Jefferson City Medical Group

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the coagulation procedure manual, reference range verification study for prothrombin time reagent (Innovin) in use from July 23, 2024 to date March 4, 2025, prothrombin time test report, patient test volumes and interview with the technical supervisor, the laboratory failed to follow the written procedure to monitor and assess results of prothrombin time reference range studies. Findings: 1. Coagulation procedure section VIII, "Interpretation of Results" dated January 2018 states, " The normal patient reference range is calculated each time a new lot # of reagent is received." 2. Review of the reference range verification study for prothrombin time testing showed the laboratory calculated a patient normal range of 10.59-11.14 seconds for Innovin lot # 564652. The 21 patient reference range study approved July 9, 2024 showed 100% of patient results exceeded the reference range in use. 3. Review of patient test report #258705 resulted March 4, 2025 at 08:56 AM showed a normal prothrombin time reference range of 9.0-11.4 seconds. 4. The laboratory performed 825 protime tests since reagent was placed into use on July 23, 2024. 5. Interview on March 4, 2025 at 11:00 AM the technical supervisor agreed the laboratory failed to follow procedures when introducing a new lot of prothrombin time reagent. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) 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 -- (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 the lack of documentation and interview with testing personnel #4, the laboratory failed to define criteria for room temperature, refrigerator temperature and humidity in the hematology testing room of the oncology clinic. The laboratory did not document conditions for essential storage and testing environment since January 30, 2023. Findings: 1. The laboratory did not have documentation to show that staff monitored the room temperature, refrigerator temperature used to store quality control (QC) and humidity of the hematology testing room in the oncology clinic. 2. Interview with testing personnel #4 on March 4, 2025 at 10:45 AM confirmed, the laboratory failed to define criteria for storage and testing environment and document those conditions. 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. This STANDARD is not met as evidenced by: Based on observation of laboratory refrigerator, and interview with the technical supervisor (TS), the laboratory failed to ensure laboratory chemistry calibrators were not used when they had exceeded their expiration date. Findings: 1. Observation of laboratory refrigerator showed chemistry calibrators FT3 111 lot # (10)74633405 expired January 31, 2025 and still in use. 2. Interview with the TS on March 4, 2025 at 10:00 AM confirmed the laboratory failed to ensure laboratory chemistry calibrators were not used when they had exceeded their expiration date. D5427 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(c) (c) Documentation. The laboratory must document all activities specified in this section. This STANDARD is not met as evidenced by: Based on the lack of Activated Partial Thromboplastin (APTT) normal range verification records for reagent in use, procedure manual, patient testing volume and interview with the technical supervisor, the laboratory failed to have documentation of a normal range patient study for Actin and Calcium Choride reagents in use for testing March 4, 2025. Findings: 1. No documentation was available to show the laboratory performed a normal range patient study for reagents in use for APTT testing; Actin, -- 2 of 4 -- lot # 562766 placed in use March 2024 and Calcium Chloride lot #56393528 placed in use January 14, 2025. 2. The procedure manual states, "Normal range for Partial Thromboplastin time has been set and verified by a normal range study on each new lot of reagent." 3. The laboratory performed 125 patient APTT tests since March 2024. 4. Interview with the technical supervisor on March 4, 2025 at 09:50 AM confirmed, the laboratory failed to provide documentation of an APTT patient normal range study for reagents in use. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (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 review of 2023, 2024 and 2025 calibration records for the Roche Cobas chemistry analyzer and interview with the technical supervisor (TS), the laboratory failed to perform calibration verification procedures at least once every six months that included at least a minimal value, a mid-point value, and a maximum value near the upper limit to verify the laboratory's reportable range in 2023 and 2024 for 3 of 35 analytes. Findings: 1. Review of the Roche Cobas chemistry analyzer calibration records for 2023 and 2024 showed no calibration every six months that included at least a minimal value, a mid-point value, and a maximum value near the upper limit to verify the laboratory's reportable range for the analytes: sodium, potassium, and chloride. 