Melbourne Medical Laboratory

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Melbourne Medical Laboratory on April 28, 2025 - September 23, 2025. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Condition was cited: D6108 - 493.1447 Condition: Laboratory Technical Supervisor 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, the laboratory failed to provide a clean eye washing station for safety incidents. Finding included: 1. On 4/29/2025 at 5: 26 PM, the eye wash station had brown debris in the sink. When the eye wash station was turned on brown liquid came out of the water head. The shower had brown stains around the head as well. 2. Review of laboratory safety read, "Use the eyewash or the shower located near the employee bathroom if any employee was splashed or spilled with any chemicals or samples." 3. On 4/28/2025 at 5:45 PM, the Laboratory Technologist confirmed the eyewash station was not cleaned for emergency use. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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. 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 -- This STANDARD is not met as evidenced by: Based on interview, review of quality control records, and patient test reports, the laboratory failed to use non-expired reagents on the Horiba ABX Pentra XL 80 Hematology Analyzer on 03/06/2024, 05/06/2024, 05/07/2024, 05/09/2024, 07/10 /2024, 07/12/2024, 07/15/2024, 07/18/2024, and 07/19/2024. Findings Included: 1. Review of the Quality Control List showed hematology controls for lot numbers PX445L, PX445N, and PX445H expired on 03/05/2024, and showed the controls were run on 03/06/2024. Review of Quality Control List showed the first day the hematology controls for lot number PX446L, PX446N, and PX446H were on 03/07 /2024. Review of the Report by date: 03/06/2024 showed nine Patients' samples were tested. A comparison of the Report by date and the Patients test reports confirmed the results from 03/06/2024 were reported. 2. Review of Quality Control List showed the hematology controls for lot number PX446L, PX446N, and PX446H expired on 05/05 /2024, and showed the controls were run on 05/06/2024, 05/07/2024, and 05/09/2024. Review of Quality Control List showed the first day the hematology controls for lot number PX447L, PX447N, and PX447H were on 05/13/2025. Review of the Report by date: 05/06/2024 showed 22 Patient samples were tested. Review of the Report by date: 05/07/2024 showed 21 Patient samples were tested. Review of the Report by date: 05/09/2024 showed 25 Patient samples were tested. A comparison of the Report by date and the Patient test reports confirmed the results from 05/06/2024, 05/07 /2024, and 05/09/2024 were reported. 3. Review of the Quality Control List showed hematology controls for lot number PX447L, PX447N, and PX447H expired on 07/05 /2024, and showed the controls were run on 07/08/2024, 07/10/2024, 07/12/2024, 07 /15/2024, 07/18/2024, and 07/19/2024. Review of Quality Control List showed the first day the hematology controls for lot number PX4478, PX448N, and PX448H were on 07/22/2024. Review of the Report by date: 07/08/2024 showed 20 patient samples were tested. Review of the Report by date: 07/09/2024 showed five patient samples were tested. Review of the Report by date: 07/10/2024 showed seven Patient samples were tested. Review of the Report by date: 07/12/2024 showed one Patient sample was tested. Review of the Report by date: 07/15/2024 showed six Patient samples were tested. Review of the Report by date: 07/18/2024 showed seven Patient samples were tested. Review of the Report by date: 07/19/2024 showed one Patient's sample was tested. A comparison of the Report by date and the Patient's test reports confirmed the results from 07/08/2024, 07/10/2024, 07/12/2024, 07/15/2024, 07/18 /2024, and 07/19/2024 were reported. 4. During an interview on 04/29/2025 at 3:45 PM, Testing Personnel A confirmed Patient test results from the hematology analyzer were reported out when the controls were expired. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) (d)(3)(i) Each quantitative procedure, include two control materials of different concentrations; This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to have 2 levels of Vitamin D chemistry controls pass on 05/23/20253 and 5/24/2023 before running Patient specimens. Findings Included: Review of Advia QC Review revealed the following: 1. Vitamin D level 1 control failed on 05/23/2023 at 10:39 AM, with no rerun. 