Kathleen Knapp, Do Pc

Summary Statement of Deficiencies D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: . Based on record review and a lack of documentation, the laboratory failed to ensure testing personnel were qualified prior to performing moderately complex testing. Refer to D6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: . Based on record review and a lack of documentation, the laboratory failed to ensure 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 -- testing personnel were qualified prior to performing moderately complex testing for 2 (Testing Personnel #3 and #4) of 5 testing personnel listed on Form CMS-209. Findings include: 1. A review of testing personnel qualifications revealed a lack of documentation for Testing Personnel #3 and #4 to meet moderate complexity testing personnel qualification requirements at 493.1423. 2. The surveyor requested additional qualification documentation for Testing Personnel #3 and #4 on 1/31/24 at 1:33 pm and they were not made available. 3. The laboratory was provided and additional 7 days to provide the missing qualification documents and they were not made available. -- 2 of 2 --

Summary Statement of Deficiencies D1000 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(c) Certificate of waiver tests. A laboratory may qualify for a certificate of waiver under section 353 of the PHS Act if it restricts the tests that it performs to one or more of the following tests or examinations (or additional tests added to this list as provided under paragraph (d) of this section) and no others: (1) Dipstick or Tablet Reagent Urinalysis (non-automated) for the following: (i) Bilirubin; (ii) Glucose; (iii) Hemoglobin; (iv) Ketone; (v) Leukocytes; (vi) Nitrite; (vii) pH; (viii) Protein; (ix) Specific gravity; and (x) Urobilinogen. (2) Fecal occult blood; (3) Ovulation tests-visual color comparison tests for human luteinizing hormone; (4) Urine pregnancy tests - visual color comparison tests; (5) Erythrocyte sedimentation rate-non-automated; (6) Hemoglobin- copper sulfate-non-automated; (7) Blood glucose by glucose monitoring devices cleared by the FDA specifically for home use; (8) Spun microhematocrit; and (9) Hemoglobin by single analyte instruments with self-contained or component features to perform specimen/reagent interaction, providing direct measurement and readout. This STANDARD is not met as evidenced by: . A. Based on record review and interviews, the laboratory failed to use the analyzer portion of the BD Veritor SARS-CoV-2 test system while testing for 1 (12/8/20) of 7 testing days. Findings include: 1. During a tour of the laboratory on 12/8/20 at 9:38 am, the surveyor requested to see the laboratory's BD Veritor System analyzer. 2. An interview on 12/8/20 at 9:38 am with Testing Personnel #1 revealed the analyzer was not in the office and the test system can be used without the analyzer. 3. A review of the laboratory's BD Veritor System For Rapid Detection of SARS-CoV-2 instructions for use revealed a section stating, "When specimens are processed and added to the test device, SARS-CoV-2 antigens present in the specimen bind to antibodies conjugated to detector particles in the test strip. The antigen-conjugate complexes migrate across the test strip to the reaction area and are captured by a line of antibodies bound on the membrane. A positive result is determined by the BD Veritor 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 -- Plus Analyzer when antigen-conjugate is deposited at the Test "T" position and the Control "C" position on the assay device. the instrument analyzed and corrects for non-specific binding and detects positives not recognized by the unaided eye to provide an objective result." and a section stating, "The test is not intended to be interpreted visually." 4. An interview on 12/8/20 at 10:29 am with the Laboratory Director revealed she had brought the analyzer home and performed testing on a family member, but did not use the analyzer to read the result. Instead, the result was read visually from the test cartridge. B. Based on record review and interviews, the laboratory failed to use the BD Veritor SARS-CoV-2 test system in a laboratory certified under the Clinical Laboratory Improvement Amendments for 1 (12/8/20) of 7 testing dates. Findings include: 1. During a tour of the laboratory on 12/8/20 at 9:38 am, the surveyor requested to see the laboratory's BD Veritor System analyzer. 2. An interview on 12/8/20 at 9:38 am with Testing Personnel #1 revealed the analyzer was not in the office. 3. An interview on 12/8/20 at 9:50 am with the Laboratory Director revealed she brought the test system home to test a family member. 4. A review of the laboratory's BD Veritor System For Rapid Detection of SARS-CoV-2 instructions for use revealed a section stating, "In the USA, testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet the requirements to perform moderate, high, or waived complexity tests." C. Based on record review and interview with Testing Personnel #1, the laboratory failed to issue authorized Fact Sheets with the BD Veritor System for Rapid Detection of SARS-CoV-2 test results for 10 of 10 patients tested. Findings include: 1. A review of the laboratory's BD Veritor System For Rapid Detection of SARS-CoV-2 instructions for use revealed a section stating, "Authorized laboratories using your product will include with test result reports, all authorized Fact Sheets. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media." 2. An interview on 12/8/20 at 10:51 am with Testing Personnel #1 revealed the laboratory does not give authorized Fact Sheets with test result reports. -- 2 of 2 --