PRINTER'S NO. 1658
No. 1263 Session of 2002
INTRODUCED BY MOWERY, JUBELIRER, M. WHITE, TARTAGLIONE, GERLACH
AND HOLL, JANUARY 23, 2002
REFERRED TO PUBLIC HEALTH AND WELFARE, JANUARY 23, 2002
AN ACT
1 Establishing a health care quality assurance authority;
2 providing for its powers and duties; requiring patient safety
3 plans; mandating serious event reporting; defining peer
4 review and quality review activities; establishing privileges
5 and confidentiality afforded to peer review and quality
6 review activities and records; and allocating staffing and
7 funds for physician oversight.
8 TABLE OF CONTENTS
9 Chapter 1. General Provisions
10 Section 101. Short title.
11 Section 102. Statement of purpose.
12 Section 103. Definitions.
13 Chapter 3. Health Care Quality Assurance Authority
14 Section 301. Establishment of authority.
15 Section 302. Confidentiality and privilege.
16 Section 303. Powers and duties.
17 Section 304. Health Care Quality Assurance Trust Fund.
18 Chapter 5. Patient Safety
19 Section 501. Patient safety plans.
20 Section 502. Confidentiality and privilege.
1 Section 503. External reporting and information exchange.
2 Chapter 7. Mandatory Reporting of Serious Events
3 Section 701. Reporting requirements.
4 Section 702. Confidentiality and privilege.
5 Section 703. Duties of the Department of Health and
6 Department of Public Welfare.
7 Section 704. Reports to public and General Assembly.
8 Section 705. Sanctions for failure to report.
9 Chapter 9. Peer Review Activities
10 Section 901. Standards for peer review activities.
11 Section 902. Immunity from liability.
12 Chapter 11. Quality Review Records
13 Section 1101. Confidentiality and privilege.
14 Section 1102. Aggregate data.
15 Section 1103. Exceptions.
16 Section 1104. Waiver.
17 Chapter 13. Physician Oversight
18 Section 1301. Staffing and salaries.
19 Section 1302. Disciplinary committee.
20 Section 1303. Temporary immediate suspensions.
21 Section 1304. Appropriations.
22 Chapter 15. Miscellaneous Provisions
23 Section 1501. Severability.
24 Section 1502. No private right of action.
25 Section 1503. Repeals.
26 Section 1504. Regulations.
27 Section 1505. Applicability.
28 Section 1506. Effective date.
29 The General Assembly of the Commonwealth of Pennsylvania
30 hereby enacts as follows:
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1 CHAPTER 1
2 GENERAL PROVISIONS
3 Section 101. Short title.
4 This act shall be known and may be cited as the Patient
5 Safety and Quality Assurance Act.
6 Section 102. Statement of purpose.
7 It is the purpose of this act to promote, preserve and
8 protect the health, safety and welfare of patients by the
9 effective management of patient safety and quality improvement
10 activities through:
11 (1) The creation of a health care environment that
12 encourages error identification and the implementation of
13 remedial steps to reduce the likelihood of future serious
14 events by minimizing the use of blame or retribution as a
15 means of addressing individual involvement in a medical
16 error. This includes encouraging organizational learning
17 about medical errors and supports the sharing of that
18 knowledge to effect behavioral changes in itself and other
19 health care organizations to improve patient safety.
20 (2) The creation of a health care quality assurance
21 authority to identify those conditions that minimize medical
22 errors, improve patient outcomes and enhance health care
23 delivery.
24 (3) The establishment of a process for confidential,
25 effective and appropriate peer review and quality review
26 activities.
27 (4) The imposition of mandatory serious event reporting
28 by all licensed health care facilities.
29 (5) The allocation of staffing and funds to the State
30 Board of Medicine and the State Board of Osteopathic Medicine
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1 in order to strengthen oversight of physician practice.
2 Section 103. Definitions.
3 The following words and phrases when used in this act shall
4 have the meanings given to them in this section unless the
5 context clearly indicates otherwise:
6 "Act." The Patient Safety and Quality Assurance Act.
7 "Adverse event." An injury caused by medical management
8 rather than the underlying condition of the patient.
9 "Adverse outcome." An outcome that results from an adverse
10 event.
11 "Authority." The Health Care Quality Assurance Authority
12 established in section 301.
13 "Clinical privileges." Permission to provide specific care
14 services in an organization within well-defined limits, based on
15 the following factors, including: license, education, training,
16 experience, competence, health status and judgment.
17 "Credentialing." The process of obtaining, verifying and
18 assessing the qualifications of a health care practitioner to
19 provide patient care services in or for a health care
20 organization.
21 "Electronic communication" or "e-mail." The process whereby
22 information is transferred electronically between information
23 systems, replacing traditional paper, mail and verbal
24 communication of this information.
25 "Error." The failure of a planned action to be completed as
26 intended or the use of a wrong plan to achieve an aim.
27 "Fund." The Health Care Quality Assurance Trust Fund
28 established in section 304.
29 "Health care insurer." Any insurance company, association or
30 exchange authorized to transact the business of insurance in
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1 this Commonwealth that provides coverage for health care
2 services. This shall also include any entity operating under any
3 of the following:
4 (1) Section 630 of the act of May 17, 1921 (P.L.682,
5 No.284), known as The Insurance Company Law of 1921.
6 (2) The act of December 29, 1972 (P.L.1701, No.364),
7 known as the Health Maintenance Organization Act.
8 (3) The act of December 14, 1992 (P.L.835, No.134),
9 known as the Fraternal Benefit Societies Code.
10 (4) 40 Pa.C.S. Ch. 61 (relating to hospital plan
11 corporations).
12 (5) 40 Pa.C.S. Ch. 63 (relating to professional health
13 services plan corporations).
14 (6) 40 Pa.C.S. Ch. 67 (relating to beneficial
15 societies).
16 "Health care organization." A licensed health care facility,
17 group practice, integrated delivery system, health care insurer
18 or any entity which is authorized by the laws of this
19 Commonwealth to deliver, contract to deliver or arrange for the
20 delivery of health care services.
21 "Health care practitioner." An individual who is licensed,
22 certified or otherwise authorized to provide health care
23 services within this Commonwealth.