2. Vitamin D level 2 control failed on 05/23/2023 at 10:39 AM, with no rerun. 3. No Vitamin D level 1 and Vitamin D level 2 controls were run on 05/24/2023. Review of Patient reports revealed the following: 1. Patient #1 specimen was received -- 2 of 5 -- on 05/23/2024 and reported on 05/24/2023 for Vitamin D 25 Hydroxy. 2. Patient #2 specimen was received on 05/23/2024 and reported on 05/24/2023 for Vitamin D 25 Hydroxy. Review of Quality Control policy revealed no policy for how vitamin D controls should be performed. On 04/28/2025 at 5:45 PM, the Technologist confirmed failure to have 2 levels of Vitamin D chemistry controls pass on 05/23/20253 and 05 /24/2023 before running Patient specimens. D5781

Summary Statement of Deficiencies D0000 A recertification survey was conducted from March 15, 2021 to March 17, 2021. Melbourne Medical Laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. The following Condition was cited: D5300 Preanalytic Systems 493.1240 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 record review and interview, the laboratory failed to report moderately complex Corona Virus Disease 2019 (COVID 19) antibody tests run on the Advia Centaur chemistry analyzer. The total volume of COVID 19 antibody tests was 1,307. Findings Included: Review of validations performed on the Advia Centaur chemistry analyzer revealed COVID 19 antibody test was validated on 08/27/20. There had been 1,307 patients tested since 08/27/20. On 03/17/21 at 10:00 AM, Testing Person A revealed he faxed the COVID 19 antibody tests to another section per the laboratory policy. On 03/17/21 at 10:10 AM, the Office Manager responsible for faxing COVID 19 results to the Department of Health (DOH) revealed via phone that she did not fax the antibody results to DOH, only the antigen results. On 03/16/21 at 5:00 PM, Testing Person A acknowledged the laboratory did not have a policy for reporting Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- COVID 19 results to the DOH. On 03/17/21 at 2:00 PM, the Manager acknowledged the laboratory did not have documentation to show that COVID 19 antibody results were reported to the DOH. 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 and interview, the laboratory failed to retain Quality Control records for at least two years. Findings: Review of the "Quality Assurance Program for Melbourne Medical Laboratory" signed and dated by the Laboratory Director on 02 /02/2021 read, "All quality control records must be documented and maintained for all analytes performed in our facility. These records must be kept for a minimum of two years." Review of the lot to lot comparison for hematology controls showed the laboratory failed to retain the documentation of the comparisons from 03/15/19 to 10 /26/20. On 03/16/2021 at 3:35 PM, Testing Personnel B stated the lab did not print the records and she was unable to retrieve the documentation from the hematology instrument. 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: Based on record review and interview, the laboratory failed to follow the Quality Assessment (QA) procedure for monitoring, assessing and correcting identified problems. Findings: 1. Review of the Monthly QA Checklists showed the checklist was not completed for 11/2019 and 12/2019. The checklist was completed but not signed by the Laboratory Director for the months of 03/2019, and 01/2020 to 01/2021. On 03/15/2021 at 4:50 PM, Testing Personnel B stated two months of QAs were missing and the Laboratory Director had not signed all the QAs. 2. Review of "Laboratory Quarterly Quality Assurance Review" last signed by the Laboratory Director on 02/02/21 revealed that "Every three months the Medical Director and Laboratory Manager will meet to discuss the overall functionality of the lab. A quarterly report detailing the information reviewed in the meeting will be signed and dated by the Medical Director and Laboratory Manager." Review of Quality Assurance documents found quarterly reviews for 01/15/19, 04/18/19, and 08/08/19. No other quarterly reviews were provided. On 03/16/2021 at 3:50 PM, Testing Person A stated the quarterly report had not been documented since 08/08/2019. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 -- 2 of 11 -- 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 interview, the laboratory's Quality Assessment program failed to monitor and evaluate the overall quality of the preanalytic system and correct identified problems. Findings: Cross Reference D5311: Based on observation, record review, and interview, the laboratory's procedure on Quality Assurance failed to include the rejection of patient specimens collected in expired tubes. Cross Reference D5391: Based on observation, record review, and interview, the laboratory failed to have an effective Quality Assurance (QA) plan that identified issues during the pre- analytic phase of testing from 06/30/2019 to 03/15/2021. 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 observation, record review, and interview, the laboratory's procedure on Quality Assurance failed to include the rejection of patient specimens collected in expired tubes. Findings: During a tour of the laboratory's in-house blood drawing station on 03/15/2021 at 12:45 PM, the following expired tubes where found: 218 expired EDTA (Ethylenediaminetetraacetic acid) tubes: 15 expired on 06/30/2019 42 expired on 08/31/2020 32 expired on 09/30/2020 57 expired on 10/31/2020 43 expired on 11/30/2020 29 expired on 01/31/2021 51 expired Sodium Citrate tubes: 6 expired on 07/31/2020 1 expired on 11/30/2020 30 expired on 01/31/2021 14 expired on 02/28 /2021 53 expired Sodium Fluoride Potassium Oxalate tubes: 2 expired on 05/31/2020 3 expired on 07/31/2020 1 expired on 10/31/2020 20 expired on 12/31/2020 5 expired on 01/31/2021 22 expired on 02/28/2021 87 expired PPT (Plasma Preparation tubes): 16 expired on 06/30/2020 38 expired on 12/31/2020 33 expired on 01/31/2021 171 expired SST (Serum Separation tubes): 27 expired on 07/31/2020 103 expired on 10 /31/2020 20 expired on 12/31/2020 21 expired on 02/28/2021 23 expired Serum Separator Clot Activator tubes: 4 expired on 06/30/2020 6 expired on 07/31/2020 13 expired on 03/08/2021 6 expired Para-Pak-C&S vials (culture and sensitivity vials for stool collection): 2 expired on 12/2020 4 expired on 01/2020 9 expired Total Fix stool collection vials: 9 expired on 03/2020 - 9 Observations in the patient specimen refrigerator on 03/15/2020 at 2:00 PM, revealed 9 Patients that had expired tubes. The laboratory reported laboratory test results for CBC with Differential (Diff), Vitamin B- 12, Folate, Ferretin and Iron Package on Patient #2 drawn on 03/03/2021 at 12:10 PM. The laboratory reported laboratory test results for CBC with Diff, Sediment (Sed) Rate, Comprehensive Metabolic Panel (CMP), and Vitamin D 25 Hydroxy on Patient -- 3 of 11 -- #3 drawn on 03/02/3021 at 2:13 PM. The laboratory reported laboratory test results for Lipid Profile and CMP on Patient #4 drawn on 03/10/2021 at 7:35 AM. The laboratory reported laboratory test results for CBC with Diff, and CMP on Patient #6 drawn on 03/11/2021 at 9:48 AM. The laboratory reported laboratory test results for Urinalysis, Lipid Profile, Thyroxine Total, Thyroid Stimulating Hormone (TSH), Triiodothyronine (T3), and CMP on Patient #7 drawn on 03/10/2021 at 8:21 AM. The laboratory reported laboratory test results for Lipid Profile, TSH, Free Thyroxine, T3, and CMP on Patient #8 drawn on 03/10/2021 at 13:35. The laboratory had extra tubes of blood on Patient #1 drawn on 03/03/2021 at 5:20 PM, Patient #5 drawn on 03/10 /2021 at 8:14 AM, and Patient #9 drawn on 03/10/2021 at 12:06 PM, whose blood tests were tested at other laboratories. Review of the "Quality Assurance Program for Melbourne Medical Laboratory" signed and dated by the Laboratory Director on 02/02 /2021, section E read, "Specimens may be rejected for the following..." It failed to include specimens collected in expired tube. According to the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification, signed and dated by the Laboratory Director on 03/08/21, the laboratory had a Total Estimated Annual Test Volume of 186,258 tests. On 03/15/2021 at 2:00 PM, Testing Personnel A and Testing Personnel B stated the laboratory had tubes that were expired and tests results were reported from expired tubes. On 03/16/2021 at 3:30 PM, Testing Personnel B stated that rejection of expired tubes was not included in the list of reasons for rejecting samples. 