Doctors Clinical Laboratory

Summary Statement of Deficiencies 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: REPEAT DEFICIENCY A. FAILED TO REPORT SARS-CoV-2 RAPID ANTIGEN RESULTS Based on record review, lack of documentation, and interview, the laboratory failed to report SARS-CoV-2 Antigen test results as required for 628,519 patients. Findings include: 1. The patient COVID-19 Antigen results performed on November 9, 2021 and November 11, 2021, the OCL laboratory Information System (LIS) lists, the Emergency Use Authorization (EUA) for SARS-CoV-2 Antigen testing, and the laboratory's COVID-19 reporting procedures were reviewed. 2. The OCL-LIS revealed DCL collection sites performed 8,828 COVID-19 antigen tests on November 9, 2021, and 7,653 on November 11, 2021. 3. Under the EUA's "CONDITION OF AUTHORIZATION" for CareStart, INDICAID, Celltrion DiaTrust, and SIENNA-Clartity COVID-19 Antigen tests, the health provide968r is required to report all negative and positive COVID-19 antigen results to the appropriate Public Health Agency. 4. The laboratory failed to include in its COVID- 19 reporting procedures, the requirement and process to report the COVID-19 antigen test results performed at the collection sites to the appropriate Public Health agency. 5. The laboratory failed to provide evidence of reporting to the state agency for 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 2 -- 16,481 antigen tests performed on November 9, 2021 and November 11, 2021. 6. Interview with a reporting specialist on November 17, 2021 at 3:20 PM confirmed that negative results for antigen testing are not reported to the state agency. 7. The laboratory reporting specialist was unable to provide evidence of reporting for COVID-19 antigen testing for ten of ten patient specimens requested by the surveyor. 8. Email on November 24, 2021 at 12:10 PM confirmed that upon the start of COVID- 19 antigen testing on June 7, 2021, that 628,519 patients have been tested and 605,684 were resulted as negative and 22,835 had been resulted as positive. 9. On a Recertification and Complaint survey conducted on November 17, 2021 at 1:30 PM, the laboratory director and information technology (IT) employee confirmed the above findings. B. FAILED TO REPORT SARS-CoV-2 PCR RESULTS Based on record review, lack of documentation, and interview, the laboratory failed to report SARS-CoV-2 PCR-RNA results as required for two out of two days reviewed in the week of November 2021 for 14,262 patients. Findings include: 1. The total final patient reports from the DCL laboratory information system (LIS) collected from November 9 and 11, of 2021, the DCL Laboratory reporting policy and procedures, and DoIT State of Illinois Notification confirmations were reviewed. 2. The DCL-LIS and DoIT notification confirmations revealed the following: *DCL laboratory reported 8,828 SARS-CoV-2 RNA-PCR tests results on November 9, 2021; 499 of these results were received by DoIT. *DCL laboratory reported 7653 SARS-CoV-2 RNA-PCR tests results on November 11, 2021, 1720 of these results were received by DoIT. *The transmission of 14,262 SARS-CoV-2 RNA-PCR tests results failed to be received by DoIT State Agency. 3. The laboratory failed to include in its COVID-19 reporting procedures a process to ensure COVID-19 PCR-RNA results which fail to transmit are identified and retransmitted to the appropriate Public Health Agency. 4. On a Recertification and Complaint survey conducted on November 17, 2021 at 1:30 PM, the laboratory director and information technology (IT) employee confirmed the above findings. C. FAILED TO REPORT SARS-CoV-2 PCR RESULTS TO STATE PUBLIC HEALTH AUTHORITY 1. The laboratory failed to report SARS-CoV-2 PCR (SCP) patient test results to the applicable state public health authority for the following states: a) Texas- 4064 SCP patient test results b) Michigan- 6210 SCP patient test results c) Colorado- 14172 SCP patient test results d) Florida- 9699 SCP patient test results e) Ohio- 9750 SCP patient test results f) South Carolina- 356 SCP patient test results g) Arizona- 4669 SCP patient test results h) Massachusetts- 954 SCP patient test results i) Georgia- 46 SCP patient test results j) Indiana- 1194 SCP patient test results k) Washington- 3403 SCP patient test results l) Virginia- 369 SCP patient test results m) Oregon- 7078 SCP patient test results n) Minnesota- 491 SCP patient test results o) California- 190 SCP patient test results p) Missouri- 1597 SCP patient test results q) Maryland- 856 SCP patient test results r) Rhode Island- 154 SCP patient test results s) Arkansas- 369 SCP patient test results t) New York- 126 SCP patient test results 2. The IT employee confirmed the above findings on November 18, 2021 at 12:00 PM. -- 2 of 2 --

