S T A T E   O F   N E W   Y O R K
________________________________________________________________________

                                  11180

                          I N  A S S E M B L Y

                              May 24, 2010
                               ___________

Introduced  by  M.  of  A. GOTTFRIED -- (at request of the Department of
  Health) -- read once and referred to the Committee on Health

AN ACT to amend the public health law and the education law, in relation
  to adverse event reporting and notification by hospitals and  diagnos-
  tic  and  treatment centers; and to amend part X2 of chapter 62 of the
  laws of 2003, amending the public health law relating to allowing  for
  the  use  of  funds  of the office of professional medical conduct for
  activities of the patient health information and  quality  improvement
  act  of  2000,  in relation to omitting sunset provisions for enhanced
  penalties

  THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND  ASSEM-
BLY, DO ENACT AS FOLLOWS:

  Section  1. Section 2805-l of the public health law, as added by chap-
ter 266 of the laws of 1986, subdivision 3 as amended by chapter 542  of
the laws of 2000, subdivision 4 as added and subdivision 5 as renumbered
by chapter 632 of the laws of 2006, is amended to read as follows:
  S  2805-l.  [Incident] ADVERSE EVENT reporting. 1. (A) FOR PURPOSES OF
THIS SECTION, "HOSPITAL" MEANS ANY GENERAL HOSPITAL  OR  DIAGNOSTIC  AND
TREATMENT CENTER.
  (B)  All  hospitals[, as defined in subdivision ten of section twenty-
eight hundred one of this article,] shall be required to  report  [inci-
dents]  ADVERSE  EVENTS  described by subdivision two of this section to
the department WITHIN TWENTY-FOUR HOURS OF OBTAINING  KNOWLEDGE  OF  ANY
INFORMATION  WHICH REASONABLY APPEARS TO SHOW THAT SUCH AN ADVERSE EVENT
HAS OCCURRED. SUCH REPORT SHALL BE MADE in a  manner  [and  within  time
periods] as may be specified by regulation of the department.
  2.  The  following [incidents] ADVERSE EVENTS shall be reported to the
department:
  (a) patients' deaths or impairments of  bodily  functions  in  circum-
stances  other  than  those  related  to  the natural course of illness,
disease or  proper  treatment  in  accordance  with  generally  accepted
medical standards;
  (b)  fires in the hospital which disrupt the provision of patient care
services or cause harm to patients or staff;