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, observation, and interview, the laboratory failed to have an effective Quality Assurance (QA) plan that identified issues during the pre-analytic phase of testing from 06/30/2019 to 03/15/2021. Findings: Review of the "Quality Assurance Program for Melbourne Medical Laboratory" signed and dated by the Laboratory Director on 02/02/2021, section E read, "Specimens may be rejected for the following..." It failed to include specimens collected in expired tube." Review of the laboratory's Monthly QA Checklist from 06/30/2019 to 03/15/2021 read, no problems with the "optimum integrity of a specimen from time of collection through the testing process." The laboratory's QA program failed to identify issues with expired blood collection tubes. During a tour of the laboratory's in-house blood drawing station on 03/15/2021 at 12:45 PM, the following expired tubes were found: 218 expired EDTA (Ethylenediaminetetraacetic acid) tubes, 51 expired Sodium Citrate tubes, 53 expired Sodium Fluoride Potassium Oxalate tubes, 87 expired Plasma Preparation tubes, 6 expired Para-Pak-C&S vials (culture and sensitivity vials for stool collection), and 9 expired Total Fix stool collection vials. Observations in the patient specimen refrigerator on 03/15/2020 at 2:00 PM, revealed 9 Patients (#1, #2, #3, #4, #5, #6, #7, #8, #9) that had expired tubes and 6 patients (#2, #3, #4, #6, #7, #8) with test results reported by the laboratory. According to the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification, signed and dated by the Laboratory Director on 03/08/21, the laboratory had a Total Estimated Annual Test Volume of 186,258 tests. On 03/15/2021 at 2:00 PM, Testing Personnel A and Testing Personnel B stated the laboratory had tubes that were expired and tests results -- 4 of 11 -- were reported from expired tubes. On 03/16/2021 at 3:30 PM, Testing Personnel B stated that rejection of expired tubes was not included in the list of reasons for rejecting samples. 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 observation, record review, and interview, the laboratory failed to have an effective Quality Assurance (QA) plan that identified issues during the analytic phase of testing from 03/15/2019 to 03/15/2021. Findings Cross Reference D5403: Based on record review and interview, the laboratory procedure manual failed to include the rejection of patient specimens collected in expired blood collection tubes. Cross Reference D5413: Based on record review and interview with Testing Person A, the laboratory failed to have refrigerator temperatures within the manufacturers' instructions for 2 (July 2019 and December 2019) out of 5 months (February 2021, May 2020, September 2020, July 2019, and December 2019) reviewed. Cross Reference D5415: Based on observation, record review, and interview, the laboratory failed to label the quality control vials currently in use with the open date and expiration date. Cross Reference D5417: Based on observation and interview, the laboratory used Microalbumin controls that were expired since 01/31/21 and the laboratory failedto ensure blood tubes were not used past their expiration date since 06 /30/19. Cross Reference D5429: Based on record review and interview, the laboratory failed to perform maintenance per the manufacturers' instructions for at least 2 (2019- 2021) out of 2 years reviewed. Cross Reference D5439: Based on record review and interview, the laboratory failed to provide documentation of the performance of the calibration on the Horiba ABX Pentra XL80 hematology instrument at least once every 6 months. This is a repeat deficiency from recertification survey on 11/28/2018. 