Summary:
Summary Statement of Deficiencies D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to enroll in proficiency testing (PT) on time for the subspecialty of bacteriology. Findings include: 1. Record review of the Centers for Medicare & Medicaid Services Casper 155D report on 8/22/18 revealed the analyte 0005 Bacteriology with no scores for 2017 Events 1 and 2 and a score of 100% for Event 3. 2. Record review of the laboratory test menu on 8/22/18 revealed the laboratory performs moderately complex throat culture testing utilizing the Strep Select Agar requiring proficiency testing. 3. Record review of the laboratory's College of American Pathologists (CAP) proficiency program records on 8/22/18 revealed the following: a) A CAP packing slip dated 9/7/17 for the shipment of D1-A and D1-B 2017 as additional material. b) CAP Throat Culture survey D1-A and D1-B were self-graded with scores of 100%. Scores from CAP were not available. c) CAP Throat Culture survey D1-C was performed and the laboratory received a score of 100% from CAP. 4. Staff interview with testing personnel #1 (TP1) on 8/22/18 at 11:30 AM confirmed the above. TP1 stated the laboratory had forgotten to order proficiency testing at the end of 2016 and it was not realized until late summer of 2017. 5. The laboratory performs approximately 1,000 throat cultures annually. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --