Summary:
Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on a review of a reference laboratory tracking form and an interview with the manager/supervisor and the testing person, the laboratory is referring toxicology confirmation tests to a laboratory that does not hold a CLEP laboratory permit. Findings: 1. Patient specimens sent to a NY laboratory from an out of state laboratory are considered NY specimens and fall under all NY regulations. NY requires all specimens referred from a NY laboratory to another laboratory to be certified by the Clinical Laboratory Evaluation Program (CLEP). 2. At approximately 10:00 AM it was confirmed by laboratory staff that specimens requiring toxicology confirmation were sent to Acculab LLC, 1043 Perdigo Way, Bowling Green, KY 42103. This laboratory does not have a NY State Clinical Laboratory Permit. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- 493.1253. (7) Control procedures. (8)