Licences required for a lab collection center |
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Licences required for a lab collection center
Dr KK Aggarwal,  18 March 2019
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Evidence-based medicine has become the norm today. Laboratory tests are now integral to clinical practice as they are greatly relied upon in the diagnosis of a condition, its treatment and follow up. There is a huge footfall of patients in hospitals every day and almost all of them are prescribed laboratory investigations at some point of time or the other in the course of their treatment. 

Catering to such a large number of patients is a formidable task for a lab, where there is no scope of mistakes. A mix up of specimens in the lab can lead to a serious error.

Many laboratories, especially in the private sector, have established specimen collection centers, where the patient can walk-in and give his/her sample. These collection centers act as a link between the central laboratory and the consumer. They store the samples collected and transport them to the main lab for testing. Reports can be then collected from the collecting center itself, without the patient having the need to travel to the main lab.

However, similar to the central lab, it is mandatory for collection centers to comply with various quality standards, laws, rules and regulations. They are required to obtain several licenses before they can operate.

Here is a list of licenses that are required for a lab collection center.

  1. State medical council registration certificate of the treating doctors and to be displayed
  2. State nursing council registration certificate of the nurse
  3. Registration certificate of the lab technician
  4. Registration under State Shop & Commercial Establishment, if applicable
  5. Registration under Clinical Establishment Act if applicable
  6. PNDT Registration (if radiology services provided)
  7. AERB Approvals (if any radiotherapy services)
  8. Trade License if executing business
  9. Registration under CMO/ Director Health Services of Inpatient services
  10. Registration under NH act if attached to a nursing home
  11. VAT Registration
  12. ESI compliance (if >10 employees)
  13. PF registration for employees
  14. NOC for DG Set
  15. NOC for Fire Safety
  16. Compliance under Water (Prevention & Control of Pollution) Act 1974
  17. Compliance under Air (Prevention & Control of Pollution) Act 1981
  18. NOC from Electricity Department
  19. Approval from local municipal authority for sign Boards, bill board
  20. Collection Center agreement with path lab or a nursing home
  21. Hg free environment (no mercury instruments)
  22. Instruments calibration certificates (thermometer, refrigerator, centrifuge)
  23. Daily QC logs for refrigerator, centrifuge, room temperature and humidity, House-keeping, premises etc
  24. Display of charges
  25. Display of services
  26. Display of the name of the path lab
  27. AC facilities and negative pressure ventilation systems (for infectious disease sample)
  28. Personnel and professional records of staff
  29. Police verification of staff (where applicable)
  30. Income tax compliance
  31. Proprietary, partnership or company compliance
  32. Vaccination data of staff
  33. Bio Medical Waste Management Certificate
  34. Any other License/ Registration required as per local Law
  35. NABL registration (preferred)
  36. MCI ethics regulation copy
  37. Lift license if applicable
  38. Compliance of workman compensation act
  39. Explosive license for oxygen
  40. Registration under MTP act if applicable
  41. Narcotic Drugs and Psychotropic Substances (NDPS) license ( if applicable)
  42. Organ Transplant (specify separately type of organ transplant permitted) if applicable
  43. Blood Bank license if applicable
  44. Compliance of IT Act
  45. Clearance from RWA
  46. Noise regulations
  47. Applicable lift rules
  48. Notification of TB
  49. Notification of other diseases to municipal corporation
  50. Mosquito breeding index

 

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA

 

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