Singapore legislation

Regulation 42

of Healthcare Services (Clinical Laboratory Service and Radiological Service) Regulations 2021

Regulation 42

Clinical laboratory service licensee — records to be kept for each specimen

A clinical laboratory service licensee must keep records of all of the following information in relation to each specimen that the licensee receives:

(a)

all of the following identifying information:

(i)

the patient’s name;

(ii)

the patient’s identification number or passport number;

(iii)

where the information in sub‑paragraphs (i) and (ii) is not known to the clinical laboratory service licensee — other information to enable the specimen to the traced to the patient;

(b)

the gender of the patient;

(c)

where the information is known to the clinical laboratory service licensee — the date and time the specimen was derived from the patient;

(d)

the date and time of the receipt of the specimen by the licensee;

(e)

the type of specimen;

(f)

for a tissue specimen, the anatomical site of the specimen;

(g)

where the specimen is derived from a patient for the purposes of blood grouping, crossmatching, tissue typing or genetic testing — the name of the person who took the specimen from the patient;

(h)

the relevant clinical status of the patient (where required), including whether the patient has fasted before the taking of the specimen;

(i)

the characteristics of the specimen that may provide information that is relevant to the interpretation of the test results;

(j)

the name of the requestor.