2. Interview with the TS on March 4, 2025, at 11:00 AM confirmed the laboratory failed to perform calibration verification procedures at least once every six months for sodium, potassium, and chloride. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) (d)(3)(ii) Each qualitative procedure, include a negative and positive control material; This STANDARD is not met as evidenced by: Based on review of the Cardinal Health hCG Combo Rapid Test quality control (QC), and interview with the technical supervisor (TS), the laboratory failed to perform a negative and positive control material each day of serum pregnancy patient testing -- 3 of 4 -- from March 2023 to date March 4, 2025. Findings: 1. Review of Cardinal Health hCG Combo Rapid QC showed no documentation of a negative and positive control material each day of patient testing from March 2023 to date March 4, 2025. The laboratory could not provide the number of serum pregnancy tests performed. 2. Interview with TS on March 4, 2025 at 10:30 AM confirmed the laboratory failed to perform a negative and positive control material each day of patient testing for the Cardinal Health hCG Combo Rapid Test for serum pregnancy. 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 review of two of two selected patient test reports from March 4, 2025, laboratory procedure manual and interview with the general supervisor, the laboratory failed to ensure pertinent normal values as determined by the laboratory were available for interpretation for activated partial thromboplastin time (APTT) and serum calcium. Findings: 1. The difference between normal values included on two selected patient test reports from March 4 , 2025 and those included in the approved procedure manual are as follows: -APTT normal values included on test reports ( 22- 32.8 seconds) -APTT normal values stated in the approved procedure manual (23-32.8 seconds) -serum calcium normal range (adult 60-90 years) stated in approved procedure manual (8.8-10.2 mg/dl) -serum calcium normal range (adult age 69) stated on test report 44885 ( 8-6-10.3 mg) 2. Interview with the general supervisor on March 4, 2025 at 11:30 AM confirmed the discrepant normal values for serum calcium and APTT tests. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individuals performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on review of personnel records and interview with the technical supervisor (TS), the TS failed to evaluate and document competency/performance for one of five testing personnel (TP) at least annually during 2023, 2024 and to date March 4, 2025. Findings: 1. Review of personnel records showed the TS did not evaluate competency /performance for TP #4 performing patient testing during 2023, 2024 and to date March 4, 2025. 2. Interview with TS on March 4, 2025 at 11:00 AM, confirmed competency/performance evaluations were not conducted at least annually for TP #4. -- 4 of 4 --

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 2021, 2022 and 2023 chemistry proficiency testing (PT) results reported to the CLIA database by the PT provider and phone interview with the technical consultant, the laboratory failed to successfully participate in PT. See D-tag 2096; unsatisfactory performance in consecutive two out of three total bilirubin PT challenges. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- 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 review of chemistry proficiency testing (PT) results for 2021, 2022 and 2023 and phone interview with the technical consultant, the laboratory failed to achieve satisfactory performance for the total bilirubin analyte in consecutive two out of three PT events. Findings: 1. Review of chemistry PT results for the third event of 2021 revealed the laboratory obtained an unacceptable score of 20 percent for the total bilirubin analyte. 2. Review of chemistry PT results for the second event of 2022 revealed the laboratory obtained an unacceptable score of 40 percent for the total bilirubin analyte. 3. Review of chemistry PT results for the first event of 2023 revealed the laboratory obtained an unacceptable score of 40 percent for the total bilirubin analyte. 4. Phone interview with the technical consultant on March 28, 2023 @ 08:39 AM confirmed the laboratory failed to achieve satisfactory performance for total bilirubin in consecutive two out of three testing events. -- 2 of 2 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of proficiency testing records and interview with the technical supervisor (TS) #3, the laboratory failed to maintain a copy of all records for proficiency testing, including the signed attestation statement and the raw data for reporting of results for a minimum of two years. Findings: 1. Review of proficiency testing records showed the laboratory failed to provide a signed attestation form for the 3rd event for immunology in 2021. 2. Review of proficiency testing records showed the laboratory failed to provide raw data for reporting of results for the 2nd event for immunology 2021 for the following tests on the Cobas chemistry analyzer: 3. Review of records showed the laboratory failed to provide raw data for the 2nd event for miscellaneous chemistry in 2021 for the following tests on the Cobas chemistry analyzer: 3. Interview with TS #3 on January 24, 2023 at 12:00 pm confirmed the laboratory failed to maintain a copy of all records for proficiency testing, including the attestation statement and the raw data for a minimum of two years. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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 review of the performance verification procedures for the Sysmex XN-1000 hematology analyzer and the Alcor Scientific iSED erythrocyte sedimentation rate (ESR) analyzer, review of laboratory pipettes, lack of maintenance documentation, review of quality control records, review of Roche Cobas e801 quality control (QC) records in the laboratory's LIS, review of Bio-Rad liquid assayed multiqual quality control package insert, lack of hematology records, review of laboratory procedures, Sysmex CA-600 analyzer quality control (QC), patient results and interviews, the laboratory failed to meet the condition of analytic systems. The laboratory failed to verify performance specifications prior to reporting patient test results (Refer to D5421); the laboratory failed to perform function checks on 13 of 13 laboratory pipettes in 2022 (Refer to D5435); the laboratory failed to ensure the quality control procedures were performed every 30 days for d-dimer, Clostridium difficile, and Chlamydia trachomatis and Neisseria gonorrhoeae (Refer to D5445); the laboratory failed to establish criteria for acceptability of control materials providing quantitative results for 26 of 26 analytes (Refer to 5469); the laboratory failed to document the quality of staining materials each day of use for manual differentials for 2021, 2022 and to date January 24, 2023 (Refer to D5473); the laboratory failed to include two levels of control material each 8 hours of operation for prothrombin time (PT) and partial thromboplastin time (PTT) for 77 of 79 testing days from October 1, 2022 to date January 23, 2023 (Refer to D5545). 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 review of the performance verification procedures for the Sysmex XN-1000 hematology analyzer and the Alcor Scientific iSED erythrocyte sedimentation rate (ESR) analyzer and interview with the technical supervisor (TS) #3, the laboratory failed to verify performance specifications prior to reporting patient test results. Findings: 1. Review of the performance specifications for the Sysmex XN-1000 hematology analyzer showed the laboratory failed to verify that the manufacturer's reference intervals (normal ranges) were appropriate for the laboratory's patient -- 2 of 6 -- population for the analytes: red blood cell (RBC), hemoglobin, hematocrit, platelet, white blood cell (WBC) and differential prior to the beginning of patient testing in June 2021. 2. Review of patient results from June 2021 to date January 24, 2023 showed approximately 60,281 complete blood count (CBC) patient results were reported. 3. Review of the performance specifications for the Alcor Scientific iSED ESR analyzer showed the laboratory failed to verify that the manufacturer's reference intervals (normal ranges) were appropriate for the laboratory's patient population prior to the beginning of patient testing in February 2022. 4. Review of patient results from February 2022 to date January 24, 2023 showed approximately 5,219 ESR patient results were reported. 5. Interview with the TS #3 on January 24, 2023 at 11:30 AM confirmed the laboratory failed to verify performance specifications prior to reporting patient test results. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of laboratory, lack of maintenance documentation and interview with the technical supervisor (TS) #3, the laboratory failed to perform function checks on 13 of 13 laboratory pipettes in 2022. Findings: 1. Based on review of the laboratory showed 13 laboratory pipettes in use. 2. Lack of maintenance documentation showed the laboratory failed to perform functions checks in 2022 on the pipettes still in use below: #1000-1 MLA 200-1000uL due 08/31/2022 #503469 MLA 3ML due 08/31 /2022 #700795 MLA 200-1000uL due 09/30/2022 #503650 MLA 2ML due 08/31 /2022 #100-1 MLA 100uL due 09/30/2022 #5000-1 MLA 1-5ML due 08/31/2022 #400386 MLA 1-5ML due 08/31/2022 #702346 MLA 200-1000uL due 09/30/2022 #SEL-5000 MLA 2-5ML due 09/30/2022 #1(50-1) MLA 50uL due 09/30/2022 #803289 MLA 5uL due 08/31/2022 #1 MLA 50uL due 08/31/2022 #1(100-1) MLA 100uL due 08/31/2022 3. Interview with TS #3 on January 24, 2023 at 12:00 PM confirmed the laboratory failed to perform function checks on laboratory pipettes in 2022. 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. -- 3 of 6 -- This STANDARD is not met as evidenced by: Based on review of policy for test systems, quality control records, and interview with the technical supervisor (TS) #3, the laboratory failed to ensure the quality control procedure was performed every 30 days for d-dimer, Clostridium difficile, and Chlamydia trachomatis and Neisseria gonorrhoeae. Findings: 1. Review of the policy named "D-Dimer Procedure", states "external controls should be tested with each new lot or shipment of test devices and or every 30 days". 