Genesis Medical Laboratory

Summary Statement of Deficiencies D0000 A recertification survey conducted from 05/07/2024 to 05/31/2024 found GENESIS MEDICAL LABORATORY not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following Condition was cited: -D6168 Testing Personnel 493.1487 D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to examine Proficiency Testing samples in the same manner as patient testing with personnel who routinely perform the testing in the laboratory. Findings included: 1- Personnel records reviewed revealed that in the Microbiology section there were three testing person TP#2, TP#3 and TP#5 (as per 209 Form). 2- Review of Attestations for Microbiology 2022 revealed that TP#2: signed 1st event on 02/25/2022, 2nd event on 06/28/2022 and 3rd event 2022 (no date record). There were no attestation signature records for TP#3 and TP#5 for year 2022. During an interview on 05/10/2024 at 1:30 PM, the General Supervisor confirmed that attestation on 2022 for the Microbiology specialty were signed by TP#2. 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. 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 -- This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to have a signed attestation for Proficiency Testing for Microbiology/Molecular for two events (2nd and 3rd) out of three events in 2023 by the Testing Person. Findings included: 1- Review of Attestation for 2023 Second event of Microbiology revealed that the Testing Person, who performed tests for Human Papillomavirus (HPV), Chlamydia Trachomatis (CT), Neisseria Gonorrhea (NG) and Respiratory Panel with SARS-CoV- 2 liquid molecular failed to sign attestation. 2- No record found for attestation for 2023 Microbiology 3rd Event for molecular tests: HPV, CT, NG, Respiratory Panel, Urinary Tract Infection (UTI) and SARS-CoV-2 liquid. 3- Interview on 05/08/2023 at 5:00 PM, the laboratory manager stated, "all attestations are signed on survey submit date.", she confirmed that the records of reference were not found during the inspection. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the laboratory had REMEL XLD Agar plate in use and expired since 04/30/2024. Based on observation, record review and interview the laboratory used Complete Blood Cell (CBC) Controls after the expiration date on 05/04/2024 as per manufacturer instructions. Findings included: - During the laboratory tour on 05/07/2024 at 9:30 AM, the surveyor observed that the laboratory was using a REMEL AGAR PLATE with Lot number 802134 expired since 04/30/2024. The laboratory tested two patients with the expired plate for stool culture. -During the laboratory tour on 05/07/2024 at 9:40 AM, the surveyor observed that the laboratory had in use the CBC controls with Lot number 123175400, 133185400 and 143195400 in the CBC Beckman DXH900 analyzer, the vials in use were opened on 04/19/2024. Based on manufacturer instructions the controls are stable after opening for 16 days (05/04/2024), the laboratory tested 90 patients on 05 /06/2024 using the CBC controls expired. During an interview on 05/07/2024 at 10:30 AM the laboratory manager confirmed that the laboratory used the expired culture plate and the CBC controls listed above. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on record review and interview, the laboratory failed to identify the personnel performing the testing in the final report for 5 out of 5 patients reports reviewed. Findings included: A random review of 5 patients reports dated: 10/27/2022 (patient#1), 03/31/2023 (patient#2), 10/02/2023 (patient#3), 04/05/2024 (patient#4) and 04/11/2024 (patient#5) revealed they did not have any indication of who performed the testing. During an interview on 05/10/2024 at 02:30 PM, the laboratory manager confirmed that the final reports failed to document who performed the test. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview, Testing Person #1 performed proficiency testing for Huma Papillomavirus, Chlamydia Trachomatis and Neisseria Gonorrhea in 2022 and 2023 without having the Microbiology Specialty in the State of Florida Laboratory Personnel License. Refer to D6170. D6170 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(a) Each individual performing high complexity testing must possess a current license issued by the State in which the laboratory is located, if such licensing is required. This STANDARD is not met as evidenced by: Based on record review and interview, Testing Person(TP)#1 performed proficiency testing (PT) for Human Papillomavirus Virus (HPV), Chlamydia Trachomatis (CT) and Neisseria Gonorrhea (NG) in 2022 and 2023 without having the Microbiology Specialty in the State of Florida Laboratory Personnel License. Findings included: - Review of personnel records for TP#1 revealed that he had a Cytology Supervisor License since 01/17/1984, he failed to have the Microbiology specialty. -Review of PT records for 2022 and 2023 for Microbiology Specialty revealed the following: a) 06 /28/20222: TP#1 signed attestation for Microbiology 2nd event. b) 09/29/2022: TP#1 signed attestation for Microbiology 3rd event for the tests for CT/NG and HPV. Instrument prints out for Cobas 4800 with date 09/23/2022 listed TP#1 as the operator and the person that accepted the results for HPV on the day the PT samples were included in the worklist. c) 02/14/2023: Instrument printout for Cobas 4800 listed TP#1 as the operator and the PT samples for CT/NG first event were listed. d) 02/16 /2023: Instrument printout for Cobas 4800 listed TP#1 as the operator and the PT samples for HPV first event were listed e) 06/25/2023: Attestation signed by TP#1 and listed CT/NG as samples tested. During an interview on 05/10/2024 at 2:30 PM, the General Supervisor confirmed the findings and she explained that the Molecular Supervisor for the period of reference is no longer with the laboratory and she was the person managing the area. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on 4/14/2022 to 4/15/2022 at Genesis Medical laboratory. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the laboratory failed to store chemistry and molecular reagents in freezers according to manufacturer guidelines. Findings included: During observation on 4/14/2022 at 11:20 AM in the chemistry room revealed freezer # 4 temperature listed as -18.3 Celsius (C). In the freezer #4 were the following reagents that required storage of -20 C to -70 C: 1. 6 out of 6 Biorad Therapeutic Drug monitoring control Level 1 2. 6 out of 6 Biorad Therapeutic Drug monitoring control Level 3 3. 4 out of 4 Immunoassay Plus Control level 1 4. 3 out of 3 Immunoassay Plus Control level 3 5. 1 out of 1 liquid assayed Multi level 3 Review of January 2022 -March 2022 Freezer #4 Temperature log revealed 45 out of 65 days from 1/3/2022 - 3/31/2022 freezer temperatures were recorded below -20 C. During observation on 4/14/2022 at 3:54 PM in the Molecular hallway revealed freezer # 1 temperature listed as -30 C. In the freezer 1 were the following reagents that required storage of -15 C to -25 C: 1.96-Well Spectral Calibration Plate ABY for multiplex qPCR 2.HDPCR SARS- CoV-2 Box1 HT Assay 3.HDPCR SARS- CoV-2 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 -- Box 2 Controls 4.HDPCR SARS- CoV-2 Box 2 Calibrators During an interview on 4 /15/2022 at 3:45 PM, the office manager and staff confirmed the laboratory failed to store chemistry and molecular reagents in freezers according to manufacture guidelines. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to complete interfering substances in their validation for their laboratory developed COVID Test HDPCR SARS-CoV 2 assay since 1/23/2021. Findings Included: A review of Genesis HDPCR SARS COV-2 validation revealed the laboratory developed the COVID Test HDPCR SARS-CoV 2 for testing for COVID. There was no written documentation that interfering substances had been performed in the validation. The validation had been signed by the laboratory director on 1/23/2022, 4/7/2021 and 7/29/2021. During an interview on 4/15/2022 at 3:00 PM, the office manager stated 79,050 PCR COVID-19 Test have been performed from 7/29/2021 to present. During an interview on 4/15 /2022 at 3:44 PM, the molecular supervisor confirmed that interfering substances was not performed in the validation before patient testing. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An unannounced complaint survey (#2020017755) conducted on 11/18/2020 -11/19 /2020, found that Genesis Medical Laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following condition was cited: -D3000 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). This CONDITION is not met as evidenced by: Based on record review and staff interview the laboratory failed to follow the Florida Emergency Rule 64DER20-18 (64D-3.029) to report all COVID 19 tests results immediately to the Florida Department of Health (DOH) from 4/15/2020 to 11/19 /2020. See 3009 D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to follow the State of Florida Emergency Rule 64DER20-18(64D-3.029) to report all positive and negative COVID-19 test results immediately to the Department of Health (DOH), failed to have a procedure in place to report real time polymerase chain reaction (RT-PCR) 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 -- Coronavirus 2019 (COVID-19) and COVID-19 immunoglobulin G (IgG) results to the Florida Department of Health (FDOH) as per current guidelines, and the laboratory failed to ensure that the FDOH received all the notifications for the tests performed from 4/15/2020 to 11/19/2020. Findings include: -Review of policy GEN- 14, for Reporting Results signed by the laboratory Director on 3/16/2020, stated that for Infection Disease Test positive (reactive) a result report must be faxed to FDOH using a report form, to keep record of the form and the fax confirmation (Hepatis B, C, RPR, Chlamydia, Gonorrhea). No further revision done after addition of the PCR COVID-19 added to the test menu on 4/15/2020 and COVID-19 IgG on 5/2020. - Review of FDOH Emergency Rule 64DER20-26 (64D-3.029) of April 10th 2020, revealed for COVID-19; the timeframe is immediately and had special reporting requirements. Results should be reported and accompanied by any testing conducted (positive and negative). For laboratories performing electronic laboratory reporting as described in subsection 64D-3.031 (5). F.A.C., all test results (positive and negative) are to be submitted, including screening test results (positive and negative). -The laboratory performed 42618 COVID-19 PCR test from 4/22/2020 to 11/10/2020 and 2435 IgG test from 5/2020 to 11/2020. -Review of Genesis report of test results for PCR COVID-19 on 7/1/2020 showed that the laboratory performed 187 tests, for 32 tests positive and 155 negatives. Review of the notifications sent to FDOH revealed the following: a) Fax confirmation records for PCR COVID-19 sent to FDOH for 7/1 /2020 showed 6 fax reports (each with 4 positive case reports): b) 3 fax confirmation with the following PCR COVID_19 cases: 373352, 373397, 373398,373278, 373618, 373631, 373485, 373541, 373658,372632, 373613 and 373614, had error in transmission. No documentation available of further transmission to the FDOH. c) 3 fax confirmation reported OK transmission for PCR COVID-19 cases: 373610, 373600, 373273, 373277, 373300, 373350, 373351, 373464, 373287, 373290, 373291, 393292). d) No documentation of report to the FDOH found for 8 PCR COVID-19 positive cases (373458, 375459, 373460, 373461, 373468, 373473, 373639 and 373644). e) No documentation of the report to the FDOH of the 155 PCR COVID-19 negative cases. -Review of the FDOH report records for serology COVID- 19 IgG on 9/11/2020 revealed that the laboratory had 16 cases listed on 4 reporting forms, but no fax confirmation found of the notifications sent. During an interview on 11/19/2020 at 5:30 PM, the general supervisor, confirmed that the laboratory failed to have a policy that follow the guidelines for reporting COVID-19, that the laboratory failed to report negative cases for PCR COVID-19, that the laboratory failed to have all fax confirmation of the reports sent to the FDOH and failed to ensure that all PCR COVID-19 cases tested were reported to the FDOH. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Genesis Medical Laboratory on 03/16/2020 thru 03/26/2020. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. Based on the survey findings, an Immediate Jeopardy situation was identified and the laboratory was notified at 5:00 PM on 03/20/2020. Based on record review and staff interviews the laboratory failed to ensure blood tubes were not used past their expiration since 12/09/19 and failed to ensure 1 of 2 centrifuges produced platelet poor specimens for Coagulation testing for 2 (2018-2020) out of 2 years reviewed (See D5311), failed to document the date and time of 1786 QuantiFERON (QFT) specimen after blood collection, and failed to have an effective quality assurance (QA) plan that identified issues during the pre-analytic phase of testing for 2 (2018-2020) out of 2 years reviewed (See D5300). Based on observation, record review and staff interview, the laboratory failed to follow the QuantiFERON (QFT) manufacturer's instructions (MI) for documenting QFT specimen incubation times for 16 to 24 hour and failed to follow MI for bacteriology cultures for 2 (2018-2020) out of 2 years reviewed, failed to provide water and 70% ethanol spray bottles that were not expired in Molecular Genetics room, failed to perform the initial instrument validation for the Qiagen QIA stat-Dx Analyzer per the Manufacturer's Instructions (MI) when validating the instrument on 09/09/19 for a Respiratory Panel, failed to document controls for QuantiFERON TB Gold Plus testing and Pharmacogenomics (PGX) testing for the years of January 2018 through January 2020, failed to create a policy for quality control and use positive controls for each mutation, negative control and a non-template control for the Pharmacogenomics (PGX) assay CYP2C19, CYP4502D6-BC and CYP4502C9 from June 2018 to January 2020, failed to perform and document the comparison of the two methodologies used to perform the microscopic evaluation of Hematology White Blood Cell (WBC) differential at least twice annually from 01/17/19 to 03/23/20, failed to follow Pharmacogenomics manufactures instructions for acceptable specimens and provide patient testing results without expired samples on the instrument from January 2018 thru January 2020 and failed to document each step from media inoculation to organism isolation and identification and who ran each part of the test in Bacteriology for 2 (2018-2020) out of 2 years reviewed, and failed to Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- perform all required maintenance on the BD Phoenix Microbiology analyzer since 07 /10/18 (See D5400). The following Conditions were cited: D5300 Preanalytic Systems 493.1240 D5400 Analytic Systems 493.1250 D6076 Laboratory Director 493.1441 D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed do an initial and 6- month personnel competency assessment for 1 (TP#C) out of 9 testing personnel (TP) . Findings Included: A review of CMS 209 Laboratory Personnel record revealed Employee C was a TP#C Review of "Competency Assessment" policy (last reviewed by the Laboratory Director on 05/08/2018) revealed that "The Laboratory will assess competency of all technical personnel subsequent to initial training, after six months, yearly and as needed there after (due to additions in testing equipment-protocols or any other reason that may warrant it) in accordance with CLIA regulations." A review of Personnel Competency Assessment record showed that TP#C was missing an initial and 6-month personnel competency assessment. During an interview on 03/20 /2020 at 12:30 pm, General manager confirmed that Initial and 6-month personnel competency assessment were not preformed. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the College of American Pathologist (CAP) proficiency testing (PT) and interview, the laboratory failed to provide documentation to verify the accuracy of the testing methods for 21 out of 98 analytes tested in urine toxicology from 01/01/19 to 12/31/19, at least twice annually. Findings Included: Review of the College of American Pathologist (CAP) proficiency testing (PT) showed that 21 analytes were not included in CAP's test menu. The following 21 analytes were not included in CAP's test menu: 7-Hydroxyquetiapine, Alpha-hydroxytriazolam, Alpha- PVP (Alpha Pyrrolidinopentiophenone), Amobarbital Pentobarbital, Butalbital, JWH- 018 4-Hydroxypenty, JWH-073 3-Hydroxybutyl, JWH 250-N-4 Hydroxypentyl, Maprotiline, MDEA (3,4-Methylenedioxy-N-ethylamphetamine), Mephedrone, Methylone, Mitragynine, Naloxone, Naltrexone, Oxcarbazepine, Ritalinic Acid, Secobarbital, Sufentanil, Yangonin, and Zaleplon. The raw date for the split testing performed on 4/20/19 with an outside laboratory was not available for review. During an interview on 03/20/19 at 5:30 PM, the Technical Supervisor stated that they were unable to locate the raw data for the split testing. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 -- 2 of 10 -- Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and staff interviews the laboratory failed to ensure blood tubes were not used past their expiration since 12/09/19 and failed to ensure 1 of 2 centrifuges produced platelet poor specimens for Coagulation testing for 2 (2018- 2020) out of 2 years reviewed (See D5311), failed to document the date and time of 1786 QuantiFERON (QFT) specimen after blood collection (See D5313), and failed to have an effective quality assurance (QA) plan that identified issues during the pre- analytic phase of testing for 2 (2018-2020) out of 2 years reviewed (See D5391). D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on record review and interview with the General Manager the laboratory failed to ensure blood tubes were not used past their expiration since 12/09/19 and failed to ensure 1 of 2 centrifuges produced platelet poor specimens for Coagulation testing for 2 (2018-2020) out of 2 years reviewed. Findings Included: 1. During a tour of the laboratory's in-house blood drawing station on 03/16/2020 at 2:00 PM revealed 12 expired blue top (Coagulation tubes with 3.2% Sodium Citrate) used for Pro-time testing that expired 03/08/2020. Observations in the patient specimen refrigerator on 03/16/2020 at 2:00 PM revealed 8 Patients that had expired tubes. Patient #1 was drawn on 03/14/20 at 13:46 and the tube expired 03/08/20, Patient #2 was drawn on 03 /13/20 at 10:03 and the tube expired 03/08/20, Patient #3 was drawn on 03/13/20 at 16: 34 and the tube expired 12/09/19, Patient #4 was drawn on 03/13/20 at 18:58 and the tube expired 12/09/19, Patient #5 was drawn on 03/14/20 at 16:12 and the tube expired 01/04/20, Patient #6 was drawn on 03/13/20 at 19:48 and the tube expired 03 /08/20, Patient #7 was drawn on 03/13/20 at 16:29 and the tube expired 12/09/19, and Patient #8 was drawn on 03/14/20 at 13:35 and the tube expired on 03/08/20. Patients' #1, #2, #6, and #8 had testing performed and each result was high. Patient #5 had testing ordered but the sample quantity was not sufficient for analysis. Review of the manufacturer's instruction for the blue top tubes revealed under "Vacuette Precautions /Cautions" to "Do not use the tubes after the expiration date." Review of the Coagulation policy and procedures (last reviewed by the Laboratory Director on 03/16 /20) under "Rejection Criteria" does not list expired tube as a criteria for rejection. 2. Review of the manufacturer's instructions for the blue top tubes revealed routine tests need a platelet poor specimen or spun at 1500-2000 g-force for 10 minutes. Review of -- 3 of 10 -- "Plasma Poor Study" procedure (last reviewed by the Laboratory Director on 03/16 /20) revealed that "Platelet poor plasma (5 samples) is randomly tested twice a year to ensure quality of platelet poor plasma specimens received from different institutions and all in-house centrifuges are used to prepare PPP". Tour of the laboratory on 03/16 /20 at 2:00 PM revealed 2 centrifuges (an Eppendorf Centrifuge 5702 and a LW Scientific Combo Centrifuge) with a sticker on each that said "CENTRIFUGUE BLUE TUBES 10 MIN". Review of the poor plasma study revealed one performed on 07/08/19, 01/29/19, 07/23/18, and 05/04/18. Interview on 03/20/20 at 3:30 PM the Technical Supervisor confirmed that a platelet poor specimen study was only performed on the Eppendorf Centrifuge 5702 and that blue top Coagulation tubes were spun down in both centrifuges. 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 record review, observation and Staff interview, the laboratory failed to document the time of QuantiFERON (QFT) specimen after blood collection through March 2019 through January 2020. Findings Included: A review of TB QuantiFERON Gold Plus procedure record revealed lithium heparin tubes can be stored up to 12 hours after blood collection. QFT blood specimen tubes must be placed into an incubator within 2 hours. A review of QuantiFERON Gold Plus specimen record revealed QFT samples had no time collection recorded for March 2019 through January 2020. During an interview on 03/20/2020 at 12:30 PM, the general manager confirmed that QFT samples had no time collection documented for March 2019 through January 2020. 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 record review and interview with the General Manager the laboratory failed to have an effective quality assurance (QA) plan that identified issues during the pre- analytic phase of testing for 2 (2018-2020) out of 2 years reviewed. Findings Included: Review of the "Quality Assurance Program" policy (last signed as reviewed by the Laboratory Director on 03/16/20) revealed that it should monitor "Pre-Analytic (patient test management)", to "Identify and correct problems", and "Parameters to be monitored (proficiency testing, competency review, unacceptable specimen, turnaround time, wrong patient report, unlabeled specimen, etc.) are established." Review of the "Monthly Laboratory Quality Assessment" revealed no issues identified in "Evaluated specimen submissions and test ordered, handling and rejections." Interview on 03/16/20 at 5:00 PM the General Manager confirmed that the QA did not identify the pre-analytic issues found in D5311 and D5313. D5400 ANALYTIC SYSTEMS -- 4 of 10 -- 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 observation, record review and staff interview, the laboratory failed to follow the QuantiFERON (QFT) manufacturer's instructions (MI) for documenting QFT specimen incubation times for 16 to 24 hour and failed to follow MI for bacteriology cultures for 2 (2018-2020) out of 2 years reviewed (See D5411), failed to provide water and 70% ethanol spray bottles that were not expired in Molecular Genetics room (See D5417), failed to perform the initial instrument validation for the Qiagen QIA stat-Dx Analyzer per the Manufacturer's Instructions (MI) when validating the instrument on 09/09/19 for a Respiratory Panel (See D5421), failed to document controls for QuantiFERON TB Gold Plus testing and Pharmacogenomics (PGX) testing for the years of January 2018 through January 2020 (See D5441), failed to create a policy for quality control and use positive controls for each mutation, negative control and a non-template control for the Pharmacogenomics (PGX) assay CYP2C19, CYP4502D6-BC and CYP4502C9 from June 2018 to January 2020 (See D5445), failed