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Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of the operator's guide for the Cepheid Genexpert Xpress PCR analyzer, review of laboratory temperature logs, and interview with the testing personnel (TP) #1, the laboratory failed to follow manufacturer's instructions for acceptable operating temperature and humidity for the Cepheid Genexpert Xpress PCR analyzer for 288 of 288 days from January 23, 2023 to date November 7, 2023. Findings: 1. Review of the operator's guide for the Cepheid Genexpert Xpress PCR analyzer states, "Your laboratory must meet the following requirements: Operating Temperature: 15 - 30 degrees Celsius. Relative Humidity: 20% - 80%, non- condensing." 2. Review of laboratory temperature logs from January 23, 2023 to date November 7, 2023 showed no documented room temperature or humidity for the PCR testing room for 288 of 288 days. 3. The laboratory was unable to provide the number of PCR tests performed from January 23, 2023 to date November 7, 2023 while the room temperature and humidity were not documented. 4. Interview with the TP #1 on November 7, 2023 at 11:00 AM confirmed the laboratory failed to follow manufacturer's instructions for acceptable operating temperature and humidity for the Cepheid Genexpert Xpress PCR analyzer 5. Interview with the TP #1 on January 3, 2024 at 11:00 AM confirmed the laboratory failed to follow manufacturer's instructions for acceptable operating temperature and humidity for the Cepheid Genexpert Xpress PCR analyzer. **This was cited on tag D5413 from the initial survey performed on November 7, 2023. D3000 FACILITY ADMINISTRATION 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 -- 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 review of waived tests, the laboratory failed to follow manufacturer's instructions for Cepheid Genexpert Xpress PCR analyzer (Refer to D1001). -- 2 of 2 --

Summary Statement of Deficiencies D0000 An initial survey was completed on November 7, 2023. It was determined that Immediate Jeopardy (IJ) existed for the following condition level deficiencies: 42 C.F. R. 493.1250 Condition: Analytic Systems 42 C.F.R. 493.1403 Condition: Laboratory Director 42 C.F.R. 493.1409 Condition: Technical Consultant 42 C.F.R. 493.1415 Condition: Clinical Consultant 42 C.F.R. 493.1421 Condition: Testing Personnel 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 review of proficiency testing (PT) records for 2023, interview with the testing personnel (TP) #1 and laboratory owner, the laboratory failed to provide attestation documentation for one of one PT testing events in 2023. Findings: 1. Review of PT records for 2023 showed the laboratory could not provide attestation records for testing personnel and the laboratory director to show routine integration of samples into the patient workload for the following proficiency testing events: 2023 Hematology/Coagulation-2nd event 2. Interview with the TP #1 and laboratory owner on November 7, 2023 at 10:30 AM confirmed the laboratory could not provide PT testing events attestation records for one PT testing events in 2023. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 16 -- proficiency testing program report forms used by the laboratory to record proficiency 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 review of American Proficiency Institute proficiency testing (PT) records for 2023 and interview with testing personnel (TP) #1 and laboratory owner, the laboratory failed to maintain a copy of all instrumentation data printouts for one of one PT events in 2023. Findings: 1. Review of 2023 PT records showed no instrument data printouts for 2023 Hematology/Coagulation- second event. 2. Interview with the TP #1 and laboratory owner on November 7, 2023 at 10:30 AM confirmed the laboratory failed to maintain a copy of all instrumentation data printouts. 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 proficiency records for 2023, interview with the testing personnel (TP) #1 and laboratory owner, the laboratory failed to establish a means to verify the accuracy of the Cepheid Genexpert analyzer for four of four analytes twice yearly. Findings: 1. Review of proficiency records for 2023 showed the laboratory failed to prove accuracy on the non-regulated analytes: SARS-CoV-2, respiratory syncytial virus (RSV), influenza A and influenza B. 2. Interview with the TP #1 and the laboratory owner on November 7, 2023 at 10:30 AM confirmed the laboratory failed to verify the accuracy of four non-regulated analytes twice annually. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of procedures, review of temperature logs, observation of quality control (QC) and supplies, performance specifications, CBC quality control, and Cepheid Genexpert QC the laboratory failed to meet the condition of analytic systems. The laboratory failed to ensure an procedure manual is available (Refer to D5401); the laboratory failed to follow manufacturer's instructions for acceptable operating temperature and humidity for the Cepheid Genexpert Xpress PCR analyzer (D5413); -- 2 of 16 -- the laboratory failed to ensure laboratory QC and supplies were not used when they had exceeded their expiration date (Refer to D5417); the laboratory failed to verify performance specifications prior to reporting patient test results (Refer to D5421); the laboratory failed to include two control materials each day of patient testing for CBC testing (Refer to D5447); the laboratory failed to perform a positive and negative quality control for SARS CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV) each day of patient testing (Refer to D5449); and the laboratory failed to establish criteria for acceptability of control materials providing quantitative results (Refer to D5469). 