Sml Inc Dba Solis Medical Laboratory

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on July 21, 2025, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity 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 a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute's proficiency reports, the laboratory failed to achieve satisfactory 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 -- performance for the chemistry analyte AST/SGOT for two of three events in 2024 and 2025, and for the toxicology analytes of Salicylate and Valproic Acid for two consecutive events in 2025, resulting in an initial unsuccessful performance for the analytes of AST/SGOT, Salicylate, and Valproic Acid. Refer to D2096 and D2118. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (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 the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute's proficiency reports, the laboratory failed to achieve satisfactory performance for two of three testing events in 2024 and 2025 for the analyte AST /SGOT, resulting in an initial unsuccessful performance. The findings were: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile report, the laboratory received the following unsatisfactory performances for AST/SGOT: 2024 API 3rd event 60% 2025 API 2nd 60% 2. Based on review of the American Proficiency Institute's proficiency reports, the laboratory received the following unsatisfactory performances for AST/SGOT: 2024 API 3rd event 60% 2025 API 2nd 60% D2118 TOXICOLOGY CFR(s): 493.845(f) (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 the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute's proficiency reports, the laboratory failed to achieve satisfactory performance for two of two consecutive testing events in 2025 for toxicology analytes Valproic Acid and Salicylate, resulting in an initial unsuccessful performance. The findings were: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile report, the laboratory received the following unsatisfactory performances for Valproic Acid and Salicylate: Valproic Acid: 2025 1st event 0% 2025 2nd event 60% Salicylate 2025 1st event 0% 2025 2nd event 60% 2. Based on review of the American Proficiency Institute's proficiency reports, the laboratory received the following unsatisfactory performances for Valproic Acid and Salicylate: Valproic Acid: 2025 1st event 0% 2025 2nd event 60% Salicylate 2025 1st event 0% 2025 2nd event 60% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. -- 2 of 3 -- 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute's proficiency reports, 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) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute's proficiency reports, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for the specialties of chemistry (2 of 3 events in 2024 and 2025) and toxicology (2 consecutive events in 2025), resulting in an initial unsuccessful performance for the analytes of AST/SGOT, Salicylate, and Valproic Acid. Refer to D2096 and D2118. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on the review of the laboratory's API proficiency testing record, and confirmed in an interview, the laboratory failed to have documentation of attestation statement for 1 of 14 proficiency testing events: 2024 Hematology/Coagulation 2nd Event. The findings were: 1. Review of the laboratory's proficiency testing from API revealed no documentation of attestation statement for 1 of 14 proficiency testing events. 2024 Hematology/Coagulation 2nd Event 2. An interview on 12/11/2024 at 10:1 am in the office, the technical consultant #2 (as indicated on the 209 form) confirmed the above findings. Key: API= American Proficiency Institute D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. 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 -- This STANDARD is not met as evidenced by: Based on the manufacturer's package insert, the laboratory's HIV worksheet, patients results from 08/16/2024-11/04/2024, and confirmed in an interview, the laboratory failed to follow the manufacturer's instructions for 6 of 25 patient samples to perform the patient samples within 7 days of collection. The findings were: 1. Review of the manufacturer's package insert titled Abbott Determine HIV-1/2 Ag/Ab Combo under SPECIMEN STORAGE revealed "Serum and plasma specimens may be stored at room temperature (15- 30C) for up to two days before testing. If testing will not be performed within two days of sample collection, serum and plasma specimens should be stored at 2- 8C if the test is to be run within 7 days of collection." 2. Review of the laboratory's HIV worksheet revealed "EXT (External) Controls run per day of Testing" 3. Review of the patient results from 08/16/2024-11/04/2024 revealed 6 patients samples were not within 7 day collection. QC date: 08/23/2024 7 collection day period: 08/16/2024-08/23/2024 Patient specimen ID: 2688947 Collection date and time: 08/15/2024 at 04:50 am Elapsed days from collection to QC date: 8 days Patient specimen ID: 2688966 Collection date and time: 08/15/2024 at 07:32 pm Elapsed days from collection to QC date: 8 days QC date: 10/10/2024 7 collection day period: 10/03/2024-10/10/2024 Patient specimen ID: 2698087 Collection date and time: 09/29 /2024 at 05:56 am Elapsed days from collection to QC date: 11 days Patient specimen ID: 2698441 Collection date and time: 09/30/2024 at 05:04 am Elapsed days from collection to QC date: 10 days QC date: 11/04/2024 7 collection day period: 10/28 /2024-11/04/2024 Patient specimen ID: 2702035 Collection date and time: 10/17 /2024 at 12:57 pm Elapsed days from collection to QC date: 18 days Patient specimen ID: 2702332 Collection date and time: 10/18/2024 at 03:30 pm Elapsed days from collection to QC date: 17 days 4. An interview on 12/12/2024 at 10:25 am in the office, the technical consultant #2 and the testing personnel #2 (as indicated on CMS 209 form) confirmed the above findings. Key: CMS=Center for Medicare and Medicaid Services 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. -- 2 of 6 -- This STANDARD is not met as evidenced by: I. Based on the manufacturer's manual, direct observation of the surveyor, the laboratory's calibration verification records from 2023 to 2024, and confirmed in an interview, the laboratory failed to have total 12 of 12 documentation of calibration verification every 6 months for iSTAT analyzer (SN: 350079) for 3 of 3 cartridges. The findings were: 1. Review of the manufacturer's manual titled iSTAT System Manual (Rev. Date: 18-OCT-2021 Art: 714336-00R) under Chapter 15 Overview revealed "it is the responsibility of the laboratory to determine when and how this procedure should be performed." (Rev. Date: 18-OCT-2021 Art: 714377-00U) 2. Direct observation of the surveyor on 12/11/2024 at 3:10 pm in the lab revealed the laboratory performed CHEM8+ cartridges Creatinine (CREA) cartridges and Troponin I (cTnI) on i-STAT analyzer. 2. Review of the laboratory's calibration verification records from 2023 to 2024 revealed the laboratory failed to have 12 of 12 documentation of calibration verification every 6 months for 3 of 3 cartridge performed on iSTAT analyzer. 3. An interview on 12/11/2024 at 3:12 pm in the office, the testing personnel #2 (as indicated on the CMS 209 form) confirmed the above findings. II. Based on the laboratory's calibration verification records from 2023 to 2024, and confirmed in an interview, the laboratory failed to have 4 of 4 documentation of calibration verification every 6 months for Beckman Coulter DxC- 700 Chemistry analyzer for 1 of 31 analytes: Lithium. The findings were: 1. An interview on 12/11/2024 at 3:05 pm in the office, the testing personnel #2 (as indicated on CMS 209 form) confirmed there was only 1 calibrator for the analyte Lithium, performed on DxC-700 chemistry analyzer. 