24 "Licensed health care facility." Those entities operating
25 under the act of October 20, 1966 (3rd Sp.Sess., P.L.96, No.6),
26 known as the Mental Health and Mental Retardation Act of 1966,
27 the act of June 13, 1967 (P.L.31, No.21), known as the Public
28 Welfare Code and the act of July 19, 1979 (P.L.130, No.48),
29 known as the Health Care Facilities Act.
30 "Licensure board." The State Board of Medicine or the State
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1 Board of Osteopathic Medicine.
2 "Medical staff." The organization of physicians or dentists
3 who are credentialed and have privileges at a licensed health
4 care facility.
5 "Medication error." Any preventable event that may cause or
6 lead to inappropriate medication use or patient harm. Such
7 events may be related to professional practice, health care
8 products, procedures and systems, including: prescribing; order
9 communication; product labeling, packaging and nomenclature;
10 compounding; dispensing; distribution; administration;
11 education; monitoring; and use.
12 "Near error." Used to describe any process variation which
13 did not affect the outcome but for which a recurrence carries a
14 significant chance of a serious adverse outcome.
15 "Original source document." A document that was created
16 outside the scope of any quality review, including peer review,
17 activities and for a purpose unrelated to quality review,
18 including peer review.
19 "Patient safety officer." An individual designated by a
20 medical facility to coordinate the activities set forth in the
21 patient safety plan under Chapter 5.
22 "Peer review." The procedure for evaluation by professional
23 health care providers of the performance of other similar health
24 care providers for the purposes of:
25 (1) evaluating the quality of health care rendered;
26 (2) review of patient outcomes; or
27 (3) evaluating the cost of providing health care
28 services.
29 "Peer review action." An action or recommendation of a peer
30 review committee which affects, or may affect, adversely the
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1 medical staff membership or clinical privileges, or membership
2 in a professional society, of the professional health care
3 provider. The term includes a formal decision of a peer review
4 committee not to take an action or make a recommendation
5 described in the previous sentence and also includes quality
6 review activities relating to a peer review action.
7 "Peer review activity." An activity of a licensed health
8 care facility, professional society, group practice, integrated
9 delivery system or other professional health care provider with
10 respect to an individual physician to:
11 (1) determine whether the physician may have clinical
12 privileges with respect to or membership in the entity;
13 (2) determine the scope and conditions of such privilege
14 or membership; or
15 (3) change or modify such privileges or membership.
16 "Peer review committee."
17 (1) A licensed health care facility, professional
18 society, group practice, integrated delivery system or other
19 professional health care provider and the governing body
20 thereof, engaging in peer review activities.
21 (2) Any individual or committee engaging in, or
22 assisting in, peer review activities on behalf of a licensed
23 health care facility, professional society, group practice,
24 integrated delivery system or other professional health care
25 provider.
26 "Privileging." The process whereby clinical privileges are
27 granted for a health care practitioner by a health care
28 organization.
29 "Professional health care provider." An individual or
30 organization which is approved, licensed, certified or otherwise
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1 regulated to practice or operate in the health care field under
2 the laws of this Commonwealth, including the following
3 individuals or organizations:
4 (1) Health care practitioners.
5 (2) An administrator of a licensed health care facility.
6 (3) A corporation or other organization operating a
7 licensed health care facility or any not-for-profit
8 corporation that is a member or corporate affiliate of the
9 licensed health care facility or of which the health care
10 facility is a member.
11 "Professional society." An organization of health care
12 practitioners.
13 "Quality improvement." An approach to the continuous study
14 and improvement of the process of providing health care services
15 to meet the needs of individuals and others.
16 "Quality of care" or "quality of health care." The degree to
17 which health services for individuals and populations increase
18 the likelihood of desired health outcomes and are consistent
19 with current professional knowledge.
20 "Quality review." The process of review and evaluation by a
21 review organization or review committee of the quality of
22 services provided by a professional health care provider for the
23 purposes of:
24 (1) evaluating and improving the quality of health care
25 rendered;
26 (2) reducing morbidity or mortality;
27 (3) evaluating the cost of providing health care
28 services;
29 (4) engaging in self-critical analysis;
30 (5) evaluating and conducting reporting to Federal or
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1 State regulatory agencies, national accrediting organizations
2 or organizations serving as repositories or clearinghouses
3 for voluntary medical error reporting programs, including
4 reports contemplated under this act;
5 (6) compiling aggregate data concerning the procedures
6 and the outcomes of care of professional health care
7 providers for the purposes of evaluating the quality and
8 efficiency of health care services, including practice
9 analysis, review of incident reports, inpatient and
10 outpatient utilization review, medical audit, claims review
11 and compliance review of a licensed health care facility with
12 applicable laws, rules and regulations; or
13 (7) peer review.
14 "Quality review activities." All activities, including peer
15 review, engaged in by a review organization or a review
16 committee, or an employee, agent or contractor thereof, or by
17 the person or entity which is the subject of the quality review,
18 or an employee, agent or contractor thereof, as part of the
19 quality review process.
20 "Quality review records." All data, information, reports,
21 documents, findings, compilations and summaries, testimony and
22 any other records generated by, acquired by, created for or
23 given to a review organization or review committee, either oral
24 or written, as a part of any quality review, including peer
25 review, regardless of when the record is created. The term does
26 not include original source documents.
27 "Review organization" or "review committee."
28 (1) Any person, panel, national accrediting organization
29 or committee of a health care organization or organizations
30 engaging in quality review, including peer review, to gather
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1 and review information relating to the care and treatment of
2 patients.
3 (2) Any licensed health care facility's board, committee
4 or individual reviewing the professional qualifications or
5 activities of its medical staff or applicants for admission
6 thereto.
7 (3) A committee of an association comprised in large
8 part of professional health care providers reviewing the
9 operation of a licensed health care facility or facilities,
10 including an organization established by such associations
11 that contracts with a licensed health care facility or
12 facilities to assist in performing quality review, including
13 peer review.
14 "Self-critical analysis." All procedures a professional
15 health care provider uses or functions it performs to undergo
16 self-evaluation to identify, investigate and eliminate safety
17 problems and medical or system errors in order to change and
18 improve health care practices and patient care.
19 CHAPTER 3
20 HEALTH CARE QUALITY ASSURANCE AUTHORITY
21 Section 301. Establishment of authority.
22 (a) Establishment.--There is hereby established a body
23 corporate and politic to be known as the Health Care Quality
24 Assurance Authority.
25 (b) Appointments.--
26 (1) The authority shall consist of 17 members appointed
27 in accordance with the following:
28 (i) The Physician General of the Department of
29 Health who shall act as chair.
30 (ii) Eight members appointed by the Governor.
