Monday, March 18, 2019

Licences required for a lab collection center

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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