Integrated Health Concepts, Llc

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services CASPER Report 155 (CMS 155) and the laboratory's proficiency testing (PT) evaluation reports, the laboratory failed to maintain satisfactory participation for two out of three proficiency testing events in 2023 and 2024, resulting in initial unsuccessful participation for the red blood cell (RBC) analyte. (See D2130) D2130 HEMATOLOGY CFR(s): 493.851(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Failure to achieve satisfactory performance for the same analyte in two consecutive 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 CMS 155 and the laboratory's American Proficiency Institute (API) PT evaluation reports, the laboratory failed to maintain satisfactory performance for two out of three test events for the red blood cell (RBC) analyte, resulting in initial unsuccessful PT occurrence. The findings include: 1. A review of the CMS 155 report revealed the following unsatisfactory RBC scores: - 2023 Event three: 20% - 2024 Event two: 20% 2. A review of the laboratory's API PT evaluation report revealed the following unsatisfactory RBC scores: - 2023 Event three: 20% - 2024 Event two: 20% -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the laboratory's quality control (QC) records, lack of records, and staff interviews, the laboratory failed to retain two of two QC package inserts for the Beckman Coulter Access-2 (Access-2) immunoassay chemistry analyzer and one of one QC package insert for the Ortho Clinical Diagnostics Vitros-350 (Vitros-350) chemistry analyzer used for patient testing in 2023 and 2024. The findings include: 1. Observation of the laboratory on 08.20.2024 at 9:30 a.m. revealed an Access-2 (serial number 511210) immunoassay chemistry analyzer and a Vitros-350 (serial number 27005665) chemistry analyzer used for patient testing. 2. A review of the laboratory's daily chemistry QC records revealed the following: -Access-2: Lot Numbers 85301-L1 and 85303 L-3 used on 02.15.2023 - Access-2: Lot Numbers 85351 and 85353 used on 03.26.2024 -Vitros-350: Lot Numbers 45911 and 45913 used on 03.16.2023 and 08.09.2023 3. The laboratory was unable to provide the QC package inserts for Access-2 lots 85301-L1, 85303 L-3, 85351, 85353, and Vitros-350 lots 45911 and 45913. 4. An interview with testing person one (TP #1) and the office manager on 08.20.2024 at 1:30 p.m. confirmed the survey findings. 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 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 -- 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 observation of the laboratory, review of the laboratory's policy, patient test reports, quality control (QC) records, and staff interviews, the laboratory failed to follow its quality control and assessment procedure in 2023 and 2024. The findings include: 1. Observation of the laboratory on 08.20.2024 at 9:30 a.m. revealed a Beckman Coulter Access-2(Access-2) (serial number 511210) immunoassay chemistry analyzer and an Ortho Clinical Diagnostics Vitros-350(Vitros-350) (serial number 27005665) chemistry analyzer used for patient testing. 2. A review of the laboratory's Quality Control and Assessment policy under the section titled "Two Control Protocol" stated: "Reject the run if: a. Both controls are greater than 2SD from the mean (2-2SRule) b. One control is greater than 2SD and less than 3 SD on two consecutive runs (2-2S Rule) c. One control is greater than 3 SD from the mean (1-3S Rule)" 3. A random review of patient test reports revealed that a patient with accession number 9845 was tested for alanine aminotransferase (ALT) on 03.16.2023, a patient with accession number 10898 was tested for calcium on 08.09.2023, and a patient with accession number 12661 was tested for folate on 03.26.2024 when quality control fell outside of the laboratory's established acceptable limits. 4. A review of quality control records revealed the following, which fell outside of the laboratory's established acceptable limits; -Vitros-350 ALT QC on 03.16.2023: level 3 QC unacceptable at greater than 2 SD for 2 consecutive runs -Vitros-350 Calcium QC on 08.09.2023: level 3 QC unacceptable at 3 SD -Access-2 Folate QC on 03.26.2024: both level 1 and level 3 QC were unacceptable at greater than 2 SD 5. An interview with TP #1 and the office manager on 08.20.2024 at 1:30 p.m. confirmed the survey findings. Word Key: SD = Standard Deviation D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on laboratory observation, manufacturer instructions, environment records, and staff interviews, the laboratory failed to monitor and document temperature ranges that were consistent with the manufacturer's requirement for the storage of the Ortho Clinical Diagnostics Vitros-350 (Vitros-350) chemistry reagent slides used on the Vitros-350 analyzer in 2023 and 2024. Findings include: 1. Observation of the laboratory on 08.20.2024 at 9:30 a.m. revealed the Ortho Clinical Diagnostics Vitro- 350 (Vitros-350) analyzer (serial number 27005665) used for patient testing. Additional observation of the laboratory revealed an M3 Turbo air refrigerator (serial number M3R1LAY015) used to store the following Vitros-350 reagent slides: -Three boxes of TP -Five boxes of ALKP -Three boxes of ECO2 -Three boxes of TBIL - Three boxes of ALB -Three boxes of CL- -Four boxes of Ca -Two boxes of Bun/Urea -- 2 of 3 -- -Two boxes of K+ 2. A review of manufacturer instructions revealed the storage requirements of 8 degrees Celsius or less. 3. A review of environment records revealed no documentation of temperature monitoring for the ME Turbo air refrigerator. 