CHAPTER 3

PATIENT SAFETY

<< PA ST 40 P.S. § 1303.301 >>

Section 301. Scope [FN8]

This chapter relates to the reduction of medical errors for the purpose of ensuring patient safety.

<< PA ST 40 P.S. § 1303.302 >>

Section 302. Definitions [FN9]

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:
"Ambulatory surgical facility." An entity defined as an ambulatory surgical facility under the act of July 19, 1979 (P.L. 130, No. 48), known as the Health Care Facilities Act.
"Authority." The Patient Safety Authority established in section 303.
"Board." The board of directors of the Patient Safety Authority.
"Department." The Department of Health of the Commonwealth.
"Fund." The Patient Safety Trust Fund established in section 305.
"Health care worker." An employee, independent contractor, licensee or other individual authorized to provide services in a medical facility.
"Incident." An event, occurrence or situation involving the clinical care of a patient in a medical facility which could have injured the patient but did not either cause an unanticipated injury or require the delivery of additional health care services to the patient. The term does not include a serious event.
"Infrastructure." Structures related to the physical plant and service delivery systems necessary for the provision of health care services in a medical facility.
"Infrastructure failure." An undesirable or unintended event, occurrence or situation involving the infrastructure of a medical facility or the discontinuation or significant disruption of a service which could seriously compromise patient safety.
"Licensee." An individual who is all of the following:
(1) Licensed or certified by the department or the Department of State to provide professional services in this Commonwealth.
(2) Employed by or authorized to provide professional services in a medical facility.
"Medical facility." An ambulatory surgical facility, birth center or hospital.
"Patient safety officer." An individual designated by a medical facility under section 309.
"Serious event." An event, occurrence or situation involving the clinical care of a patient in a medical facility that results in death or compromises patient safety and results in an unanticipated injury requiring the delivery of additional health care services to the patient. The term does not include an incident.

<< PA ST 40 P.S. § 1303.303 >>

Section 303. Establishment of Patient Safety Authority [FN10]

(a) Establishment.--There is established a body corporate and politic to be known as the Patient Safety Authority. The powers and duties of the authority shall be vested in and exercised by a board of directors.
(b) Composition.--The board of the authority shall consist of 11 members composed and appointed in accordance with the following:
(1) The Physician General or a physician appointed by the Governor if there is no appointed Physician General.
(2) Four residents of this Commonwealth, one of whom shall be appointed by the President pro tempore of the Senate, one of whom shall be appointed by the Minority Leader of the Senate, one of whom shall be appointed by the Speaker of the House of Representatives and one of whom shall be appointed by the Minority Leader of the House of Representatives, who shall serve terms coterminous with their respective appointing authorities.
(3) A health care worker residing in this Commonwealth who is a physician and is appointed by the Governor, who shall serve an initial term of three years.
(4) A health care worker residing in this Commonwealth who is licensed by the Department of State as a nurse and is appointed by the Governor, who shall serve an initial term of three years.
(5) A health care worker residing in this Commonwealth who is licensed by the Department of State as a pharmacist and is appointed by the Governor, who shall serve an initial term of two years.
(6) A health care worker residing in this Commonwealth who is employed by a hospital and is appointed by the Governor, who shall serve an initial term of two years.
(7) Two residents of this Commonwealth, one of whom is a health care worker and one of whom is not a health care worker, appointed by the Governor, who shall each serve a term of four years.
(c) Terms.--With the exception of paragraphs (1) and (2), members of the board shall serve for terms of four years after completion of the initial terms designated in subsection (b) and shall not be eligible to serve more than two full consecutive terms.
(d) Quorum.--A majority of the members of the board shall constitute a quorum. Notwithstanding any other provision of law, action may be taken by the board at a meeting upon a vote of the majority of its members present in person or through the use of amplified telephonic equipment if authorized by the bylaws of the board.
(e) Meetings.--The board shall meet at the call of the chairperson or as may be provided in the bylaws of the board. The board shall hold meetings at least quarterly, which shall be subject to the requirements of 65 Pa.C.S. Ch. 7 (relating to open meetings). Meetings of the board may be held anywhere within this Commonwealth.
(f) Chairperson.--The chairperson shall be the person appointed under subsection (b)(1).
(g) Formation.--The authority shall be formed within 60 days of the effective date of this section.

