World Wide Labz

Summary Statement of Deficiencies D0000 The purpose of this unannounced survey was for complaint #MI00138493. The Department of Licensing and Regulatory Affairs has evaluated this facility and determined that it is not in compliance with CLIA regulations (42 CFR Part 93, effective April 24, 2003) and has identified Immediate Jeopardy for the following Conditions: 493.1100 Condition: Facility administration (D3000) 493.1250 Condition: Analytic systems (D5400) 493.1441 Condition: Laboratories performing high complexity testing; laboratory director (D6076) 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 observations and interviews, the laboratory failed to have separate areas for specimen preparation and reagent preparation for its laboratory-developed open molecular amplification SARS-CoV-2 test system (refer to D3005 A) and failed to ensure its laboratory-developed open molecular amplification SARS-CoV-2 test system utilized a unidirectional workflow (refer to D3005 B). D3005 FACILITIES CFR(s): 493.1101(a)(3) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- Molecular amplification procedures that are not contained in closed systems have a uni-directional workflow. This must include separate areas for specimen preparation, amplification and product detection, and, as applicable, reagent preparation. This STANDARD is not met as evidenced by: . A. Based on observation and interview with Testing Personnel #2, the laboratory failed to have separate areas for specimen preparation and reagent preparation for its laboratory-developed open SARS-CoV-2 test system for 6 (March 2023 to August 2023) of 6 months the laboratory has been using this test system. Findings include: 1. The surveyor observed Testing Personnel #2 perform a walkthrough of the laboratory's SARS-CoV-2 testing process using their laboratory-developed, open test system on 8/14/23 at 2:46 pm which revealed the laboratory uses the same biosafety cabinet for specimen preparation and reagent preparation. 2. An interview on 8/14/23 at 2:46 pm with Testing Personnel #2 confirmed the laboratory uses the same biosafety cabinet for specimen preparation and reagent preparation. B. Based on observation and interview with Testing Personnel #2, the laboratory failed to ensure its laboratory-developed open molecular amplification SARS-CoV-2 test system utilized a unidirectional workflow for 6 (March 2023 to August 2023) of 6 months the laboratory has been using this test system. Findings include: 1. The surveyor observed Testing Personnel #2 perform a walkthrough of the laboratory's SARS-CoV-2 testing process using their laboratory-developed, open test system on 8/14/23 at 2:46 pm and revealed testing personnel takes off the post-amplification plate from the QuantStudio 5 analyzer at the same time it loads the pre-amplification test plate on the analyzer. 2. An interview on 8/14/23 at 2:46 pm with Testing Personnel #2 confirmed the laboratory takes off the post-amplification plate from the QuantStudio 5 analyzer at the same time it loads the pre-amplification test plate on the analyzer. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, 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 preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: . Based on record review and interviews, the laboratory failed to have test requests from an authorized provider (refer to D5301) and failed to follow its specimen acceptability and rejection policies and procedures (refer to D5311). D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: -- 2 of 9 -- . Based on record review and interview with the General Supervisor, the laboratory failed to have test requests from an authorized provider for 8 (Patients 230005083, 230004091, 230004093, 230009114, 230006123, 230005123, 230002128, and 230024159) of 15 test requests reviewed. Findings include: 1. A review of 15 patient test requests revealed the following did not include an authorized provider and had been collected at the laboratory: a. Patient 230005083 had SARS-CoV-2 testing reported on 3/25/23. b. Patient 230004091 had SARS-CoV-2 testing reported on 4/3 /23. c. Patient 230004093 had SARS-CoV-2 testing reported on 4/3/23. d. Patient 230009114 had SARS-CoV-2 testing reported on 4/24/23. e. Patient 230006123 had SARS-CoV-2 testing reported on 5/3/23. f. Patient 230005123 had SARS-CoV-2 testing reported on 5/3/23. g. Patient 230002128 had SARS-CoV-2 testing reported on 5/8/23. h. Patient 230024159 had SARS-CoV-2 testing reported on 6/9/23. 2. The surveyor requested additional information, or a standing order policy used by the laboratory on 8/14/23 at 2:19 pm and it was not made available. 