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| PRIOR PRINTER'S NO. 1932 | PRINTER'S NO. 3671 |
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| THE GENERAL ASSEMBLY OF PENNSYLVANIA |
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| HOUSE BILL |
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| INTRODUCED BY REICHLEY, CLYMER, CUTLER, EVERETT, GILLESPIE, GODSHALL, GROVE, HARHART, HESS, LONGIETTI, MILLER, WATSON, DAY, TOOHIL, HENNESSEY, HAHN, FARRY, BAKER AND MALONEY, MAY 23, 2011 |
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| AS REPORTED FROM COMMITTEE ON HEALTH, HOUSE OF REPRESENTATIVES, AS AMENDED, JUNE 6, 2012 |
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| AN ACT |
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1 | Amending the act of July 19, 1979 (P.L.130, No.48), entitled "An |
2 | act relating to health care; prescribing the powers and |
3 | duties of the Department of Health; establishing and |
4 | providing the powers and duties of the State Health |
5 | Coordinating Council, health systems agencies and Health Care |
6 | Policy Board in the Department of Health, and State Health |
7 | Facility Hearing Board in the Department of Justice; |
8 | providing for certification of need of health care providers |
9 | and prescribing penalties," in licensing of health care |
10 | facilities, further providing for definitions, and for | <-- |
11 | licensure, providing for medical staff requirements for | <-- |
12 | hospital licensure, further providing for term and content of |
13 | license and for reliance on accrediting agencies and Federal |
14 | Government; and providing for reliance on national | <-- |
15 | accreditation organizations for hospitals. |
16 | The General Assembly of the Commonwealth of Pennsylvania |
17 | hereby enacts as follows: |
18 | Section 1. The definition of "health care facility" in | <-- |
19 | section 802.1 of the act of July 19, 1979 (P.L.130, No.48), |
20 | known as the Health Care Facilities Act, amended July 7, 2006 |
21 | (P.L.334, No.69), is amended and the section is amended by |
22 | adding definitions to read: |
23 | Section 802.1. Definitions. |
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1 | The following words and phrases when used in this chapter |
2 | shall have, unless the context clearly indicates otherwise, the |
3 | meanings given them in this section: |
4 | * * * |
5 | "Health care facility." [For purposes of Chapter 8, a health |
6 | care facility includes, but is not limited to, a general, |
7 | chronic disease or other type of hospital, a home health care |
8 | agency, a home care agency, a hospice, a long-term care nursing |
9 | facility, cancer treatment centers using radiation therapy on an |
10 | ambulatory basis, an ambulatory surgical facility, a birth |
11 | center regardless of whether such health care facility is |
12 | operated for profit, nonprofit or by an agency of the |
13 | Commonwealth or local government. The department shall have the |
14 | authority to license other health care facilities as may be |
15 | necessary due to emergence of new modes of health care. When the |
16 | department so finds, it shall publish its intention to license a |
17 | particular type of health care facility in the Pennsylvania |
18 | Bulletin in accordance with the act of June 25, 1982 (P.L.633, |
19 | No.181), known as the "Regulatory Review Act." The term health |
20 | care facility shall not include an office used primarily for the |
21 | private practice of a health care practitioner, nor a program |
22 | which renders treatment or care for drug or alcohol abuse or |
23 | dependence unless located within a health facility, nor a |
24 | facility providing treatment solely on the basis of prayer or |
25 | spiritual means. The term health care facility shall not apply |
26 | to a facility which is conducted by a religious organization for |
27 | the purpose of providing health care services exclusively to |
28 | clergymen or other persons in a religious profession who are |
29 | members of a religious denomination.] For the purposes of this |
30 | act, the term shall include hospitals, cancer treatment centers |
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1 | using radiation therapy on an ambulatory basis, ambulatory |
2 | surgical facilities, specialized health care services and |
3 | outpatient health care facilities regardless of whether the |
4 | health care facility is operated for profit, nonprofit or by an |
5 | agency of the Commonwealth or local government. The term shall |
6 | not include an office used primarily for the private practice of |
7 | a health care practitioner nor a program which renders treatment |
8 | or care for drug or alcohol abuse or dependence unless located |
9 | within a health care facility, nor a facility providing |
10 | treatment solely on the basis of prayer or spiritual means. The |
11 | term shall not apply to a facility which is conducted by a |
12 | religious organization for the purpose of providing health care |
13 | services exclusively to the clergymen or other persons in a |
14 | religious profession who are members of a religious |
15 | denomination. |
16 | * * * |
17 | "Outpatient health care facility." For the purposes of this |
18 | act, the term shall be defined as a facility, whether fixed or |
19 | mobile, providing diagnostic, therapeutic, treatment or |
20 | rehabilitation services on an outpatient basis or to individual |