<< PA ST 40 P.S. § 1303.304 >>

Section 304. Powers and duties [FN11]

(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 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 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 and the authority's publicly accessible World Wide Web site.
(8) Meet with the department for purposes of implementing this chapter.
(b) Anonymous reports to the authority.--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 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).
(c) Annual report to General Assembly.--
(1) The authority shall report no later than May 1, 2003, and annually thereafter to the department and the General Assembly on the authority's activities in the preceding year. The report shall include:
(i) A schedule of the year's meetings.
(ii) A list of contracts entered into pursuant to this section, including the amounts awarded to each contractor.
(iii) A summary of the fund receipts and expenditures, including a financial statement and balance sheet.
(iv) The number of serious events and incidents reported by medical facilities on a geographical basis.
(v) The information derived from the data collected, including any recognized trends concerning patient safety.
(vi) The number of anonymous reports filed and reviews conducted by the authority.
(vii) The number of referrals to licensure boards for failure to report under this chapter.
(viii) Recommendations for statutory or regulatory changes which may help improve patient safety in the Commonwealth.
(2) The report shall be distributed to the Secretary of Health, the chair and minority chair of the Public Health and Welfare Committee of the Senate and the chair and minority chair of the Health and Human Services Committee of the House of Representatives.
(3) The annual report shall be made available for public inspection and shall be posted on the authority's publicly accessible World Wide Web site.

<< PA ST 40 P.S. § 1303.305 >>

Section 305. Patient Safety Trust Fund [FN12]

(a) Establishment.--There is hereby established a separate account in the State Treasury to be known as the Patient Safety Trust Fund. The fund shall be administered by the authority. All interest earned from the investment or deposit of moneys accumulated in the fund shall be deposited in the fund for the same use.
(b) Funds.--All moneys deposited into the fund shall be held in trust and shall not be considered general revenue of the Commonwealth but shall be used only to effectuate the purposes of this chapter as determined by the authority.
(c) Assessment.--Commencing July 1, 2002, each medical facility shall pay the department a surcharge on its licensing fee as necessary to provide sufficient revenues to operate the authority. The total assessment for all medical facilities shall not exceed $5,000,000. The department shall transfer the total assessment amount to the fund within 30 days of receipt.
(d) Base amount.--For each succeeding calendar year, the department shall determine and assess each medical facility its proportionate share of the authority's budget. The total assessment amount shall not exceed $5,000,000 in fiscal year 2002-2003 and shall be increased according to the Consumer Price Index in each succeeding fiscal year.
(e) Expenditures.--Moneys in the fund shall be expended by the authority to implement this chapter.
(f) Dissolution.--In the event that the fund is discontinued or the authority is dissolved by operation of law, any balance remaining in the fund, after deducting administrative costs of liquidation, shall be returned to the medical facilities in proportion to their financial contributions to the fund in the preceding licensing period.
(g) Failure to pay surcharge.--If, after 30 days' notice, a medical facility fails to pay a surcharge levied by the department under this chapter, the department may assess an administrative penalty of $1,000 per day until the surcharge is paid.

