Doctors General Laboratory

Summary Statement of Deficiencies D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, American Proficiency Institute (API) proficiency testing (PT) records, lack of documentation, and interview with the laboratory owner; the laboratory failed to ensure accuracy of 55 of 55 analytes not evaluated by the PT provider for seven of seven PT events in the specialties of diagnostic immunology, hematology, microbiology, and chemistry in 2023 and 2024. Findings include: 1. Review of laboratory policies and procedures revealed the policy titled, "Proficiency Testing", which stated, under "Receipt of Survey Results", "For all flagged results, review the QC for that day. Attempt to explain all flagged results." 2. Review of API comparative evaluation summaries for the following PT events of 2023 and 2024 revealed the following un-graded PT samples: PT Event: Analyte : Sample: 2023 Event 3 C-Reactive Protein CRP-05 2024 Event 1 Bilirubin, total CH-02 2024 Event 1 Bilirubin, total CH-03 2024 Event 1 Bilirubin, total CH-05 2024 Event 1 TMS* UR-01 2024 Event 1 Vancomycin UR-01 2024 Event 2 Urobilinogen UA-04 2024 Event 2 Iron, total CH-08 2024 Event 2 Iron, total CH-08 2024 Event 2 Ciprofloxacin UR-06 2024 Event 3 Azithromycin UR-11 2024 Event 3 CTX-M Group 1** UTI-11 2024 Event 3 CTX-M Group 1** UTI-13 2024 Event 3 CTX-M Group 1** UTI-14 2024 Event 3 CTX-M Group 1** UTI-15 2024 Event 3 CTX-M Group 2** UTI-11 2024 Event 3 CTX-M Group 2** UTI-13 2024 Event 3 CTX-M Group 2** UTI-14 2024 Event 3 CTX-M Group 2** UTI-15 2024 Event 3 ErmA** UTI-12 2024 Event 3 ErmA** UTI-13 2024 Event 3 ErmA** UTI-14 2024 Event 3 ErmB** UTI-11 2024 Event 3 ErmB** UTI-13 2024 Event 3 ErmB** UTI-14 2024 Event 3 ErmC** UTI-13 2024 Event 3 ErmC** UTI-14 2024 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 -- Event 3 mecA** UTI-11 2024 Event 3 mecA** UTI-12 2024 Event 3 mecA** UTI- 13 2024 Event 3 mecA** UTI-14 2024 Event 3 mecA** UTI-15 2024 Event 3 NDM** UTI-11 2024 Event 3 NDM** UTI-13 2024 Event 3 NDM** UTI-14 2024 Event 3 NDM** UTI-15 2024 Event 3 OXA** UTI-11 2024 Event 3 OXA** UTI-13 2024 Event 3 OXA** UTI-14 2024 Event 3 OXA** UTI-15 2024 Event 3 qnr** UTI- 11 2024 Event 3 qnr** UTI-13 2024 Event 3 qnr** UTI-14 2024 Event 3 qnr** UTI- 15 2024 Event 3 qnrB** UTI-11 2024 Event 3 qnrB** UTI-13 2024 Event 3 qnrB** UTI-14 2024 Event 3 qnrB** UTI-15 2024 Event 3 Tet M** UTI-12 2024 Event 3 Tet M** UTI-13 2024 Event 3 Tet M** UTI-14 2024 Event 3 VIM** UTI-11 2024 Event 3 VIM** UTI-13 2024 Event 3 VIM** UTI-14 2024 Event 3 VIM** UTI-15 *TMS = Trimethoprim/Sulfamethoxazole **Molecular Resistance Markers 3. Review of laboratory records found no documented review of the ungraded PT analytes in the specialties of diagnostic immunology, hematology, microbiology, and chemistry in 2023 and 2024. 4. Interview with the laboratory owner on 12/04/2024, at 3:44 pm, confirmed the laboratory failed to ensure accuracy of analytes not evaluated by the PT provider for seven of seven applicable PT events. 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 laboratory policies and procedures, laboratory records, lack of documentation, and interviews with the laboratory owner and technical supervisor (TS) #2; the laboratory failed to ensure negative and positive control materials were tested each day of patient testing for four of four patients reviewed in the specialty of microbiology (See D5449). 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. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, lack of documentation, and interviews with the laboratory owner and technical supervisor (TS) #2; the laboratory failed to ensure negative and positive control materials were tested each day of patient testing for four of four patients reviewed in the specialty of microbiology from the beginning of 2023 to the date of survey, 12/04/2024, affecting 3,603 patients. Findings include: 1. Review of laboratory policies and procedures revealed the policy titled, "Quality Control Program and Policy", which stated, under -- 2 of 3 -- "[Section] IV", "Positive and negative controls are used for each run of patients ...." 