Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on December 20, 2019. The laboratory was found not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: A review of the procedure manual and interview with the Office Administrator, determined that the laboratory failed to establish a written policy that assess employee competency for the hematology assay performed in the laboratory from March 2018 to December 2019. The findings include: 1. A review of testing personnel records and procedure manual revealed that competency assessments were not performed on any of the testing personnel from March 2018 to December 2019 for the specialty of hematology. 2. The laboratory failed to have a written policy and procedure to assess competency based on the position responsibilities on an initial, semi-annual, and annual bases. 3. An annual competency was not performed for any of the staff from March 2018- 2019. 4. An interview with the Office Administrator in the breakroom on December 20, 2019, at 11:30 AM, confirmed that the laboratory did not have a written policy for assessing employee competency for all tests performed in the laboratory. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) 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 -- The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with the Office Administrator, the laboratory failed to follow their own written quality assessment (QA) to monitor, assess, and correct problems in the general laboratory system for quality assessment from June 2018 to December 2019. The findings include: 1. The laboratory failed to follow their own QA that assess patient confidentially, specimen integrity and identification, complaint,