3. An interview on 8 /14/23 at 4:00 pm with the General Supervisor confirmed the laboratory had no standing order policy and the test requests listed above did not have an authorized provider requesting testing. 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 record review and interview with the General Supervisor, the laboratory failed to ensure test requests included the date and time of specimen collection for 9 (Patients) of 15 patient test records reviewed. Findings include: 1. A review of patient test requisitions revealed the following patients had not had either the date or time of specimen collection indicated: a. Patient 230004091 has SARS-CoV-2 testing reported on 4/3/23 and the test request did not include both the date and time of collection. b. Patient 230002168 had SARS-CoV-2 testing reported on 6/17/23 and the test request did not include the time of collection. c. Patient 230002168 had SARS- CoV-2 testing reported on 6/17/23 and the test request did not include the time of collection. d. Patient 230004191 had SARS-CoV-2 testing reported on 7/10/23 and the test request did not include the time of collection. e. Patient 230004191 had SARS- CoV-2 testing reported on 7/10/23 and the test request did not include the time of collection. f. Patient 230042200 had SARS-CoV-2 testing reported on 7/19/23 and the test request did not include the time of collection. g. Patient 230023200 had SARS CoV-2 testing reported on 7/19/23 and the test request did not include the time of collection. h. Patient 230042200 had SARS-CoV-2 testing reported on 7/19/23 and -- 3 of 9 -- the test request did not include the time of collection. i. Patient 230023200 had SARS- CoV-2 testing reported on 7/19/23 and the test request did not include the time of collection. 2. An interview on 8/14/23 at 4:00 pm with the General Supervisor confirmed the laboratory had not ensured the date and time of collection had been indicated on the test requests for the patients listed above. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: . Based on record review and interview with the General Supervisor, the laboratory failed to follow its specimen acceptability and rejection policies and procedures for 4 (Patients 1230001060, 1230012094, 1230003097, and 1230025103) of 4 patients having Complete Blood Count (CBC) testing reviewed. Findings include: 1. A review of the laboratory's "CBC with differential on ABX Micros 60" procedure revealed a section titled "Specimen Requirements" stating, "Specimens should be transported at room temperature 18-26 degrees Celsius and can be store in the refrigerator of 2-8 degrees C up to 6 hours." 2. A review of the laboratory's "ABX Micros 60" user manual revealed a section titled "4.2.2 Sample Stability" stating, "Fresh Whole Blood specimens are recommended. The ICSH (International Committee for Standardization in Hematology) defines a Fresh blood specimen as one processed within 4 hours after collection. Well mixed Whole Blood specimens, collected in EDTA anti-coagulant and run eight hours after collection, provide the most accurate results for all parameters. The white cell size distribution may shift when specimens are assayed between 5 and 20 minutes after collection and more than 8 hours after collection." 3. A review of patient test reports revealed the following patients with CBC testing performed more than six hours after collection: a. Patient 1230001060 collected 3/1 /23 at 9:15 am and was performed and reported on 3/2/23 at 10:35 pm. b. Patient 1230012094 collected 4/4/23 at 10:33 am and was performed and reported on 4/4/23 at 7:24 pm. c. Patient 1230003097 collected 4/7/23 at 9:37 am and was performed and reported on 4/7/23 at 9:28 pm. d. Patient 1230025103 collected 4/13/23 at 2:25 pm and was performed and reported on 4/13/23 at 10:39 pm. 4. An interview on 8/14/23 at 4:00 pm with the General Supervisor confirmed the laboratory had not followed its policy for specimen rejection for the patients listed above. 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. -- 4 of 9 -- This CONDITION is not met as evidenced by: . Based on record review, observation, and interviews, the laboratory failed to establish accuracy performance specifications for its laboratory-developed SARS- CoV-2 test system (refer to D5423 A), failed to establish performance specifications for its laboratory-developed SARS-CoV-2 test system to include the extraction method, the amplification method, the software used to analyze amplification data, the specimen type, and the specimen collection device (refer to D5423 B), and failed to perform