21 | patients for less than a 24-hour consecutive period, by or under |
22 | the supervision of physicians or other clinical staff in |
23 | accordance with their scope of practice. The term does not |
24 | include an office used primarily for the private practice of a |
25 | health care practitioner, but does include clinics and group |
26 | practice facilities providing diagnostic and treatment services |
27 | other than primary care in a specific specialized area of |
28 | medicine. Outpatient health care services provided under the |
29 | license of a hospital are excluded from this definition. |
30 | Outpatient services on the site of a hospital but not provided |
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1 | under the hospital license are included. |
2 | "Outpatient health care services." The term includes |
3 | emergency services, cardiac catheterization, cancer treatment |
4 | services involving radiation therapy, imaging services, pain |
5 | management services, burn center services, ambulatory surgery |
6 | services, dialysis services or any other clinical service deemed |
7 | by the Department of Health and published in the Pennsylvania |
8 | Bulletin to be subject to this act. |
9 | "Physical status." The American Society of Anesthesiologists |
10 | Physical Status Classification System. |
11 | "Specialized health care services." Certain diagnostic, |
12 | treatment or rehabilitative services which involve highly |
13 | technical medical procedures and require extraordinary expertise |
14 | and resources to be effective and safe as determined by the |
15 | Department of Health. |
16 | Section 2. Section 806(a), (b) and (c) of the act, amended |
17 | December 18, 1992 (P.L.1602, No.179) and October 16, 1998 |
18 | (P.L.777, No.95), are amended and the section is amended by |
19 | adding subsections to read: |
20 | Section 806. Licensure. |
21 | (a) License required.--No person shall maintain or operate |
22 | or hold itself out to be a health care facility or provide |
23 | specialized services without first having obtained a license |
24 | [therefor] issued by the department. [No health care facility |
25 | can be a provider of medical assistance services unless it is |
26 | licensed by the department and certified as a medical assistance |
27 | provider.]: |
28 | (1) Facilities or specialized health care services |
29 | accredited by a national accrediting organization approved by |
30 | the Centers for Medicare and Medicaid Services (CMS) shall be |
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1 | deemed to meet licensure requirements and shall be issued a |
2 | license by the department. |
3 | (2) Facilities not accredited by a CMS-approved national |
4 | accrediting organization shall be required to meet the |
5 | applicable Medicare Conditions of Participation or Medicare |
6 | Conditions of Coverage. |
7 | (3) Facilities or specialized health care services that |
8 | are not accredited and do not participate in Medicare shall |
9 | be required to comply with regulations adopted by the |
10 | department. |
11 | (a.1) Additional requirements.--Specific facilities or |
12 | specialized health care services shall be required, as a |
13 | condition of licensure, to do the following: |
14 | (1) Class A ambulatory surgical facilities (ASF) shall |
15 | meet the following criteria: |
16 | (i) A license is not required for the operation of a |
17 | Class A ASF; however, the facility shall be accredited by |
18 | the Accreditation Association for Ambulatory Health Care, |
19 | the Joint Commission on the Accreditation of Health Care |
20 | Organizations, the American Association for the |
21 | Accreditation of Ambulatory Surgical Facilities or |
22 | another nationally recognized accrediting organization |
23 | acknowledged by the Medicare program in order to be |
24 | identified as providing ambulatory service. |
25 | (ii) A Class A ASF shall register with the |
26 | department and shall forward a copy of its accreditation |
27 | survey to the department. |
28 | (iii) The Class A ASF must provide the following |
29 | information with the registration form and update the |
30 | department on an annual basis: |
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1 | (A) A list of operative procedures proposed to |
2 | be performed at the facility and the ages of the |
3 | patients to be served. |
4 | (B) The type of anesthetic proposed to be used |
5 | for each operative procedure. |
6 | (C) The facility's current accreditation survey |
7 | and the designation of accreditation status by the |
8 | nationally recognized accrediting organization. |
9 | (D) Other information the department deems |
10 | necessary for registration. |
11 | (2) A license shall be obtained to operate a |
12 | freestanding Class B or Class C ASF. |
13 | (3) An ASF license shall designate the licensed facility |
14 | as either a Class B or Class C ASF. |
15 | (4) An applicant for a license to operate an ASF shall |
16 | request licensure by the department by means of a written |
17 | communication which sets forth: |
18 | (i) A list of operative procedures proposed to be |
19 | performed at the facility and the ages of the patients to |
20 | be served. |
21 | (ii) The highest level of anesthetic proposed to be |
22 | used for each proposed operative procedure. |
23 | (iii) The highest physical status proposed to |
24 | receive ambulatory surgery at the facility. |