Summary Statement of Deficiencies 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: A. FAILED TO REPORT SARS-CoV-2 RAPID ANTIGEN RESULTS Based on record review, lack of documentation, and interview, the laboratory failed to report SARS-CoV-2 test results as required for four out of four days reviewed in the week of August 2021 for 4120 patients. Findings include: 1. 20 final reports of selected patients from the Doctors Clinical laboratory (DCL) laboratory information system (LIS) collected from August 10, 2021 through August 13, 2021, the DCL Laboratory Accession GUIDE User manual, and DoIT State of Illinois Notification confirmations were reviewed. 2. The employees at the collection sites performed the following duties: *Tested patients using the SARS-CoV-2 Rapid test, *Collected patients' nasopharyngeal swabs for SARS-CoV-2 RT-PCR testing; and *Generated the patient's requisition in the DCL-LIS. 3. The LIS User manual failed to include instructions on entering Rapid results or provide a 'field' or space for the result to be documented for each patient at the collection sites. 4. 20 final laboratory reports were reviewed and found to have not had COVID testing results reported as required. 5. DoIT confirmations were also reviewed for a period of two out of four days and investigation revealed that 4110 Rapid COVID test results from August 10 to 11, 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 -- 2021 also were not reported as required. 6. The laboratory director confirmed the above findings on 09/29/2021 at 3:15PM. B. FAILED TO REPORT SARS-CoV-2 PCR RESULTS Based on record review and interview, the laboratory failed to report SARS-CoV-2 test results as required for two out of four days reviewed in the week of August 2021 for 4110 patients. Findings include: 1. The 20 final reports of selected patients from the DCL laboratory information system (LIS) collected from August 10, 2021 through August 13, 2021, the DCL Laboratory Accession GUIDE User manual, and DoIT State of Illinois Notification confirmations were reviewed. Findings include: 2. 10 out of 20 final reports were reviewed and found to have not had SARS- CoV-2 PCR test results reported as required for two (August 10 and 11, 2021) out of four days. 3. DoIT confirmations were also reviewed for August 10 and August 11, 2021 and investigation revealed that 4110 SARS-CoV-2 test results also were not reported as required. 4. The laboratory director confirmed the above findings on 09/15 /2021 at 6:46PM. -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the CASPER Report 0155D Proficiency Testing (PT) records and communication with the American Association of Bioanalysts (AAB) PT program representative; the laboratory failed to successfully participate in the testing of PT samples for the endocrinology analyte Triiodothyronine (T3) Uptake during events 2 and 3 of 2020 and event 1 of 2021 resulting in non-initial (subsequent-not the first) unsuccessful performance. Findings include: 1. Review of CASPER Report 0155D generated on 05-03-2021 and communication with the AAB PT provider on 05/04 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 -- /2021 at 2:37 PM, confirmed the non-initial (subsequent-not the first) unsuccessful performance for the analyte T3 Uptake under the sub-specialty of endocrinology for PT events 2 and 3 of 2020 and event 1 of 2021. See D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the CASPER Report 0155D Proficiency Testing (PT) records and communication with the PT provider American Association of Bioanalysts (AAB) program representative; the laboratory failed to successfully participate in the testing of the endocrinology analyte Triiodothyronine (T3) Uptake during events 2 and 3 of 2020 and event 1 of 2021, resulting in non-initial (subsequent-not the first) unsuccessful PT performance. Findings include: 1. Review of the CASPER Report 0155D, generated on 05-03-2021, revealed the non-initial (subsequent -not the first) unsuccessful performance for the endocrinology analyte listed below. ENDOCRINOLOGY T3 Uptake - EVENT-2, 2020 = 0% Unsatisfactory T3 Uptake - EVENT-3, 2020 = 0% Unsatisfactory T3 Uptake - EVENT-1, 2021 = 0% Unsatisfactory 2. A phone interview with the (AAB) PT vendor on 05/04/2021 at 2:37 PM, confirmed the unsatisfactory scores for T3 Uptake, under the sub-specialty of endocrinology, for