STATE OF NEW YORK
________________________________________________________________________
1117
2013-2014 Regular Sessions
IN SENATE(Prefiled)
January 9, 2013
___________
Introduced by Sen. MAZIARZ -- read twice and ordered printed, and when
printed to be committed to the Committee on Health
AN ACT to amend the public health law and the state finance law, in
relation to establishing the medical harm disclosure act
The People of the State of New York, represented in Senate and Assem-bly, do enact as follows:
1 Section 1. Short title. This act shall be known and may be cited as
2 the "medical harm disclosure act".
3 § 2. Article 29-D of the public health law is amended by adding a new
4 title 1-A to read as follows:
5 TITLE 1-A
6 MEDICAL HARM DISCLOSURE ACT
7 Section 2997-e. Definitions.
8 2997-f. Hospital requirements.
9 2997-g. Medical harm disclosure advisory committee.
10 2997-h. Methodologies for collecting, analyzing and validating
11 data.
12 2997-i. Public reports.
13 2997-j. Privacy.
14 2997-k. Protection for taking action.
15 2997-l. Patient safety trust fund.
16 2997-m. Department actions and penalties.
17 2997-n. Oversight information.
18 2997-o. Public awareness.
19 § 2997-e. Definitions. For purposes of this title, the following terms
20 shall have the following meanings:
21 1. "Hospital" shall mean a hospital as defined pursuant to article
22 twenty-eight of this chapter.
23 2. "Medical harm event" shall mean harm to a patient as a result of
24 medical care or in a health care setting. It may include, but should not
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD02299-01-3
S. 1117 2
1 be limited to, the national quality forum's list of serious reportable
2 events, and shall include the following categories of events:
3 (a) Surgical and related anesthesia events including unexpected
4 complications and deaths, surgery performed on a wrong body part,
5 surgery performed on the wrong patient, the wrong surgical procedure
6 performed on a patient, and retention of a foreign object in a patient
7 after surgery or other procedure, excluding objects intentionally
8 implanted as part of a planned intervention and objects present prior to
9 surgery that are intentionally retained.
10 (b) Medication events related to professional practice, or health care
11 products, procedures, and systems, including, but not limited to,
12 prescribing, prescription order communications, product labeling, pack-
13 aging and nomenclature, compounding, dispensing, distribution, adminis-
14 tration, education, monitoring, and use.
15 (c) Product or device events related to the use or function of a
16 device in patient care in which the device is used for functions other
17 than as intended, including, but not limited to, catheters, infusion
18 pumps, or ventilators.
19 (d) Care management events including, but not limited to, stage 3 or 4
20 pressure ulcers acquired after admission to a health facility, failure
21 to rescue, IV injuries, and maternal death or serious disability associ-
22 ated with labor or delivery, including events that occur within forty-
23 two days post-delivery.
24 (e) Environmental deaths including, but not limited to, unintended
25 electric shock, delivery of the wrong gas or contaminated toxic
26 substance, burns incurred from any source, patient falls, and harm asso-
27 ciated with the use of restraints or bedrails.
28 (f) Death of a previously healthy person while undergoing medical
29 care.
30 § 2997-f. Hospital requirements. 1. In addition to the reporting
31 requirements set forth in section twenty-eight hundred five-l of this
32 chapter, a hospital shall report a medical harm event to the department
33 not later than five days after the event has been detected, or, if that
34 event is an ongoing urgent or emergent threat to the welfare, health, or
35 safety of patients, personnel, or visitors, not later than twenty-four
36 hours after the adverse event has been detected. The reports shall be
37 made on a form prescribed by the department.
38 2. The report shall indicate the level of medical harm to the patient,
39 such as whether it resulted in serious injury or death, using the format
40 developed by the department.
41 3. On a quarterly basis, each hospital that has had no medical harm
42 events to report during that quarter shall affirmatively declare this
43 fact to the department, using a form developed by the department.
44 4. Each hospital shall create facility-wide patient safety programs to
45 routinely review patient records for medical harm, analyze these events
46 to determine if they were preventable and implement changes to prevent
47 similar harmful events. Each hospital shall provide an annual summary of
48 its patient safety program to the department.
49 5. Each hospital shall inform the patient, the party responsible for
50 the patient, or an adult member of the immediate family in cases of
51 death or serious bodily injury, of the medical harm event by the time
52 the report is made to the department.
53 6. Each hospital shall interview patients, family members, and/or
54 parties responsible for the patient about medical harm events and docu-
55 ment a detailed summary of that interview in the patient's medical
56 record.
S. 1117 3
1 7. If the medical harm event contributed to the death of a patient,
2 the hospital shall include that event as a contributing cause on the
3 patient's death certificate.
4 8. If the hospital is a division or subsidiary of another entity that
5 owns or operates multiple hospitals or related organizations, a report
6 shall be made for each specific division or subsidiary and not aggre-
7 gately for multiple hospitals.
