THE GENERAL ASSEMBLY OF PENNSYLVANIA

HOUSE BILL

INTRODUCED BY DeLUCA, BARRAR, BRENNAN, CALTAGIRONE, D. COSTA, CREIGHTON, DONATUCCI, FRANKEL, GINGRICH, GOODMAN, HALUSKA, HENNESSEY, JOSEPHS, KORTZ, KOTIK, MELIO, MICOZZIE, MOUL, MUNDY, MURT, MYERS, PYLE, SIPTROTH, K. SMITH, SOLOBAY AND WHITE, FEBRUARY 19, 2009

REFERRED TO COMMITTEE ON INSURANCE, FEBRUARY 19, 2009  

AN ACT

Amending the act of March 20, 2002 (P.L.154, No.13), entitled

"An act reforming the law on medical professional liability;

providing for patient safety and reporting; establishing the

Patient Safety Authority and the Patient Safety Trust Fund;

abrogating regulations; providing for medical professional

liability informed consent, damages, expert qualifications,

limitations of actions and medical records; establishing the

Interbranch Commission on Venue; providing for medical

professional liability insurance; establishing the Medical

Care Availability and Reduction of Error Fund; providing for

medical professional liability claims; establishing the Joint

Underwriting Association; regulating medical professional

liability insurance; providing for medical licensure

regulation; providing for administration; imposing penalties;

and making repeals," further providing for declaration of

policy, for patient safety definitions, for powers and duties

of the Patient Safety Authority and for powers and duties of

the Department of Health; and providing for whistleblower

protection.

The General Assembly of the Commonwealth of Pennsylvania

hereby enacts as follows:

Section 1.  Section 102 of the act of March 20, 2002 (P.L.

154, No.13), known as the Medical Care Availability and

Reduction of Error (Mcare) Act, is amended to read:

Section 102.  Declaration of policy.

The General Assembly finds and declares as follows:

(1)  It is the purpose of this act to ensure that medical

care is available in this Commonwealth through a

comprehensive and high-quality health care system.

(2)  Access to a full spectrum of hospital services and

to highly trained physicians in all specialties must be

available across this Commonwealth.

(3)  To maintain this system, medical professional

liability insurance has to be obtainable at an affordable and

reasonable cost in every geographic region of this

Commonwealth.

(4)  A person who has sustained injury or death as a

result of medical negligence by a health care provider must

be afforded a prompt determination and fair compensation.

(5)  Every effort must be made to reduce and eliminate

medical errors by identifying problems and implementing

solutions that promote patient safety.

(6)  Recognition and furtherance of all of these elements

is essential to the public health, safety and welfare of all

the citizens of Pennsylvania.

(7)  It is the purpose of this act to enhance patient

safety by establishing meaningful whistleblower protection

and a reporting system for medical errors which is responsive

to legitimate concerns.

Section 2.  Section 302 of the act is amended by adding

definitions to read:

Section 302.  Definitions.

The following words and phrases when used in this chapter

shall have the meanings given to them in this section unless the

context clearly indicates otherwise:

* * *

"Disciplinary action."  An action against an individual which

has a negative impact on the individual in relation to salary or

terms of employment or professional affiliation. The term

includes discharge and loss or alteration of privileges of

affiliation.

* * *

"Health care facility."  A facility licensed under the act of

July 19, 1979 (P.L.130, No.48), known as the Health Care

Facilities Act.

"Health care practitioner."  An individual who is authorized

to practice some component of the healing arts by a license,

permit, certificate or registration, issued by a Commonwealth

licensing agency.

* * *

Section 3.  Section 304(a) and (b) of the act are amended to

read:

Section 304.  Powers and duties.

(a)  General rule.--The authority shall do all of the

following:

(1)  Adopt bylaws necessary to carry out the provisions

of this chapter.

(2)  Employ staff as necessary to implement this chapter.

(3)  Make, execute and deliver contracts and other

instruments.

(4)  Apply for, solicit, receive, establish priorities

for, allocate, disburse, contract for, administer and spend

funds in the fund and other funds that are made available to

the authority from any source consistent with the purposes of

this chapter.

(5)  Contract with a for-profit or registered nonprofit

entity or entities, other than a health care provider, to do

the following:

(i)  Collect, analyze and evaluate data regarding

reports of serious events and incidents, including the

identification of performance indicators and patterns in

frequency or severity at certain medical facilities or in

certain regions of this Commonwealth.

