NOTICES
DEPARTMENT OF
HEALTH AND
PATIENT SAFETY AUTHORITY
Freestanding Abortion Facilities--Requirement to Comply with the Medical Care Availability and Reduction of Error (MCARE) Act
[36 Pa.B. 6905]
[Saturday, November 11, 2006]On May 1, 2006, the Medical Care Availability and Reduction of Error (MCARE) Act (40 P. S. §§ 1303.101--1303.910) was amended by the act of May 1, 2006 (P. L. 103, No. 30) to require certain freestanding abortion facilities to comply with its terms, beginning no earlier than January 1, 2007.
By way of background, the MCARE Act established the Patient Safety Authority (Authority) and charged it with, among other responsibilities, the development of a reporting system for facilities subject to the MCARE Act to report ''incidents,'' ''serious events'' and ''infrastructure failures'' as defined in the MCARE Act. The Statewide reporting system developed is known as the Pennsylvania Patient Safety Reporting System (PA-PSRS), through which facilities report ''incidents'' and ''serious events'' to the Authority and ''serious events'' and ''infrastructure failures'' to the Department of Health (Department).
Facilities subject to the MCARE Act are required to make the mandatory reports through PA-PSRS, pay a proportionate share of the Authority's annual budget into the Patient Safety Trust, develop and implement a Patient Safety Plan meeting the requirements of the MCARE Act, identify a Patient Safety Officer and establish a Patient Safety Committee to fulfill certain responsibilities set forth in the MCARE Act, provide written notification to patients upon the occurrence of a ''serious event'' and notify the appropriate licensing board if a health care worker fails to report a ''serious event.''
Freestanding abortion facilities that perform 100 or more abortions between June 30, 2006, and December 31, 2006, are subject to the MCARE Act beginning January 1, 2007, and are required to comply with its terms and begin reporting through PA-PSRS upon submission of a Patient Safety Plan to the Department no later than 60 days after January 1, 2007. Other freestanding abortion facilities that perform 100 or more abortions in any calendar year beginning 2007 and thereafter are subject to the MCARE Act on the day following the 100th abortion. Once subject to the MCARE Act, each facility must continue to satisfy the requirements unless it provides written notice to the Department that it will not be performing and does not perform 100 or more abortions in that calendar year.
Following this notice is a summary of the MCARE Act requirements as they pertain to freestanding abortion facilities. Nothing therein is intended to supersede or modify anything set forth in the MCARE Act.
Persons with a disability who require an alternative format of this notice (for example, large print, audiotape or Braille) should contact Janice Staloski, 132 Kline Plaza, Suite A, Harrisburg, PA 17104, (717) 783-2500. Speech and/or hearing impaired persons may use V/TT (717) 783-6514 or the Pennsylvania AT&T Relay Services at (800) 654-5984.
ANA MCKEE, M. D.,
Chair of Board of Directors
Patient Safety AuthorityRICHARD H. LEE,
Deputy Secretary for Quality Assurance
Department of Health
Summary of MCARE Act Responsibilities as They Pertain to Freestanding Abortion Facilities
Definitions For purposes of this summary, the following definitions apply:
A ''health care worker'' is an employee, independent contractor, licensee or other individual authorized to provide health care services in the freestanding abortion facility.
An ''incident'' is an event, occurrence or situation involving the clinical care of a patient in the freestanding abortion facility that 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.
An ''infrastructure failure'' is an undesirable or unintended event, occurrence or situation involving the infrastructure of a freestanding abortion facility or the discontinuation or significant disruption of a service which could seriously compromise patient safety.
A ''serious event'' is an event, occurrence or situation involving the clinical care of a patient in the freestanding abortion facility that results in death or compromises patient safety and results in an unanticipated injury requiring the delivery of additional health services to the patient.
Freestanding Abortion Facilities That Perform 100 or More Abortions in 2006 After June 30, 2006 Effective January 1, 2007, any freestanding abortion facility that performs 100 or more abortions in the 2006 calendar year after June 30, 2006, will be subject to the requirements of Chapter 3 (relating to patient safety) of the MCARE Act (40 P. S. §§ 1303.301--1303.315), which include, but are not limited to, the following:
Assessment--It shall pay an assessment, to be deposited into the Patient Safety Trust Fund (Fund), within 30 days after the assessment is levied by the Department of Health (Department). Section 305(g) of the MCARE Act. The Department shall determine the assessment by applying the same methodology for calculating the assessment that it utilizes for ambulatory surgical facilities. Section 305(c) of the MCARE Act (40 P. S. § 1303.305(c)).