Summary Statement of Deficiencies 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 record review, interview, and email correspondence, the laboratory failed to follow its policy when interpreting patient testing results for COVID-19 testing using the PhoenixDx SARS-CoV-2 multiplex qualitative RT-PCR assay for 6 (11/4 /20, 11/18/20, 11/20/20, 11/25/20, 12/4/20, and 12/22/20) of 10 testing dates reviewed. Findings include: 1. A review of the laboratory's "PhoenixDx SARS-CoV-2 Multiplex Qualitative" instructions for use (IFU) and their "PhoenixDx SARS-CoV-2 Multiplex Quality Control and Results Interpretation Procedure" revealed a section titled "Examination and Interpretation of Patient Specimen Results" stating, "A sample result is invalid if the detection of RNase P (HEX/VIC channel) in the sample fails and the sample also fails to show amplification of SARS-CoV-2 targets (N / ORF1ab in the FAM channel) within less than or equal to 35 Ct. Invalid results cannot be interpreted. Check reaction setup and device settings and repeat the RNA extraction if necessary. These samples should be repeated from the extraction step. Note: Failure to amplify the negative human extraction control may indicate inadequate RNA extraction or loss of RNA isolate due to RNAse contamination. Late Ct values for the IC may indicate a low RNA quality / amount in the extract. For a sample to be considered positive for SARS-CoV-2, the SARS-CoV-2 targets (FAM channel) must give a positive Ct value. Amplification of the IC in the HEX/VIC channel is expected around Ct 22-29. The IC may fail to amplify in the presence of high virus titers. Therefore, a sample with positive amplification of SARS-CoV-2 is positive even in the absence of RNase P amplification (IC). For a sample to be Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- considered negative for SARS-COV-2, the SARS-CoV-2 assays in the FAM. channel must not give a positive Ct value. The IC must give a positive Ct value in the HEX /VIC channel (Ct 22-29) for these samples to ensure that sample material of suitable quality was present." 2. A review of the laboratory's testing records and patient test reports revealed the following patients, their Ct values, and the final test report results that do not meet the criteria listed above for testing performed on 11/5/20 and 11/2/20: a. Patient 912803MJ i. internal control Ct value (VIC) of 25.908054 ii. SARS-CoV-2 viral target Ct (FAM) of 32.506565 iii. Test report result of negative b. Patient 462140HD i. VIC of 24.49584 ii. FAM of 18.4142 iii. Test report result of negative c. Patient 627107RF i. VIC of 26.584219 ii. FAM of 25.739803 iii. Test report result of negative d. Patient 589330ME i. VIC of Undetermined ii. FAM of 24.361181 iii. Test report result of negative e. Patient 251909JB i. VIC of 27.050365 ii. FAM of 34.74326 iii. Test report result of negative f. Patient 132579GD i. VIC of 26.781395 ii. FAM of 33.514103 iii. Test report result of negative g. Patient 713951LE i. VIC of 27.649044 ii. FAM of 38.688583 with the amplification status of "inconclusive" iii. Test report result of negative h. Patient 828238SD i. VIC of 25.821924 ii. FAM of 29.226145 iii. Test report result of negative i. Patient 409555MS i. VIC of 26.977304 ii. FAM of 26.598774 iii. Test report result of negative j. Patient 876718LJ i. VIC of 28.033558 ii. FAM of 28.71747 iii. Test report result of negative k. Patient 789513BD i. VIC of Undetermined ii. FAM of Undetermined iii. Test report result of negative l. Patient 133594RC i. VIC of 26.938522 ii. FAM of 30.515833 iii. Test report result of negative m. Patient 249106HK i. VIC of 23.868858 ii. FAM of 27.466122 iii. Test report result of negative n. Patient 546125EC i. VIC of 25.305733 ii. FAM of 24.28536 iii. Test report result of negative o. Patient 080109DD i. VIC of 29.47441 ii. FAM of 33.01652 iii. Test report result of negative p. Patient 488447JA i. VIC of 27.187027 ii. FAM of 28.438496 iii Test report result of negative q. Patient 201104008778 i. VIC of 31.882978 ii. FAM of 33.999035 iii. Test report result of negative r. Patient 201104008807 i. VIC of 31.360435 ii. FAM of 31.072567 iii. Test report result of negative s. Patient 201104008808 i. VIC of 31.990444 ii. FAM of 33.633293 iii. Test report result of negative t. Patient 201104008796 i. VIC of 31.22648 ii. FAM of 33.20088 iii. Test report result of negative u. Patient 201104008775 i. VIC of 31.123308 ii. FAM of 26.890274 iii. Test report result of negative v. Patient 201104008806 i. VIC of 30.952454 ii. FAM of 32.557846 iii. Test report result of negative w. Patient 