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 D0000 A recertification survey was conducted from March 15, 2021 to March 17, 2021. Melbourne Medical Laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. The following Condition was cited: D5300 Preanalytic Systems 493.1240 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 record review and interview, the laboratory failed to report moderately complex Corona Virus Disease 2019 (COVID 19) antibody tests run on the Advia Centaur chemistry analyzer. The total volume of COVID 19 antibody tests was 1,307. Findings Included: Review of validations performed on the Advia Centaur chemistry analyzer revealed COVID 19 antibody test was validated on 08/27/20. There had been 1,307 patients tested since 08/27/20. On 03/17/21 at 10:00 AM, Testing Person A revealed he faxed the COVID 19 antibody tests to another section per the laboratory policy. On 03/17/21 at 10:10 AM, the Office Manager responsible for faxing COVID 19 results to the Department of Health (DOH) revealed via phone that she did not fax the antibody results to DOH, only the antigen results. On 03/16/21 at 5:00 PM, Testing Person A acknowledged the laboratory did not have a policy for reporting Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- COVID 19 results to the DOH. On 03/17/21 at 2:00 PM, the Manager acknowledged the laboratory did not have documentation to show that COVID 19 antibody results were reported to the DOH. 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 and interview, the laboratory failed to retain Quality Control records for at least two years. Findings: Review of the "Quality Assurance Program for Melbourne Medical Laboratory" signed and dated by the Laboratory Director on 02 /02/2021 read, "All quality control records must be documented and maintained for all analytes performed in our facility. These records must be kept for a minimum of two years." Review of the lot to lot comparison for hematology controls showed the laboratory failed to retain the documentation of the comparisons from 03/15/19 to 10 /26/20. On 03/16/2021 at 3:35 PM, Testing Personnel B stated the lab did not print the records and she was unable to retrieve the documentation from the hematology instrument. 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: Based on record review and interview, the laboratory failed to follow the Quality Assessment (QA) procedure for monitoring, assessing and correcting identified problems. Findings: 1. Review of the Monthly QA Checklists showed the checklist was not completed for 11/2019 and 12/2019. The checklist was completed but not signed by the Laboratory Director for the months of 03/2019, and 01/2020 to 01/2021. On 03/15/2021 at 4:50 PM, Testing Personnel B stated two months of QAs were missing and the Laboratory Director had not signed all the QAs. 2. Review of "Laboratory Quarterly Quality Assurance Review" last signed by the Laboratory Director on 02/02/21 revealed that "Every three months the Medical Director and Laboratory Manager will meet to discuss the overall functionality of the lab. A quarterly report detailing the information reviewed in the meeting will be signed and dated by the Medical Director and Laboratory Manager." Review of Quality Assurance documents found quarterly reviews for 01/15/19, 04/18/19, and 08/08/19. No other quarterly reviews were provided. On 03/16/2021 at 3:50 PM, Testing Person A stated the quarterly report had not been documented since 08/08/2019. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 -- 2 of 11 -- 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 interview, the laboratory's Quality Assessment program failed to monitor and evaluate the overall quality of the preanalytic system and correct identified problems. Findings: Cross Reference D5311: Based on observation, record review, and interview, the laboratory's procedure on Quality Assurance failed to include the rejection of patient specimens collected in expired tubes. Cross Reference D5391: Based on observation, record review, and interview, the laboratory failed to have an effective Quality Assurance (QA) plan that identified issues during the pre- analytic phase of testing from 06/30/2019 to 03/15/2021. 