21 Nov 2022
MH 78:44/1
ADDENDUM TO LICENCE CONDITIONS FOR CLINICAL LABORATORY SERVICE LICENSEES PROVIDING OR INTENDING TO PROVIDE TRANSFUSION
We refer to MOH Circular 90/2022 titled “Written Directions to Licensees of a Clinical Laboratory Service to Licence Conditions Imposed Under the Healthcare Services Act 2020” (“MOH Circular 90/2022”) and Appendix B thereto, wherein the Director of Medical Services (“Director”) gave effect to modifications to your licence granted under the HCSA (“Licence”) by imposing Licence Conditions for Clinical Laboratory Service Licensees Providing or Intending to Provide Transfusion Medicine (“Licence Conditions”).
2. The Director has considered feedback submitted in relation to Paragraph 4.16 (a)1 of the Licence Conditions. We wish to inform licensees of a clinical laboratory service (“CLS”) that for the purposes of Paragraph 4.16, you may regard the validity of the crossmatch sample as up to 3 days or 72 hours for a patient who (i) has been transfused with any blood in the last 3 months, or (ii) has been pregnant in the last 3 months.
3. You may wish to refer to the FAQs published at https://www.moh.gov.sg/hcsa/resources for further details.
4. For avoidance of doubt, all other conditions of your Licence shall remain unchanged and in full force and effect, and the Licence Conditions shall be read and construed with the requirements stipulated in the HCSA and its Regulations (including but not limited to the Healthcare Services (General) Regulations 2021, the Healthcare Services (Clinical Laboratory Service and Radiological Service) Regulations 2021, and the Healthcare Services (Advertisement) Regulations 2021).
5. A breach of the Licence Conditions may result in regulatory action being taken against licensees under section 20 of the HCSA, including but not limited to — (a) suspension or revocation of the licensee’s CLS Licence; (b) shortening the term of the licensee’s CLS Licence; (c) a direction requiring the licensee to rectify the contravention, or prevent a recurrence of the contravention; and/or (d) a direction requiring the licensee to pay a financial penalty.
6. Should you require any further information or clarification, please email us at HCSA_Enquiries@moh.gov.sg .
ASSOCIATE PROFESSOR KENNETH MAK
DIRECTOR OF MEDICAL SERVICES
MINISTRY OF HEALTH
The full document may be downloaded below:
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