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
              

                                                           LBD15998-05-0

A. 11180                            2

  (c) equipment malfunction during treatment or diagnosis of  a  patient
which did or could have adversely affected a patient or hospital person-
nel;
  (d) poisoning occurring within the hospital;
  (e) strikes by hospital staff;
  (f)  disasters  or other emergency situations external to the hospital
environment which affect hospital operations; [and]
  (g) termination of any services vital to the continued safe  operation
of  the hospital or to the health and safety of its patients and person-
nel, including but not limited to the anticipated or actual  termination
of telephone, electric, gas, fuel, water, heat, air conditioning, rodent
or pest control, laundry services, food or contract services[.];
  (H)  SERIOUS  CRIMES  OCCURRING  ON  HOSPITAL  PREMISES OR GROUNDS, AS
DEFINED BY THE COMMISSIONER; AND
  (I) OTHER SERIOUS ADVERSE EVENTS AS  DETERMINED  BY  THE  COMMISSIONER
AFTER  CONSIDERATION  OF  NATIONAL  STANDARDS AND EXPERT ADVICE PROVIDED
PURSUANT TO SUBDIVISION SIX OF THIS SECTION.
  3. (A)(I) The hospital shall conduct an investigation  of  [incidents]
ADVERSE  EVENTS  described  in  paragraphs  (a) [through (d)] AND (C) of
subdivision two of this section. THE HOSPITAL SHALL COMPLETE SUCH INVES-
TIGATION AND PROVIDE TO THE DEPARTMENT A WRITTEN REPORT  THEREOF  within
thirty  days  of obtaining knowledge of any information which reasonably
appears to show that such an [incident]  ADVERSE  EVENT  has  occurred[,
provided  that, if the hospital reasonably expects such investigation to
extend beyond such thirty day period,  the  hospital  shall  notify  the
department of such expectation and the reason therefor, and shall inform
the department of the expected completion date of the investigation. The
hospital  shall  provide  to  the department a copy of the investigation
report within twenty-four hours  of  completion.  Nothing  herein  shall
limit  the  authority  of  the department to conduct an investigation of
incidents occurring in general hospitals].
  (II) IF DIRECTED TO DO  SO  BY  THE  DEPARTMENT,  THE  HOSPITAL  SHALL
CONDUCT  AN  INVESTIGATION OF ADVERSE EVENTS DESCRIBED IN PARAGRAPHS (B)
AND (D) THROUGH (I)  OF  SUBDIVISION  TWO  OF  THIS  SECTION  AND  SHALL
COMPLETE  SUCH  INVESTIGATION  AND  PROVIDE  TO THE DEPARTMENT A WRITTEN
REPORT THEREOF WITHIN THIRTY DAYS OF RECEIVING SUCH DIRECTION  FROM  THE
DEPARTMENT.
  (B) A HOSPITAL MAY SUBMIT TO THE COMMISSIONER A WRITTEN REQUEST FOR AN
EXTENSION  OF  TIME  TO COMPLETE AN INVESTIGATION AND SUBMIT AN INVESTI-
GATION REPORT PURSUANT  TO  PARAGRAPH  (A)  OF  THIS  SUBDIVISION.  SUCH
REQUEST  SHALL  STATE  THE  LENGTH  OF THE EXTENSION REQUESTED, WHY SUCH
EXTENSION IS NECESSARY, AND WHAT STEPS HAVE BEEN OR WILL BE TAKEN BY THE
HOSPITAL TO ENSURE THAT PATIENT  SAFETY  WOULD  NOT  BE  COMPROMISED  BY
APPROVAL   OF SUCH EXTENSION. THE COMMISSIONER MAY GRANT AN EXTENSION IF
HE OR SHE FINDS IT TO BE REASONABLE AFTER CONSIDERATION OF THE  INFORMA-
TION  SUBMITTED BY THE HOSPITAL AND FACTORS INCLUDING BUT NOT LIMITED TO
THE SERIOUSNESS OF THE EVENT, THE MAGNITUDE AND URGENCY OF THE  RISK  IT
PRESENTS,  THE  LIKELIHOOD OF REPETITION AND THE IMPACT AN EXTENSION MAY
HAVE  UPON  PATIENT  SAFETY.  THE  COMMISSIONER  MAY,  IN  HIS  OR   HER
DISCRETION,  GRANT  AN  EXTENSION  OF TIME WHICH IS OF LONGER OR SHORTER
DURATION THAN THAT REQUESTED BY THE HOSPITAL AND  MAY,  IN  HIS  OR  HER
DISCRETION,  GRANT  ADDITIONAL EXTENSIONS UNDER THE SAME CRITERIA LISTED
HEREIN.
  4. NOTHING HEREIN SHALL LIMIT  THE  AUTHORITY  OF  THE  DEPARTMENT  TO
CONDUCT  INVESTIGATIONS OF ADVERSE EVENTS OCCURRING IN HOSPITALS, NOR TO
ENFORCE THE PROVISIONS OF THIS CHAPTER BASED ON SUCH EVENTS.

