LBD02299-01-3
S. 1117 2
BE LIMITED TO, THE NATIONAL QUALITY FORUM'S LIST OF SERIOUS REPORTABLE
EVENTS, AND SHALL INCLUDE THE FOLLOWING CATEGORIES OF EVENTS:
(A) SURGICAL AND RELATED ANESTHESIA EVENTS INCLUDING UNEXPECTED
COMPLICATIONS AND DEATHS, SURGERY PERFORMED ON A WRONG BODY PART,
SURGERY PERFORMED ON THE WRONG PATIENT, THE WRONG SURGICAL PROCEDURE
PERFORMED ON A PATIENT, AND RETENTION OF A FOREIGN OBJECT IN A PATIENT
AFTER SURGERY OR OTHER PROCEDURE, EXCLUDING OBJECTS INTENTIONALLY
IMPLANTED AS PART OF A PLANNED INTERVENTION AND OBJECTS PRESENT PRIOR TO
SURGERY THAT ARE INTENTIONALLY RETAINED.
(B) MEDICATION EVENTS RELATED TO PROFESSIONAL PRACTICE, OR HEALTH CARE
PRODUCTS, PROCEDURES, AND SYSTEMS, INCLUDING, BUT NOT LIMITED TO,
PRESCRIBING, PRESCRIPTION ORDER COMMUNICATIONS, PRODUCT LABELING, PACK-
AGING AND NOMENCLATURE, COMPOUNDING, DISPENSING, DISTRIBUTION, ADMINIS-
TRATION, EDUCATION, MONITORING, AND USE.
(C) PRODUCT OR DEVICE EVENTS RELATED TO THE USE OR FUNCTION OF A
DEVICE IN PATIENT CARE IN WHICH THE DEVICE IS USED FOR FUNCTIONS OTHER
THAN AS INTENDED, INCLUDING, BUT NOT LIMITED TO, CATHETERS, INFUSION
PUMPS, OR VENTILATORS.
(D) CARE MANAGEMENT EVENTS INCLUDING, BUT NOT LIMITED TO, STAGE 3 OR 4
PRESSURE ULCERS ACQUIRED AFTER ADMISSION TO A HEALTH FACILITY, FAILURE
TO RESCUE, IV INJURIES, AND MATERNAL DEATH OR SERIOUS DISABILITY ASSOCI-
ATED WITH LABOR OR DELIVERY, INCLUDING EVENTS THAT OCCUR WITHIN
FORTY-TWO DAYS POST-DELIVERY.
(E) ENVIRONMENTAL DEATHS INCLUDING, BUT NOT LIMITED TO, UNINTENDED
ELECTRIC SHOCK, DELIVERY OF THE WRONG GAS OR CONTAMINATED TOXIC
SUBSTANCE, BURNS INCURRED FROM ANY SOURCE, PATIENT FALLS, AND HARM ASSO-
CIATED WITH THE USE OF RESTRAINTS OR BEDRAILS.
(F) DEATH OF A PREVIOUSLY HEALTHY PERSON WHILE UNDERGOING MEDICAL
CARE.
S 2997-F. HOSPITAL REQUIREMENTS. 1. IN ADDITION TO THE REPORTING
REQUIREMENTS SET FORTH IN SECTION TWENTY-EIGHT HUNDRED FIVE-L OF THIS
CHAPTER, A HOSPITAL SHALL REPORT A MEDICAL HARM EVENT TO THE DEPARTMENT
NOT LATER THAN FIVE DAYS AFTER THE EVENT HAS BEEN DETECTED, OR, IF THAT
EVENT IS AN ONGOING URGENT OR EMERGENT THREAT TO THE WELFARE, HEALTH, OR
SAFETY OF PATIENTS, PERSONNEL, OR VISITORS, NOT LATER THAN TWENTY-FOUR
HOURS AFTER THE ADVERSE EVENT HAS BEEN DETECTED. THE REPORTS SHALL BE
MADE ON A FORM PRESCRIBED BY THE DEPARTMENT.
2. THE REPORT SHALL INDICATE THE LEVEL OF MEDICAL HARM TO THE PATIENT,
SUCH AS WHETHER IT RESULTED IN SERIOUS INJURY OR DEATH, USING THE FORMAT
DEVELOPED BY THE DEPARTMENT.