2. Review of laboratory policies and procedures revealed the procedure titled, "Analysis of Urinary Tract Microbiota by PCR [Polymerase Chain Reaction]" found the following pathogens and antibiotic resistance markers (ABRs) tested on the Urinary Tract Microbiota (UTM) PCR Panel: Pathogens: Candida albicans Citrobacter freundii Enterobacter aerogenes Enterobacter cloacae Enterococcus faecalis Enterococcus faecium Escherichia coli Klebsiella oxytoca Klebsiella pneumonia Morganella morganii Proteus mirabilis Proteus vulgaris Providencia stuartii Pseudomonas aeruginosa Staphylococcus saprophyticus Streptococcus agalactiae (Group B) Chlamydia trachomatis Neisseria gonorrhoeae Trichomonas vaginalis Gardnerella vaginalis ABRs: NDM Beta-lactam resistance VIM Beta-lactam resistance Methicillin resistance Tetracycline resistance Fox Beta-lactam resistance Erythromycin A, B, C resistances GES Beta-lactam resistance Quinolone resistance Quinolone B resistance CTX-M Group 1, 2 resistances Vancomycin resistance CTX- M Group 8/25, Group 9 resistances Oxacillinase resistance Carbapenem resistance Extended resistance 3. Review of laboratory quality control records for four of four patient testing dates review for UTM PCR Panel found positive and negative control materials were not utilized on each day of patient testing. Date: Patient: Positive Control: Negative Control: Extraction Control: 01/13/2023 257352 Not performed Performed Performed 09/06/2023 257894 Not performed Performed Performed 02/26 /2024 484288 Not performed Not Performed Not Performed 10/22/2024 499986 Not performed Not Performed Not Performed 4. Interviews with the laboratory owner and TS #2 on 12/04/2024, at 2:39 pm, confirmed the laboratory failed to ensure negative and positive control materials were tested each day of patient testing. 5. Interview with the laboratory owner on 12/04/2024, at 3:56 pm, revealed 3,603 UTM PCR Panels had been performed from the beginning of 2023 through the date of survey, 12 /04/2024. -- 3 of 3 --

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 and interview with an American Association of Bioanalysts (AAB) representative the laboratory failed to successfully participate in proficiency testing (PT) for the routine chemistry analyte amylase during event three of 2021 and event one of 2022 (See D2096) and the endocrinology analyte thyroxine during events one and two of 2021 (See D2107). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- 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 CASPER Report 0155D and interview with an American Association of Bioanalysts (AAB) representative; the laboratory failed to successfully participate in proficiency testing (PT) for the routine chemistry analyte amylase during event three of 2021 and event one of 2022. Findings include: 1. Review of the CASPER Report 0155D ran on 9-1-2022 identified the initial unsuccessful PT performance for the specialty of chemistry for the analyte amylase. ROUTINE CHEMISTRY Amylase- EVENT-3, 2021 = 0% - Unsatisfactory Amylase- EVENT-1, 2022 = 0% - Unsatisfactory 2. A phone interview with the AAB PT representative on 09/01/2022, at 9:43 AM, confirmed the unsuccessful PT performance for amylase during event three of 2021 and event one of 2022. 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 CASPER Report 0155D and interview with an American Association of Bioanalysts (AAB) representative; the laboratory failed to successfully participate in proficiency testing (PT) for the endocrinology analyte thyroxine (TT4) during events one and two of 2021. Findings include: 1. Review of the CASPER Report 0155D ran on 9-1-2022 identified the initial unsuccessful PT performance for the subspecialty of endocrinology analyte thyroxine (TT4). ENDOCRINOLOGY Thyroxine (TT4) - EVENT-1, 2021 = 0% - Unsatisfactory Thyroxine (TT4) - EVENT- 2, 2021 = 0% - Unsatisfactory 2. A phone interview with the AAB PT representative on 09/01/2022, at 9:43 AM, confirmed the unsuccessful PT performance for thyroxine (TT4) during events one and two of 2021. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A complaint survey was performed on 1/18/2022 at approximately 12:00 pm at 1100 Blairs Ferry Rd NE Suite 113, Cedar Rapids, IA 52402. The sign at the entrance of the facility located at 1100 Blairs Ferry Rd NE Suite 113, Cedar Rapids, IA 52402 stated "Quick N Free COVID testing conducting PCR and Rapid Tests". Management personnel #1 confirmed via email on 1/18/2022 at 4:13 pm that COVID-19 antigen testing had been performed at Quick N Free COVID located at 1100 Blairs Ferry Rd NE, Suite 113 Cedar Rapids, IA 52402 under CLIA identification number 14D0419924, Doctors General Laboratory, 59 Ogden Avenue, Clarendon Hills, IL 60514. 