A. 11180                            3

  5. THE DEPARTMENT SHALL ANALYZE REPORTS OF INVESTIGATIONS  OF  ADVERSE
EVENTS  AND  USE  SUCH  ANALYSES  IN  THE DEVELOPMENT, DISSEMINATION AND
TRACKING OF PATIENT SAFETY GOALS AND BEST PRACTICES IN  PATIENT  SAFETY.
THE  DEPARTMENT  MAY  ALSO RELEASE TO HOSPITALS OR TO THE PUBLIC OR BOTH
ANALYSES  AND  FINDINGS  DERIVED FROM THE ADVERSE EVENT DATA IN A FORMAT
THAT DOES NOT IDENTIFY SPECIFIC PATIENTS.
  6. THE DEPARTMENT SHALL  CONSULT,  AS  APPROPRIATE,  WITH  CLINICIANS,
HOSPITAL ADMINISTRATORS, RESEARCHERS AND CONSUMERS WITH EXPERTISE IN THE
AREA OF PATIENT SAFETY AND QUALITY IMPROVEMENT CONCERNING:
  (A)  IMPROVEMENTS TO THE ADVERSE EVENT REPORTING SYSTEM, INCLUDING BUT
NOT LIMITED TO, CHANGES IN THE TYPES OF ADVERSE EVENTS AND  OTHER  RELE-
VANT PATIENT DATA THAT SHOULD BE REPORTED;
  (B)  INTEGRATION  OF  ADVERSE  EVENT  DATA  WITH  OTHER DATA REPORTING
SYSTEMS FOR PURPOSES OF IMPROVING PATIENT SAFETY;
  (C) COLLABORATIVE STRATEGIES  TO  IMPROVE  PATIENT  SAFETY  WHICH  MAY
INCLUDE, BUT ARE NOT LIMITED TO, CONSULTATION WITH HOSPITALS TO IDENTIFY
EFFECTIVE  STRATEGIES DEPLOYED TO PROMOTE PATIENT SAFETY AND DEVELOPMENT
OF EDUCATION PROGRAMS TO TARGET AREAS IN NEED OF  IMPROVEMENT  BASED  ON
FINDINGS OF THE ADVERSE EVENT REPORTING SYSTEM;
  (D)  THE  TYPES  OF ADVERSE EVENT DATA THAT SHOULD BE DISCLOSED TO THE
PUBLIC; AND
  (E) STRATEGIES TO ENCOURAGE REPORTING UNDER THIS SECTION.
  7. (A) EACH GENERAL HOSPITAL, AND EACH DIAGNOSTIC AND TREATMENT CENTER
THAT PROVIDES AMBULATORY SURGERY, DIAGNOSTIC OR THERAPEUTIC RADIATION OR
END STAGE RENAL DISEASE  SERVICES,  SHALL  ESTABLISH  A  PATIENT  SAFETY
COMMITTEE WHICH SHALL BE CHARGED WITH:
  (I)  CONDUCTING  ONGOING  ANALYSIS  AND  APPLICATION OF EVIDENCE-BASED
PATIENT SAFETY PRACTICES IN ORDER TO REDUCE THE PROBABILITY  OF  ADVERSE
EVENTS;
  (II)  CONDUCTING  ANALYSES OF ADVERSE EVENTS AND NEAR-MISS EVENTS THAT
OCCUR WITHIN THE FACILITY; AND
  (III) DEVELOPING AND PROMOTING THE IMPLEMENTATION  OF  RISK  REDUCTION
STRATEGIES TO PREVENT THE OCCURRENCE OF ADVERSE OR NEAR-MISS EVENTS.
  (B)  THE  RESPONSIBILITIES  OF  THE  PATIENT  SAFETY  COMMITTEE MAY BE
ASSUMED BY AN EXISTING COMMITTEE OF THE  HOSPITAL,  PROVIDED  THAT  SUCH
COMMITTEE  SATISFIES  THE  REQUIREMENTS SET FORTH IN THIS SECTION AND IN
REGULATIONS PROMULGATED BY THE COMMISSIONER.
  (C) THE PATIENT SAFETY COMMITTEE SHALL BE CHAIRED BY A PATIENT  SAFETY
OFFICER  WHO  SHALL  REPORT  DIRECTLY  TO THE CHIEF EXECUTIVE OFFICER OR
ADMINISTRATOR, AS APPLICABLE, AND SHALL PRESENT ON AT LEAST A  QUARTERLY
BASIS  TO THE GOVERNING BODY OF THE HOSPITAL A REPORT ON THE COMMITTEE'S
ACTIVITIES, FINDINGS AND RECOMMENDATIONS AND THE STATUS  OF  EFFORTS  TO
IMPLEMENT  THOSE  RECOMMENDATIONS  PREVIOUSLY  MADE BY THE COMMITTEE AND
ADOPTED.
  (D) FOR PURPOSES OF THIS SUBDIVISION, "NEAR-MISS EVENT" MEANS AN EVENT
OR SITUATION THAT COULD HAVE RESULTED IN AN ADVERSE EVENT BUT  DID  NOT,
EITHER BY CHANCE OR THROUGH TIMELY INTERVENTION.
  [4.]  8.  The  commissioner  shall  establish  protocols  for hospital
personnel where a patient under the age of eighteen  years  dies  during
transportation  to  the hospital or while at the hospital, under circum-
stances other than those related  to  the  natural  course  of  illness,
disease  or  proper  treatment  in  accordance  with  generally accepted
medical standards. Such protocols shall address matters  including,  but
not limited to, the following:
  (a) medical and social history, and examination of the patient;
  (b) preservation of evidence and chain of custody;