3. ON A QUARTERLY BASIS, EACH HOSPITAL THAT HAS HAD NO MEDICAL HARM
EVENTS TO REPORT DURING THAT QUARTER SHALL AFFIRMATIVELY DECLARE THIS
FACT TO THE DEPARTMENT, USING A FORM DEVELOPED BY THE DEPARTMENT.
4. EACH HOSPITAL SHALL CREATE FACILITY-WIDE PATIENT SAFETY PROGRAMS TO
ROUTINELY REVIEW PATIENT RECORDS FOR MEDICAL HARM, ANALYZE THESE EVENTS
TO DETERMINE IF THEY WERE PREVENTABLE AND IMPLEMENT CHANGES TO PREVENT
SIMILAR HARMFUL EVENTS. EACH HOSPITAL SHALL PROVIDE AN ANNUAL SUMMARY OF
ITS PATIENT SAFETY PROGRAM TO THE DEPARTMENT.
5. EACH HOSPITAL SHALL INFORM THE PATIENT, THE PARTY RESPONSIBLE FOR
THE PATIENT, OR AN ADULT MEMBER OF THE IMMEDIATE FAMILY IN CASES OF
DEATH OR SERIOUS BODILY INJURY, OF THE MEDICAL HARM EVENT BY THE TIME
THE REPORT IS MADE TO THE DEPARTMENT.
6. EACH HOSPITAL SHALL INTERVIEW PATIENTS, FAMILY MEMBERS, AND/OR
PARTIES RESPONSIBLE FOR THE PATIENT ABOUT MEDICAL HARM EVENTS AND DOCU-
MENT A DETAILED SUMMARY OF THAT INTERVIEW IN THE PATIENT'S MEDICAL
RECORD.
S. 1117 3
7. IF THE MEDICAL HARM EVENT CONTRIBUTED TO THE DEATH OF A PATIENT,
THE HOSPITAL SHALL INCLUDE THAT EVENT AS A CONTRIBUTING CAUSE ON THE
PATIENT'S DEATH CERTIFICATE.
8. IF THE HOSPITAL IS A DIVISION OR SUBSIDIARY OF ANOTHER ENTITY THAT
OWNS OR OPERATES MULTIPLE HOSPITALS OR RELATED ORGANIZATIONS, A REPORT
SHALL BE MADE FOR EACH SPECIFIC DIVISION OR SUBSIDIARY AND NOT AGGRE-
GATELY FOR MULTIPLE HOSPITALS.
9. NOTHING IN THIS SECTION SHALL BE INTERPRETED TO CHANGE OR OTHERWISE
AFFECT HOSPITAL REPORTING REQUIREMENTS REGARDING REPORTABLE DISEASES OR
UNUSUAL OCCURRENCES, AS PROVIDED ELSEWHERE IN THIS CHAPTER.
S 2997-G. MEDICAL HARM DISCLOSURE ADVISORY COMMITTEE. 1. THE COMMIS-
SIONER SHALL APPOINT A MEDICAL HARM DISCLOSURE ADVISORY COMMITTEE,
INCLUDING REPRESENTATIVES FROM PUBLIC AND PRIVATE HOSPITALS, DIRECT CARE
NURSING STAFF, PHYSICIANS, EPIDEMIOLOGISTS WITH EXPERTISE IN PATIENT
SAFETY, ACADEMIC RESEARCHERS, CONSUMER ORGANIZATIONS, HEALTH INSURERS,
HEALTH MAINTENANCE ORGANIZATIONS, ORGANIZED LABOR, AND PURCHASERS OF
HEALTH INSURANCE, SUCH AS EMPLOYERS. THE ADVISORY COMMITTEE SHALL HAVE A
MAJORITY OF MEMBERS REPRESENTING INTERESTS OTHER THAN HOSPITALS.
2. THE MEDICAL HARM DISCLOSURE ADVISORY COMMITTEE SHALL ASSIST THE
DEPARTMENT IN THE DEVELOPMENT OF ALL ASPECTS OF THE DEPARTMENT'S METHOD-
OLOGY FOR COLLECTING, ANALYZING, AND DISCLOSING THE INFORMATION
COLLECTED UNDER THIS TITLE, INCLUDING COLLECTION METHODS, FORMATTING,
EVALUATION OF METHODS USED AND THE METHODS AND MEANS FOR RELEASE AND
DISSEMINATION.
