Ramzi S Dakour, Md & Ramona S Ataya-Dakour,

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the CLIA regulations. The conditions not met were: D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems; D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. D1000 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(c) Certificate of waiver tests. A laboratory may qualify for a certificate of waiver under section 353 of the PHS Act if it restricts the tests that it performs to one or more of the following tests or examinations (or additional tests added to this list as provided under paragraph (d) of this section) and no others: (1) Dipstick or Tablet Reagent Urinalysis (non-automated) for the following: (i) Bilirubin; (ii) Glucose; (iii) Hemoglobin; (iv) Ketone; (v) Leukocytes; (vi) Nitrite; (vii) pH; (viii) Protein; (ix) Specific gravity; and (x) Urobilinogen. (2) Fecal occult blood; (3) Ovulation tests-visual color comparison tests for human luteinizing hormone; (4) Urine pregnancy tests - visual color comparison tests; (5) Erythrocyte sedimentation rate-non-automated; (6) Hemoglobin- copper sulfate-non-automated; (7) Blood glucose by glucose monitoring devices cleared by the FDA specifically for home use; (8) Spun microhematocrit; and (9) Hemoglobin by single analyte instruments with self-contained or component features to perform specimen/reagent interaction, providing direct measurement and readout. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions, laboratory records from June 2020 to June 2021, and confirmed in interview, the laboratory failed to follow the manufacturer's instructions to document quality control using the Medline Evencare G2 blood glucose test strips for 22 of 22 weeks reviewed. Findings included: 1. Review of the Medline Evencare G2 blood glucose test strips package insert (P/N Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- 65056000069, Rev 11/18) under quality control revealed "run low and high control solution tests. Follow the User's guide instructions. Do control tests: -at least once per week to make sure the meter and test strips are working properly -every time you open a new bottle of test strips" 2. Review of the laboratory records from 6/5/20 to 6/4 /21 revealed the laboratory performed 29 glucose testing using the Medline Evencare G2 blood glucose test strips. date patient ID 06/10/2020 4778 06/11/2020 9079 06/19 /2020 5602 06/23/2020 3550 07/27/2020 423 08/04/2020 5453 09/03/2020 1961 09/09 /2020 9367 09/11/2020 7737 09/11/2020 7737 09/15/2020 5446 09/22/2020 7737 09 /29/2020 9510 10/09/2020 62 10/16/2020 9581 10/21/2020 1000 10/23/2020 4014 11 /20/2020 4938 11/23/2020 3125 12/03/2020 7950 01/05/2021 7934 01/14/2021 9559 01/21/2021 3289 03/05/2021 9935 03/31/2021 4855 04/12/2021 1254 05/05/2021 5327 05/06/2021 5514 05/12/2021 7902 3. Review of the laboratory records from 6/5 /20 to 6/4/21 revealed no documentation of the high and low quality control for 22 of 22 weeks reviewed when the above testing were performed. 4. An interview with the testing person # 1 on 6/4/21 at 1215 hours in the office confirmed the above findings. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the CMS national database, laboratory's American Proficiency Institute's proficiency testing records from 2019 to 2021 and confirmed in interview, the laboratory failed to have documentation of the laboratory director or designee and testing person signing 5 of 7 attestation statements reviewed. The findings were: 1. A review of the CMS national database from 2019 to 2021 revealed the laboratory participated in the following 5 test events. 2021 Hematology 1st event 2020 Hematology 2nd event 2020 Hematology 3rd event 2019 Hematoloty 1st event 2019 Hematology 2nd event 2. A review of the laboratory's American Proficiency Institute's proficiency testing records from 2019 to 2021 revealed no documentation of the laboratory director or designee and testing person signing 5 of 7 attestation statements. 2021 Hematology 1st event 2020 Hematology 2nd event 2020 Hematology 3rd event 2019 Hematoloty 1st event 2019 Hematology 2nd event 3. An interview with facility manager on 6/4/21 at 1005 hours in the office and after her review of the records confirmed the findings. 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 8 -- This CONDITION is not met as evidenced by: Based on review of the manufacturer's instructions, laboratory and patient test records from 2020-2021, and confirmed in interview, the laboratory failed to report 807 SARS-CoV-2 negative Antigen test results as required by 400.200 for 136 of 136 days reviewed from 10/1/2020 to 6/4/2021. Findings were: 1. Review of the Instructions for Use for the BD Veritor of SARS-CoV-2 & Flu A + B (256088, 500051910(01), 2021-03) under Reporting of Results revealed "Testing facilities within the United States and its territories are required to report all SARS-CoV-2 results to the appropriate public health authorities." 2. Review of the laboratory test records from 2020 to 2021 revealed the laboratory started SARS-CoV-2 Antigen patient testing using BD Veritor of SARS-CoV-2 & Flu A + B test on 11/4/20. 3. Review of the Instructions for Use for the Sofia 2 Flu + SARS Antigen FIA test cassettes under CONDITIONS OF AUTHORIZATION FOR THE LABORATORY revealed "authorized laboratories using your product will have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate." 4. Review of the laboratory test records from 2020 to 2021 revealed the laboratory started SARS-CoV-2 Antigen patient testing Sofia 2 Flu + SARS Antigen FIA test cassettes on 9/21/20. 5. Review of the laboratory policies available revealed no documentation of a policy/procedure related to SARS-CoV-2 test reporting. 6. Review of the laboratory SARS-CoV-2 Antigen patient test records from 2020 to 2021 revealed no documentation the laboratory reported 807 patient negative test records for 136 of 136 days of testing. Refer to Covid Antigen Patient Alias list. 7. An interview with the testing person #1 on 6/4/21 at 1155 hours in the office confirmed the above findings 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 a random review of the laboratory patient logs from 2020 to 2021, and confirmed in interview,the laboratory failed to retain all patient test records for at least 2 years for 9 of 9 patient records reviewed. Findings were: 1. Random review of the patient test logs from 2020 to 2021 revealed no documentation of the original test reports for 9 of 9 patients reviewed. 12/17/20 - patient ID 232749 12/11/20 - patient ID 232991 05/11/21 - patient ID 234495 05/11/21 - patient ID 230630 04/09/21 - patient ID 232974 05/11/21 - patient ID 234561 01/19/21 - patient ID RIDEJA0032024 01/18/21 - patient ID 230758 01/18/21 - patient ID MONRBR0013087 2. An interview with the testing person #1 on 6/4/21 at 1135 hours in the office confirmed the above findings. She acknowledged that the testing personnel discarded the printouts from the analyzer after the results are transferred onto their LIS system. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance -- 3 of 8 -- (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of the CMS national database, 2019 to 2021 American Proficiency Institute (API) proficiency testing records, and confirmed in interview, the laboratory failed to verify the accuracy of their hematology testing after receiving a score of an artificial 100% for 1 of 7 of the hematology proficiency testing events reviewed. Findings were: 1. Review of the CMS national database revealed the laboratory received "100" for all the analytes for 1 of 7 API testing events in 2019 to 2021. 2020 1st event WBC - 100% RBC - 100% HGB - 100% HCT - 100% PLT - 100% WBC Diff - 100% 2. Review of the laboratory API test records revealed the laboratory received "100" for Not Graded for the above proficiency testing event. 2020 1st event WBC - Not Graded RBC - Not Graded HGB - Not Graded HCT - Not Graded PLT - Not Graded WBC Diff - Not Graded 3. Review of the evaluation sheet for the above test event revealed "great job" on the evaluation along with the lab director's signature. 4. An interview with the facility manager on 6/4/21 at 1020 hours in the office confirmed the above findings. She confirmed that the laboratory entered lab reported test problem and did not perform the test event and no results were evaluated. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Review of the laboratory's policy, American Proficiency Institute (API) proficiency testing (PT) records from 2019 to 2021 and confirmed in interview, the laboratory failed to have quality assessment policies and procedures that can identify, monitor and correct problems in the general laboratory systems for 2 of 7 PT events reviewed. Findings were: 1. Review of the laboratory policy Quality Assurance Policies and Procedures under Proficiency Testing revealed "all proficiency test results will be reviewed and