A. 11180                            4

  (c)  questioning  of  the  patient's  family,  guardian  or  person in
parental authority;
  (d) circumstances surrounding the injury resulting in death;
  (e) determination of the cause of death;
  (f) notification of law enforcement personnel; and
  (g)  reporting  requirements  under  title  six  of article six of the
social services law.
  In developing such protocols, the commissioner shall consult with  the
office  of  children  and  family  services, local departments of social
services, coordinators of child fatality review teams established pursu-
ant to section four hundred twenty-two-b of the social services law, law
enforcement agencies, pediatricians preferably  with  expertise  in  the
area  of  child  abuse and maltreatment or forensic pediatrics, and such
other persons as the commissioner deems necessary.
  [5.] 9. The commissioner shall make,  adopt,  promulgate  and  enforce
such  rules and regulations as he may deem appropriate to effectuate the
purposes of this section.
  10. (A) NOTWITHSTANDING ANY INCONSISTENT PROVISION OF  SECTION  TWELVE
OF  THIS  CHAPTER  OR ANY OTHER LAW, THE COMMISSIONER MAY IMPOSE A CIVIL
PENALTY NOT TO EXCEED FIVE THOUSAND DOLLARS FOR EACH  VIOLATION  OF  THE
REQUIREMENTS  OF  THIS  SECTION OR THE RULES AND REGULATIONS PROMULGATED
PURSUANT TO SUCH SECTION PERTAINING TO THE TIMELY REPORTING AND INVESTI-
GATION OF ADVERSE EVENTS AND THE  SUBMISSION  OF  INVESTIGATION  REPORTS
CONCERNING SUCH EVENTS.
  (B)  THE PENALTY PROVIDED FOR IN PARAGRAPH (A) OF THIS SUBDIVISION MAY
BE INCREASED TO AN AMOUNT NOT TO  EXCEED  SEVEN  THOUSAND  FIVE  HUNDRED
DOLLARS  FOR  A  SUBSEQUENT  VIOLATION  IF THE PERSON COMMITTED THE SAME
VIOLATION, WITH RESPECT TO THE SAME OR  ANY  OTHER  PERSON  OR  PERSONS,
WITHIN  TWELVE  MONTHS  OF THE INITIAL VIOLATION FOR WHICH A PENALTY WAS
ASSESSED PURSUANT TO PARAGRAPH (A) OF THIS SUBDIVISION.
  (C) THE PENALTY PROVIDED FOR IN PARAGRAPH (A) OF THIS SUBDIVISION  MAY
BE  INCREASED  TO  AN AMOUNT NOT TO EXCEED TEN THOUSAND DOLLARS FOR EACH
VIOLATION IF THE ADVERSE EVENT DIRECTLY  RESULTED  IN  SERIOUS  PHYSICAL
HARM TO A PATIENT OR PATIENTS.
  (D) IN ADDITION TO THE PENALTIES AVAILABLE UNDER SUBDIVISIONS (A), (B)
AND (C) OF THIS SUBDIVISION, THE COMMISSIONER MAY IMPOSE A CIVIL PENALTY
OF  FIVE HUNDRED DOLLARS FOR EACH DAY THAT A HOSPITAL FAILS TO SUBMIT AN
INVESTIGATION REPORT AS REQUIRED PURSUANT TO PARAGRAPH (A)  OF  SUBDIVI-
SION  THREE  OF  THIS SECTION, IF THE COMMISSIONER HAS NOT AUTHORIZED AN
EXTENSION OF TIME PURSUANT TO PARAGRAPH (B) OF SUBDIVISION THREE OF THIS
SECTION.
  (E) THE COMPTROLLER IS  HEREBY  AUTHORIZED  AND  DIRECTED  TO  DEPOSIT
AMOUNTS  COLLECTED  UNDER  THIS SUBDIVISION TO THE PATIENT SAFETY CENTER
ACCOUNT TO BE USED FOR PURPOSES OF THE PATIENT SAFETY CENTER CREATED  BY
TITLE TWO OF ARTICLE TWENTY-NINE-D OF THIS CHAPTER.
  (F)  ANY  CIVIL  PENALTIES  AVAILABLE  UNDER THIS SUBDIVISION SHALL BE
ASSESSED SUBJECT TO THE APPLICABLE PROVISIONS  OF  SECTIONS  TWELVE  AND
TWELVE-A OF THIS CHAPTER.
  S  2.  Section  2805-m of the public health law, as amended by chapter
808 of the laws of 1987, is amended to read as follows:
  S  2805-m.  Confidentiality.    1.  The  information  required  to  be
collected  and  maintained  pursuant  to  sections  twenty-eight hundred
five-j and twenty-eight  hundred  five-k  of  this  article[,]  AND  THE
reports  required  to  be  submitted  pursuant  to  section twenty-eight
hundred five-l of this article [and any incident reporting  requirements
imposed upon diagnostic and treatment centers pursuant to the provisions

