that the hospital is not in full compliance or substantial compliance as defined in §  101.92(b) (relating to regular license) but the hospital otherwise meets the requirements of §  101.93(b) (relating to provisional license).

   The provisions of this §  101.102 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)); and section 803 of the Health Care Facilities Act (35 P. S. §  448.803).

 Whenever the Department proposes to revoke, modify or refuse to issue a license or to issue a provisional license, or to suspend admissions or withholds State funds available to the hospital, it will give written notice to the hospital by certified mail.

   The provisions of this §  101.103 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)); and section 803 of the Health Care Facilities Act (35 P. S. §  448.803).

   The provisions of this §  101.103 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (37767).

 A notice under §  101.103 (relating to notice) will conform to 1 Pa. Code §  35.14 (relating to orders to show cause). The order will specify the reasons for the proposed action of the Department and will notify the hospital of its right to a hearing. The order will specify the time within which the request of the hospital for a hearing must be filed with the Department.

   The provisions of this §  101.104 issued under sections 2101—3002 of The Administrative Code of 1929 (71 P. S. § §  531—732); Articles IX and X of the Public Welfare Code (62 P. S. § §  901—1059); and Reorganization Plan No. 3 of 1975.

   The provisions of this §  101.104 adopted December 9, 1977, 7 Pa.B. 3631.

CORRECTION OF DEFICIENCY

§ 101.111. Policy.

 Whenever any hospital 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 §  101.92(b) (relating to regular license), the Department may issue a regular license.

   The provisions of this §  101.111 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)); and section 803 of the Health Care Facilities Act (35 P. S. §  448.803).

   The provisions of this §  101.111 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (37768).

HEARINGS

§ 101.121. Demand for hearing.

 Any administrative hearing held pursuant to this subpart shall be conducted in accordance with 1 Pa. Code Part II (relating to general rules of administrative practice and procedure).

ADDITIONAL REMEDIES

§ 101.141. Principle.

 After proper notice and the opportunity for a hearing, the Department may withhold, in whole or in part, any and all State funds available to any hospital which does either:

   (1)  Fails to comply with a compliance directive without having timely requested a hearing.

   (2)  Operates without a valid license.

   The provisions of this §  101.142 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)); and section 803 of the Health Care Facilities Act (35 P. S. §  448.803).

 The Department may request the Office of Attorney General to institute appropriate legal proceedings to enforce compliance with this subpart.

   The provisions of this §  101.143 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)); and section 803 of the Health Care Facilities Act (35 P. S. §  448.803).

   The provisions of this §  101.143 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (37769).

CHILD ABUSE

§ 101.151. Principle.

 All hospitals shall comply with the Child Protective Services Law, 23 Pa.C.S. § §  6301—6384, and with any regulations promulgated thereunder by the Department of Public Welfare.

CIVIL RIGHTS

§ 101.161. Principle.

 Civil rights compliance shall be a condition required for the issuance of a license. The Department may make onsite visits at its discretion to verify the civil rights compliance status of the hospital.

   The provisions of this §  101.162 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)); and section 803 of the Health Care Facilities Act (35 P. S. §  448.803).

 (a)  Inpatient and outpatient care including all clinic locations, emergency room care and any contracted services for patients shall be provided without regard to race, color, national origin, sex or sexual preference or religion.

 (b)  All patients shall be assigned to rooms, floors and sections in accordance with their medical needs.

 (c)  Patients shall not be asked whether they are willing or desire to share a room with a person of another race or religion.

 (d)  Employes shall be assigned to patient services without regard to the race, color, national origin, or religion of either the patient or employe.

 (e)  Transfer of patients from rooms assigned or selected, or both, shall not be made for other than valid medical reasons.

 (f)  At discharge, patients shall be referred only to those skilled nursing care facilities, intermediate care facilities, personal care facilities or foster homes which are not known to the hospital to be in noncompliance with the provisions of the Pennsylvania Human Relations Act (43 P. S. § §  951—963). The hospital shall report immediately to the Compliance Office of the Department all instances of posthospital discriminatory practices experienced by patients referred by the hospital when such practices are brought to the attention of the hospital.

 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 any care or services on the ground of race, creed, color, sex, sexual preference, national origin or religion.