3. MEETINGS OF THE ADVISORY COMMITTEE SHALL BE OPEN TO THE PUBLIC
PURSUANT TO ARTICLE SEVEN OF THE PUBLIC OFFICERS LAW.
S 2997-H. METHODOLOGIES FOR COLLECTING, ANALYZING AND VALIDATING DATA.
1. THE DEPARTMENT SHALL, WITH THE ADVICE OF THE MEDICAL HARM DISCLOSURE
ADVISORY COMMITTEE CREATED IN SECTION TWENTY-NINE HUNDRED NINETY-SEVEN-G
OF THIS TITLE, DEVELOP GUIDELINES FOR HOSPITALS IN IDENTIFYING MEDICAL
HARM EVENTS.
2. THE DEPARTMENT SHALL CREATE STANDARDIZED REPORTING FORMATS FOR
HOSPITALS TO USE TO COMPLY WITH ALL PROVISIONS OF THIS TITLE.
3. IN DEVELOPING THE METHODOLOGY FOR COLLECTING THE DATA ON MEDICAL
HARM EVENTS, THE DEPARTMENT AND THE MEDICAL HARM DISCLOSURE ADVISORY
COMMITTEE SHALL USE THE "COMMON FORMATS" FORMS DEVELOPED BY THE AGENCY
FOR HEALTHCARE RESEARCH AND QUALITY OR A SIMILAR STANDARDIZED COLLECTION
METHOD.
4. IN DEVELOPING THE METHODOLOGY FOR ANALYZING THE DATA, THE DEPART-
MENT SHALL INCLUDE A STANDARDIZED METHOD OF CATEGORIZING THE LEVEL OF
HARM EXPERIENCED BY THE PATIENT, SUCH AS THE NATIONAL COORDINATING COUN-
CIL FOR MEDICATION ERRORS REPORTING AND PREVENTION INDEX FOR CATEGORIZ-
ING ERRORS.
5. THE DEPARTMENT SHALL AT LEAST QUARTERLY CHECK THE ACCURACY OF
INFORMATION REPORTED BY HOSPITALS UNDER THIS TITLE BY COMPARING THE
INFORMATION WITH OTHER AVAILABLE DATA SUCH AS PATIENT SAFETY INDICATORS
FROM HOSPITAL PATIENT DISCHARGE DATA, COMPLAINTS FILED WITH THE LICENS-
ING DIVISION, DEATH CERTIFICATES, INSPECTION AND SURVEY REPORTS, AND
MEDICAL MALPRACTICE INFORMATION. THE DEPARTMENT SHALL ANNUALLY CONDUCT
RANDOM REVIEWS OF HOSPITAL MEDICAL RECORDS.
6. THE DATA COLLECTION, ANALYSIS AND VALIDATION METHODOLOGIES SHALL BE
DISCLOSED TO THE PUBLIC.
7. EVERY THREE YEARS, THE DEPARTMENT SHALL HAVE AN INDEPENDENT AUDIT
CONDUCTED BY A STATE UNIVERSITY OF NEW YORK ENTITY NOT AFFILIATED WITH
ANY HOSPITAL REQUIRED TO REPORT UNDER THIS TITLE. SUCH AUDIT SHALL:
S. 1117 4
(A) ASSESS THE ACCURACY OF REPORTING BY HOSPITALS, ESPECIALLY SEEKING
TO IDENTIFY UNDERREPORTING;
(B) BE FUNDED BY THE PATIENT SAFETY TRUST FUND ESTABLISHED IN SECTION
NINETY-FIVE-H OF THE STATE FINANCE LAW; AND
(C) BE AVAILABLE TO THE PUBLIC ON THE DEPARTMENT'S WEBSITE WITHIN ONE
MONTH OF RECEIVING THE FINAL REPORT.
8. THE DEPARTMENT SHALL ADOPT REGULATIONS TO CARRY OUT THE PROVISIONS
OF THIS TITLE.
S 2997-I. PUBLIC REPORTS. 1. EACH QUARTER, THE DEPARTMENT SHALL
PUBLISH DETAILS OF THE FINES ASSESSED TO HOSPITALS FOR FAILURE TO REPORT
MEDICAL HARM EVENTS UNDER SECTION TWENTY-NINE HUNDRED NINETY-SEVEN-M OF
THIS TITLE, AND SHALL ISSUE A NEWS RELEASE ABOUT THAT PUBLICATION.
