Being Human Medical, Llc, Am Laboratory

Summary Statement of Deficiencies D0000 A complaint survey was completed on April 6, 2022. It was determined that Immediate Jeopardy (IJ) existed for the following condition level deficiencies: 42 C.F. R. 493.1240 Condition: Preanalytic systems 42 C.F.R. 493.1250 Condition: Analytic systems 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview, the laboratory failed to retain patient test records for the COVID-19 antigen tests and requisition logs for SARS-CoV-2 Reverse Transcriptase (RT) Polymerase Chain Reaction (PCR) testing for at least 2 years, affecting 203,645 patients tests. Findings include: The laboratory's pre-analytic policies and procedures, collection sites' patient log sheet and notebook, and patients' final reports were reviewed. 1. Interview with Staff A on April 5, 2022 at 3:20 PM, described the following process for Rapid COVID-19 antigen testing and PCR specimen collection: *The collection facilities performed the Rapid antigen tests on-site and collected patients' nasopharyngeal swabs for SARS-CoV-2 RT-PCR testing performed at Being Human Medical [d/b/a AM Laboratory (AM Lab)]. *At the collection sites, the antigen results were written on a 'Patient Log' and entered into the AM Lab's laboratory's information System (OCL-LIS). *The specimens collected for RT-PCR testing were shipped via courier with the Patient log list and specimens mailed to the laboratory were sent without the Patient log list. *Once the specimens were received in the laboratory the log lists were discarded. 2. The collection log sheet and notebook revealed the following: *The log sheet included the patients' name, date Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 15 -- of birth, Rapid antigen test results, testing personnel name, date of collection, and site name. *The shipment notebook documented the site name and address, telephone number, date specimens were received in the laboratory and the date shipped from collection sites. *The number of specimens received with each shipment, the patients' name, date of birth, testing personnel name, and COVID-19 antigen test results for each specimen in the shipments were not documented in the notebook. 3. The procedure manual revealed the laboratory failed to include a written policy and procedure that instructs the retention of collection sites' patients' log sheets for both courier delivered and mailed patients' specimens for at least 2 years. 4. The patients' log for 13 of 13 patients' final results were unavailable to confirm collection site location, patient's name and date of birth, antigen test results, and date of collection and shipment. 5. The laboratory performed 93,274 antigen tests and 203,645 RT-PCR tests since 09/18/2021. 6. The laboratory director and staff confirmed the above findings on April 6, 2022 at 11:40 AM. 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 direct observation, record review, and interview, the laboratory failed to follow and established specimen collection, handling, and storage policies and procedures (D5311); failed to document the date and time specimens were received in the laboratory (D5313); and failed to monitor and evaluate the overall quality of the preanalytic systems and correct problems identified (5391) as specified in 42 CFR 493.1249 for the SARS-CoV-2 Reverse Transcriptase (RT) Polymerase Chain Reaction (PCR) performed, affecting 203,645 patients' tests. 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 direct observation, record review, and interview, the laboratory failed to follow written policies and procedures for specimen collection and storage for the SARS-CoV-2 Reverse Transferase (RT) Polymerase Chain Reaction (PCR) testing performed and failed to establish specimen rejection criteria procedures, affecting 203,645 patients' tests. Findings Includes: 1. The Atila Biosystems iAMP-COVID-19 Detection Kit Emergency Use Authorization (EUA) and Information of Use (IFU), the -- 2 of 15 -- laboratory's pre-analytic policy and procedures, and patients' reports were reviewed. Item 1. 2. Direct observation of Staff B on April 5, 2022 at 11:47 AM, demonstration of patient's COVID-19 Antigen test and nasopharyngeal swab collection, and it was observed that the swab specimen collected for PCR testing was placed in viral transport media (VTM). 