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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