Andrew Chung Md, Pllc

Summary Statement of Deficiencies D0000 An announced routine recertification survey of the laboratory was conducted on 07/08 /2025. The laboratory was found in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories) for the specialties/subspecialties for which it was surveyed. Standard level deficiencies were cited. D5807 TEST REPORT CFR(s): 493.1291(d) (d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policy, a random review of patient test reports from June 2025, and staff interview, the laboratory failed to include its own reference intervals for 11 of 11 chemistry patient final reports. Findings include: 1. Review of the laboratory's policy titled "Evaluation of Automated Test Methods", approved by the laboratory director on 06/01/2021 stated: "Normal Ranges (Reference Intervals) ... 2. The results to these 20 samples will be used to validate the established reference intervals ... Summary ... This evaluation should be documented, and all worksheets, instrument printouts, and related documents shall be retained for the life of the method plus two years for regulatory inspection purposes." 2. A random review of patient final reports determined the laboratory failed to include its own reference intervals for 11 of 11 chemistry patient final reports: a. Accession ID: 213852X751920 Collection date: 06/09/2025 10:39:00 Received date: 06/09/2025 15:36:04 1. Analyte: Alanine Aminotransferase Laboratory policy range: 7 - 52 U/L Patient final report range: 0 - 40 U/L 2. Analyte: Aspartate Aminotransferase Laboratory policy range: 10 - 40 U/L Patient final report range: 0 - 40 U/L 3. Analyte: Alkaline Phosphatase Laboratory policy range: 40 - 130 U/L Patient final report range: 0 - 130 U/L 4. Analyte: Creatinine Laboratory policy range: 0.60 - 1.30 mg/dL Patient final report range: 0 - 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 -- 1.3 mg/dL 5. Analyte: Blood Urea Nitrogen Laboratory policy range: 9 - 20 mg/dL Patient final report range: 0 - 20 mg/dL b. Accession ID: 213852X811782 Collection date: 06/10/2025 07:41:00 Received date: 06/10/2025 15:21:08 1. Analyte: Alanine Aminotransferase Laboratory policy range: 7 - 52 U/L Patient final report range: 0 - 40 U/L 2. Analyte: Aspartate Aminotransferase Laboratory policy range: 10 - 40 U/L Patient final report range: 0 - 40 U/L 3. Analyte: Alkaline Phosphatase Laboratory policy range: 40 - 130 U/L Patient final report range: 0 - 130 U/L 4. Analyte: Creatinine Laboratory policy range: 0.60 - 1.30 mg/dL Patient final report range: 0 - 1.3 mg/dL 5. Analyte: Blood Urea Nitrogen Laboratory policy range: 9 - 20 mg/dL Patient final report range: 0 - 20 mg/dL c. Accession ID: 213852X845419 Collection date: 06/12/2025 07:51:00 Received date: 06/13/2025 13:03:07 1. Analyte: Alanine Aminotransferase Laboratory policy range: 7 - 52 U/L Patient final report range: 0 - 40 U/L 2. Analyte: Aspartate Aminotransferase Laboratory policy range: 10 - 40 U/L Patient final report range: 0 - 40 U/L 3. Analyte: Alkaline Phosphatase Laboratory policy range: 40 - 130 U/L Patient final report range: 0 - 130 U/L 4. Analyte: Creatinine Laboratory policy range: 0.60 - 1.30 mg/dL Patient final report range: 0 - 1.3 mg/dL 5. Analyte: Blood Urea Nitrogen Laboratory policy range: 9 - 20 mg/dL Patient final report range: 0 - 20 mg/dL d. Accession ID: 213852X846713 Collection date: 06/12/2025 10:37:00 Received date: 06/12/2025 15:00:05 1. Analyte: Alanine Aminotransferase Laboratory policy range: 7 - 52 U/L Patient final report range: 0 - 40 U/L 2. Analyte: Aspartate Aminotransferase Laboratory policy range: 10 - 40 U/L Patient final report range: 0 - 40 U/L 3. Analyte: Alkaline Phosphatase Laboratory policy range: 40 - 130 U/L Patient final report range: 0 - 130 U/L 4. Analyte: Creatinine Laboratory policy range: 0.60 - 1.30 mg/dL Patient final report range: 0 - 1.3 mg/dL 5. Analyte: Blood Urea Nitrogen Laboratory policy range: 9 - 20 mg/dL Patient final report range: 0 - 20 mg/dL e. Accession ID: 213852X806482 Collection date: 06/19/2025 07:43:00 Received date: 06/23/2025 15:42:05 1. Analyte: Alanine Aminotransferase Laboratory policy range: 7 - 52 U/L Patient final report range: 0 - 40 U/L 2. Analyte: Aspartate Aminotransferase Laboratory policy range: 10 - 40 U/L Patient final report range: 0 - 40 U/L 3. Analyte: Alkaline Phosphatase Laboratory policy range: 40 - 130 U/L Patient final report range: 0 - 130 U/L 4. Analyte: Creatinine Laboratory policy range: 0.60 - 1.30 mg/dL Patient