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 observation, record review, and interview, the laboratory's procedure on Quality Assurance failed to include the rejection of patient specimens collected in expired tubes. Findings: During a tour of the laboratory's in-house blood drawing station on 03/15/2021 at 12:45 PM, the following expired tubes where found: 218 expired EDTA (Ethylenediaminetetraacetic acid) tubes: 15 expired on 06/30/2019 42 expired on 08/31/2020 32 expired on 09/30/2020 57 expired on 10/31/2020 43 expired on 11/30/2020 29 expired on 01/31/2021 51 expired Sodium Citrate tubes: 6 expired on 07/31/2020 1 expired on 11/30/2020 30 expired on 01/31/2021 14 expired on 02/28 /2021 53 expired Sodium Fluoride Potassium Oxalate tubes: 2 expired on 05/31/2020 3 expired on 07/31/2020 1 expired on 10/31/2020 20 expired on 12/31/2020 5 expired on 01/31/2021 22 expired on 02/28/2021 87 expired PPT (Plasma Preparation tubes): 16 expired on 06/30/2020 38 expired on 12/31/2020 33 expired on 01/31/2021 171 expired SST (Serum Separation tubes): 27 expired on 07/31/2020 103 expired on 10 /31/2020 20 expired on 12/31/2020 21 expired on 02/28/2021 23 expired Serum Separator Clot Activator tubes: 4 expired on 06/30/2020 6 expired on 07/31/2020 13 expired on 03/08/2021 6 expired Para-Pak-C&S vials (culture and sensitivity vials for stool collection): 2 expired on 12/2020 4 expired on 01/2020 9 expired Total Fix stool collection vials: 9 expired on 03/2020 - 9 Observations in the patient specimen refrigerator on 03/15/2020 at 2:00 PM, revealed 9 Patients that had expired tubes. The laboratory reported laboratory test results for CBC with Differential (Diff), Vitamin B- 12, Folate, Ferretin and Iron Package on Patient #2 drawn on 03/03/2021 at 12:10 PM. The laboratory reported laboratory test results for CBC with Diff, Sediment (Sed) Rate, Comprehensive Metabolic Panel (CMP), and Vitamin D 25 Hydroxy on Patient -- 3 of 11 -- #3 drawn on 03/02/3021 at 2:13 PM. The laboratory reported laboratory test results for Lipid Profile and CMP on Patient #4 drawn on 03/10/2021 at 7:35 AM. The laboratory reported laboratory test results for CBC with Diff, and CMP on Patient #6 drawn on 03/11/2021 at 9:48 AM. The laboratory reported laboratory test results for Urinalysis, Lipid Profile, Thyroxine Total, Thyroid Stimulating Hormone (TSH), Triiodothyronine (T3), and CMP on Patient #7 drawn on 03/10/2021 at 8:21 AM. The laboratory reported laboratory test results for Lipid Profile, TSH, Free Thyroxine, T3, and CMP on Patient #8 drawn on 03/10/2021 at 13:35. The laboratory had extra tubes of blood on Patient #1 drawn on 03/03/2021 at 5:20 PM, Patient #5 drawn on 03/10 /2021 at 8:14 AM, and Patient #9 drawn on 03/10/2021 at 12:06 PM, whose blood tests were tested at other laboratories. Review of the "Quality Assurance Program for Melbourne Medical Laboratory" signed and dated by the Laboratory Director on 02/02 /2021, section E read, "Specimens may be rejected for the following..." It failed to include specimens collected in expired tube. According to the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification, signed and dated by the Laboratory Director on 03/08/21, the laboratory had a Total Estimated Annual Test Volume of 186,258 tests. On 03/15/2021 at 2:00 PM, Testing Personnel A and Testing Personnel B stated the laboratory had tubes that were expired and tests results were reported from expired tubes. On 03/16/2021 at 3:30 PM, Testing Personnel B stated that rejection of expired tubes was not included in the list of reasons for rejecting samples. 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, observation, and interview, the laboratory failed to have an effective Quality Assurance (QA) plan that identified issues during the pre-analytic phase of testing from 06/30/2019 to 03/15/2021. Findings: Review of the "Quality Assurance Program for Melbourne Medical Laboratory" signed and dated by the Laboratory Director on 02/02/2021, section E read, "Specimens may be rejected for the following..." It failed to include specimens collected in expired tube." Review of the laboratory's Monthly QA Checklist from 06/30/2019 to 03/15/2021 read, no problems with the "optimum integrity of a specimen from time of collection through the testing process." The laboratory's QA program failed to identify issues with expired blood collection tubes. During a tour of the laboratory's in-house blood drawing station on 03/15/2021 at 12:45 PM, the following expired tubes were found: 218 expired EDTA (Ethylenediaminetetraacetic acid) tubes, 51 expired Sodium Citrate tubes, 53 expired Sodium Fluoride Potassium Oxalate tubes, 87 expired Plasma Preparation tubes, 6 expired Para-Pak-C&S vials (culture and sensitivity vials for stool collection), and 9 expired Total Fix stool collection vials. Observations in the patient specimen refrigerator on 03/15/2020 