   (1)  A signed and dated copy of the policies of the hospital 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 race, creed, color, religion, national origin, sex or sexual preference.

   (2)  Copies of signed and dated notification forms by which doctors and other persons who normally refer to admit patients to the hospitals have been informed of the nondiscriminatory admission policy of the hospital.

   (3)  A copy of the date, notification, and description of the continuing method used to inform employes of the nondiscriminatory policies.

   (4)  Evidence that nondiscriminatory practices of the facility have been publicized in the community by one of the following methods: newspaper, radio, television, brochure, yellow pages in the telephone book, patient handbooks and so on.

   (5)  Records, by race, showing the utilization of inpatient rooms; intensive care and other units; outpatient clinics; emergency rooms; and referrals to nursing homes or other posthospital care facilities, homes, or agencies and showing the participation in training programs for such periods of time as may be required by the Department to determine compliance with the Pennsylvania Human Relations Act (43 P. S. § §  951—963).

   (6)  Written personnel policies giving evidence that employment practices of the hospital are in conformity with the Pennsylvania Human Relations Act (43 P. S. § §  951—963). These policies shall be made available to all employes and shall be discussed with each new employe.

   (7)  The stated ethical policy of the hospital, as defined in 16 Pa. Code §  51.2 (relating to definitions) with regard to abortion or sterilization if the hospital has adopted such a policy pursuant to 16 Pa. Code §  51.31 (relating to adoption and substance of a stated ethical policy) and any written objections to participating in such procedures submitted by any employe or staff member pursuant to 16 Pa. Code §  51.41 (relating to written objection to performance, participation in or cooperation in abortion or sterilization procedures).

   (8)  Such other records or reports as may be required by the Department, from time to time, to determine compliance with the Pennsylvania Human Relations Act (43 P. S. § §  951—963). This includes the competion of the Department’s Civil Rights Compliance Form.

   The provisions of this §  101.164 issued under 67 Pa.C.S. § §  6101—6104; and Reorganization Plan No. 2 of 1973 (71 P. S. §  755-2).

 When it is substantiated that the regular patient population of the hospital contains a foreign language speaking population for whom the language barrier constitutes a service disadvantage, the hospital should do all of the following:

   (1)  Have a roster of bilingual personnel or volunteers, or both.

   (2)  Post bilingual signs and have other printed materials, such as hospital handbooks, medical care instructions and follow-up care, readily available.

BED COMPLEMENT

§ 101.171. [Reserved].

 The number of patients admitted to any area of the hospital shall not exceed the number for which the area is designed, equipped, and staffed except in cases of emergency, and then only in accordance with the emergency or disaster plan of the hospital.

LICENSE FEES

§ 101.181. Principle.

 License fees will be charged and collected in accordance with section 807 of the act (35 P. S. §  448.807).

   The provisions of this §  101.191 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)); and section 803 of the Health Care Facilities Act (35 P. S. §  448.803).

   The provisions of this §  101.181 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (52733).

MISCELLANEOUS PROVISIONS

§ 101.191. Multiple-clinical facilities.

 A general or special hospital or medical center may operate any number of separate or distinct clinical facilities under its ownership and direct management. Such facilities may be structurally integrated or may be physically located elsewhere. The Department will rule on all requests for single licensing of multiple-clinical facilities according to pre-established criteria which are available from the Department. All such patient care facilities except physicians’ offices shall be subject to appropriate onsite inspection and survey to determine whether there is compliance with applicable provisions of this subpart.

   The provisions of this §  101.191 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)); and section 803 of the Health Care Facilities Act (35 P. S. §  448.803).

   A hospital shall provide the Department with a written list of the names and addresses of all persons having a 5.0% or more ownership or controlling interest in the hospital. As used in this section, ‘‘person’’ means any natural person, partnership, or corporate entity, including any public agency or religious, fraternal or philanthropic organization.

   The provisions of this §  101.192 issued under 67 Pa.C.S. § §  6101—6104; and Reorganization Plan No. 2 of 1973 (71 P. S. §  755-2).

 A hospital shall give written notice of an intent to close to the Department, not later than 90 days prior to the anticipated date of closing.