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the CLIA regulations. The conditions not met were: D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems; D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. D1000 Based on review of the manufacturer's instructions, laboratory records from June 2020 to June 2021, and confirmed in interview, the laboratory failed to follow the manufacturer's instructions to document quality control using the Medline Evencare G2 blood glucose test strips for 22 of 22 weeks reviewed. Findings included: 1. Review of the Medline Evencare G2 blood glucose test strips package insert (P/N 65056000069, Rev 11/18) under quality control revealed "run low and high control solution tests. Follow the User's guide instructions. Do control tests: -at least once per week to make sure the meter and test strips are working properly -every time you open a new bottle of test strips" 2. Review of the laboratory records from 6/5/20 to 6/4 /21 revealed the laboratory performed 29 glucose testing using the Medline Evencare G2 blood glucose test strips. date patient ID 06/10/2020 4778 06/11/2020 9079 06/19 /2020 5602 06/23/2020 3550 07/27/2020 423 08/04/2020 5453 09/03/2020 1961 09/09 /2020 9367 09/11/2020 7737 09/11/2020 7737 09/15/2020 5446 09/22/2020 7737 09 /29/2020 9510 10/09/2020 62 10/16/2020 9581 10/21/2020 1000 10/23/2020 4014 11 /20/2020 4938 11/23/2020 3125 12/03/2020 7950 01/05/2021 7934 01/14/2021 9559 01/21/2021 3289 03/05/2021 9935 03/31/2021 4855 04/12/2021 1254 05/05/2021 5327 05/06/2021 5514 05/12/2021 7902 3. Review of the laboratory records from 6/5 /20 to 6/4/21 revealed no documentation of the high and low quality control for 22 of 22 weeks reviewed when the above testing were performed. 4. An interview with the testing person # 1 on 6/4/21 at 1215 hours in the office confirmed the above findings. D2009 Based on review of the CMS national database, laboratory's American Proficiency Institute's proficiency testing records from 2019 to 2021 and confirmed in interview, the laboratory failed to have documentation of the laboratory director or designee and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- testing person signing 5 of 7 attestation statements reviewed. The findings were: 1. A review of the CMS national database from 2019 to 2021 revealed the laboratory participated in the following 5 test events. 2021 Hematology 1st event 2020 Hematology 2nd event 2020 Hematology 3rd event 2019 Hematoloty 1st event 2019 Hematology 2nd event 2. A review of the laboratory's American Proficiency Institute's proficiency testing records from 2019 to 2021 revealed no documentation of the laboratory director or designee and testing person signing 5 of 7 attestation statements. 2021 Hematology 1st event 2020 Hematology 2nd event 2020 Hematology 3rd event 2019 Hematoloty 1st event 2019 Hematology 2nd event 3. An interview with facility manager on 6/4/21 at 1005 hours in the office and after her review of the records confirmed the findings. D3000 Based on review of the manufacturer's instructions, laboratory and patient test records from 2020-2021, and confirmed in interview, the laboratory failed to report 807 SARS-CoV-2 negative Antigen test results as required by 400.200 for 136 of 136 days reviewed from 10/1/2020 to 6/4/2021. Findings were: 1. Review of the Instructions for Use for the BD Veritor of SARS-CoV-2 & Flu A + B (256088, 500051910(01), 2021-03) under Reporting of Results revealed "Testing facilities within the United States and its territories are required to report all SARS-CoV-2 results to the appropriate public health authorities." 2. Review of the laboratory test records from 2020 to 2021 revealed the laboratory started SARS-CoV-2 Antigen patient testing using BD Veritor of SARS-CoV-2 & Flu A + B test on 11/4/20. 3. Review of the Instructions for Use for the Sofia 2 Flu + SARS Antigen FIA test cassettes under CONDITIONS OF AUTHORIZATION FOR THE LABORATORY revealed "authorized laboratories using your product will have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate." 4. Review of the laboratory test records from 2020 to 2021 revealed the laboratory started SARS-CoV-2 Antigen patient testing Sofia 2 Flu + SARS Antigen FIA test cassettes on 9/21/20. 