<< PA ST 40 P.S. § 1303.306 >>

Section 306. Department responsibilities [FN13]

(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.
(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, 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. [FN14]

<< PA ST 40 P.S. § 1303.307 >>

Section 307. Patient safety plans [FN15]

(a) Development and compliance.--A medical facility shall develop, implement and comply with an internal patient safety plan that shall be established for the purpose of improving the health and safety of patients. The plan shall be developed in consultation with the licensees providing health care services in the medical facility.
(b) Requirements.--A patient safety plan shall:
(1) Designate a patient safety officer as set forth in section 309.
(2) Establish a patient safety committee as set forth in section 310.
(3) Establish a system for the health care workers of a medical facility to report serious events and incidents which shall be accessible 24 hours a day, seven days a week.
(4) Prohibit any retaliatory action against a health care worker for reporting a serious event or incident in accordance with the act of December 12, 1986 (P.L. 1559, No. 169), known as the Whistleblower Law. [FN16]
(5) Provide for written notification to patients in accordance with section 308(b).
(c) Approval.--Within 60 days from the effective date of this section, a medical facility shall submit its patient safety plan to the department for approval consistent with the requirements of this section. Unless the department approves or rejects the plan within 60 days of receipt, the plan shall be deemed approved.
(d) Employee notification.--Upon approval of the patient safety plan, a medical facility shall notify all health care workers of the medical facility of the patient safety plan. Compliance with the patient safety plan shall be required as a condition of employment or credentialing at the medical facility.

<< PA ST 40 P.S. § 1303.308 >>

Section 308. Reporting and notification [FN17]

(a) Reporting.--A health care worker who reasonably believes that a serious event or incident has occurred shall report the serious event or incident according to the patient safety plan of the medical facility unless the health care worker knows that a report has already been made. The report shall be made immediately or as soon thereafter as reasonably practicable, but in no event later than 24 hours after the occurrence or discovery of a serious event or incident.
(b) Duty to notify patient.--A medical facility through an appropriate designee shall provide written notification to a patient affected by a serious event or, with the consent of the patient, to an available family member or designee within seven days of the occurrence or discovery of a serious event. If the patient is unable to give consent, the notification shall be given to an adult member of the immediate family. If an adult member of the immediate family cannot be identified or located, notification shall be given to the closest adult family member. For unemancipated patients who are under 18 years of age, the parent or guardian shall be notified in accordance with this subsection. The notification requirements of this subsection shall not be subject to the provisions of section 311(a). Notification under this subsection shall not constitute an acknowledgment or admission of liability.
(c) Liability.--A health care worker who reports the occurrence of a serious event or incident in accordance with subsection (a) or (b) shall not be subject to any retaliatory action for reporting the serious event or incident and shall have the protections and remedies set forth in the act of December 12, 1986 (P.L. 1559, No. 169), known as the Whistleblower Law.
(d) Limitation.--Nothing in this section shall limit a medical facility's ability to take appropriate disciplinary action against a health care worker for failure to meet defined performance expectations or to take corrective action against a licensee for unprofessional conduct, including making false reports or failure to report serious events under this chapter.

<< PA ST 40 P.S. § 1303.309 >>

Section 309. Patient safety officer [FN18]

A patient safety officer of a medical facility shall do all of the following:
(1) Serve on the patient safety committee.
(2) Ensure the investigation of all reports of serious events and incidents.
(3) Take such action as is immediately necessary to ensure patient safety as a result of any investigation.
(4) Report to the patient safety committee regarding any action taken to promote patient safety as a result of investigations commenced pursuant to this section.

<< PA ST 40 P.S. § 1303.310 >>

Section 310. Patient safety committee [FN19]

(a) Composition.--
(1) A hospital's patient safety committee shall be composed of the medical facility's patient safety officer and at least three health care workers of the medical facility and two residents of the community served by the medical facility who are not agents, employees or contractors of the medical facility. No more than one member of the patient safety committee shall be a member of the medical facility's board of trustees. The committee shall include members of the medical facility's medical and nursing staff.
The committee shall meet at least monthly.
(2) An ambulatory surgical facility's or birth center's patient safety committee shall be composed of the medical facility's patient safety officer and at least one health care worker of the medical facility and one resident of the community served by the ambulatory surgical facility or birth center who is not an agent, employee or contractor of the ambulatory surgical facility or birth center. No more than one member of the patient safety committee shall be a member of the medical facility's board of governance. The committee shall include members of the medical facility's medical and nursing staff. The committee shall meet at least quarterly.
(b) Responsibilities.--A patient safety committee of a medical facility shall do all of the following:
(1) Receive reports from the patient safety officer pursuant to section 309.
(2) Evaluate investigations and actions of the patient safety officer on all reports.
(3) Review and evaluate the quality of patient safety measures utilized by the medical facility. A review shall include the consideration of reports made under sections 304(a)(5) and (b), 307(b)(3) and 308(a).
(4) Make recommendations to eliminate future serious events and incidents.
(5) Report to the administrative officer and governing body of the medical facility on a quarterly basis regarding the number of serious events and incidents and its recommendations to eliminate future serious events and incidents.