PT events 2 and 3 of 2020 and event 1 of 2021 due to the laboratory's failure to report to the PT program. -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the CASPER Report 0155D Proficiency Testing (PT) records and communication with the American Association of Bioanalysts (AAB) PT program representative; this laboratory failed to successfully participate in the testing of PT samples for the endocrinology analyte Triiodothyronine (T3) Uptake during events 2 and 3 of 2020. Findings include: 1. Review of CASPER Report 0155D and communication with the (AAB) PT provider on 12/09/2020 at 1:23 PM, confirmed the initial unsuccessful performance for the analyte T3 Uptake under the sub-specialty of endocrinology for PT events 2 and 3 of 2020. See D2107. 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 -- D2107 ENDOCRINOLOGY CFR(s): 493.843(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the CASPER Report 0155D Proficiency Testing (PT) records and communication with the PT provider American Association of Bioanalysts (AAB) program representative; this laboratory failed to successfully participate in the testing of the endocrinology analyte Triiodothyronine (T3) Uptake during events 2 and 3 of 2020. Findings include: 1. Review of the CASPER Report 0155D, generated on 12-01- 2020, revealed the initial unsuccessful performance for the endocrinology analyte listed below. ENDORINOLOGY T3 Uptake - EVENT-2, 2020 = 0% Unsatisfactory T3 Uptake - EVENT-3, 2020 = 0% Unsatisfactory 2. A phone interview with the (AAB) PT vendor on 12/09/2020 at 1:23 PM, confirmed the unsatisfactory scores for T3 Uptake, under the sub-specialty of endocrinology, for PT events 2 and 3 of 2020. -- 2 of 2 --

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 and an interview with the technical supervisor (TS); the laboratory failed to follow written quality control procedures for the antimicrobial susceptibility tests performed. Findings include: 1. The laboratory's individual quality control plan (IQCP) and the Mueller Hinton Plates and Sensitivity Disks (MHSD) quality control (QC) logs from May through July of 2019 were reviewed. 2. The IQCP required testing personnel (TP) to perform weekly testing of pathogenic control organisms for drug sensitivity and/or resistance. The zone sizes to the various drug discs, their lot numbers and expiration date, and the media's lot number and expiration date must be recorded in the MHSD-QC log. 3. The MHSD-QC logs revealed the following: *The pathogenic organisms were tested only 1 week in the months of May, June, and July of 2019. *The TP failed to document the lot number and expiration dates of the media used for the susceptibility test in the months of June and July of 2019. 4. On a Recertification survey conducted on 07/31/2019 at 2:30 PM, the TS and TP confirmed the above findings. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report 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 -- destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on record review and an interview with the technical supervisor (TS); the laboratory failed to accurately and reliably enter patient-specific data from their requisition into the patient's electronic medical records (EMR), for 1 (Patient-CX3) out of 8 patients. Findings include: 1. The patients' final reports from the EMR and their requisitions were reviewed. 2. The review revealed that 1 out of 8 patients' information was inaccurately enter into the EMR: Patient-CX3's requisition states patient's date of birth as 04/09/1939, the date of birth reported from the Patient-CX3 EMR is 04/19/1939. 3. On a Recertification survey conducted on 07/31/2019 at 2:00 PM, the TS confirmed the above findings. 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: Based on record review and an interview with the technical supervisor (TS); the laboratory failed to indicate information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability, for 1 (Patient- D9) out of 8 patients. Findings include: 1. The patients' final reports from the EMR and their requisitions were reviewed. 2. The review of 8 patients' final reports revealed the following: *Patient-D9's requisition included a request for Urine Culture testing and sensitivity. *Patient-D9's final report does not include results from a urine Culture test. 3. The laboratory failed to indicate in the test report the reason a urine culture test was not performed on Patient-D9. 4. On a Recertification survey conducted on 07/31/2019 at 2:00 PM, the TS confirmed the above findings. -- 2 of 2 --