2. THE DEPARTMENT SHALL ANNUALLY SUBMIT A REPORT TO THE LEGISLATURE
DETAILING MEDICAL HARM EVENTS REPORTED AT EACH HOSPITAL REQUIRED TO
REPORT UNDER THIS TITLE. THE REPORT MAY INCLUDE POLICY RECOMMENDATIONS,
AS APPROPRIATE. SUCH REPORT SHALL:
(A) BE PUBLISHED ON THE DEPARTMENT'S WEBSITE AT THE SAME TIME IT IS
SUBMITTED TO THE LEGISLATURE;
(B) INCLUDE HOSPITAL-SPECIFIC INFORMATION ON THE NUMBER AND TYPE OF
MEDICAL HARM EVENTS REPORTED, THE LEVEL OF HARM TO PATIENTS, FINES
ASSESSED AND ENFORCEMENT ACTIONS TAKEN, AND THE QUARTERLY AFFIRMATION BY
HOSPITALS IN WHICH NO MEDICAL HARM EVENTS HAVE OCCURRED;
(C) PROVIDE INFORMATION IN A MANNER THAT STRATIFIES THE DATA BASED ON
CHARACTERISTICS OF THE HOSPITALS, SUCH AS NUMBER OF PATIENT ADMISSIONS
AND PATIENT DAYS IN EACH HOSPITAL; AND
(D) CONTAIN TEXT WRITTEN IN PLAIN LANGUAGE THAT INCLUDES A DISCUSSION
OF FINDINGS, CONCLUSIONS, AND TRENDS CONCERNING THE OVERALL PATIENT
SAFETY IN THE STATE, INCLUDING A COMPARISON TO PRIOR YEARS, AND THE
METHODS THE DEPARTMENT USED TO CHECK FOR THE ACCURACY OF HOSPITAL
REPORTS.
3. EACH QUARTER, THE DEPARTMENT SHALL MAKE INFORMATION REGARDING
OUTCOMES OF HOSPITAL INSPECTIONS AND INVESTIGATIONS CONDUCTED PURSUANT
TO ITS REGULATORY DUTIES UNDER THIS CHAPTER, READILY ACCESSIBLE TO THE
PUBLIC ON THE DEPARTMENT WEBSITE.
4. NO HOSPITAL REPORT OR DEPARTMENT PUBLIC DISCLOSURE MAY CONTAIN
INFORMATION IDENTIFYING A PATIENT, EMPLOYEE, OR LICENSED HEALTH CARE
PROFESSIONAL IN CONNECTION WITH A SPECIFIC INFECTION INCIDENT.
5. THE FIRST REPORT REQUIRED UNDER SUBDIVISION TWO OF THIS SECTION
SHALL BE SUBMITTED AND PUBLISHED NO LATER THAN DECEMBER THIRTY-FIRST,
TWO THOUSAND FOURTEEN. FOLLOWING THE INITIAL REPORT, THE DEPARTMENT
SHALL PUBLISH THESE REPORTS ANNUALLY.
S 2997-J. PRIVACY. IT IS THE EXPRESSED INTENT OF THE LEGISLATURE THAT
A PATIENT'S RIGHT OF CONFIDENTIALITY SHALL NOT BE VIOLATED IN ANY
MANNER. PATIENT SOCIAL SECURITY NUMBERS OR ANY OTHER INFORMATION THAT
COULD BE USED TO IDENTIFY AN INDIVIDUAL PATIENT SHALL NOT BE RELEASED
NOTWITHSTANDING ANY OTHER PROVISION OF LAW.
S 2997-K. PROTECTION FOR TAKING ACTION. NO HOSPITAL SHALL DISCHARGE,
REFUSE TO HIRE, REFUSE TO SERVE, RETALIATE IN ANY MANNER OR TAKE ANY
ADVERSE ACTION AGAINST ANY EMPLOYEE, APPLICANT FOR EMPLOYMENT OR HEALTH
CARE PROVIDER BECAUSE SUCH EMPLOYEE, APPLICANT FOR EMPLOYMENT OR HEALTH
CARE PROVIDER TAKES OR HAS TAKEN ANY ACTION IN FURTHERANCE OF THE
ENFORCEMENT OF THE PROVISIONS OF THIS TITLE.