<< PA ST 40 P.S. § 1303.311 >>

Section 311. Confidentiality and compliance [FN20]

(a) Prepared materials.--Any documents, materials or information solely prepared or created for the purpose of compliance with section 310(b) or of reporting under section 304(a)(5) or (b), 306(a)(2) or (3), 307(b)(3), 308(a), 309(4), 310(b)(5) or 313 which arise out of matters reviewed by the patient safety committee pursuant to section 310(b) or the governing board of a medical facility pursuant to section 310(b) are confidential and shall not be discoverable or admissible as evidence in any civil or administrative action or proceeding. Any documents, materials, records or information that would otherwise be available from original sources shall not be construed as immune from discovery or use in any civil or administrative action or proceeding merely because they were presented to the patient safety committee or governing board of a medical facility.
(b) Meetings.--No person who performs responsibilities for or participates in meetings of the patient safety committee or governing board of a medical facility pursuant to section 310(b) shall be allowed to testify as to any matters within the knowledge gained by the person's responsibilities or participation on the patient safety committee or governing board of a medical facility, provided, however, the person shall be allowed to testify as to any matters within the person's knowledge which was gained outside of the persons's responsibilities or participation on the patient safety committee or governing board of a medical facility pursuant to section 310(b).
(c) Applicability.--The confidentiality protections set forth in subsections (a) and (b) shall only apply to the documents, materials or information prepared or created pursuant to the responsibilities of the patient safety committee or governing board of a medical facility set forth in section 310(b).
(d) Received materials.--Except as set forth in subsection (f), any documents, materials or information received by the authority or department from the medical facility, health care worker, patient safety committee or governing board of a medical facility solely prepared or created for the purpose of compliance with section 310(b) or of reporting under section 304(a)(5) or (b), 306(a)(2) or (3), 307(b)(3), 308(a), 309(4), 310(b)(5) or 313 shall not be discoverable or admissible as evidence in any civil or administrative action or proceeding. Any records received by the authority or department from the medical facility, health care worker, patient safety committee or governing board of a medical facility pursuant to the requirements of this act shall not be discoverable from the department or the authority in any civil or administrative action or proceeding. Documents, materials, records or information may be used by the authority or department to comply with the reporting requirements under subsection (f) and section 304(a)(7) or (c) or 306(b).
(e) Document review.--
(1) Except as set forth in paragraph (2), no current or former employee of the authority, the department or the Department of State shall be allowed to testify as to any matters gained by reason of his or her review of documents, materials, records or information submitted to the authority by the medical facility or health care worker pursuant to the requirements of this act.
(2) Paragraph (1) does not apply to findings or actions by the department or the Department of State which are public records.
(f) Access.--
(1) The department shall have access to the information under section 313(a) or (c) and may use such information for the sole purpose of any licensure or corrective action against a medical facility. This exemption to use the information received pursuant to section 313(a) or (c) shall only apply to licensure or corrective actions and shall not be utilized to permit the disclosure of any information obtained under section 313(a) or (c) for any other purpose.
(2) The Department of State shall have access to the information under section 313(a) and may use such information for the sole purpose of any licensure or disciplinary action against a health care worker. This exemption to use the information received pursuant to section 313(a) shall only apply to licensure or disciplinary actions and shall not be utilized to permit the disclosure of any information obtained under section 313(a) for any other purpose.
(g) Original source document.--In the event an original source document as set forth in subsection (a) is determined by a court of competent jurisdiction to be unavailable from the health care worker or medical facility in a civil action or proceeding, then in that circumstance alone the department may be required pursuant to a court order to release that original source document to the party identified in the court order.
(h) Right-to-know requests.--Any documents, materials or information made confidential by subsection (a) shall not be subject to requests under the act of June 21, 1957 (P.L. 390, No. 212), referred to as the Right-to-Know Law. [FN21]
(i) Liability.--Notwithstanding any other provision of law, no person providing information or services to the patient safety committee, governing board of a medical facility, authority or department shall be held by reason of having provided such information or services to have violated any criminal law, or to be civilly liable under any law, unless such information is false and the person providing such information knew or had reason to believe that such information was false and was motivated by malice toward any person directly affected by such action.

