Resolve Molecular Diagnostics Llc

Summary Statement of Deficiencies D0000 An Initial survey was performed at Resolve Molecular Diagnostics, LLC, CLIA ID 19D2237355, on May 20, 2024. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 policies and twice a year verification records as well as interview with personnel, the laboratory failed to verify the accuracy of all tests performed in microbiology at least twice a year for two (2) of two (2) events reviewed from 2023. Findings: 1. Review of the laboratory's "Proficiency Testing" policy revealed "The appropriate specimen type for PT includes CAP/commercial survey specimens, previously tested patient samples, or other previously analyzed DNA obtained for alternative proficiency testing. The appropriate specimen type for proficiency testing includes commercial survey specimens and/or in-house prepared blinded alternative proficiency testing (prepared by RMDx TN or in-house in Metairie). Alternative PT testing is instituted when commercial products do not cover the targets on the custom panel." 2. Review of the 2023 proficiency testing (PT) records revealed the laboratory performed split sample testing with another laboratory twice during 2023, but did not verify the following targets for accuracy: Coronavirus HKU1 Coronavirus NL63 Coronavirus 229E Coronavirus OC43 Human parainfluenza virus 2 Human parainfluenza virus 3 Influenza A RSV SARS-CoV-2 Staphylococcus aureus Streptococcus pneumoniae Mycoplasma pneumoniae 3. In interview on May 20, 2024 at 1:04 p.m., the Testing Personnel confirmed not all tests performed by the laboratory were verified for accuracy twice 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 7 -- D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on review of the laboratory's test menu and test requisition as well as interview with personnel, the laboratory failed to ensure test requisitions included all tests performed at the laboratory. Findings: 1. Review of the laboratory's test menu revealed the laboratory included the following tests in the Respiratory Pathogen Panel (RPP): Adenovirus, Coronavirus HKU1, Coronavirus NL63, Coronavirus 229E, Coronavirus OC43, Enterovirus, Human Metapneumovirus, Human parainfluenza virus 1, Human parainfluenza virus 2, Human parainfluenza virus 3, Human parainfluenza virus 4, Influenza A, Influenza A/H3, Influenza A/H1-2009, Influenza B, Rhinovirus, RSV, SARS-CoV-2, Staphylococcus aureus, Streptococcus pneumoniae, and Mycoplasma pneumoniae. 2. Review of the laboratory's test requisition revealed the following tests were not included in the RPP: Coronavirus HKU1, Coronavirus NL63, Coronavirus 229E, Coronavirus OC43, Human parainfluenza virus 2, Human parainfluenza virus 3, Influenza A/H3, Influenza A/H1- 2009, Rhinovirus, SARS-CoV-2, Staphylococcus aureus, and Streptococcus pneumoniae. 3. Further review of the laboratory's test requisition revealed the following tests were included as part of the RPP, but were not performed: Human Bocavirus, Chlamydia pneumoniae, Bordatella parapertussis, and Bordatella pertussis. 4. In interview on May 20, 2024 at 12:22 p.m., the Testing Personnel confirmed the lab requisition did not include all tests performed by the laboratory. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 A Special focus survey was performed at Resolve Molecular Diagnostics, LLC-CLIA ID 19D2237355 on June 15, 2022 through June 16, 2022. Resolve Molecular Diagnostics was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1100 CONDITION: Facility Administration D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on observation by surveyor, review of test logs, and interview with personnel, the laboratory failed to report one (1) positive SARS COV-2 result to the state as required. Findings: 1. Observation by surveyor during the laboratory on June 15, 2022 at 9:42 am revealed the laboratory utilizes Accula for SARS COV-2 testing. 2. In interview on June 15, 2022 at 9:44 am, the General Supervisor stated the laboratory began testing patients utilizing the Accula test kits in April 2022. 3. In interview on June 16, 2022 at 10:07 am the laboratory's three (3) Testing Personnel and greeter stated the laboratory did not report positive results to the state for the Accula test. 4. Review of the laboratory's Accula test log revealed the laboratory had one (1) patient in May 2022 with a positive result that was not reported to the state. The laboratory tested seventeen patients in May 2022. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 21 -- D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Review of the laboratory's CMS-209 form, policies, personnel records, and interview with personnel revealed the laboratory failed to ensure the Laboratory Director performed a competency assessment for two (2) personnel serving as Technical Supervisor and General Supervisor. Findings: 1. Review of the laboratory's CMS-209 form (Laboratory Personnel Report) revealed one (1) personnel serving as Technical Supervisor and General Supervisor. 2. Review of the laboratory's "Competency Assessments" policy revealed the laboratory did not include performance of competency for the Technical Supervisor and General Supervisor, to include, but not limited to the frequency. 3. Review of the personnel records for the Technical Supervisor/ General Supervisor revealed the laboratory did not have a competency assessment for her duties as Technical Supervisor and General Supervisor. 4. Further review of personnel records revealed Technical Supervisor 2 previously served as Technical Supervisor from January 3, 2022 through April 10, 2022. The laboratory did not have documentation of a competency assessment for her duties as Technical Supervisor. 5. In interview on June 15, 2022 at 11:26 am, the General Supervisor confirmed a competency assessment was not performed for her duties as Technical Supervisor and General Supervisor. The General Supervisor confirmed the laboratory's policies did not include performance of competency assessments for Technical Supervisor and General Supervisor. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual and interview with personnel, the laboratory failed to establish a complete policy and procedure manual. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not include the following: a) Proficiency Testing to include,but not limited to,

Summary Statement of Deficiencies D0000 A Special focus survey was performed at Resolve Molecular Diagnostics, LLC-CLIA ID 19D2237355 on June 15, 2022 through June 16, 2022. Resolve Molecular Diagnostics was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1100 CONDITION: Facility Administration D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on observation by surveyor, review of test logs, and interview with personnel, the laboratory failed to report one (1) positive SARS COV-2 result to the state as required. Findings: 1. Observation by surveyor during the laboratory on June 15, 2022 at 9:42 am revealed the laboratory utilizes Accula for SARS COV-2 testing. 2. In interview on June 15, 2022 at 9:44 am, the General Supervisor stated the laboratory began testing patients utilizing the Accula test kits in April 2022. 3. In interview on June 16, 2022 at 10:07 am the laboratory's three (3) Testing Personnel and greeter stated the laboratory did not report positive results to the state for the Accula test. 4. Review of the laboratory's Accula test log revealed the laboratory had one (1) patient in May 2022 with a positive result that was not reported to the state. The laboratory tested seventeen patients in May 2022. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 21 -- D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Review of the laboratory's CMS-209 form, policies, personnel records, and interview with personnel revealed the laboratory failed to ensure the Laboratory Director performed a competency assessment for two (2) personnel serving as Technical Supervisor and General Supervisor. Findings: 1. Review of the laboratory's CMS-209 form (Laboratory Personnel Report) revealed one (1) personnel serving as Technical Supervisor and General Supervisor. 2. Review of the laboratory's "Competency Assessments" policy revealed the laboratory did not include performance of competency for the Technical Supervisor and General Supervisor, to include, but not limited to the frequency. 3. Review of the personnel records for the Technical Supervisor/ General Supervisor revealed the laboratory did not have a competency assessment for her duties as Technical Supervisor and General Supervisor. 4. Further review of personnel records revealed Technical Supervisor 2 previously served as Technical Supervisor from January 3, 2022 through April 10, 2022. The laboratory did not have documentation of a competency assessment for her duties as Technical Supervisor. 5. In interview on June 15, 2022 at 11:26 am, the General Supervisor confirmed a competency assessment was not performed for her duties as Technical Supervisor and General Supervisor. The General Supervisor confirmed the laboratory's policies did not include performance of competency assessments for Technical Supervisor and General Supervisor. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual and interview with personnel, the laboratory failed to establish a complete policy and procedure manual. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not include the following: a) Proficiency Testing to include,but not limited to,