A. 11180                            5

of  this  chapter]  shall be kept confidential and shall not be released
except to the department or pursuant  to  subdivision  four  of  section
twenty-eight hundred five-k of this article.
  2.  Notwithstanding  any other provisions of law, none of the records,
documentation or committee  actions  or  records  required  pursuant  to
sections  twenty-eight hundred five-j [and], twenty-eight hundred five-k
OR TWENTY-EIGHT HUNDRED  FIVE-L  of  this  article[,]  NOR  the  reports
required pursuant to section twenty-eight hundred five-l of this article
[nor  any  incident  reporting  requirements imposed upon diagnostic and
treatment centers pursuant to the provisions of this chapter]  shall  be
subject  to  disclosure  under article six of the public officers law or
article thirty-one of the civil practice law and rules, except as  here-
inafter provided or as provided by any other provision of law. No person
in  attendance  at  a meeting of any such committee shall be required to
testify as to what  transpired  thereat.  The  prohibition  relating  to
discovery  of  testimony  shall  not apply to the statements made by any
person in attendance at such a meeting who is a party to  an  action  or
proceeding the subject matter of which was reviewed at such meeting.
  3.  There  shall be no monetary liability on the part of, and no cause
of action for damages shall  arise  against,  any  person,  partnership,
corporation,  firm,  society, or other entity on account of the communi-
cation of information in the possession of such person or entity, or  on
account  of  any  recommendation or evaluation, regarding the qualifica-
tions, fitness, or professional conduct or practices of a physician,  to
any  governmental agency, medical or specialists society, or hospital as
required by sections twenty-eight hundred five-j,  twenty-eight  hundred
five-k  and twenty-eight hundred five-l of this article [or any incident
reporting requirements imposed upon  diagnostic  and  treatment  centers
pursuant  to  the  provisions  of this chapter]. The foregoing shall not
apply to information which is untrue  and  communicated  with  malicious
intent.
  S 3. Subdivision 3 of section 6527 of the education law, as amended by
chapter 257 of the laws of 1987, is amended to read as follows:
  3. No individual who serves as a member of (a) a committee established
to  administer  a  utilization  review  plan  of a hospital, including a
hospital as defined in article twenty-eight of the public health law  or
a  hospital  as defined in subdivision ten of section 1.03 of the mental
hygiene law, or (b) a committee having the responsibility of the  inves-
tigation of an incident reported pursuant to section 29.29 of the mental
hygiene  law  or  the  evaluation and improvement of the quality of care
rendered in a hospital as defined in article twenty-eight of the  public
health  law  or a hospital as defined in subdivision ten of section 1.03
of the mental hygiene law,  or  (c)  any  medical  review  committee  or
subcommittee thereof of a local, county or state medical, dental, podia-
try  or  optometrical  society,  any such society itself, a professional
standards review organization or  an  individual  when  such  committee,
subcommittee,  society,  organization  or  individual  is performing any
medical or quality assurance review function including the investigation
of an incident reported pursuant to section 29.29 of the mental  hygiene
law,  either  described  in  clauses  (a)  and  (b) of this subdivision,
required by law, or involving any controversy or dispute between  (i)  a
physician,  dentist, podiatrist or optometrist or hospital administrator
and a patient concerning  the  diagnosis,  treatment  or  care  of  such
patient  or  the  fees or charges therefor or (ii) a physician, dentist,
podiatrist or optometrist or hospital administrator and  a  provider  of
medical,  dental,  podiatric  or  optometrical  services  concerning any