8 9. Nothing in this section shall be interpreted to change or otherwise
9 affect hospital reporting requirements regarding reportable diseases or
10 unusual occurrences, as provided elsewhere in this chapter.
11 § 2997-g. Medical harm disclosure advisory committee. 1. The commis-
12 sioner shall appoint a medical harm disclosure advisory committee,
13 including representatives from public and private hospitals, direct care
14 nursing staff, physicians, epidemiologists with expertise in patient
15 safety, academic researchers, consumer organizations, health insurers,
16 health maintenance organizations, organized labor, and purchasers of
17 health insurance, such as employers. The advisory committee shall have a
18 majority of members representing interests other than hospitals.
19 2. The medical harm disclosure advisory committee shall assist the
20 department in the development of all aspects of the department's method-
21 ology for collecting, analyzing, and disclosing the information
22 collected under this title, including collection methods, formatting,
23 evaluation of methods used and the methods and means for release and
24 dissemination.
25 3. Meetings of the advisory committee shall be open to the public
26 pursuant to article seven of the public officers law.
27 § 2997-h. Methodologies for collecting, analyzing and validating data.
28 1. The department shall, with the advice of the medical harm disclosure
29 advisory committee created in section twenty-nine hundred ninety-seven-g
30 of this title, develop guidelines for hospitals in identifying medical
31 harm events.
32 2. The department shall create standardized reporting formats for
33 hospitals to use to comply with all provisions of this title.
34 3. In developing the methodology for collecting the data on medical
35 harm events, the department and the medical harm disclosure advisory
36 committee shall use the "common formats" forms developed by the agency
37 for healthcare research and quality or a similar standardized collection
38 method.
39 4. In developing the methodology for analyzing the data, the depart-
40 ment shall include a standardized method of categorizing the level of
41 harm experienced by the patient, such as the national coordinating coun-
42 cil for medication errors reporting and prevention index for categoriz-
43 ing errors.
44 5. The department shall at least quarterly check the accuracy of
45 information reported by hospitals under this title by comparing the
46 information with other available data such as patient safety indicators
47 from hospital patient discharge data, complaints filed with the licens-
48 ing division, death certificates, inspection and survey reports, and
49 medical malpractice information. The department shall annually conduct
50 random reviews of hospital medical records.
51 6. The data collection, analysis and validation methodologies shall be
52 disclosed to the public.
53 7. Every three years, the department shall have an independent audit
54 conducted by a state university of New York entity not affiliated with
55 any hospital required to report under this title. Such audit shall:
S. 1117 4
1 (a) assess the accuracy of reporting by hospitals, especially seeking
2 to identify underreporting;
3 (b) be funded by the patient safety trust fund established in section
4 ninety-five-h of the state finance law; and
5 (c) be available to the public on the department's website within one
6 month of receiving the final report.
7 8. The department shall adopt regulations to carry out the provisions
8 of this title.
9 § 2997-i. Public reports. 1. Each quarter, the department shall
10 publish details of the fines assessed to hospitals for failure to report
11 medical harm events under section twenty-nine hundred ninety-seven-m of
12 this title, and shall issue a news release about that publication.
13 2. The department shall annually submit a report to the legislature
14 detailing medical harm events reported at each hospital required to
15 report under this title. The report may include policy recommendations,
16 as appropriate. Such report shall:
17 (a) be published on the department's website at the same time it is
18 submitted to the legislature;
19 (b) include hospital-specific information on the number and type of
20 medical harm events reported, the level of harm to patients, fines
21 assessed and enforcement actions taken, and the quarterly affirmation by
22 hospitals in which no medical harm events have occurred;
23 (c) provide information in a manner that stratifies the data based on
24 characteristics of the hospitals, such as number of patient admissions
25 and patient days in each hospital; and
26 (d) contain text written in plain language that includes a discussion
27 of findings, conclusions, and trends concerning the overall patient
28 safety in the state, including a comparison to prior years, and the
29 methods the department used to check for the accuracy of hospital
30 reports.
31 3. Each quarter, the department shall make information regarding
32 outcomes of hospital inspections and investigations conducted pursuant
33 to its regulatory duties under this chapter, readily accessible to the
34 public on the department website.
35 4. No hospital report or department public disclosure may contain
36 information identifying a patient, employee, or licensed health care
37 professional in connection with a specific infection incident.
38 5. The first report required under subdivision two of this section
39 shall be submitted and published no later than December thirty-first,
40 two thousand fourteen. Following the initial report, the department
41 shall publish these reports annually.
42 § 2997-j. Privacy. It is the expressed intent of the legislature that
43 a patient's right of confidentiality shall not be violated in any
44 manner. Patient social security numbers or any other information that
45 could be used to identify an individual patient shall not be released
46 notwithstanding any other provision of law.
47 § 2997-k. Protection for taking action. No hospital shall discharge,
48 refuse to hire, refuse to serve, retaliate in any manner or take any
49 adverse action against any employee, applicant for employment or health
50 care provider because such employee, applicant for employment or health
51 care provider takes or has taken any action in furtherance of the
52 enforcement of the provisions of this title.