3. Direct observation on April 5, 2022 at 11:57 AM, the surveyor observed in the laboratory's refrigerators, several racks of previously tested patients' specimens and a rack of patients' samples waiting to be tested for SARS- CoV-2. All the patient's swab in-view were immersed in VTM. In the laboratory was also observed two refrigerators with the temperature ranges from 2-8 degrees Celsius and one freezer with temperatures at -20 to -25 degree Celsius. 4. The Atila EUA/IFU reviewed stated the following: *"...swabs collected dry with the Atila Sample Collection Device (iAMP-COVID19-SCD; provided in the kit). After sample collection, immediately insert swab into the collection tube provided with the Atila COVID-19 Sample Collection Device." *"Specimens can be stored at room temperature for up to 12 hours, or -20 degree Celsius for up to 2 days after collection and before sample processing. If a delay in sample processing is expected, store dry swab specimens at -70 degree Celsius or lower." 5. Interview on April 5, 2022 at 12: 15 PM, Staff A stated specimen swabs collected at the laboratory, shipped, and received by courier were transported in VTM. Item 2. 6. Review of five patients' final reports revealed the following: Patient C1 was collected on 03/29/2022 at 12:18 AM and Results reported 04/05/2022 at 7: 20 PM; and Patient C2 was collected on 11/13 /2021 at 1:46 PM and Results reported 11/16/2021 at 11:26 AM. Patient C3 was collected on 11/14/2021 at 12:00 AM and Results reported 11/18/2021 at 4:00 PM. Patient C4 was collected on 11/14/2021 at 12:00 AM and Results reported 11/18/2021 at 4:01 PM. Patient C5 was collected on 11/14/2021 at 12:00 AM and Results reported 11/18/2021 at 7:25 PM. All the above patients were reported as "NEGATIVE" for SARS-CoV-2. 7. The pre-analytic policies and procedures showed that the laboratory failed to include the EUA/IFU specimen storage requirements needed to maintain optimal specimen integrity and failed to include policies and procedures that would identify and reject specimens shipped/mailed or dropped-off that did not meet the EUA/IFU's acceptable testing criteria. 8. The laboratory performed 203,645 RT-PCR tests since 09/18/2021. 9. The laboratory director and laboratory staff confirmed the above findings on April 6, 2022 at 11:40 AM and stated that the laboratory did not have a -70 degree Celsius freezer. D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on direct observation, record review, and interview, the laboratory failed to document the date and time received on four of four patients requisitions submitted for SARS-CoV-2 Reverse Transcriptase (RT) Polymerase Chain Reaction (PCR) testing, affecting 203,645 patients' tests. Findings include: The laboratory's pre- analytic policies and procedures and collection sites' patient log sheet and notebook were reviewed. 1. Direct observation of Staff C on April 5, 2022 at 3:20 PM, demonstration of the receiving process for shipped and courier delivered patients' specimens, and it was observed that a patient log listing four patients from the Brickyard collection site had no visible indication of the date and time these specimens were received in the laboratory. 2. Interview with Staff A on April 5, 2022 at 3:27 PM, stated when specimens were received by courier, the laboratory staff -- 3 of 15 -- would process the specimens for testing, the time and dates received were not added to the log sheets. For the patients' specimens shipped by mail, the data entry staff were responsible for processing, they document the date but not the time received in the laboratory. 3. The manual showed the preanalytic policies failed to include the 'date and time received' requirement and failed to establish a method to document this activity when specimens were received from collection sites via courier or mail. 4. Review of patient test volume records found 203,645 patient samples were received into the laboratory when the date and time received was not documented. 5. The laboratory director and staff confirmed the above findings on April 6, 2022 at 11:00 AM. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on review of laboratory records, direct observation, and interview, the laboratory failed to establish policies and procedures to assess, monitor and correct problems with COVID-19 specimen collection, handling, and storage affecting 203,645 patient test results. Findings Include: 1. Surveyor requested all quality assurance documentation from Staff A on 04/05/2022 at 3:30 PM. The laboratory failed to provide the laboratory's quality assessment policy and documentation during the survey that was completed on 04/06/2022. 