25 | (iv) A statement from the applicant which may be |
26 | accompanied by a written opinion from a nationally |
27 | recognized accrediting body stating the most appropriate |
28 | facility class. |
29 | (5) If a facility desires to change its classification |
30 | level from a Class B enterprise to a Class C enterprise, the |
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1 | facility shall request and obtain a license prior to |
2 | providing services to patients with a physical status of ASF |
3 | Class III or level III. |
4 | (6) The department may enter and inspect an ASF Class A, |
5 | B or C, at any time, announced or unannounced, to investigate |
6 | any complaints. The department may mandate closure of an ASF |
7 | that the department determines to be providing substandard |
8 | care or for any other lawful reason. |
9 | (7) Criteria for ambulatory surgery: |
10 | (i) Ambulatory surgical procedures are limited to |
11 | those procedures that do not exceed a total of four hours |
12 | of operating time and four hours of directly supervised |
13 | recovery. |
14 | (ii) The time limits may be exceeded only if the |
15 | patient's condition demands care or recovery beyond the |
16 | four-hour limit and the need for additional time could |
17 | not have been anticipated prior to surgery. |
18 | (iii) The surgical procedure shall not require more |
19 | than local or regional anesthesia or less than four hours |
20 | of general anesthesia. |
21 | (iv) The procedure may not be of a type that is |
22 | associated with the risk of extreme blood loss or |
23 | directly involves major blood vessels. |
24 | (v) The surgery may not require major or prolonged |
25 | invasion of body cavities. |
26 | (vi) The procedure may not be an emergency or be |
27 | life threatening in nature unless no hospitals are |
28 | available for the procedure and the need for surgery |
29 | could not have been anticipated. |
30 | (vii) The practitioner performing the surgery is |
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1 | responsible for obtaining the informed consent of the |
2 | patient for disclosure to the patient of the risks, |
3 | benefits and alternatives associated with the anesthesia |
4 | which will be administered, the procedure that will be |
5 | performed and the comparative risks, benefits and |
6 | alternatives to performance of the procedure in the ASF. |
7 | (viii) The department may issue interpretations of |
8 | this subsection, which apply to the question of whether |
9 | the performance of certain surgical procedures will |
10 | require licensure as an ASF. |
11 | (ix) Interpretations adopted by the department shall |
12 | be submitted to the Legislative Reference Bureau for |
13 | publication in the Pennsylvania Bulletin and the |
14 | Pennsylvania Code as a statement of policy of the |
15 | department. |
16 | (a.2) Pediatric patients.--The following criteria must be |
17 | met to perform ambulatory surgery on patients that are under 18 |
18 | years of age: |
19 | (1) A child under six months of age shall not be treated |
20 | in an ASF. |
21 | (2) The medical record shall include documentation that |
22 | the child's primary care provider was notified by the surgeon |
23 | in advance of the performance of a procedure in an ASF and |
24 | that an opinion was sought from the primary care provider |
25 | regarding the appropriateness of the use of an ASF for the |
26 | proposed procedure. When an opinion from the child's primary |
27 | care provider is not obtainable, the medical record shall |
28 | include documentation which explains why an opinion could not |
29 | be obtained. |
30 | (3) Anesthesia services shall be provided by an |
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1 | anesthesiologist who is a graduate of an anesthesiology |
2 | residency program accredited by the Accreditation Council for |
3 | Graduate Medical Education or its equivalent or by a |
4 | certified registered nurse anesthetist trained in pediatric |
5 | anesthesia either of whom shall have documented demonstrated |
6 | historical and continuous competence in the care of these |
7 | patients. |
8 | (4) The practitioner performing the surgery shall be |
9 | either board certified by or have obtained preboard |
10 | certification status with the American Board of Medical |
11 | Specialties, the American Osteopathic Board of Surgery, the |
12 | American Board of Podiatric Surgery or the American Board of |
13 | Oral and Maxillofacial Surgery. |
14 | (5) A medical professional who has successfully |
15 | completed a course in advanced pediatric life support offered |
16 | by the American Academy of Pediatrics and either the American |
17 | College of Emergency Physicians or the American Heart |
18 | Association shall be present in the facility. |
19 | (a.3) Specialized health care services.--The department |
20 | shall annually determine the types of specialized health care |
21 | services to be licensed under the provisions of this chapter: |
22 | (1) The department shall base its determination on the |
23 | following factors: |
24 | (i) Whether the quality of the services to be |
25 | offered is likely to be compromised through insufficient |
26 | volumes or utilization. |
27 | (ii) The cost and specialized expertise necessary |
28 | for safe and effective care. |
29 | (iii) Whether the service dependent is upon the |
30 | availability of scarce natural resources such as human |