5. Review of the laboratory policies available revealed no documentation of a policy/procedure related to SARS-CoV-2 test reporting. 6. Review of the laboratory SARS-CoV-2 Antigen patient test records from 2020 to 2021 revealed no documentation the laboratory reported 807 patient negative test records for 136 of 136 days of testing. Refer to Covid Antigen Patient Alias list. 7. An interview with the testing person #1 on 6/4/21 at 1155 hours in the office confirmed the above findings D3031 Based on a random review of the laboratory patient logs from 2020 to 2021, and confirmed in interview,the laboratory failed to retain all patient test records for at least 2 years for 9 of 9 patient records reviewed. Findings were: 1. Random review of the patient test logs from 2020 to 2021 revealed no documentation of the original test reports for 9 of 9 patients reviewed. 12/17/20 - patient ID 232749 12/11/20 - patient ID 232991 05/11/21 - patient ID 234495 05/11/21 - patient ID 230630 04/09/21 - patient ID 232974 05/11/21 - patient ID 234561 01/19/21 - patient ID RIDEJA0032024 01/18/21 - patient ID 230758 01/18/21 - patient ID MONRBR0013087 2. An interview with the testing person #1 on 6/4/21 at 1135 hours in the office confirmed the above findings. She acknowledged that the testing personnel discarded the printouts from the analyzer after the results are transferred onto their LIS system. D5215 Based on review of the CMS national database, 2019 to 2021 American Proficiency Institute (API) proficiency testing records, and confirmed in interview, the laboratory failed to verify the accuracy of their hematology testing after receiving a score of an artificial 100% for 1 of 7 of the hematology proficiency testing events reviewed. -- 2 of 5 -- Findings were: 1. Review of the CMS national database revealed the laboratory received "100" for all the analytes for 1 of 7 API testing events in 2019 to 2021. 2020 1st event WBC - 100% RBC - 100% HGB - 100% HCT - 100% PLT - 100% WBC Diff - 100% 2. Review of the laboratory API test records revealed the laboratory received "100" for Not Graded for the above proficiency testing event. 2020 1st event WBC - Not Graded RBC - Not Graded HGB - Not Graded HCT - Not Graded PLT - Not Graded WBC Diff - Not Graded 3. Review of the evaluation sheet for the above test event revealed "great job" on the evaluation along with the lab director's signature. 4. An interview with the facility manager on 6/4/21 at 1020 hours in the office confirmed the above findings. She confirmed that the laboratory entered lab reported test problem and did not perform the test event and no results were evaluated. D5291 Review of the laboratory's policy, American Proficiency Institute (API) proficiency testing (PT) records from 2019 to 2021 and confirmed in interview, the laboratory failed to have quality assessment policies and procedures that can identify, monitor and correct problems in the general laboratory systems for 2 of 7 PT events reviewed. Findings were: 1. Review of the laboratory policy Quality Assurance Policies and Procedures under Proficiency Testing revealed "all proficiency test results will be reviewed and

Summary Statement of Deficiencies D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: . Based on review of American Proficiency Institute (API) proficiency testing documentation for 2017, confirmed by staff interview, the laboratory failed to take remedial action for unacceptable analyte scores in hematology. Findings: 1. Review of API proficiency scores for the second testing event of 2017 showed the following unacceptable scores for hematology: Hematocrit (%) Specimen Reported Expected Grade HSY-07 52 31-36 Unacceptable Hemoglobin (grams per deciliter) Specimen Reported Expected Grade HSY-07 19.2 11.6-13.4 Unacceptable Lymphocytes (%) Specimen Reported Expected Grade HSY-07 27.7 28.1-33.1 Unacceptable Red Cell Count (X 10E12/liter) Specimen Reported Expected Grade HSY-07 6.77 4.11-4.65 Unacceptable White Cell Count (X 10E9/liter) Specimen Reported Expected Grade HSY-07 12.7 6.1-8.3 Unacceptable 2. Accompanying documentation did not include evidence of investigation or remedial action for unacceptable scores. In an interview at the site on 04-11-2018, the clinic manager stated no such action was taken. . 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 --