National Registry of Diseases (Liver — Post Hepatic Resection (Donor) Notification) Regulations 2009

No. S 530

National Registry of Diseases Act

(Chapter 201B)

National Registry of Diseases (Liver — Post Hepatic Resection (Donor) Notification) Regulations 2009

In exercise of the powers conferred by sections 6, 7 and 23 of the National Registry of Diseases Act, the Minister for Health hereby makes the following Regulations:

Citation and commencement

1.  These Regulations may be cited as the National Registry of Diseases (Liver — Post Hepatic Resection (Donor) Notification) Regulations 2009 and shall come into operation on 1st November 2009.

Definitions

2.  In these Regulations, unless the context otherwise requires —

“hepatic resection” means the surgical removal of a part of the liver;

“liver — post hepatic resection (donor)” refers to the absence of a part of the liver in a person due to having undergone hepatic resection for the purpose of transplantation of a part of his liver into the body of another living person;

“patient” means a person to whom a notification referred to in regulation 3 relates;

“recipient” means the person into whose body a part of the patient’s liver is or will be transplanted.

Form, time and manner of notification for liver — post hepatic resection (donor)

3.  For the purposes of section 6(1) of the Act, a notification by the manager of a healthcare institution to the Registrar that a person has undergone hepatic resection for the purpose of transplantation into the body of another living person or is undergoing any treatment for liver — post hepatic resection (donor), at the healthcare institution shall —

(a) contain, in relation to that patient, the information specified in the First Schedule;

(b) be made in any of the Forms set out in the Second Schedule or at the Registry’s Internet website at http://www.nrdo.gov.sg;

(c) be sent to the Registrar —

(i) by hand (including by courier);

(ii) by registered mail; or

(iii) by using such secure electronic notification system as may be approved by the Registrar; and

(d) be made within the following time:

(i) where the patient has undergone hepatic resection, not later than 3 months after hepatic resection; or

(ii) where the patient is undergoing treatment for liver — post hepatic resection (donor) in the healthcare institution, not later than 3 months after the first of such treatments received by the patient at that healthcare institution on or after 1st November 2009.

Collection of additional information under section 7 of Act

4.  Upon receiving a notification referred to in regulation 3, the Registrar or an authorised Registry officer may, for the purposes of section 7(1) of the Act, require the manager of the healthcare institution who made the notification to provide all or any of the additional information specified in the Third and Fourth Schedules concerning the patient.

FIRST SCHEDULE

Regulation 3(a)

Information of Patient to be Submitted With Notification

1.  Identification number (including NRIC number, passport number, Foreign Identification Number or hospital registration number).

2.  Name.

3.  Date of birth or age (if date of birth is unknown).

4.  Name of notifying healthcare institution (including department).

5.  Date of hepatic resection (for new cases).

SECOND SCHEDULE

Regulation 3(b)

Forms of Notification

1.  New Case Registration Form for Liver Donor set out at the Registry’s Internet website at http://www.nrdo.gov.sg.

2.  Follow-up Form for Liver Donor set out at the Registry’s Internet website at http://www.nrdo.gov.sg.

3.  Hospital inpatient discharge summaries.

4.  Donor case listings.

THIRD SCHEDULE

Regulation 4

Additional Information for New Cases

1.  Particulars of patient for new case registration:

(a) citizenship or resident status;

(b) gender;

(c) ethnic group;

(d) marital status;

(e) country of birth;

(f) educational level;

(g) employment status;

(h) relationship to recipient.

2.  Particulars of recipient:

(a) name;

(b) identification number (including NRIC number, passport number, Foreign Identification Number or hospital registration number);

(c) date of birth or age (if date of birth is unknown);

(d) citizenship or resident status;

(e) gender;

(f) ethnic group;

(g) marital status;

(h) name of recipient’s healthcare institution.

3.  Patient baseline information (pre-donation):

(a) date of baseline information;

(b) weight;

(c) height;

(d) smoking status;

(e) EQ-5D (including mobility, self-care, usual activities, pain or discomfort and anxiety or depression);

(f) liver panel (including date);

(g) full blood count (including date);

(h) prothrombin time (PT) (including date);

(i) ultrasound, CT scan or MRI (including findings and date).

4.  Data related to donor hepatic resection:

(a) place of surgery;

(b) type of hepatic resection;

(c) complications during hospitalisation (including type(s), and date if the donor has liver failure or impairment);

(d) date of initial discharge;

(e) live donor discharge disposition.

5.  Details of notifying healthcare institution:

    person who made the notification.

FOURTH SCHEDULE

Regulation 4

Additional Information for Cases Undergoing Treatment

1.  Patient’s status (at follow-up):

(a) date of consultation;

(b) healthcare institution (including specific centre, department or clinic) responsible for subsequent treatment or follow-up;

(c) weight;

(d) height;

(e) smoking status;

(f) employment status;

(g) EQ-5D (including mobility, self-care, usual activities, pain or discomfort and anxiety or depression);

(h) other illnesses since last visit (including diagnosis and date of diagnosis);

(i) admission to hospital since last visit (including diagnosis and date of admission).

2.  Investigations (at follow-up):

(a) liver panel (including date);

(b) full blood count (including date);

(c) prothrombin time (PT) (including date);

(d) ultrasound, CT Scan or MRI (including date and findings);

(e) ERCP or MRCP (including date and findings).

3.  Adverse condition relating to liver:

whether or not the patient has liver failure (including date, cause of liver failure, on transplant waiting list and reason for not on transplant waiting list).

4.  Vital status:

(a) whether patient is living or deceased;

(b) where the patient is deceased, the date, place and cause of death.

5.  Details of notifying healthcare institution:

    person who made the notification.

Made this 29th day of October 2009.

TAN CHING YEE

Permanent Secretary,
Ministry of Health,
Singapore.

[MH(CF)78:81/6-2; AG/LEG/SL/201B/2007/4 Vol. 1]