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1 | organs. |
2 | (iv) Whether the service involves the use of new |
3 | medical technology. |
4 | (v) Consideration shall be given to the availability |
5 | and accessibility of specialized health care services to |
6 | accommodate populations in this Commonwealth. |
7 | (2) Exceptions may be granted by the department to |
8 | accommodate populations in this Commonwealth based on |
9 | availability and accessibility of health care services. |
10 | (b) Development of regulations.--In developing rules and |
11 | regulations for licensure of facilities or specialized health |
12 | care services not accredited and who do not participate in |
13 | Medicare, the department shall [take] adopt reasonable rules and |
14 | regulations, taking into consideration [Federal certification |
15 | standards and the standards of other third party payors for |
16 | health care services and such nationally recognized accrediting |
17 | agencies as the department may find appropriate.] applicable |
18 | standards of nationally recognized accrediting organizations |
19 | applicable to the service or setting. At a minimum, the |
20 | regulations shall address the following areas: |
21 | (1) The care of patients. |
22 | (2) The medical supervision of patients. |
23 | (3) The physical environment. |
24 | (4) Infection control. |
25 | (5) Quality assurance. |
26 | (6) Transfer protocols or procedures with receiving |
27 | facilities, where applicable. |
28 | (7) Sanitation. |
29 | (8) Safety. |
30 | (9) Dietary matters. |
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1 | (c) Fire and emergency standards.--Notwithstanding any other |
2 | provision of law other than standards required for Federal |
3 | certification by that type of health care facility in the |
4 | Medicare or Medicaid program[, no]: |
5 | (1) No health care facility shall be required to satisfy |
6 | any regulation relating to fire or similar emergency |
7 | circumstance more stringent than those required [of hospitals |
8 | by the Joint Commission on Accreditation of Health |
9 | Organizations or such nationally recognized accrediting |
10 | agencies as the department may find appropriate, and the |
11 | department shall adopt and enforce the appropriate] by the |
12 | accrediting organization, and the department shall adopt and |
13 | enforce these standards. |
14 | (2) Nonaccredited, non-Medicare participating facilities |
15 | shall comply with the Life Safety Code standards for medical |
16 | facilities defined by the National Fire Protection |
17 | Association. |
18 | * * * |
19 | Section 3. Sections 809(a) and (d) and 810(a) of the act, |
20 | amended December 18, 1992 (P.L.1602, No.179), are amended to |
21 | read: |
22 | Section 809. Term and content of license. |
23 | (a) Contents.--All licenses issued by the department under |
24 | this chapter shall: |
25 | (1) be issued for a specified length of time as follows, |
26 | including the provision of section 804(b): |
27 | (i) all accredited health care facilities [other |
28 | than hospitals for a period of one year, and for |
29 | hospitals for a period of two years], for the duration of |
30 | the accreditation cycle in good standing with the |
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1 | expiration date to be the last day of the month in which |
2 | license is issued; |
3 | (ii) provisional licenses for the length of time to |
4 | be determined by the department upon issuance of the |
5 | provisional license; and |
6 | (iii) all nonaccredited facilities' time frames |
7 | shall correspond to the time frames for accredited |
8 | facilities; |
9 | (2) be on a form prescribed by the department; |
10 | (3) not be transferable except upon prior written |
11 | approval of the department; |
12 | (4) be issued only to the health care provider and for |
13 | the health care facility [or], facilities or specialized |
14 | health care services named in the application; |
15 | (5) specify the maximum number of beds, if any, to be |
16 | used for the care of patients in the facility at any one |
17 | time; and |
18 | (6) specify limitations which have been placed on the |
19 | facility. |
20 | * * * |
21 | (d) Use of beds in excess of maximum.--Except in case of |
22 | [extreme emergency] natural disasters, catastrophes, acts of |
23 | bio-terrorism, epidemics or other emergencies, no license shall |
24 | permit the use of beds for inpatient use in the licensed |
25 | facility in excess of the maximum number set forth in the |
26 | license [without first obtaining written permission from the |
27 | department: Provided, That during the period of a license, a |
28 | health care facility may without the prior approval of the |
29 | department increase the total number of beds by not more than |
30 | ten beds or 10% of the total bed capacity, whichever is less]. |
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1 | Section 810. Reliance on accrediting agencies and Federal |
2 | Government. |
3 | (a) Reports of other agencies.--After a provider has been |
4 | licensed or approved to operate a health care facility or |
5 | provide specialized health care services for at least [two] |
6 | three years under this or prior acts, none of which has been |
7 | pursuant to a provisional license, the department [may] shall |
8 | rely on the reports of the Federal Government or nationally |