2. Review of d-dimer quality control records showed that the laboratory failed to perform quality controls every thirty days during 2021 and 2022 for the following dates: Level /1 11/23/21 to 12/30 /2021 - 37 days 4/1/22 to 5/2/22 - 31 days 5/13/22 to 6/14/22 - 32 days 6/14/22 to 7/18 /22 - 34 days 7/18/22 to 9/19/22 - 63 days 9/19/22 to 11/02/22 - 44 days 12/15/22 to 01 /16/23 - 32 days Level 2 10/4/21 to 11/19/21 - 46 days 11/23/21 to 12/30/21 - 37 days 4/1/22 to 5/2/22 - 31 days 5/13/22 to 6/14/22 - 32 days 6/14/22 to 7/18/22 - 34 days 7 /18/22 to 9/19/22 - 63 days 9/19/22 to 11/02/22 - 44 days 3. Review of patient results from January 2021 to date January 24, 2023 showed approximately 681 d-dimer patient results were reported. 4. Review of the policy named "Clostridium Difficile", states "external controls are run with every new shipment and each new lot of test cartridges and at least every 30 days". 5. Review of Clostridium difficile quality control records showed that the laboratory failed to perform quality controls every thirty days during 2021 and 2022 for the following dates: 2/10/21 to 3/17/21 - 35 days 3/17/22 to 4/21/21 - 35 days 5/21/21 to 7/6/21 - 34 days 11/23/21 to 1/24/23 - 63 days 3/2/22 to 4/5/22 - 34 days 4/28/22 to 6/1/22 - 34 days 6/1/22 to 7/14/22 - 43 days 7/14 /22 to 8/26/22 - 43 days 9/16/22 to 10/19/22 - 33 days 10/19/22 to 11/21/22 - 33 days 11/21/22 to 12/27/22 - 36 days 6. Review of patient results from January 2021 to date January 24, 2023 showed approximately 885 Clostridium difficile patient results were reported. 7. Review of the policy named "CT/NG by PCR", states "external controls are run with every new shipment and each new lot of test cartridges and at least every 30 days". 8. Review of Chlamydia trachomatis and Neisseria gonorrhoeae quality control records showed that the laboratory failed to perform quality controls every thirty days during 2021 and 2022 for the following dates: 3/10/21 to 4/30/21 - 51 days 5/13/21 to 6/28/21 - 46 days 7/21/21 to 8/23/21 - 33 days 10/13/21 to 11/17/21 - 35 days 12/23/21 to 1/24/22 - 32 days 2/28/22 to 4/5/22 - 36 days 4/28/22 to 6/1/22 - 34 days 6/29/22 to 8/3/22 - 35 days 8/16/22 to 10/19/22 - 64 days 10/19/22 to 11/22/22 - 34 days 11/22/22 to 12/27/22 - 35 days 9. Review of patient results from January 2021 to date January 24, 2023 showed approximately 3,459 Chlamydia trachomatis and 3,458 Neisseria gonorrhoeae patient results were reported. 10. Interview with the TS #3 on January 24, 2023 at 1:00 PM confirmed the laboratory failed to show the quality control procedure was performed every 30 days for D-dimer, Clostridium difficile, and Chlamydia trachomatis and Neisseria gonorrhoeae. 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 -- 4 of 6 -- 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 interview with technical supervisor (TS) #3, review of Roche Cobas e801 quality control (QC) records in the laboratory's LIS, review of Bio-Rad liquid assayed multiqual quality control package insert, the laboratory failed to establish criteria for acceptability of control materials providing quantitative results for 26 of 26 analytes. Findings: 1. Interview with TS #3 confirmed the laboratory uses Bio-Rad liquid assayed multiqual quality control (QC) for their Roche Cobas e801. The laboratory started using Bio-Rad assayed multiqual , lot # 45930 on December 1, 2022. 2. Review of the Roche Cobas e801 QC records showed the laboratory did not establish and define statistical parameter criteria (mean and standard deviations) for acceptability of quantitative QC results reported on the chemistry analyzer for the analytes: aspartate aminotransferase, alanine aminotransferase, albumin, alkaline phosphate, calcium, cholesterol, chloride, creatinine, creatinine kinase, direct bilirubin, CO2, gamma glutamyltransferase (GGT), glucose, iron, lactate dehydrogenase (LDH), lipase, magnesium, phosphorus, potassium, sodium, total bilirubin, total protein, triglyceride, urea, and uric acid. 3. Interview with the TS #3 on January 24, 2023 at 12:00 PM, confirmed the laboratory failed to establish criteria for acceptability of chemistry control materials providing quantitative results. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of hematology records and interview with the technical supervisor (TS) #3, the laboratory failed to document the quality of staining materials each day of use for manual differentials for 2021, 2022 and to date January 24, 2023. Findings: 1. Lack of hematology records showed the laboratory failed to document the quality of staining materials each day of use for manual differentials in 2021, 2022 and to date January 24, 2023. 2. Review of patient results from January 2021 to date January 24, 2023 showed approximately 2,695 manual differential patient results were reported. 