2. The laboratory failed to identify multiple issues with specimen collection, handling, and storage. See D5311 & D5313. 3. Surveyor requested on 04/05/22 at 2:55 PM patient test reports for 13 of 15 specimens that were received during the tour of the specimen receiving area on 04/05 /22 and found 13 of 13 patient sample reports reviewed were reported out by the laboratory and all were reported as negative for SARS-CoV-2. The remaining 2 patients' reports were marked cancelled. 4. Review of patient testing for SARS-CoV-2 found the laboratory has reported 203,645 patients in the past year when no preanalytical quality assessment policy had been established and performed. 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 direct observation, record review, the Reverse Transcriptase (RT) Polymerase Chain Reaction (PCR) Emergency Use Authorization (EUA) for SARS- C0V-2, and interviews, the laboratory failed to have completely written procedures for two of two test systems used detect and identify SARS-CoV-2 (D5401, D5403); failed to establish the performance specifications for the laboratory developed test -- 4 of 15 -- used to detect and identify SARS-CoV-2 (D5423); failed to verify the performance specifications of the LumiraDx EUA(D5421); failed to establish and perform control procedures for two of two RT-PCR procedures performed (D5441); and failed to establish and follow written policies and procedures to perform quality assessment (QA) of all analytic systems (D5791), affecting 203,645 patients' tests. 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 direct observation, record review, lack of documentation, and interview, the laboratory failed to establish and follow a written procedure for the Reverse Transcriptase (RT) Polymerase Chain Reaction (PCR) performed on the QuantStudio 5 to detect and identify SARS-CoV-2 prior to testing patients, affecting 203,645 patients' tests. Findings include: 1. Direct observation on April 5, 2022 at 11:50 AM, on the workbench in the laboratory stood two PCR analyzers, the Atila Biosystems 9600 Real-Time PCR thermocycler and the Applied Biosystems Quantstudio 5 PCR thermocycler. It was also observed in the -20 degree Celsius freezers the iAMP COVID-19 Detection kits used on the Atila 9600 and the LumiraDx SARS-CoV-2 RNA STAR Complete kits for the Quantstudio 5. 2. The Food and Drug Administration (FDA) website, procedures manual, Quantstudio data logs, and maintenance records were reviewed. 3. The FDA listed the LumiraDx RNA STAR Complete RT-PCR assay for Emergency Use Authorization (EUA) to identify and detect SARS-CoV-2 virus. 4. The manual revealed that an approved written laboratory procedure for the LumiraDx EUA and Information for Use (IFU) assay was not available for the testing personnel to follow. 5. Further review of the manual showed the laboratory had not established any procedures for the LumiraDx RNA RT- PCR test system. 6. From the QC and maintenance records reviewed it could not be determined when the laboratory used the QuantStudio 5 Rt-PCR procedure or how many patient test results were reported. 7. The laboratory performed 203,645 RT-PCR tests since 09/18/2021. 8. The laboratory director and staff confirmed the above findings on April 6, 2022 at 11:00 AM. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on interview, observation, and record review, the laboratory director failed to ensure that laboratory personnel are performing SARS-CoV-2 antigen testing as required for accurate and reliable testing at one of two sites surveyed. Findings: 1. During a tour of site B on March 3, 2022 at approximately 11:30 A.M., the surveyor observed the Indicaid (Trademark) COVID-19 Rapid Antigen Test in use. 2. During interview on March 3, 2022 at approximately 11:35 A.M., Testing Personnel #2 (TP2) stated that the antigen test was read 10-15 minutes after the sample was added to the cassette. 3. On March 3, 2022 at approximately 11:36 A.M., the surveyor observed the timer at site B was set for 15 minutes. 4. The surveyor requested the manufacturer's instructions for the Indicaid (Trademark) COVID-19 Rapid Antigen Test at approximately 11:37. TP2 was unable to locate the instructions. 5. Review of the Indicaid (Trademark) COVID-19 Rapid Antigen Test Instructions for Use obtained at site A stated "Read the test line (T) and control line (C) results promptly at 20 minutes, and not earlier to ensure proper test performance." 6. At approximately 11:52 A.M. on March 3, 2022, TP2 stated that site B started using the Indicaid (Trademark) COVID-19 Rapid Antigen Test approximately three weeks ago. