Cajah's Mountain Medical Associates

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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D on 7/30/25 and desk review of 2024 and 2025 API (American Proficiency Institute) proficiency testing results 9/3/25, the laboratory failed to achieve satisfactory performance for Hematocrit on 2 consecutive test events, resulting in unsuccessful participation in proficiency testing. Findings: See the deficiency cited at 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 -- (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 desk review of CMS Casper reports 153D and 155D on 7/30/25 and desk review of 2024 and 2025 API proficiency testing results 9/3/25, the laboratory failed to achieve satisfactory performance for Hematocrit on 2 consecutive testing events, resulting in unsuccessful performance. Findings: 1. Desk review of CMS Casper reports 153D and 155D and 2024 API proficiency testing results revealed the laboratory received a score of 60% for Hematocrit on the 2024 Hematology /Coagulation 3rd Event. 2. Desk review of CMS Casper reports 153D and 155D and 2025 API proficiency testing results revealed the laboratory received a score of 40% for Hematocrit on the 2025 Hematology/Coagulation 1st Event. 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 desk review of CMS Casper reports 153D and 155D on 7/30/25 and desk review of 2024 and 2025 API proficiency testing results 9/3/25, the laboratory director failed to provide overall management and direction to ensure successful proficiency testing participation. Findings: See the deficiency cited at 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 CMS Casper reports 153D and 155D on 7/30/25 and desk review of 2024 and 2025 API proficiency testing results 9/3/25, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Findings: See the deficiency cited at D2130. -- 2 of 2 --

Summary Statement of Deficiencies D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) (b) The laboratory must verify the accuracy of the following: (b)(1) Any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of 2024 American Proficiency Institute (API) proficiency testing (PT) records, lack of documentation, and interview with testing personnel (TP) #1, 07 /24/25, the laboratory failed to review "Not Graded" PT results to determine if the laboratory PT results met the consensus of the participant summary results. Findings: Review of 2024 API PT Hematology/Coagulation - 2nd event revealed the laboratory received a "Not Graded" result for PT sample #VA-02. There PT records failed to include documentation of the review of the "Not Graded" PT result. Interview with TP #1 at approximately 12:30 p.m. confirmed the laboratory did not review the "Not Graded" PT result. D5807 TEST REPORT CFR(s): 493.1291(d) (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 review of 2025 DXH520 hematology analyzer reports and corresponding electronic medical record reports, review of the DXH520 validation records, and interview with testing personnel (TP), the laboratory failed to provide appropriate 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 -- reference ranges to the ordering provider. Findings: 1. Review of 2025 patient test reports revealed reference range discrepancies between the DXH520 hematology analyzer printout and the electronic health record hematology report. Examples: Specimen 133297278, 82 year old female: Red Blood Cell (RBC) reported as 4.15 x 10^12 per Liter (L) DXH520 analyzer RBC reference range = 3.72 - 4.93 x 10 ^6 per microliter (uL) Electronic Medical Record RBC reference range = 3.72 - 5.24 x 10^12 per Liter (L) Hemoglobin (HGB) reported as 12.1 grams per deciliter (g/dl) DXH520 analyzer HGB reference range = 11.50 - 15.00 g/dl Electronic Medical Record HGB reference range = 10.8 - 15.5 g/dl Specimen 133296803, 74 year old male: Red Blood Cell (RBC) reported as 4.05 x 10^12 per Liter (L) DXH520 analyzer RBC reference range = 4.16 - 5.83 x 10 ^6 per microliter (uL) Electronic Medical Record RBC reference range = 3.95 - 5.72 x 10^12 per Liter (L) Hemoglobin (HGB) reported as 12.6 grams per deciliter (g/dl) DXH520 analyzer HGB reference range = 13.00 - 17.40 g/dl Electronic Medical Record report contains a HGB reference range = 12.1 - 17.4 g/dl Specimen 133234833, 13 year old male: Red Blood Cell (RBC) reported as 4.78 x 10^12 per Liter (L) DXH520 analyzer RBC reference range = 3.70 - 5.48 x 10 ^6 per microliter (uL) Electronic Medical Record RBC reference range = 4.50 - 5.30 x 10^12 per Liter (L) Hemoglobin (HGB) reported as 14.9 grams per deciliter (g/dl) DXH520 analyzer HGB reference range = 10.60 - 15.40 g/dl Electronic Medical Record HGB reference range = 13.0 - 16.0 g/dl 2. Review of the DXH520 hematology analyzer's validation records revealed the analyzer's current age and sex specific reference ranges were adopted during the analyzers initial validation. During an interview at approximately 11:45 a.m., TP#1 verified that providers review patient results in the electronic medical record. TP#1 also verified that reference ranges were not part of the chart review process for quality assessment. -- 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 upon review of 2022 and 2023 calibration verification records and review of the laboratory's policies and procedures, the laboratory failed to perform calibration verification activities that included a minimal value near the lower limit of the laboratory's reportable range for 5 of 18 analytes performed on the Alfa-Wasserman instrument. Findings: Review of the November 2023 calibration verification records revealed the following: 1. Five concentrations of linearity materials were used to 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 -- assess the reportable range of Total Protein: 2.23, 4.70, 7.18, 9.65 and 12.13 g/dL. 2. Five concentrations of linearity materials were used to assess the reportable range of Sodium: 78.63, 109.2, 139.76, 170.33 and 200.9 mmol/L. 3. Four concentrations of linearity materials were used to assess the reportable range of Chloride: 68.3, 108.4, 148.5 and 188.6 mmol/L. 4. Five concentrations of linearity materials were used to assess the reportable range of Calcium: 1.76, 5.11, 8.46, 11.81 and 15.16 mg/dL. 5. Five concentrations of linearity materials were used to assess the reportable range of Albumin: 1.7, 3.26, 4.83, 6.4 and 7.96 g/dL. Review of the laboratory's procedure manual revealed an "ACE Axcel Reportable Range" chart. The laboratory utilizes the manufacturer's ranges as their reportable ranges. The following ranges were observed on the chart: 1. The reportable range for Total Protein is 0.4-14.0 g/dL 2. The reportable range for Sodium is 40-205 mmol/L 3. The reportable range for Chloride is 5-200 mmol/L 4. The reportable range for Calcium is 0.4-15 mg/dL 5. The reportable range for Albumin is 0.3-7 g/dL D5783