S 2997-L. PATIENT SAFETY TRUST FUND. 1. ALL MONEYS RECEIVED PURSUANT
TO SECTION TWENTY-NINE HUNDRED NINETY-SEVEN-M OF THIS TITLE AND SUBDIVI-
SION TWO OF THIS SECTION SHALL BE CREDITED TO THE PATIENT SAFETY TRUST
FUND, ESTABLISHED PURSUANT TO SECTION NINETY-FIVE-H OF THE STATE FINANCE
S. 1117 5
LAW. THE COMMISSIONER SHALL USE THE FUND FOR REGULATORY OVERSIGHT AND
PUBLIC ACCOUNTABILITY FOR SAFE HEALTH CARE, INCLUDING, BUT NOT LIMITED
TO THE AUDIT SPECIFIED UNDER SECTION TWENTY-NINE HUNDRED NINETY-SEVEN-H
OF THIS TITLE.
2. IN ADDITION TO THE MONEYS RECEIVED PURSUANT TO SECTION TWENTY-NINE
HUNDRED NINETY-SEVEN-M OF THIS TITLE, AN ANNUAL PATIENT SAFETY SURCHARGE
ON LICENSING FEES CHARGED TO THOSE MEDICAL FACILITIES REQUIRED TO REPORT
UNDER THIS TITLE IS HEREBY ESTABLISHED.
S 2997-M. DEPARTMENT ACTIONS AND PENALTIES. 1. IN ANY CASE IN WHICH
THE DEPARTMENT RECEIVES A REPORT FROM A HOSPITAL PURSUANT TO SECTION
TWENTY-NINE HUNDRED NINETY-SEVEN-F OF THIS TITLE, THAT INDICATES AN
ONGOING THREAT OR IMMINENT DANGER OF DEATH OR SERIOUS BODILY HARM, THE
DEPARTMENT SHALL MAKE AN ONSITE INSPECTION OR INVESTIGATION WITHIN
FORTY-EIGHT HOURS OR TWO BUSINESS DAYS, WHICHEVER IS GREATER, OF THE
RECEIPT OF THE REPORT AND SHALL COMPLETE THAT INVESTIGATION WITHIN
FORTY-FIVE DAYS.
2. IF A HOSPITAL FAILS TO REPORT A MEDICAL HARM EVENT PURSUANT TO
SECTION TWENTY-NINE HUNDRED NINETY-SEVEN-F OF THIS TITLE, THE DEPARTMENT
MAY ASSESS THE LICENSEE A CIVIL PENALTY IN AN AMOUNT NOT TO EXCEED ONE
HUNDRED DOLLARS FOR EACH DAY THAT THE ADVERSE EVENT IS NOT REPORTED
FOLLOWING THE INITIAL FIVE-DAY PERIOD OR TWENTY-FOUR-HOUR PERIOD, AS
APPLICABLE. IF THE LICENSEE DISPUTES A DETERMINATION BY THE DEPARTMENT
REGARDING ALLEGED FAILURE TO REPORT AN ADVERSE EVENT, THE LICENSEE MAY,
WITHIN TEN DAYS, REQUEST A HEARING PURSUANT TO SECTION TWENTY-EIGHT
HUNDRED SIX OF THIS CHAPTER. PENALTIES SHALL BE PAID WHEN APPEALS PURSU-
ANT TO SUCH SECTION HAVE BEEN EXHAUSTED.
3. THE DEPARTMENT SHALL BE RESPONSIBLE FOR ENSURING COMPLIANCE WITH
THIS TITLE AS A CONDITION OF LICENSURE UNDER ARTICLE TWENTY-EIGHT OF
THIS CHAPTER AND SHALL ENFORCE SUCH COMPLIANCE ACCORDING TO THE
PROVISIONS OF SUCH ARTICLE.
S 2997-N. OVERSIGHT INFORMATION. THE DEPARTMENT'S HOSPITAL LICENSING
DIVISION AND THE DIVISION COLLECTING THE INFORMATION REQUIRED BY THIS
TITLE SHALL SHARE DATA REGARDING MEDICAL HARM EVENTS IN HOSPITALS, WITH
PATIENT CONFIDENTIALITY MAINTAINED BY BOTH DIVISIONS.