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 Based on interviews with laboratory personnel identifier #1 (refer to appendix 1) at approximately 1:50 pm on 1/05/2022, laboratory personnel identifier #1 confirmed the COVID antigen testing being performed at Amita Laboratory 320 W Kimberly Rd, Davenport Iowa fell under the CLIA number 14D2233521 - Being Human Medical, LLC. Identifier #1 again confirmed via interview at approximately 2:15 pm the COVID antigen testing being performed at Amita Laboratory 320 W Kimberly Rd, Davenport Iowa fell under the CLIA number 14D2233521 - Being Human Medical, LLC. 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 at the time of the survey, lack of temperature records, review of the Sienna COVID-19 Antigen Rapid Test Cassette Instruction for use, and interview with laboratory personnel identifier #2 (refer to Appendix 1), the laboratory failed to follow manufacturer's instructions for storage of COVID-19 antigen test kits. The findings include: 1. The Sienna COVID-19 Antigen Rapid Test Cassette Instruction for use states under the Precautions section: *"Allow the test cassette, specimen, supporting buffer to equilibrate to room temperature 15 degrees Celsius (C) - 30 degrees C [59 degrees Fahrenheit (F) - 86 degrees F] prior to testing." *"Do not store this kit in frozen conditions." 2. On 1/5/22, the temperature around the time of the survey was approximately 11 degrees F with a windchill of -10 degrees F. The testing personnel performed the testing in a mobile storage unit that had two small heaters. Testing personnel constantly went in and out of the door (which is located directly across from the testing area) to collect COVID samples from patients waiting 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 -- in their vehicles. The surveyor wore a long winter coat, stocking cap, wool socks and boots during the survey and still felt cold, indicating a temperature below 59 degree F. 3. At the time of the survey, the laboratory did not have a thermometer available to document the temperature inside the facility. Additionally, the laboratory did not have temperature records documenting the daily room temperature of inside the facility for any previous dates of testing. 4. Interview at 2:30 pm on 1/5/2022 with laboratory personnel identifier #2 revealed that the generator used to heat the storage facility did not run 24 hours a day. The laboratory used the generator to heat the storage facility during the 8 hours of operation. The Sienna COVID-19 Antigen Rapid Test Cassettes remained in the facility 24 hours a day. Based on observations at the time of the survey, review of the Sienna COVID-19 Antigen Rapid Test Cassette Instruction for use and confirmed by testing personnel identifiers #2 and #3 (refer to Appendix 1) at approximately 2:30 pm on 1/5/2022, the laboratory failed to follow manufacturer's instructions for performing COVID-19 antigen testing. The findings include: 1. The Sienna COVID-19 Antigen Rapid Test Cassette Instruction for use states under the Directions for Use section: *"Place the extraction buffer in the workstation. Open the cap 1 and place the swab specimen in the extraction buffer. Rotate the swab for approximately 10 seconds while pressing the head against the inside of the tube to release the antigen in the swab. Leave the swab in the extraction buffer for 1 minute." *Add 3 drops of the solution to the sample well and then start the timer. Read the result at 10 minutes. Do not interpret the result after 20 minutes. Note: Erroneous results can occur if the test results are read before or after 10-20 minutes." 2. At the time of the survey, the laboratory did not have timers available in the storage facility and testing personnel identifiers #2 and #3 confirmed the laboratory did not use timers when performing COVID antigen testing. 4. Observations of testing being performed at the time of the survey revealed that testing personnel would put the patient sample in the extraction buffer for approximately 10 - 20 seconds instead of 1 minute. 5. Testing personnel identifier #2 revealed that once the swab has been taken out of the extraction buffer and 3 drops of the solution are placed in the sample well of the cassette, the cassette has a red color in the region where the test results are interpreted. The testing personnel confirmed they interpreted the results when the testing region of cassette has turned white in color. Observation of this process revealed that testing personnel read the COVID antigen test results at approximately 5 minutes instead of 10 -20 minutes. Interview at 2:30 pm on 1/5/2022 with personnel identifier #2 confirmed the laboratory failed to follow manufacturer's instructions for performing COVID-19 antigen testing. 