Truhealth Integrated Care

Summary Statement of Deficiencies D0000 The recertification survey was performed on 02/20,21,22/2024. The laboratory was found out of compliance with the following CLIA Conditions: 493.1250; D5400: Analytic Systems 493.1405; D6000: Laboratory Director 493.1409; D6033: Technical Consultant The findings were reviewed with the technical consultant, testing person #1, and testing person #2 during an exit conference performed at the conclusion of the survey. 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 a review of records, written policies and procedures, manufacturer's instructions, and interview with the technical consultant, the laboratory failed to monitor and evaluate the overall quality of analytic systems and correct identified problems for each specialty and subspecialty of testing performed during the review period of June 2022 through the current date. Findings include: (1) The laboratory failed to follow their written policy for performing quality control for CBC testing for one of one day of patient testing reviewed from 07/28/2023 through 08/15/2023. Refer to D5401; (2) The laboratory failed to have complete written procedures for one of one procedure reviewed. Refer to D5403; (3) The laboratory failed to ensure one of one policy had been approved, signed, and dated by the laboratory director. Refer to D5407; (4) The laboratory failed to ensure the laboratory humidity was maintained as required by the manufacturer of the TOSOH ALA-360 analyzer for three of three Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 14 -- months reviewed. Refer to D5413; (5) The laboratory failed to ensure the manufacturer's instructions were followed for performing weekly maintenance procedures on the Sysmex XN-330 analyzer and the Siemens Viva Pro E analyzer during the review period of January 2023 through December 2023. Refer to D5429; (6) The laboratory failed to perform calibration verification procedures at least once every six months for the Piccolo test system during the review period of January 2023 through the current date. Refer to D5439; (7) The laboratory failed to perform quality control procedures each day of patient testing for eight of 40 days reviewed. Refer to D5447; (8) The laboratory failed to have a system that twice a year evaluated and defined the relationship between test results using different Piccolo reagent discs for three of 12 analytes reviewed from June 2022 through the current date. Refer to D5775; (9) The laboratory failed to have an ongoing mechanism for performing quality assessment. Refer to D5791. NOTE: D5400 was cited on the initial survey performed on 01/28/2022. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of records, written policies and procedures, and interview with the technical consultant, the laboratory failed to follow their written policy for performing QC (quality control) for CBC testing for one of one day of patient testing reviewed between 07/28/2023 through 08/16/2023. Findings include: (1) On 02/20/2024 at 03: 00 pm, the technical consultant stated the following: (a) The laboratory performed CBC (Complete Blood Count) testing using the Sysmex XN-330 analyzer; (b) Three levels of XN-L CHECK QC (Quality Control) materials were tested each day of patient testing. (2) A review of the policy titled, "Complete Blood Count (CBC)" under section titled "Quality Control Procedure - QC Frequency" stated, "Test three levels of QC samples once per day using Commercial Control"; (3) A review of QC and patient test reports from 07/28/2023 through 08/16/2023 identified the laboratory had tested two levels of QC materials instead of three levels (no evidence the laboratory performed level 1 QC) for the following patients: (a) Patient #512714332831745, tested on 08/11/2023 at 11:52 am; (b) Patient #268257629503489, tested on 08/11/2023 at 01:41 pm. (4) The findings were reviewed with the technical consultant who stated on 02/21/2024 at 02:15 pm, the laboratory had not followed their policy for performing QC procedures as stated above. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. -- 2 of 14 -- (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and from the proficiency testing provider. 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 scores obtained from the Casper 0155D report and the proficiency testing Comparative Evaluation obtained from American Proficiency Institute, the laboratory failed to successfully participate in a proficiency testing program for the specialty of Hematology. Findings include: (1) The laboratory failed to achieve satisfactory performance for two consecutive testing events for Cell Identification/White Blood Cell differential for %Basophils, %Eosinophils, % 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 -- Immature Granulocytes, Absolute Immature Granulocytes, %Monocytes, and % Neutrophils. Refer to D2128 and D2130. D2128 HEMATOLOGY CFR(s): 493.851(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 a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing Comparative Evaluation obtained from American Proficiency Institute, the laboratory failed to achieve successful performance for Cell Identification/White Blood Cell Differential for %Basophils, %Eosinophils, % Immature Granulocytes, Absolute Immature Granulocytes, %Monocytes, and % Neutrophils. Findings include: (1) The laboratory failed to achieve satisfactory performance on the third event in 2021 and the first event in 2022. Refer to D2130. NOTE: The only acceptable

Summary Statement of Deficiencies D0000 The initial survey was performed on 01/28/2022. The findings were reviewed with the testing person during an exit conference performed at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulations: 493.1250; D5400: Analytic Systems 493.1403; D6000: Laboratory Director, Moderate Complexity Testing 493.1409; D6033: Technical Consultant 493.1441; D6076: Laboratory Director, High Complexity Testing D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of records, written policy, and interview with the testing person, the laboratory failed to follow a written technical consultant competency policy based on the position responsibilities as listed in Subpart M for one of one technical consultant. Findings include: (1) On 01/28/2022, surveyor #2 reviewed personnel records for competency assessments performed during 2020 and 2021. There was no evidence a competency had been performed for the technical consultant based on their job responsibilities; (2) Surveyor #2 asked the testing person if a written policy to evaluate the technical consultant based on job responsibilities was available. Testing person #1 provided the policy for surveyor #2 review; (3) Surveyor #2 reviewed the policy titled, "LABORATORY STAFF ORIENTATION, TRAINING, AND ASSESSMENT" which stated, (a) "PURPOSE" (i) "To provide a comprehensive plan for laboratory employees' orientation upon hire, for six month and annual evaluations, and for determination of competency within their respective departments. All employees should be knowledgeable of their job description and duties in each position throughout the laboratory."; (4) Surveyor #2 asked the testing person if 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 -- competencies based on job responsibilities had been performed during the review period. Testing person #1 stated on 01/28/2022 at 11:50 am, competencies had not been performed. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the testing person, the laboratory failed to review and evaluate proficiency testing results for three of nine events. Findings include: FAILURE (1) On 01/28/2022, surveyor #2 reviewed 2021 proficiency testing records and identified the following failure: (a) Third 2020 Hematology Event (i) Basophils- The laboratory failed the results for five of five samples (XE-11, XE-12, XE-13, XE-14, XE-15); (ii) Eosinophils - The laboratory failed the results for five of five samples (XE-11, XE-12, XE-13, XE-14, XE-15); (iii) Lymphocytes - The laboratory failed the results for one of five samples (XE-12); (2) The surveyor could not locate evidence in the records proving the failure had been addressed; (3) Surveyor #2 reviewed the records with the testing person, and asked if