to perform and document the comparison of the two methodologies used to perform the microscopic evaluation of Hematology White Blood Cell (WBC) differential at least twice annually from 01/17/19 to 03/23/20 (See D5775), failed to follow Pharmacogenomics manufactures instructions for acceptable specimens and provide patient testing results without expired samples on the instrument from January 2018 thru January 2020 and failed to document each step from media inoculation to organism isolation and identification and who ran each part of the test in Bacteriology for 2 (2018-2020) out of 2 years reviewed (See D5787), and failed to perform all required maintenance on the BD Phoenix Microbiology analyzer since 07/10/18 (See D5429). D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on observation, record review and staff interview, the laboratory failed to follow the QuantiFERON (QFT) manufacturer's instructions (MI) for documenting QFT specimen incubation times for 16 to 24 hr and failed to follow MI for bacteriology cultures for 2 (2018-2020) out of 2 years reviewed. Findings Included: 1. An observation of the hallway showed an incubator on the floor . A review of QuantiFERON TB Gold Plus EIA-700 procedure record revealed that QFT- Plus Blood Collection Tubes are incubated upright at 37 C for 16 to 24 hours . Unreliable or indeterminate results may occur do to exceeding specimen draw to incubation . -- 5 of 10 -- During an interview on 03/20/2020 at 12:30 PM , the office manager confirmed 16-24 incubation times were not documented for QFT specimen . 2. Interview on 03/19/20 at 9:30 AM the Bacteriology Testing Personnel revealed that all culture plates were preliminarily read at 24 hours and final read and reported at 48 hours. She confirmed that no one works Sundays and that the culture plates that were at 48 hours on Sunday would be read at 72 hours on Monday. Review of MI reveal that Blood, Macconkey, Xylose-Lysine-Desoxycholate, Phenylethyl alcohol, Thioglycollate Medium, and Mueller Hinton agar plates are to be read at 18-24 hours, Chocolate agar plates are to be read at 24-48 hours, and Thayer Martin and Anaerobic Blood agar plates are examined 24-48 hours however negative plates need to be incubated 72-96 hours before reporting as negative. Interview on 03/19/20 at 9:30 AM the Bacteriology Testing Personnel confirmed that Bacteriology culture plates were not being read and reported out per MI. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and staff interview, the laboratory failed to provide water and 70% ethanol spray bottles that were not expired in Molecular Genetics room . Findings Included: An observation of Molecular Genetics room revealed a water and 70% ethanol spray bottle that had an expiration date of 12/21/19 on a work counter. During an interview on 03/20/2020 at 12:30 PM, the General Supervisor confirmed that water and 70% ethanol spray were expired. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on record review and interview with the General Manager the laboratory failed to perform the initial instrument validation for the Qiagen QIA stat-Dx Analyzer per the Manufacturer's Instructions (MI) when validating the instrument on 09/09/19 for a Respiratory Panel. Findings Included: Review of the MI for the Qiagen QIA Stat-Dx Analyzer revealed that to validate the analyzer "For each assay run the method provides either 5 or 6 positive results and, correspondingly, 15 or 14 negative results for the 20 pathogens, in total, which are detected and differentiated by the QIA stat- Dx Respiratory Panel." Review of the validation conducted on 09/09/19 and approved -- 6 of 10 -- by the Laboratory Director on 09/10/19 the laboratory ran 1 negative sample and 16 positive samples. Interview on 03/20/20 at 5:00 PM the General Manager confirmed that the samples tested for validation did not meet the MI instructions. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on record review and interview with the Technical Supervisor and General Supervisor the laboratory failed to perform all required maintenance on the BD Phoenix Microbiology analyzer since 07/10/18. Findings Included: Review of the BD Phoenix maintenance log revealed that every 3 months the Nephelometer needs calibrated. No documentation of the Nephelometer calibration was provided. Logs were reviewed since the instrument began testing on 07/10/18. Interview on 03/20/20 at 1:00 PM the Technical Supervisor confirmed that the calibration of the Nephelometer was not done. Review of the BD Phoenix maintenance log revealed that the printer paper needed to be checked on the instrument daily and documented on the log. The log had no documentation of the paper being checked since 02/05/19. Interview on 03/19/20 at 11:00 AM the General Supervisor confirmed that the BD Phoenix maintenance logs were not complete. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to document controls for QuantiFERON TB Gold Plus testing and Pharmacogenomics(PGX) testing for the years of 2018 through January 2020. Findings Included: A review of QuantiFERON TB Gold Plus assay record revealed the Nil (gray top tube) served as the negative control and Mitogen (purple cap tube) serves as the positive control. A review of QuantiFERON Assay Results record revealed that Nil and Mitogen controls were documented for March 2019 through January 2020 . A review CYP2C19 , CYP4502D6-BC and CYP4502C9 Assay package insert record showed in quality control section "positive samples for each mutation (heterozygous and homozygous ) , A negative control (wild-type ) and a non template control (molecular grade water) should also be included in each run." A review of the PGX Results July 2018 -January -- 7 of 10 -- 2020 record revealed that controls were not documented . The Molecular Testing person stated that controls would be in the first 3 rows on the sample preparation sheet . Sample preparation sheet contained no controls in the first three rows . A review Molecular Pharmacogenetics procedure manual was missing a procedure on quality control for CYP2C19 ,CYP4502D6-BC and CYP4502C9. During an interview on 3/20 /2020 at 10 am , the office manager confirmed that testing personnel were not documenting controls for QuantiFERON and Pharmacogenetics for 2018 through January 2020. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation, record review, and staff interview the laboratory failed to create a policy for quality control, use positive controls for each mutation , a negative control, and a non-template control for the Pharmacogenomics (PGX) assay CYP2C19 ,CYP4502D6-BC and CYP4502C9 from June 2018 to January 2020. Findings Included: An observation of Molecular Genetics room revealed 2 Eppendorf mastercycler , 2 Eppendorf Vapoprotect , Microarray and Mircoarray analyzer . A review of PGX Procedure record revealed no policy on quality control . A review CYP2C19 ,CYP4502D6-BC and CYP4502C9 Assay package insert record showed in quality control section "positive samples for each mutation (heterozygous and homozygous ) , A negative control (wild-type ) and a non template control (molecular grade water ) should also be included in each test run." A review of the PGX Results July 2018 - January 2020 record revealed that controls were not done and documented . The Molecular Testing person stated that control would be in the first 3 rows on the sample preparation sheet . Sample preparation sheet contained no controls in the first three rows . During an interview on 03/20/2020 at 12:30 PM , the General Supervisor confirmed the lab failed to create a policy for quality control and use positive controls for each mutation , negative control and a non-template control for the Molecular genetics assay CYP2C19 ,CYP4502D6-BC and CYP4502C9. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: -- 8 of 10 -- Based on record review and interview, the laboratory failed to perform and document the comparison of the two methodologies used to perform the microscopic evaluation of Hematology White Blood Cell (WBC) differential at least twice annually from 01 /17/19 to 03/23/20. Findings Included: Review of the quality control documentation showed that there was no documentation comparing the automated WBC differential performed on the Beckman Coulter DxH 900 Hematology analyzer to the manual microscopic WBC differential. Initial calibration records for the Beckman Coulter DxH 900 Hematology analyzer were dated 01/17/19. During an interview on 03/20/19 at 2:55 PM, the Laboratory Consultant confirmed that method to method comparison for microscopic examinations of WBC differentials had not been done. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to follow Pharmacogenomics manufacturer's instructions for acceptable specimens and provide patient testing results without expired samples on the instrument from January 2018 thru January 2020 and failed to document each step from media inoculation to organism isolation and identification and who ran each part of the test in Bacteriology for 2 (2018-2020) out of 2 years reviewed. Findings Included: 1. A review CYP2C19 , CYP4502D6-BC and CYP4502C9 Assay package insert record revealed that extracted Specimen should be kept refrigerated (2 to 8 Celsius) and extracted within nine days from the day the specimen was collected . Extracted DNA samples should be kept refrigerated (2 to 8 Celsius) and assayed within two days from the day the specimen was extracted. Buccal swab specimen should be assayed up to 7 days from collection day . A review of the PGX Results July 2018 -January 2020 record showed specimens were tested 7 days past collection date and the specimens were run in two monthly batches and patient results were reported. During an interview on 03/20/20 at 12:30 pm , the General Supervisor and previous Testing Personnel confirmed that specimens were tested past expiration and patient test results were reported for January 2018 thru January 2020. 2. Review of Bacteriology worksheets revealed no date, time, or Testing Personnel of who made the identification of result of culture. Interview on 03/19/20 at 9:30 AM the Bacteriology Testing Personnel confirmed that each step was not documented for time, date, and person who performed the test. 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: -- 9 of 10 -- Based on record review and staff interview the Laboratory Director failed to have oversight of the laboratory for 2 (2018-2020) out of 2 years reviewed (See D6079). D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on record review and staff interview the Laboratory Director failed to have oversight of the laboratory for 2 (2018-2020) out of 2 years reviewed. Findings Included: See D5300: Based on record review and staff interviews the laboratory failed to ensure blood tubes were not used past their expiration since 12/09/19 and failed to ensure 1 of 2 centrifuges produced platelet poor specimens for Coagulation testing for 2 (2018-2020) out of 2 years reviewed (See D5311), failed to document the date and time of 1786 QuantiFERON (QFT) specimen after blood collection (See D5313), and failed to have an effective quality assurance (QA) plan that identified issues during the pre-analytic phase of testing for 2 (2018-2020) out of 2 years reviewed (See D5391). See D5400: Based on observation, record review and staff interview, the laboratory failed to follow the QuantiFERON (QFT) manufacturer's instructions (MI) for documenting QFT specimen incubation times for 16 to 24 hour and failed to follow MI for bacteriology cultures for 2 (2018-2020) out of 2 years reviewed (See D5411), failed to provide water and 70% ethanol spray bottles that were not expired in Molecular Genetics room (See D5417), failed to perform the initial instrument validation for the Qiagen QIA