Changes in Systems or Procedures

DOE-STD-1112-98

5.7.1 Partial Accreditation. The service laboratory may be partially accredited if it has

demonstrated satisfactory performance in a particular matrix and/or analyte of the DOELAP

categories, and does not demonstrate program deficiencies that may affect the entire laboratory

capability. If a service laboratory has not satisfactorily demonstrated compliance with the test

criteria in a particular matrix and/or analyte, and if a remedial action plan is initiated, the

accreditation process may continue in all other categories.

5.7.2 Changes in Systems or Procedures. The service laboratory shall inform the Performance

Evaluation Program Administrator prior to implementing changes in counting systems or

analytical procedures that could affect the system performance with respect to meeting

DOELAP criteria or evaluations. The service laboratory shall provide evidence supporting a

conclusion that the proposed changes are technically equivalent to the accredited system or

procedure. The Performance Evaluation Program Administrator, with the Oversight Board's

approval, shall make a determination of technical equivalence. If the determination is that the

proposed changes are not technically equivalent, implementation of the proposed changes by

the service laboratory will void accreditation.

5.7.3 Changes in Accredited Services. The service laboratory shall inform the Performance

Evaluation Program Administrator of proposed changes in performance specifications for

accredited services (e.g., changes in analytes or detection levels). The service laboratory shall

also evaluate their proposed changes in service, and provide written justification either that the

existing accreditation is adequate or that additional accreditation testing is required. The

Performance Evaluation Program Administrator shall recommend approval or disapproval of

the accreditation change request. The recommendation, with the justification, shall be

forwarded to the Oversight Board for action. If the Oversight Board rules that the current

accreditation does not cover the change in radiobioassay service, the facility may: a) apply to

accredit the current system for the new radiobioassay service, b) apply to accredit a new or

modified system for the new radiobioassay service, c) obtain the new radiobioassay services

from a radiobioassay service laboratory currently accredited for that service, or d) request that

the Appeals Board review the decision of the Oversight Board.