at 2:00 PM, revealed 9 Patients (#1, #2, #3, #4, #5, #6, #7, #8, #9) that had expired tubes and 6 patients (#2, #3, #4, #6, #7, #8) with test results reported by the laboratory. According to the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification, signed and dated by the Laboratory Director on 03/08/21, the laboratory had a Total Estimated Annual Test Volume of 186,258 tests. On 03/15/2021 at 2:00 PM, Testing Personnel A and Testing Personnel B stated the laboratory had tubes that were expired and tests results -- 4 of 11 -- were reported from expired tubes. On 03/16/2021 at 3:30 PM, Testing Personnel B stated that rejection of expired tubes was not included in the list of reasons for rejecting samples. 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 observation, record review, and interview, the laboratory failed to have an effective Quality Assurance (QA) plan that identified issues during the analytic phase of testing from 03/15/2019 to 03/15/2021. Findings Cross Reference D5403: Based on record review and interview, the laboratory procedure manual failed to include the rejection of patient specimens collected in expired blood collection tubes. Cross Reference D5413: Based on record review and interview with Testing Person A, the laboratory failed to have refrigerator temperatures within the manufacturers' instructions for 2 (July 2019 and December 2019) out of 5 months (February 2021, May 2020, September 2020, July 2019, and December 2019) reviewed. Cross Reference D5415: Based on observation, record review, and interview, the laboratory failed to label the quality control vials currently in use with the open date and expiration date. Cross Reference D5417: Based on observation and interview, the laboratory used Microalbumin controls that were expired since 01/31/21 and the laboratory failedto ensure blood tubes were not used past their expiration date since 06 /30/19. Cross Reference D5429: Based on record review and interview, the laboratory failed to perform maintenance per the manufacturers' instructions for at least 2 (2019- 2021) out of 2 years reviewed. Cross Reference D5439: Based on record review and interview, the laboratory failed to provide documentation of the performance of the calibration on the Horiba ABX Pentra XL80 hematology instrument at least once every 6 months. This is a repeat deficiency from recertification survey on 11/28/2018. 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 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 2018 and 2019, the laboratory did not have successful performance in proficiency testing for the subspecialty of routine chemistry. Refer to D2096. 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 October 24, 2019 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, total bilirubin (T bil) for two out of three testing events in 2019. D2096 ROUTINE CHEMISTRY 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 -- CFR(s): 493.841(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 performance in proficiency testing in the subspecialty of routine chemistry. Findings include: On October 24, 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, total bilirubin, (T bil), as shown below. Event #1, 2019 total bilirubin-40% Event #3, 2019 total bilirubin-40% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 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 routine chemistry. Findings include: On October 24, 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, total bilirubin (T bil), in the subspecialty of routine chemistry. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2096. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that 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 for the analyte, total bilirubin (T bil) in the subspecialty of routine chemistry. Findings -- 2 of 3 -- Include: The review of the American Proficiency (API) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on October 24, 2019 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores as shown below. Event #1, 2019 total bilirubin-40 % Event #3, 2019 total bilirubin-40 % -- 3 of 3 --