2. Review of the laboratory's calibration verification records from 2023 to 2024 revealed the laboratory failed to have 4 of 4 documentation of calibration verification every 6 months for 1 of 31 analytes, Lithium, performed on Beckman Coulter DxC-700 Chemistry analyzer. 3. An interview on 12/11/2024 at 3:12 pm in the office, the testing personnel #2 (as indicated on the CMS 209 form) confirmed the above findings. Key: CMS=Center of Medicare and Medicaid Services D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the review of the laboratory's QC records from January, 2024 to June, 2024, In-house test lists, and confirmed in an interview, the laboratory failed to have documentation of monitoring QC values over time for 3 of 3 cartridges performed on iSTAT analyzer for 6 of 6 months reviewed. The findings were: 1. Review of the iSTAT analyzer QC records from January, 2024 to June, 2024 revealed 3 cartridges were performed on iSTAT (SN: 350079): CHEM8+ cartridge Creatinine (CREA) cartridge Troponin I (cTnI) cartridge 2. Further review of the iSTAT analyzer QC -- 3 of 6 -- records from January, 2024 to June, 2024 revealed no documentation of the laboratory monitoring the QC values over time for 3 of 3 cartridges QC for iSTAT analyzer for 6 of 6 months reviewed. 3. Review of the In-house testlist provided by the laboratory on 12/11/2024 revealed 88 patients performed CHEM8+ testing, 116 patients performed CREA testing, and 148 patients performed Troponin I testing on iSTAT analyzer from January, 2024 to June, 2024. 4. An interview on 12/11/2024 on 3:12 pm in the office, the testing personnel #2 (as indicated on CMS 209 form) confirmed the above findings. Key: QC=Quality Control CMS=Center of Medicare and Medicaid Services D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on the direct observation of the surveyor, the review of the manufacturer's package inserts, the review of the laboratory's test menu, the laboratory's records from 2023 to 2024, and confirmed in an interview, the laboratory failed to have documentation of performing instrument comparison for 8 of 8 analytes. The findings were: 1. Direct observation of the surveyor on 12/11/2024 at 3:10 pm in the lab revealed the laboratory performed CHEM8+ cartridges and Creatinine (CREA) cartridges. 2. Review of the manufacture's package insert titled i-STAT CHEM8+ cartridge (Art: 765859-01 Rev. B Rev. Date: 06-Nov-2020) revealed CHEM8+ cartridge performed Sodium (Na), Potassium (K), Chloride (CL), Ionized Calcium (iCa), Glucose (Glu), Blood Urea Nitrogen (BUN/UREA), Creatinine (Crea), Hematocrit (Hct), and Total Carbon Dioxide (TCO2) analytes. 3. Review of the manufacture's package insert titled i-STAT CREA cartridge (Art: 765859-01 Rev. B Rev. Date: 06-Nov-2020) revealed CREA cartridge performed Creatinine (Crea) 4. Review of the laboratory's test menu provided on 12/11/2024 revealed the laboratory performed Sodium (Na), Potassium (K), Chloride (CL), Glucose (Glu), Blood Urea Nitrogen (BUN/UREA), Creatinine (Crea), and Total Carbon Dioxide (TCO2) analytes on Beckman coulter DxC-700 Chemistry analyzer (SN: 61591425) and Hematocrit (Hct) on Beckman Coulter DxH690T Hematology analyzer. 5. Review of the laboratory's records from 2023 to 2024 revealed no documentation of comparison study for 8 of 8 analytes for the instrument between iSTAT and DxC 700 chemistry analyzer and iSTAT and DxH 690T hematology analyzer. Na, K, CL, Glu, BUN /UREA, Crea, and TCO2 analytes: Performed on DxC-700 chemistry analyzer and i- STAT CHEM8+ cartridge and CREA cartridge. Hct analyte: Performed on DxH690T Hematology analyzer and i-STAT CHEM8+ cartridge. 6. An interview on 12/11/2024 at 3:34 pm in the office, the technical consultant #2 and the testing personnel #2 (as indicated on the CMS 209 form) confirmed the above findings. Key: CMS=Center for Medicare and Medicaid Services D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least -- 4 of 6 -- semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on the review of the laboratory's CMS 209 Laboratory Personnel Report, the laboratory's personnel competency records, and confirmed in an interview, the Technical consultant failed to have documentation of testing personnel Initial training and 6 month competency assessment for 1 of 10 testing personnel performing moderate complexity testing. The findings were: 1. Review of CMS 209 form Laboratory Personnel Report (CLIA) revealed the laboratory identified 10 testing personnel performing moderate complexity tests. 2. Review of the laboratory's personnel competency records revealed the technical consultant failed to have documentation of Initial training and 6 month competency assessment documentation for 1 of 10 testing personnel performing moderate complexity testing. Testing personnel #5 Re-hired date: 01/16/2024 3. An interview on 12/11/2024 at 1:54 pm in the office, the technical consultant #2 (as indicated on the CMS 209 form) confirmed the above findings. Key: CMS=Center of Medicare and Medicaid Services D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on the review of the laboratory's CMS 209 Laboratory Personnel Report, the laboratory's personnel competency records, and confirmed in an interview, the Technical consultant failed to have documentation of testing personnel annual competency assessment for 2023 for 1 of 10 testing personnel performing moderate complexity testing. The findings were: 1. Review of CMS 209 form Laboratory Personnel Report (CLIA) revealed the laboratory identified 10 testing personnel performing moderate complexity tests. 2. Review of the laboratory's personnel competency records revealed the technical consultant failed to have documentation of annual competency assessment documentation for 2023 for 1 of 10 testing personnel performing moderate complexity testing. Testing personnel #4 Hired date: 02/10/2022 3. An interview on 12/11/2024 at 1:54 pm in the office, the technical consultant #2 (as indicated on the CMS 209 form) confirmed the above findings. Key: CMS=Center of Medicare and Medicaid Services D6127 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on the review of the laboratory's CMS 209 Laboratory Personnel Report, the laboratory's personnel competency records, and confirmed in an interview, the Technical Supervisor failed to have documentation of testing personnel Initial training -- 5 of 6 -- and 6 month competency assessment for 2 of 13 testing personnel performing high complexity testing. The findings were: 1. Review of CMS 209 form Laboratory Personnel Report (CLIA) revealed the laboratory identified 13 testing personnel performing high complexity tests. 2. Review of the laboratory's personnel competency records revealed the technical supervisor failed to have documentation of Initial training and 6 month competency assessment documentation for 2 of 13 testing personnel performing high complexity testing. Testing personnel #5 Re-hired date: 01 /16/2024 Testing personnel #13 Hired date: 09/28/2022 (Hired as needed. The testing personnel#13 did not work in 2023 and 2024) 3. An interview on 12/11/2024 at 1:54 pm in the office, the technical consultant #2 (as indicated on the CMS 209 form) confirmed the above findings. Key: CMS=Center of Medicare and Medicaid Services 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 the review of the laboratory's CMS 209 Laboratory Personnel Report, the laboratory's personnel competency records, and confirmed in an interview, the Technical Supervisor failed to have documentation of testing personnel annual competency assessment for 2023 for 1 of 13 testing personnel performing high complexity testing. The findings were: 1. Review of CMS 209 form Laboratory Personnel Report (CLIA) revealed the laboratory identified 13 testing personnel performing high complexity tests. 