Ezmed Urgent Care

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the personnel report, review of proficiency testing (PT) records, and interview with the clinical coordinator (CC), the laboratory failed to ensure that PT was performed by all testing personnel (TP) who routinely performed patient testing. Findings: 1. The Laboratory Personnel Report (form CMS-209) listed eight TP. 2. Attestation forms for four PT events from 2022 through 2023 were reviewed. 3. The attestation forms from the 2022 3rd event showed that TP #1 and TP #2 performed PT testing and from all three 2023 events showed that TP #1 performed PT testing. 4. During the exit interview on 02/28/2024 at 4:00 PM, the CC confirmed that PT testing was not performed by all TP who routinely tested patient specimens. 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: Based on review of the competency procedure and interview with the clinical coordinator (CC), the laboratory failed to ensure that a competency assessment was performed for the technical consultant (TC) in their regular and delegated Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- responsibilities. Findings: 1. The procedure titled "Laboratory Personnel Competency Assessment Program" stated "The LD [laboratory director] will perform a competency assessment of the individual serving as the TC, TS [technical supervisor], and/or GS [general supervisor] based on their regulatory responsibilities." 2. The laboratory's TC performed the responsibilities of a TC in addition to LD responsibilities that were delegated by the LD. 3. During the exit interview on 02/28/2024 at 4:00 PM, the CC confirmed that a competency assessment was not performed by the LD for the TC based on the TC's regular and delegated responsibilities. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) 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 review of proficiency testing (PT) records and email communication with the clinical coordinator (CC), the laboratory did not have documentation that the PT results were reviewed and evaluated for three of four PT events reviewed. Findings: 1. Records for four PT events from 2022 through 2023 were reviewed. 2. The results evaluations provided by the PT provider were present and signed as reviewed by the technical consultant (TC) for the 2023 1st PT event. There were no signed PT results evaluations present for the 2022 3rd or 2023 2nd and 3rd PT events. 3. At 4:06 PM on 03/01/2024, the CC emailed the available PT documents that were scanned by the TC. The documents did not contain the signed PT results evaluations from the 2022 3rd or 2023 2nd and 3rd PT events. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the standard operating procedure manual (SOPM) and interview with the clinical coordinator (CC), the laboratory's SOPM did not have an approved procedure for performing the Quidel Solana Strep Complete assay. Findings: 1. The laboratory began testing patient specimens using the Quidel Solana Strep Complete test system in August 2023. 2. The SOPM did not include an approved procedure detailing how to perform the Solana Strep Complete testing. 3. During the exit interview on 02/28/2024 at 4:00 PM, the CC confirmed that an approved copy of the Solana Strep Complete testing procedure was not part of the laboratory's SOPM. 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) -- 2 of 6 -- 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 review of the verification documentation and interview with the clinical coordinator (CC), the laboratory failed to document whether they could obtain performance specifications comparable to those established by the manufacturer for the Quidel Solana Strep Complete test system. Findings: 1. The laboratory began testing patient specimens using the Quidel Solana Strep Complete test system in August 2023. 2. Verification documentation included instructions for performing the "Quidel Molecular Direct Strep Training Panel for Lyra Direct and Solana" which stated was "intended to be used to assist in the training process for Quidel Molecular Direct Assays (Lyra Direct and Solana) for the qualitative detection of Streptococcus pyogenes and Streptococcus dysgalactiae. The panel set consists of twenty-four contrived throat swab specimens that have been spiked with one of two concentrations of Streptococcus pyogenes and Streptococcus dysgalactiae or with negative media." 3. Included in the documentation was the "Quidel Molecular Direct Strep Panel Answer Key" that provided the expected results for the twenty-four contrived throat swab specimens. 4. There was no procedure defining how to compare performance specifications with those established by the manufacturer, including the acceptability criteria, and there was no documentation that the laboratory's results were evaluated against the expected results to confirm that the assay's accuracy and precision met the defined acceptability criteria and the assay was cleared to use for patient testing. 5. During the exit interview on 02/28/2024 at 4:15 PM, the CC confirmed that there was no documentation that the results from the Quidel Molecular Direct Strep Training Panel were evaluated to determine whether performance specifications were comparable with those established by the manufacturer. 