United Clinical Lab, Llc

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and an interview with the sole General Supervisor (GS), the Laboratory Director failed to attest to the routine integration of proficiency testing (PT) samples into the patient workload using the laboratory's routine methods for two out of six American Proficiency Institute (API) PT events. This deficient practice had the potential to affect 12,750 out of 12,750 patient tests performed in this laboratory between the 02/28/2024 and 06/26/2024 in the subspecialties of Bacteriology and Virology. Findings Include: 1. Review of the laboratory's "Proficiency Testing Program" policy and procedure, approved via signature and date by the Laboratory Director on 06/20/2024, found the following statement: "Attestation statement is signed by the laboratory director or qualified designee and all individuals involved in the testing process." 2. Review of the laboratory's "SOP-500-A2 Proficiency Testing Management" worksheet procedure, approved via signature and date on 06/20/2024 by the Laboratory Director and provided on the date of the inspection, found the following line item: "Attestation sheets signed by all testing personnel involved and Lab Director? Yes No" 3. Review of the laboratory's 2024 API documentation did not find a Proficiency Testing Management worksheet for the first and second PT events. 4. Further review of the laboratory's 2024 first and second API PT event documentation, provided on the date of the inspection, did not find any attestation signature by the Laboratory Director. 5. The Inspector requested the laboratory's 2024 first and second API PT attestation pages signed by the Laboratory Director from the sole GS. The sole GS confirmed that the Laboratory Director did not attest to the routine integration of proficiency testing (PT) samples into the patient workload using Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- the laboratory's routine methods for the 2024 first and second API PT events and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 12/04/2024 at 2:45 PM. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on record review and an interview with the sole General Supervisor (GS), the laboratory failed to successfully participate in one out of six American Proficiency Institute (API) PT events for influenza A (Flu A) in the subspecialty of Virology. This deficient practice had the potential to affect 1,668 out of 1,668 Flu A tests performed between the 10/09/2024 through 12/04/2024. Findings Include: 1. The laboratory failed to attain an overall testing event score of at least 80% in one out of six American Proficiency Institute (API) PT events for influenza A (Flu A) in the subspecialty of Virology, which is unsatisfactory performance. (Refer to D2056) 2. The laboratory failed to undertake appropriate training, employ the technical assistance and document the remedial action necessary to correct problems associated with one out of six American Proficiency Institute (API) PT events for influenza A (Flu A) testing in the subspecialty of Virology with a score of 60%. (Refer to D2062) D2056 VIROLOGY CFR(s): 493.831(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on record review and an interview with the sole General Supervisor (GS), the laboratory failed to attain an overall testing event score of at least 80% in one out of six American Proficiency Institute (API) PT events for influenza A (Flu A) in the subspecialty of Virology which is unsatisfactory performance. This deficient practice had the potential to affect 1,668 out of 1,668 Flu A tests performed between the 10/09 /2024 through 12/04/2024. Findings Include: 1. Review of the laboratory's 2024 third -- 2 of 8 -- API PT event revealed the laboratory obtained a score of 60% for Flu A. 2. The sole GS confirmed the laboratory's API PT scores of 60% for the third PT event in 2024 for Flu A. The interview occurred on 12/04/2024 at 2:45 PM. D2062 VIROLOGY CFR(s): 493.831(d) (1) For any unsatisfactory testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unsatisfactory testing events, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on record review and an interview with the sole General Supervisor (GS), the laboratory failed to undertake appropriate training, employ the technical assistance and document the remedial action necessary to correct problems associated with one out of six American Proficiency Institute (API) PT events for influenza A (Flu A) testing in the subspecialty of Virology with a score of 60%. This deficient practice had the potential to affect 1,668 out of 1,668 Flu A tests performed between 10/09 /2024 through 12/04/2024. Findings Include: 1. Review of the laboratory's "Proficiency Testing Program" policy and procedure, approved via signature and date by the Laboratory Director and provided on the date of the inspection found the following statements: "t. It is recommended that the laboratory investigate acceptable results that show significant bias or trends. u. Unacceptable indicates the response was not the same as many referees. v. For each unacceptable result, a comprehensive investigation must be done and documented. Lab supervisor initiates the investigation, works with testing personnel to ensures