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1 (iii) Two members appointed by the President pro
2 tempore of the Senate and two members appointed by the
3 Minority Leader of the Senate.
4 (iv) Two members appointed by the Speaker of the
5 House of Representatives and two members appointed by the
6 Minority Leader of the House of Representatives.
7 (2) No authority member may act or attend through a
8 designee or a proxy.
9 (3) All of the appointments shall be individuals
10 knowledgeable in or experienced with patient safety or
11 quality improvement practices, philosophies and initiatives.
12 (c) Composition.--The authority shall be comprised of the
13 following:
14 (1) Six of the members appointed to the authority by the
15 Governor must possess expertise in health care, with
16 representation by institution-based, practicing pharmacists,
17 nurses, physicians and risk managers/quality improvement
18 personnel. At least three of these members shall be
19 physicians.
20 (2) Two of the members appointed to the authority by the
21 Governor shall be health care consumers.
22 (3) Members appointed to the authority by the
23 legislature must be representatives of licensed health care
24 facilities. At least three of these members shall represent
25 hospitals and at least two of these members shall represent
26 long-term care.
27 (4) The members of the authority shall not receive any
28 compensation for serving but shall be reimbursed at
29 established Commonwealth rates for necessary expenses
30 incurred in the performance of their duties.
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1 (d) Terms.--
2 (1) With the exception of the Physician General, members
3 of the authority shall serve for terms of four years. No
4 appointed member shall be eligible to serve more than two
5 full consecutive terms.
6 (2) All members to the authority shall be appointed
7 within 90 days of the effective date of this act, and the
8 operations of the authority shall begin immediately upon
9 constitution of the full authority. The Physician General
10 shall convene the first meeting within 30 days after
11 constitution of the full authority.
12 (e) Quorum.--A majority of the members of the authority
13 shall constitute a quorum. Notwithstanding any other provision
14 of law, action may be taken by the authority at a meeting upon a
15 vote of the majority of its members present in person or through
16 the use of amplified telephonic equipment.
17 (f) Meetings.--
18 (1) The authority shall meet at least four times a year
19 and may provide for special meetings as may be necessary.
20 Meetings of the authority may be held anywhere within this
21 Commonwealth.
22 (2) All meetings of the authority shall be advertised
23 and conducted pursuant to 65 Pa.C.S. Ch. 7 (relating to open
24 meetings) and shall be subject to the act of June 21, 1957
25 (P.L.390, No.212), referred to as the Right-to-Know Law.
26 Section 302. Confidentiality and privilege.
27 The authority established to carry out the functions
28 specified in this chapter shall constitute a "review
29 organization" or "review committee" as defined in section 103.
30 All data, logs, information, documents, findings, compilations
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1 and summaries, testimony and any other record generated by,
2 acquired by, created for or given to the authority under this
3 section shall constitute "quality review records" as defined in
4 section 103 and shall be afforded the statutory protections for
5 quality review records set forth in section 1101.
6 Section 303. Powers and duties.
7 The authority shall do all of the following:
8 (1) Employ staff as necessary to implement this act.
9 (2) Receive reports and recommendations from the list of
10 approved organizations recognized as experts in collecting,
11 independently reviewing and analyzing information regarding
12 patient safety and medical errors under section 503.
13 (3) Establish a list of approved organizations
14 recognized as experts for licensed health care facilities to
15 choose from for the purposes of collecting, independently
16 reviewing and analyzing information submitted by health care
17 organizations and practitioners regarding improving patient
18 outcomes, reducing medical errors and increasing patient
19 safety.
20 (4) Identify those conditions that improve patient
21 outcomes and enhance health care delivery, reduce medical
22 errors and increase patient safety. Develop strategies, goals
23 and action plans for achieving improvements in these areas.
24 (5) Identify new technologies which enhance the delivery
25 of health care by improving patient outcomes, reducing
26 medical errors and increasing patient safety.
27 (6) Set priorities on what medical conditions could
28 benefit from systems-wide approaches to improving health care
29 outcomes.
30 (7) Report as necessary to all licensed health care
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1 facilities on trends and recommendations to improve patient
2 outcomes, reduce medical errors and increase patient safety.
3 (8) Apply for, solicit, receive, establish priorities
4 for, allocate, disburse, administer and spend funds in the
5 fund and other funds that are made available to the authority
6 from any source consistent with the purposes of this act.
7 (9) Advise the State Treasurer in relation to the
8 investment of any money held in the fund and advise the State
9 Treasurer in relation to the use of depositories for moneys
10 of the fund.
11 (10) Receive reports and recommendations from the
12 Department of Health and the Department of Public Welfare
13 regarding the reportable events collected under Chapter 7.
14 (11) Evaluate the effectiveness of the State's mandatory
15 serious event reporting system. Identify known and suspected
16 obstacles to reporting, recommend alternative methods that
17 will enhance reporting and assess the reporting system's
18 utility in improving patient safety in licensed health care
19 facilities.
20 (12) Make recommendations to the General Assembly and
21 the executive branch of government regarding changes in the
22 delivery of health care that improve patient outcomes, reduce
23 medical errors and increase patient safety.
24 (13) Meet at least quarterly with the Department of
25 Health and the Department of Public Welfare to advise and
26 assist them in implementing this act.
27 (14) Prepare and publish annually a report of its
28 findings, conclusions and activities conducted under this
29 act, including a list of priorities of key issues relating to
30 patient safety and quality improvement that need to be
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1 addressed in this Commonwealth and a plan on how to implement
2 these recommendations. This report shall be submitted to the
3 members of the following standing committees of the General
4 Assembly: the Public Health and Welfare Committee of the
5 Senate; the Consumer Protection and Professional Licensure
6 Committee of the Senate; the Health and Human Services
7 Committee of the House of Representatives; and the
8 Professional Licensure Committee of the House of
9 Representatives; and posted on the Department of Health's and
10 the Department of Public Welfare's Would Wide Web sites.
11 (15) Sponsor two educational forums each year to
12 facilitate the sharing and exchange of information among
13 licensed health care facilities and health care practitioners
14 regarding patient safety issues.