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 at the time of the survey, lack of COVID reporting -- 2 of 4 -- documentation and interview with laboratory personnel identifiers #1 and #2 (refer to Appendix 1) at approximately 2:30 pm on 1/5/2022, the laboratory failed to report SARS-CoV-2 test results to the proper State Health Department for 73 out of 73 patients on 1/5/2022. The findings include: 1. Observation showed the laboratory documented on a patient log the patient's name, date of birth, and phone number of each patient having COVID antigen testing performed. As of approximately 2:30 pm on 1/5/22 , the patient log for the day of testing had 73 patients list as having COVID antigen testing performed. 2. Laboratory personnel #1 stated the laboratory reported SARS-CoV-2 results to the appropriate State Health Department but did not know how or when the laboratory transmitted the results. 3. Laboratory personnel #2 did not know if the laboratory reported SARS-CoV-2 results to the appropriate State Health Department. 4. At the time of the survey, the laboratory did not have documentation of SARS-CoV-2 results being reported to the appropriate State Health Department. 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 at the time of the survey, lack of temperature records, review of the Sienna COVID-19 Antigen Rapid Test Cassette Instruction for use and interviews with testing personnel, the laboratory directior 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 at the time of the survey, lack of temperature records, review of the Sienna COVID-19 Antigen Rapid Test Cassette Instruction for use and interviews, the laboratory director failed to ensure the tests systems used in the laboratory provide quality laboratory services for all aspects of test performance for COVID-19 antigen testing. The findings include: 1. The Sienna COVID-19 Antigen Rapid Test Cassette Instruction for use states under the precautions section: *"Allow the test cassette, specimen, supporting buffer to equilibrate to room temperature 15 degrees Celsius (C) - 30 degrees C [59 degrees Fahrenheit (F) - 86 degrees F] prior to testing." *"Do not store this kit in frozen conditions." 2. On 1/5/22, the temperature around the time of the survey was approximately 11 degrees F with a windchill of -10 degrees F. The testing personnel performed the testing in a mobile storage unit that had two small heaters. Testing personnel constantly went in and out of the door (which is located directly across from the testing area) to collect COVID-19 samples -- 3 of 4 -- from patients waiting in their vehicles. The surveyor wore a long winter coat, stocking cap, wool socks and boots during the survey and still felt cold, indicating a temperature below 59 degree F. 3. At the time of the survey, the laboratory did not have a thermometer available to document the temperature inside the facility. Additionally, the laboratory did not have temperature records documenting the daily room temperature of inside the facility for any previous dates of testing. 4. Laboratory personnel identifier #2 revealed that the generator used to heat the storage facility did not run 24 hours a day. The laboratory used the generator to heat the storage facility during the 8 hours of operation. The Sienna COVID-19 Antigen Rapid Test Cassettes remained in the facility 24 hours a day. Based on observations at the time of the survey and interview, the laboratory director failed to ensure the tests systems used in the laboratory provide quality laboratory services for all aspects of test performance for COVID-19 antigen testing by failing to ensure confidentiality of patient information. The findings include: 1. Observation showed patients waited in their cars for a COVID-19 antigen test. 2. Testing personnel would go to the patients vehicle and hand them a clipboard with a paper log. The patient would write down their name, date of birth and phone number on the clipboard. Multiple patients recorded their personal health information on the same log. Therefore, patients could see the personal health information of other individuals who had COVID-19 antigen testing performed. 