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 review of the individualized quality control plan (IQCP), the procedure manual, and quality control (QC) records and interview with the clinical coordinator (CC), the laboratory failed to include a quality control plan (QCP) plan in their IQCP and failed to perform QC for the Solana Strep Complete assay with the frequency defined in their quality management plan. Findings: 1. The laboratory is required to test two levels of QC materials each day of testing unless they have written an IQCP. An IQCP includes three components: 1) the risk assessment (RA) which identifies and evaluates potential problems or errors that may occur in the testing process, 2) the quality control plan (QCP) which at least includes the number, type and frequency of testing and criteria for acceptable result(s) of the quality control, and 3) the quality -- 3 of 6 -- assessment (QA) which is the continuous process of monitoring the effectiveness of the QCP. 2. The "Laboratory Order Change (Strep A/C/G Testing)" procedure stated "Please note that as of 10/01/2023, Ezmed Timonium will begin to implement the moderate complexity Solana Strep A and C/G assay testing. External quality controls will be performed according to our established IQCP." 3. The laboratory's IQCP only included the RA component and not the QCP and QA components. 4. Though the IQCP did not have the QCP component, the "EZMED UC AKA Care Solution LLC (CLIA 21D2231439) Lab Quality Management Plan" (quality management plan) stated that "2. Systems that will be evaluated include the pre-analytical phase, analytical phase, and post-analytical phase. The relevant tests that will be covered in these system evaluations include Strep Complete panels and TV performed on the Solana" and "External quality controls for Solana laboratory tests listed above in part 2 will be run once every 31 days, every new lot, or every new user, whichever is more frequent, in accordance with the manufacturer's recommendations and the laboratory's approved IQCP." 5. Records showed that QC was run on 06/22/2023, 07/06/2023, and 07/18/2023 for lot number 234724, 09/28/2023 for lot number 240290, and 02/27 /2024 for lot number 243386. All QC results were signed by the same testing person. 6. During the exit interview on 02/28/2024 at 4:15 PM, the CC confirmed that the laboratory was not performing external QC for the Solana Strep Complete assay once every 31 days, every new lot, or every new user (whichever was more frequent) as required in their quality management plan. D5785

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of the "Clinical Laboratory Improvement Amendments (CLIA) Application for Certification" (CMS-116) and interview with the testing personnel, the laboratory failed to enroll in an approved proficiency testing (PT) program for Trichomonas vaginalis (TV), Chlamydia trachomatis (CT), and Neisseria gonorrhea (NG) performed on the Cepheid GeneXpert analyzer. Findings: 1. The laboratory listed the following on the CMS-116 under "Section VII. Non-Waived Testing": Analyte/Test Test Name Manufacturer M or H TV TV Cepheid M CT/NG CT/NG Cepheid M 2. On 07/22/2022 at 12:10 PM, the testing person was contacted and confirmed that the laboratory was not enrolled in an approved PT program for TV and CT/NG using the Cepheid analyzer. The cumulative effect of this problem has the potential to result in the laboratory's inability to ensure the accuracy and reliability of patient test results. D2001 ENROLLMENT CFR(s): 493.801(a)(1)(2)(i) The laboratory must-- (1) Notify HHS of the approved program or programs in which Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- it chooses to participate to meet proficiency testing requirements of this subpart. (2)(i) Designate the program(s) to be used for each specialty, subspecialty, and analyte or test to determine compliance with this subpart if the laboratory participates in more than one proficiency testing program approved by CMS; This STANDARD is not met as evidenced by: Based on review of the laboratory records and interview with the testing personnel (TP), the laboratory failed to enroll in an approved proficiency testing (PT) program during 2021 and 2022 to verify the accuracy of the trichomonas vaginalis (TV), chlamydia trachomatis (CT), and neisseria gonorrhea (NG) performed on the Cepheid GeneXpert analyzer. Findings: 1. To meet the PT requirements, the laboratory is required to be enrolled in an approved PT program when performing moderate complexity patient testing. 2. During the exit survey 08/02/2022 at 2:45 PM, the TP confirmed that the laboratory was not enrolled in the appropriate PT modules for testing 2021 and 2022 to ensure the accuracy and reliability of patient test results. 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: Based on record review and interview with the testing personnel (TP), the laboratory did not establish written policies and procedures for assessing the testing personnel as defined in subpart M- CFR 493.1413(b)(8) through (9): Findings: 1. The laboratory's written procedure manual did not include all the required elements for evaluating the competency of the testing personnel and assuring that they maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to: direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; monitoring the recording and reporting of test results; review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records; direct observation of performance of instrument maintenance and function checks; assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and assessment of problem solving skills; and evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. 2. Evaluations must be performed at six months and annually thereafter unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. 3. During the survey on 07/07/2022 at 2:45 PM, TP provided a "Quality Management Plan" that did not include a written training program along with worksheets for the documentation of the training of the TP who perform pre-analytic, analytical and post analytic procedures. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) -- 2 of 6 -- 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)