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 the general supervisor (GS), the laboratory failed to establish a policy or procedure to document complaints, or establish a policy or procedure to investigate complaints as needed since the laboratory's last survey was conducted on 2/22/2022. The laboratory performs approximately 44,802 tests annually. Findings include: 1. Based on a review of the laboratory's QA plan revealed the laboratory failed to establish a policy or procedure to document complaints, or establish a policy or procedure to investigate complaints as needed. 2. A review of the laboratory's policies and procedures manual revealed the laboratory failed to establish a policy or procedure to document complaints, or establish a policy or procedure to investigate complaints as needed. 3. An interview with the GS, on 4/2/2024, at approximately 1:00 PM, confirmed that the laboratory failed to establish a policy or procedure to document complaints, or establish a policy or procedure to investigate complaints as needed. 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 2 -- 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 the general supervisor (GS), 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 2/22/2022. The laboratory performs approximately 44,802 tests annually. Findings include: 1. Based on 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. Based on 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 the GS, on 4/2/2024, at approximately 1:05 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. -- 2 of 2 --