15 Section 304. Health Care Quality Assurance Trust Fund.
16 (a) Establishment.--There is hereby established a separate
17 account in the State Treasury to be known as the Health Care
18 Quality Assurance Trust Fund. The fund shall be administered by
19 the State Treasurer with the advice of the authority. All
20 interest earned from the investment or deposit of moneys
21 accumulated in the fund shall be deposited in the fund for the
22 same use.
23 (b) Funds.--All moneys deposited into the fund shall be held
24 in trust and shall not be considered general revenue of the
25 Commonwealth but shall be used only to effectuate the purposes
26 of this act as determined by the authority.
27 (c) Receipts and other credits.--There shall be paid or
28 credited to the fund:
29 (1) Amounts appropriated to the fund in the manner
30 provided by law.
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1 (2) The following surcharges, which are hereby imposed:
2 (i) A surcharge upon the health care facility
3 licensure application and renewal fees of the Department
4 of Health established under section 807(b) of the act of
5 July 19, 1979 (P.L.130, No.48), known as the Health Care
6 Facilities Act, in the amount of 10% of each such fee.
7 (ii) A surcharge upon the civil penalties collected
8 by the Department of Health established under section
9 817(b) of the Health Care Facilities Act, in the amount
10 of 25% of each such fee.
11 (iii) A surcharge upon the licensing, examination,
12 registration, certificates and other fees of all health
13 care-related professionals of the Bureau of Professional
14 and Occupational Affairs of the Department of State in
15 the amount of 10% of each such fee.
16 (d) Expenditures.--Moneys in the fund may be expended by the
17 authority to implement this act.
18 CHAPTER 5
19 PATIENT SAFETY
20 Section 501. Patient safety plans.
21 (a) Development.--Licensed health care facilities shall
22 develop and implement a patient safety plan that incorporates
23 mechanisms and internal, organization-wide systems for
24 identification and reporting of incidents or occurrences
25 relating to patient safety and medical errors and the
26 implementation of remedial steps to reduce the likelihood of
27 future serious events. The plan shall be developed in
28 consultation with the medical staff, nursing staff and other
29 health care practitioners and employees providing health care
30 services in the facility. The medical staff shall have the
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1 primary role in developing and implementing the patient safety
2 plan as a result of its responsibility for the quality of
3 medical care provided at the facility.
4 (b) Requirements.--The licensed health care facility's
5 patient safety plan shall:
6 (1) Establish a system for employees and independent
7 contractors to report incidents or occurrences relating to
8 patient safety and medical errors as defined in subsection
9 (c).
10 (2) Be accessible 24 hours a day, 7 days a week.
11 (3) Utilize any method or form of information exchange
12 to receive reports from employees and independent
13 contractors, including, but not limited to, hotlines,
14 including anonymous hotlines, electronic communication or e-
15 mails and written memoranda, including event reporting forms.
16 If the licensed health care facility establishes a hotline,
17 the telephone number shall be made readily available to all
18 employees and independent contractors, such as by
19 conspicuously posting the telephone number in common work
20 areas.
21 (4) Develop more than one communication reporting path
22 for an employee or independent contractor to report incidents
23 or occurrences relating to patient safety and medical errors.
24 One of the reporting modes must allow for anonymous
25 reporting.
26 (5) Notify all employees and independent contractors of
27 the existence of the mechanisms and internal, organization-
28 wide systems for performance improvement that include the
29 identification and reporting of incidents or occurrences
30 relating to patient safety and medical errors.
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1 (6) Incorporate findings and recommendations under the
2 patient safety plan, where appropriate, into the health care
3 facility's existing processes and structures for quality
4 review, quality improvement or other performance measurement
5 and analysis activities.
6 (7) Designate and individual within the licensed health
7 care facility to serve as a patient safety officer. This
8 person shall be responsible for coordinating the activities
9 set forth in the patient safety plan.
10 (c) Scope of reporting.--The types of incidents or
11 occurrences that shall be reported shall include, but not be
12 limited to:
13 (1) Events that cause no harm to patients but are
14 categorized as "near errors."
15 (2) Serious events which could compromise quality
16 assurance or patient safety as defined in section 701.
17 (3) Those events with serious adverse outcomes.
18 (d) Investigations.--Matters reported shall be documented
19 and investigated through the licensed health care facility's
20 process of self-critical analysis with the active involvement of
21 its medical staff. Data shall be maintained by the licensed
22 health care facility that includes:
23 (1) The specific report made.
24 (2) The nature of any investigation or analysis.
25 (3) The results of any investigation or analysis.
26 (e) Retaliatory action prohibited.--Licensed health care
27 facilities shall:
28 (1) Establish policies and procedures which provide that
29 all employees, medical staff members, and independent
30 contractors must be involved in identifying deficiencies in
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1 current care delivery processes and in designing and
2 executing solutions needed to create safer systems.
3 (2) Develop and distribute nonretaliation policies to
4 all employees, medical staff members and independent
5 contractors to encourage the identification and reporting of
6 incidents or occurrences relating to patient safety and
7 medical errors under this chapter.
8 (3) Include the identification and reporting of
9 incidents or occurrences relating to patient safety and
10 medical errors as a factor in evaluating the performance of
11 all employees and independent contractors, and in reviewing
12 and acting upon matters relating to the medical staff
13 membership and privileges of its medical staff.
14 (4) Develop methods to encourage reporting of errors or
15 patient safety concerns which shall include, but not be
16 limited to:
17 (i) Incorporating accountability for patient safety
18 into employee position descriptions and establishing a
19 comparable mechanism that does the same with members of
20 the licensed health care facility's medical staff.
21 (ii) Developing a policy setting forth the degrees
22 of disciplinary actions that may be imposed on all
23 employees and independent contractors and the types of
24 corrective action that may be imposed on members of its
25 medical staff for failing to report identified incidents
26 or occurrences relating to patient safety and medical
27 errors.
28 (f) Disciplinary action.--Nothing in this section shall
29 limit a licensed health care facility's ability to take
30 appropriate disciplinary action against an employee or
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1 independent contractor for not meeting defined performance
2 expectations or to take corrective action against medical staff
3 members for unprofessional conduct consistent with medical staff
4 bylaws, including making false reports regarding errors, near
5 errors or complaints related to patient safety.
