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 review of the Maryland State licensing database and interview with the general supervisor (GS), the laboratory failed to apply for a Maryland State Permit for medical laboratory testing as required in the Code of Maryland Regulations COMAR10.10.01-08 Laboratories. Findings: 1. Review of the Maryland state licensing database showed that the laboratory failed to submit a Maryland State license application when the laboratory moved from another state. 2. The GS confirmed that the laboratory had moved to Maryland in August of 2021 and was not aware of the licensing requirement. 3. During the survey on 11/10/2022 at 2:20 PM, the GS confirmed that the laboratory had not submitted an application to be licensed to perform laboratory testing in the state of Maryland. The laboratory failed to be in compliance with the applicable Maryland State laboratory requirements. 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) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)