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 observations made during the survey, review of Celltrion DiaTrust COVID- 19 Antigen Rapid Test and Sienna-Clarity COVID-19 Antigen Rapid Test instructions for use, lack of training and reporting documents, lack of temperature records and interview with testing personnel #1, management personnel #1, and Iowa Department of Public Health personnel #1, the laboratory failed to follow the manufacturer's instructions for performing the rapid antigen test. The findings include: 1. On 1/18 /2022 at approximately 12:00 pm, observations of the testing facility included a laboratory area consisting of a reception desk, two tables and a electronic tablet. One of the tables had biohazard bags that contained labeled swabs with patient information. 2. Interview with testing personnel #1 on 1/18/2022 at approximately 12: 00 pm, confirmed samples were being collected for PCR testing. 3. Testing personnel #1 also stated COVID rapid antigen testing had been performed, but the laboratory ran Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- out of test kits. Testing personnel #1 stated that they had performed COVID rapid antigen testing on 1/15/2022 - 1/17/2022. Testing personnel #1 did not know that name or the manufacturer of the rapid antigen test kits. 4. Management personnel #1 confirmed via email on 1/18/2022 at 4:13 pm that the facility used either the Celltrion DiaTrust COVID-19 Rapid Antigen Test or the Sienna-Clarity COVID-19 Rapid Antigen Test on 1/15/2022 - 1/17/2022. 5. Review of the Celltrion DiaTrust COVID- 19 Rapid Antigen Test and Sienna-Clarity COVID-19 Rapid Antigen Test instructions for use indicated storage of both test kits between 2 - 30 degrees C (36 - 86 degrees F). 6. The laboratory failed to monitor and document daily room temperature of the testing facility. Testing personnel #1 confirmed she did not document the room temperature on 1/15/2022 - 1/17/2022. 7. Review of the Celltrion DiaTrust COVID- 19 Rapid Antigen Test and Sienna-Clarity COVID-19 Rapid Antigen Test instructions for use indicated that both kits were, "intended for use by medical professionals or trained operators who are proficient in performing tests, trained clinical laboratory personnel, or individuals trained in Point of Care (POC) settings." 8. Testing personnel #1 confirmed that they did not have documented training prior to performing patient testing. 9. Review of the Celltrion DiaTrust COVID-19 Rapid Antigen Test and Sienna-Clarity COVID-19 Rapid Antigen Test instructions for use indicated for both kits,"Laboratories within the United States and its territories are required to report all results to the appropriate public health laboratories." 10. Management personnel #1 confirmed via email on 1/18/2022 at 4:13 pm that the facility performed rapid COVID testing at Quick N Free COVID located at 1100 Blairs Ferry Rd, NE, Suite 113 Cedar Rapids, IA, 52402 from 1/15/2022 - 1/17/2022. When asked for the exact volume of rapid antigen testing, Management personnel #1 confirmed via email on 1/24/2022 at 10:42 am, the facility performed 47 rapid tests on 1/15/2022 and 37 rapid tests on 1/16/2022. 11. Management personnel #1 confirmed via email on 1/18/2022 at 4:13 pm that COVID antigen testing had been performed at Quick N Free COVID located at 1100 Blairs Ferry Rd NE, Suite 113 Cedar Rapids, IA 52402 under the CLIA identification number 14D0419924, Doctors General Laboratory, 59 Ogden Avenue, Clarendon Hills, IL 60514. 12. Iowa Department of Public Health (IDPH) personnel #1 confirmed via email on 1/21/22 , IDPH had not receive any rapid antigen testing results from either Quick N Free COVID located at 1100 Blairs Ferry Rd, NE, Suite 113 Cedar Rapids, IA, 52402 or Doctors General Laboratory, 14D0419924, 59 Ogden Ave, Clarendon Hills, IL, 60514. 