6 (g) Report to the governing body.--At least quarterly, after
7 review by and input from the medical staff consistent with the
8 licensed health care facility's medical staff bylaws, and in
9 accordance with the process set forth in the patient safety
10 plan, a report to the licensed health care facility's governing
11 body shall be made on the occurrence of medical errors and
12 actions taken by the facility to improve patient safety. Such
13 report shall include information generated from the licensed
14 health care facility's internal, organization-wide systems for
15 the identification and reporting of incidents or occurrences
16 relating to patient safety and medical errors.
17 (h) Records.--All data, logs, reports, information,
18 documents, findings, compilations and summaries and any other
19 records generated by, acquired by, created for or given to the
20 licensed health care facility's governing body under this
21 section shall constitute "quality review records" as defined in
22 section 103 and shall be afforded the statutory protections for
23 quality review records set forth in Chapter 11.
24 Section 502. Confidentiality and privilege.
25 Any committee established to carry out the functions
26 specified in this chapter shall constitute a "review
27 organization" or "review committee" as defined in section 103.
28 All data, logs, information, documents, findings, compilations
29 and summaries, testimony and any other record generated by,
30 acquired by, created for or given to the review organization or
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1 review committee under this section shall constitute "quality
2 review records" as defined in section 103 and shall be afforded
3 the statutory protections for quality review records set forth
4 in section 1101.
5 Section 503. External reporting and information exchange.
6 (a) Establishment.--Performance monitoring and improvement
7 in health care are data driven. As part of the patient safety
8 plan, licensed health care facilities shall:
9 (1) Establish a mechanism and participate in the
10 voluntary reporting and sharing of information or knowledge
11 with an organization that has been approved for use in
12 collecting, independently reviewing and analyzing information
13 submitted by health care organizations and practitioners for
14 the purpose of education and organizational learning about
15 improving patient outcomes, reducing medical errors and
16 increasing patient safety.
17 (2) Each licensed health care facility shall choose at
18 least one organization to voluntarily report to and share
19 information with that which is listed by the authority as
20 acceptable for use as set forth in section 302. The licensed
21 health care facility shall maintain the relationship with
22 this organization for at least two years.
23 (3) Each licensed health care facility shall notify the
24 authority of any changes in its relationship with the
25 selected organization or the selection of a new or additional
26 organization used to meet the external reporting and
27 information exchange requirements.
28 (b) Data collection.--Licensed health care facilities shall
29 plan and design information management processes to meet
30 internal and external information needs. Licensed health care
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1 facilities shall choose which types of data and information are
2 important to monitor and voluntarily report based on its
3 mission, the scope of care and services provided and populations
4 served, and which meets the data reporting requirements of the
5 organization it chooses to voluntarily report to and share
6 information with.
7 (c) Submission of reports.--Each licensed health care
8 facility shall ensure that aggregate data and trending
9 information based on the expert organization's findings and
10 analysis is submitted to the authority at least quarterly. The
11 data and trending information shall be reported to the authority
12 directly by the expert organization.
13 (d) Mandatory participation.--To effectively implement
14 processes for reporting and sharing of information or knowledge
15 with organizations recognized as experts in collecting,
16 independently reviewing and analyzing information submitted by
17 health care organizations and practitioners for the purpose of
18 education and organizational learning about medical errors and
19 to effect behavioral changes to improve patient safety,
20 participation by licensed health care facilities shall be
21 voluntary for two years. At the expiration of two years,
22 participation with at least one of these organizations shall be
23 mandatory by all licensed health care facilities.
24 CHAPTER 7
25 MANDATORY REPORTING OF SERIOUS EVENTS
26 Section 701. Reporting requirements.
27 (a) Establishment.--If a licensed health care facility is
28 aware of a situation or the occurrence of an event at the
29 facility which could seriously compromise quality assurance or
30 patient safety, the facility shall notify the Department of
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1 Health for facilities operating under the act of July 19, 1979
2 (P.L.130, No.48), known as the Health Care Facilities Act, and
3 the Department of Public Welfare for facilities operating under
4 the act of October 20, 1966 (3rd Sp.Sess., P.L.96, No.6), known
5 as the Mental Health and Mental Retardation Act of 1966, and the
6 act of June 13, 1967 (P.L.31, No.21), known as the Public
7 Welfare Code, collectively, the applicable State agency with
8 licensure jurisdiction.
9 "Seriously compromise quality assurance or patient safety"
10 when used in this chapter means an unexpected occurrence
11 involving death or serious physical or psychological injury.
12 Serious injury specifically includes loss of limb or function.
13 (b) Reportable events.--For purposes of this chapter, the
14 following events shall be reported to the Department of Health
15 or the Department of Public Welfare:
16 (1) Clinical treatment or medical intervention-related
17 events, not related to the natural course of the patient's
18 illness or underlying condition or pursuant to a patient
19 directive:
20 (i) Unanticipated death or major permanent loss of
21 function.
22 (ii) Deaths due to malnutrition, dehydration or
23 sepsis that occurred following conduct on the part of the
24 licensed health care facility or its staff, employees or
25 independent contractors.
26 (iii) Deaths or serious injuries related to a
27 medication error.
28 (iv) Transfers to a hospital from another licensed
29 health care facility as a result of injuries or accidents
30 occurring in the facility and not reportable under any
20020S1263B1658 - 23 -
1 other category. Transferring facilities are responsible
2 for making the report.
3 (v) Substantiated complaints of patient abuse.
4 (vi) Surgery performed on the wrong patient or on
5 the wrong body part.
6 (vii) Hemolytic transfusion reaction involving
7 administration of blood or blood products having major
8 blood group incompatibilities.
9 (2) Nonclinical patient safety and security events:
10 (i) Suicide of a patient that occurred at the
11 licensed health care facility.
12 (ii) Elopements from the licensed health care
13 facility resulting in death or serious injury. The term
14 "elopement" includes instances where a resident or
15 inpatient of a licensed health care facility leaves
16 without the knowledge of such facility. The term does not
17 include instances where a patient leaves against medical
18 advice (AMA) or leaves a hospital emergency department
19 before being registered or admitted.
20 (iii) Rape that occurred on the premises of the
21 licensed health care facility. Reporting shall occur once
22 a licensed health care facility has substantial evidence
23 that a rape has occurred. An allegation of rape is not
24 reportable.