3. Testing personnel would then collect the COVID-19 specimens and rapid antigen testing would be performed by the laboratory. 4. Testing personnel would then text the patient results through "What's App" on their personal cellular phones to the main laboratory, where the results would be entered into an electronic health record. The text included the patient's name, date of birth and test result. For positive test results, testing personnel would also send a picture of the test cassette. 5. Interview with laboratory personnel identifier #2 (refer to Appendix 1) at approximately 2:30 pm on 1/5/2022 confirmed the laboratory director failed to ensure the tests systems used in the laboratory provide quality laboratory services for all aspects of test performance for COVID-19 antigen testing by failing to ensure confidentiality of patient information. Based on observations at the time of the survey, review of the Sienna COVID-19 Antigen Rapid Test Cassette Instruction for use, and interviews with the laboratory personnel identifiers #2 and #3 (refer to Appendix 1) at , the laboratory director failed to ensure the tests systems used in the laboratory provide quality laboratory services for all aspects of test performance for COVID antigen testing by failing to safety procedures to ensure the protection of individuals from biohazard materials. The findings include: 1. The Sienna COVID-19 Antigen Rapid Test Cassette Instruction for use states under the Precautions section: *"All samples, even after the extraction procedure, and reagents containing biological materials used for the assay must be considered as potentially able to transmit infections agents; accordingly samples, reagents and the waste must be handled with the utmost care and disposed of in compliance with the laboratory guidelines and the statutory provisions in force in each country." 2. Interviews with laboratory personnel identifiers #2 and #3 at 2:30 pm on 1/5/2022, confirmed the laboratory placed all samples, reagents, gloves and COVID antigen cassettes in the regular trash. Testing personnel identifiers #2 and #3 confirmed that they did not take biohazard precautions. -- 4 of 4 --

Summary Statement of Deficiencies D0000 Based on interviews with laboratory personnel identifier #1 (refer to appendix 1) at approximately 1:50 pm on 1/05/2022, laboratory personnel identifier #1 confirmed the COVID antigen testing being performed at Amita Laboratory 320 W Kimberly Rd, Davenport Iowa fell under the CLIA number 14D2233521 - Being Human Medical, LLC. Identifier #1 again confirmed via interview at approximately 2:15 pm the COVID antigen testing being performed at Amita Laboratory 320 W Kimberly Rd, Davenport Iowa fell under the CLIA number 14D2233521 - Being Human Medical, LLC. A complaint survey was completed on January 5, 2022. It was determined that Immediate Jeopardy (IJ) existed for the following condition level deficiency: 42 C.F. R. 493.1441 Condition: Laboratory Director 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 at the time of the survey, lack of temperature records, review of the Sienna COVID-19 Antigen Rapid Test Cassette Instruction for use, and interview with laboratory personnel identifier #2 (refer to Appendix 1), the laboratory failed to follow manufacturer's instructions for storage of COVID-19 antigen test kits. The findings include: 1. The Sienna COVID-19 Antigen Rapid Test Cassette Instruction for use states under the Precautions section: *"Allow the test cassette, specimen, supporting buffer to equilibrate to room temperature 15 degrees Celsius (C) - 30 degrees C [59 degrees Fahrenheit (F) - 86 degrees F] prior to testing." *"Do not store this kit in frozen conditions." 2. On 1/5/22, the temperature around the time of the survey was approximately 11 degrees F with a windchill of -10 degrees F. The testing personnel performed the testing in a mobile storage unit that had two small 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 -- heaters. Testing personnel constantly went in and out of the door (which is located directly across from the testing area) to collect COVID samples from patients waiting in their vehicles. The surveyor wore a long winter coat, stocking cap, wool socks and boots during the survey and still felt cold, indicating a temperature below 59 degree F. 3. At the time of the survey, the laboratory did not have a thermometer available to document the temperature inside the facility. Additionally, the laboratory did not have temperature records documenting the daily room temperature of inside the facility for any previous dates of testing. 