PRINTER'S NO. 1249
No. 1087 Session of 2005
INTRODUCED BY BROWNE, BENNINGHOFF, BALDWIN, BARRAR, BELARDI,
BELFANTI, BISHOP, BUXTON, CALTAGIRONE, CAPPELLI, CAWLEY,
CRAHALLA, CREIGHTON, CURRY, DeLUCA, DENLINGER, DERMODY,
DeWEESE, DIVEN, DONATUCCI, FORCIER, FRANKEL, FREEMAN, GANNON,
GEIST, GINGRICH, GOOD, GOODMAN, GRUCELA, HENNESSEY, HERMAN,
HERSHEY, JAMES, W. KELLER, LEACH, LEDERER, LEH, LESCOVITZ,
MANDERINO, McCALL, McGEEHAN, McGILL, McILHATTAN, McILHINNEY,
METCALFE, R. MILLER, MUNDY, O'NEILL, PICKETT, PISTELLA, RAPP,
READSHAW, REICHLEY, ROSS, RUBLEY, SAYLOR, SCAVELLO, SHANER,
STABACK, T. STEVENSON, STURLA, SURRA, E. Z. TAYLOR, THOMAS,
TIGUE, WALKO, WANSACZ, WHEATLEY, YOUNGBLOOD, FABRIZIO,
RAMALEY AND PALLONE, MARCH 24, 2005
REFERRED TO COMMITTEE ON HEALTH AND HUMAN SERVICES,
MARCH 24, 2005
AN ACT
1 Amending the act of March 20, 2002 (P.L.154, No.13), entitled
2 "An act reforming the law on medical professional liability;
3 providing for patient safety and reporting; establishing the
4 Patient Safety Authority and the Patient Safety Trust Fund;
5 abrogating regulations; providing for medical professional
6 liability informed consent, damages, expert qualifications,
7 limitations of actions and medical records; establishing the
8 Interbranch Commission on Venue; providing for medical
9 professional liability insurance; establishing the Medical
10 Care Availability and Reduction of Error Fund; providing for
11 medical professional liability claims; establishing the Joint
12 Underwriting Association; regulating medical professional
13 liability insurance; providing for medical licensure
14 regulation; providing for administration; imposing penalties;
15 and making repeals," further providing for declaration of
16 policy, for patient safety definitions, for powers and duties
17 of the Patient Safety Authority and for powers and duties of
18 the Department of Health; and providing for whistleblower
19 protection.
20 The General Assembly of the Commonwealth of Pennsylvania
21 hereby enacts as follows:
1 Section 1. Section 102 of the act of March 20, 2002
2 (P.L.154, No.13), known as the Medical Care Availability and
3 Reduction of Error (Mcare) Act, is amended to read:
4 Section 102. Declaration of policy.
5 The General Assembly finds and declares as follows:
6 (1) It is the purpose of this act to ensure that medical
7 care is available in this Commonwealth through a
8 comprehensive and high-quality health care system.
9 (2) Access to a full spectrum of hospital services and
10 to highly trained physicians in all specialties must be
11 available across this Commonwealth.
12 (3) To maintain this system, medical professional
13 liability insurance has to be obtainable at an affordable and
14 reasonable cost in every geographic region of this
15 Commonwealth.
16 (4) A person who has sustained injury or death as a
17 result of medical negligence by a health care provider must
18 be afforded a prompt determination and fair compensation.
19 (5) Every effort must be made to reduce and eliminate
20 medical errors by identifying problems and implementing
21 solutions that promote patient safety.
22 (6) Recognition and furtherance of all of these elements
23 is essential to the public health, safety and welfare of all
24 the citizens of Pennsylvania.
25 (7) It is the purpose of this act to enhance patient
26 safety by establishing meaningful whistleblower protection
27 and a reporting system for medical errors which is responsive
28 to legitimate concerns.
29 Section 2. Section 302 of the act is amended by adding
30 definitions to read:
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1 Section 302. Definitions.
2 The following words and phrases when used in this chapter
3 shall have the meanings given to them in this section unless the
4 context clearly indicates otherwise:
5 * * *
6 "Disciplinary action." An action against an individual which
7 has a negative impact on the individual in relation to salary or
8 terms of employment or professional affiliation. The term
9 includes discharge and loss or alteration of privileges of
10 affiliation.
11 * * *
12 "Health care facility." A facility licensed under the act of
13 July 19, 1979 (P.L.130, No.48), known as the Health Care
14 Facilities Act.
15 "Health care practitioner." An individual who is authorized
16 to practice some component of the healing arts by a license,
17 permit, certificate or registration, issued by a Commonwealth
18 licensing agency.
19 * * *
20 Section 3. Sections 304(a) and (b) and 306 of the act are
21 amended to read:
22 Section 304. Powers and duties.
23 (a) General rule.--The authority shall do all of the
24 following:
25 (1) Adopt bylaws necessary to carry out the provisions
26 of this chapter.
27 (2) Employ staff as necessary to implement this chapter.
28 (3) Make, execute and deliver contracts and other
29 instruments.