4. An interview with TP #1 on 08.20.2024 at 9:35 a.m. confirmed the above findings. Word Key: TP = Total Protein ALKP = Alkaline Phosphatase ECO2 = Carbon Dioxide TBIL = Total Bilirubin ALB = Albumin CL- = Chloride Ca = Calcium Bun/Urea = Blood Urea Nitrogen K+ = Potassium 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 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 review of laboratory demographic information in Aspen Web 116, final patient test reports, and staff interviews, the laboratory failed to ensure the correct physical address was on the final patient test report for three of three final patient test reports reviewed from 2023 and 2024. The findings include: 1. A review of the laboratory demographic information in Aspen Web 116 revealed a physical address of 1615 Bluff City Hwy, Bristol, TN 37620. 2. A review of final patient test reports revealed the laboratory address listed as 28 Midway Street, Bristol, TN 37620, as follows: -Patient with accession 10898 (Complete Blood Count, Comprehensive Metabolic Panel, Vitamin B12 with Folate reported on 08.09.2023) -Patient with accession number 9845 (Complete Blood count, Comprehensive Metabolic Panel, Hormone Panel, Lipid Panel, Magnesium, Thyroid Panel, Vitamin B12 with Folate, and Vitamin D reported on 03.16.2023) -Patient with accession number 12661 (Complete Blood Count, Comprehensive Metabolic Panel, Hormone Panel, Lipid Panel, Magnesium, Thyroid Panel, Vitamin B12 with Folate, and Vitamin D reported on 03.26.2024) 3. An interview with TP #1 and the office manager on 08.20.2024 at 1: 30 p.m. confirmed the survey findings. -- 3 of 3 --

Summary Statement of Deficiencies 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 review and request of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records and interview with the testing person, it was determined the testing personnel and/or the laboratory director failed to sign the attestation sheets for 12 of 12 PT events for 2021 and 2022. The findings include: 1. Request of the laboratory's PT records revealed the following: -No attestation pages available for the following: Chemistry 2022 event one -Attestation pages not signed by the testing personnel for the following: Hematology/Coagulation 2022 event one and three Chemistry 2021 event one -Attestation pages not signed by the laboratory director for the following: Hematology/Coagulation 2022 event two -Attestation pages not signed by the testing personnel and the laboratory director for the following: Hematology/Coagulation 2021 event one and three, 2022 event two Chemistry 2021 event two and three, 2022 event two and three 2. Interview with the testing person on January 9,2023 at approximately 10:45 am confirmed the above findings. 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. 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 -- This STANDARD is not met as evidenced by: Citation #1 Based on review of the laboratory's competency policy, the Centers for Medicare and Medicaid Services Laboratory Personnel Report (Form CMS-209), review of testing personnel records, and interview with the laboratory testing person, the laboratory failed to follow the policy for competency assessment in 2021 and 2022. Findings include: 1) Review of the laboratory's staff orientation, training and competency policy revealed that "After initial competency assessment at the completion of orientation and training, competency assessment will occur at 6 months, 12 months and annually thereafter." 2) Review of the CMS-209 revealed one of one testing personnel performing moderately complex testing. 3) Review of testing personnel records revealed no documentation of annual competency assessments for one of one testing personnel for 2021 and 2022. 4) Interview with the laboratory testing person at approximately 10:45am on January 9, 2023 confirmed the laboratory failed to follow the policy for competency assessment in 2021 and 2022. Citation #2 Based on review of the laboratory's manual review policy, the Centers for Medicare and Medicaid Services Laboratory Personnel Report (Form CMS-209), review of procedure manuals, and interview with the laboratory testing person, the laboratory failed to follow the policy for annually reviewing procedures in 2021 and 2022. Findings include: 1) Review of the laboratory's manual review policy revealed that "All policies must be reviewed annually and documentation of review documented on each SOP policy signature page in this manual by Laboratory Director. Laboratory Personnel must document review of this manual by signing below:" 2)Review of the CMS-209 revealed one of one testing personnel performing moderately complex testing. 