201104008806 i. VIC of 30.977468 ii. FAM of 31.541794 iii. Test report result of negative x. Patient 201104008766 i. VIC of 30.75918 ii. FAM of 30.448345 iii. Test report result of negative y. Patient 201104008790 i. VIC of 30.354326 ii. FAM of 19.277208 iii. Test report result of negative z. Patient 201104008790 i. VIC of Undetermined ii. FAM of 24.269781 iii. Test report result of negative aa. Patient 201104008768 i. VIC of 30.150524 ii. FAM of 29.350496 ii. Test report result of negative 3. A review of the laboratory's testing records revealed the following discrepancies for patients' Ct values and the results that do not meet the criteria listed above for testing completed on 11/18/20, 11/25/20, 12/4 /20, and 12/22/20: Testing performed on 11/18/20 a. Patient 420643GD i. VIC of 29.067991 ii. FAM of 21.122551 iii. Results of negative Testing performed on 11/25 /20 a. Patient HFOH1020 i. VIC of 28.855377 ii. FAM of 34.21538 iii. Result of negative b. Patient HFOH1243 i. VIC of 30.694355 ii. FAM of 34.42861 iii. Result of negative c. Patient 051441FY i. VIC of 24.594633 ii. FAM of 34.501133 iii. Result of negative d. Patient 073378SC i. VIC of 24.439243 ii. FAM of 23.478592 iii. Result of negative e. Patient HFOH1061 i. VIC of 28.744646 ii. FAM of 34.598576 iii. Result of negative f. Patient HLX67901527 i. VIC of 26.797724 ii. FAM of 34.040012 iii. Result of negative g. Patient HLX67901540 i. VIC of 27.283403 ii. FAM of 27.031754 iii. Result of negative Testing performed on 12/4/20 a. Patient WS2115 i. VIC of 31.29995 ii. FAM of 21.526726 iii. Result of negative Testing performed on 12 -- 2 of 3 -- /22/20 a. Patient HLX67901656 i. VIC of 34.328255 ii. FAM of 28.54934 iii. Result of negative 4. An interview on 1/19/21 with the Laboratory Director revealed the laboratory's process was to review the confidence levels for the specimens. If the confidence levels were not acceptable, the laboratory would interpret the results from the run prior to the software interpretation, then report the patient results. 5. A review of email correspondence sent to the surveyor on 1/20/21 from the laboratory consultant revealed the following criteria used, "Please see below the interpretation of Cq Conf as our techs learned from the onsite training (10/30/2020). The Cq Conf value were included in the raw PCR result table for review. Once the lab encountered a questionable Cq Conf value, the lab used to consult with manufacturer for further review and interpretation. During our in-lab training (10/30/2020) with a technical consultant from Trax team. Our techs were told that Cq Conf should be considered when reviewing results. A Cq Conf value lower than ~0.8 should be considered as false positive, or a rerun should be considered. Starting from December 2020, the laboratory is performing QC review on a daily basis with techs and LD. The lab has been performing interpretation strictly following the IFU and lab procedure. Only Ct values and amplification status were utilized for interpretation and review. If any run returned positive or undetermined results, the lab will immediately perform a rerun." 6. The surveyor requested

Summary Statement of Deficiencies D0000 The purpose of this unannounced survey was for complaint #MI00111924. The Department of Licensing and Regulatory Affairs has evaluated this facility and determined that it is not in compliance with CLIA regulations (42 CFR Part 93, effective April 24, 2003). 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 record review and interview with the Laboratory Manager, the laboratory failed to ensure the test requisition listed the tests to be performed for 8 (patients W3- W10) of 10 patient testing records audited. Findings include: 1. An audit of patient testing records revealed the following patients had test requisitions without the tests to be performed indicated on the requisition: a. Patient W3 b. Patient W4 c. Patient W5 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- d. Patient W6 e. Patient W7 f. Patient W8 g. Patient W9 h. Patient W10 2. An interview with the Laboratory Manager on 8/26/2020 at 4:00 pm confirmed the laboratory did not ensure the test requisitions indicated the test to be performed. