PRINTER'S NO. 403
No. 353 Session of 2007
INTRODUCED BY DeLUCA, MICOZZIE, BIANCUCCI, FRANKEL, GERGELY,
JOSEPHS, LEACH, MUNDY, PASHINSKI, RAMALEY, STURLA, TANGRETTI,
THOMAS, WALKO AND WATERS, FEBRUARY 9, 2007
REFERRED TO COMMITTEE ON HEALTH AND HUMAN SERVICES,
FEBRUARY 9, 2007
AN ACT
1 Establishing a reporting system for adverse health care events;
2 and providing for powers and duties of the Department of
3 Health.
4 TABLE OF CONTENTS
5 Chapter 1. Preliminary Provisions
6 Section 101. Short title.
7 Section 102. Definitions.
8 Chapter 3. Adverse Health Events
9 Section 301. Reports of adverse health care events.
10 Section 302. Surgical events.
11 Section 303. Product or device events.
12 Section 304. Patient protection events.
13 Section 305. Care management events.
14 Section 306. Environmental events.
15 Section 307. Criminal events.
16 Chapter 5. Action Following Adverse Event
17 Section 501. Root cause analysis and corrective action plan.
1 Section 502. Liability following adverse event.
2 Chapter 7. Department Responsibilities
3 Section 701. Electronic reporting.
4 Section 702. Establishment of reporting system.
5 Section 703. Duty to analyze reports and communicate findings.
6 Section 704. Sanctions.
7 Section 705. Interstate coordination and reports.
8 Chapter 11. Miscellaneous Provisions
9 Section 1101. Effective date.
10 The General Assembly of the Commonwealth of Pennsylvania
11 hereby enacts as follows:
12 CHAPTER 1
13 PRELIMINARY PROVISIONS
14 Section 101. Short title.
15 This act shall be known and may be cited as the Adverse
16 Health Care Events Reporting Act.
17 Section 102. Definitions.
18 The following words and phrases when used in this act shall
19 have the meanings given to them in this section unless the
20 context clearly indicates otherwise:
21 "Adverse health event." An event described under Chapter 3.
22 "Department." The Department of Health of the Commonwealth.
23 "Facility." A health care facility as defined in section
24 802.1 of the act of July 19, 1979 (P.L.130, No.48), known as the
25 Health Care Facilities Act.
26 "Hyperbilirubinemia." Bilirubin levels greater than 30
27 milligrams per deciliter.
28 "Serious disability." The term includes:
29 (1) A physical or mental impairment that substantially
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1 limits one or more of the major life activities of an
2 individual.
3 (2) A loss of bodily function, if the impairment or loss
4 lasts more than seven days or is still present at the time of
5 discharge from an inpatient health care facility.
6 (3) Loss of a body part.
7 "Surgery." The treatment of disease, injury or deformity by
8 manual or operative methods. The term includes endoscopies and
9 other invasive procedures.
10 CHAPTER 3
11 ADVERSE HEALTH EVENTS
12 Section 301. Reports of adverse health care events.
13 Each facility shall report to the department the occurrence
14 of any of the adverse health care events described in sections
15 302, 303, 304, 305, 306 and 307 as soon as is reasonably and
16 practically possible but no later than 15 working days after
17 discovery of the event. The report shall be filed in a format
18 specified by the department and shall identify the facility but
19 shall not include any identifying information for any of the
20 health care professionals, facility employees or patients
21 involved. The department may consult with experts and
22 organizations familiar with patient safety when developing the
23 format for reporting and in further defining events in order to
24 be consistent with industry standards.
25 Section 302. Surgical events.
26 Events reportable under this section are:
27 (1) Surgery performed on a wrong body part that is not
28 consistent with the documented informed consent for that
29 patient. Reportable events under this paragraph do not
30 include situations requiring prompt action that occur in the
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1 course of surgery or situations whose urgency precludes
2 obtaining informed consent.
3 (2) Surgery performed on the wrong patient.
4 (3) The wrong surgical procedure performed on a patient
5 that is not consistent with the documented informed consent
6 for that patient. Reportable events under this paragraph do
7 not include situations requiring prompt action that occur in
8 the course of surgery or situations whose urgency precludes
9 obtaining informed consent.
10 (4) Retention of a foreign object in a patient after
11 surgery or other procedure, excluding objects intentionally
12 implanted as part of a planned intervention and objects
13 present prior to surgery that are intentionally retained.
