AN ACT

 

1Amending the act of July 19, 1979 (P.L.130, No.48), entitled "An
2act relating to health care; prescribing the powers and
3duties of the Department of Health; establishing and
4providing the powers and duties of the State Health
5Coordinating Council, health systems agencies and Health Care
6Policy Board in the Department of Health, and State Health
7Facility Hearing Board in the Department of Justice;
8providing for certification of need of health care providers
9and prescribing penalties," in licensing of health care
10facilities, further providing for definitions, <-for 
11administration, for licensure, for term and content of
12license and for reliance on accrediting agencies and Federal
13Government; and providing for reliance on national
14accreditation organizations for hospitals.

15The General Assembly of the Commonwealth of Pennsylvania
16hereby enacts as follows:

17Section 1. Section 802.1 of the act of July 19, 1979
18(P.L.130, No.48), known as the Health Care Facilities Act, is
19amended by adding definitions to read:

1Section 802.1. Definitions.

2The following words and phrases when used in this chapter
3shall have, unless the context clearly indicates otherwise, the
4meanings given them in this section:

5* * *

6"Deemed" or "deemed status." A process under which a
7hospital may be exempt from routine licensure renewal surveys
8conducted by the Department of Health.

9* * *

10"National accreditation <-organization." organization" or
11"accreditation organization." A nongovernmental organization
12that has been authorized by the Centers for Medicare and
13Medicaid Services (CMS) to conduct hospital surveys to ensure
14compliance with the CMS Conditions of Participation.

<-15"Survey." An announced or unannounced examination by the
16Department of Health or its representatives, which may include
17an onsite visit, interviews with employees, patients and other
18individuals and review of medical and facility records, for the
19purpose of determining a health care facility's compliance with
20licensure requirements.

<-21Section 2. Section 806 of the act is amended by adding a
22subsection to read:

23Section 806. Licensure.

<-24Section 2. Section 804 of the act, amended December 18, 1992
25(P.L.1602, No.179), is amended to read:

26Section 804. Administration.

27(a) Discrimination prohibited.--Except as otherwise provided
28by law, no provider shall discriminate in the operation of a
29health care facility on the basis of race, creed, sex or
30national origin.

1(b) Prevention of duplication.--In carrying out the
2provisions of this chapter and other statutes of this
3Commonwealth relating to health care facilities, the department
4and other departments and agencies of the State and local
5governments shall make every reasonable effort to prevent
6duplication of inspections and examinations. The department may
7make the dates of licensure expiration coincide with medical
8assistance and Medicare certification or applicable [nationally
9recognized accrediting agencies accreditation] accreditation by 
10national accreditation organizations and shall combine these
11surveys and inspections where practical.

12(c) Health care innovation.--The department shall administer
13this chapter so as to encourage innovation and experimentation
14in health care and health care facilities consistent with the
15provisions of this chapter and shall encourage contributions of
16private funds and services to health care facilities.

17(d) Reports.--The department shall report annually to the
18General Assembly on the effectiveness of the licensing and
19enforcement of this chapter. Such report shall include
20appropriate data according to nature of facility relating to
21provisional licenses issued, nature of violations of regulations
22and number of facilities against which sanctions had to be
23taken.

24Section 3. Section 806(b), (c) and (d) of the act, amended
25December 18, 1992 (P.L.1602, No.179), are amended and the
26section is amended by adding a subsection to read:

27Section 806. Licensure.

28* * *

29(b) Development of regulations.--In developing rules and
30regulations for licensure the department shall take into

1consideration Federal certification standards and the standards
2of other third party payors for health care services and such
3[nationally recognized accrediting agencies] national 
4accreditation organizations as the department may find
5appropriate.

6(c) Fire and emergency standards.--Notwithstanding any other
7provision of law other than standards required for Federal
8certification by that type of health care facility in the
9Medicare or Medicaid program, no health care facility shall be
10required to satisfy any regulation relating to fire or similar
11emergency circumstance more stringent than those required of
12hospitals by the Joint Commission on Accreditation of Health
13Organizations or such [nationally recognized accrediting
14agencies] national accreditation organizations as the department
15may find appropriate, and the department shall adopt and enforce
16the appropriate standards.

17(d) Home health care agency regulations.--In developing 
18rules and regulations for licensure of home health care agencies 
19the department shall take into consideration the standards of 
20[nationally recognized accrediting agencies] national 
21accreditation organizations as the department may find 
22appropriate. Home health care agencies certified as providers by 
23the department to the Federal Government for purposes of the 
24Medicare program shall be deemed to comply with and satisfy the 
25department's regulations governing home health care agencies.

