Covenant Laboratories Llc

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records, lack of verification of accuracy, and interview with the technical supervisor, the laboratory failed to verify the accuracy, at least twice annually, of Real Time-Polymerase Chain Reaction (RT- PCR) testing with the Applied Biosystem QuantStudio 5 amplification instrument for organisms and antibiotic resistant genes on three, of four, identification panels, used for patient testing. Findings include: 1. Review of proficiency testing records since the last survey on 5/19/2022 and lack of documentation of verification of accuracy revealed the laboratory failed to verify the accuracy, at least twice annually, for the following three, of four, RT-PCR identification panels used for patiet testing since 5 /19/2022: (a) Sexually Transmitted Infection (STI) panel, which included 11 organisms--Chlamydia trachomatis, Gardnerella vaginalis, Haemophilus ducreyi, Herpes Simplex Virus-1, Herpes Simplex Virus-2, Mycoplasma genitalium, Mycoplasma hominis, Neisseria gonorrhoeae, Treponema pallidum, Trichomonas vaginalis, Ureaplasma urealyticum. The laboratory's annual volume for STI panels was 1,238. (b) Urinary Tract Infection (UTI) panel, which included 19 organisms-- Candida albicans, Candida glabrata, Candida parapsilosis, Candida tropicalis, Enterobacter cloacae, Enterococcus faecalis, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Mycoplasma hominis, Proteus mirabilis, Providencia stuartii, Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus aureus, Staphylococcus saprophyticus, Streptococcus agalactiae, Ureaplasma urealyticum. The laboratory's annual volume for UTI panels was 1,857. (c) Antibiotic Resistant Gene (ABR) panel, which included 6 antibiotic resistant genes--Verona integron-encoded metallo-Beta-lactamase, Klebsiella pneumoniae 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 -- carbapenemase, Sulfhydryl Variable-Beta-lactamase, Methyl Resistant Staphylococcus aureus, Vancomycin A, Vancomycin B. 2. In an interview on 1/23 /2024 at 2:45 p.m., the technical supervisor confirmed the laboratory failed to verify the accuracy of the UTI, STI, and ABR panels, at least twice annually. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of RT-PCR pathogen identification test reports in patients' electronic medical records and interview with the owner of the laboratory, the laboratory test reports reviewed in the electronic medical record system did not include one of seven test report indicators. Findings include: 1. Review of test reports in patients' electronic medical records failed to include one of seven test report indicators. The laboratory's patient test report did not include the address of the laboratory location where the tests were performed. 2. Interview with the owner of the laboratory on 1/23/2024 at 1:30 p. m. revealed the current electronic medical record system was put in use on 11/20 /2023. -- 2 of 2 --

Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control records and patient test logs for Real Time- Polymerase Chain Reaction (RT-PCR) testing with the Applied Biosystem QuantStudio 5 amplification instrument from 9/13/21 through 12/31/21, review of the laboratory's PCR Standard Operating Procedure manual, lack of documentation of an Individualized Quality Control Plan (IQCP), and confirmation by the general supervisor, the laboratory failed to include a positive control each day of patient testing during this time frame for each organism on the three pathogen panels tested. A total of two patient Sexually Transmitted Infection (STI) panels, nine patient Urinary Tract Infection (UTI) panels, and nineteen patient Respiratory Pathogen panels (RPP) were tested and results reported on fourteen testing days during this time frame when a positive control for each organism was not performed. Findings include: Review of the PCR Standard Operating Procedure manual revealed the PCR test procedure states, "Once a week a QC plate (containing all of the validated molecular assays on that instrument) will be run to confirm the stability of the chemistry and all analytical systems for all assays." However, there was no documentation of the establishment of an Individualized Quality Control Plan (IQCP) for pathogen identification performed with the Applied Biosystem QuantStudio 5 amplification instrument, in order to reduce the frequency of quality control to weekly. The general supervisor confirmed an IQCP was not established. Review of quality control records and patient test logs for RT-PCR testing with the Applied Biosystem QuantStudio 5 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 -- amplification instrument from 9/13/21 through 12/31/21 revealed a positive control was not included for each organism tested on these panels on the following days when patient specimens were tested and results reported: STI Panel Testing (includes 11 organisms) 9/16/21--Patient #1B21I15001. 11/10/21--Patient #1921K09001. UTI Panel Testing (includes 19 organisms) 9/16/21--Patient #1B21I15001. 9/22/21-- Patients #1B21I21001, #1B21I21002. 10/8/21--Patients #1921J08002, #1921J08003, #1921J08004. 10/22/21--Patient #1C21J22001. 12/18/21--Patient #1921L17002. 12/28 /21--Patient #1921L27003. RP Panel Testing (includes 27 organisms) 9/22/21--Patient #1521I21001. 10/22/21--Patient #1321J21001. 12/17/21--Patient #1921L16001, #1B21L17001, #1B21L17002, #1B21L17003, #1B21L17004, #1B21L17005. 12/18 /21--Patient #1921L17001, #1B21L18001, #1I21L18001. 12/29/21--Patient #1921L28001, #1921L28003, #1921L28004, #1921L28006, #1921L28007. 12/30/21-- Parient #1B21L30006, #1921L29003, #1921L29009. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of quality control records and patient test logs for Real Time- Polymerase Chain Reaction (RT-PCR) testing with the Applied Biosystem QuantStudio 5 amplification instrument from 9/13/21 through 12/31/21, review of the laboratory's PCR Standard Operating Procedure manual, lack of documentation of an Individualized Quality Control Plan (IQCP), and confirmation by the general supervisor, the laboratory director failed to ensure a quality control program was established to include a positive control each day of patient testing for each organism on the three pathogen panels tested. A total of two patient Sexually Transmitted Infection (STI) panels, nine patient Urinary Tract Infection (UTI) panels, and nineteen patient Respiratory Pathogen panels (RPP) were tested and results reported on fourteen testing days during this time frame when a positive control for each organism was not performed. Refer to D5449 (Failure to ensure a positive and negative control were performed each day of patient testing). -- 2 of 2 --