14 (5) Death during or immediately after surgery of a
15 normal, healthy patient who has no organic, physiologic,
16 biochemical or psychiatric disturbance and for whom the
17 pathologic processes for which the operation is to be
18 performed are localized and do not entail a systemic
19 disturbance.
20 Section 303. Product or device events.
21 Events reportable under this section are:
22 (1) Patient death or serious disability associated with
23 the use of contaminated drugs, devices or biologics provided
24 by the facility when the contamination is the result of
25 generally detectable contaminants in drugs, devices or
26 biologics regardless of the source of the contamination or
27 the product.
28 (2) Patient death or serious disability associated with
29 the use or function of a device in patient care in which the
30 device is used for functions other than as intended. The term
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1 "device" includes, but is not limited to, catheters, drains
2 and other specialized tubes, infusion pumps and ventilators.
3 (3) Patient death or serious disability associated with
4 intravascular air embolism that occurs while being cared for
5 in a facility, excluding deaths associated with neurosurgical
6 procedures known to present a high risk of intravascular air
7 embolism.
8 Section 304. Patient protection events.
9 Events reportable under this section are:
10 (1) An infant discharged to the wrong person.
11 (2) Patient death or serious disability associated with
12 patient disappearance for more than four hours, excluding
13 events involving adults who have decisionmaking capacity.
14 (3) Patient suicide or attempted suicide resulting in
15 serious disability while being cared for in a facility due to
16 patient actions after admission to the facility, excluding
17 deaths resulting from self-inflicted injuries that were the
18 reason for admission to the facility.
19 Section 305. Care management events.
20 Events reportable under this section are:
21 (1) Patient death or serious disability associated with
22 a medication error, including, but not limited to, errors
23 involving the wrong drug, the wrong dose, the wrong patient,
24 the wrong time, the wrong rate, the wrong preparation or the
25 wrong route of administration, excluding reasonable
26 differences in clinical judgment on drug selection and dose.
27 (2) Patient death or serious disability associated with
28 a hemolytic reaction due to the administration of ABO-
29 incompatible blood or blood products.
30 (3) Maternal death or serious disability associated with
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1 labor or delivery in a low-risk pregnancy while being cared
2 for in a facility, including events that occur within 42 days
3 postdelivery and excluding deaths from pulmonary or amniotic
4 fluid embolism, acute fatty liver of pregnancy or
5 cardiomyopathy.
6 (4) Patient death or serious disability directly related
7 to hypoglycemia, the onset of which occurs while the patient
8 is being cared for in a facility.
9 (5) Death or serious disability, including kernicterus,
10 associated with failure to identify and treat
11 hyperbilirubinemia in neonates during the first 28 days of
12 life.
13 (6) Stage 3 or stage 4 ulcers acquired after admission
14 to a facility, excluding progression from stage 2 to stage 3
15 if stage 2 was recognized upon admission.
16 (7) Patient death or serious disability due to spinal
17 manipulative therapy.
18 Section 306. Environmental events.
19 Events reportable under this section are:
20 (1) Patient death or serious disability associated with
21 an electric shock while being cared for in a facility,
22 excluding events involving planned treatments such as
23 electric countershock.
24 (2) Any incident in which a line designated for oxygen
25 or other gas to be delivered to a patient contains the wrong
26 gas or is contaminated by toxic substances.
27 (3) Patient death or serious disability associated with
28 a burn incurred from any source while being cared for in a
29 facility.
30 (4) Patient death associated with a fall while being
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1 cared for in a facility.
2 (5) Patient death or serious disability associated with
3 the use of restraints or bedrails while being cared for in a
4 facility.
5 Section 307. Criminal events.
6 Events reportable under this section are:
7 (1) Any instance of care ordered by or provided by
8 someone impersonating a physician, nurse, pharmacist or other
9 licensed health care provider.
10 (2) Abduction of a patient of any age.
11 (3) Sexual assault on a patient within or on the grounds
12 of a facility.
13 (4) Death or significant injury of a patient or staff
14 member resulting from a physical assault that occurs within
15 or on the grounds of a facility.
16 CHAPTER 5
17 ACTION FOLLOWING ADVERSE EVENT
18 Section 501. Root cause analysis and corrective action plan.
19 (a) Analysis required.--Following the occurrence of an
20 adverse health care event, the facility must conduct a root
21 cause analysis of the event. Following the analysis, the
22 facility must:
23 (1) implement a corrective action plan to implement the
24 findings of the analysis; or
25 (2) report to the department any reasons for not taking
26 corrective action.
