Duly Health And Care - Rickert Lab

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on direct observation, review of laboratory records, quality control (QC) records, lack of documentation, and interviews with testing personnel (TP) #1; the laboratory failed to perform control procedures on each analyzer in use for both BD Affirm VPIII analyzers and both Cepheid GeneXpert analyzers as required per 493. 1256. Findings include: 1. Upon direct observation on 02/06/2024, at 4:50 pm, surveyors observed two BD Affirm VPIII analyzers (Serial Numbers: A608012 and A605032) and two Cepheid GeneXpert analyzers (Serial Numbers: 821282 and 835922) being utilized for patient testing. 2. Review of the laboratory's Individualized Quality Control Plan (IQCP)s, for both the Cepheid GeneXpert testing systems and the BD Affirm VPIII testing systems, revealed a lack of documentation to run positive and negative QC on both analyzers every 30 days. 3. On 02/06/2024 at 4:50 pm, an interview with TP #1 confirmed that positive and negative QC was not performed on both the Cepheid GeneXpert analyzers and both the BD Affirm VPIII analyzers. 4. Two of four patients reviewed for Cepheid GeneXpert testing showed the patient test was performed on one Cepheid GeneXpert analyzer while corresponding QC was performed on the other Cepheid GeneXpert analyzer: a. Patient GE12165131 had a Strep test (Reagent Lot Number: 25905) performed on Cepheid GeneXpert A (Serial 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 -- Number: 821282) on 10/30/2023. Corresponding positive and negative QC for Strep Reagent Lot Number 25905 was performed on Cepheid GeneXpert B (Serial Number: 835922) on 10/27/2023. b. Patient GE40628083 had a Covid test (Reagent Lot Number: 04733) performed on Cepheid GeneXpert B on 01/03/2024. Corresponding negative QC for Covid Reagent Lot Number 04733 was performed on Cepheid GeneXpert A on 12/21/2023. 5. Review of QC records revealed a lack of documentation to indicate which BD Affirm VPIII analyzer (A608012 or A605032) was used to perform QC on three of three testing dates reviewed (06/06/2023, 10/31 /2023, 01/03/2024). 6. An additional interview with TP #1 on 02/07/2024 at 2:40 pm, confirmed the above findings. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on lack of documentation, direct observation, and interview with testing personnel (TP) #1, the laboratory failed to have a system in place that twice a year evaluates and defines the comparison of test results between two of two Cepheid GeneXpert instruments used in the years of 2022 and 2023. Findings include: 1. A lack of documentation, including a policy/procedure and documents/results, of instrument-to-instrument test result comparisons as required by 493.1281 for two of two Cepheid GeneXpert instruments. 2. Upon direct observation on 02/06/2024, at 4: 50 pm, two Cepheid GeneXpert instruments were used to perform Strep, Covid, Influenza A and B, and RSV testing in the years of 2022 and 2023: Instrument: Serial Number: A 821282 B 835922 3. An interview with TP #1 on 02/06/2024, at 4:50 pm, confirmed that no policy/procedure or documents/results of instrument-to-instrument test result comparisons were available nor had been performed. -- 2 of 2 --

Summary Statement of Deficiencies D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on review of laboratory records and interview the technical supervisor (TS); the laboratory failed to ensure testing personnel met the qualification requirements 493. 1489 for high complexity testing. Findings Include: 1. No education records were available to qualify 1 of 8 testing personnel listed on the CMS-209 for high complexity testing. See D6171. D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry 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; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or 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 -- medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the technical supervisor (TS); the laboratory failed to ensure 1 of 8 testing personnel were qualified to perform high complexity testing. Findings Include: 1. Review of educational documentation found 1 of 8 testing personnel (TP), TP#8, failed to have qualifying documentation for high complexity testing. 2. On survey date 09-05-2018, at 2:00 pm, the above findings were confirmed by the TS. -- 2 of 2 --