9 | recognized accrediting [agencies to the extent those standards |
10 | are determined by the department to be similar to regulations of |
11 | the department and if] agencies' current applicable standards as |
12 | long as the provider agrees to: |
13 | (1) direct the agency or government to provide a copy of |
14 | its findings to the department; and |
15 | (2) permit the department to inspect those areas or |
16 | programs of the health care facility [not covered by the |
17 | agency or government inspection or] where the agency or |
18 | government report discloses more than a minimal violation of |
19 | [department regulations] current standards. |
20 | * * * |
21 | Section 4. This act shall take effect in 60 days. |
22 | Section 1. Section 802.1 of the act of July 19, 1979 | <-- |
23 | (P.L.130, No.48), known as the Health Care Facilities Act, is |
24 | amended by adding definitions to read: |
25 | Section 802.1. Definitions. |
26 | The following words and phrases when used in this chapter |
27 | shall have, unless the context clearly indicates otherwise, the |
28 | meanings given them in this section: |
29 | * * * |
30 | "Deemed status." A process under which a hospital may be |
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1 | exempt from routine licensure renewal surveys conducted by the |
2 | Department of Health. |
3 | * * * |
4 | "National accredited organization." A nongovernmental |
5 | organization that has been authorized by the Centers for |
6 | Medicare and Medicaid Services (CMS) to conduct hospital surveys |
7 | to ensure compliance with the CMS Conditions of Participation. |
8 | Section 2. Section 806(a), (b) and (c) of the act, amended |
9 | December 18, 1992 (P.L.1602, No.179) and October 16, 1998 |
10 | (P.L.777, No.95), are amended and the section is amended by |
11 | adding a subsection to read: |
12 | Section 806. Licensure. |
13 | (a) License required.--[No] Except as provided for in |
14 | subsection (i), no person shall maintain or operate or hold |
15 | itself out to be a health care facility without first having |
16 | obtained a license therefor issued by the department. No health |
17 | care facility can be a provider of medical assistance services |
18 | unless it is licensed by the department and certified as a |
19 | medical assistance provider. |
20 | (b) Development of regulations.--[In] Except as provided for |
21 | in subsection (i), in developing rules and regulations for |
22 | licensure the department shall take into consideration Federal |
23 | certification standards and the standards of other third party |
24 | payors for health care services and such nationally recognized |
25 | accrediting agencies as the department may find appropriate. |
26 | (c) Fire and emergency standards.--[Notwithstanding] Except |
27 | as provided for in subsection (i), notwithstanding any other |
28 | provision of law other than standards required for Federal |
29 | certification by that type of health care facility in the |
30 | Medicare or Medicaid program, no health care facility shall be |
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1 | required to satisfy any regulation relating to fire or similar |
2 | emergency circumstance more stringent than those required of |
3 | hospitals by the Joint Commission on Accreditation of Health |
4 | Organizations or such nationally recognized accrediting agencies |
5 | as the department may find appropriate, and the department shall |
6 | adopt and enforce the appropriate standards. |
7 | * * * |
8 | (i) Hospitals.-- |
9 | (1) In issuing a license to a hospital, the department |
10 | shall, at the request of the hospital, rely on the reports of |
11 | national accreditation organizations designated as acceptable |
12 | to the department pursuant to the requirements set forth in |
13 | section 810.1 and shall issue a license to a hospital that |
14 | received approval or accreditation from such a designated |
15 | organization. |
16 | (2) A hospital that is not accredited by a national |
17 | accreditation organization or does not request that the |
18 | department rely on such accreditation shall be required to |
19 | comply with regulations adopted by the department. |
20 | (3) This subsection shall not be construed as a |
21 | limitation on the department's right of inspection otherwise |
22 | permitted under section 813, including, but not limited to, |
23 | the right to inspect in response to complaints or other |
24 | reports made to the department. |
25 | (4) A hospital that is accredited by a national |
26 | accreditation organization shall comply with the standards |
27 | established by that organization. Any inspection of a |
28 | participating accredited hospital shall be based on the |
29 | standards established by the national accreditation |
30 | organization that accredits the hospital and State law. |
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1 | (5) A hospital that is not accredited by a national |
2 | accreditation organization shall comply with the following: |
3 | (i) The licensure regulations adopted by the |
4 | department. |
5 | (ii) In revising the rules and regulations for |
6 | licensure of hospitals not accredited by a national |
7 | accreditation organization, the department shall take |
8 | into consideration applicable standards of nationally |
9 | recognized accreditation organizations specific to |
10 | hospitals. At a minimum, the regulations shall address |