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 observation of the laboratory located at 1100 Blairs Ferry Rd NE Suite 113, Cedar Rapids, IA 52402, lack of documentation, email correspondence, and interview, the laboratory failed to report SARS-CoV-2 Antigen test results as required for 84 -- 2 of 4 -- patients. The findings include: 1. Management personnel #1 confirmed via email on 1 /18/2022 at 4:13 pm that the facility used either the Celltrion DiaTrust COVID-19 Rapid Antigen Test or the Sienna-Clarity COVID-19 Rapid Antigen Test on 1/15 /2022 - 1/17/2022. 2. Review of the Celltrion DiaTrust COVID-19 Rapid Antigen Test and Sienna-Clarity COVID-19 Rapid Antigen Test instructions for use indicated for both kits,"Laboratories within the United States and its territories are required to report all results to the appropriate public health laboratories." 3. Management personnel #1 confirmed via email on 1/18/2022 at 4:13 pm that the facility performed rapid COVID testing at Quick N Free COVID located at 1100 Blairs Ferry Rd, NE, Suite 113 Cedar Rapids, IA, 52402 from 1/15/2022 - 1/17/2022. When asked for the exact volume of rapid antigen testing, Management personnel #1 confirmed via email on 1/24/2022 at 10:42 am, the facility performed 47 rapid tests on 1/15/2022 and 37 rapid tests on 1/16/2022. 4. Management personnel #1 confirmed via email on 1/18 /2022 at 4:13 pm that COVID antigen testing had been performed at Quick N Free COVID located at 1100 Blairs Ferry Rd NE, Suite 113 Cedar Rapids, IA 52402 under the CLIA identification number 14D0419924, Doctors General Laboratory, 59 Ogden Avenue, Clarendon Hills, IL 60514. 5. Iowa Department of Public Health (IDPH) personnel #1 confirmed via email on 1/21/22 , IDPH had not receive any rapid antigen testing results from either Quick N Free COVID located at 1100 Blairs Ferry Rd, NE, Suite 113 Cedar Rapids, IA, 52402 or Doctors General Laboratory, 14D0419924, 59 Ogden Ave, Clarendon Hills, IL, 60514. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on observations made during the survey, review of Celltrion DiaTrust COVID- 19 Antigen Rapid Test and Sienna-Clarity COVID-19 Antigen Rapid Test instructions for use, lack of training and reporting documents, lack of temperature records and interview with testing personnel #1, management personnel #1, and Iowa Department of Public Health personnel #1, the laboratory director failed to ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing, refer to D6082 D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) The laboratory director must ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. This STANDARD is not met as evidenced by: Based on observations made during the survey, review of Celltrion DiaTrust COVID- 19 Antigen Rapid Test and Sienna-Clarity COVID-19 Antigen Rapid Test instructions for use, lack of training and reporting documents, lack of temperature records and -- 3 of 4 -- interview with testing personnel #1, management personnel #1, and Iowa Department of Public Health personnel #1, the laboratory director failed to ensure the test systems used in the laboratory provide quality laboratory services for all aspects of test performance for COVID-19 antigen testing. The findings include: 1. On 1/18/2022 at approximately 12:00 pm, observations of the testing facility included a laboratory area consisting of a reception desk, two tables and a electronic tablet. One of the tables had biohazard bags that contained labeled swabs with patient information. 2. Interview with testing personnel #1 on 1/18/2022 at approximately 12:00 pm, confirmed samples were being collected for PCR testing. 3. Testing personnel #1 also stated COVID rapid antigen testing had been performed, but the laboratory ran out of test kits. Testing personnel #1 stated that they had performed COVID rapid antigen testing on 1/15/2022 - 1/17/2022. Testing personnel #1 did not know that name or the manufacturer of the rapid antigen test kits. 4. Management personnel #1 confirmed via email on 1/18/2022 at 4:13 pm that the facility used either the Celltrion DiaTrust COVID-19 Rapid Antigen Test or the Sienna-Clarity COVID-19 Rapid Antigen Test on 1/15/2022 - 1/17/2022. 5. Review of the Celltrion DiaTrust COVID-19 Rapid Antigen Test and Sienna-Clarity COVID-19 Rapid Antigen Test instructions for use indicated storage of both test kits between 2 - 30 degrees C (36 - 86 degrees F). 6. The laboratory failed to monitor and document daily room temperature of the testing facility. Testing personnel #1 confirmed she did not document the room temperature on 1/15/2022 - 1/17/2022. 7. Review of the Celltrion DiaTrust COVID-19 Rapid Antigen Test and Sienna-Clarity COVID-19 Rapid Antigen Test instructions for use indicated that both kits were, "intended for use by medical professionals or trained operators who are proficient in performing tests, trained clinical laboratory personnel, or individuals trained in Point of Care (POC) settings." 8. Testing personnel #1 confirmed that they did not have documented training prior to performing patient testing. 9. Review of the Celltrion DiaTrust COVID-19 Rapid Antigen Test and Sienna-Clarity COVID-19 Rapid Antigen Test instructions for use indicated for both kits,"Laboratories within the United States and its territories are required to report all results to the appropriate public health laboratories." 10. Management personnel #1 confirmed via email on 1/18/2022 at 4:13 pm that the facility performed rapid COVID testing at Quick N Free COVID located at 1100 Blairs Ferry Rd, NE, Suite 113 Cedar Rapids, IA, 52402 from 1/15/2022 - 1/17/2022. When asked for the exact volume of rapid antigen testing, Management personnel #1 confirmed via email on 1/24/2022 at 10:42 am, the facility performed 47 rapid tests on 1/15/2022 and 37 rapid tests on 1/16 /2022. 11. Management personnel #1 confirmed via email on 1/18/2022 at 4:13 pm that COVID antigen testing had been performed at Quick N Free COVID located at 1100 Blairs Ferry Rd NE, Suite 113 Cedar Rapids, IA 52402 under the CLIA identification number 14D0419924, Doctors General Laboratory, 59 Ogden Avenue, Clarendon Hills, IL 60514. 12. Iowa Department of Public Health (IDPH) personnel #1 confirmed via email on 1/21/22 , IDPH had not receive any rapid antigen testing results from either Quick N Free COVID located at 1100 Blairs Ferry Rd, NE, Suite 113 Cedar Rapids, IA, 52402 or Doctors General Laboratory, 14D0419924, 59 Ogden Ave, Clarendon Hills, IL, 60514. -- 4 of 4 --

Summary Statement of Deficiencies D0000 A complaint survey was performed on 1/18/2022 at approximately 12:00 pm at 1100 Blairs Ferry Rd NE Suite 113, Cedar Rapids, IA 52402. The sign at the entrance of the facility located at 1100 Blairs Ferry Rd NE Suite 113, Cedar Rapids, IA 52402 stated "Quick N Free COVID testing conducting PCR and Rapid Tests". Management personnel #1 confirmed via email on 1/18/2022 at 4:13 pm that COVID-19 antigen testing had been performed at Quick N Free COVID located at 1100 Blairs Ferry Rd NE, Suite 113 Cedar Rapids, IA 52402 under CLIA identification number 14D0419924, Doctors General Laboratory, 59 Ogden Avenue, Clarendon Hills, IL 60514. 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 observations made during the survey, review of Celltrion DiaTrust COVID- 19 Antigen Rapid Test and Sienna-Clarity COVID-19 Antigen Rapid Test instructions for use, lack of training and reporting documents, lack of temperature records and interview with testing personnel #1, management personnel #1, and Iowa Department of Public Health personnel #1, the laboratory failed to follow the manufacturer's instructions for performing the rapid antigen test. The findings include: 1. On 1/18 /2022 at approximately 12:00 pm, observations of the testing facility included a laboratory area consisting of a reception desk, two tables and a electronic tablet. One of the tables had biohazard bags that contained labeled swabs with patient information. 2. Interview with testing personnel #1 on 1/18/2022 at approximately 12: 00 pm, confirmed samples were being collected for PCR testing. 3. Testing personnel #1 also stated COVID rapid antigen testing had been performed, but the laboratory ran Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- out of test kits. Testing personnel #1 stated that they had performed COVID rapid antigen testing on 1/15/2022 - 1/17/2022. Testing personnel #1 did not know that name or the manufacturer of the rapid antigen test kits. 4. Management personnel #1 confirmed via email on 1/18/2022 at 4:13 pm that the facility used either the Celltrion DiaTrust COVID-19 Rapid Antigen Test or the Sienna-Clarity COVID-19 Rapid Antigen Test on 1/15/2022 - 1/17/2022. 5. Review of the Celltrion DiaTrust COVID- 19 Rapid Antigen Test and Sienna-Clarity COVID-19 Rapid Antigen Test instructions for use indicated storage of both test kits between 2 - 30 degrees C (36 - 86 degrees F). 