4. Interview at 2:30 pm on 1/5/2022 with laboratory personnel identifier #2 revealed that the generator used to heat the storage facility did not run 24 hours a day. The laboratory used the generator to heat the storage facility during the 8 hours of operation. The Sienna COVID-19 Antigen Rapid Test Cassettes remained in the facility 24 hours a day. Based on observations at the time of the survey, review of the Sienna COVID-19 Antigen Rapid Test Cassette Instruction for use and confirmed by testing personnel identifiers #2 and #3 (refer to Appendix 1) at approximately 2:30 pm on 1/5/2022, the laboratory failed to follow manufacturer's instructions for performing COVID-19 antigen testing. The findings include: 1. The Sienna COVID-19 Antigen Rapid Test Cassette Instruction for use states under the Directions for Use section: *"Place the extraction buffer in the workstation. Open the cap 1 and place the swab specimen in the extraction buffer. Rotate the swab for approximately 10 seconds while pressing the head against the inside of the tube to release the antigen in the swab. Leave the swab in the extraction buffer for 1 minute." *Add 3 drops of the solution to the sample well and then start the timer. Read the result at 10 minutes. Do not interpret the result after 20 minutes. Note: Erroneous results can occur if the test results are read before or after 10-20 minutes." 2. At the time of the survey, the laboratory did not have timers available in the storage facility and testing personnel identifiers #2 and #3 confirmed the laboratory did not use timers when performing COVID antigen testing. 4. Observations of testing being performed at the time of the survey revealed that testing personnel would put the patient sample in the extraction buffer for approximately 10 - 20 seconds instead of 1 minute. 5. Testing personnel identifier #2 revealed that once the swab has been taken out of the extraction buffer and 3 drops of the solution are placed in the sample well of the cassette, the cassette has a red color in the region where the test results are interpreted. The testing personnel confirmed they interpreted the results when the testing region of cassette has turned white in color. Observation of this process revealed that testing personnel read the COVID antigen test results at approximately 5 minutes instead of 10 -20 minutes. Interview at 2:30 pm on 1/5/2022 with personnel identifier #2 confirmed the laboratory failed to follow manufacturer's instructions for performing COVID-19 antigen testing. 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. -- 2 of 4 -- This CONDITION is not met as evidenced by: Based on observations at the time of the survey, lack of COVID reporting documentation and interview with laboratory personnel identifiers #1 and #2 (refer to Appendix 1) at approximately 2:30 pm on 1/5/2022, the laboratory failed to report SARS-CoV-2 test results to the proper State Health Department for 73 out of 73 patients on 1/5/2022. The findings include: 1. Observation showed the laboratory documented on a patient log the patient's name, date of birth, and phone number of each patient having COVID antigen testing performed. As of approximately 2:30 pm on 1/5/22 , the patient log for the day of testing had 73 patients list as having COVID antigen testing performed. 2. Laboratory personnel #1 stated the laboratory reported SARS-CoV-2 results to the appropriate State Health Department but did not know how or when the laboratory transmitted the results. 3. Laboratory personnel #2 did not know if the laboratory reported SARS-CoV-2 results to the appropriate State Health Department. 4. At the time of the survey, the laboratory did not have documentation of SARS-CoV-2 results being reported to the appropriate State Health Department. 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 at the time of the survey, lack of temperature records, review of the Sienna COVID-19 Antigen Rapid Test Cassette Instruction for use and interviews with testing personnel, the laboratory directior 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 at the time of the survey, lack of temperature records, review of the Sienna COVID-19 Antigen Rapid Test Cassette Instruction for use and interviews, the laboratory director failed to ensure the tests systems used in the laboratory provide quality laboratory services for all aspects of test performance for COVID-19 antigen testing. The findings include: 1. The Sienna COVID-19 Antigen Rapid Test Cassette Instruction for use states under the precautions section: *"Allow the test cassette, specimen, supporting buffer to equilibrate to room temperature 15 degrees Celsius (C) - 30 degrees C [59 degrees Fahrenheit (F) - 86 degrees F] prior to testing." *"Do not store this kit in frozen conditions." 