11 | the following areas: |
12 | (A) the care of patients; |
13 | (B) the medical supervision of patients; |
14 | (C) the physical environment; |
15 | (D) infection control; |
16 | (E) quality assurance; |
17 | (F) transfer protocols; |
18 | (G) sanitation; |
19 | (H) safety; and |
20 | (I) dietary matters. |
21 | (6) All hospitals, whether licensed through |
22 | accreditation or compliance with the department's |
23 | regulations, shall: |
24 | (i) Comply with medical staff requirements set forth |
25 | in section 806.5. |
26 | (ii) Submit plans for new construction and |
27 | renovation of facilities to the department and must |
28 | receive approval from the department before providing |
29 | services in the newly constructed or renovated areas. |
30 | (7) The department shall review and revise the |
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1 | regulations promulgated under this section no less often than |
2 | every five years. |
3 | Section 3. The act is amended by adding a section to read: |
4 | Section 806.5. Medical staff requirements for hospital |
5 | licensure. |
6 | (a) Requirement.--In addition to the licensure requirements |
7 | set forth in section 806, all hospitals shall comply with the |
8 | provisions set forth in this section. |
9 | (b) Responsibility and authority of medical staff.-- |
10 | (1) The hospital shall have an organized medical staff |
11 | that is delegated the responsibility and authority to |
12 | maintain and promote proper standards of medical care, the |
13 | quality of all medical care provided to patients and the |
14 | ethical conduct and professional practice of its members. |
15 | (2) The medical staff shall be accountable to the |
16 | hospital governing body for the performance of its |
17 | responsibilities. |
18 | (3) The hospital governing body shall ensure that there |
19 | is communication between the medical staff and the governing |
20 | body, including a process for the medical staff to |
21 | participate in hospital deliberations involving matters |
22 | within the scope of the responsibility and authority |
23 | delegated to the medical staff. |
24 | (c) Bylaws.--The medical staff shall adopt, subject to the |
25 | approval of the governing body, a set of bylaws, rules and |
26 | regulations. The medical staff shall determine the methods for |
27 | selection, appointment and election of its officers, including |
28 | members of the medical executive committee and department and |
29 | service chairpersons. |
30 | (d) Organization of medical staff.--The medical staff shall |
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1 | be: |
2 | (1) Organized to accomplish its required functions, |
3 | including providing for the election and appointment of its |
4 | officers. The complexity of the medical staff shall be |
5 | commensurate with the size of the hospital and the scope of |
6 | the activities of the medical staff. |
7 | (2) Responsible for its own organization and |
8 | administration and shall perform all significant duties |
9 | pertaining thereto. Every member of the active medical staff |
10 | shall be eligible to vote at staff meetings and to hold |
11 | office. |
12 | (e) Medical staff membership.-- |
13 | (1) The medical staff shall be limited to physicians, |
14 | dentists and podiatrists who have made application in |
15 | accordance with the bylaws, rules and regulations of the |
16 | medical staff and the bylaws of the hospital. |
17 | (2) The medical staff shall determine in its bylaws the |
18 | qualifications and other requirements for medical staff |
19 | membership. |
20 | (3) Members of the medical staff shall currently hold |
21 | licenses to practice in this Commonwealth. |
22 | (f) Clinical privileges.-- |
23 | (1) The governing body of the hospital may grant |
24 | clinical privileges to qualified practitioners in accordance |
25 | with the medical staff bylaws and the practitioners' |
26 | training, experience and demonstrated competence and |
27 | judgment. |
28 | (2) Any person granted clinical privileges shall |
29 | currently hold a license to practice in this Commonwealth and |
30 | act within the scope of the license, the requirements of the |
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1 | medical staff bylaws and privilege delineation. |
2 | (3) A member of the medical staff shall have the |
3 | ultimate responsibility for the medical care of each patient. |
4 | (g) Due process.-- |
5 | (1) The medical staff shall determine in its bylaws the |
6 | appropriate due process procedures for the granting, |
7 | curtailing, suspending and revoking of medical staff |
8 | membership and clinical privileges. |
9 | (2) These processes shall provide for the governing body |
10 | to consider a recommendation from the medical staff before |
11 | taking action. |
12 | (h) Anesthesia.--Anesthesia care shall be provided by a |
13 | qualified physician, anesthesiologist, resident physician-in- |
14 | training, dentist anesthetist, qualified nurse anesthetist under |
15 | the supervision of the operating physician or anesthesiologist |
16 | or supervised nurse trainees enrolled in a course approved by |
17 | the American Association of Nurse Anesthetists. |
18 | (i) Proof of compliance.-- |
19 | (1) Compliance with the provisions of this section may |
20 | be demonstrated by the submission of documentation of |
21 | compliance accompanied by a sworn statement signed by the |