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and interviews with the Laboratory Owner (LO), the sole Testing Personnel (TP) and the Laboratory Assistant (LA), the Laboratory Director (LD) and TP failed to attest to the routine integration of proficiency testing (PT) samples into the patient workload using the laboratory's routine methods for the only American Proficiency Institute (API) testing event performed since laboratory testing was implemented on 02/01/2023. This deficient practice had the potential to affect 13,000 patient tests performed in this laboratory in the subspecialty of Virology since the implementation of testing on 02/01/2023 through 05/09/2023. Findings Include: 1. Review of the laboratory's "Proficiency Testing Program" policy and procedure, unapproved by the LD and provided for the inspection, found the following statement: "PT program general information... 10. Attestation statement is signed by the laboratory director or qualified designee and all individuals involved in the testing process." 2. Review of the laboratory's 2023 Microbiology first testing event documentation did not find the LD or TP's signature attesting to the routine integration of proficiency testing (PT) samples into the patient workload using the laboratory's routine methods. 3. The LO, TP and LA confirmed that the LD and TP did not attest to the routine integration of proficiency testing (PT) samples into the patient workload using the laboratory's routine methods. The interviews occurred on 05/09/2023 at 11:20 AM. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(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 4 -- The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on record review and interviews with the Laboratory Owner (LO), the sole Testing Personnel (TP) and the Laboratory Assistant (LA), the laboratory failed to review and evaluate their reported results from the only American Proficiency Institute (API) testing event, as specified in subpart H of this part, since laboratory testing was implemented on 02/01/2023. This deficient practice had the potential to affect 13,000 patient tests performed in this laboratory in the subspecialty of Virology since the implementation of testing on 02/01/2023 through 05/09/2023. Findings Include: 1. Review of the laboratory's "Proficiency Testing Program" policy and procedure, unapproved by the LD and provided for the inspection, found the following statement: "Evaluation... r. Evaluation report is reviewed by the Lab supervisor, Lab directory [sic] or designee. The results are evaluated as good, acceptable, unacceptable, or not graded. Good and acceptable indicate satisfactory performance. s. Acceptable results should be signed and dated by the laboratory director or designee." 2. Review of the laboratory's 2023 Microbiology first testing event documentation did not find any signature, date and documented evidence of review/evaluation of the scored API results submitted. 3. The LO, TP and LA confirmed that the laboratory did not document their review/evaluation of the first API testing event in 2023 via signature and date. The interviews occurred on 05/09 /2023 at 11:20 AM. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on record review and interviews with the Laboratory Owner (LO), the sole Testing Personnel (TP) and the Laboratory Assistant (LA), the Laboratory Director failed to ensure, prior to testing patients' specimens, that the sole TP had appropriate and documented evidence that they had been trained and could perform all testing operations reliably to provide and report accurate results for the high complexity COVID, Influenza A (FluA), Influenza B (FluB) and respiratory syncytial virus (RSV) testing procedures performed. This deficient practice had the potential to affect 13,000 patient tests performed in this laboratory in the subspecialty of Virology since the implementation of testing on 02/01/2023 through 05/09/2023. Findings Include: 1. Review of the laboratory's Form CMS-209, approved by the Laboratory Director (LD) on 05/11/2023, revealed one individual listed as a TP to perform high complexity PCR COVID, FluA, FluB and RSV testing procedures which were implemented on 02 /01/2023. 