final report range: 0 - 1.3 mg/dL 5. Analyte: Blood Urea Nitrogen Laboratory policy range: 9 - 20 mg/dL Patient final report range: 0 - 20 mg/dL f. Accession ID: 213852X848410 Collection date: 06/19/2025 09:39:00 Received date: 06/23/2025 15:45:19 1. Analyte: Alanine Aminotransferase Laboratory policy range: 7 - 52 U/L Patient final report range: 0 - 40 U/L 2. Analyte: Aspartate Aminotransferase Laboratory policy range: 10 - 40 U/L Patient final report range: 0 - 40 U/L 3. Analyte: Alkaline Phosphatase Laboratory policy range: 40 - 130 U/L Patient final report range: 0 - 130 U/L 4. Analyte: Creatinine Laboratory policy range: 0.60 - 1.30 mg/dL Patient final report range: 0 - 1.3 mg/dL 5. Analyte: Blood Urea Nitrogen Laboratory policy range: 9 - 20 mg/dL Patient final report range: 0 - 20 mg/dL g. Accession ID: 213852X825084 Collection date: 06/23/2025 08:34:00 Received date: 06/23/2025 16:12:12 1. Analyte: Alanine Aminotransferase Laboratory policy range: 7 - 52 U/L Patient final report range: 0 - 40 U/L 2. Analyte: Aspartate Aminotransferase Laboratory policy range: 10 - 40 U/L Patient final report range: 0 - 40 U/L 3. Analyte: Alkaline Phosphatase Laboratory policy range: 40 - 130 U/L Patient final report range: 0 - 130 U/L 4. Analyte: Creatinine Laboratory policy range: 0.60 - 1.30 mg/dL Patient final report range: 0 - 1.3 mg/dL 5. Analyte: Blood Urea Nitrogen Laboratory policy range: 9 - 20 mg/dL Patient final report range: 0 - 20 mg/dL h. Accession ID: 213852X845558 Collection date: 06/24/2025 09:58:00 Received date: 06/25/2025 10:03:06 1. Analyte: Alanine Aminotransferase Laboratory policy range: 7 - 52 U/L Patient final report range: 0 - 40 U/L 2. Analyte: Aspartate Aminotransferase Laboratory policy range: 10 - 40 U/L -- 2 of 3 -- Patient final report range: 0 - 40 U/L 3. Analyte: Alkaline Phosphatase Laboratory policy range: 40 - 130 U/L Patient final report range: 0 - 130 U/L 4. Analyte: Creatinine Laboratory policy range: 0.60 - 1.30 mg/dL Patient final report range: 0 - 1.3 mg/dL 5. Analyte: Blood Urea Nitrogen Laboratory policy range: 9 - 20 mg/dL Patient final report range: 0 - 20 mg/dL i. Accession ID: 213852X812668 Collection date: 06/23/2025 12:45:00 Received date: 06/23/2025: 16:15:08 1. Analyte: Alanine Aminotransferase Laboratory policy range: 7 - 52 U/L Patient final report range: 0 - 40 U/L 2. Analyte: Aspartate Aminotransferase Laboratory policy range: 10 - 40 U/L Patient final report range: 0 - 40 U/L 3. Analyte: Alkaline Phosphatase Laboratory policy range: 40 - 130 U/L Patient final report range: 0 - 130 U/L 4. Analyte: Creatinine Laboratory policy range: 0.60 - 1.30 mg/dL Patient final report range: 0 - 1.3 mg/dL 5. Analyte: Blood Urea Nitrogen Laboratory policy range: 9 - 20 mg/dL Patient final report range: 0 - 20 mg/dL j. Accession ID: 213852X771731 Collection date: 06/25/2025 08:34:00 Received date: 06/25/2025 16:06:02 1. Analyte: Alanine Aminotransferase Laboratory policy range: 7 - 52 U/L Patient final report range: 0 - 40 U/L 2. Analyte: Aspartate Aminotransferase Laboratory policy range: 10 - 40 U/L Patient final report range: 0 - 40 U/L 3. Analyte: Alkaline Phosphatase Laboratory policy range: 40 - 130 U/L Patient final report range: 0 - 130 U/L 4. Analyte: Creatinine Laboratory policy range: 0.60 - 1.30 mg/dL Patient final report range: 0 - 1.3 mg/dL 5. Analyte: Blood Urea Nitrogen Laboratory policy range: 9 - 20 mg/dL Patient final report range: 0 - 20 mg/dL k. Accession ID: 213852X840359 Collection date: 06/26/2025 08:55:00 Received date: 06/26/2025 13:48:05 1. Analyte: Alanine Aminotransferase Laboratory policy range: 7 - 52 U/L Patient final report range: 0 - 40 U/L 2. Analyte: Aspartate Aminotransferase Laboratory policy range: 10 - 40 U/L Patient final report range: 0 - 40 U/L 3. Analyte: Alkaline Phosphatase Laboratory policy range: 40 - 130 U/L Patient final report range: 0 - 130 U/L 4. Analyte: Creatinine Laboratory policy range: 0.60 - 1.30 mg/dL Patient final report range: 0 - 1.3 mg/dL 5. Analyte: Blood Urea Nitrogen Laboratory policy range: 9 - 20 mg/dL Patient final report range: 0 - 20 mg/dL 3. The technical consultant (as listed on the CMS-209 form) confirmed the findings in an interview conducted on 07/08/2025 at 1400 hours in the office. Key: U/L - Units per liter mg/dL - milligrams per deciliter CMS - Centers for Medicare and Medicaid Services -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted 05/24/2023 to 05/25/2023. The laboratory was found out of compliance with the following conditions: 493.1240 Preanalytic systems 493.1403 Laboratories performing moderate complexitytesting; laboratory director D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of laboratory policy, manufacturer's instructions, patient test records, and confirmed in interview, the laboratory failed to meet the requirements of the preanalytical phase of testing as evidenced by: 1. The laboratory failed to ensure patient complete blood count (CBC) specimens were not analyzed beyond the manufacturer's stability requirements prior to testing on the Sysmex XN- 330 hematology analyzer for 6 of 20 specimens in May 2023 (random sampling). Refer to D5311. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- 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 review of laboratory policy, manufacturer's instructions, patient test records, and confirmed in interview, the laboratory failed to ensure patient complete blood count (CBC) specimens were not analyzed beyond the manufacturers stability requirements prior to testing on the Sysmex XN- 330 hematology analyzer for 6 of 20 specimens in May 2023 (random sampling). The findings include: 1. Review of the laboratory policy titled "Hematology Analyzer XN-330" revealed: "E. Stored Specimen Stability 1. EDTA blood samples should be analyzed with [sic] 24 hours when stored at room temperature (18-26C). 2. If samples cannot be analyzed within 24 hours, store in a refrigerator at 2-8C." 2. Review of the Sysmex Basic Operation guide revealed: "Chapter 4 Analyzing Samples ... 4.3 Preparing Samples ... Handling whole blood Mix the venous blood with an anticoagulant (EDTA-2K or EDTA-3K). Draw the amount of venous blood that is specified for the amount of EDTA anticoagulant. The sample should be analyzed within 4 hours after collection. If it is not possible to analyze the sample within 4 hours, store it in a refrigerator at 2 to 8C until it can be analyzed ..." 3. Review of the Sysmex Method Verification Manual revealed: "Section 3 Method Verification Protocols ... It is the customer's responsibility to perform additional studies, following the requirements of their accrediting agency. The following protocols are provided: Correlation Studies (CAS assists with data reduction) Sensitivity Studies (See Application Manual) Reference Range Verification (See Application Manual) Stability Study (See Application Manual) Mixing Study (See Application Manual) Typically, integration studies are performed on new analyzers to verify and document satisfactory analyzer performance according to the manufacturer's specifications. It is up to the laboratory to perform more extensive studies if they deem it necessary to satisfy requirements over and above what is contained in these protocols." 4. Review of the "Stability Study" section from the Sysmex Application Manual revealed: "Stability Study (for Customer Reference Only) Stability studies may be performed to determine the readiness of a sample for CBC, differential and reticulocyte count analysis. Short term stability may be performed with fresh samples drawn and analyzed at intervals within one (1) hour. Long term stability is conducted under storage conditions and over a period of time defined by the laboratory as acceptable for specimen analysis. Typical long term studies include analysis of room temperature (18-26C) and refrigerated (4C) samples at intervals from zero to 48, 56 or 72 hours." 5. A random review of patient test records from May 2023 revealed the following 6 patients whose CBCs were performed beyond the manufacturer's 4-hour stability requirement: Sample Number: 99061960 Collection date/time: 05/22/2023 at 07:42 hours Analysis date/time: 05/22 /2023 at 15:36 hours Elapsed time from collection to analysis: 7 hours 54 minutes Sample Number: 99061980 Collection date/time: 05/23/2023 at 07:37 hours Analysis date/time: 05/23/2023 at 13:38 hours Elapsed time from collection to analysis: 6 hours 1 minutes Sample Number: 99061971 Collection date/time: 05/23/2023 at 07:28 hours Analysis date/time: 05/23/2023 at 11:56 hours Elapsed time from collection to analysis: 4 hours 28 minutes Sample Number: 99061977 Collection date/time: 05/23 /2023 at 07:31 hours Analysis date/time: 05/23/2023 at 11:58 hours Elapsed time from collection to analysis: 4 hours 27 minutes Sample Number: 99061972 Collection date /time: 05/23/2023 at 07:28 hours Analysis date/time: 05/23/2023 at 12:34 hours Elapsed time from collection to analysis: 5 hours 6 minutes Sample Number: 99061978 Collection date/time: 05/23/2023 at 07:34 hours Analysis date/time: 05/23 -- 2 of 8 -- /2023 at 12:40 hours Elapsed time from collection to analysis: 5 hours 6 minutes The laboratory did not ensure their written preanalytical requirements were consistent with manufacturer's preanalytical requirements. The laboratory extended the specimen stability beyond manufacturer's instructions for the above CBC specimens and could not provide studies to support the extended stability. 