26* * *

27(i) Hospitals.--

28(1) In issuing a license to a hospital, the department
29shall, at the request of the hospital, rely on the reports of
30national accreditation organizations designated as acceptable

1to the department pursuant to the requirements set forth in
2section 810.1 and shall issue a license to a hospital that
3received approval or accreditation from the designated
4organization.

5(2) A hospital that is not accredited by a national
6accreditation organization or does not request that the
7department rely on the accreditation shall be required to
8comply with 28 Pa. Code Chs. 51 (relating to general
9information) and 101 (relating to general information).

10(3) This subsection shall not be construed as a
11limitation on the department's right of inspection permitted
12under section 813, including the right to inspect in response
13to complaints or other reports made to the department.

14(4) A hospital that is deemed shall comply with the
15standards established by a national accreditation
16organization that accredits the hospital. Any licensure
<-17inspection survey of a deemed hospital shall be based on the
18standards established by the national accreditation
19organization that accredits the hospital and State law.

20(5) All hospitals, whether licensed through
21accreditation or compliance with the department's
22regulations, shall submit plans for new construction and
23renovation of facilities to the department and must receive
24approval from the department before providing services in the
25newly constructed or renovated areas.

26Section <-3 4. Sections 809 and 810 heading and (a) of the
27act, amended December 18, 1992 (P.L.1602, No.179), are amended
28to read:

29Section 809. Term and content of license.

30(a) Contents.--All licenses issued by the department under

1this chapter shall:

2(1) be issued for a specified length of time as follows,
3including the provision of section 804(b):

4(i) all health care facilities other than hospitals
5for a period of one year[, and for hospitals for a period
6of two years] with the expiration date to be the last day
7of the month in which license is issued;

8(ii) provisional licenses for the length of time to
9be determined by the department upon issuance of the
10provisional license;

<-11(iii) all deemed hospitals for the duration of the
12accreditation cycle in good standing with the expiration
13date to be the last day of the month in which the license
14is issued; and

<-15(iii) all hospitals requesting that the department
16rely on the reports of a national accreditation
17organization as set forth under section 806(i)(1) and
18meeting the requirements of section 810.1(a):

19(A) an initial license with an expiration date
20to be the last day of the month of the hospital's
21current accreditation cycle; and

22(B) subsequently, provided the hospital is a
23deemed hospital in good standing, a license for the
24duration of the accreditation cycle with the
25expiration date to be the last day of the month in
26which the accreditation expires; and

27(iv) all hospitals licensed by compliance with the
28department's regulations for a period of three years,
29with the expiration date to be the last day of the month
30in which the license is issued;

1(2) be on a form prescribed by the department;

2(3) not be transferable except upon prior written
3approval of the department;

4(4) be issued only to the health care provider and for
5the health care facility or facilities named in the
6application;

7(5) specify the maximum number of beds, if any, to be
8used for the care of patients in the facility at any one
9time; and

10(6) specify limitations which have been placed on the
11facility.

12(b) Posting.--The license shall at all times be posted in a
13conspicuous place on the provider's premises.

14(c) Visitation.--Whenever practicable, the department shall
15make its visitations and other reviews necessary for licensure
16contemporaneously with similar visitations and other reviews
17necessary for provider certification in the Medicare and medical
18assistance programs and the department shall endeavor to avoid
19duplication of effort by the department and providers in the
20[certificate of need,] medical assistance and Medicare provider
21certification and licensure procedures. This shall not preclude
22the department from unannounced visits.

23(d) Use of beds in excess of maximum.--Except in case of
24[extreme emergency] natural disasters, catastrophes, acts of 
25bio-terrorism, epidemics or other emergencies, no license shall
26permit the use of beds for inpatient use in the licensed
27facility in excess of the maximum number set forth in the
28license without first obtaining written permission from the
29department: Provided, That during the period of a license, a
30health care facility may without the prior approval of the

1department increase the total number of beds by not more than
2ten beds or 10% of the total bed capacity, whichever is less.

3Section 810. Reliance on [accrediting agencies<-] national 
4accreditation organizations and Federal Government
5for health care facilities other than hospitals.

6(a) Reports of other agencies.--After a provider has been
7licensed or approved to operate a health care facility other 
8than a hospital for at least two years under this or prior acts,
9none of which has been pursuant to a provisional license, the
10department may rely on the reports of the Federal Government or
11[nationally recognized accrediting agencies<-] national 
12accreditation organizations to the extent those standards are
13determined by the department to be similar to regulations of the
14department and if the provider agrees to:

15(1) direct the [agency<-] national accreditation 
16organization or government to provide a copy of its findings
17to the department; and

18(2) permit the department to inspect those areas or
19programs of the health care facility not covered by the
20[agency<-] national accreditation organization or government
21inspection or where the [agency<-] national accreditation 
22organization or government report discloses more than a
23minimal violation of department regulations.