Patient Safety Plan--It shall develop in consultation with the licensees providing health care services in the facility, and then implement and comply with an internal patient safety plan that it shall establish for the purpose of improving the health and safety of its patients. Section 307(a) of the MCARE Act (40 P. S. § 1303.307(a)). By March 2, 2007, it shall submit its patient safety plan to the Department for the Department's approval. Section 315(b) and (d) of the MCARE Act (40 P. S. § 1303.315(b) and (d)). It shall also begin reporting incidents, infrastructure failures, and serious events on the date it submits its patient safety plan to the Department. The Department will approve or disapprove the patient safety plan within 60 days after receiving it. Section 307(c) of the MCARE Act. Upon approval of the patient safety plan by the Department, the facility shall notify its health care workers of the plan. The facility shall require compliance with the plan by a health care worker as a condition of employment or credentialing at the facility. Section 307(d) of the MCARE Act. The patient safety plan shall do all of the following:
1. Designate a patient safety officer.
2. Establish a patient safety committee.
3. Establish a system for the facility's health care workers to report incidents and serious events 24 hours a day, 7 days a week.
4. Prohibit any retaliatory action against a health care worker for reporting an incident or serious event in accordance with the Whistleblower Law (43 P. S. §§ 1421--1428).
5. Provide for written notification of patients who are affected by a serious event. Section 307(b)(1)--(5) of the MCARE Act.
Patient Safety Officer--It shall have a patient safety officer, which it must designate no later than the date it submits its patient safety plan to the Department. Sections 307(b)(1) and 315(b) and (d) of the MCARE Act. The patient safety officer shall do all of the following:
1. Serve on the facility's patient safety committee.
2. Ensure the investigation of all reports of incidents and serious events.
3. Take action as is immediately necessary to ensure patient safety against any harm identified from the investigation of a report of an incident or serious event.
4. Report to the patient safety committee regarding any action taken to promote patient safety as a result of an investigation of a report of an incident or serious event. Section 309(1)--(4) of the MCARE Act (40 P. S. § 1303.309(1)--(4)).
Patient Safety Committee--It shall have a patient safety committee, which it must establish no later than the date it submits its patient safety plan to the Department. Sections 307(b)(2) and 315(b) and (d) of the MCARE Act. The patient safety committee shall meet at least quarterly and be composed of the patient safety officer, at least one health care worker at the facility, and at least one resident of the community served by the facility who is not an agent, employee or contractor of the facility. Additional membership requirements are that no more than one member of the facility's governing board may serve on the patient safety committee, and the committee shall include members of both the facility's medical and nursing staff. Section 310(a)(2) of the MCARE Act (40 P. S. § 1303.310(a)(2)). The patient safety committee shall do all of the following:
1. Receive reports from the patient safety officer regarding any action taken to promote patient safety as a result of an investigation of a report of an incident or serious event.
2. Evaluate investigations and actions of the patient safety officer on all reports of incidents and serious events.
3. Review and evaluate the quality of patient safety measures utilized by the facility. These reviews shall include consideration of the following:
a. Reports to the facility from the contracted entity of the Authority of immediate changes that can be instituted for the purpose of reducing the number and severity of incidents and serious events. Section 304(a)(5)(iii) of the MCARE Act (40 P. S. § 1303.304(a)(5)(iii)).
b. Reports to the facility from the Authority of reports of incidents or serious events filed with the Authority by health care workers. Section 304(a)(5)(iii) and (7) of the MCARE Act.
c. Reports to the facility from its health care workers of incidents and serious events. Section 308(a) of the MCARE Act (40 P. S. § 1303.308(a)).
4. Make recommendations to eliminate future incidents and serious events.
5. Report to the administrative officer and governing body of the facility on a quarterly basis regarding the number of incidents and serious events and its recommendations to eliminate future incidents and serious events. Section 310(b)(1)--(5) of the MCARE Act.
Duty to Notify Patient--Through an appropriate designee it shall provide written notification to a patient who has been affected by a serious event or, with the consent of the patient, to an available family member or designee. The notice shall be give within 7 days after the facility's discovery of the serious event. If the patient is unable to give consent and has not designated a person to receive the notice, the facility shall give the written notification to an adult member of the patient's immediate family and, if the facility is unable to identify or locate such a person, it shall give the written notification to the closest adult family member. If the patient is an unemancipated minor under 18 years of age, the facility shall provide the written notification to the patient's parent of guardian. Section 308(b) of the MCARE Act. Its duty to provide such written notifications begins when it submits its patient safety plan to the Department. Sections 307(b)(5), 308(b) and 1303.315(b) and (d) of the MCARE Act.