3. Interview with TS #3 on January 24, 2023 at 12:00 PM confirmed the laboratory failed to document the quality of the manual differential stain each day of use. D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) The laboratory must document all control procedures performed, as specified in this section. -- 5 of 6 -- This STANDARD is not met as evidenced by: Based on review of laboratory procedures, Sysmex CA-600 analyzer quality control (QC), patient results and interview with the technical supervisor (TS) #3, the laboratory failed to include two levels of control material each 8 hours of operation for prothrombin time (PT) and partial thromboplastin time (PTT) for 77 of 79 testing days from October 1, 2022 to date January 23, 2023. Findings: 1. Review of laboratory procedures "Prothrombin Time" and "Partial Thromboplastin Time" states, "Run Coagulation Controls level 1 and 3 at the beginning of the shift and again in the afternoon, preferably early afternoon". 2. Review of Sysmex CA-600 analyzer QC from October 1, 2022 to date January 23, 2023 showed QC was not performed every 8 hours for 77 of 79 testing days. 3. Review of patient results showed approximately 64 patient PT results and 5 PTT patient results were released when QC was not performed. 4. Interview with the TS #3 on January 24, 2023 at 11:30 AM confirmed the laboratory failed to perform two levels of PT and PTT QC each 8 hours of operation. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on review of employee competencies and interview with the technical supervisor (TS) #3, the TS failed to perform annual performance evaluations for 2 of 3 testing personnel (TP). Findings: 1. Review of employee performance evaluations showed the TS failed to perform the annual performance evaluations for TP #1 in 2022 and TP #2 for 2021 and 2022. 2. Interview with TS #3 on January 24 , 2023 at 12:00 pm confirmed that the TS failed to perform the annual performance evaluations for TP #1 and TP #2. -- 6 of 6 --

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 2021 and 2022 chemistry proficiency testing (PT) results reported to the CLIA database by the PT provider and phone interview with the technical consultant, the laboratory failed to successfully participate in PT. See D-tag 2096; unsatisfactory performance in two out of three consecutive total bilirubin PT challenges. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- 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 review of chemistry proficiency testing (PT) results for 2021, 2022 and phone interview with the technical consultant, the laboratory failed to achieve satisfactory performance for the total bilirubin analyte in two out of three consecutive PT events. Findings: 1. Review of the chemistry PT results for the third event of 2021 revealed the laboratory obtained an unacceptable score of 20 percent for the total bilirubin analyte. 2. Review of the chemistry PT results for the second event of 2022 revealed the laboratory obtained an unacceptable score of 40 percent for the total bilirubin analyte. 3. Phone interview with the technical consultant on August 9, 2022 at 3:50 PM confirmed the laboratory failed to achieve satisfactory performance for total bilirubin in two out of three consecutive testing events. -- 2 of 2 --

Summary Statement of Deficiencies 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 review of the procedure manuals, lack of performance verification records and interview with the technical supervisors (TS) #1 and TS #2 confirmed the laboratory failed to meet the requirements specified in 493.1250. (Refer to D5407, D5421) D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on the review of the procedure manual for the Roche Cobas 8000 and interview with the Technical Supervisor (TS) #1, confirmed the laboratory director (LD) failed to approve the procedure manual. Findings: 1. Review of the procedure manual in use by the laboratory for the Roche Cobas 8000 confirmed the LD failed to approve the procedure manual. 2. Interview with the TS #1 on December 15, 2020 at 10:00 AM confirmed the LD failed to approve the procedure manual. 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 -- 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 review of the performance verification procedures for the Roche Cobas 8000 chemistry analyzer, Sysmex CA-600 coagulation analyzer, Cepheid GeneXpert CT/NG analyzer and the interview with the technical supervisors (TS) #1 and # 2, the laboratory failed to verify the manufacturer's reference intervals with the laboratory's normal values for 43 of 43 analytes for the Roche Cobas 8000 chemistry analyzer and failed to have documentation to show the laboratory established test system performance specifications for the Sysmex CA-600 coagulation analyzer and the Cepheid GeneXpert CT/NG analyzer. Findings: 1. Review of the verification procedures for the Roche Cobas 8000 chemistry analyzer for Albumin, Alkaline phosphatase, Alanine aminotransferase, Amylase, Aspartate aminotransferase, Bilirubin, Calcium, Chloride, Cholesterol, Creatine kinase, Carbon dioxide, Creatinine, Glucose, High-density lipoprotein, Iron, Lactic acid, Lactate dehydrogenase, Lipase, Magnesium, Phosphorus, Potassium, Sodium, Total bilirubin, Total protein, Tryglycerides, Urea, Uric acid, Total iron-binding capacity, Free T3, Total T3, Total T4, Ferritin, Folate, Free T4, Thyroid stimulating hormone, Vitamin B12, Vitamin D, Beta HCG, Prostrate specific antigen, N-terminal pro b-type natruretic peptide, Troponin T, Creatine kinase MB, and Parathyroid hormone showed no verification of manufacturer's reference intervals with the laboratory's reported normal values. 