Tyler Internal Medicine Associates Pa

Summary Statement of Deficiencies D0000 The laboratory was found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, CLIA requirements for laboratories as a result of an recertification survey completed on July 27, 2026 and recertification is recommended. Standard level deficiencies were cited. 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. In addition, retain the following: This STANDARD is not met as evidenced by: Based on review of calibration instructions for use, calibration records, and interview, the laboratory failed to ensure the retention of manufacturers' assay information sheets for the Tosoh Bioscience G8 Hemoglobin A1c calibrators for records requested 7/27 /2026. The findings included: 1. Review of the laboratory instructions for the "Hemoglobin A1c Calibrator Set" included the following assigned values for calibrator assigned values and acceptability criteria: "Lot No ZS4001, Exp 9/2/2026 Calibrator 1: 5.94% Calibrator 2: 10.71% ... Calibrator (1) will be automatically measured three times and Calibrator (2) will be automatically measured two times to calculate calibration coefficients "a" and "b". This will, in turn, calibrate subsequent samples using those calibration coefficients. Note that Calibration will have to be performed again if the following results are produced. - Difference between the 2nd and 3rd s-A1c (%) values exceeds 0.3%. - Difference between the 4th and 5th s-A1c (%) values exceeds 0.3%. - Any of the four calibrator results differ from its assigned value by 30 % or more." 2. Review of laboratory calibration records for hemoglobin A1C for the Tosoh Bioscience G8 analyzer failed to include the lot number and expiration date of the calibrator set being utilized on the analytical printout records 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 -- from the analyzer. Surveyor asked for the mechanisms that the laboratory used to track the calibration lot acceptability, when they weren't on the analytical data, and none could be provided Surveyor asked for the Hemoglobin A1C Calibration assay sheets for previous lots, and none could be provided. 3. In an interview on 7/27/2026 at 15:53 hours, in the conference room, technical consultant 1 confirmed the laboratory did not retain the Hemoglobin A1C Calibration assay sheets, that included the calibration acceptability, for the Tosho Bioscience G8 Hemoglobin A1C analyzer. 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. This STANDARD is not met as evidenced by: I. Based on review of laboratory policy, Bio-Rad instructions for use for chemistry quality control (QC), laboratory quality control records, and interview, the laboratory failed to have a mechanism in place to ensure the detection of immediate errors as they occur in QC for NT-ProBNP testing during one of one lot rollover reviewed in July 2026. The findings included: 1. Review of the laboratory policy titled "New Lot Quality Control - Chemistry", section II "Procedure" included the following instructions: ".. 2. Enter the mean and standard deviation (SD) for the associated assays for that lot of QC from the manufacturer's insert." 2. Based on review the "Bio- Rad Liquichek Cardiac Markers Plus Control LT" instructions for use, section "Assignment of Values" stated the following: "The mean values and corresponding +/- 3SD ranges in the Assignment of Values Data Chart were derived from replicate analyses and are specific for this lot of product." 3. Review of NT-proBNP QC lot rollover, started 6/29/2026, included the following QC acceptable ranges from the assayed QC sheets, and the laboratory acceptable ranges used for daily acceptability: Lot 10030150, EXP 12/31/2028 QC Level, mean, [2SD] Level 1, 45.6 pg/mL, [36.6 - 54.6 pg/mL] Level 3, 2270 pg/mL, [1936.6 - 2603.3 pg/mL] Verses in laboratory acceptability: QC level, mean [2SD] Level 1, 45.6 pg/mL, [32.1 - 59.1 pg/mL] Level 2, 2270 pg/mL, [1770.0 - 2770.0 pg/mL] Surveyor asked for an explanation of how the 2SD laboratory acceptability was larger than the 3SD acceptability from the assayed control sheet, and the TC stated they didn't realize the acceptable range listed in the manufacturer's instructions were 3SD ranges and not 2SD ranges. 4. Review of laboratory daily NT-ProBNP QC from 6/29/2026 through 7/28/2026 included the following 5 days where QC was outside of the assayed 2 SD acceptability and not detected: 7/17/2026 Level 3, 1932.0 pg/mL 7/20/2026 Level 1, 31.8 pg/mL Level 3, 1823.0 pg/mL 7/21/2026 Level 1, 34.9 pg/mL Level 3, 1927.0 pg/mL 7/22/2026 Level 1, 32.9 pg/mL Level 3, 1873.0 pg/mL 7/23/2026 Level 1, 32.1 pg/mL Level 3, 1864.0 pg/mL 5. In an interview on 7/28/2026 at 10:12 hours in the conference room, after the review of records, the technical consultant (TC) confirmed the laboratory acceptability range exceeded the assayed 2SD acceptability range, and was unable to detect errors as they occurred. Key: pg/mL: picograms per milliliter NT-ProBNP: N -- 2 of 3 -- terminal Pro Brain Natriuretic Peptide II. Based on review of laboratory policy, laboratory quality control instructions for use, laboratory QC records, and confirmed in interview, the laboratory failed to ensure a mechanism was in place for the detection of errors as they occur in daily QC for eight of eight chemistry analytes reviewed in October 2025 and April 2026. The findings included: 1. Review of the laboratory policy titled "New Lot Quality Control - Chemistry", section II "Procedure" included the following instructions: ".. 