25 (iv) Infant abduction or infant discharged to the
26 wrong family.
27 (v) Unlicensed practice of a regulated profession.
28 (vi) A health care facility going on "divert status"
29 when the diversion is for eight continuous hours or over
30 12 hours in a 24-hour period. Reporting shall include
20020S1263B1658 - 24 -
1 when the facility went on divert status, when the
2 facility went off divert status, the reasons for divert
3 status and what the facility did to avoid the divert
4 status.
5 (3) Threats to the continuation of health care services:
6 (i) Significant disruption of services due to
7 disaster such as fire, storm, flood or other occurrence.
8 This includes instances where the disruption of services
9 can not be remedied by alternative back-up or support
10 systems, such as auxiliary generators. It also includes
11 instances where the licensed health care facility must
12 transfer all or a portion of its patients or residents to
13 other licensed health care facilities.
14 (ii) Notification of termination of any services
15 vital to the continued safe operation of the facility or
16 the health and safety of its patients and personnel,
17 including the anticipated or actual termination of
18 electric, gas, steam heat, water, sewer and local
19 exchange telephone service.
20 (iii) Receipt of a strike notice.
21 (c) Changes.--Modification of this list or requirements for
22 reporting of additional events shall only be done based on the
23 recommendations of the authority. These changes shall be made by
24 statement of policy following a 60-day public comment period and
25 publication in the Pennsylvania Bulletin.
26 (d) Notification.--Reporting to the Department of Health or
27 the Department of Public Welfare shall:
28 (1) Be made within seven calendar days following
29 recognition by the licensed health care facility of any
30 matter reportable under section 702.
20020S1263B1658 - 25 -
1 (2) Be made by telephone, facsimile or electronic
2 communication or e-mail.
3 (e) Agency responsibilities.--The Department of Health and
4 the Department of Public Welfare shall:
5 (1) Have in place systems capable of receiving reports
6 24 hours a day, 7 days a week.
7 (2) Use the information contained in the notification
8 from the licensed health care facility only in connection
9 with the enforcement of its licensure responsibilities.
10 (f) Report details.--Initial notification shall include
11 sufficient detail and information to alert the Department of
12 Health or the Department of Public Welfare as to the nature of
13 the event and the preliminary steps which the licensed health
14 care facility intends to take to further investigate or rectify
15 the situation. Within 60 calendar days of making the initial
16 notification to the Department of Health or the Department of
17 Public Welfare, the licensed health care facility shall conclude
18 its internal investigation regarding the event and provide to
19 the applicable State agency with licensure jurisdiction a final
20 written report that shall include the following information:
21 (1) a description of the event;
22 (2) any steps the facility has taken to rectify the
23 situation; and
24 (3) any steps the facility intends to implement to
25 reduce the risk of similar events occurring in the future.
26 (g) Confidentiality.--The notification requirements of this
27 section do not require a facility to include information which
28 is deemed confidential and not reportable to the Department of
29 Health or the Department of Public Welfare under other
30 provisions of Federal or State law or regulations.
20020S1263B1658 - 26 -
1 Section 702. Confidentiality and privilege.
2 All data, information, documents, findings, compilations and
3 summaries, testimony and any other record generated by, acquired
4 by, created for or given to the Department of Health or the
5 Department of Public Welfare under this section shall be held in
6 confidence and shall not be disclosed to any person except to
7 the extent necessary to carry out the purposes of this chapter.
8 Information contained in section 701 shall not be subject to
9 discovery or introduction into evidence in any civil,
10 administrative or arbitration action or proceeding except a
11 proceeding of the Bureau of Professional and Occupational
12 Affairs of the Department of State brought under this chapter.
13 No person who participated in any review, investigation or
14 subsequent action taken by the Department of Health or the
15 Department of Public Welfare regarding an event reported under
16 this chapter shall be permitted or required to testify in any
17 civil, administrative or arbitration action or proceeding as to
18 any evidence or other matters relating to such review,
19 investigation or subsequent action except in a proceeding of the
20 Bureau of Professional and Occupational Affairs of the
21 Department of State brought under this chapter.
22 Section 703. Duties of Department of Health and Department of
23 Public Welfare.
24 Following notification of a serious event, receipt of a final
25 written report and after an investigation, if warranted, if the
26 Department of Health or the Department of Public Welfare has
27 reasonable cause to believe that practices occurred involving
28 moral turpitude, dishonesty or corruption or were outside of the
29 scope of the profession involving an individual or individuals
30 who are licensed, certified or otherwise regulated to practice
20020S1263B1658 - 27 -
1 or operate in the health care field under the laws of the
2 Commonwealth, the agency shall refer the matter to the Bureau of
3 Professional and Occupational Affairs of the Department of State
4 for investigation.
5 Section 704. Reports to public and General Assembly.
6 (a) Annual reporting.--The Department of Health and the
7 Department of Public Welfare shall prepare and publish on an
8 annual basis a report regarding the information collected under
9 this chapter. These reports shall be posted on the Department of
10 Health's and the Department of Public Welfare's World Wide Web
11 sites and submitted to the members of the following standing
12 committees of the General Assembly: the Public Health and
13 Welfare Committee of the Senate and the Consumer Protection and
14 Professional Licensure Committee of the Senate, and the Health
15 and Human Services Committee of the House of Representatives and
16 the Professional Licensure Committee of the House of
17 Representatives.
18 (b) Content.--The reports shall only contain the following
19 aggregate information:
20 (1) the total number of reports received by type of
21 licensed health care facility;
22 (2) the total number of referrals for investigation made
23 to the Bureau of Professional and Occupational Affairs of the
24 Department of State; and
25 (3) the total number of reports made for each specified
26 category listed in this chapter.
27 (c) Licensure actions.--The Department of Health and the
28 Department of Public Welfare shall publish on its respective
29 World Wide Web site any licensure actions taken against a
30 licensed health care facility relating to any of the reportable
20020S1263B1658 - 28 -
1 events listed under section 701.