3)Review of procedure manuals revealed no Laboratory Director or testing personnel signatures in 2021 or 2022. 4)Interview with the laboratory testing person at approximately 10:45am on January 9, 2023 confirmed the laboratory failed to follow the policy for manual review in 2021 and 2022. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on review of the laboratory's calibration/calibration verification procedure, review of the Horiba Micros 60 calibration records, observation of the laboratory and interview with the testing person, the laboratory failed to follow the laboratory's requirements for CBC instrument calibration frequency in 2021 and 2022. The findings include: 1. Review of the laboratory's Calibration/Calibration Verification procedure revealed, "Calibration verification must be performed minimally every 6 months to substantiate the continued accuracy of the monitors throughout the reportable range, after initial validation studies are performed with the setup of the analyzer. Calibration verification is performed every six months, as stated in current -- 2 of 3 -- CLIA and State regulations." 2. Review of the Horiba Micros 60 calibration records revealed calibration was not performed from November 2021 until November 2022, resulting in the laboratory not following their calibration/calibration verification procedure. 3. Observation of the laboratory revealed a Horibas 60 CBC analyzer in use for CBC testing. 4.Interview with testing person on January 9, 2023 at approximately 10:45 am confirmed the above findings. -- 3 of 3 --

Summary Statement of Deficiencies 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 for the Hematology analyzer and upon interview with the Lead Testing Personnel and Laboratory Director determined the laboratory failed to ensure that calibration verification was performed at six month intervals for 2018 and 2019. The findings include: 1. A review of Calibration Verification records for the hematology analyzer revealed no calibration verification 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 -- documented for 2018 and 2019, thus not being performed at 6 months intervals. 2. An interview with the Lead Testing Personnel and Laboratory Director at 2:30 p.m. on February 18, 2020 confirmed no documentation for calibration verifications could be located for the Hematology Analyzer for 2018 and 2019. =================================== D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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 quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: =================================== Based on review of patient CBC (Complete Blood Count) test audit which lacked CBC QC (Quality Control) documentation for 11/5/2018 and 6/26/2018 and patient Progesterone test audit which lacked 2 levels of acceptable QC for 2/6/2020 and interview with the Lead Testing Personnel and Laboratory Director, determined the laboratory failed to perform daily CBC and Progesterone QC prior to patient testing. The findings include: 1. Review of patient CBC test audit revealed no documentation of daily CBC QC being performed 11/5/2018 and 6/26/2018 on the Hematology Horiba-ABX analyzer prior to testing and reporting 2 patient results. 2. Review of patient Progesterone test audit revealed daily QC level 1 to be unacceptable on 2/6/2020 on the Chemistry Access 2 analyzer prior to testing and reporting 25 patient results. 3. Interview at approximately 2:30 p. m. February 18, 2020 with the Lead Testing Personnel and Laboratory Director confirmed the laboratory failed to perform daily CBC QC on 11/5/2018 and 6/26/2018 and 2 levels of acceptable Progesterone QC on 2/6/2020 prior to testing and reporting patient results. =================================== D6021 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 quality assessment programs are 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 Quality Assessment (QA) Plan, lack of Director review of QC and QA for May 2019 through January 2020, and an interview with the Lead Testing Personnel and Laboratory Director, determined the Laboratory Director did not ensure quality of laboratory services was maintained for the 8 month time period per QA plan. The findings include: 1. A review of the QA Plan demonstrated a monthly quality review will be completed by the Laboratory Director to ensure the quality of the laboratory services and identify failures as they occur. 2. There was no documentation of -- 2 of 3 -- Director review for Quality Controls or Qualtiy Assessments for May 2019 through January 2020. 3. An interview with the Lead Testing Personnel and Laboratory Director at approximately 2:30 p.m. February 18, 2020 confirmed there was no documentation of Director review of quality controls or quality assessment records to ensure quality of the laboratory services were maintained for the 8 month time period. =================================== -- 3 of 3 --

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)