(ii)  Transmit to the authority recommendations for

changes in health care practices and procedures which may

be instituted for the purpose of reducing the number and

severity of serious events and incidents.

(iii)  Directly advise reporting medical facilities

of immediate changes that can be instituted to reduce

serious events and incidents.

(iv)  Conduct reviews in accordance with subsection

(b).

(6)  Receive and evaluate recommendations made by the

entity or entities contracted with in accordance with

paragraph (5) and [report] advise the department of those

recommendations [to the department, which shall have no more

than 30 days to approve or disapprove the recommendations].

(7)  [After consultation and approval by the department,

issue] Issue recommendations to medical facilities on a

facility-specific or on a Statewide basis regarding changes,

trends and improvements in health care practices and

procedures for the purpose of reducing the number and

severity of serious events and incidents. Prior to issuing

recommendations, consideration shall be given to the

following factors that include expectation of improved

quality care, implementation feasibility, other relevant

implementation practices and the cost impact to patients,

payors and medical facilities. Statewide recommendations

shall be issued to medical facilities on a continuing basis

and shall be published and posted on the department's

publicly accessible Internet website and the authority's

publicly accessible [World Wide Web site] Internet website.

(8)  Meet with the department for purposes of

implementing this chapter.

(9)  Upon receipt of a complaint under subsection (b), do

all of the following:

(i)  Distribute copies of the complaint to each

director on the board.

(ii)  Within ten business days, require the

department to investigate the complaint under section

306(a)(6).

(iii)  Maintain the confidentiality of all

information resulting from the complaint and the

investigation. Information under this subparagraph may be

released only when sanctions are pursued under section

306(a)(7) or until section 316(d) is invoked by a health

care practitioner.

(10)  Disseminate, through publications and training

sessions, information about patient safety reporting under

subsection (b)(2).

(b)  [Anonymous reports] Reports to the authority.--

(1)  A health care worker who has complied with section

308(a) may file an anonymous report regarding a serious event

with the authority. Upon receipt of the report, the authority

shall give notice to the affected medical facility that a

report has been filed. [The authority shall conduct its own

review of the report unless the medical facility has already

commenced an investigation of the serious event.] The medical

facility [shall] may provide the authority with the results

of its investigation no later than 30 days after receiving

notice pursuant to this subsection. [If the authority is

dissatisfied with the adequacy of the investigation conducted

by the medical facility, the authority shall perform its own

review of the serious event and may refer a medical facility

and any involved licensee to the department for failure to

report pursuant to section 313(e) and (f).] This paragraph

shall not preclude a direct report to the authority under

paragraph (2).

(2)  The authority shall maintain a Statewide

confidential, toll-free telephone line to enable health care

practitioners to report on patient safety and the quality of

patient care provided by a health care facility. If a health

care practitioner who files a complaint under this paragraph

requests anonymity, the authority shall, except to the extent

necessary to verify credentials, maintain anonymity.

* * *

Section 4.  Section 306 of the act, amended May 1, 2006 (P.L.

103, No.30), is amended to read:

Section 306.  Department responsibilities.

(a)  General rule.--The department shall do all of the

following:

(1)  Review and approve patient safety plans in

accordance with section 307.

(2)  Receive reports of serious events and infrastructure

failures under section 313.

(3)  Investigate serious events and infrastructure

failures.

(4)  In conjunction with the authority, analyze and

evaluate existing health care procedures and approve

recommendations issued by the authority pursuant to section

304(a)(6) and (7).

(5)  Meet with the authority for purposes of implementing

this chapter.

(6)  Upon referral of a complaint under section 304(a)

(9), do all of the following:

(i)  Within ten business days, investigate the

complaint. In order to carry out the investigation under

this subparagraph, the department shall consult with one,

or, if the department deems necessary, a second,

independent, external quality review team to examine the

team's recommendations and findings. A team under this

subparagraph shall consider the appropriate use of

patient care standards in the situation under

investigation and make recommendations based upon its

findings. The following apply to a team under this

subparagraph:

(A)  The team shall consist of at least all of

the following:

(I)  A registered nurse who holds a license

under the act of May 22, 1951 (P.L.317, No.69),

known as The Professional Nursing Law; is engaged

in active practice for at least 20 hours per

week; and holds a specialty-specific

certification from the American Nurses

Credentialing Center.

(II)  A physician or an osteopath who is

engaged in active practice for at least 20 hours

per week and who is board-certified in a

specialty which is recognized by the American

Board of Medical Specialties or the American

Osteopathic Association and which is specific to

the situation under investigation.