Serious Event Reports by Facility--It shall report to the Department and the Authority the occurrence of a serious event within 24 hours after it confirms the occurrence of a serious event. Section 313(a) of the MCARE Act (40 P. S. § 1303.313(a)). It shall begin reporting serious events upon submission of its patient safety plan to the Department. Section 315(e) of the MCARE Act.
Incident Reports by Facility--It shall report to the Authority the occurrence of an incident in a form and manner prescribed by the Authority. The report shall not include the name of any patient or any other identifiable individual information. Section 313(b) of the MCARE Act. It shall begin reporting incidents upon submission of its patient safety plan to the Department. Section 315(e) of the MCARE Act.
Infrastructure Failure Reports by Facility--It shall report to the Department the occurrence of an infrastructure failure within 24 hours after it confirms the occurrence of an infrastructure failure. Section 313(c) of the MCARE Act. It shall begin reporting infrastructure failures upon submission of its patient safety plan to the Department. Section 315(e) of the MCARE Act.
Notification to Licensure Boards--If it discovers that a health care worker regulated by a licensing board failed to report a serious event as required by the MCARE Act, it shall notify the licensing board of that health care worker's failure to report. Section 313(e) of the MCARE Act. A health care worker's responsibility to report serious events begins when the abortion facility submits its patient safety plan to the Department. Sections 307(b)(3), 308(a) and 315(b) and (d) of the MCARE Act.
Continuation of Responsibilities in Subsequent Years--It shall continue to satisfy the duties imposed upon it under Chapter 3 of the MCARE Act in subsequent calendar years unless it gives the Department written notice that it will not be performing 100 or more abortions in a calendar year and does not perform 100 or more abortions in that calendar year. Section 315(b) of the MCARE Act.
Freestanding Abortion Facilities That Do Not Perform 100 or More Abortions in 2006 After June 30, 2006, But Perform 100 or More Abortions in a Subsequent Calendar Year A freestanding abortion facility that does not perform 100 or more abortions in the 2006 calendar year after June 30, 2006, but does perform 100 or more abortions in a subsequent calendar year, shall be subject to Chapter 3 of the MCARE Act, and the requirements with the following variations, the day following the performance of its 100th abortion in that calendar year. Section 315(c) of the MCARE Act. Within 60 days following its performance of its 100th abortion in that calendar year it shall submit its patient safety plan to the Department. Section 315(d) of the MCARE Act. It shall begin reporting incidents, infrastructure failures, and serious events on the date it submits its patient safety plan to the Department. Section 315(e) of the MCARE Act. By the date it submits its patient safety plan it shall also designate a patient safety officer, establish a patient safety committee, establish a system accessible at all times for its health care workers to report serious events and incidents, begin required patient notifications of serious events, and begin reporting to licensing boards health care workers regulated by the boards who failed to report a serious event as required by the MCARE Act. Sections 307(b) 315(c) and (d) of the MCARE Act.
It shall be the responsibility of a freestanding abortion facility to determine when it performs 100 abortions in a calendar year and to then come into compliance with the requirements of Chapter 3 of the MCARE Act.
Sanctions Against Abortion Facilities Late Payment of Assessment--If after 30 days' notice the facility fails to pay an assessment levied by the Department under Chapter 3 of the MCARE Act, the Department may impose an administrative penalty of $1,000 per day against it until the assessment is paid. Section 305(g) of the MCARE Act.
Failure to Report or Notify--If the facility fails to satisfy the requirements of Chapter 3 of the MCARE Act to report an infrastructure failure or serious event; or to develop and comply with a patient safety plan; or to notify a patient of a serious event, the Department may revoke the facility's approval to perform abortions under 28 Pa. Code § 29.43 (relating to facility approval). Section 313(f) of the MCARE Act. This applies to both freestanding and hospital abortion facilities that are subject to Chapter 3 of the MCARE Act. In addition, if the facility fails to report a serious event or an infrastructure failure, or fails to notify a licensing board of a health care worker's failure to report a serious event, as required by Chapter 3 of the MCARE Act, the Department may impose a $1,000 per day administrative penalty on the facility until it files the required report or makes the required notification. Id.
Responsibilities of Health Care Workers Compliance With Patient Safety Plan--A health care worker shall comply with the facility's patient safety plan as a condition of employment or credentialing at the facility. Section 307(d) of the MCARE Act.
Reporting Incidents and Serious Events--A health care worker who reasonably believes that an incident or serious event has occurred shall report the incident or serious event as directed in the facility's patient safety plan unless the health care worker knows that a report has already been made. The health care worker shall report the matter immediately upon discovering it or as soon thereafter as reasonably practical, but in no event less than 24 hours after discovery. Section 308(a) of the MCARE Act.
[Pa.B. Doc. No. 06-2221. Filed for public inspection November 9, 2006, 9:00 a.m.]
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