Licences required for a lab collection center

Health Care Comments Off

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

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

Lack of sleep major cause for several lifestyle disorders including Type 2 diabetes and infertility

Health Care, Heart Care Foundation of India, Medicine Comments Off

At least 6 to 7 hours of sleep are needed for optimal body functioning

New Delhi, 18 March 2019: More than 80% of those suffering from shift work sleep disorder are from the IT and BPO sector, according to recent estimates. This is because they work in the same shifts, disrupting their sleep pattern. Shift Work Sleep Disorder occurs when the body’s internal biological clock gets altered or confused. While there are many professionals who work at night, it is the employees of the IT sector who are the most affected, mainly due to the regular night shift patterns.

For those with this sleep disorder, the symptoms are like chronic jet lag. Irritability, anxiety and depression are among the symptoms. The hormonal cycle is messed up. We are noticing menstrual irregularities among women and infertility among men.

Speaking about this, Padma Shri Awardee, Dr KK Aggarwal, President, HCFI, said, “Majority of the Indian population remains unaware of the fact that common ailments such as obesity, depression, hypertension, diabetes, heart disease are all linked to an irregular sleep pattern. Sleep deprivation also is a key influencer of stressed relationships, decreased performance at school and work, accidental injuries, memory and cognitive impairment and a poor quality of life. It is thus essential that awareness be raised about good sleep habits and the importance of getting adequate sleep. The present generation is mostly found sleeping only for 3 to 5 hours in a day and then compensating their sleep requirements by sleeping for 14 hours on the weekends. This is extremely dangerous for their overall health. They also depend on caffeine and energy drinks to stay awake, which impact their overall cognitive ability.”

A recent study also indicates that people working irregular or rotating shifts with usual night shifts were 44% more likely to have Type 2 diabetes. In addition, compared to day workers, all shift workers were more likely to have Type 2 diabetes, except for permanent night shift workers.

Adding further, Dr Aggarwal, who is also the Group Editor-in-Chief of IJCP, said, “The time has come for each one of us to be cautious about the impact our day to day actions have on our health and take necessary preventive measures. Sleeping well and on time is a harm reduction methodology as it can help avoid many diseases and health complications over time.”

Some tips from HCFI

  • Try to go to bed and get up at the same time every day — at the very least, on weekdays. If need be, use weekends to make up for lost sleep.
  • Create a sleep sanctuary. Reserve your bedroom for sleep and intimacy.
  • Banish the television, computer, smartphone or tablet, and other diversions you’re your bedroom
  • Taking a nap at the peak of sleepiness in the afternoon can help to supplement hours missed at night. But naps can also interfere with your ability to sleep at night and throw your sleep schedule into disarray.
  • If you need to nap, limit it to 20 to 30 minutes.
  • Avoid caffeine after noon and go light on alcohol. Caffeine can stay in your body for up to 12 hours. Alcohol can act as a sedative, but it also disturbs sleep.
  • Get regular exercise, but not within three hours of bedtime. Exercise acts as a short-term stimulant.