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Manager, the laboratory failed to maintain a record system that included the identity of the testing personnel performing COVID-19 IgM/IgG testing for 10 (patients W1-W10) of 10 patient testing records audited. Findings include: 1. An audit of patient testing records revealed the laboratory did not have a record system in place that included the identity of the testing personnel who performed and documented the COVID-19 IgM and IgG testing results for the patients listed below: a. Patient W1 b. Patient W2 c. Patient W3 d. Patient W4 e. Patient W5 f. Patient W6 g. Patient W7 h. Patient W8 i. Patient W9 j. Patient W10 2. An interview with the Laboratory Manager on 8/26/2020 at 4:00 pm confirmed the laboratory did not have a record system in place to document the identity of the testing personnel performing patient testing. 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: . A. Based on record review and interview with the Laboratory Manager, the laboratory failed to include the test report date on 10 (Patients W1- W10) of 10 patient testing records audited. Findings include: 1. An audit of the laboratory's patient testing records revealed a lack of documentation of the test report date on the test reports for the following patients: a. Patient W1 b. Patient W2 c. Patient W3 d. Patient W4 e. Patient W5 f. Patient W6 g. Patient W7 h. Patient W8 i. Patient W9 j. Patient W10 2. An interview with the Laboratory Manager on 8/26/2020 at 4:00 pm confirmed the laboratory did not include the test report date on patient test reports. B. Based on record review and interview with the Laboratory Manager, the laboratory failed to indicate the test performed on the test report for 8 (Patients W3-W10) of 10 patient testing records audited. Findings include: 1. An audit of the laboratory's patient testing -- 2 of 8 -- records revealed a lack of documentation of the test performed on the test report for the following patients: a. Patient W3 b. Patient W4 c. Patient W5 d. Patient W6 e. Patient W7 f. Patient W8 g. Patient W9 h. Patient W10 2. An interview with the Laboratory Manager on 8/26/2020 at 4:00 pm confirmed the laboratory did not have a system in place to ensure the test performed was indicated on patient test reports. C. Based on record review and interview with the Laboratory Manager, the laboratory failed to provide patients receiving testing with the Healgen COVID-19 IgM/IgG Rapid Test Cassette test with the Fact Sheet for recipients required for interpretation of results for 4 (April 2020 to August 2020) of 4 months. Findings include: 1. A record review of the laboratory's patient test records revealed the earliest test report was signed by the patient on 4/17/2020. 2. A review of the Fact Sheet given to patients with their COVID-19 IgM/IgG results revealed it was not the Fact Sheet authorized by the Food and Drug Administration (FDA) Emergency Use Authorization (EUA). 3. A record review of the "Healgen COVID-19 IgM/IgM Rapid Test Cassette" manufacturer's package insert revealed a section stating, "Authorized laboratories using your product will include with result reports of your product, all authorized Fact Sheets. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media. Authorized laboratories using your product will use your product as outlined in the Instructions for Use. Deviations from the authorized procedures, including the authorized clinical specimen types, authorized control materials, authorized other ancillary reagents and authorized materials required to use your product are not permitted." 4. A record review of the EUA letter from the FDA for the Healgen COVID-19 IgM/IgG Rapid Test Cassette revealed a section titled "Authorized Laboratories" stating, "Authorized laboratories using your product will include with test result reports, all authorized Fact Sheets. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media. Authorized laboratories will use your product as outlined in the Instructions for Use. Deviations from the authorized procedures, including the authorized clinical specimen types, authorized control materials, authorized other ancillary reagents and authorized materials required to use your product are not permitted." 5. An interview with the Laboratory Manager on 8/26/2020 at 4:00 pm confirmed the laboratory had not been distributing the authorized Fact Sheets to patients according to the manufacturer's instructions. 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 record review and interviews with the Laboratory Manager, the Laboratory Director failed to provide overall management and direction in accordance with 493.1407 of this subpart. Findings include: 1. The Laboratory Director failed to ensure the Healgen COVID-19 IgM/IgG Rapid Test Cassette could provide quality results prior to testing patient specimens. Refer to D6012. 2. The Laboratory Director failed to ensure a quality control program was implemented and followed for the Healgen COVID-19 IgM/IgG Rapid Test Cassette test system. Refer to D6020. 