27 (b) Report of findings.--If the root cause analysis and the
28 implementation of a corrective action plan are complete at the
29 time an event must be reported, the findings of the analysis and
30 the corrective action plan must be included in the report of the
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1 event. The findings of the root cause analysis and a copy of the
2 corrective action plan must otherwise be filed with the
3 department within 60 days of the event.
4 Section 502. Liability following adverse event.
5 Neither an affected patient nor the patient's insurer is
6 liable for or under obligation to pay any medical expense
7 incurred in relation to an adverse health care event.
8 CHAPTER 7
9 DEPARTMENT RESPONSIBILITIES
10 Section 701. Electronic reporting.
11 The department must design the reporting system so that a
12 facility may file by electronic means the reports required under
13 this act. The department shall encourage a facility to use the
14 electronic filing option when that option is feasible for the
15 facility.
16 Section 702. Establishment of reporting system.
17 (a) General rule.--The department shall establish an adverse
18 health event reporting system designed to facilitate quality
19 improvement in the health care system. The reporting system
20 shall not be designed to punish errors by health care
21 practitioners or health care facility employees.
22 (b) Requirements.--The reporting system shall consist of:
23 (1) Mandatory reporting by facilities of adverse health
24 care events.
25 (2) Mandatory completion of a root cause analysis and a
26 corrective action plan by the facility and reporting of the
27 findings of the analysis and the plan to the department or
28 reporting of reasons for not taking corrective action.
29 (3) Analysis of reported information by the department
30 to determine patterns of systemic failure in the health care
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1 system and successful methods to correct these failures.
2 (4) Sanctions against facilities for failure to comply
3 with reporting system requirements.
4 (5) Communication from the department to facilities,
5 health care purchasers and the public to maximize the use of
6 the reporting system to improve health care quality.
7 (c) Limitation.--The department is not authorized to select
8 from or between competing alternate acceptable medical
9 practices.
10 Section 703. Duty to analyze reports and communicate findings.
11 The department shall:
12 (1) Analyze adverse event reports, corrective action
13 plans and findings of the root cause analyses to determine
14 patterns of systemic failure in the health care system and
15 successful methods to correct these failures.
16 (2) Communicate to individual facilities the
17 department's conclusions, if any, regarding an adverse event
18 reported by the facility.
19 (3) Communicate with relevant facilities any
20 recommendations for corrective action resulting from the
21 department's analysis of submissions from facilities.
22 (4) Publish an annual report:
23 (i) Describing, by facility, adverse events
24 reported.
25 (ii) Outlining, in aggregate, corrective action
26 plans and the findings of root cause analyses.
27 (iii) Making recommendations for modifications of
28 State health care operations.
29 Section 704. Sanctions.
30 (a) Grounds.--The department shall take steps necessary to
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1 determine if adverse event reports, the findings of the root
2 cause analyses and corrective action plans are filed in a timely
3 manner. The department may sanction a facility for:
4 (1) Failure to file a timely adverse event report under
5 section 301.
6 (2) Failure to conduct a root cause analysis, to
7 implement a corrective action plan or to provide the findings
8 of a root cause analysis or corrective action plan in a
9 timely fashion under section 501.
10 (b) License suspension, revocation or nonrenewal.--If a
11 facility fails to develop and implement a corrective action plan
12 or report to the department why corrective action is not needed,
13 the department may suspend, revoke, fail to renew or place
14 conditions on the license under which the facility operates.
15 Section 705. Interstate coordination and reports.
16 The department shall report the definitions and the list of
17 reportable events adopted in this act to the National Quality
18 Forum and, working in coordination with the National Quality
19 Forum, to the other states. The department shall monitor
20 discussions by the National Quality Forum of amendments to the
21 forum's list of reportable events and shall report to the
22 General Assembly whenever the list is modified. The department
23 shall also monitor implementation efforts in other states to
24 establish a list of reportable events and shall make
25 recommendations to the General Assembly as necessary for
26 modifications in the list under this act or in the other
27 components of the reporting system under this act to keep the
28 system as nearly uniform as possible with similar systems in
29 other states.
30 CHAPTER 11
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1 MISCELLANEOUS PROVISIONS
2 Section 1101. Effective date.
3 This act shall take effect in one year.
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