30 (4) Apply for, solicit, receive, establish priorities
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1 for, allocate, disburse, contract for, administer and spend
2 funds in the fund and other funds that are made available to
3 the authority from any source consistent with the purposes of
4 this chapter.
5 (5) Contract with a for-profit or registered nonprofit
6 entity or entities, other than a health care provider, to do
7 the following:
8 (i) Collect, analyze and evaluate data regarding
9 reports of serious events and incidents, including the
10 identification of performance indicators and patterns in
11 frequency or severity at certain medical facilities or in
12 certain regions of this Commonwealth.
13 (ii) Transmit to the authority recommendations for
14 changes in health care practices and procedures which may
15 be instituted for the purpose of reducing the number and
16 severity of serious events and incidents.
17 (iii) Directly advise reporting medical facilities
18 of immediate changes that can be instituted to reduce
19 serious events and incidents.
20 (iv) Conduct reviews in accordance with subsection
21 (b).
22 (6) Receive and evaluate recommendations made by the
23 entity or entities contracted with in accordance with
24 paragraph (5) and [report] advise the department of those
25 recommendations [to the department, which shall have no more
26 than 30 days to approve or disapprove the recommendations].
27 (7) [After consultation and approval by the department,
28 issue] Issue recommendations to medical facilities on a
29 facility-specific or on a Statewide basis regarding changes,
30 trends and improvements in health care practices and
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1 procedures for the purpose of reducing the number and
2 severity of serious events and incidents. Prior to issuing
3 recommendations, consideration shall be given to the
4 following factors that include expectation of improved
5 quality care, implementation feasibility, other relevant
6 implementation practices and the cost impact to patients,
7 payors and medical facilities. Statewide recommendations
8 shall be issued to medical facilities on a continuing basis
9 and shall be published and posted on the department's
10 publicly accessible Internet website and the authority's
11 publicly accessible [World Wide Web site] Internet website.
12 (8) Meet with the department for purposes of
13 implementing this chapter.
14 (9) Upon receipt of a complaint under subsection (b), do
15 all of the following:
16 (i) Distribute copies of the complaint to each
17 director on the board.
18 (ii) Within ten business days, require the
19 department to investigate the complaint under section
20 306(a)(6).
21 (iii) Maintain the confidentiality of all
22 information resulting from the complaint and the
23 investigation. Information under this subparagraph may be
24 released only when sanctions are pursued under section
25 306(a)(7) or until section 315(d) is invoked by a health
26 care practitioner.
27 (10) Disseminate, through publications and training
28 sessions, information about patient safety reporting under
29 subsection (b)(2).
30 (b) [Anonymous reports] Reports to the authority.--
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1 (1) (i) A health care worker who has complied with
2 section 308(a) may file an anonymous report regarding a
3 serious event with the authority. Upon receipt of the report,
4 the authority shall give notice to the affected medical
5 facility that a report has been filed. [The authority shall
6 conduct its own review of the report unless the medical
7 facility has already commenced an investigation of the
8 serious event.] The medical facility [shall] may provide the
9 authority with the results of its investigation no later than
10 30 days after receiving notice pursuant to this subsection.
11 [If the authority is dissatisfied with the adequacy of the
12 investigation conducted by the medical facility, the
13 authority shall perform its own review of the serious event
14 and may refer a medical facility and any involved licensee to
15 the department for failure to report pursuant to section
16 313(e) and (f).]
17 (ii) This paragraph shall not be construed to
18 preclude a direct report to the authority under paragraph
19 (2).
20 (2) The authority shall maintain a Statewide
21 confidential, toll-free telephone line to enable health care
22 practitioners to report on patient safety and the quality of
23 patient care provided by a health care facility. If a health
24 care practitioner who files a complaint under this paragraph
25 requests anonymity, the authority shall, except to the extent
26 necessary to verify credentials, maintain anonymity.
27 * * *
28 Section 306. Department responsibilities.
29 (a) General rule.--The department shall do all of the
30 following:
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1 (1) Review and approve patient safety plans in
2 accordance with section 307.
3 (2) Receive reports of serious events and infrastructure
4 failures under section 313.
5 (3) Investigate serious events and infrastructure
6 failures.
7 (4) In conjunction with the authority, analyze and
8 evaluate existing health care procedures and approve
9 recommendations issued by the authority pursuant to section
10 304(a)(6) and (7).
11 (5) Meet with the authority for purposes of implementing
12 this chapter.
13 (6) Upon referral of a complaint under section
14 304(a)(9), do all of the following:
15 (i) Within ten business days, investigate the
16 complaint. In order to carry out the investigation under
17 this subparagraph, the department shall consult with one,
18 and, if the department deems necessary, a second,
19 independent, external quality review team to examine the
20 team's recommendations and findings. A team under this
21 subparagraph shall consider the appropriate use of
22 patient care standards in the situation under
23 investigation and make recommendations based upon its
24 findings. The following apply to a team consulted under
25 this subparagraph:
26 (A) The team shall consist of at least all of
27 the following:
28 (I) A registered nurse who holds a license
29 under the act of May 22, 1951 (P.L.317, No.69),
30 known as The Professional Nursing Law; is engaged
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1 in active practice for at least 20 hours per
2 week; and holds a specialty-specific
3 certification from the American Nurses
4 Credentialing Center.
5 (II) A physician or an osteopath who is
6 engaged in active practice for at least 20 hours
7 per week and who is board-certified in a
8 specialty which is recognized by the American
9 Board of Medical Specialties or the American
10 Osteopathic Association and which is specific to
11 the situation under investigation.