Summary Statement of Deficiencies D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to participate in proficiency testing (PT) that resulted in a score of zero (0)% or the Hematology /Coagulation testing third event in 2017. Findings: Review of the American Proficiency Institute (API) records for 2018 Hematology/Coagulation 3rd Event showed the laboratory received a score of 0% for all analytes to be tested. otes on the API "Performance Summary" sheet stated "Failure to Participate". During an interview on 11/26/18 at 3:25 PM, Testing Personnel A acknowledged that he failed to get the test results submitted on time. 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. 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 -- This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to verify the accuracy at least twice annually of parathyroid, opiates, total iron-binding capacity (TIBC), low- density lipoprotein cholesterol (LDL), direct bilirubin and urine sediment in 2017, and phosphate in 2018 Findings: The laboratory is enrolled in proficiency testing (PT) with American Proficiency Institute (API). API provides PT samples for analytes in Chemistry - Miscellaneous two times a year, and for analytes in Chemistry - Core and Hematolog/Coagulation three times a year. Review of the laboratory's API PT records showed that the laboratory failed to verify the accuracy by obtain two successful scores of at least 80% or above annually for the following results. 2017 Chemistry - Miscellaneous 1st Event - Parathyroid 67% 2nd Event - Parathyroid 67% 2017 Chemistry - Miscellaneous 1st Event - Opiates 100% 2nd Event - Opiates 67% 2017 Chemistry - Core 1st Event - TIBC 100% 2nd Event - TIBC 0% 3rd Event - TIBC 0% 2017 Chemistry - Core 1st Event - LDL Cholesterol 20% 2nd Event - LDL Cholesterol 100% 3rd Event - LDL Cholesterol 0% 2017 Chemistry - Core 1st Event - Bilirubin, Direct 100% 2nd Event - Bilirubin, Direct 40% 3rd Event - Bilirubin, Direct 0% 2017 Hematology / Coagulation 1st Event - Urine Sediment 100% 2nd Event - Urine Sediment 50% 3rd Event - Urine Sediment 0% 2018 Chemistry - Core 1st Event - Phosphate 40% 2nd Event - Phosphate 20% During an interview on 11/27/18 at 3:20 PM, Testing Personnel A acknowledged that they had some unsuccessful PT results. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform and document calibration on the Horiba Medical ABX Pentra XL800 hematology analyzer at least twice a year in 2017. Findings: Review of calibration records on the ABX Pentra XL800 showed that calibration was performed only once in 2017 on 4/25/17. During an interview on 11/28/18 at 11 AM, Testing Personnel A acknowledged that the calibration was performed only once in 2017. -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the laboratory's proficiency testing records for 2017 and 2018, the laboratory did not have successful performance in proficiency testing for the subspecialty of routine chemistry. Refer to D2097. 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 August 13, 2018 on or about 2:00 PM, showed that the laboratory had unsatisfactory testing scores for the analyte, blood urea nitrogen (BUN) for two out of three testing events in 2017 and 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 -- D2097 ROUTINE CHEMISTRY CFR(s): 493.841(g) Failure to achieve an overall testing event score of satisfactory performance for 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 routine chemistry. Findings include: On August 13, 2018 on or about 2:00 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, blood urea nitrogen, BUN, as shown below. Event #3, 2017 BUN-0% Event #2, 2018 BUN-60% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 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 routine chemistry. Findings include: On August 13, 2018, on or about 2:00 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 testing scores for two out of three testing events for the analyte, blood urea nitrogen, BUN, in the subspecialty of routine chemistry. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2097. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that 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 -- 2 of 3 -- the subspecialty of routine chemistry. 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 August 13, 2108 on or about 2:00 PM showed that the laboratory received unsatisfactory proficiency testing scores as shown below. Event #3, 2017 BUN-0% Event #2, 2018 BUN-60% -- 3 of 3 --