53 § 2997-l. Patient safety trust fund. 1. All moneys received pursuant
54 to section twenty-nine hundred ninety-seven-m of this title and subdivi-
55 sion two of this section shall be credited to the patient safety trust
56 fund, established pursuant to section ninety-five-h of the state finance
S. 1117 5
1 law. The commissioner shall use the fund for regulatory oversight and
2 public accountability for safe health care, including, but not limited
3 to the audit specified under section twenty-nine hundred ninety-seven-h
4 of this title.
5 2. In addition to the moneys received pursuant to section twenty-nine
6 hundred ninety-seven-m of this title, an annual patient safety surcharge
7 on licensing fees charged to those medical facilities required to report
8 under this title is hereby established.
9 § 2997-m. Department actions and penalties. 1. In any case in which
10 the department receives a report from a hospital pursuant to section
11 twenty-nine hundred ninety-seven-f of this title, that indicates an
12 ongoing threat or imminent danger of death or serious bodily harm, the
13 department shall make an onsite inspection or investigation within
14 forty-eight hours or two business days, whichever is greater, of the
15 receipt of the report and shall complete that investigation within
16 forty-five days.
17 2. If a hospital fails to report a medical harm event pursuant to
18 section twenty-nine hundred ninety-seven-f of this title, the department
19 may assess the licensee a civil penalty in an amount not to exceed one
20 hundred dollars for each day that the adverse event is not reported
21 following the initial five-day period or twenty-four-hour period, as
22 applicable. If the licensee disputes a determination by the department
23 regarding alleged failure to report an adverse event, the licensee may,
24 within ten days, request a hearing pursuant to section twenty-eight
25 hundred six of this chapter. Penalties shall be paid when appeals pursu-
26 ant to such section have been exhausted.
27 3. The department shall be responsible for ensuring compliance with
28 this title as a condition of licensure under article twenty-eight of
29 this chapter and shall enforce such compliance according to the
30 provisions of such article.
31 § 2997-n. Oversight information. The department's hospital licensing
32 division and the division collecting the information required by this
33 title shall share data regarding medical harm events in hospitals, with
34 patient confidentiality maintained by both divisions.
35 § 2997-o. Public awareness. The department shall promote public aware-
36 ness regarding where and how consumers can file complaints about hospi-
37 tals, including a requirement that information about filing complaints
38 be posted in a visible manner:
39 1. on the department's licensing website;
40 2. on each hospital's website;
41 3. in public areas in hospital facilities;
42 4. on all hospital correspondence and billing documents; and
43 5. on all correspondence by the department's hospital licensing divi-
44 sion and the division collecting data on medical harm events under this
45 title.
46 § 3. Subdivision 1 of section 2806 of the public health law, as
47 amended by chapter 490 of the laws of 1983, is amended to read as
48 follows:
49 1. A hospital operating certificate may be revoked, suspended, limited
50 or annulled by the commissioner on proof that: (a) the hospital has
51 failed to comply with the provisions of this article or rules and regu-
52 lations promulgated thereunder; [or] (b) a general hospital has refused
53 or failed to admit or to provide for necessary emergency care and treat-
54 ment for an unidentified person brought to it in an unconscious, seri-
55 ously ill or wounded condition; or (c) a hospital has violated any
56 provision of title one-A of article twenty-nine-D of this chapter. A
S. 1117 6
1 hospital operating certificate shall be revoked, limited or annulled by
2 the commissioner upon revocation, limitation or annulment by the public
3 health council of approval of establishment of such hospital.
4 § 4. The state finance law is amended by adding a new section 95-h to
5 read as follows:
6 § 95-h. Patient safety trust fund. 1. There is hereby established in
7 the joint custody of the commissioner of taxation and finance and the
8 comptroller, a special fund to be known as the "patient safety trust
9 fund".
10 2. Such fund shall consist of all moneys appropriated for the purpose
11 of such fund, any civil penalties paid pursuant to section twenty-nine
12 hundred ninety-seven-m of the public health law and the annual patient
13 safety surcharge established by section twenty-nine hundred ninety-sev-
14 en-l of the public health law.
15 3. Moneys of the fund shall be available for regulatory oversight and
16 public accountability for safe health care, including, but not limited
17 to the purposes set forth in title one-A of article twenty-nine-D of the
18 public health law.
19 4. Moneys in the fund shall be kept separate and shall not be commin-
20 gled with any other moneys in the custody of the commissioner of taxa-
21 tion and finance and the comptroller.
22 5. The moneys of the fund shall be paid out on the audit and warrant
23 of the comptroller on vouchers certified or approved by the commissioner
24 of health, or by an officer or employee of the department of health
25 designated by such commissioner.
26 § 5. This act shall take effect on the one hundred twentieth day after
27 it shall have become a law. Effective immediately, the addition, amend-
28 ment and/or repeal of any rule or regulation necessary for the implemen-
29 tation of this act on its effective date is authorized to be made on or
30 before such date.