2. Enter the mean and standard deviation (SD) for the associated assays for that lot of QC from the manufacturer's insert." 2. Review the "Bio-Rad Liquid Assayed Multiqual" and "Lyphochek Immunoassay Plus Control" instructions for use, section "Assignment of Values" stated the following: "The mean values and corresponding +/- 3SD ranges in the Assignment of Values Data Chart were derived from replicate analyses and are specific for this lot of product." 3. Review of laboratory quality control acceptability for use in daily testing, and assay acceptability ranges included the following eight analytes with a laboratory 2SD acceptability the same, or wider, than the manufacturer's 3SD acceptability range, for records reviewed in October 2025 and April 2026: Bio-Rad Multiqual, Lot 46023, EXP 5/31/2027, put into use March 2025 Calcium: Laboratory 2SD acceptability, [IFU Assayed 3SD acceptability] Level 1: 5.18 - 6.19 mg/dL, [5.18 - 6.19 mg/dL] Level 3: 12 - 13.7 mg/dL, [12.0 - 13.7 mg/dL] CK: Laboratory 2SD acceptability, [IFU Assayed 3SD acceptability] Level 1: 55 - 87 U/L, [54.6 - 86.9 U/L] Level 3: 355 - 496 U/L, [355 - 496 U/L] Chloride: Laboratory 2SD acceptability, [IFU Assayed 3SD acceptability] Level 1: 73 - 84 mEq/L, [72.8 - 83.7 mEq/L] Level 3: 114 - 136 mEq/L, [114 - 136 mEq/L] CO2: Laboratory 2SD acceptability, [IFU Assayed 3SD acceptability] Level 1: 9 - 18 mEq/L, [9.22 - 18.3 mEq/L] Level 3: 18 - 30 mEq/L, [17.6 - 29.8 mEq/L] Lyphocheck Immunoassay Plus Control, Lot 40460, EXP 5/31/2027, put into use July 2025. Ferritin: Laboratory 2SD acceptability, [IFU Assayed 3SD acceptability] Level 1: 42.7-68.2 ng/mL, [42.7 - 68.2 ng/mL] Level 3: 271.0 - 412.0 ng/mL, [271 - 412 ng/mL] PSA: Laboratory 2SD acceptability, [IFU Assayed 3SD acceptability] Level 1: 0.66 - .098 ng/mL, [0.656 - 0.982 ng/mL] Level 3: 9.35 - 13.7 ng/mL, [9.35 - 13.7 ng/mL] TSH: Laboratory 2SD acceptability, IFU [Assayed 3SD acceptability] Level 1: 0.142 - 0.362 mIU/mL, [0.142 - 0.362 mIU/mL] Level 3: 24.5 - 34.10 mIU/mL, [24.5 - 34.1 mIU/mL] Estradiol: Laboratory 2SD acceptability, [IFU Assayed 3SD acceptability] Level 1: 33.8 - 142.0 pg/mL, [33.8 - 142 pg/mL] Level 3: 483.0 - 959.0 pg/mL, [483 - 959 pg /mL] Surveyor asked why the 2SD laboratory acceptability was the same as, or larger than, the 3SD acceptability from the assayed control sheet. The TC stated they didn't realize the acceptable range listed in the manufacturer's instructions were 3SD ranges and not 2SD ranges. 4. In an interview on 7/28/2026 at 10:12 hours in the conference room, after the review of records, the technical consultant (TC) confirmed the laboratory acceptable 2SD range was equal to, or exceeded the manufacturers assayed 3SD acceptability range, and was unable to detect errors as they occurred. Key: CO2 - carbon dioxide CK - creatine kinase PSA - prostate specific antigen TSH - thyroid stimulating hormone mEq/L - milliequivalents per liter mg/dL - milligrams per deciliter mIU/mL - micro International Units per milliliter ng/mL - nanograms per milliliter pg/mL - picograms per milliliter U/L - units per liter -- 3 of 3 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on June 1, 2026, 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: 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 (CASPER) Report 155 Individual Laboratory Profile, and American Proficiency Institute (API) proficiency testing records, the laboratory failed to achieve successful 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 -- performance in two out of three consecutive testing events from the 2nd event 2025 through the 1st event 2026, resulting in unsuccessful performance. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) 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 Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, American Proficiency Institute (API) proficiency testing records from 2025 and 2026, the laboratory failed to achieve an overall testing event score of satisfactory performance (80% or greater) for two out of three testing events for White Blood Cell (WBC) differential testing. 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 listed the following scores for the PT Program WBC Differential testing: Specialty /Analyte - Event - Score WBC Differential - 2025 Event 2, 0% WBC Differential - 2026 Event 1, 56% 2. A desk review of American Proficiency Institute (API) proficiency testing records confirmed that the laboratory received the above scores. 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) Report 155 Individual Laboratory Profile, and American Proficiency Institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for white blood cell (WBC) differential testing in for two out of three testing events from the 2nd event 2025 through the 1st event 2026. 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 a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, and American Proficiency Institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in a HHS approved proficiency testing program white blood cell (WBC) differential testing for two of three testing events from the 2nd event 2025 through the 1st event 2026. Refer to D2130. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An onsite survey conducted from 08/24/2022 to 8/25/2022 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 laboratory policy, reagent instructions for use, laboratory documents, and confirmed in interview, the laboratory failed to perform calibration verification, as described by the laboratory policy, for one out of six reagents, Vitamin D, reviewed meeting the designated criteria in 2021. The findings include: 1. Review of the laboratory policy titled "Laboratory Procedure Quality Control Program", section D. Calibration Verification stated: "Calibration verification is required for most tests that do not use at least (3) levels of calibration materials that challenge the limits of linearity for the test or test system." 2. Review of the Vitamin D instructions for use, section "Calibrator Contents" listed the following 2 calibrators: "1 Set of VITROS 25-OH Vitamin D Total calibrators 1 and 2". Surveyor queried on 8/24/2022 at 1435 hours for the calibration verification records for 2021 for Vitamin D and none was provided. 3. Review of the laboratory monthly usage total report from 8/1/2021 to 8/1/2022 listed the total volume of Vitamin D tests performed at 9,121. 4. In an interview on 8/24/2022 at 14:45 hours, in the conference room, the technical consultant confirmed that Vitamin-D calibration only had two levels and that calibration verification had not been performed on Vitamin-D as per the laboratory policy for 2021. 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 -- 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)

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 of American Proficiency Institute (API) proficiency testing documentation for 2017 and 2018, confirmed by staff interview, the laboratory director failed to attest that proficiency testing was performed by routine integration of samples into the patient workload using the laboratory's routine methods or to delegate that attestation to an individual meeting the education requirements of a technical consultant for moderate complexity testing. 1. API proficiency testing documentation was reviewed. Examination of attestation forms revealed that the following were signed by testing person 1 (CMS form 209) as the laboratory director's designee: 2017 1st event--Chemistry, core 2017 1st, 2nd, 3rd events--Hematology 2017 2nd, 3rd events--Microbiology 2017 1st, 2nd, 3rd events--Immunology 2018 1st, 2nd events--Chemistry, miscellaneous 2018 1st, 2nd, 3rd events--Chemistry, core 2018 1st, 2nd events--Hematology 2018 1st, 2nd, 3rd events--Microbiology 2018 1st, 2nd events--Immunology 2. Review of laboratory employee education and training documentation revealed that testing person 1 held an associate's degree in medical laboratory technology and did not meet the educational requirements of a technical consultant for moderate complexity testing according to 42 CFR 493.1409. 3. In an interview at the site on 11-08-2018, testing person 1 stated she was not aware of the requirements regarding delegation of signatory authority for proficiency testing attestation forms. . D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) 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 -- Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: . Based on review of performance validation documentation for the Vitros 5600 chemistry analyzer, confirmed by staff interview, the laboratory failed to verify that reference ranges for chemistry testing were appropriate for the patient population served. Findings: 1. Validation studies for the Vitros 5600 chemistry analyzer, put in service in August 2017, were reviewed. No documentation of studies for the verification of reference ranges was found. 2. In an interview at the site on 11-08- 2018, testing person 1 stated that the reference ranges in use had been established previously using a different platform and to her knowledge no validation data had been analyzed to verify the appropriateness of the ranges using the Vitros analyzer. . D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: . Based on review of laboratory testing personnel competency verification documentation for 2017 and 2018, confirmed by staff interview, the laboratory director failed to delegate the responsibility to verify the competency of testing personnel to a qualified technical consultant. Findings: 1. Competency verification documentation was reviewed. Examination of the Laboratory Competency Assessment Checklists for testing personnel revealed that the forms were signed by "evaluators" as follows: Testing person 1-2018 annual--signed by testing person 2 Testing person 2-2017 and 2018 annual--signed by testing person 1 Testing person 3- 2017 6-month--signed by testing person 1 Testing person 4-2017 annual--signed by testing person 1 Testing person 5-2018 annual--signed by testing person 1 2. Review of laboratory employee education and training documentation revealed that testing person 1 held an associate's degree in medical laboratory technology and did not meet the educational requirements of a technical consultant for moderate complexity testing according to 42 CFR 493.1409. 3. In an interview at the site on 11-08-2018, testing person 1 stated she was unaware of the of the requirements regarding delegation of authority for testing personnel competency verification. . -- 2 of 2 --