revised reporting process for adverse events … · mortality transplant donor or recipient passes...
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10 Apr 2019 MOH Circular No. 22/2019
MH 78:18 CEOs and CMBs of Public Hospitals CEOs and General Managers of Private Sector Hospitals REVISED REPORTING PROCESS FOR ADVERSE EVENTS PERTAINING TO ORGAN TRANSPLANT SERVICES
The revised reporting process for adverse events pertaining to organ transplant
services, as detailed in the Annex, replaces the previous MOH Circular 70/2016 titled “Updated Reporting Processes for Adverse Events Pertaining to Organ Transplant Services” that was issued on 30 November 2016. 2. To strengthen the effectiveness of the monitoring of post-transplant infectious diseases and achieve higher standards of patient care to improve patient safety pertaining to transplant services, healthcare institutions would be required to report all positive and negative post-transplant screening test results of blood-borne infections at the stipulated timeframe to the National Organ Transplant Unit (NOTU). Details of the revised reporting process are specified in the Annex. 3. MOH will implement an online Infectious Disease Monitoring (IDM) module in the National Transplant Registry System (NTRS) to facilitate the reporting of all blood-borne infections screening results in transplant recipients. The online module will replace the manual submission of “Form D: Notification of Blood-Borne Infection in Transplant Recipient”, with effect from 1 July 2019. There will be no changes to the reporting processes for mortality and serious reportable event (SRE). 4. Training sessions will be organised by NOTU for the respective healthcare institutions end users on the usage of the new online module in NTRS. 5. Please bring this circular to the attention of the relevant departments and healthcare staff for their information and compliance. For further clarifications, please email [email protected] or [email protected].
ASSOCIATE PROFESSOR BENJAMIN ONG DIRECTOR OF MEDICAL SERVICES MINISTRY OF HEALTH cc National Organ Transplant Unit
ANNEX
REPORTING OF MORTALITY AND BLOOD-BORNE INFECTION INCIDENCES IN
TRANSPLANT PATIENTS
The following reporting requirements apply to all kidney, liver, heart and cornea transplants performed locally in Singapore.
Event Criteria Reporting Requirement
Mortality Transplant donor or recipient passes away in the hospital within one year from the date of transplant
A. (1) Death of transplant donor or recipient occurs in the same transplant hospital where the transplant surgery was performed Transplant hospital is to submit: i) Form C or a copy of the Cause of Death Certificate (CCOD) (if available) via fax to NOTU within 2 working days from date of death (Appendix A1); and
ii) Medical report and other supporting documents signed off by the transplant surgeons/physicians via email to NOTU ([email protected]) within 7 working days from date of death
(2) Death of transplant donor or recipient occurs in a hospital different from where the transplant surgery was performed Hospital ward is to submit a copy of the CCOD (Appendix A2) of deceased patients with transplant indicated as a condition directly leading to or contributing to the death via fax to the specific transplant hospital (where the transplant surgery was performed) and NOTU within 2 working days from date of death. Contact details of transplant hospitals and NOTU are listed in Appendix A3 Transplant centre is to submit medical report and other supporting documents signed off by the transplant surgeons/physicians via email to NOTU ([email protected]) within 7 working days from date of death
B. Transplant centres to submit review findings, recommendations and implementation status of recommendations made by the Mortality and Morbidity Quality Assurance Committee(s) for all mortality cases of organ transplant donors or recipients that occurred within one year from the date of transplant to MOH’s Clinical Quality, Performance and Technology division ([email protected]) and NOTU ([email protected]) following the timeline stipulated according to the Private Hospitals and Medical Clinics Act1
