PRINTER'S NO. 700
No. 644 Session of 2001
INTRODUCED BY DeLUCA, BELFANTI, BISHOP, CRUZ, GEORGE, GRUCELA, LAUGHLIN, MELIO, PISTELLA, ROBINSON, SOLOBAY, TANGRETTI, THOMAS, WALKO, WASHINGTON AND C. WILLIAMS, FEBRUARY 12, 2001
REFERRED TO COMMITTEE ON HEALTH AND HUMAN SERVICES, FEBRUARY 12, 2001
AN ACT 1 Providing for reportable events in medical treatment and for 2 powers and duties of the Department of Health; and imposing 3 duties on health care practitioners and health care 4 facilities. 5 The General Assembly of the Commonwealth of Pennsylvania 6 hereby enacts as follows: 7 Section 1. Short title. 8 This act shall be known and may be cited as the Reportable 9 Events in Medical Treatment Act. 10 Section 2. Definitions. 11 The following words and phrases when used in this act shall 12 have the meanings given to them in this section unless the 13 context clearly indicates otherwise: 14 "Administrator." The chief executive officer, chief 15 operating officer or administrator of a health care facility or 16 an individual owning, directing or controlling a health care 17 facility. 18 "Attending physician." The physician who acted as the
1 attending physician at the time a reportable medical event 2 occurred. 3 "Department." The Department of Health of the Commonwealth. 4 "Health care facility." A general or special hospital, 5 including tuberculosis and psychiatric hospitals; rehabilitation 6 facilities; skilled nursing facilities; kidney disease treatment 7 centers, including freestanding hemodialysis units; intermediate 8 care facilities; and ambulatory surgical facilities, both profit 9 and nonprofit. The term includes those facilities operated by an 10 agency of State or local government, but shall not include an 11 office used exclusively for private or group practice by 12 physicians or dentists; a program which renders treatment or 13 care for drug or alcohol abuse or dependence, unless located 14 within, by or through a health care facility; a facility 15 providing treatment solely on the basis of prayer or spiritual 16 means in accordance with the tenets of any church or religious 17 denomination; or a facility conducted by a religious 18 organization for the purpose of providing health care services 19 exclusively to clergymen or other persons in a religious 20 profession who are members of the religious denominations 21 conducting the facility. 22 "Health care practitioner." A licensed, certified or 23 registered practitioner of the healing arts. 24 "Reportable medical event." An unusual incident occurring in 25 the treatment of a patient which is unexpected or out-of-the- 26 ordinary or incidents investigated by the facility under 27 regulations issued by the Secretary of Health. Reportable 28 medical events may include, but are not limited to, unexpected 29 massive bleeding, tearing or perforation of blood vessels or 30 body organs, obstruction of airways, inadvertent penetration of 20010H0644B0700 - 2 -
1 body cavities, anaphylaxis, overdose of drugs, medication or 2 chemicals, sudden collapse, shock or coma. 3 "Responsible party." The family member, guardian or other 4 individual designated by the patient as responsible to receive 5 information concerning or in making decisions on behalf of a 6 patient, when necessary. 7 "Risk manager." The individual designated by a health care 8 facility or administrator to administer the facility's internal 9 risk management program or an individual appointed by the health 10 care facility, or its administrator, to receive information 11 regarding reportable medical events. 12 "Secretary." The Secretary of Health of the Commonwealth. 13 "Substantiated reportable medical event." A reportable 14 medical event, the occurrence of which is established by clear 15 and convincing evidence to the satisfaction of the risk manager, 16 and one which both the risk manager and the attending physician 17 agree poses a clear risk of harming the patient. 18 Section 3. Reporting. 19 (a) Health care practitioners.--It shall be the duty of each 20 health care practitioner charged with the care or involved in 21 the care of a patient in a health care facility at the time a 22 reportable medical event occurs to: 23 (1) Complete and file an incident report in accordance 24 with the health care facility's standard operating procedures 25 for any reportable medical event of which the health care 26 practitioner becomes aware as promptly as possible after a 27 reportable medical event, but no later than 48 hours from the 28 time the health care practitioner becomes aware or is 29 notified of the event. 30 (2) Inform the patient's attending physician of the 20010H0644B0700 - 3 -