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 laboratory procedures, interview with the testing personnel (TP) #1 and the laboratory owner, the laboratory failed to ensure an approved procedure manual is available. Findings: 1. Review of procedures showed no procedure for the: - Sysmex XP300 hematology analyzer - Cepheid Genexpert analyzer for SARS-CoV-2, respiratory syncytial virus (RSV), influenza A and influenza B - Piccolo Xpress chemistry analyzer - testing personnel competency - proficiency testing 2. Interview with the TP #1 and the laboratory owner on November 7, 2023 at 11:00 AM confirmed the laboratory failed to ensure an procedure manual is available. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of the operator's guide for the Cepheid Genexpert Xpress PCR analyzer, review of laboratory temperature logs, and interview with the testing personnel (TP) #1, the laboratory failed to follow manufacturer's instructions for acceptable operating temperature and humidity for the Cepheid Genexpert Xpress PCR analyzer for 288 of 288 days from January 23, 2023 to date November 7, 2023. Findings: 1. Review of the operator's guide for the Cepheid Genexpert Xpress PCR analyzer states, "Your laboratory must meet the following requirements: Operating Temperature: 15 - 30 degrees Celsius. Relative Humidity: 20% - 80%, non- condensing." 2. Review of laboratory temperature logs from January 23, 2023 to date November 7, 2023 showed no documented room temperature or humidity for the PCR testing room for 288 of 288 days. 3. The laboratory was unable to provide the number -- 3 of 16 -- of PCR tests performed from January 23, 2023 to date November 7, 2023 while the room temperature and humidity were not documented. 4. Interview with the TP #1 on November 7, 2023 at 11:00 AM confirmed the laboratory failed to follow manufacturer's instructions for acceptable operating temperature and humidity for the Cepheid Genexpert Xpress PCR analyzer. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation of laboratory refrigerator, laboratory room temperature supplies, and interview with the testing personnel (TP) #1 and the laboratory owner, the laboratory failed to ensure laboratory quality control (QC), and supplies were not used when they had exceeded their expiration date. Findings: 1. Observation of laboratory refrigerator showed the following still in use: - 1 bottle BRT liquid assayed chemistry & lipid lot #2204012-1 expiration 9/30/23 - 1 bottle BRT liquid assayed chemistry & lipid lot #2204012-2 expiration 9/30/23 - 1 box BRT verification samples lot #2206001 expiration 10/31/23 - 1 bottle Sysmex EightCheck X-TRA - L lot# 31650710 expiration 09/20/2023 - 1 bottle Sysmex EightCheck X-TRA - N lot# 31650711 expiration 09/20/2023 - 1 bottle Sysmex EightCheck X-TRA - H lot# 31650712 expiration 09/20/2023 - 1 bottle Sysmex SCS-1000 lot# 32480525 expiration 10/08/2023 2. Observation of room temperature supplies showed the following still in use: - 3 blood culture bottles lot #0004059496 expiration 11/5/23 - 2 blood culture bottles lot #004059424 expiration 10/20/23 - 9 BD vacutainer Na Citrate lot #2291888 expiration 7/31/23 - 10 BD vacutainer K2 EDTA lot #2292119 expiration 10/31/23 - 10 BD vacutainer Na Citrate lot #2259112 expiration 9/30/23 3. Interview with the TP #1 and the laboratory owner on November 7, 2023 at 10:00 AM confirmed the laboratory failed to ensure laboratory QC and supplies were not used when they had exceeded their expiration date. 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 review of the performance verification procedures for the Sysmex XP-300 hematology analyzer and the lack of performance verification procedures for the Cepheid Genexpert Xpress PCR analyzer, patient results, and interview with the testing personnel (TP) #1 and the laboratory owner, the laboratory failed to verify performance specifications prior to reporting patient test results. Findings: 1. Review -- 4 of 16 -- of the performance specifications for the Sysmex XP-300 hematology analyzer showed the laboratory failed to verify accuracy, precision, reportable range, and that the manufacturer's reference intervals (normal ranges) were appropriate for the laboratory's patient population for the analytes: red blood cell (RBC), hemoglobin, hematocrit, platelet, white blood cell (WBC) and differential prior to the beginning of patient testing in January 2023. 2. Lack of performance specifications for the Cepheid Genexpert Xpress PCR analyzer showed the laboratory failed to verify accuracy, precision, reportable range, and that the manufacturer's reference intervals (normal ranges) were appropriate for the laboratory's patient population for the analytes: SARS-CoV 2, influenza A, influenza B, and respiratory syncytial virus (RSV) prior to the beginning of patient testing in January 2023. 