Dr V M Baich Pa

Summary Statement of Deficiencies D0000 The Dr V M Baich PA laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the proficiency testing desk review survey performed on June 5, 2026. The following condition-level deficiency was cited: 493.803 Successful Participation The following standard-level deficiency was cited: 493.851 Hematology . 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 (PT) records from the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report and American 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 -- Proficiency Institute (API) from 2025 and 2026, the laboratory failed to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the Specialty of Hematology for the analyte Red Blood Cells. 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 review of proficiency testing (PT) reports from CASPER and API, the laboratory failed to achieve successful PT performance (80% or better) for Red Blood Cells (RBC) testing under the specialty of Hematology in two of three consecutive PT events in 2025 and 2026. Findings include: 1. Review of the CMS CASPER 0155D report revealed the following results: Hematology 2025 3rd Event: The laboratory received an unsatisfactory score of 60% for RBC. Hematology 2026 1st Event: The laboratory received an unsatisfactory score of 40% for RBC. 2. Review of API 2025 Hematology / Coagulation - 3rd Event and 2026 Hematology / Coagulation - 1st Event Comparative Evaluation reports confirmed the laboratory received the above results. . -- 2 of 2 --

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 observation, document review and interview with laboratory personnel, the laboratory failed to perform calibration verification on a hematology analyzer at least once every 6 months. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory on 01/08/20, at 1:05 p.m. 2. A Cell-Dyn Emerald hematology analyzer was observed as present and available for use during the tour. 3. The laboratory did not 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 -- perform calibration verification activities during the time period reviewed, 2/8/18 through 1/8/20. 4. The laboratory was unable to provide calibration verification records for this time period upon request. 5. In an interview on 01/08/20, at 2:30 p.m., TP1 confirmed the above findings *This is a repeat finding from each of the 10/25 /2015 and 02/08/18 surveys* . -- 2 of 2 --

Summary Statement of Deficiencies 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 document review and interview with laboratory personnel, the laboratory failed to evaluate unacceptable proficiency testing (PT) results. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory on 02/02/18 at 9:00 a.m. 2. The laboratory performed PT using the American Proficiency Institute (API) proficiency provider. 3. The laboratory received unacceptable PT results from API for the events and analytes listed below. Event/Analyte ID Lab API 2016 3rd event PLT* HEM-03 54 55-92 2017 2nd event MCV* HEM-06 83.9 84.6-91.5 HEM-07 87.1 87.4-94.0 HEM-08 91.6 91.9-99.0 HEM-09 87.3 87.9-94.8 4. PT records indicated a calibration verification would be performed to evaluate the unacceptable PT result from 2016. Calibration verification records from 2016 were not found. The laboratory was unable to provide calibration verification records from 2016 upon request. 5. An evaluation of the unacceptable PT results from 2017 was not found during review of laboratory records. The laboratory was unable to provide evaluations upon request. 6. In an interview on 02/02/18 at 10:30 a.m., TP1 confirmed the above finding. * Note PLT - Platelets MCV - Mean Corpuscular Volume 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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)