6. The laboratory failed to monitor and document daily room temperature of the testing facility. Testing personnel #1 confirmed she did not document the room temperature on 1/15/2022 - 1/17/2022. 7. Review of the Celltrion DiaTrust COVID- 19 Rapid Antigen Test and Sienna-Clarity COVID-19 Rapid Antigen Test instructions for use indicated that both kits were, "intended for use by medical professionals or trained operators who are proficient in performing tests, trained clinical laboratory personnel, or individuals trained in Point of Care (POC) settings." 8. Testing personnel #1 confirmed that they did not have documented training prior to performing patient testing. 9. Review of the Celltrion DiaTrust COVID-19 Rapid Antigen Test and Sienna-Clarity COVID-19 Rapid Antigen Test instructions for use indicated for both kits,"Laboratories within the United States and its territories are required to report all results to the appropriate public health laboratories." 10. Management personnel #1 confirmed via email on 1/18/2022 at 4:13 pm that the facility performed rapid COVID testing at Quick N Free COVID located at 1100 Blairs Ferry Rd, NE, Suite 113 Cedar Rapids, IA, 52402 from 1/15/2022 - 1/17/2022. When asked for the exact volume of rapid antigen testing, Management personnel #1 confirmed via email on 1/24/2022 at 10:42 am, the facility performed 47 rapid tests on 1/15/2022 and 37 rapid tests on 1/16/2022. 11. Management personnel #1 confirmed via email on 1/18/2022 at 4:13 pm that COVID antigen testing had been performed at Quick N Free COVID located at 1100 Blairs Ferry Rd NE, Suite 113 Cedar Rapids, IA 52402 under the CLIA identification number 14D0419924, Doctors General Laboratory, 59 Ogden Avenue, Clarendon Hills, IL 60514. 12. Iowa Department of Public Health (IDPH) personnel #1 confirmed via email on 1/21/22 , IDPH had not receive any rapid antigen testing results from either Quick N Free COVID located at 1100 Blairs Ferry Rd, NE, Suite 113 Cedar Rapids, IA, 52402 or Doctors General Laboratory, 14D0419924, 59 Ogden Ave, Clarendon Hills, IL, 60514. 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 observation of the laboratory located at 1100 Blairs Ferry Rd NE Suite 113, Cedar Rapids, IA 52402, lack of documentation, email correspondence, and interview, the laboratory failed to report SARS-CoV-2 Antigen test results as required for 84 -- 2 of 4 -- patients. The findings include: 1. Management personnel #1 confirmed via email on 1 /18/2022 at 4:13 pm that the facility used either the Celltrion DiaTrust COVID-19 Rapid Antigen Test or the Sienna-Clarity COVID-19 Rapid Antigen Test on 1/15 /2022 - 1/17/2022. 2. Review of the Celltrion DiaTrust COVID-19 Rapid Antigen Test and Sienna-Clarity COVID-19 Rapid Antigen Test instructions for use indicated for both kits,"Laboratories within the United States and its territories are required to report all results to the appropriate public health laboratories." 3. Management personnel #1 confirmed via email on 1/18/2022 at 4:13 pm that the facility performed rapid COVID testing at Quick N Free COVID located at 1100 Blairs Ferry Rd, NE, Suite 113 Cedar Rapids, IA, 52402 from 1/15/2022 - 1/17/2022. When asked for the exact volume of rapid antigen testing, Management personnel #1 confirmed via email on 1/24/2022 at 10:42 am, the facility performed 47 rapid tests on 1/15/2022 and 37 rapid tests on 1/16/2022. 4. Management personnel #1 confirmed via email on 1/18 /2022 at 4:13 pm that COVID antigen testing had been performed at Quick N Free COVID located at 1100 Blairs Ferry Rd NE, Suite 113 Cedar Rapids, IA 52402 under the CLIA identification number 14D0419924, Doctors General Laboratory, 59 Ogden Avenue, Clarendon Hills, IL 60514. 5. Iowa Department of Public Health (IDPH) personnel #1 confirmed via email on 1/21/22 , IDPH had not receive any rapid antigen testing results from either Quick N Free COVID located at 1100 Blairs Ferry Rd, NE, Suite 113 Cedar Rapids, IA, 52402 or Doctors General Laboratory, 14D0419924, 59 Ogden Ave, Clarendon Hills, IL, 60514. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on observations made during the survey, review of Celltrion DiaTrust COVID- 19 Antigen Rapid Test and Sienna-Clarity COVID-19 Antigen Rapid Test instructions for use, lack of training and reporting documents, lack of temperature records and interview with testing personnel #1, management personnel #1, and Iowa Department of Public Health personnel #1, the laboratory director failed to ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing, refer to D6082 D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) The laboratory director must ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. This STANDARD is not met as evidenced by: Based on observations made during the survey, review of Celltrion DiaTrust COVID- 19 Antigen Rapid Test and Sienna-Clarity COVID-19 Antigen Rapid Test instructions for use, lack of training and reporting documents, lack of temperature records and -- 3 of 4 -- interview with testing personnel #1, management personnel #1, and Iowa Department of Public Health personnel #1, the laboratory director failed to ensure the test systems used in the laboratory provide quality laboratory services for all aspects of test performance for COVID-19 antigen testing. The findings include: 1. On 1/18/2022 at approximately 12:00 pm, observations of the testing facility included a laboratory area consisting of a reception desk, two tables and a electronic tablet. One of the tables had biohazard bags that contained labeled swabs with patient information. 2. Interview with testing personnel #1 on 1/18/2022 at approximately 12:00 pm, confirmed samples were being collected for PCR testing. 3. Testing personnel #1 also stated COVID rapid antigen testing had been performed, but the laboratory ran out of test kits. Testing personnel #1 stated that they had performed COVID rapid antigen testing on 1/15/2022 - 1/17/2022. Testing personnel #1 did not know that name or the manufacturer of the rapid antigen test kits. 4. Management personnel #1 confirmed via email on 1/18/2022 at 4:13 pm that the facility used either the Celltrion DiaTrust COVID-19 Rapid Antigen Test or the Sienna-Clarity COVID-19 Rapid Antigen Test on 1/15/2022 - 1/17/2022. 5. Review of the Celltrion DiaTrust COVID-19 Rapid Antigen Test and Sienna-Clarity COVID-19 Rapid Antigen Test instructions for use indicated storage of both test kits between 2 - 30 degrees C (36 - 86 degrees F). 6. The laboratory failed to monitor and document daily room temperature of the testing facility. Testing personnel #1 confirmed she did not document the room temperature on 1/15/2022 - 1/17/2022. 7. Review of the Celltrion DiaTrust COVID-19 Rapid Antigen Test and Sienna-Clarity COVID-19 Rapid Antigen Test instructions for use indicated that both kits were, "intended for use by medical professionals or trained operators who are proficient in performing tests, trained clinical laboratory personnel, or individuals trained in Point of Care (POC) settings." 8. Testing personnel #1 confirmed that they did not have documented training prior to performing patient testing. 9. Review of the Celltrion DiaTrust COVID-19 Rapid Antigen Test and Sienna-Clarity COVID-19 Rapid Antigen Test instructions for use indicated for both kits,"Laboratories within the United States and its territories are required to report all results to the appropriate public health laboratories." 10. Management personnel #1 confirmed via email on 1/18/2022 at 4:13 pm that the facility performed rapid COVID testing at Quick N Free COVID located at 1100 Blairs Ferry Rd, NE, Suite 113 Cedar Rapids, IA, 52402 from 1/15/2022 - 1/17/2022. When asked for the exact volume of rapid antigen testing, Management personnel #1 confirmed via email on 1/24/2022 at 10:42 am, the facility performed 47 rapid tests on 1/15/2022 and 37 rapid tests on 1/16 /2022. 11. Management personnel #1 confirmed via email on 1/18/2022 at 4:13 pm that COVID antigen testing had been performed at Quick N Free COVID located at 1100 Blairs Ferry Rd NE, Suite 113 Cedar Rapids, IA 52402 under the CLIA identification number 14D0419924, Doctors General Laboratory, 59 Ogden Avenue, Clarendon Hills, IL 60514. 12. Iowa Department of Public Health (IDPH) personnel #1 confirmed via email on 1/21/22 , IDPH had not receive any rapid antigen testing results from either Quick N Free COVID located at 1100 Blairs Ferry Rd, NE, Suite 113 Cedar Rapids, IA, 52402 or Doctors General Laboratory, 14D0419924, 59 Ogden Ave, Clarendon Hills, IL, 60514. -- 4 of 4 --