3. Review of patient results confirmed the laboratory was performing patient testing on the Sysmex XP-300 hematology analyzer and the Cepheid Genexpert Xpress PCR analyzer on the day of the survey, November 7, 2023. The laboratory was unable to provide the number of patient tests performed on the Sysmex XP-300 hematology analyzer and the Cepheid Genexpert Xpress PCR analyzer from January 2023 to date November 7, 2023. 4. Interview with the TP #1 and the laboratory owner on November 7, 2023 at 10:00 AM confirmed the laboratory failed to verify performance specifications prior to reporting patient test results. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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 quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the Sysmex XP-300 hematology analyzer quality control (QC), patient results, and interview with the testing personnel (TP) #1, the laboratory failed to include two acceptable control materials of different concentrations for complete blood count (CBC) testing for 41 of 41 patient testing days. Findings: 1. Review of the Sysmex XP-300 hematology analyzer quality control (QC) from September 21, 2023 to date November 7, 2023 showed two acceptable levels of CBC QC were not performed for 41 of 41 patient testing days due to the laboratory using Sysmex Eightcheck X-TRA quality control material that expired on September 20, 2023. 2. The laboratory was unable to provide the number of patient tests performed on the Sysmex XP-300 hematology analyzer from September 21, 2023 to date November 7, 2023. 3. Interview with the TP #1 on November 7, 2023 at 10:00 AM confirmed the laboratory failed to include two control materials each day of patient testing for CBC testing. 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. -- 5 of 16 -- This STANDARD is not met as evidenced by: Based on review of the Cepheid Genexpert Xpress quality control (QC) records from January 23, 2023 to date November 7, 2023, review of patient results and interview with the testing personnel (TP) #1, the laboratory failed to perform a positive and negative quality control for SARS CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV) each day of patient testing. Findings: 1. Review of the Cepheid Genexpert Xpress quality control (QC) records from January 23, 2023 to date November 7, 2023 showed the laboratory failed to perform a positive and negative quality control each day of patient testing for SARS CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV). 2. The laboratory was unable to provide the number of patient tests performed on the Cepheid Genexpert Xpress PCR analyzer from January 23, 2023 to date November 7, 2023 while QC was not performed. 3. Interview with the TP #1 on November 7, 2023 at 10:00 AM confirmed, the laboratory failed to perform a positive and negative quality control for SARS CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV) each day of patient testing. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of Sysmex XP300 quality control (QC) records, and interview with the testing personnel (TP) #1 and the laboratory owner, the laboratory failed to establish criteria for acceptability of complete blood count (CBC) control materials providing quantitative results. Findings: 1. Review of the Sysmex XP300 QC records showed the laboratory did not establish, document, and define statistical parameter criteria (mean and standard deviations) for acceptability of quantitative hematology QC for the analytes: white blood cell (WBC), red blood cell (RBC), hemoglobin, hematocrit, mean corpuscular volume (MCV), MCH, MCHC, platelets and automated differential. 2. The laboratory was unable to provide the number of patient tests performed on the Sysmex XP300 analyzer from January 2023 to date November 7, 2023. 3. Interview with the TP #1 and laboratory owner on November 7, 2023 at 10: 00 AM confirmed the laboratory failed to establish criteria for acceptability of control materials providing quantitative results. D5805 TEST REPORT CFR(s): 493.1291(c) -- 6 of 16 -- 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 patient test reports and interview with the testing personnel (TP) #1 and the laboratory owner, the laboratory failed to include the address of the laboratory location where the test was performed on the patient test report. Findings: 1. Review of patient test report from 10/07/2023 for SARS CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV) showed no address of the laboratory location where the tests were performed. 2. Interview with the TP #1 and the laboratory owner on November 7, 2023 at 11:00 AM confirmed the laboratory failed to include the address of the laboratory location where the test was performed on the patient test report. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on lack of personnel documentation, review of American Proficiency Institute (API) proficiency testing (PT) documentation for 2023, review of the laboratory's procedures, review of Sysmex XP-300 analyzer quality control (QC) procedure, Cepheid Genexpert analyzer QC procedure, review of patient test reports, lack of testing personnel (TP) training documents, lack of available delegation of duties for the technical consultant and interviews, the laboratory director (LD) failed to provide overall management and direction to the laboratory. The laboratory failed to provide academic credentials to qualify the LD for moderate complexity testing (Refer to D6003); the LD failed to ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance (Refer to D6018); the LD failed to ensure an approved