Amarillo Physicians Clinic

Summary Statement of Deficiencies D0000 A validation survey was performed on February 10-11, 2026 with standard level deficiencies 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 laboratory records and confirmed in interview with the laboratory manager, the laboratory failed to maintain testing personnel (TP) records for at least two years for two of two TP. Findings included: 1. On 02/10/26 at 9:30 am, the laboratory manager confirmed the laboratory performed the following: a. CBC (Complete Blood Count) testing on the Sysmex XN-1000i b. Peripheral blood smears for manual differential testing by laboratory personnel. c. Urine Sediment examination d. Vaginal Wet Prep e. KOH examination 2. Review of the 2025 Hematology First Event PT attestation record dated 03/05/25 revealed the following: a. Testing person #4 (TP #4) - performed the Vaginal Wet Prep and KOH examination challenges (PT sample VA-01 and VKP-01) and Blood Cell ID (Educational) challenges (PT samples ECI-01, ECI-02, ECI-03, ECI-04, ECI-05) b. Testing person #5 (TP #5) performed the Hematology challenges (PT samples XE-01, EX-02, XE-03, XE-04, XE-05) 3. Review of 2025 TP records revealed no evidence of training records or competency assessments for TP#4 and TP#5. a. TP #4 -02/04/25 date of hire; 03/26/2025 last day of employment b. TP #5 - 09/05/2019 date of hire; 08/26/2025 last day of employment 4. In an interview on 2/10/26 at 2:15 pm, the laboratory manager stated TP records could not be located. Word Key: ID - Identification KOH - Potassium Hydroxide PT - Proficiency Test 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 -- D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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: I. Based on review of the laboratory's written procedure manual, record review, and confirmed in an interview with the laboratory manager, the laboratory failed to follow their own competency assessment procedure for one of one testing person (TP). Findings included: 1.The Laboratory Personnel Report (Form CMS-209) signed by the laboratory director on 2/11/26, listed two technical consultants. 2. A review of the laboratory's written procedure manual titled "LABORATORY PROCEDURE MANUAL", under the technical consultant job description, stated, "8. Evaluating competency." 3. Record review of one annual competency assessment revealed testing person #3, not the technical consultant, performed the annual competency assessment for testing person #1 (TP#1). 4. In an interview on 2/10/26 at 2:10 pm, the laboratory manager confirmed the findings above. II. Based on review of the laboratory's procedure manual, laboratory records, and confirmed in an interview with the laboratory manager, the laboratory failed to follow a hematology calculation verification procedure for one of one year. Findings included: 1.On 02/10/26 at 9:30 am, the laboratory manager confirmed the laboratory performed CBC (Complete Blood Count) testing on the Sysmex XN-1000i. 2. Review of the laboratory's written procedure manual titled "LABORATORY PROCEDURE MANUAL", under "SUBJECT: QUALITY CONTROL PROCEDURE", section "CALCULATION VERIFICATION" stated, "The parameters HCT, MCH, and MCHC are obtained from the XN 1000 instrument by calculation. The calculation of these parameters on the XN 1000 must be verified twice a year." 3. Review of quality control records from January 2025 through December 2025 revealed no evidence of a calculation verification every six months performed by the laboratory. 4. In an Interview on 2/10 /26 at 1:25 pm, the laboratory manager confirmed the findings above. Word Key: HCT - Hematocrit MCH - Mean Corpuscular Hemoglobin MCHC - Mean Corpuscular Hemoglobin Concentration III. Based on review of the laboratory's written procedure manual, patient test reports, and confirmed in interview with the laboratory manager and testing person #2 (TP #2), the laboratory failed to follow its own hematology procedure for nine of 16 patients. Findings included: 1.On 02/10/26 at 9:30 am, the laboratory manager confirmed the laboratory performed CBC (Complete Blood Count) testing on the Sysmex XN-1000i and also performed manual differential testing. 2. Review of the laboratory's written procedure manual titled "LABORATORY PROCEDURE MANUAL", under "SUBJECT: CBC REVIEW PROCEDURE", stated the following: a. "ATYPICAL LYMPHO" - "Perform a manual differential. Report out manual differential" b. "BLASTS/ABN LYMPHO?" - "Perform a manual differential. If immature WBCs are seen, send smear out. If no immature cells are seen, report out manual Differential". c. "PLT ABN DISTRIBUTION" - "Perform a peripheral smear and review platelets. Check for platelet clumps. Comment: "Platelet clumps seen" or "No platelet clumps seen"" d. "RBC AGGLUTINATION" - "Perform a peripheral smear. If rouleaux is seen, prewarm and repeat CBC" e. "TURBIDITY/HGB INTERF?"- "Check plasma for turbidity. If present report comments: "Lipemia present, Hgb results may be affected". 3. Review of patient reports revealed the laboratory failed to follow its procedure for 9 -- 2 of 5 -- of 16 patients as follows: a. ATYPICAL LYMPHO FLAG Patient ID: 1275752 - Reported on 12/04/25 - no manual differential performed Patient ID: 1280619 - Reported on 12/29/25 - no manual differential performed Patient ID: 1280653 - Reported on 12/29/25 - no manual differential performed b. BLASTS/ABN LYMPHO FLAG Patient ID: 1274806 - Reported on 12/02/25 - no manual differential performed Patient ID: 1276616 - Reported on 12/08/25 - no manual differential performed Patient ID: 1277211 - Reported on 12/10/25 - no manual differential performed c. PLT ABN DISTRIBUTION FLAG Patient ID: 1281168 - Reported on 12/30/25 - comment documented was "OCC large plts". This comment was not an acceptable comment associated with this flag. d. RBC AGGLUTINATION FLAG Patient ID: 1281040 - Reported on 12/30/25 - comment documented "Some RBC agglutination seen". No evidence of the prewarm and repeat of the CBC. e. TURBIDITY/HGB INTERF? FLAG Patient ID: 1281040 - Reported on 12/30/25 - comment documented "Noted" Patient ID: 1279655 - Reported on 12/22/25 - comment documented "Noted" 4. In an interview on 2/11/26 at 9:40 am, TP #2 confirmed the laboratory failed to follow its written procedure for flagged specimens. TP#2 stated the laboratory performed peripheral blood smears not manual differentials as required. Word Key: ABN - Abnormal HGB - Hemoglobin INTERF - Interference LYMPHO - Lymphocyte PLT - Platelet RBC - Red Blood Cells WBC - White Blood Cells D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)