Apply for Collection Station Approval
Contact for Apply for Collection Station Approval
Clinical Laboratory Program
The Details of Apply for Collection Station Approval
What you need for Apply for Collection Station Approval
A Collection Station is a facility where materials or specimens are either:
- Withdrawn or collected from patients, or
- Assembled after being withdrawn or collected elsewhere from patients for subsequent delivery to a clinical laboratory for examination
A collection station, often referred to as a Patient Service Center, is maintained at a separate physical location, not on the grounds or premises of the main licensed laboratory or institution which performs the testing.
Collection Station requirements
The following facilities may operate a Collection Station:
- A clinical laboratory licensed by the Commonwealth of Massachusetts
- A hospital or clinic licensed by the Commonwealth of Massachusetts
- Out-of-state laboratories accredited or licensed in accordance with federal law
Collection Stations are authorized for the collection and processing of specimens, including centrifugation, planting, and incubation. Please note that no laboratory testing may be performed at a collection station.
The director of the licensed laboratory is responsible for all aspects of the Collection Station, including the physical plant, personnel, and processing and transport of specimens. The laboratory director must:
- Be available to collection station personnel at all times during the operation of the station for personal or telephone consultation;
- Make periodic personal inspections of the station to insure suitable handling of patients and specimens and to instruct the employees in such matters and in the most recent improvements in technique; and
- Establish protocol for action in cases of emergency which must include, without limitation, the immediate availability of a physician or emergency medical services
The occupancy permit for the building in which the Collection Station is located must be kept up-to-date.
The Collection Station’s parent laboratory is responsible for the “contaminated” waste generated at the Collection Station. A manifest must be completed by the Collection Station and the appropriate signed copies must be filed on-site.
How to apply Apply for Collection Station Approval
Opening a Collection Station
Before a licensed laboratory can open a Collection Station, DPH must complete an inspection to determine if the location is in compliance with all applicable regulations.
Clinical Laboratory Program
Department of Public Health
99 Chauncy St., 11th Floor
Boston, MA 02111
Relocating a Collection Station
To change the location of your Collection Station, please complete and send the Notification Form for Collection Stations (DOC) to DPH at the address listed above. The new location must be approved by DPH prior to providing services.
Closing a Collection Station
To close an approved Collection Station, the licensee or director of a laboratory must notify DPH in writing immediately when an approved Collection Station operations are about to terminate. Please include the Notification Form for Collection Stations (DOC).
Written correspondence should be sent to the address listed above. Please include the location where the records will be stored, the person who will be responsible for the records, and the effective closure date.