12 (III) A pharmacist who is engaged in active
13 practice for at least 20 hours per week and who
14 is board-certified as a clinical pharmacist.
15 (B) A member of the team may not:
16 (I) be an employee or a contractor of the
17 health care facility or the health care
18 practitioner under investigation;
19 (II) be a past or current colleague of the
20 health care practitioner under investigation;
21 (III) have a past or current financial or
22 practice relationship with the health care
23 practitioner under review, that practitioner's
24 group, that practitioner's employer or that
25 practitioner's privilege-granting health care
26 facility;
27 (IV) have a past or current financial or
28 practice relationship with the health care
29 facility under investigation; or
30 (V) reside within 75 miles of the health
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1 care facility under investigation.
2 (ii) If warranted by the investigation:
3 (A) Seek sanctions under paragraph (7).
4 (B) Recommend sanctions or other action to the
5 appropriate licensing board under Chapter 9. A
6 licensing board or agency which receives a
7 recommendation under this clause shall report to the
8 authority concerning its action every 30 days until
9 the matter is finally disposed of. A report under
10 this clause shall be available to each director of
11 the board upon request.
12 (C) Recommend sanctions or other action to any
13 other appropriate Commonwealth agency.
14 (iii) Maintain the confidentiality of all
15 information resulting from the complaint and the
16 investigation until sanctions are sought under paragraph
17 (7) or until section 315(d) is invoked by a health care
18 practitioner.
19 (7) Impose an administrative penalty of up to $5,000
20 upon a health care facility for an act or omission which
21 impairs patient safety or the quality of patient care or, at
22 the department's discretion, take other remedial actions as
23 authorized by law. This paragraph is subject to 2 Pa.C.S. Ch.
24 5 Subch. A (relating to practice and procedure of
25 Commonwealth agencies) and Ch. 7 Subch. A (relating to
26 judicial review of Commonwealth agency action).
27 (b) Department consideration.--The recommendations made to
28 medical facilities pursuant to subsection (a)(4) may be
29 considered by the department for licensure purposes under the
30 act of July 19, 1979 (P.L.130, No.48), known as the Health Care
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1 Facilities Act, but shall not be considered mandatory unless
2 adopted by the department as regulations pursuant to the act of
3 June 25, 1982 (P.L.633, No.181), known as the Regulatory Review
4 Act.
5 Section 4. The act is amended by adding a section to read:
6 Section 315. Whistleblower protection.
7 (a) Applicability.--This section applies to a health care
8 practitioner who does any of the following:
9 (1) Files a complaint under section 304(b).
10 (2) Makes a report to an agency which has jurisdiction
11 over patient safety, health care or the quality of patient
12 care provided by any health care facility or health care
13 professional.
14 (3) Makes a report to a health care facility on patient
15 safety or the quality of patient care provided by the health
16 care facility. This paragraph includes a report to any
17 employer, supervisor, coworker or other person with
18 privileges.
19 (b) Prohibition.--A health care facility that employs or
20 grants conditional or unconditional privileges to a health care
21 practitioner may not take disciplinary action against the health
22 care practitioner in retaliation for filing a complaint in good
23 faith or making a report in good faith under subsection (a).
24 (c) Immunity.--A health care practitioner who in good faith
25 files a complaint or makes a report under subsection (a) shall
26 be immune from civil liability arising from filing the complaint
27 or making the report.
28 (d) Remedy.--
29 (1) A health care practitioner who is aggrieved by a
30 violation of subsection (b) may recover damages proximately
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1 caused by the violation, including pain and suffering; cost
2 of the litigation; and attorney fees.
3 (2) Notwithstanding any other provision of law, in an
4 action under this section, all patient records relating to
5 the complaint under this section, including peer review
6 documents, shall be available to the court and each party for
7 possible use as documentary evidence.
8 (e) Deterring complaints and reports.--Any provision of a
9 contract or a professional affiliation arrangement, including a
10 document granting privileges, entered into with a health care
11 practitioner which limits the health care practitioner's ability
12 to file a complaint or make a report under subsection (a) or
13 which contains any threat, implicit or otherwise, or contains
14 any penalty for filing a complaint or making a report under
15 subsection (a) is against public policy and shall be void.
16 (f) Notification to health care practitioners.--Within 12
17 months of the effective date of this section, every Commonwealth
18 licensing agency that licenses, permits, certifies or registers
19 health care practitioners within this Commonwealth shall notify
20 the health care practitioners of the Statewide confidential,
21 toll-free telephone line and the whistleblower protection
22 provided through this act through already scheduled newsletters,
23 annual notices and other mailings.
24 Section 5. This act shall take effect in 90 days.
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