22 | hospital chief executive officer, which shall be provided to |
23 | the accrediting organization or the department, whichever |
24 | shall apply, no less than 30 days prior to the current |
25 | license termination date. |
26 | (2) In the event that a complaint alleging the |
27 | hospital's noncompliance with this section is received by the |
28 | department, the department may conduct an on-site inspection, |
29 | notwithstanding the submission of the sworn statement |
30 | permitted above. |
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1 | Section 4. Sections 809 and 810(a) of the act, amended |
2 | December 18, 1992 (P.L.1602, No.179), are amended to read: |
3 | Section 809. Term and content of license. |
4 | (a) Contents.--All licenses issued by the department under |
5 | this chapter shall: |
6 | (1) be issued for a specified length of time as follows, |
7 | including the provision of section 804(b): |
8 | (i) all health care facilities other than hospitals |
9 | for a period of one year[, and for hospitals for a period |
10 | of two years] with the expiration date to be the last day |
11 | of the month in which license is issued; |
12 | (ii) provisional licenses for the length of time to |
13 | be determined by the department upon issuance of the |
14 | provisional license; |
15 | (iii) all accredited hospitals for the duration of |
16 | the accreditation cycle in good standing with the |
17 | expiration date to be the last day of the month in which |
18 | the license is issued; and |
19 | (iv) all nonaccredited hospitals for a period of |
20 | three years, with the expiration date to be the last day |
21 | of the month in which the license is issued; |
22 | (2) be on a form prescribed by the department; |
23 | (3) not be transferable except upon prior written |
24 | approval of the department; |
25 | (4) be issued only to the health care provider and for |
26 | the health care facility or facilities named in the |
27 | application; |
28 | (5) specify the maximum number of beds, if any, to be |
29 | used for the care of patients in the facility at any one |
30 | time; and |
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1 | (6) specify limitations which have been placed on the |
2 | facility. |
3 | (b) Posting.--The license shall at all times be posted in a |
4 | conspicuous place on the provider's premises. |
5 | (c) Visitation.--Whenever practicable, the department shall |
6 | make its visitations and other reviews necessary for licensure |
7 | contemporaneously with similar visitations and other reviews |
8 | necessary for provider certification in the Medicare and medical |
9 | assistance programs and the department shall endeavor to avoid |
10 | duplication of effort by the department and providers in the |
11 | certificate of need, medical assistance and Medicare provider |
12 | certification and licensure procedures. This shall not preclude |
13 | the department from unannounced visits. |
14 | (d) Use of beds in excess of maximum.--Except in case of |
15 | [extreme emergency] natural disasters, catastrophes, acts of |
16 | bio-terrorism, epidemics or other emergencies, no license shall |
17 | permit the use of beds for inpatient use in the licensed |
18 | facility in excess of the maximum number set forth in the |
19 | license without first obtaining written permission from the |
20 | department: Provided, That during the period of a license, a |
21 | health care facility may without the prior approval of the |
22 | department increase the total number of beds by not more than |
23 | ten beds or 10% of the total bed capacity, whichever is less. |
24 | Section 810. Reliance on accrediting agencies and Federal |
25 | Government for health care facilities other than |
26 | hospitals. |
27 | (a) Reports of other agencies.--After a provider has been |
28 | licensed or approved to operate a health care facility other |
29 | than a hospital for at least two years under this or prior acts, |
30 | none of which has been pursuant to a provisional license, the |
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1 | department may rely on the reports of the Federal Government or |
2 | nationally recognized accrediting agencies to the extent those |
3 | standards are determined by the department to be similar to |
4 | regulations of the department and if the provider agrees to: |
5 | (1) direct the agency or government to provide a copy of |
6 | its findings to the department; and |
7 | (2) permit the department to inspect those areas or |
8 | programs of the health care facility not covered by the |
9 | agency or government inspection or where the agency or |
10 | government report discloses more than a minimal violation of |
11 | department regulations. |
12 | * * * |
13 | Section 5. The act is amended by adding a section to read: |
14 | Section 810.1. Reliance on national accreditation organizations |
15 | for hospitals. |
16 | (a) Report of other agencies.--After a provider has been |
17 | licensed or approved to operate a hospital for at least three |
18 | years under this or a prior act, no portion of which has been |
19 | pursuant to a provisional or other restricted license, if |
20 | requested by the facility, the department shall rely on the |
21 | report of an acceptable accreditation organization authorized |
22 | pursuant to this section and section 806. |
23 | (b) Application and approval process.--An accreditation |