S 2997-O. PUBLIC AWARENESS. THE DEPARTMENT SHALL PROMOTE PUBLIC AWARE-
NESS REGARDING WHERE AND HOW CONSUMERS CAN FILE COMPLAINTS ABOUT HOSPI-
TALS, INCLUDING A REQUIREMENT THAT INFORMATION ABOUT FILING COMPLAINTS
BE POSTED IN A VISIBLE MANNER:
1. ON THE DEPARTMENT'S LICENSING WEBSITE;
2. ON EACH HOSPITAL'S WEBSITE;
3. IN PUBLIC AREAS IN HOSPITAL FACILITIES;
4. ON ALL HOSPITAL CORRESPONDENCE AND BILLING DOCUMENTS; AND
5. ON ALL CORRESPONDENCE BY THE DEPARTMENT'S HOSPITAL LICENSING DIVI-
SION AND THE DIVISION COLLECTING DATA ON MEDICAL HARM EVENTS UNDER THIS
TITLE.
S 3. Subdivision 1 of section 2806 of the public health law, as
amended by chapter 490 of the laws of 1983, is amended to read as
follows:
1. A hospital operating certificate may be revoked, suspended, limited
or annulled by the commissioner on proof that: (a) the hospital has
failed to comply with the provisions of this article or rules and regu-
lations promulgated thereunder; [or] (b) a general hospital has refused
or failed to admit or to provide for necessary emergency care and treat-
ment for an unidentified person brought to it in an unconscious, seri-
ously ill or wounded condition; OR (C) A HOSPITAL HAS VIOLATED ANY
PROVISION OF TITLE ONE-A OF ARTICLE TWENTY-NINE-D OF THIS CHAPTER. A
S. 1117 6
hospital operating certificate shall be revoked, limited or annulled by
the commissioner upon revocation, limitation or annulment by the public
health council of approval of establishment of such hospital.
S 4. The state finance law is amended by adding a new section 95-h to
read as follows:
S 95-H. PATIENT SAFETY TRUST FUND. 1. THERE IS HEREBY ESTABLISHED IN
THE JOINT CUSTODY OF THE COMMISSIONER OF TAXATION AND FINANCE AND THE
COMPTROLLER, A SPECIAL FUND TO BE KNOWN AS THE "PATIENT SAFETY TRUST
FUND".
2. SUCH FUND SHALL CONSIST OF ALL MONEYS APPROPRIATED FOR THE PURPOSE
OF SUCH FUND, ANY CIVIL PENALTIES PAID PURSUANT TO SECTION TWENTY-NINE
HUNDRED NINETY-SEVEN-M OF THE PUBLIC HEALTH LAW AND THE ANNUAL PATIENT
SAFETY SURCHARGE ESTABLISHED BY SECTION TWENTY-NINE HUNDRED NINETY-SEV-
EN-L OF THE PUBLIC HEALTH LAW.
3. MONEYS OF THE FUND SHALL BE AVAILABLE FOR REGULATORY OVERSIGHT AND
PUBLIC ACCOUNTABILITY FOR SAFE HEALTH CARE, INCLUDING, BUT NOT LIMITED
TO THE PURPOSES SET FORTH IN TITLE ONE-A OF ARTICLE TWENTY-NINE-D OF THE
PUBLIC HEALTH LAW.
4. MONEYS IN THE FUND SHALL BE KEPT SEPARATE AND SHALL NOT BE COMMIN-
GLED WITH ANY OTHER MONEYS IN THE CUSTODY OF THE COMMISSIONER OF TAXA-
TION AND FINANCE AND THE COMPTROLLER.
5. THE MONEYS OF THE FUND SHALL BE PAID OUT ON THE AUDIT AND WARRANT
OF THE COMPTROLLER ON VOUCHERS CERTIFIED OR APPROVED BY THE COMMISSIONER
OF HEALTH, OR BY AN OFFICER OR EMPLOYEE OF THE DEPARTMENT OF HEALTH
DESIGNATED BY SUCH COMMISSIONER.
S 5. This act shall take effect on the one hundred twentieth day after
it shall have become a law. Effective immediately, the addition, amend-
ment and/or repeal of any rule or regulation necessary for the implemen-
tation of this act on its effective date is authorized to be made on or
before such date.