6. During an interview on 05/24 /2023 at 11:44 a.m., the surveyor asked the Technical Consultant if the laboratory performed specimen stability studies to support the laboratory's established specimen stability parameters. The Technical Consultant stated that the laboratory did not perform any specimen stability studies. This confirmed the above findings. 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 direct observation and confirmed in interview, the laboratory failed to ensure Abbott Architect ci4100 calibration materials did not exceed their expiration dates. The findings include: 1. During a tour of the laboratory storage areas on 05/25 /2023 at 02:03 p.m., the surveyor observed the following expired calibration materials in the K2 Scientific refrigerator behind a clinical workstation: 1 box of CoV-2 IgG Calibrators; Lot# 46098FN00; Expiration: 2023-04-28 1 box of Ferritin Calibrators; Lot# 34005UD00; Expiration: 2023-03-18 1 box of Total PSA Calibrators; Lot# 39035FN00; Expiration: 2023-03-11 1 box of Vitamin B12 Calibrators; Lot# 40665UD00; Expiration: 2023-02-24 1 box of Total PSA Calibrators; Lot# 39035FN00; Expiration: 2023-03-11 1 box of CoV-2 IgG II Calibrators; Lot# 44088FN00; Expiration: 2023-04-06 1 box of iPTH Calibrators; Lot# 02422E000; Expiration: 2023-02-16 1 box of FSH Calibrators; Lot# 36297UD00; Expiration: 2023-05-22 1 box of BNP Calibrators; Lot# 44K24022; Expiration: 2023-05-02 During a tour of the laboratory storage areas on 05/25/2023 at 02:08 p.m., the surveyor observed the following expired calibration materials in the Danby freezer next door to the draw station: 1 box of CoV-2 IgG II Calibrators; Lot# 41477FN00; Expiration: 2023-01-27 1 box of LH Calibrators; Lot# 381202UD00; Expiration: 2023-02-14 2. During the exit interview on 05/25/2023 at 02:11 p.m., the Technical Consultant confirmed the above findings. Key: CoV-covid IgG- immunoglobulin G PSA- prostate specific antigen iPTH- intact parathyroid hormone FSH- follicle stimulating hormone BNP- B-type natriuretic peptide LH- luteinizing hormone 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 -- 3 of 8 -- 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 review of laboratory policy, laboratory records, and confirmed in interview, the laboratory failed to perform calibration verification for the Abbott Architect ci4100 chemistry analyzer every 6 months in 2022 and 2023. The findings include: 1. Review of the laboratory policy titled "Linearity and Calibration Verification" revealed: "CALIBRATION VERIFICATION... Calibration verification is performed every six months, as stated in current CLIA regulations." 2. Review of the laboratory's "Linearity Calibration Log Book" for the Abbott Architect ci4100 chemistry analyzer revealed calibration verification was performed 01/2022 and 07/2022. The following analytes (random sampling) did not have documented calibration verification in 01 /2022: Follicle stimulating hormone (FSH) Free thyroxine (FT4) Further review of the "Linearity Calibration Log Book" revealed no calibration verification was performed for any analytes at the next scheduled time on 01/2023. The laboratory failed to perform calibration verification for the Abbott Architect ci4100 chemistry analyzer every 6 months. 3. During an interview on 05/25/2023 at 12:21 p.m., the Technical Consultant confirmed the above findings. This is a repeat citation from the previous survey conducted on 10/26/2021. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory policy, quality control (QC) package inserts, QC records, and confirmed in interview, the laboratory failed to perform QC material overlap studies for 3 of 3 levels of Technopath liquid controls (Multichem S Plus and MultiChem IA Plus) for the Abbott Architect ci4100 chemistry analyzer in 2022. The findings include: 1. A review of the laboratory policy titled "Quality Control and -- 4 of 8 -- Assessment" revealed: "PROCEDURE FOR CHANGE IN LOT OF ASSAYED CONTROL MATERIAL (when performing daily quality control testing) "Assayed" controls have stated means and standard deviations in their product literature, we have established means and adjust them to our facility as necessary: The laboratory should run each level of new control material 5 times, with alternating personnel and on multiple days when possible, to verify that control samples fall within manufacturer stated ranges. Results may be compared to against those found within the package insert and placed in the quality control binder, or results may be placed on the chart template following, to show acceptability of new lot control material. Additionally, the laboratory may begin the new [sic] of control material using the manufacturers stated means and ranges, but should verify and adjust according to the following procedure: 1. You may begin patient testing with the stated means and ranges, but you should gather at least 20 control points for each level in use. 2. The sum of these points divided by the number of samples run is your "actual mean" for that control." 2. Review of the package inserts for the Technopath liquid controls (Multichem S Plus and MultiChem IA Plus) revealed the following: "ASSIGNMENT OF VALUES The values provided in the data sheet were derived from replicate analyses and are specific for a particular lot of product. These values have been generated using third party manufacturers' instrument systems and are specific to one measurement procedure. Technopath makes no accuracy claims regarding these values. Tests were performed by the control manufacturer and/or by independent laboratories, for various methods and instrument systems. As a tool to assist in establishing their own mean, laboratories can import the values into their ARCHITECT system ... Values are provided only as guidelines, each laboratory should establish its own statistical limits. Laboratory means may vary from the values listed during the shelf life of the control ..." 3. Review of quality control records from 2022 and 2023 revealed the following quality control lot numbers that were placed into service and the laboratory failed to perform QC material overlap studies: Multichem S Plus Level 1- Lot# 10907211; Expiration: 2023-12-31 Level 2- Lot# 10907212; Expiration: 2023-12-31 Level 3- Lot# 10907213; Expiration: 2023-12-31 Multichem IA Plus Level 1- Lot# 35006211; Expiration: 2023-09-30 Level 2- Lot# 35006212; Expiration: 2023-09-30 Level 3- Lot# 35006213; Expiration: 2023-09-30 The laboratory was asked to provide documentation of QC material overlap studies for the Technopath liquid controls (Multichem S Plus and Multichem IA Plus) levels 1,2, and 3. None was provided. 4. During an interview on 05/24/2023 at 03:10 p.m., the Technical Consultant confirmed the above findings. D5781

Summary Statement of Deficiencies D0000 An entrance conference was held with the laboratory representative. The survey process was discussed and survey forms were provided. An opportunity for questions and comments was given. Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The laboratory representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in COMPLIANCE with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: ++++++++++++++++++++++++ Revisit Conducted 09/14/2020-09/15/2020 New Finding Based on review of laboratory policy, quality control (QC) records and confirmed in interview, the laboratory failed to follow it's own written policy for repeating QC when all parameters were not within range or had flags for 5 of 45 days in 2020 (random review Jun-Aug). Findings included: 1. Review of Hematology Analyzer (AcT Diff 2) laboratory policy, approved on 01/2020 revealed: "QUALITY CONTROL... 6. Successful control runs will have all parameters within range with no flags present. All out of range controls will be flagged with a (L) or (H). The only acceptable flags for 4C+ control is the * for PLT count on Low control and * on MO# and Mo/o on High Control. All other flags must be investigated, and controls repeated until no flags are present." 2. Review of QC data from 06/24/20 through 08/25/2020 revealed the following dates QC was not repeated when flags or failures were obtained during a QC run: QC normal level lot #077700 expiration date 09/03/2020 WBC acceptable range: 7.1-8.7*10^3/uL Lymphocyte% acceptable range: 38.2-44.2 % RBC acceptable range: 3.84-4.4*10^6/uL HCT acceptable range: 32-36.6 % QC high level lot #087700 expiration date 09/03/2020 RBC acceptable range: 4.89-5.11 *10^6/uL 07/01/2020 normal control RBC: 3.70 L HCT: 30.7 L 07/16/2020 normal control Lymphocyte %: 37.4 L 07/28/2020 high control RBC: 4.85 L 08/03/20 normal control WBC: 7.7 L 08/06/2020 normal control RBC: 3.84 L QC was not repeated for any of the above dates. The laboratory failed to follow thier own written policy for repeating QC when failures or flags were obtained for all parameters. 3. During an 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 -- interview on 09/15/2020 at 11:00 am, the technical consultant confirmed the above findings. ++++++++++++++++++++++++ -- 2 of 2 --