A. 11180                            6

medical or health charges or fees of such physician, dentist, podiatrist
or optometrist, or (d) a committee appointed pursuant to  section  twen-
ty-eight  hundred  five-j of the public health law to participate in the
medical and dental malpractice prevention program, or (e) any individual
who  participated in the preparation of [incident] ADVERSE EVENT reports
required by the department of health pursuant  to  section  twenty-eight
hundred  five-l of the public health law, or (f) a committee established
to administer a utilization review  plan,  or  a  committee  having  the
responsibility  of  evaluation  and  improvement  of the quality of care
rendered, in a health maintenance organization organized  under  article
forty-four of the public health law or article forty-three of the insur-
ance law, including a committee of an individual practice association or
medical  group  acting pursuant to a contract with such a health mainte-
nance organization, shall be liable in damages to  any  person  for  any
action  taken  or  recommendations  made, by him within the scope of his
function in such capacity provided that (a) such  individual  has  taken
action  or  made  recommendations  within  the scope of his function and
without malice, and (b) in the reasonable belief after reasonable inves-
tigation that the act or recommendation was warranted,  based  upon  the
facts disclosed.
  Neither  the  proceedings nor the records relating to performance of a
medical or a quality assurance review function  or  participation  in  a
medical  and  dental  malpractice  prevention  program  nor  any  report
required by the department of health pursuant  to  section  twenty-eight
hundred  five-l of the public health law described herein, including the
investigation of an incident reported pursuant to section 29.29  of  the
mental  hygiene  law, shall be subject to disclosure under article thir-
ty-one of the  civil  practice  law  and  rules  except  as  hereinafter
provided  or  as  provided  by  any other provision of law. No person in
attendance at a meeting when a medical or a quality assurance review  or
a  medical  and  dental  malpractice  prevention  program or an incident
reporting function described herein was performed, including the  inves-
tigation of an incident reported pursuant to section 29.29 of the mental
hygiene law, shall be required to testify as to what transpired thereat.
The  prohibition  relating  to discovery of testimony shall not apply to
the statements made by any person in attendance at such a meeting who is
a party to an action or proceeding  the  subject  matter  of  which  was
reviewed at such meeting.
  S  4. Section 4 of part X2 of chapter 62 of the laws of 2003, amending
the public health law relating to allowing for the use of funds  of  the
office  of  professional  medical  conduct for activities of the patient
health information and quality improvement act of 2000,  as  amended  by
chapter 21 of the laws of 2010, is amended to read as follows:
  S  4.  This  act  shall  take  effect  immediately;  provided that the
provisions of section one of this act shall be deemed to  have  been  in
full  force  and  effect  on  and after April 1, 2003[, and shall expire
March 31, 2011 when upon such date the provisions of such section  shall
be deemed repealed].
  S 5. This act shall take effect on the one hundred eightieth day after
it shall have become law; provided, however, that effective immediately,
the  addition,  amendment and repeal of any rule or regulation necessary
for the implementation of this act on its effective date  is  authorized
and directed to be made and completed on or before such effective date.