healthysoch
New Delhi, March 18, 2019 :
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.
- State medical council registration certificate of the treating doctors and to be displayed
- State nursing council registration certificate of the nurse
- Registration certificate of the lab technician
- Registration under State Shop & Commercial Establishment, if applicable
- Registration under Clinical Establishment Act if applicable
- PNDT Registration (if radiology services provided)
- AERB Approvals (if any radiotherapy services)
- Trade License if executing business
- Registration under CMO/ Director Health Services of Inpatient services
- Registration under NH act if attached to a nursing home
- VAT Registration
- ESI compliance (if >10 employees)
- PF registration for employees
- NOC for DG Set
- NOC for Fire Safety
- Compliance under Water (Prevention & Control of Pollution) Act 1974
- Compliance under Air (Prevention & Control of Pollution) Act 1981
- NOC from Electricity Department
- Approval from local municipal authority for sign Boards, bill board
- Collection Center agreement with path lab or a nursing home
- Hg free environment (no mercury instruments)
- Instruments calibration certificates (thermometer, refrigerator, centrifuge)
- Daily QC logs for refrigerator, centrifuge, room temperature and humidity, House-keeping, premises etc
- Display of charges
- Display of services
- Display of the name of the path lab
- AC facilities and negative pressure ventilation systems (for infectious disease sample)
- Personnel and professional records of staff
- Police verification of staff (where applicable)
- Income tax compliance
- Proprietary, partnership or company compliance
- Vaccination data of staff
- Bio Medical Waste Management Certificate
- Any other License/ Registration required as per local Law
- NABL registration (preferred)
- MCI ethics regulation copy
- Lift license if applicable
- Compliance of workman compensation act
- Explosive license for oxygen
- Registration under MTP act if applicable
- Narcotic Drugs and Psychotropic Substances (NDPS) license ( if applicable)
- Organ Transplant (specify separately type of organ transplant permitted) if applicable
- Blood Bank license if applicable
- Compliance of IT Act
- Clearance from RWA
- Noise regulations
- Applicable lift rules
- Notification of TB
- Notification of other diseases to municipal corporation
- Mosquito breeding index
Dr KK Aggarwal
Padma Shri Awardee
healthy soch