2 Section 705. Sanctions for failure to report.
3 Any licensed health care facility that fails to report any
4 matter under section 701 shall be subject to all available
5 sanctions by the applicable State agency with licensure
6 jurisdiction as set forth in the act of October 20, 1966 (3rd
7 Sp.Sess., P.L.96, No.6), known as the Mental Health and Mental
8 Retardation Act of 1966, the act of June 13, 1967 (P.L.31,
9 No.21), known as the Public Welfare Code, and the act of July
10 19, 1979 (P.L.130, No.48), known as the Health Care Facilities
11 Act.
12 CHAPTER 9
13 PEER REVIEW ACTIVITIES
14 Section 901. Standards for peer review activities.
15 (a) Peer review activities.--For purposes of the protection
16 set forth in section 902, peer review activities must be taken:
17 (1) in the reasonable belief that the action was in the
18 furtherance of quality health care;
19 (2) with a reasonable effort to obtain the facts of the
20 matter; and
21 (3) in the case of a peer review action:
22 (i) after adequate notice and hearing procedures are
23 afforded to the professional health care provider
24 involved or after such other procedures as are fair to
25 the professional health care provider under the
26 circumstances; and
27 (ii) in the reasonable belief that the action was
28 warranted by the facts known after such reasonable effort
29 to obtain facts and after meeting the requirement of this
30 paragraph.
20020S1263B1658 - 29 -
1 Peer review activities shall be presumed to have met the
2 preceding standards necessary for the protection set out in
3 section 902 unless the presumption is rebutted by a
4 preponderance of the evidence. The standard of review shall be
5 an objective one which looks to the totality of the
6 circumstances.
7 (b) Notice and hearing.--Peer review activities are deemed
8 to have met the adequate notice and hearing requirement of
9 subsection (a)(3) with respect to a professional health care
10 provider if the conditions set forth in the Health Care Quality
11 Improvement Act of 1986 (Public Law 99-660, 42 U.S.C. §
12 11112(2)(a) and (b)) are met. Nothing in this section precludes
13 the use of alternative dispute resolution consistent with
14 medical staff and hospital bylaws.
15 (c) Construction of section.--For purposes of section 902,
16 nothing in this section shall be construed as:
17 (1) requiring the procedures referred to in subsection
18 (a)(3):
19 (i) where there is no adverse peer review action
20 taken; or
21 (ii) in the case of a suspension or restriction of
22 clinical privileges, for a period of not longer than 14
23 days, during which an investigation is being conducted to
24 determine the need for a peer review action; or
25 (2) precluding an immediate suspension or restriction of
26 clinical privileges, subject to subsequent notice and hearing
27 or other adequate procedures, where the failure to take such
28 an action may result in an imminent danger to the health of
29 any individual.
30 Section 902. Immunity from liability.
20020S1263B1658 - 30 -
1 (a) Immunity.--If peer review action or peer review
2 activities meet all the standards specified in section 901,
3 notwithstanding any other provision of law, the following
4 persons or entities shall not be held to have violated any
5 criminal law or to be civilly liable under any law for money
6 damages by reason of having participated in such review, by
7 furnishing professional counsel or services or by reason of
8 having provided such information:
9 (1) The peer review committee.
10 (2) Any person acting as a member or staff to the peer
11 review committee.
12 (3) Any person under contract or other agreement with
13 the peer review committee.
14 (4) Any person who participates with or assists the peer
15 review committee.
16 (5) Any person providing information to the peer review
17 committee.
18 (b) Applicability.--The immunity provisions in subsection
19 (a) shall apply unless:
20 (1) the information provided is unrelated to the
21 performance of the duties and functions of such peer review
22 committee;
23 (2) the information provided is false and the person
24 providing such information knew, or had reason to believe,
25 that such information was false; or
26 (3) any actions taken by such peer review committee were
27 motivated by malice toward any person affected by such
28 action.
29 CHAPTER 11
30 QUALITY REVIEW RECORDS
20020S1263B1658 - 31 -
1 Section 1101. Confidentiality and privilege.
2 (a) Review activities.--All quality review activities,
3 including peer review, and all records of a review organization
4 or review committee, including a peer review committee, shall be
5 held in confidence and shall not be disclosed to any person
6 except to the extent necessary to carry out the functions of the
7 review committee or review organization or as provided in
8 sections 1102 and 1104. Except as provided for in subsection
9 (c), quality review records shall not be subject to discovery or
10 introduction into evidence in any civil, administrative or
11 arbitration action or proceeding, and no person who participated
12 in any quality review activities of such review organization or
13 review committee shall be permitted or required to testify in
14 any civil, administrative or arbitration action or proceeding as
15 to any evidence or other matters relating to such quality review
16 activities.
17 (b) Use of records.--A review organization or review
18 committee may not use quality review records for any purpose
19 other than conducting quality review or quality review
20 activities except as provided in subsection (c).
21 (c) Actions and proceedings.--Notwithstanding the provisions
22 of subsections (a) and (b), in a civil action or fair hearing
23 procedure brought by the practitioner who is the subject of the
24 peer review to challenge the outcome of the peer review, the
25 presiding officer or judge may upon a showing of good cause by
26 the practitioner or licensed health care facility order the
27 disclosure to the practitioner or permit the licensed health
28 care facility the use of such records of the peer review
29 committee as are necessary in order to enable the practitioner
30 or licensed health care facility to adequately prepare and
20020S1263B1658 - 32 -
1 present its case. If disclosure is ordered, such disclosure
2 shall not constitute a waiver of the quality review privilege
3 for any purpose, and the practitioner or licensed health care
4 facility to whom the records are disclosed shall be bound to
5 maintain their confidentiality in accordance with the terms of
6 this act.
7 Section 1102. Aggregate data.
8 Under no circumstances shall any aggregate data concerning
9 the procedures and outcomes of professional health care
10 providers compiled for the purposes of evaluating the quality
11 and efficiency of health care services be disclosed or released
12 to any person or entity other than a review organization or
13 review committee without the express prior written consent of
14 such professional health care provider. Such aggregate data and
15 other quality review records shall be used for quality review
16 purposes only, and in no event shall such aggregate data or any
17 other quality review records be sold or otherwise similarly
18 distributed, but a review organization or review committee shall
19 be authorized to utilize the services of and/or pay a fee to
20 another person or entity to compile or analyze such aggregate
21 data. Notwithstanding the former provisions, a review
22 organization or review committee shall have the authority to
23 publish aggregate data in blinded form so long as the published
24 data does not disclose any information identifying any patient
25 or professional health care provider. Such publication shall not
26 constitute a waiver of the quality review privilege or any other
27 privilege.