24* * *

25Section <-4 5. The act is amended by adding a section to read:

26Section 810.1. Reliance on national accreditation organizations
27for hospitals.

28(a) Report of other agencies.--After a provider has been
29licensed or approved to operate a hospital for at least three
30years under this or a prior act, no portion of which has been

1pursuant to a provisional or other restricted license, if
2requested by the facility, the department shall rely on the
3report of an acceptable accreditation organization authorized
4pursuant to this section and section 806.

5(b) Application and approval process.--An accreditation
6organization shall apply to the department for approval. Prior
7to approval, the department shall:

8(1) determine that the standards of the accreditation
9organization are equal to or more stringent than existing
10licensure survey requirements;

11(2) evaluate the survey <-or inspection process of the
12accreditation organization to ensure the integrity of the
13survey <-or inspection process; and

14(3) enter into a written agreement with the
15accreditation organization that includes requirements for:

16(i) notice of all surveys <-and inspections;

17(ii) sharing of complaints and other relevant
18information;

19(iii) participation of the department in
20accreditation organization activities if determined to be
21appropriate by the department;

22(iv) protection of the confidentiality of medical
23and personal records;

24(v) all licensure <-inspections surveys of deemed
25hospitals shall be based on the standards established by
26the national accreditation organization and State law;
27and

28(vi) any other provision necessary to ensure the
29integrity of the accreditation and <-licensure survey
30process.

1(c) Finding of substantial compliance of hospital.--

2(1) If an approved accreditation organization has issued
3a final report finding a hospital to be in substantial
4compliance with the accreditation organization's standards,
5the department shall accept the report as evidence that the
6hospital has met the department's licensure requirements and
7shall grant the hospital deemed status, if the hospital
8provides a copy of the final report to the department within
9ten business days of the hospital receiving it from the
10approved accreditation organization. The final report must
11have been issued no more than one year prior to the
12expiration date of the hospital's license.

13(2) A hospital that receives anything less than full
14accreditation shall be subject to full licensure survey by
15the department.

16(d) Reports to department.--

<-17(1) A final report of an approved accreditation
18organization shall be made immediately available to the
19public in accordance with department practice.

<-20(1) The department shall, in accordance with department
21practice, make a final report of an approved accreditation
22organization immediately available to the public.

23(2) A preliminary or final report of an approved
24accreditation organization shall not be admissible as
25evidence in a civil action or proceeding.

26(e) Inspection by department.--The department may inspect an
27accredited hospital to:

28(1) follow up on a systemic concern or event identified
29by an approved accreditation organization or by report filed
30by the facility;

1(2) investigate a complaint;

2(3) validate the findings of an approved accreditation
3organization that determined that a hospital is in compliance
4with conditions of participation issued by the Centers for
5Medicare and Medicaid Services and State licensure
6requirements; or

7(4) comply with the request of any Federal or State
8regulatory entity.

<-9(f) Participation or observation of surveys or inspections
10by accreditation organization by the department <-(f) Department
11participation or observation of surveys by accreditation
12organization.--The department may participate in or observe a
13survey <-or inspection of a hospital conducted by an approved
14accreditation organization.

15(g) Actions by the department on accreditation
16organization's failure to meet obligations.--

17(1) Upon determination by the department that an
18approved accreditation organization has failed to meet its
19obligations under this section, the department shall have 30
20days from the time it notifies the accreditation organization
21to resolve any issues that are resulting in the <-accrediting
22agency's <-accreditation organization not meeting its
23obligations.

24(2) If, after 30 days, the department and the
<-25accrediting accreditation organization have not reached an
26agreement that brings the <-accrediting accreditation
27organization back into compliance with this act, the
28department shall provide notice in the Pennsylvania Bulletin
29that it intends to take action to withdraw the approval of
30the accreditation organization, list the reasons the action

1is being taken, make available the accreditation
2organization's response to the department and receive public
3comment regarding the decision for a period of not less than
430 days.

5(3) If, after the conclusion of the public comment
6period, the department's determination is that the approved
7accreditation organization has failed to meet its obligation
8under this section, the department may withdraw approval of
9the accreditation organization granted under sections 806 and
10810 and immediately terminate the agreement between the
11department and the accreditation organization.

12(4) Any hospital that has achieved deemed status as a
13result of being accredited by the accreditation organization
14terminated by the department shall keep the deemed status
15until the end of the current licensure period. To renew a
16license, the hospital shall either be accredited by another
17department-approved accreditation organization or shall be
18subject to the department's licensure regulations as provided
19for in section 806(i)(2).

20Section <-5 6. This act shall take effect in 180 days.