2. Review of the laboratory's personnel competency records revealed the technical supervisor failed to have documentation of annual competency assessment documentation for 2023 for 1 of 13 testing personnel performing high complexity testing. Testing personnel #4 Hired date: 02/10/2022 3. An interview on 12/11/2024 at 1:54 pm in the office, the technical consultant #2 (as indicated on the CMS 209 form) confirmed the above findings. Key: CMS=Center of Medicare and Medicaid Services -- 6 of 6 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company on 07/15/2024. The laboratory was found out of compliance with the CLIA regulations (42 CFR Part 493, Requirements for Laboratories). The CONDITIONS NOT MET were: 493.803 D2016 Condition: Successful participation [proficiency testing] 493.1403 D6000 Condition: Laboratories performing moderate complexity testing; laboratory director 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 a desk review of proficiency testing records obtained from the Certification 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 -- and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and verified with American Proficiency Institute (API), the laboratory failed to attain successful performance for two of three consecutive testing events in specialty of Endocrinology Testing for the analyte of Thyroxine for 2023 and 2024, resulting in unsuccessful performance. Refer to D2096. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Reports and the American Proficiency Institute (API) testing records for 2023 Chemistry Core 3rd Event and 2024 Chemistry Core 2nd Event, the laboratory failed to attain of a score of 80% in two out of three consecutive proficiency testing (PT) events for the analyte Thyroxine. The findings included: 1. Review of the CASPER Report 155 (Individual Laboratory Profile) revealed the following: 2023 Chemistry Core 3rd Event laboratory received unsatisfactory score of 0% for the analyte Thyroxine. 2024 Chemistry Core 2nd Event laboratory received unsatisfactory score of 60% for the analyte Thyroxine. 2. Review of the laboratory's API proficiency testing records for each event revealed the following results: API 2023 Chemistry Core 3rd Event: 0% for the analyte of Thyroxine due to failure of participate. API 2024 Chemistry Core 2nd Event: 60% for the analyte of Thyroxine. Sample: CH-07 Report Result: 5.7 (ug/dL) Expected Result: 6.0-9.1 (ug/dL) Performance: Unacceptable Sample: CH-09 Report Result: 4.8 (ug/dL) Expected Result: 5.2-7.8 (ug /dL) Performance: Unacceptable 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 the Certification and Survey Provider Enhanced Reporting (CASPER) Reports and the American Proficiency Institute (API) testing records, the laboratory director failed to ensure successful participation in an CMS approved proficiency testing program for the analyte of Thyroxine for two of three consecutive events from 2023 to 2024. 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 -- 2 of 3 -- 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 a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Reports and the American Proficiency Institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in a CMS approved proficiency testing program for the analyte of Thyroxine for two of three consecutive events from 2023 to 2024. Refer to D2107. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company on 03/13/2024. The laboratory was found out of compliance with the CLIA regulations (42 CFR Part 493, Requirements for Laboratories). The CONDITIONS NOT MET were: 493.803 D2016 Condition: Successful participation [proficiency testing] 493.1403 D6000 Condition: Laboratories performing moderate complexity testing; laboratory director 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 a review of the Certification and Survey Provider Enhanced 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 3 -- (CASPER) Reports and American Proficiency Institute (API) records, the laboratory failed to achieve successful performance for two of three consecutive testing events for 2023 and 2024, resulting in unsuccessful performance. Refer to D2096. 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 a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Reports and the American Proficiency Institute (API) testing records for 2023 and 2024, the laboratory failed to achieve an overall testing event score of satisfactory performance (80% or greater) for two of three consecutive proficiency testing (PT) events for the analyte Total Iron. Two out of three overall testing event scores of unsatisfactory performance results in unsuccessful PT performance. The findings included: 1. A review of the CASPER Report 155 (Individual Laboratory Profile) revealed the following scores for the PT analyte Total Iron: Year Event: Analyte - Score 2023 Event 3: Total Iron - 0 2024 Event 1: Total Iron - 60 2. A desk review of API proficiency testing records for 2023 and 2024 confirmed that the laboratory received a Total Iron score of 0% for the 3rd Event of 2023 and 60% for the 1st Event of 2024. 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 the Certification and Survey Provider Enhanced Reporting (CASPER) Reports and the American Proficiency Institute (API) testing records, the laboratory director failed to ensure successful participation in an CMS approved proficiency testing program for the analyte Toral Iron for two of three consecutive events from 2023 to 2024. 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 required under Subpart H of this part; This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Reports and the American Proficiency Institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in a CMS approved proficiency testing program for the analyte Total iron for two of three consecutive events from 2023 to 2024. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the CLIA regulations. The condition not met was: D2000 - 42 C.F.R. 493.801 Condition: Enrollment and testing of [proficiency testing] samples; D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems; Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representatives were given an opportunity to provide evidence of compliance with noted deficiencies and no such evidence was provided prior to survey exit. D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a review of the laboratory's records and staff interview, it was revealed that the laboratory failed to have documentation of being enrolled in an HHS approved proficiency testing program for the analyte Human Chorionic Gonadotropin- Serum in 2022. Findings include: 1. A review of the laboratory's testing records revealed the laboratory performed Human Chorionic Gonadotropin (HCG) testing using patient's serum specimens. 2. A review of the laboratory's records revealed the laboratory failed to provide documentation of enrollment in an HHS approved proficiency testing program for the analyte Human Chorionic Gonadotropin- Serum in 2022. 3. Further review of the laboratory's records revealed the laboratory estimated performing 546 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 15 -- HGC tests using patient's serum specimens in 2022. 4. An interview with the technical director on 2/1/23 at 2:30 p.m. in the laboratory, after review of the records, confirmed the above findings. Key: HHS= Health and Human Services D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of the laboratory's test records and staff interview, it was revealed that the laboratory failed to have documentation of performing twice annual accuracy assessments in 2022 for two unregulated analytes tested on the Beckman Coulter DxC 700 chemistry analyzer. Findings include: 1. A review of the laboratory's test records revealed the laboratory tested for C- Reactive Protein (CRP) and CRP- high sensitivity on the Beckman Coulter DxC 700 chemistry analyzer. 