(III)  A pharmacist who is engaged in active

practice for at least 20 hours per week and who

is board-certified as a clinical pharmacist.

(B)  A member of the team may not:

(I)  be an employee or a contractor of the

health care facility or the health care

practitioner under investigation;

(II)  be a past or current colleague of the

health care practitioner under investigation;

(III)  have a past or current financial or

practice relationship with the health care

practitioner under review, that practitioner's

group, that practitioner's employer or that

practitioner's privilege-granting health care

facility;

(IV)  have a past or current financial or

practice relationship with the health care

facility under investigation; or

(V)  reside within 75 miles of the health

care facility under investigation.

(ii)  If warranted by the investigation:

(A)  Seek sanctions under paragraph (7).

(B)  Recommend sanctions or other action to the

appropriate licensing board under Chapter 9. A

licensing board or agency which receives a

recommendation under this clause shall report to the

authority concerning its action every 30 days until

the matter is finally disposed of. A report under

this clause shall be available to each director of

the board upon request.

(C)  Recommend sanctions or other action to any

other appropriate Commonwealth agency.

(iii)  Maintain the confidentiality of all

information resulting from the complaint and the

investigation until sanctions are sought under paragraph

(7) or until section 316(d) is invoked by a health care

practitioner.

(7)  Impose an administrative penalty of up to $5,000

upon a health care facility for acts or omissions which

impair patient safety or the quality of patient care or, at

the department's discretion, take other remedial actions as

authorized by law. This paragraph is subject to 2 Pa.C.S. Ch. 

5 Subch. A (relating to practice and procedure of

Commonwealth agencies) and Ch. 7 Subch. A (relating to

judicial review of Commonwealth agency action).

(b)  Department consideration.--The recommendations made to

medical facilities pursuant to subsection (a)(4) may be

considered by the department for licensure purposes under the

act of July 19, 1979 (P.L.130, No.48), known as the Health Care

Facilities Act, and, in the case of abortion facilities, for

approval or revocation purposes pursuant to 28 Pa. Code § 29.43

(relating to facility approval), but shall not be considered

mandatory unless adopted by the department as regulations

pursuant to the act of June 25, 1982 (P.L.633, No.181), known as

the Regulatory Review Act.

Section 5.  The act is amended by adding a section to read:

Section 316.  Whistleblower protection.

(a)  Applicability.--This section applies to a health care

practitioner who does any of the following:

(1)  Files a complaint under section 304(b).

(2)  Makes a report to an agency which has jurisdiction

over patient safety, health care or the quality of patient

care provided by any health care facility or health care

professional.

(3)  Makes a report to a health care facility on patient

safety or the quality of patient care provided by the health

care facility. This paragraph includes a report to any

employer, supervisor, coworker or other person with

privileges.

(b)  Prohibition.--A health care facility that employs or

grants conditional or unconditional privileges to a health care

practitioner may not take disciplinary action against the health

care practitioner in retaliation for filing a complaint in good

faith or making a report in good faith under subsection (a).

(c)  Immunity.--A health care practitioner who in good faith

files a complaint or makes a report under subsection (a) shall

be immune from civil liability arising from filing the complaint

or making the report.

(d)  Remedy.--A health care practitioner who is aggrieved by

a violation of subsection (b) may recover damages proximately

caused by the violation, including pain and suffering; cost of

the litigation; and attorney fees. Notwithstanding any other

provision of law, in an action under this subsection, all

patient records relating to the complaint under this subsection,

including peer review documents, shall be available to the court

and each party for possible use as documentary evidence.

(e)  Deterring complaints and reports.--Any provision of a

contract or a professional affiliation arrangement, including a

document granting privileges, entered into with a health care

practitioner which limits the health care practitioner's ability

to file a complaint or make a report under subsection (a) or

which contains any threat, implicit or otherwise, or contains

any penalty for filing a complaint or making a report under

subsection (a) is against public policy and shall be void.

(f)  Notification to health care practitioners.--Within 12

months of the effective date of this section, every Commonwealth

licensing agency that licenses, permits, certifies or registers

health care practitioners within this Commonwealth shall notify

the health care practitioners of the Statewide confidential,

toll-free telephone line and the whistleblower protection

provided through this act through already scheduled newsletters,

annual notices and other mailings.

Section 6.  This act shall take effect in 90 days.