2. On 1/5/22, the temperature around the time of the survey was approximately 11 degrees F with a windchill of -10 degrees F. The testing personnel performed the testing in a mobile storage unit that -- 3 of 4 -- had two small heaters. Testing personnel constantly went in and out of the door (which is located directly across from the testing area) to collect COVID-19 samples from patients waiting in their vehicles. The surveyor wore a long winter coat, stocking cap, wool socks and boots during the survey and still felt cold, indicating a temperature below 59 degree F. 3. At the time of the survey, the laboratory did not have a thermometer available to document the temperature inside the facility. Additionally, the laboratory did not have temperature records documenting the daily room temperature of inside the facility for any previous dates of testing. 4. Laboratory personnel identifier #2 revealed that the generator used to heat the storage facility did not run 24 hours a day. The laboratory used the generator to heat the storage facility during the 8 hours of operation. The Sienna COVID-19 Antigen Rapid Test Cassettes remained in the facility 24 hours a day. Based on observations at the time of the survey and interview, the laboratory director failed to ensure the tests systems used in the laboratory provide quality laboratory services for all aspects of test performance for COVID-19 antigen testing by failing to ensure confidentiality of patient information. The findings include: 1. Observation showed patients waited in their cars for a COVID-19 antigen test. 2. Testing personnel would go to the patients vehicle and hand them a clipboard with a paper log. The patient would write down their name, date of birth and phone number on the clipboard. Multiple patients recorded their personal health information on the same log. Therefore, patients could see the personal health information of other individuals who had COVID-19 antigen testing performed. 3. Testing personnel would then collect the COVID-19 specimens and rapid antigen testing would be performed by the laboratory. 4. Testing personnel would then text the patient results through "What's App" on their personal cellular phones to the main laboratory, where the results would be entered into an electronic health record. The text included the patient's name, date of birth and test result. For positive test results, testing personnel would also send a picture of the test cassette. 5. Interview with laboratory personnel identifier #2 (refer to Appendix 1) at approximately 2:30 pm on 1/5/2022 confirmed the laboratory director failed to ensure the tests systems used in the laboratory provide quality laboratory services for all aspects of test performance for COVID-19 antigen testing by failing to ensure confidentiality of patient information. Based on observations at the time of the survey, review of the Sienna COVID-19 Antigen Rapid Test Cassette Instruction for use, and interviews with the laboratory personnel identifiers #2 and #3 (refer to Appendix 1) at , the laboratory director failed to ensure the tests systems used in the laboratory provide quality laboratory services for all aspects of test performance for COVID antigen testing by failing to safety procedures to ensure the protection of individuals from biohazard materials. The findings include: 1. The Sienna COVID-19 Antigen Rapid Test Cassette Instruction for use states under the Precautions section: *"All samples, even after the extraction procedure, and reagents containing biological materials used for the assay must be considered as potentially able to transmit infections agents; accordingly samples, reagents and the waste must be handled with the utmost care and disposed of in compliance with the laboratory guidelines and the statutory provisions in force in each country." 2. Interviews with laboratory personnel identifiers #2 and #3 at 2:30 pm on 1/5/2022, confirmed the laboratory placed all samples, reagents, gloves and COVID antigen cassettes in the regular trash. Testing personnel identifiers #2 and #3 confirmed that they did not take biohazard precautions. -- 4 of 4 --