<< PA ST 40 P.S. § 1303.312 >>

Section 312. Patient safety discount [FN22]

A medical facility may make application to the department for certification of any program that is recommended by the authority that results in the reduction of serious events at that facility. The department, in consultation with the Insurance Department, shall develop the criteria for such certification. Insurers shall file with the Insurance Department a discount in the rate or rates applicable for mandated basic insurance coverage to reflect the initiation of a certified program. The Insurance Department shall review all filings in accordance with the act of June 11, 1947 (P.L. 538, No. 246), known as The Casualty and Surety Rate Regulatory Act. [FN23] A medical facility shall receive a discount in the rate or rates applicable for mandated basic insurance coverage required by law, consistent with the level of such discount approved by the Insurance Department. In reviewing filings under this section, the commissioner shall consider whether and the extent to which the program certified under this section is otherwise covered under a program of risk management offered by an insurance company or exchange or self-insurance plan providing medical professional liability coverage.

<< PA ST 40 P.S. § 1303.313 >>

Section 313. Medical facility reports and notifications [FN24]

(a) Serious event reports.--A medical facility shall report the occurrence of a serious event to the department and the authority within 24 hours of the medical facility's confirmation of the occurrence of the serious event. The report to the department and the authority shall be in the form and manner prescribed by the authority in consultation with the department and shall not include the name of any patient or any other identifiable individual information.
(b) Incident reports.--A medical facility shall report the occurrence of an incident to the authority in a form and manner prescribed by the authority and shall not include the name of any patient or any other identifiable individual information.
(c) Infrastructure failure reports.--A medical facility shall report the occurrence of an infrastructure failure to the department within 24 hours of the medical facility's confirmation of the occurrence or discovery of the infrastructure failure. The report to the department shall be in the form and manner prescribed by the department.
(d) Effect of report.--Compliance with this section by a medical facility shall satisfy the reporting requirements of the act of July 19, 1979 (P.L. 130, No. 48), known as the Health Care Facilities Act.
(e) Notification to licensure boards.--If a medical facility discovers that a licensee providing health care services in the medical facility during a serious event failed to report the event in accordance with section 308(a), the medical facility shall notify the licensee's licensing board of the failure to report.
(f) Failure to report or notify.--Failure to report a serious event or an infrastructure failure as required by this section or to develop and comply with the patient safety plan in accordance with section 307 or to notify the patient in accordance with section 308(b) shall be a violation of the Health Care Facilities Act. In addition to any penalty which may be imposed under the Health Care Facilities Act, a medical facility which fails to report a serious event or an infrastructure failure or to notify a licensure board in accordance with this chapter may be subject to an administrative penalty of $1,000 per day imposed by the department.
(g) Report submission.--Within 30 days following notice published pursuant to section 5103, a medical facility shall begin reporting serious events, incidents and infrastructure failures consistent with the requirements of this section.

<< PA ST 40 P.S. § 1303.314 >>

Section 314. Existing regulations [FN25]

The provisions of 28 Pa. Code § 51.3(f) and (g) (relating to notification) shall be abrogated with respect to a medical facility upon the reporting of a serious event, incident or infrastructure failure pursuant to section 313.