3. The -- 3 of 8 -- Laboratory Director failed to ensure all personnel using the Healgen COVID-19 IgM /IgM Rapid Test Cassette test system received training prior to testing patients' specimens. Refer to D6029. D6012 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(ii) The test methodologies selected have the capability of providing the quality of results required for patient care; This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Manager, the Laboratory Director failed to ensure the Healgen COVID-19 IgM/IgG Rapid Test Cassette could provide quality results prior to testing patient specimens for 4 (April 2020 to August 2020) of 4 months the test system has been in use. Findings include. 1. A record review of the laboratory's patient test records revealed the earliest test report was signed by the patient on 4/17/2020. 2. When requested by the surveyor on 8/24/2020 at 2:26 pm, the laboratory's records of a verification of test performance specifications for the Healgen COVID-19 IgM/IgG Rapid Test Cassette test system were not made available. 3. An interview with the Laboratory Manager on 8/24/2020 at 3:21 pm confirmed the laboratory did not perform verification of test performance specifications for the Healgen COVID-19 IgM/IgG Rapid test Cassette test system. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Manager, the Laboratory Director failed to ensure a quality control program was implemented and followed for the Healgen COVID-19 IgM/IgG Rapid Test Cassette test system for 4 (April 2020 to August 2020) of 4 months the test system has been in use. Findings include: 1. A record review of the laboratory's patient test records revealed the earliest test report was signed by the patient on 4/17/2020. 2. A review of the Healgen COVID-19 IgM /IgG Rapid Test Cassette manufacturer package insert revealed a section titled "Quality Control" stating, "A procedural control is included in the test. A red line appearing in the control region (C) is the internal procedural control. It confirms sufficient specimen volume and correct procedural technique. Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance. Additional controls may be required according to -- 4 of 8 -- guidelines or local, state, and/or federal regulations (such as 42 CFR 493.1256) or accrediting organizations." 3. A review of the Emergency Use Authorization (EUA) letter from the Food and Drug Administration (FDA) revealed a section titled "Authorized Product Details" stating, "Your product requires the following internal control, that is processed along with the specimen on the device cassette. The internal control listed below must generate expected results in order for a test to be considered valid, as outlined in the Instructions for Use. Internal Control - The C line color change from blue to red should appear for every test and checks that flow of reagents is satisfactory. You also recommend use of external positive and negative controls, or other authorized controls, to be run as outlined in the Instructions for Use. Your product also requires the use of additional authorized materials and authorized ancillary reagents that are not included with your product and are described in the Instructions for Use." 4. When the surveyor requested documentation of control performance for the Healgen COVID-19 IgM/IgG Rapid Test Cassette test system on 8/24/2020 at 2:48 pm, the documents were not made available. 5. A review of the laboratory's established "Rapid COVID-19 IgG/IgM Testing" procedure revealed a lack of protocol for documenting control activities. 6. An interview with the Laboratory Manager on 8/24/2020 at 3:52 pm confirmed the laboratory did not have records of the Healgen COVID-19 IgM/IgM Rapid Test Cassette test system control performance. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Manager, the Laboratory Director failed to ensure all personnel using the Healgen COVID-19 IgM/IgM Rapid Test Cassette test system received training prior to testing patients' specimens for 4 (April 2020 to August 2020) of 4 months the test system has been in use. Findings include: 1. A record review of the laboratory's patient test records revealed the earliest test report was signed by the patient on 4/17/2020. 2. The surveyor requested documentation of training for the testing personnel listed on the CMS-209 form performing the Healgen COVID-19 IgM/ IgG Rapid Test Cassette test system on 8/24 /2020 at 2:16 pm and the documents were not made available. 