28 Section 1103. Exceptions.
29 Notwithstanding the confidentiality provisions of sections
30 1101 and 1102:
20020S1263B1658 - 33 -
1 (1) information, documents or records which constitute
2 original source documents may be obtained from their original
3 sources to the extent otherwise disclosable or discoverable;
4 and
5 (2) information or testimony otherwise disclosable or
6 discoverable may be elicited from any person as to matters
7 within that person's knowledge provided that the information
8 was not obtained or opinions formed by the person as a result
9 of the person's participation in any quality review
10 activities.
11 Section 1104. Waiver.
12 Except as provided in this section, the evidentiary
13 privileges created by this chapter shall be invoked by all
14 witnesses, licensed health care facilities, review organizations
15 and review committees in all judicial, administrative, civil or
16 arbitration actions or proceedings. The disclosure of
17 confidential privileged quality review records between a review
18 organization or review committee and any of the following does
19 not constitute a waiver of the privilege:
20 (1) a professional health care provider under review;
21 (2) another review organization or review committee
22 performing a quality review function whether affiliated or
23 not;
24 (3) a State agency with licensing jurisdiction and
25 authority;
26 (4) any Federal or State agency requiring by law the
27 disclosure of confidential privileged quality review records
28 or information contemplated by Chapter 5; or
29 (5) a credentials verification organization gathering
30 information relating to applications.
20020S1263B1658 - 34 -
1 The organization or witness invoking the privilege shall be
2 granted a protective order preventing the release of its
3 proceedings, records and files or the testimony of the witness
4 as applicable. The unintentional or mistaken disclosure of
5 confidential privileged quality review records does not
6 constitute a waiver of the privilege.
7 CHAPTER 13
8 PHYSICIAN OVERSIGHT
9 Section 1301. Staffing and salaries.
10 (a) General counsel.--The State Board of Medicine and the
11 State Board of Osteopathic Medicine shall each employ a board
12 general counsel and each shall also employ an executive director
13 who in turn shall employ such qualified investigators and
14 attorneys and administrative staff as are necessary to fully
15 implement the boards' authority to revoke, suspend, limit and
16 otherwise regulate the licenses of physicians and to issue
17 reprimands and fines, to require refresher educational courses
18 or require licensees to submit to independent medical
19 examination or medical treatment. The boards shall each set
20 salary ranges for such positions as are sufficient, in their
21 sole discretion and without reference to other government pay
22 scales, to attract and retain top quality individuals, nor shall
23 the selection of particular individuals be subject to the
24 approval of the administrative, judicial or legislative branches
25 of government and shall be made entirely on merit.
26 (b) Hearing examiners.--The boards shall also each employ
27 with the approval of the Governor such hearing examiners as are
28 necessary to conduct hearings in accordance with the
29 disciplinary authority granted the boards and may adopt rules
30 and regulations setting forth the powers, standards and duties
20020S1263B1658 - 35 -
1 of such examiners. The hearing examiners shall have the power to
2 conduct hearings, administer oaths and to issue subpoenas in
3 accordance with such regulations.
4 Section 1302. Disciplinary committee.
5 Each board shall appoint a five to nine member disciplinary
6 committee composed primarily of physicians to oversee the
7 disciplinary process. The disciplinary committee shall review
8 complaints and requests from investigators and prosecuting
9 attorneys to determine which complaints and requests require
10 investigation and which after investigation warrants the
11 issuance of an order to show cause. The disciplinary committee
12 may require additional investigation and shall require expert
13 reports on issues that require such unless expertise in that
14 specialty is available from a committee member. The disciplinary
15 committee shall receive its legal advice from the board counsel.
16 The disciplinary committee shall also review requests for
17 temporary immediate suspension without hearing and make
18 recommendation to the board.
19 Section 1303. Temporary immediate suspensions.
20 On recommendations and findings of the disciplinary committee
21 and findings by the board that:
22 (1) the conduct of a physician poses an immediate risk
23 of harm to patients; and
24 (2) the likelihood is that a successful prosecution will
25 lead to license revocation and not to some lesser penalty,
26 the boards may impose an immediate temporary suspension of up to
27 ten days. The physician shall receive notice and a statement of
28 findings prior to any immediate suspension and a hearing shall
29 be held before a hearing examiner within ten days of the
30 effective date of the immediate suspension at which hearing the
20020S1263B1658 - 36 -
1 issues of risk of immediate risk of harm to patients and the
2 likelihood that a successful prosecution shall lead to licensure
3 revocation shall be heard. In no case, by waiver of the
4 physician or otherwise, shall an immediate temporary suspension
5 exceed 60 days.
6 Section 1304. Appropriations.
7 The activities of the boards shall not be the financial
8 obligation of the Commonwealth but shall be supported by license
9 and other fees and charges and fines collected by the medical
10 board and by the osteopathic medical board respectively, and
11 such amounts are hereby specifically appropriated for the
12 exclusive use by the State Board of Medicine and the State Board
13 of Osteopathic Medicine respectively in carrying out the
14 provisions of this act. Further each board shall set fees,
15 charges and fines at such levels as are reasonably necessary to
16 carry out the provisions of this act.
17 CHAPTER 15
18 MISCELLANEOUS PROVISIONS
19 Section 1501. Severability.
20 The provisions of this act are severable, except with respect
21 to the provisions contained in Chapters 5, 9 and 11. Except with
22 respect to Chapters 5, 9 and 11, if any provision of this act or
23 its application to any person or circumstance is held invalid,
24 the invalidity shall not affect other provisions or applications
25 of this act which can be given effect without the invalid
26 provision or application. In the case of Chapters 5, 9 and 11,
27 if one or more of these chapters are held invalid, none of the
28 provisions in the remaining chapters shall be given effect.
29 Section 1502. No private right of action.
30 No private right of action is created through the adoption of
20020S1263B1658 - 37 -
1 this act.
2 Section 1503. Repeals.
3 All acts and parts of acts are repealed insofar as they are
4 inconsistent with this act.
5 Section 1504. Regulations.
6 The Department of Health and the Department of Public Welfare
7 shall promulgate regulations necessary to carry out the
8 provisions of this act.
9 Section 1505. Applicability.
10 Chapters 9 and 11 shall apply to peer review and quality
11 review activities occurring on or after the effective date of
12 this act.
13 Section 1506. Effective date.
14 This act shall take effect in 120 days.
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