2. The laboratory was asked to provide documentation of assessing the accuracy, twice annually, for CRP and CRP- high sensitivity. No documentation was provided. 3. Further review of the laboratory's test records revealed the laboratory estimated performing 1,364 CRP tests and 40 CRP- high sensitivity tests in 2022. 4. An interview with the technical director on 2/1/23 at 2:30 p.m. in the laboratory, after review of the records, confirmed that the laboratory overlooked these two tests when re-enrolling for proficiency testing samples in 2022. D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) At least twice annually, the laboratory must verify the accuracy of any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of the laboratory's test menu, the laboratory's records, and staff interview, it was revealed that the laboratory failed to have documentation of verifying the accuracy of one non-regulated toxicology analyte, Levitiracetam, at least twice annually in 2022. Findings include: 1. A review of the laboratory's test menu revealed the following non-regulated toxicology analyte Levitiracetam was tested by the laboratory using the Beckman Coulter DxC 700 chemistry analyzer. 2. A review of the laboratory's records revealed the laboratory failed to have documentation of performing twice annual accuracy assessments for Levitiracetam in 2022. 3. Further review of the laboratory's records revealed the laboratory estimated performing 896 Levitiracetam tests in 2022. 4. An interview with the technical director on 2/1/23 at 2: 30 p.m. in the laboratory, after review of the records, confirmed the above findings. 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 -- 2 of 15 -- 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 a review of manufacturer's instructions, review of laboratory records, and staff interview, it was revealed the laboratory failed to identify issues with analytic systems. Findings include: 1. The laboratory failed to follow the manufacturer's instructions by ensuring patients run using the Abbott Determine HIV-1/2 Ag/Ab Combo test were greater than twelve years of age. (refer to 5411I) 2. The laboratory failed to follow the manufacturer's instructions by ensuring patient's samples were tested within 30 minutes of collection for the Chem 8+ and CTnI cartridges. (refer to 5411 II) 3. The laboratory failed to follow the manufacturer's instructions for compatible viral transportation mediums for SARS-CoV-2 (COVID) testing on the Quidel Solana instrument. (refer to 5411 III) 4. The laboratory failed to follow the manufacturer's instruction to perform PTT testing within 4 hours on the Siemens CA620 coagulation instrument. (refer to 5411 IV) 5. The laboratory failed to document the revised expiration date on individual Abbott i-STAT cartridges found in the laboratory being stored at room temperature. (refer to D5415) 6. The laboratory failed to have documentation of performing precision studies for 2 test cartridges used on the Abbott i-STAT analyzer. (refer to D5421) 7. The laboratory failed to have documentation of evaluating the calibration verification records for analytes run on the Beckman Coulter DxC 700 chemistry analyzer in December 2022. (refer to D5439) 8. The laboratory failed to establish an IQCP (Individualized Quality Control Plan) to support the modification in quality control testing for two cartridges(CHEM 8+ and CTnI) run on the Abbott i-STAT analyzer. (refer to D5445) 9. The laboratory failed to perform qualitative QC to include a positive and a negative QC on the Quidel Solana instrument. (refer to D5449) 10. The laboratory failed to have documentation to perform at least two levels of control materials each eight hours of operation for Prothrombin time testing on the Siemens CA620 coagulation instrument. (refer to D5545) D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: I. Based on review of the Instructions for Use for the Abbott Determine HIV-1/2 Ag /Ab Combo test, a review of patient test records from January 2022 to January 2023, and staff interview, it was revealed that the laboratory failed to follow the manufacturer's instructions by ensuring that three patients run using the Abbott Determine HIV-1/2 Ag/Ab Combo test were greater than twelve years of age. Findings include: 1. A review of the Instructions for Use for the Abbott Determine HIV-1/2 Ag/Ab Combo test (IN02732530 Rev. 8 2021/06) revealed the following: "Limitations of the Test: This assay has not been evaluated for newborn screening, cord blood specimens, or individuals less than 12 years of age." 2. A review of the laboratory's patient test records from January 2022 to January 2023 revealed the -- 3 of 15 -- following 3 patient's samples were run using the Abbott Determine HIV-1/2 Ag/Ab Combo assay: - Patient ID: 2467722 Date of birth: 12/6/11 Test run: 4/1/22 Patient age at time of testing: 10 years, 3 months, 26 days - Patient ID: 2497620 Date of birth: 3/22/11 Test run: 7/22/22 Patient age at time of testing: 11 years, 4 months, 11 days - Patient ID: 2551287 Date of birth: 11/24/13 Test run: 1/18/23 Patient age at time of testing: 9 years, 1 month, 25 days 3. An interview with the technical director on 2/2 /23 at 3:40 p.m. in the office, after review of the records, confirmed the above findings. II. Based on a review of the Procedure Manual for the i-STAT System, the laboratory's test records, and staff interview, it was revealed that the laboratory failed to follow the manufacturer's instructions by ensuring three patient's samples were tested within 30 minutes of collection for the Chem 8+ and CTnI cartridges. Findings include: 1. A review of the Procedure Manual for the i-STAT System (714446-00C, rev date:07/12/04) revealed the following: "For the glucose and other cartridge tests, test sample within 30 minutes of collection." 2. A review of the laboratory's test records revealed the following 3 patient samples were tested greater than 30 minutes from the time of collection using the Chem 8+ or CTnI cartridges: Patient ID: 2555885 Collection date and time: 2/1/23 14:00 Tested on CTnI cartridge at 14:37 Elapsed time: 37 minutes Patient ID: 2551035 Collection date and time: 1/17/23 15:55 Tested on Chem 8 + cartridge at 16:28 Elapsed time: 33 minutes Patient ID: 2551664 Collection date and time: 1/19/23 11:25 Tested on Chem 8 + cartridge at 12:06 Elapsed time: 41 minutes 3. An interview with the technical director on 2/2/23 at 15: 44 p.m. in the office, after review of the records, confirmed the above findings. 44697 III. Based on the direct observation of the surveyor, the manufacture's instructions, and confirmed in an interview found the laboratory failed to follow the manufacturer's instructions for compatible viral transportation mediums for SARS-CoV-2 (COVID) testing on one of one Quidel Solana instrument. The findings were: 1. Review of the manufacturer's instructions titled Quidel Solana SARS-CoV-2 Assay that the laboratory director signed on 7/22/2022 under SPECIMEN COLLECTION, STORAGE, AND HANDLING revealed "Specimens collected in BD/Copan UTM, Remel M4RT, or Quidel QTM are stable at room temperature (RT), 2C to 8C or -70C or below for up to 4 days." 2. Direct observation of the surveyor on 2/1/2023 at 12:00 pm revealed three patients specimens collected in Healthlink UTM-RT, Lot#2204180, Exp. 2023-09-02 for the SARS-CoV-2 testing on one of one Quidel Solana (SN: 21022272). Collected 1/31/2023 Patient#: 1108284 Sample ID: 2555318 Cov-2 RNA RT-HAD Nasopharynx result: Not Detected Collected 1/31/2023 Patient#: 1110229 Sample ID: 2555500 Cov-2 RNA RT-HAD Nasopharynx result: Not Detected Collected 2/1/2023 Patient#: 1110284 Sample ID: 2555762 Cov-2 RNA RT-HAD Nasopharynx result: Not Detected 3. Requested the laboratory to provide validation documentation for Healthlink UTM-RT. No documentation was provided. 