2. The lack of documentation showed the the laboratory failed to establish performance specifications for accuracy, precision and reportable range for the test system CA-600 coagulation analyzer which tests for Prothombin Time and Activated Partial Thromboplastin Time. 3. The lack of documentation showed the laboratory failed to established performance specifications for accuracy, precision and reportable range for the test system Cepheid GeneXpert CT/NG analyzer which tests for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas. 4. Interview with the TS #1 and TS #2 on December 15, 2020 at 10:00 AM confirmed the laboratory failed to verify manufacturer's reference intervals for the Roche Cobas 8000 analyzer were appropriate for the laboratory's patient population and to establish performance characteristics for The CA-600 and Cepheid GeneXpert CT/NG analyzer after moving the lab to a new location and before reporting patient results. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on the lack of personnel training records for 2020, and interview with technical supervisor (TS) #2 confirmed the laboratory director (LD) failed to ensure testing personnel had documented initial training for the Roche Cobas 8000 chemistry analyzer prior to testing and reporting patient results. Approximately 1,130,000 patient test results have been reported since March 2020. Findings: 1. The lack of training records for 2020 revealed the LD failed to have initial training for 5 of 5 employees on the Roche Cobas 8000 chemistry analyzer brought on-line in March of 2020. 2. The interview with the TS #2 on December 15, 2020 at 10:40 AM confirmed, the LD failed to ensure each testing personnel had appropriate documented training for Roche Cobas 8000 chemistry analyzer before reporting patient test results. 3. Approximately 1,130,000 patient test results have been reported since March 2020. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on review of performance evaluations for the year 2019 and interview with the technical supervisor (TS) #2, the TS failed to perform 5 of 5 performance evaluations for 2019. Findings: 1. Review of performance evaluations for 2019 showed the TS failed to evaluate 5 of 5 annual employee competencies. 2. Interview with the TS #2 on December 15, 2020 at 10:30 AM confirmed the TS failed to perform annual competencies for 2019. -- 3 of 3 --

Summary Statement of Deficiencies D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of monthly postanalytic procedures and activities for 2018 and 2019 and interview with the laboratory director, the laboratory failed to follow quality assessment (QA) procedures to monitor, assess and correct problems with stat turnaround time (TAT) indicators. Findings: 1. Review of monthly postanalytic QA procedures and activities reveals the laboratory monitors stat (TAT) that exceed one hour and documents cause of delay. During January, February and March of 2018, documentation noted on the stat TAT log showed the laboratory was "one tech down" each month. During April, May, and June of 2018 documentation noted on the TAT log showed stat TAT percentages increased from 7.21% in April , to 7.65% in May and to 11.25 % in June. Documentation from June TAT log showed the laboratory noted a code (3) indicating, "busy, multiple stats, lunch, short staffing." The laboratory did not perform or document any stat TAT activity for July, August, September, October, November, December 2018. No stat TAT activity documented for January and to date February 19, 2019. 2. On interview February 19, 2019 at 10:00 AM the laboratory director said staffing has been challenging and postanalytic QA activities delayed. Interview with the laboratory director confirmed the laboratory failed to follow and maintain monthly procedures to monitor stat TAT. D6101 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(11) The laboratory director must employ a sufficient number of laboratory personnel with 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 -- the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart. This STANDARD is not met as evidenced by: Based on review of personnel records and interview with the technical supervisor, the laboratory director failed to establish criteria/procedure to ensure sufficient staffing of testing personnel performing non-waived testing. Findings: 1. No documentation was available to show the laboratory director established a procedure to assess/monitor criteria to ensure the laboratory employ a sufficient number of testing personnel performing moderate and high complexity testing. 2. Interview with the technical supervisor on February 19, 2019 at 10:30 AM confirmed no procedure was available to assess /monitor sufficient staffing for the volume of non-waived testing performed. -- 2 of 2 --