Summary:
Summary Statement of Deficiencies D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on a review of the laboratory's quality assessment plan (QA plan), the laboratory's policies and procedures manual, and an interview with general supervisor 1 (GS 1), the laboratory failed to establish a policy or procedure to document all complaints and problems reported to the laboratory, and to investigate complaints when appropriate, since the laboratory's last survey was conducted on 3/24/2021. The laboratory performs approximately 600 tests annually. Findings include: 1. A review of the laboratory's QA plan revealed the laboratory failed to establish a policy or procedure to document all complaints and problems reported to the laboratory, and to investigate complaints when appropriate. 2. A review of the laboratory's policies and procedures manual revealed the laboratory failed to establish a policy or procedure to document all complaints and problems reported to the laboratory, and to investigate complaints when appropriate. 3. An interview with GS 1, on 12/2/2024, at approximately 12:15 PM, confirmed that the laboratory failed to establish a policy or procedure to document all complaints and problems reported to the laboratory, and to investigate complaints when appropriate. D5207 COMMUNICATIONS CFR(s): 493.1234 The laboratory must have a system in place to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. 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 -- This STANDARD is not met as evidenced by: Based on a review of the laboratory's quality assessment plan (QA plan), the laboratory's policies and procedures manual, and an interview with general supervisor 1 (GS 1), the laboratory failed to establish a policy or procedure to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results since the laboratory's last survey was conducted on 3/24/2021. The laboratory performs approximately 600 tests annually. Findings include: 1. A review of the laboratory's QA plan revealed that the laboratory failed to establish a policy or procedure to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. 2. A review of the laboratory's policies and procedures manual revealed that the laboratory failed to establish a policy or procedure to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. 3. Based on an interview with GS 1, on 12/2/2024, at approximately 12:15 PM confirmed that the laboratory failed to establish a policy or procedure to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. 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 493.1253. (7) Control procedures. (8)