10-144 C.M.R. ch. 263, § 4 - APPLICATION PROCESS

A. Application requirements. These requirements pertain to all laboratories applying for accreditation, including those seeking limited accreditation or renewal of accreditation.

1. A laboratory may request to be accredited for the use of methods and analytes eligible for accreditation according to Section 3. The accreditation officer will maintain a MAT of methods and analytes by program and matrix, available for accreditation.

2. Out-of-state laboratories may not apply for programs, matrices, methods or analytes in which they do not have primary certification or accreditation by another approving body.

3. A laboratory must specify the fields of testing for which it seeks accreditation using the MAT maintained by the accreditation program. No laboratory may receive initial accreditation without approval of at least one field of testing.

4. A laboratory must apply using the appropriate form (Initial or Renewal Application) provided by MLAP. The laboratory must supply:

a. The name of the laboratory;

b. The physical location, postal mailing address and email address of the laboratory;

c. The name(s) of the owner(s) of the laboratory;

d. The name(s) and telephone number(s) of designated contact person(s) as well as the laboratory technical director and quality assurance officer;

e. The applicable fees, including a nonrefundable base accreditation fee and fees for each test method in which the laboratory seeks accreditation;

f. A QA manual meeting the standards of Section 9(A);

g. SOPs for methods requested for laboratory accreditation meeting the standards of Section 9(B). Out-of-state laboratories are required to submit SOPs only at the request of the accreditation program;

h. The most recent proficiency testing result for each field of testing for which the laboratory seeks accreditation. The proficiency testing samples must be supplied by an approved provider and be analyzed within six months of the date that the application is received by the accreditation officer;

i. An accurate copy of the MAT including the laboratory's detection limits and reporting limits for each field of testing for which the laboratory is requesting accreditation; and

j. If the laboratory is an out-of-state laboratory, a copy of the most recent on-site assessment report with final responses and current copies of all relevant certificates and scopes.

5. A laboratory that owns or manages laboratory facilities at different locations must submit a separate application for each laboratory location except as provided for mobile laboratories in Section 4(C).

B. Applications for renewal of accreditation

1. Applications must be received no later than 60 days before the expiration of accreditation.

2. The application must meet the criteria of Section 4(A).

3. If a laboratory fails to submit a renewal application before the expiration of accreditation, the accreditation officer must notify the regulatory authorities that the laboratory did not renew its accreditation.

4. The laboratory must not report results as accredited after its accreditation expires.

C. Requirements for mobile laboratories

1. A mobile laboratory is equivalent to a fixed laboratory location and is subject to all requirements, including application requirements, of this rule.

2. In addition to the requirements under Section 4(A), a mobile laboratory must submit a vehicle identification number, license plate number or other uniquely identifying information.

3. A mobile laboratory must designate which fields of testing, equipment and personnel are associated with the mobile laboratory. Changes to the numbers and types of equipment within the mobile laboratory may require reapplication according to Section 4(A). The operator of a mobile laboratory must maintain a record or log, documenting the actual location where the testing is performed, as well as the arrival and departure times of the mobile laboratory. This information must be known by the laboratory technical director or quality assurance officer.

D. Changes in scope of accreditation

1. The accreditation officer will approve a laboratory's application to add a field of testing at any time other than the time of renewal if the laboratory:

a. Submits passing proficiency test for the requested program, matrices, methods or analytes as specified in Section 10;

b. Completes the Revision Application;

c. Submits the applicable Method/Analyte Table sections with MDL/RL data;

d. Provides documentation demonstrating current, primary certification or accreditation for the requested parameter (applies to out-of-state laboratories only); and

e. Submits applicable fees according to Section 6.

2. Changes to the scope will include applicable fees for each test method added. See exception below in Section 4(D)(3). The request for methods or analytes must include current MDL/RL data in the MAT.

3. Notice of Availability

a. Requests to add fields of testing for analytes, in response to a notice of availability by the MLAP, do not require payment of additional fees if:

(i) The laboratory holds an accreditation for that test method;

(ii) The laboratory applies for a newly available analyte within the same test method; and

(iii) The laboratory submits the request within 180 days of the notice of availability.

b. Requests for the addition of fields of testing received more than 180 days after the notice of availability is posted by the MLAP are subject to fees according to Section 6.

4. There is no fee for relinquishing methods or analytes from the scope of accreditation.

E. Application processing

1. The MLAP may not process an application until a complete application is received.

2. If the application is not complete when filed, the MLAP will send the applicant written notice of what is needed to complete the application.

3. Upon notifying an applicant that the application is incomplete, the MLAP will suspend further processing of the application pending receipt of the information required to complete the application.

4. Upon determining that an application is complete, the MLAP will review it and proceed to make a decision on the application.

F. Decision on application

The MLAP will approve an application and grant accreditation only if:

1. The applicant has submitted a complete application, required documentation and payment, as applicable, for primary or secondary accreditation.

2. The criteria listed in Section 4, for primary or secondary accreditation, as applicable, have been met.

Notes

10-144 C.M.R. ch. 263, § 4