3. An interview with the Laboratory Manager on 8/26/2020 at 4:00 pm confirmed the laboratory did not have documentation of training for testing personnel performing testing using the Healgen COVID-19 IgM/IgG Rapid Test Cassette test system. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in -- 5 of 8 -- accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: . Based on review of records submitted by the Laboratory Manager, the laboratory failed to ensure the Technical Consultant met the qualification requirements at 493.1411. Findings include: 1. The laboratory failed to ensure personnel acting as the Techinical Consultant were qualified. Refer to D6033. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: . Based on a review of personnel records provided by the Laboratory Manager and lack of documentation, the laboratory failed to ensure personnel acting as the Techinical Consultant was qualified for 4 (April 2020 to August 2020) of 4 months. Findings include: 1. The surveyor requested qualification documentation for all staff listed on the CMS-209 form showing they were qualified on 8/24/2020 at 1:41 pm. 2. A record review of personnel records submitted to the surveyor from the Laboratory Manager on 9/1/2020 at 7:40 am revealed a lack of documentation of at least 2 years -- 6 of 8 -- of laboratory training or experience or both in non-waved testing in the designated specialties indicated on the laboratory's CMS-116 form. 3. The laboratory was provided 7 days to supply documentation and it was not made available. D6056 CLINICAL CONSULTANT CFR(s): 493.1415 The laboratory must have a clinical consultant who meets the qualification requirements of 493.1417 of this part and provides clinical consultation in accordance with 493.1419 of this part. This CONDITION is not met as evidenced by: Based on review of records submitted by the Laboratory Manager, the laboratory failed to ensure the Clinical Consultant met the qualification requirements at 493.1419 of this part. Findings include: 1. The laboratory failed to ensure the Clinical Consultant was qualified. Refer to D6057. D6057 CLINICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1417 The clinical consultant must be qualified to consult with and render opinions to the laboratory's clients concerning the diagnosis, treatment and management of patient care. The clinical consultant must-- (a) Be qualified as a laboratory director under 493. 1405(b)(1), (2), or (3)(i); or (b) Be a doctor of medicine, doctor of osteopathy or doctor of podiatric medicine and possess a license to practice medicine, osteopathy or podiatry in the State in which the laboratory is located. This STANDARD is not met as evidenced by: . Based on a review of personnel records provided by the Laboratory Manager and lack of documentation, the laboratory failed to ensure the Clinical Consultant was qualified for 4 (April 2020 to August 2020) of 4 months. Findings include: 1. The surveyor requested qualification documentation for all staff listed on the CMS-209 form showing they were qualified on 8/24/2020 at 1:41 pm. 2. A record review of personnel records submitted to the surveyor from the Laboratory Manager on 9/1 /2020 at 7:40 am revealed a lack of documentation showing the Clinical Consultant was a doctor of medicine, doctor of osteopathy or doctor of podiatric medicine and possesses a State of Michigan license to practice. 3. The laboratory was provided 7 days to supply documentation and it was not made available. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: . Based on review of records submitted by the Laboratory Manager, the laboratory -- 7 of 8 -- failed to ensure the testing tersonnel met the qualification requirements at 493.1423. Findings include: 1. The laboratory failed to ensure testing personnel was qualified. Refer to D6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: . Based on a review of records provided by the Laboratory Manager and lack of documentation, the laboratory failed to ensure testing personnel were qualified for 3 (Testing Personnel #2-#4) of 4 testing personnel listed on the laboratory's CMS-209 form. Findings include: 1. The surveyor requested qualification documentation for all staff listed on the CMS-209 form showing they were qualified on 8/24/2020 at 1:41 pm. 2. A record review of personnel records submitted to the surveyor from the Laboratory Manager on 9/1/2020 at 7:40 am revealed a lack of documentation of the necessary qualifications listed at 493.1423 for the following testing personnel listed on the CMS-209 form: a. Testing Personnel #2 b. Testing Personnel #3 c. Testing Personnel #4 3. The laboratory was provided 7 days to supply documentation and it was not made available. -- 8 of 8 --