Northern Ohio Medical Specialists, Llc

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on record review and an interview with the Laboratory Director, the laboratory failed to demonstrate that it could obtain performance specifications comparable to those established by the manufacturer for accuracy, precision and reference intervals for the new BD Affirm VPIII analyzer utilized for Candida (yeast), Gardnerella vaginalis (BV) and Trichomonas vaginalis (trich) testing of vaginal fluid prior to testing patient specimens. All patients tested on this new analyzer from implementation in September 2019 to 01/14/2020 had the potential to be affected by this deficient practice. Findings Include: 1. Review of the laboratory's policies and procedures, provided on the date of the inspection, did not find any mention of performance specification instructions. 2. The Inspector requested the laboratory's performance specification policy and procedure and the 2019 performance specification documentation of all activities conducted prior to implementation of the new BD Affirm VPIII analyzer in September 2019 for patient yeast, BV and trich testing from the Laboratory Director. The Laboratory Director confirmed the laboratory did not have a performance specification policy and procedure established and further stated that the analyzer was installed by the vendor in September 2019, the installation records could not be located, the laboratory did not conduct any performance verification activities and therefore, was unable to provide the requested 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 -- documentation on the date of the inspection. The interview occurred on 01/14/2020 at 1:55 PM. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and an interview with the Laboratory Director, the laboratory failed to perform external positive and negative quality control (QC) with each lot number and shipment of the BD Affirm VPIII kits utilized for Candida (yeast), Gardnerella vaginalis (BV) and Trichomonas vaginalis (trich) testing. This deficient practice had the potential to affect 675 patient test results reported from the newly implemented BD Affirm VPIII analyzer in September 2019 to the date of the inspection. Findings Include: 1. Review of the laboratory's "BD Affirm VPIII" policy and procedure, approved, signed and dated by the Laboratory Director on 04/05/2018, found instructions to only perform external positive Tri-valent QC swabs with each new lot number. 2. Review of the laboratory's "Individualized Quality Control Plan" (IQCP) and "Laboratory Director Responsibilities Regarding IQCP and Delegation Statement", provided on the date of the inspection, found instructions for the laboratory to perform external positive Tri-valent QC swabs with each new lot number. 3a. Review of the laboratory's 2019 and 2020 BD Affirm VPIII Lab Testing Logs did not find any indication of any external negative QC swab results with each lot number; only external positive QC swabs were tested and documented as listed below: Kit Lot Dates of positive Number of Number QC Testing Only Patients Tested without negative QC 9070746 09/04/2019 40 9070743 09/10/2019 24 9018889 09/16 /2019 48 9099958 09/24/2019 35 9126966 10/02/2019 49 9142513 10/10/2019 49 9133754 10/22/2019 46 9198551 10/30/2019 47 9170583 11/06/2019 48 9170583 11 /14/2019 47 9098612 11/26/2019 48 9198551 12/05/2019 8 9198551 12/09/2019 8 9198551 12/10/2019 15 9198551 12/19/2019 97 9198551 12/31/2019 66 3b. Further review of the laboratory's same 2019 and 2020 BD Affirm VPIII Lab Testing Logs did not find any record of external positive and negative Tri-valent QC swab testing with each lot number and shipment of test kits as indicated below: Kit Lot Dates of Patient Number of Patients Number Testing Tested without QC 9133754 10/22/19-10 /30/19 46 9198551 12/05/19-12/09/19 8 4. The sole testing personnel confirmed the laboratory did not perform and document external positive and negative Tri-valent QC swab testing with each new lot number and shipment of BD Affirm VPIII test kits. The interview occurred on 01/14/2020 at 2:34 PM. -- 2 of 2 --

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 Laboratory Director, the testing personnel (TP) failed to attest to the routine integration of the American Proficiency Institute (API) proficiency testing (PT) samples into the routine patient workload using the laboratory's routine methods for one of three of the testing events in 2016. Findings Include: 1. Review of the laboratory's policies and procedures, provided on the date of the inspection, did not find any PT policies and procedures. 2. Review of the laboratory's 2016 and 2017 API Microbiology PT records did not find that the TP attested to the routine integration of the API PT samples into the patient workload using the laboratory's routine methods for the third PT event in 2016. 3. The Surveyor requested the TP's attestation for the laboratory's third 2016 API Microbiology PT event from the Laboratory Director. The Laboratory Director confirmed the TP did not provide attestation, as required, and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 01/31/2018 at 10:28 AM. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on record review and an interview with the Laboratory Director, the laboratory failed to maintain all American Proficiency Institute (API) proficiency testing (PT) records for at least two years from the date of the PT event. Findings Include: 1. Review of the laboratory's policies and procedures, provided on the date of the inspection, did not find any PT policies and procedures. 2. Review of the laboratory's 2016 and 2017 API Microbiology PT records revealed the laboratory did not retain all of the API PT documentation, as required, to include the raw data, the submitted results, the report evaluations and the documentation of report review for six out of six of the 2016 and 2017 PT events reviewed. 3. The Surveyor requested all of the laboratory's 2016 and 2017 API Microbiology PT event records from the Laboratory Director. The Laboratory Director confirmed the laboratory did not maintain records of all API PT documentation, as required, and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 01/31/2018 at 10:28 AM. D5002 BACTERIOLOGY CFR(s): 493.1201 If the laboratory provides services in the subspecialty of Bacteriology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1261, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on record review and an interview with the Laboratory Director, the laboratory failed to meet the requirements in the subspecialty of Bacteriology. Findings Include: 1. The laboratory failed to document the review of proficiency testing (PT) results obtained for six out of six of the 2016 and 2017 American Proficiency Institute (API) Microbiology testing events. (Refer to D5211) 2. The laboratory failed to verify the accuracy of the GeneXpert test system for the detection and differentiation of genomic DNA (deoxyribonucleic acid) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) at least twice annually in 2017. (Refer to D5217) 3. The laboratory failed to establish, have available and follow written policies and procedures for tests, assays and examinations performed by the laboratory to include proficiency testing (PT), test accuracy verification (TAV) and performance specification activities. (Refer to D5401) 4. The laboratory failed to include interpretation of results, control procedures, the