24 | organization shall apply to the department for approval. Prior |
25 | to approval, the department shall: |
26 | (1) determine that the standards of the accreditation |
27 | organization are equal to or more stringent than existing |
28 | licensure survey requirements; |
29 | (2) evaluate the survey or inspection process of the |
30 | accreditation organization to ensure the integrity of the |
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1 | survey or inspection process; and |
2 | (3) enter into a written agreement with the |
3 | accreditation organization that includes requirements for: |
4 | (i) notice of all surveys and inspections; |
5 | (ii) sharing of complaints and other relevant |
6 | information; |
7 | (iii) participation of the department in |
8 | accreditation organization activities; |
9 | (iv) protection of the confidentiality of medical |
10 | and personal records; and |
11 | (v) any other provision necessary to ensure the |
12 | integrity of the accreditation and licensure process. |
13 | (c) Finding of substantial compliance of hospital.-- |
14 | (1) When an approved accreditation organization has |
15 | issued a final report finding a hospital to be in substantial |
16 | compliance with the accreditation organization's standards, |
17 | the department shall accept the report as evidence that the |
18 | hospital has met the department's licensure requirements and |
19 | shall grant the hospital deemed status. The final report must |
20 | have been issued no more than one year prior to the |
21 | expiration date of the hospital's license. |
22 | (2) A hospital that receives a conditional |
23 | accreditation, provisional accreditation, preliminary or |
24 | final denial of accreditation shall be subject to full |
25 | licensure survey by the department. |
26 | (d) Reports to department.-- |
27 | (1) An approved accreditation organization shall send |
28 | the department all final accreditation reports of each |
29 | inspection and survey at the time it is sent to the hospital. |
30 | (2) A final report of an approved accreditation |
|
1 | organization shall be made immediately available to the |
2 | public in accordance with department practice. |
3 | (3) A preliminary or final report of an approved |
4 | accreditation organization is not admissible as evidence in |
5 | any civil action or proceeding. |
6 | (e) Inspections by department.--The department may inspect |
7 | an accredited hospital to: |
8 | (1) follow up on any systemic concerns or events |
9 | identified by an approved accreditation organization or by |
10 | reports filed by the facility; |
11 | (2) investigate a complaint; |
12 | (3) validate the findings of an approved accreditation |
13 | organization that determined that a hospital is in compliance |
14 | with Conditions of Participation issued by the Centers for |
15 | Medicare and Medicaid Services and State licensure |
16 | requirements; or |
17 | (4) comply with the request of any Federal or State |
18 | regulatory entity. |
19 | (f) Participation or observation of surveys or inspections |
20 | by accreditation organization by the department.--The department |
21 | may participate in or observe a survey or inspection of a |
22 | hospital conducted by an approved accreditation organization. |
23 | (g) Actions by the department on accreditation |
24 | organization's failure to meet obligations.-- |
25 | (1) Upon determination by the department that an |
26 | approved accreditation organization has failed to meet its |
27 | obligations under this section, the department shall have 30 |
28 | days from the time it notifies the accreditation organization |
29 | to resolve any issues that are resulting in the accrediting |
30 | agency's not meeting its obligations. |
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1 | (2) If, after 30 days, the department and the |
2 | accrediting organization have not reached an agreement that |
3 | brings the accrediting organization back into compliance with |
4 | this act, the department shall provide notice in the |
5 | Pennsylvania Bulletin that it intends to take action to |
6 | withdraw the approval of the accreditation organization, list |
7 | the reasons this action is being taken, make available the |
8 | accreditation organization's response to the department and |
9 | receive public comment regarding this decision for a period |
10 | of not less than 30 days. |
11 | (3) If, after the conclusion of the public comment |
12 | period, the department's determination is that the approved |
13 | accreditation organization has failed to meet its obligation |
14 | under this section, the department may withdraw approval of |
15 | the accreditation organization granted under sections 806 and |
16 | 810 and immediately terminate the agreement between the |
17 | department and the accreditation organization. |
18 | (4) Any hospital that has achieved deemed status as a |
19 | result of being accredited by the accreditation organization |
20 | terminated by the department shall keep the deemed status |
21 | until the end of the current licensure period. To renew a |
22 | license, the hospital shall either be accredited by another |
23 | department-approved accreditation organization or shall be |
24 | subject to the department's licensure regulations as provided |
25 | for in section 806(i)(5). |
26 | Section 6. This act shall take effect in 180 days. |
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