National Registry of Diseases (Single Kidney — Post Nephrectomy (Donor) Notification) Regulations 2009

No. S 531

National Registry of Diseases Act

(Chapter 201B)

National Registry of Diseases (Single Kidney — Post Nephrectomy (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 (Single Kidney — Post Nephrectomy (Donor) Notification) Regulations 2009 and shall come into operation on 1st November 2009.

Definitions

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

“nephrectomy” means the surgical removal of a kidney;

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

“recipient” means the person into whose body a patient’s kidney is or will be transplanted;

“single kidney — post nephrectomy (donor)” refers to the absence of a kidney in a person due to having undergone nephrectomy for the purpose of transplantation of his kidney into the body of another living person.

Form, time and manner of notification for single kidney — post nephrectomy (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 nephrectomy for the purpose of transplantation into the body of another living person or is undergoing any treatment for single kidney — post nephrectomy (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 nephrectomy, not later than 3 months after the nephrectomy; or

(ii) where the patient is undergoing treatment for single kidney — post nephrectomy (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 nephrectomy (for new cases).

SECOND SCHEDULE

Regulation 3(b)

Forms of Notification

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

2.  Yearly Follow-up Form for Kidney 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) citizenship or resident status;

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

(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) blood pressure;

(c) weight;

(d) height;

(e) smoking status;

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

(g) diabetes mellitus;

(h) oral glucose tolerance test;

(i) hyperlipidemia;

(j) serum creatinine;

(k) creatinine clearance or radionuclide GFR;

(l) urine FEME;

(m) 24-hour urine protein;

(n) whether patient is on anti-hypertensives;

(o) whether patient is on hypolipidemics;

(p) other abnormalities of kidney (including stone, cyst and others).

4.  Data related to donor nephrectomy:

(a) place of surgery;

(b) name of lead surgeon;

(c) type of nephrectomy;

(d) date of initial discharge;

(e) live donor discharge disposition;

(f) complications during hospitalisation (including type(s); if the donor has renal failure or impairment, serum creatinine and whether creatinine is measured with IDMS Standard).

5.  Details of notifying healthcare institution:

    person who made the notification.

FOURTH SCHEDULE

Regulation 4

Additional Information for Cases Undergoing Treatment

1.  Particulars of patient (at follow-up):

(a) date of consultation;

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

(c) complications within 6 weeks of discharge (including type(s); if the patient has renal failure or impairment, serum creatinine and whether creatinine is measured with IDMS Standard; and if the patient has other re-hospitalisation, reason and duration);

(d) blood pressure;

(e) weight;

(f) smoking status;

(g) employment status;

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

2.  Risk factors (at follow-up):

(a) diabetes mellitus (including HbA1C and type of treatment if patient has diabetes mellitus; and whether the patient has impaired fasting glycemia or impaired glucose tolerance if not diabetic);

(b) hyperlipidemia.

3.  Investigations (at follow-up):

(a) fasting blood sugar;

(b) serum creatinine;

(c) creatinine clearance or radionuclide GFR;

(d) Urine FEME;

(e) 24-hour urine protein or urine protein or creatinine ratio.

4.  Medications (at follow-up):

(a) whether patient is on anti-hypertensives;

(b) whether patient is on hypolipidemics.

5.  Complications (at follow-up):

(a) other illnesses since last visit (including diagnosis);

(b) admissions to hospital since last visit (including reason and date of admission);

(c) whether or not the patient has Chronic Kidney Disease Stage 5 (including date, cause of Chronic Kidney Disease Stage 5, on transplant waiting list and reason for not on transplant waiting list).

6.  Vital status:

(a) whether patient is living or deceased;

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

7.  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/2007/5 Vol. 1]