Summary Statement of Deficiencies D0000 D000The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Proficiency Institute (API). The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 successful participation in a proficiency testing program 493.1403 laboratories performing moderate complexity testing; laboratory director 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: Based on a proficiency testing desk review of CMS form 155 and American proficiency Institute API records found that the laboratory failed to attain a satisfactory score of at least 80% of acceptable responses for each analyte in the subspecialty of chemistry for the analytes Total Bilirubin and Triglycerides. Findings: 1. API 2018 - 3rd event the laboratory received the unsatisfactory score of 20% for Total Bilirubin. 2. API 2018 - 3rd event the laboratory received the unsatisfactory score of 60% for Triglycerides. D2088 ROUTINE CHEMISTRY CFR(s): 493.841(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Review of the CMS report 155 and API proficiency testing records found that the laboratory failed to achieve a satisfactory score of at least 80% for the overall chemistry testing event score. Findings: 1. API 2019 - 1st event reported an event chemistry score of 0%. D2089 ROUTINE CHEMISTRY CFR(s): 493.841(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: Review of the CMS report 155 and API proficiency testing records found that the laboratory failed to participate in the 2019 1st Testing Event resulting in a score of 0% for the all analytes in the speciality of Chemistry, constituting unsatisfactory performance. Findings: 1. API 2019 - 1st event reported No Data Received resulting in the following unsatisfactory scores: Routine Chemistry event 0% Alanine aminotransferase ALT 0% Albumin 0% Alkaline Phosphatase 0% Aspartate aminotransferase AST 0% Bilirubin Total 0% Calcium 0% Total Cholesterol 0% Cholesterol HDL 0% Creatinine 0% Glucose 0% Potassium 0% Sodium 0% Total Protein 0% Triglycerides 0% Blood Urea Nitrogen BUN 0% D2096 ROUTINE CHEMISTRY 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 desk review of proficiency testing records, it was determined the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two consecutive testing events or two out of three consecutive testing events in the specialty of Chemistry for the analytes Total Bilirubin and Triglycerides. Two out of three unsatisfactory scores results in unsuccessful PT performance. Findings include: 1. API 2018 - 3rd testing event the laboratory received the following unsatisfactory scores: Total Bilirubin 20% Triglycerides 60% 2. API 2019 - 1st testing event the laboratory received the following unsatisfactory scores: Total Bilirubin 0% Triglycerides 0% D2099 ENDOCRINOLOGY CFR(s): 493.843(b) -- 2 of 4 -- 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 CMS form 155 and American Proficiency Institute API records the laboratory failed to obtain at least an 80 percent overall sub-specialty score for Endocrinology. Findings: 1. API 2019 - 1st testing event score was 0%. D2100 ENDOCRINOLOGY CFR(s): 493.843(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: Review of the CMS report 155 and proficiency testing records found that the laboratory failed to participate in the 2019 1st Testing Event for Endocrinology, resulting in a score of 0% for all regulated analytes for the speciality of Endocrinology, constituting unsatisfactory performance. Findings: 1. Laboratory received the following unsatisfactory scores from API 2019-1st event: Cortisol 0% Free Thyroxine 0% Thyroid Stimulating Hormone TSH - 0% 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 a desk review of laboratory proficiency testing performance it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016 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 -- 3 of 4 -- required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. Refer to D2096 -- 4 of 4 --