4. An interview with the technical supervisor on 2/1/2023 at 1:05 pm in the lab confirmed the above findings. IV. Based on the review of the manufacturer's package insert, the laboratory's patient PTT reports from 12/30/22 to 2/2/2023, and confirmed in an interview found the laboratory failed to follow the manufacturer's instruction to perform PTT testing within 4 hours on one of one Siemens CA620 coagulation instrument. The findings were: 1. Review of the manufacturer's package insert titled Dade Actin FS Activated PTT Reagent (11541731_en Rev, 08-USA only. 2021-06) under Storing the Specimen revealed "Plasma containing unfractionated heparin should be centrifuged within one hour of blood collection, stored at room temperature and tested within 4 hours." 2. Random review of the laboratory's patient PTT test results from 12/30/22 to 2/2/2023 revealed three patient with PTT tesing were performed over 4 hours on Siemens CA620 coagulation instrument (SN: 11145). Patient #:1104343 Collected time: 2/2/2023 at 12:07 am Resulted time: 2/2/2023 at 9: 16 am Elapsed time: 9 hours 9 mins Patient #:1092256 Collected time: 12/30/2022 at -- 4 of 15 -- 3:15 pm Resulted time: 12/30/2022 at 7:38 pm Elapsed time: 4 hours 23 mins Patient #:1107738 Collected time: 12/30/2022 at 4:20 am Resulted time: 12/30/2022 at 9:12 am Elapsed time: 4 hours 52 mins 3. An interview with the technical supervisor on 2/2 /2023 at 1:40 pm in the office confirmed the above findings. Key: PTT=Partial thromboplastin time D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on a review of the Procedure Manual for the i-STAT system, surveyor observation of the laboratory, a review of the laboratory's test records, and staff interview, it was revealed that the laboratory failed to document the revised expiration date on 26 of 26 individual Abbott i-STAT cartridges found in the laboratory being stored at room temperature. Findings include: 1. A review of the Procedure Manual for the i-STAT system (714446-00C, revision date: 07/12/04) revealed the following: "Room Temperature Cartridges - Verify that all boxes of cartridges at room temperature have been out of the refrigerator less than two weeks." 2. Surveyor observation of the laboratory on 2/2/23 at 2:55 p.m. revealed the following Abbott i- STAT cartridges on the counter being stored at room temperature: - 9 Chem 8+ cartridges lot: H22281 expiation: 4/6/23 - 9 CTnI cartridges lot: A22226 expiration: 3 /15/23 - 2 EG7+ cartridges lot: N22170 expiration: 2/16/23 - 6 CREA cartridges lot: A22260A expiration: 3/16/23 3. Further review of the 26 cartridges revealed no open date or revised expiration date were documented on the packs, ensuring the cartridges were used within 14 days. 4. A review of the laboratory's test records revealed the laboratory ran 33 i-STAT cartridges (Chem 8+, CREA, and CTnI) from January 6,2023 to the time of the inspection. 5. An interview with the technical director on 2/2 /23 at 3:00 p.m. in the office, after review of the records, confirmed the above findings. 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 a review of the laboratory's verification records, the laboratory's test records, and staff interview, it was revealed that the laboratory failed to have documentation of performing precision studies for 2 test cartridges used on the Abbott i-STAT analyzer. -- 5 of 15 -- Findings include: 1. A review of the laboratory's verification records for the Abbott i- STAT analyzer (Serial number 350779) revealed verification studies were performed in December 2022. 2. Further review of the i-STAT verification records revealed the laboratory failed to have documentation of a precision study for the following cartridges: - Chem 8+ - CTnI 3. A random review of the laboratory's test records revealed the following patients were run on the i-STAT using either the Chem 8+ or CTnI cartridges and there was no documentation that a precision study was performed: - Patient ID: 2548598 Chem 8+ and CTnI cartridges run on 1/10/23 - Patient ID: 2550325 CTnI cartridge run on 1/16/23 - Patient ID: 2551035 Chem 8+ cartridge run on 1/17/23 - Patient ID: 2552714 Chem 8+ and CTnI cartridges run on 1 /21/23 - Patient ID: 2555712 CTnI cartridge run on 2/1/23 4. An interview with the technical director on 2/2/23 at 3:40 p.m. in the office, after review of the records, confirmed the above findings. 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 a review of the laboratory's calibration verification records from 2022, the laboratory's test records, and staff interview, it was revealed that the laboratory failed to have documentation of evaluating the calibration verification records for six of 38 analytes run on the Beckman Coulter DxC 700 chemistry analyzer in December 2022. Findings include: 1. A review of the laboratory's calibration verification records from December 2022 revealed the following 6 analytes were tested on the Beckman Coulter DxC 700 chemistry analyzer: - Iron - Lipase - Magnesium - Ammonia - Triglyceride - Lactate Dehydrogenase 2. Further review of the records revealed the laboratory failed to have documentation of sending the results into Strek for an evaluation to determine if the results from the 6 assays listed above were linear. 3. A review of the laboratory's test records revealed the laboratory estimated performing 6,576 tests (Iron, Lipase, Magnesium, Ammonia, Triglyceride, Lactate Dehydrogenase) on the Beckman -- 6 of 15 -- Coulter DxC 700 chemistry analyzer in 2022. 4. An interview with technical director on 2/2/23 at 10:00 a.m. in the office, after review of the records, confirmed the above findings. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the laboratory's i-STAT Verification Studies, the laboratory's quality control records for the i- STAT from January 2023 to February 2023, the laboratory's test records, and staff interview, it was revealed that the laboratory failed to establish an IQCP (Individualized Quality Control Plan) to support the modification in quality control testing for two cartridges(CHEM 8+ and CTnI) run on the Abbott i- STAT analyzer. Findings include: 1. A review of the laboratory's i-STAT Verification Studies revealed the laboratory started testing the CHEM 8+ and CTnI cartridge on the i-STAT analyzer (Serial number: 350779) on January 6, 2023. 2. A review of the laboratory's quality control records for the CHEM 8+ and CTnI cartridges run on the i- STAT analyzer revealed the laboratory ran 2 levels of control material (levels 1 and 3) on the following dates: - Chem 8+ 1/10/23 - CTnI 1/30/23 3. A review of the laboratory's records revealed there was no documentation of the laboratory developing an IQCP for the CHEM 8+ or CTnI cartridges run on the i-STAT analyzer, modifying the frequency of quality control testing from two levels of quality control material every day of patient testing to two levels of quality control material with every new shipment of test cartridges or every 30 days. 4. A random review of patient test records revealed the following 8 patients were run on the i-STAT when there was no documentation of the laboratory running 2 levels of quality control material each day of patient testing: Patient's initials: PO tested on 1/7/23 using Chem 8+ cartridge Patient's initials: TS tested on 1/13/23 using CTnI cartridge Patient's initials: TD tested on 1/14/23 using CTnI cartridge Patient ID: 2550325 tested on 1/16/23 using CTnI cartridge Patient ID: 2551035 tested on 1/17/23 using Chem 8+ cartridge Patient ID: 2552011 tested on 1/20/23 using Chem 8+ and CTnI cartridges Patient ID: 323234 tested on 1/23/23 using CTnI cartridge Patient ID: 2555712 tested on 2/1/23 using CTnI cartridge 5. An interview with the technical director on 2/2/23 at 2:00 p.m. in the office, after review of the records, confirmed the above findings. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. -- 7 of 15 -- This STANDARD is not met as evidenced by: Based on the review of the laboratory's COVID QC records from August 2022 to January 2023, COVID patient logs, and confirmed in an interview found the laboratory failed to perform qualitative QC to include a positive and a negative QC for 33 of 150 days reviewed for one of one Quidel Solana instrument. The findings were: 1. Review of the laboratory's COVID QC records from August 2022 to January 2023 revealed the following dates did not have documentation of a positive and a negative qualitative QC performed for 33 of 150 days reviewed. 8/09/22 8/10/22 8/11 /22 8/17/22 9/02/22 9/08/22 9/09/22 9/15/22 10/31/22 11/17/22 11/26/22 11/27/22 12 /04/22 12/11/22 12/13/22 12/17/22 12/18/22 12/24/22 12/25/22 12/29/22 12/31/22 1 /01/23 1/07/23 1/12/23 1/13/23 1/15/23 1/18/23 1/21/23 1/22/23 1/24/23 1/26/23 1/28 /23 1/29/23 2. Review the patient logs for the dates above revealed 132 patients had COVID testing on Quidel Solana instrument (SN: 21022272). 8/09/22 ID: 2503199U Result: Negative 8/10/22 ID: 2503504U Result: Negative 8/10/22 ID: 2503508U Result: Negative 8/11/22 ID: 2503893U Result: Negative 8/11/22 ID: 2503896U Result: Negative 8/17/22 ID: 2505391U Result: Positive 9/02/22 ID: 2509957U Result: Negative 9/08/22 ID: 2511185U Result: Negative 9/08/22 ID: 2511186U Result: Negative 9/08/22 ID: 2511254U Result: Negative 9/09/22 ID: 2511577U Result: Positive 9/15/22 ID: 2513329U Result: Negative 10/31/22 ID: 2526114BU Result: Negative 10/31/22 ID: 2526118CU Result: Negative 10/31/22 ID: 2526123U Result: Negative 10/31/22 ID: 2526471U Result: Negative 10/31/22 ID: 2526572U Result: Negative 11/17/22 ID: 2532012U Result: Negative 11/17/22 ID: 2532013U Result: Negative 11/17/22 ID: 2532063U Result: Negative 11/26/22 ID: 2534307BU Result: Positive 11/26/22 ID: 2534307CU Result: Negative 11/27/22 ID: 2534405BU Result: Negative 11/27/22 ID: 2534438BU Result: Positive 12/04/22 ID: 2536513U Result: Negative 12/04/22 ID: 2536519U Result: Positive 12/04/22 ID: 2536526U Result: Negative 12/04/22 ID: 2536527U Result: Negative 12/11/22 ID: 2538927BU Result: Negative 12/11/22 ID: 2538964U Result: Negative 12/13/22 ID: 2539664U Result: Negative 12/13/22 ID: 2539722BU Result: Positive 12/13/22 ID: 2539772U Result: Positive 12/13/22 ID: 2539773BU Result: Negative 12/13/22 ID: 2539795U Result: Negative 12/13/22 ID: 2539878U Result: Negative 12/13/22 ID: 2539894U Result: Positive 12/13/22 ID: 2539897U Result: Negative 12/13/22 ID: 2539898U Result: Negative 12/13/22 ID: 2539945U Result: Positive 12/17/22 ID: 2541228U Result: Negative 12/17/22 ID: 2541233U Result: Negative 12/17/22 ID: 2541235U Result: Negative 12/17/22 ID: 2541037U Result: Negative 12/17/22 ID: 2541238U Result: Negative 12/17/22 ID: 2541239U Result: Negative 12/17/22 ID: 2541240U Result: Negative 12/17/22 ID: 2541243U Result: Negative 12/18/22 ID: 2541248U Result: Negative 12/18/22 ID: 2541288U Result: Negative 12/18/22 ID: 2541289U Result: Negative 12/24/22 ID: 2543300U Result: Negative 12/25/22 ID: 2543342BU Result: Negative 12/25/22 ID: 2543344U Result: Negative 12/25/22 ID: 2543345U Result: Negative 12/25/22 ID: 2543346U Result: Positive 12/25/22 ID: 2543347U Result: Positive 12/25/22 ID: 2543348U Result: Negative 12/25/22 ID: 2543378U Result: Negative 12/25/22 ID: 2543386U Result: Positive 12/29/22 ID: 2544584U Result: Negative 12/29/22 ID: 2544585U Result: Negative 12/29/22 ID: 2544628U Result: Negative 12/29/22 ID: 2544630U Result: Negative 12/29/22 ID: 2544633U Result: Negative 12/29/22 ID: 2544647U Result: Negative 12/29/22 ID: 2545368U Result: Negative 12/31/22 ID: 2545369U Result: Negative 1/01/23 ID: 2545482U Result: Positive 1/01/23 ID: 2545483U Result: Negative 1/01/23 ID: 2545484U Result: Positive 1/01/23 ID: 2545512U Result: Negative 1/07/23 ID: 2547502U Result: Negative 1/07/23 ID: 2547535U Result: Negative 1/07/23 ID: 2547536U Result: Negative 1/07/23 ID: 2547538U Result: Negative 1/07/23 ID: 2547564U -- 8 of 15 -- Result: Negative 1/07/23 ID: 2547619U Result: Negative 1/07/23 ID: 2547628U Result: Positive 1/12/23 ID: 2548891U Result: Negative 1/12/23 ID: 2549097U Result: Negative 1/12/23 ID: 2549100U Result: Negative 1/12/23 ID: 2549101U Result: Positive 1/12/23 ID: 2549120U Result: Negative 1/12/23 ID: 2549191U Result: Negative 1/12/23 ID: 2549252U Result: Negative 1/12/23 ID: 2549253U Result: Negative 1/13/23 ID: 2549631U Result: Negative 1/15/23 ID: 2550147U Result: Negative 1/15/23 ID: 2550149U Result: Negative 1/15/23 ID: 2550150U Result: Negative 1/18/23 ID: 2551025U Result: Negative 1/18/23 ID: 2551026U Result: Negative 1/18/23 ID: 2551121U Result: Negative 1/18/23 ID: 2551128BU Result: Negative 1/21/23 ID: 2552020U Result: Negative 1/21/23 ID: 2552022U Result: Negative 1/21/23 ID: 2552044FU Result: Negative 1/21/23 ID: 2552045U Result: Negative 1/21/23 ID: 2552046U Result: Negative 1/21/23 ID: 2552115U Result: Negative 1/22/23 ID: 2552237U Result: Negative 1/22/23 ID: 2552285BU Result: Negative 1/22/23 ID: 2552287U Result: Negative 1/22/23 ID: 2552288U Result: Negative 1/22/23 ID: 2552289U Result: Negative 1/22/23 ID: 2552290U Result: Negative 1/22/23 ID: 2552291U Result: Negative 1/24/23 ID: 2552746U Result: Negative 1/24/23 ID: 2552773U Result: Negative 1/24/23 ID: 2552886U Result: Negative 1/24/23 ID: 2552893U Result: Negative 1/24/23 ID: 2552904U Result: Negative 1/24/23 ID: 2553141U Result: Negative 1/26/23 ID: 2553592U Result: Negative 1/26/23 ID: 2553634U Result: Negative 1/26/23 ID: 2553642U Result: Negative 1/26/23 ID: 2553643U Result: Negative 1/28/23 ID: 2554265U Result: Negative 1/28/23 ID: 2554266U Result: Negative 1/28/23 ID: 2554413BU Result: Negative 1/28/23 ID: 2554435 Result: Negative 1/28/23 ID: 2554443U Result: Negative 1/29/23 ID: 2554568BU Result: Negative 1/29/23 ID: 2554579U Result: Positive 1/29/23 ID: 2554581U Result: Negative 1/29/23 ID: 2554582U Result: Positive 1/29/23 ID: 2554583U Result: Negative 1/29/23 ID: 2554627U Result: Negative 1/29/23 ID: 2554629U Result: Positive 1/29/23 ID: 2554630U Result: Negative 1/29/23 ID: 2554632U Result: Negative 3. An interview with the technical supervisor on 2/1/2023 at 11:00 am in the office confirmed the above findings. Key: QC=Quality Control 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. This STANDARD is not met as evidenced by: Based on the review of the laboratory's CMS 116 application, Prothrombin time QC records from October 2022 to January 2023, patient records, and confirmed in an interview found the laboratory failed to have documentation to perform at least two levels of control materials each eight hours of operation for Prothrombin time testing on one of one Siemens CA620 coagulation instrument. The findings were: 1. Review of the laboratory's CMS 116 application revealed the laboratory's operation hours were 24 hours, seven days a week, including weekends and holidays. 2. Random review of the laboratory's Prothrombin time QC records from Octrober 2022 to January 2023 revealed 10 of 30 days reviewed did no have docuentation of at least two levels of QC every 8 hours of opearation for Prothrombin time testing. 