1 reportable medical event's occurrence through the use of 2 incident reports in accordance with the health care 3 facility's standard operating procedures. 4 (b) Attending physicians.--As soon as possible after 5 receiving information under subsection (a)(2), the attending 6 physician shall document the facts relevant to the reportable 7 medical event in the patient's chart, stating when the attending 8 physician became aware of the event and describing subsequent 9 orders for treatment, as it relates to the event. If the 10 patient's attending physician causes a reportable medical event, 11 the attending physician shall comply with the reporting 12 requirements of subsection (a). 13 (c) Investigation.--If a risk manager receives notice of a 14 reportable medical event, the risk manager shall: 15 (1) Ensure compliance with subsection (a). 16 (2) Investigate the reportable medical event, which may 17 include interviewing the health care practitioners involved 18 and any other appropriate individuals and determining whether 19 clear and convincing evidence suggests that the incident 20 occurred. 21 (d) Substantiation.--The risk manager shall complete the 22 review of a reportable medical event and determine whether clear 23 and convincing evidence indicates that the reportable medical 24 event has occurred. After this determination has been made, the 25 risk manager and the attending physician shall then determine 26 whether the reportable medical event poses a clear risk of 27 harming the patient in accordance with the definition of a 28 "substantiated reportable medical event" under section 2. 29 Section 4. Notification. 30 The risk manager shall ensure that the patient involved is 20010H0644B0700 - 4 -
1 notified of a substantiated reportable medical event. If the 2 patient is a minor or is incapacitated, the risk manager and the 3 attending physician shall notify the patient's responsible 4 party. If notification might harm the physical or mental health 5 of the patient or if the patient cannot be located, the facts of 6 the events and rationale for nonnotification shall be documented 7 in the patient's medical record. The attending physician shall 8 notify the health care facility of the date and time the 9 physician intends to notify the patient or responsible party for 10 the patient of the substantiated reportable medical event so 11 that the facility can ensure that a member of its administration 12 or designee, or both, and its risk manager are present when the 13 patient or responsible party is notified of the event. The 14 attending physician shall document the status of patient 15 notification or the reasonable attempts which were made to 16 locate and notify the patient. 17 Section 5. Enforcement. 18 The department shall have the authority to review reports of 19 substantiated reportable medical events and to determine 20 compliance with this act. The department may conduct unannounced 21 surveys whenever it receives any complaint or has other 22 reasonable grounds to believe that the requirements of this act 23 have not been met. 24 Section 6. Immunity from liability. 25 (a) Making a report.--Notwithstanding any other provision of 26 law, no person making a report under this act shall be held, by 27 reason of making the report, to have violated any criminal law 28 or to be civilly liable under any law, unless the information 29 provided in the report is false and the person providing the 30 information knew that the information was false. 20010H0644B0700 - 5 -
1 (b) Performance of duty.--No individual who, as a member, 2 employee, agent, officer or director of a health care facility 3 shall be held, by reason of the performance of any duty, 4 function or activity authorized or required under this act, to 5 have violated any criminal law or be civilly liable under any 6 law as a result of performing any duty, function or activity, 7 unless the duty, function or activity was motivated solely by 8 malice toward a person affected by the action. 9 Section 7. Reports and confidentiality. 10 (a) Reports confidential.--Reports generated by reason of 11 this act shall remain confidential. This includes the 12 identification of the patient, the person reporting an event and 13 the health care practitioners involved. No person may be 14 required to testify in any civil action as to the contents of a 15 report. 16 (b) Annual report.--The department shall annually compile a 17 listing of all substantiated reportable medical events in health 18 care facilities throughout this Commonwealth. The substantiated 19 reportable medical event report shall include the name of the 20 health care facility where the incident occurred, the date of 21 the incident and a description of the circumstances surrounding 22 the occurrence of the substantiated reportable medical event. 23 The report shall also include recommendations from the 24 department, when applicable, to describe how the event could be 25 prevented in the future. The annual report of all substantiated 26 reportable medical events shall be distributed to every health 27 care facility risk manager by the department upon release of the 28 publication. 29 (c) Civil, administrative or criminal proceedings.--This act 30 is not intended to nor shall it be construed to prohibit any 20010H0644B0700 - 6 -
1 person from testifying during any civil, administrative or 2 criminal proceeding regarding that person's knowledge of the 3 medical treatment provided to a patient who is the subject of a 4 report generated under this act. 5 Section 8. Penalties. 6 The department may assess an administrative penalty of $1,000 7 against a health care facility that intentionally or negligently 8 violates this act. The assessment under this section is subject 9 to 2 Pa.C.S. Ch. 5 Subch. A (relating to practice and procedure 10 of Commonwealth agencies) and Ch. 7 Subch. A (relating to 11 judicial review of Commonwealth agency action). 12 Section 9. Effective date. 13 This act shall take effect in 60 days. A29L35JLW/20010H0644B0700 - 7 -