stat-Dx Analyzer per the Manufacturer's Instructions (MI) when validating the instrument on 09/09/19 for a Respiratory Panel (See D5421), failed to document controls for QuantiFERON TB Gold Plus testing and Pharmacogenomics (PGX) testing for the years of January 2018 through January 2020 (See D5441), failed to create a policy for quality control and use positive controls for each mutation, negative control and a non-template control for the Pharmacogenomics (PGX) assay CYP2C19, CYP4502D6-BC and CYP4502C9 from June 2018 to January 2020 (See D5445), failed to perform and document the comparison of the two methodologies used to perform the microscopic evaluation of Hematology White Blood Cell (WBC) differential at least twice annually from 01/17/19 to 03/23/20 (See D5775), failed to follow Pharmacogenomics manufactures instructions for acceptable specimens and provide patient testing results without expired samples on the instrument from January 2018 thru January 2020 and failed to document each step from media inoculation to organism isolation and identification and who ran each part of the test in Bacteriology for 2 (2018-2020) out of 2 years reviewed (See D5787), and failed to perform all required maintenance on the BD Phoenix Microbiology analyzer since 07/10/18 (See D5429). -- 10 of 10 --

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 laboratory's proficiency testing records for 2017 and 2018, the laboratory did not have successful performance in proficiency testing for the subspecialty of general immunology. Refer to D2084. Findings include: Review of the American Proficiency Institute (API) proficiency testing records and the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on February 18, 2019 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, rheumatoid arthritis test (RA) for two out of three testing events in 2018. 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 -- D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(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 the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful participation in proficiency testing for the subspecialty of general immunology. Findings include: On February 18, 2019 on or about 10:00 AM the American Proficiency Institute (API) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the analyte, rheumatoid arthritis (RA) test, as shown below. Event #2, 2018 RA test-40% Event #1, 2018 RA test-60% 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 the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the subspecialty of general immunology. Findings include: On February 18, 2019, on or about 10:00 AM, the American Proficiency Institute (API) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two out of three testing events for the analyte, rheumatoid arthritis (RA) test, in the specialty of general immunology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2084. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing in the subspecialty of general immunology. Findings Include: The review of the American Proficiency Institute (API) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on February 18, 2019 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency -- 2 of 3 -- testing scores as shown below. Event #2, 2018 rheumatoid arthritis test-40% Event #3, 2018 rheumatoid arthritis test-60%. -- 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 laboratory's proficiency testing records for 2017 and 2018, the laboratory did not have successful performance in proficiency testing for the specialty of hematology. Refer to D2130. Findings include: Review of the American Proficiency Institute (API) proficiency testing records and the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on September 19, 2018 on or about 1:00 PM, showed that the laboratory had unsatisfactory testing scores for the analyte, prothrombin time (PT) for two consecutive testing events in 2018. 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 -- D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful participation in proficiency testing for the specialty of hematology. Findings include: On September 19, 2018 on or about 1:00 PM the American Proficiency Institute (API) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the analyte, prothrombin time (PT), as shown below. Event #1, 2018 Prothrombin Time-60% Event #2, 2018 Prothrombin time-60% 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 the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the specialty of hematology. Findings include: On September 19, 2018, on or about 1:00 PM, the American Proficiency Institute (API) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory proficiency testing score for the analyte, prothrombin tine (PT) in the specialty of hematology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2130. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing in the specialty of hematology. Findings Include: The review of the American Proficiency Institute (API) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on September 19, 2018 on or about 1: 00 PM showed that the laboratory received unsatisfactory proficiency testing scores as shown below. Event #1, 2018 Prothrombin time-60 % Event #2, 2018 Prothrombin time-60%. -- 2 of 2 --