10/21 /2022 QC tested: 11:10 am QC due: 7:10 pm Next QC run: 10/22/2022 8:26 am Elapsed time from 8 hour QC expiration time: 13 hrs 16 mins 11/3/2022 QC tested: 5: -- 9 of 15 -- 45 am QC due: 1:45 pm Next QC run: 11/3/2022 4:45 am Elapsed time from 8 hour QC expiration time: 3 hrs 11/16/2022 QC tested: 3:52 am QC due: 11:52 am Next QC run: 11/17/2022 7:15 am Elapsed time from 8 hour QC expiration time: 19 hours 23 mins 11/21/2022 QC tested: 3:04 am QC due: 11:04 am Next QC run: 11/22/2022 11: 07 am Elapsed time from 8 hour QC expiration time: 24 hours 3 mins 11/24/2022 QC tested: 6:24 am QC due: 2:24 pm Next QC run: 11/25/2022 5:20 am Elapsed time from 8 hour QC expiration time: 14 hrs 56 mins 12/1/2022 QC tested: 8:21 am QC due: 4:21 pm Next QC run: 12/1/2022 9:18 pm Elapsed time from 8 hour QC expiration time: 4 hrs 57 mins 12/7/2022 QC tested: 4:52 am QC due: 12:52 pm Next QC run: 12/7/2022 7:22 pm Elapsed time from 8 hour QC expiration time: 7 hours 12 /15/2022 QC tested: 5:15 am QC due: 1:15 pm Next QC run: 12/16/2022 3:47 am Elapsed time from 8 hour QC expiration time: 14 hrs 32 mins 1/13/2023 QC tested: 3: 19 am QC due: 11:19 am Next QC run: 1/13/2023 3:38 pm Elapsed time from 8 hour QC expiration time: 4 hrs 19 mins 1/28/2023 QC tested: 4:48 am QC due: 12:48 pm Next QC run: 1/28/2023 8:19 pm Elapsed time from 8 hour QC expiration time: 7 hrs 31 mins 3. Review the patients records for the above dates revealed 77 patients had prothrombin time testing. 10/21/2022 Patient ID: 2523774 Time run: 9:04 pm QC due: 10/21/2022 7:10 pm 10/21/2022 Patient ID: 2523779 Time run: 9:04 pm QC due: 10/21/2022 7:10 pm 10/21/2022 Patient ID: 2523754 Time run: 11:27 pm QC due: 10 /21/2022 7:10 pm 10/21/2022 Patient ID: 2523773 Time run: 11:28 pm QC due: 10/21 /2022 7:10 pm 11/3/2022 Patient ID: 2527384 Time run: 2:08 pm QC due: 11/3/2022 1:45 pm 11/3/2022 Patient ID: 2527376 Time run: 3:29 pm QC due: 11/3/2022 1:45 pm 11/3/2022 Patient ID: 2527379 Time run: 3:29 pm QC due: 11/3/2022 1:45 pm 11 /3/2022 Patient ID: 2527384 Time run: 3:43 pm QC due: 11/3/2022 1:45 pm 11/3 /2022 Patient ID: 2527377 Time run: 3:44 pm QC due: 11/3/2022 1:45 pm 11/3/2022 Patient ID: 2527630 Time run: 3:47 pm QC due: 11/3/2022 1:45 pm 11/3/2022 Patient ID: 2527632 Time run: 4:07 pm QC due: 11/3/2022 1:45 pm 11/16/2022 Patient ID: 2531464 Time run: 12:00 pm QC due: 11/16/2022 11:52 am 11/16/2022 Patient ID: 2531393 Time run: 12:01 pm QC due: 11/16/2022 11:52 am 11/16/2022 Patient ID: 2531501 Time run: 12:13 pm QC due: 11/16/2022 11:52 am 11/16/2022 Patient ID: 2531563 Time run: 1:41 pm QC due: 11/16/2022 11:52 am 11/16/2022 Patient ID: 2531418 Time run: 2:24 pm QC due: 11/16/2022 11:52 am 11/16/2022 Patient ID: 2531511 Time run: 2:24 pm QC due: 11/16/2022 11:52 am 11/16/2022 Patient ID: 2531395 Time run: 6:22 pm QC due: 11/16/2022 11:52 am 11/16/2022 Patient ID: 2531629 Time run: 6:22 pm QC due: 11/16/2022 11:52 am 11/16/2022 Patient ID: 2531740 Time run: 7:47 pm QC due: 11/16/2022 11:52 am 11/16/2022 Patient ID: 2531725 Time run: 7:50 pm QC due: 11/16/2022 11:52 am 11/16/2022 Patient ID: 2531740 Time run: 8:10 pm QC due: 11/16/2022 11:52 am 11/21/2022 Patient ID: 2532587 Time run: 11:34 am QC due: 11/21/2022 11:04 am 11/21/2022 Patient ID: 2532732 Time run: 12:25 pm QC due: 11/21/2022 11:04 am 11/21/2022 Patient ID: 2532945 Time run: 1:26 pm QC due: 11/21/2022 11:04 am 11/21/2022 Patient ID: 2532763 Time run: 1:41 pm QC due: 11/21/2022 11:04 am 11/21/2022 Patient ID: 2532754 Time run: 1:41 pm QC due: 11/21/2022 11:04 am 11/21/2022 Patient ID: 2532669 Time run: 2:58 pm QC due: 11/21/2022 11:04 am 11/21/2022 Patient ID: 2532730 Time run: 6:56 pm QC due: 11/21/2022 11:04 am 11/21/2022 Patient ID: 2532770 Time run: 6:56 pm QC due: 11/21/2022 11:04 am 11/21/2022 Patient ID: 2532769 Time run: 6:57 pm QC due: 11/21/2022 11:04 am 11/21/2022 Patient ID: 2532750 Time run: 6:57 pm QC due: 11/21/2022 11:04 am 11/21/2022 Patient ID: 2532999 Time run: 6:58 pm QC due: 11/21/2022 11:04 am 11/21/2022 Patient ID: 2532883 Time run: 9:44 pm QC due: 11/21/2022 11:04 am 11/22/2022 Patient ID: 2533177 Time run: 11/22/2022 12:08 am QC due: 11/21/2022 11:04 am 11 /22/2022 Patient ID: 2532799 Time run: 11/22/2022 12:08 am QC due: 11/21/2022 11: 04 am 11/22/2022 Patient ID: 2533198 Time run: 11/22/2022 12:09 am QC due: 11/21 -- 10 of 15 -- /2022 11:04 am 11/22/2022 Patient ID: 2533259 Time run: 11/22/2022 1:25 am QC due: 11/21/2022 11:04 am 11/24/2022 Patient ID: 2533961 Time run: 11/24/2022 11: 10 pm QC due: 11/24/2022 2:24 pm 12/1/2022 Patient ID: 2535704 Time run: 12/1 /2022 4:26 pm QC due: 12/1/2022 4:21 pm 12/1/2022 Patient ID: 2535724 Time run: 12/1/2022 4:26 pm QC due: 12/1/2022 4:21 pm 12/1/2022 Patient ID: 2535711 Time run: 12/1/2022 4:27 pm QC due: 12/1/2022 4:21 pm 12/1/2022 Patient ID: 2535714 Time run: 12/1/2022 4:27 pm QC due: 12/1/2022 4:21 pm 12/1/2022 Patient ID: 2535726 Time run: 12/1/2022 4:28 pm QC due: 12/1/2022 4:21 pm 12/1/2022 Patient ID: 2535704 Time run: 12/1/2022 4:40 pm QC due: 12/1/2022 4:21 pm 12/1/2022 Patient ID: 2535724 Time run: 12/1/2022 4:40 pm QC due: 12/1/2022 4:21 pm 12/1 /2022 Patient ID: 2535961 Time run: 12/1/2022 4:56 pm QC due: 12/1/2022 4:21 pm 12/1/2022 Patient ID: 2535960 Time run: 12/1/2022 4:58 pm QC due: 12/1/2022 4:21 pm 12/1/2022 Patient ID: 2535963 Time run: 12/1/2022 5:01 pm QC due: 12/1/2022 4:21 pm 12/1/2022 Patient ID: 2535710 Time run: 12/1/2022 5:46 pm QC due: 12/1 /2022 4:21 pm 12/1/2022 Patient ID: 2536000 Time run: 12/1/2022 5:59 pm QC due: 12/1/2022 4:21 pm 12/1/2022 Patient ID: 2535715 Time run: 12/1/2022 7:25 pm QC due: 12/1/2022 4:21 pm 12/1/2022 Patient ID: 2536029 Time run: 12/1/2022 9:01 pm QC due: 12/1/2022 4:21 pm 12/7/2022 Patient ID: 2537771 Time run: 12/7/2022 1:33 pm QC due: 12/7/2022 12:52 pm 12/7/2022 Patient ID: 2537716 Time run: 12/7/2022 1:42 pm QC due: 12/7/2022 12:52 pm 12/7/2022 Patient ID: 2537716 Time run: 12/7 /2022 1:50 pm QC due: 12/7/2022 12:52 pm 12/7/2022 Patient ID: 2537581 Time run: 12/7/2022 4:37 pm QC due: 12/7/2022 12:52 pm 12/7/2022 Patient ID: 2537841 Time run: 12/7/2022 5:26 pm QC due: 12/7/2022 12:52 pm 12/7/2022 Patient ID: 2537857 Time run: 12/7/2022 5:43 pm QC due: 12/7/2022 12:52 pm 12/15/2022 Patient ID: 2540385 Time run: 12/15/2022 1:56 pm QC due: 12/7/2022 1:15 pm 12/15 /2022 Patient ID: 2540391 Time run: 12/15/2022 1:56 pm QC due: 12/7/2022 1:15 pm 12/15/2022 Patient ID: 2540392 Time run: 12/15/2022 1:57 pm QC due: 12/7 /2022 1:15 pm 12/15/2022 Patient ID: 2540409 Time run: 12/15/2022 1:57 pm QC due: 12/7/2022 1:15 pm 12/15/2022 Patient ID: 2540385 Time run: 12/15/2022 2:07 pm QC due: 12/7/2022 1:15 pm 12/15/2022 Patient ID: 2540409 Time run: 12/15 /2022 2:07 pm QC due: 12/7/2022 1:15 pm 12/15/2022 Patient ID: 2540412 Time run: 12/15/2022 2:40 pm QC due: 12/7/2022 1:15 pm 12/15/2022 Patient ID: 2540411 Time run: 12/15/2022 2:41 pm QC due: 12/7/2022 1:15 pm 12/15/2022 Patient ID: 2540603 Time run: 12/15/2022 3:04 pm QC due: 12/7/2022 1:15 pm 12/15/2022 Patient ID: 2540641 Time run: 12/15/2022 5:20 pm QC due: 12/7/2022 1:15 pm 12/15 /2022 Patient ID: 2540390 Time run: 12/15/2022 5:20 pm QC due: 12/7/2022 1:15 pm 1/13/2023 Patient ID: 2549721 Time run: 1/13/2023 11:58 am QC due: 1/13/2023 11:19 pm 1/13/2023 Patient ID: 2549596 Time run: 1/13/2023 12:08 am QC due: 1/13 /2023 11:19 pm 1/13/2023 Patient ID: 2549591 Time run: 1/13/2023 12:31 am QC due: 1/13/2023 11:19 pm 1/13/2023 Patient ID: 2549807 Time run: 1/13/2023 2:02 pm QC due: 1/13/2023 11:19 pm 1/13/2023 Patient ID: 2549802 Time run: 1/13/2023 2:02 pm QC due: 1/13/2023 11:19 pm 1/13/2023 Patient ID: 2549795 Time run: 1/13 /2023 2:08 pm QC due: 1/13/2023 11:19 pm 1/28/2023 Patient ID: 2554430 Time run: 1/28/2023 1:28 pm QC due: 1/28/2023 12:48 pm 4. An interview with the technical supervisor on 2/2/2023 at 11:32 am in the office confirmed the above findings Key: CMS=Center of Medicare and Medicaid Services QC=Quality Control D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where -- 11 of 15 -- the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a random review of patient's microbiology test reports from January 2023 and staff interview, it was revealed that the laboratory failed to include the correct address of the testing facility on two of two patient's microbiology test reports reviewed from January 2023. Findings include: 1. A random review of patient's microbiology test reports from January 2023 revealed the laboratory failed to include the correct address of the testing facility on the following 2 patient's test reports: Patient ID: 027913 Wound culture resulted 1/31/23 Patient ID: 06031940 Urine culture resulted 1/31/23 *The above listed patient reports indicated the testing was performed at the address: 7501 Fannin St. Suite 800 Houston, TX 77054. Actual address for the laboratory is 4200 Twelve Oaks Place Houston, TX 77027. 