2. Review of the laboratory's "Competency and Training" policy and procedure, provided on the date of the inspection revealed the following statements: "a. For testing personnel, prior to starting patient/client testing and prior to reporting patient/client results for new methods or instruments, each individual must have -- 2 of 4 -- training and be evaluated for proper test performance. The records must cover all testing performed by each individual." ..."j. Qualifications of Individuals Assessing Competency i. Individuals responsible for competency assessments have the education and experience to evaluate the complexity of the testing being assessed. ii. The laboratory director must delegate, in writing, the performance of competency assessment to qualified personnel. The required qualifications for the assessor vary by the complexity of the testing." 3. Review of the laboratory's competency assessment documentation for the sole TP found the following: Orientation Checklist - initialed and signed by the TP and signed by the prior LD on 03/08/2023. Training Checklist - only initialed and dated by the TP on "04/21" and did not find any indication of a qualified individual who conducted the assessment. 4. The Inspector requested the laboratory's documentation of training and demonstration of the TP's competence via signature and date from a qualified Technical Supervisor or General Supervisor for the high complexity PCR COVID, FluA, FluB and RSV testing procedures, prior to testing patients' specimens, from the LO, TP and LA. The LO, TP and LA confirmed the laboratory did not document, as required, via signature and date from a qualified individual who assessed the training and demonstration of competence of the TP, prior to testing patients' specimens and were not able to provide the requested documentation on the date of the inspection. The interviews occurred on 05/09/2023 at 11:45 AM. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. This STANDARD is not met as evidenced by: Based on record review and interviews with the Laboratory Owner (LO), the sole Testing Personnel (TP) and the Laboratory Assistant (LA), the Laboratory Director (LD) failed to ensure that an approved procedure manual was available to all personnel responsible for any aspect of the testing procedures performed. This deficient practice had the potential to affect all patient tests performed in this laboratory in the subspecialty of Virology since the change in laboratory directorship on 04/03/2023. Findings Include: 1. Review of the laboratory's policy and procedure manual, provided on the date of inspection, did not find the policies and procedures approved via signature and date by the current LD upon the change in directorship on 04/03/2023. 2. The Inspector requested the laboratory's approved policies and procedures by the current LD upon the change in directorship from the LO, TP and LA. The LO, TP and LA confirmed the current LD did not approve all of the laboratory policies and procedures via signature and date upon the change in directorship on 04/03/2023 and were unable to provide the requested documentation on the date of the inspection. The interviews occurred on 05/09/2023 at 1:13 PM. D6115 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(2) The technical supervisor is responsible for verification of the test procedures performed and establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on record review and interviews with the Laboratory Owner (LO), the sole Testing Personnel (TP) and the Laboratory Assistant (LA), the Technical Supervisor (TS) failed to evaluate and verify the laboratory's established test performance activities for the high complexity Polymerase Chain Reaction (PCR) COVID, Influenza A (FluA), Influenza B (FluB) and respiratory syncytial virus (RSV) testing procedures performed. This deficient practice had the potential to affect 13,000 patient tests performed in this laboratory in the subspecialty of Virology since the implementation of testing on 02/01/2023 through 05/09/2023. Findings Include: 1. Review of the laboratory's "Atila Real Time PCR Procedure for COV/FLU/RSV Detection" and "Validation of iAMP COV/FLU/RSV Detection" policies and procedures, provided for the inspection, did not find any mention of instructions on review and approval of the laboratory's performance validation documentation prior to beginning patient testing. 2. Review of the laboratory's Atila Real Time PCR performance validation documentation did not find any review and approval of the performance validation activities via signature and date by the TS. The signatures of the TP and prior LD were dated 03/08/2023 (5 weeks after patient testing was implemented). 3. The Inspector requested the review and approval documentation, via signature and date of the TS, prior to the implementation of patient testing on 02/01 /2023 from the LO, TP and LA. The LO and LA stated that the TS did review and gave a verbal approval of the performance validation activities, the TS did not physically sign and date the performance validation documentation and were unable to provide the requested documentation on the date of the inspection. The interviews occurred on 05/09/2023 at 1:20 PM. -- 4 of 4 --