Summary Statement of Deficiencies D2066 SYPHILIS SEROLOGY CFR(s): 493.835(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of American Proficiency Testing (API) testing results and interview with the office manager, the laboratory failed to have satisfactory results in Syphilis Serology in 1 out of 3 events. The findings include: API results for year 2016 showed a score of 40 % for Syphilis serology and 20 % for Syphilis (titer, serum) in 2016 3rd event. During an interview with the office manager at 2:00 pm on January 30th 2018 she confirmed that laboratory failed PT for syphilis serology and syphilis (titers serum) in 2016 third event. 39027 D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: 39027 Based on review of American Proficiency Testing (API) testing results and interview with the office manager, the laboratory failed to have satisfactory results in sodium in 1 out of 3 events. The findings include: API results for year 2016 showed a score of 60 % for sodium test for 2016 first event. During an interview with the office manager at 2:00 pm on January 30th 2018 she confirmed that the laboratory failed PT sodium analyte test result for first event 2016. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: 39027 Based on review of American Proficiency Testing (API) testing results and interview with the office manager, the laboratory failed to have satisfactory results in lymphocytes and neutrophils analytes in the Hematology specialty in 2 out of 2 consecutive events. The findings include: API results for years 2016 showed a score of 40 and 60 % for the lymphocyte and 60 % and 60 % for neutrophils in the specialty of hematology in the white blood cell differential lymphocyte respectively for the second and third event of 2016. During an interview with the office manager at 2:00 pm on January 30th 2018, she confirmed that the laboratory failed PT second and third event for lymphocyte and neutrophils analyte test for year 2016. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation, record review and interview with the laboratory staff, laboratory failed to provide the safety and sanitary conditions to the patients and personnel by; 1) The blood-draw chair was in the entrance passage to the laboratory. 2) There were big boxes on the floor along with big biohazard bin, leaving not adequate room for testing personnel to move around and to have smooth work flow. 3) There were reagent bottles and reagent boxes on workbench, along with daily work log binders for the tests performed and test specimens, leaving no workspace on workbench for testing personnel. 4) The employee bathroom did not have paper towel and bathroom toilet did not flush. 5) Allow the processing personnel to use the laboratory computer with gloves, and not having specific sign or written procedure posted on computer or in procedure manual, for the use of computer and any sterility measures or means for disinfection. Findings include: During the tour of the laboratory on January 30, 2018, the surveyor observed; A) Blood-draw chair was in the entrance passage to the laboratory not leaving any room for smooth blood drawing, or leaving privacy for the patient. The passage had 3 doors: laboratory door, patient waiting area door and a door to a very small office opened up in the laboratory entrance passage, where the blood-draw chair was. B) There were big boxes on the floor along with big biohazard bin in testing area. C) There were reagent bottles and reagent boxes on workbench, along with daily work log binders for the tests performed and urine and blood test specimens leaving no room for workspace. D) The employee bathroom did not flush and there was no paper towels to use after hand wash. E) Testing personnel using computer with gloves on in the laboratory. there was no written procedure posted on the computer, nearby bulletin board or in procedure manual for any safety procedure, sterility measures or means of disinfection for the computer. F) There was no posted sign on computer or nearby bulletin board, for use of computer with gloves. Procedure manual did not include the procedure for -- 2 of 9 -- decontamination of computer. (i) On 1/30/18 at 5PM, laboratory assistant and laboratory manager confirmed that the blood- drawing chair was in the laboratory entrance passage. The passage had three doors opening from the laboratory, a very small office and a patient waiting area, leaving no room for smooth blood collection or leaving privacy of the patient. (ii) On 1/30/18 at 12PM, the supervisor and the laboratory assistant confirmed about the big boxes on the floor along with big biohazard bin in testing area. (iii) On 1/30/18 at 12PM, the supervisor and the laboratory assistant confirmed that reagent bottles and reagent boxes were on workbench, along with daily work log binders for the tests performed and urine and blood test specimens leaving no room for work. (iv) On 1/30/18 at 11:30AM, the laboratory manager confirmed that employee bathroom that did not flush after it was used and there was no paper towels to use after hand wash. (v) On 2/6/18 at 8:45 AM, the laboratory supervisor confirmed on the phone that the laboratory personnel used gloves while using computer and there was no posted sign or written procedure for decontamination of the computer. D5201 CONFIDENTIALITY OF PATIENT INFORMATION CFR(s): 493.1231 The laboratory must ensure confidentiality of patient information throughout all phases of the total testing process that are under the laboratory's control. This STANDARD is not met as evidenced by: Based on observation and interview with the laboratory staff, the laboratory failed to ensure the patient's privacy by having the blood-drawing chair in the entrance passage to the laboratory. The findings include: On January 30, 2018 at 9:30 am, the surveyor observed the blood-draw chair was in the entrance passage to the laboratory, which did not allow any privacy for patient or enough room for smooth blood drawing. Blood-draw chair was in the passage where laboratory door, patient waiting area door and a door to a very small office opened up. On 1/30/18 at 5PM, the laboratory assistant, the laboratory manager and the laboratory supervisor confirmed that the blood-draw chair was in the laboratory entrance passage and had three doors opening from laboratory, a very small office and a patient waiting area, leaving no room for smooth blood collection or leaving privacy of the patient. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of