2. An interview with the technical director on 2/2/23 at 3:35 p.m. in the office, after review of the records, confirmed the above findings. D5807 TEST REPORT CFR(s): 493.1291(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 the review of the laboratory's records, patient's final reports, and confirmed in an interview found the laboratory failed to provide the accurate normal reference range for PT for two of two months reviewed on one of one Siemens CA620 coagulation instrument. The findings were: 1. Review of the laboratory's records for new PT reagent, Innovin, lot#564621, expiration date 4/21/2025, the laboratory director signed on 11/29/2022, revealed the new normal reference range for PT was 9.3-11.5. 2. Random review of the patient final reports from December 2022 to January 2023 revealed 2 patients reports with the reference range of 8.4-11.5. Collection Date: 1/25/23 Patient #: 1103365 Prothrombin Time (PT) Result: 10.4 INR Result: 1.06 Collection Date: 1/27/23 Patient #: 1109975 Prothrombin Time (PT) Result: 10.8 INR Result: 1.10 3. An interview with the technical supervisor on 2/2 /2023 at 3:00 pm in the office confirmed the above findings. Key: PT=Prothrombin Time D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. -- 12 of 15 -- This STANDARD is not met as evidenced by: Based on a review of the laboratory's proficiency testing records and staff interview, it was revealed that the laboratory director failed to ensure the laboratory was enrolled in an HHS approved proficiency testing program for the analyte Human Chorionic Gonadotropin in 2022. (Refer to D2000) D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the laboratory's records and staff interview, it was revealed the laboratory director failed to ensure a quality control program was established and maintained (refer to D5445, D5449, and D5545). D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) 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. This STANDARD is not met as evidenced by: Based on a review of the laboratory's personnel records and staff interview, it was revealed that the laboratory director failed to ensure that testing personnel had documentation of training to perform moderate complexity testing (refer to D6066). D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: -- 13 of 15 -- Based on a review of the laboratory's records and staff interview, it was revealed that the technical consultant failed to ensure a quality control program was established and maintained (refer to D5445, D5449, and D5545). D6050 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iv) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observation of performance of instrument maintenance and function checks. This STANDARD is not met as evidenced by: Based on a review of the laboratory's competency assessment forms for 2022, the laboratory's personnel records, and staff interview, it was revealed that the technical consultant failed to ensure the competency assessments performed on five of ten testing personnel included the direct observation of instrument maintenance and function checks on the six analyzers used in the laboratory. Findings include: 1. A review of the laboratory's competency assessment forms revealed the technical consultant assessed competency for the following 6 analyzers: - DXC 700 - DXI 800 - Sysmex XS-1000i - Clinitek Advantus - Sysmex CA 620 - Solana 2. Further review of the laboratory's competency assessment forms revealed the technical consultant failed to include the direct observation of instrument maintenance and function checks for the above listed analyzers. 3. A review of the laboratory's personnel records revealed the following testing personnel (as indicated on the CMS 209 form) had competency assessments performed by the technical consultant in 2022 that failed to include the direct observation of instrument maintenance and function checks on the 6 laboratory analyzers: - Testing person #2 assessment performed: 4/21/22 - Testing person #3 assessment performed: 11/21/22 - Testing person #4 assessment performed: 7/21/22 - Testing person #5 assessment performed: 5/20/22 - Testing person #6 assessment performed: 5/20/22 4. An interview with technical director on 2/2/23 at 3:30 p.m. in the office, after review of the records, confirmed the above findings. D6055 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing whenever test methodology or instrumentation changes. The individual's performance must be reevaluated to include the use of the new test methodology or instrumentation prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on a review of the verification studies for the Beckman Coulter DxH 690 hematology analyzer, the laboratory's personnel files, and staff interview, it was revealed that the technical consultant failed to evaluate and document the performance of five of ten testing personnel following a change in instrumentation in March 2022. Findings include: 1. A review of the laboratory's verification studies revealed the laboratory received a new instrument, a Beckman Coulter DxH 690 hematology analyzer (serial number: BFO3003) in March 2022. 2. A review of the laboratory's personnel files revealed that testing performance for the Beckman Coulter DxH 690 had not been evaluated and documented prior to reporting patient test results for the -- 14 of 15 -- following testing personnel (as indicated on the CMS 209 form): - Testing person #2 - Testing person #3 - Testing person #4 - Testing person #5 - Testing person #6 3. An interview with the technical director on 2/2/23 at 3:30 p.m. in the office, after review of the records, confirmed the above findings. D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) Have documentation of training appropriate for the testing performed prior to analyzing patient specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's submitted CMS 209 form, review of the laboratory's personnel records, and staff interview, it was revealed that the laboratory failed to have documentation of training prior to performing patient testing for the following: a) four of five testing personnel for COVID testing on the Solana analyzer. b) two of five testing personnel for Complete Blood Count (CBC) testing on the Beckman Coulter DxH 690 hematology analyzer. c) one of five testing personnel for Clostridium difficile (cdiff) testing on the Solana analyzer. d) five of five testing personnel for Chem 8+ and Troponin cartridge testing on the Abbott i-STAT analyzer. Findings include: 1. A review of the laboratory's submitted CMS 209 form revealed the laboratory identified ten testing personnel performing moderate complexity testing. 2. A review of the l

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the CLIA regulations. The conditions not met were: D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems; D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of the laboratory American Proficiency Institute (API) proficiency testing records, and confirmed in interview, the laboratory failed to document remedial action for PT failures for the analyte Total Iron Binding Capacity (UIBC). Findings were: 1. Review of the 2018 API proficiency testing records revealed the laboratory failed to attain an 80% for the analyte UIBC for 2 of 3 testing event for Chemistry. 2018 Event 1 UIBC (60%) lab result acceptable result CH-04 130 133 - 165 CH-05 171 176 - 207 2018 Event 2 UIBC (60%) lab result acceptable result CH- 06 194 153 - 189 CH-07 124 88 - 121 2. Review of the laboratory