1 Under the M&M System Review Directive 04/2013 Section 18, the licensee shall ensure that the following is documented, and shall furnish the Director, as and when required by him, with: a) The activities of the M&M QAC(s), including M&M QAC systems review findings and recommendations; b) The total number of deaths reviewed by the M&M QAC(s) with their respective category as defined in Annex A; c) Details of the implementation status of specific recommendations made by the M&M QAC(s); and
Event Criteria Reporting Requirement
Serious Reportable Event (SRE)
As per the various specifications stated in the Directive for Review of Serious Reportable Events for Prescribed Healthcare Institutions
Hospitals notify MOH’s Clinical Quality, Performance & Technology Division via the National Quality Assurance System (NQAS) within 2 working days of identification of the event (https://elis.moh.gov.sg/NQAS/login/login.action) and forward a printout of the submission via email to NOTU ([email protected])
Blood-borne Infection
Organ transplant recipient (for transplant performed in Singapore only) with both positive and negative test results for Hepatitis B, Hepatitis C, HIV, Treponemal & Non-Treponemal tests within one year from date of transplant Note: If the recipient had tested positive for, or was a known carrier of, the specific blood-borne infection prior to transplant, there is no need to report the case
A. Transplant centres are required to submit all screening results, both positive and negative results, for the specified screening tests as listed in Appendix A4 within 72 hours from time of diagnosis through Infectious Disease Monitoring (IDM) module via National Transplant Registry System (NTRS)
B. Should the screening results be positive for certain
blood-borne infections, transplant centres are required to send an SMS notification to NOTU Selection TC (call 6222 3322 to look for NOTU Selection TC on call) upon update of screening tests in IDM module
System Downtime C. In the event of system downtime, transplant centres are
to submit manual Form D (Appendix A5) for reporting of recipients tested with positive results within 72 hours from time of diagnosis to CDD via email ([email protected]) and NOTU via email ([email protected]) or fax (62240956) accompanied with a call or SMS to NOTU Selection TC (call 6222 3322 to look for NOTU Selection TC on call)
D. Upon restoration of online system, transplant centres are
required to submit the test results (both positive and negative) within 2 weeks
Comparison between Current & New Reporting Processes
Process Current New
Submission of results
Only positive results
All positive and negative results
Reporting of results
Form D via email and fax
Online via IDM module in NTRS
Use of Form D For all positive cases
With minor changes in design, for reporting of positive cases during system downtime
d) Such records relating to any other quality assurance activity undertaken by the M&M QAC(s)
APPENDIX A1
FORM C: NOTIFICATION OF DEATH OF ORGAN DONOR* / RECIPIENT* *please delete accordingly
[Applicable for donor / recipient of organ transplants within 1 year of date of transplant] [To be faxed to NOTU (62240956) &/or email to [email protected] within two days of diagnosis
AND accompanied by an SMS notification to NOTU selection TC]
1 To be completed if patient passed away outside of transplant centre. Please indicate reasons for difference between date of death and date
transplant centre informed in “Remarks” field, if applicable. 2 Medical report by attending physician to include indication for transplant and whether there were any medical or surgical
complications during transplant admission and subsequent admissions, if applicable.
TO BE COMPLETED BY TRANSPLANT CENTRE
Donor Name: Donor NRIC / Passport:
Recipient Name: Recipient NRIC / Passport:
Transplant Type: □ Living donor transplant □ Deceased donor transplant
Transplant Centre: Date of Transplant:
Organ Transplanted: □ Heart □ Liver □ Kidney □ Cornea □ Others, please state:
Original Cause of End-stage Organ Failure Indicating Transplant:
Cause of death as in CCOD: □ Pending Coroner’s report, to be sent to NOTU within 72 hours of release.
Time of death: Date of death
Place of death:
SRE Reporting Is the death of the donor / recipient
associated with a SRE? □ Yes: Incident Reference No.:
□ No
□ To be determined: NOTU will be notified of the final outcome by (Date)
Date Transplant Centre Informed1:
Attachment of medical report2: □ Medical report attached □ Medical report to be sent to NOTU within 7 days from date of death.
Remarks:
Submitted by: (Indicate Name, Contact Number, Designation & Signature)
Date submitted to NOTU:
APPENDIX A2
CAUSE OF DEATH CERTIFICATE
APPENDIX A3
CONTACT DETAILS FOR REPORTING OF MORTALITY INCIDENCES IN TRANSPLANT PATIENTS
Institution
EMAIL (To include all addressees)
FAX (Please call before faxing)
Contact Number
Fax Number
SNEC Corneal Transplant [email protected] 96733063 62213143
NHCS Heart & Lung Transplant
[email protected] [email protected]
67048133
68449036
SGH Liver Transplant
[email protected] 81232934 67021210
SGH Renal Transplant
[email protected] 63214661 62200730
NUH Liver and Renal Transplant
[email protected] [email protected]
98226909 90188716
67787913
Parkway Liver and Renal Transplant Programme
64703386
64705685
Raffles Liver and Renal Transplant Programme
63111111
63112390
NOTU [email protected] 63214390 62240956
APPENDIX A4
PRE- AND POST-TRANSPLANT SCREENING PROTOCOL FOR SOLID ORGAN & CORNEAL RECIPIENTS
RECIPIENT Pre-Transplant
Screening Post-Transplant Screening
Type of Organ
Screening Test At 0-4 weeks pre At 1 and 3 months post At 12 months post
Kidney, Liver, Heart
HBs Ag Yes Yes Yes
HBc Ab (total) Yes
HBs Ab Yes If HBsAb titre < 10, recipients to be vaccinated
Yes Yes
HBV NAT Yes Yes To be done if HBsAg is positive
HCV Ab Yes No screening Yes
HCV NAT Yes Yes To be done if HCV Ab is positive
HIV Ab/Ag combo test Yes No screening Yes
HIV NAT Yes Yes To be done if HIV Ab/Ag combo test is positive
Non-Treponemal (e.g. RPR)
Yes Only if donor is positive Only if donor is positive
Treponemal (e.g. TPPA, Syphilis IgG)
Yes If non-treponemal test is positive
Only if donor is positive Only if donor is positive
Corneas NOT Screened by NAT *No pre and post-transplant screening for NAT screened corneas
HBsAg Yes Yes Yes
HBc Ab (total) Yes
HBs Ab Yes Yes
HBV NAT Yes Yes To be done if HBsAg is positive
HCV Ab Yes
Yes If recipient receives systemic immunosuppression
HCV NAT Yes Yes To be done if HCV Ab is positive
HIV Ab/Ag Yes Yes
Yes If recipient receives systemic immunosuppression
HIV NAT Yes To be done if HIV Ab/Ag is positive
To be done if HIV Ab/Ag is positive
Non-treponemal (e.g. RPR)
Yes
N.A Corneas tested positive for syphilis will be discarded
N.A
Treponemal (e.g. TPPA, Syphilis IgG)
Yes If non-treponemal test is positive
N.A N.A
APPENDIX A5
FORM D: NOTIFICATION OF BLOOD-BORNE INFECTION IN TRANSPLANT RECIPIENT [This form to be used only during system downtime]
During system downtime4, all positive results of blood-borne infection in organ transplant recipient must be reported within 72 hours from time of diagnosis to CDD via email ([email protected]) AND NOTU via email ([email protected]) or fax (62240956) accompanied with a call or SMS to NOTU Selection TC (call 6222 3322 to look for NOTU Selection TC on call)
4 Upon restoration of online system, transplant centres are to submit the tests results (both positive and negative) within 2
weeks.
TO BE COMPLETED BY TRANSPLANT CENTRE
Donor Name: Donor NRIC / Passport:
Recipient Name: Recipient NRIC / Passport:
Transplant Type □ Living donor transplant □ Deceased donor transplant
Transplant Centre: Date of Transplant:
Organ / Tissue Transplanted:
□ Heart □ Liver □ Kidney □ Cornea □ Others: Please state: ___________________________
Infection Screened Positive: HIV/ HBV/ HCV/ Others: Please specify: ___________________
Screening Test
Date Screened and Screening
Results Pre-transplant
Post-transplant
(1 month)
Post-transplant
(3 months)
Post-transplant
(12 months)
Date Screened
Type of Test
Result POSITIVE / NEGATIVE POSITIVE / NEGATIVE POSITIVE / NEGATIVE POSITIVE / NEGATIVE
Date Screened
Type of Test
Result POSITIVE / NEGATIVE POSITIVE / NEGATIVE POSITIVE / NEGATIVE POSITIVE / NEGATIVE
Date Screened
Type of Test
Result POSITIVE / NEGATIVE POSITIVE / NEGATIVE POSITIVE / NEGATIVE POSITIVE / NEGATIVE
Clinician’s Findings/Assessment 1. Clinical Findings: 2. Was the recipient likely to have been infected through the transplant procedure?
3. Was there any evidence that points to other sources of infection e.g. breach in infection prevention and control procedures?
(Please indicate other clinical findings relevant to positive screen. Attach additional sheets/memo if required)
Submitted by:
(Indicate Name, Contact Number, Designation & Signature)
Date Submitted to CDD/NOTU: