Family Health Center Of Ozona

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on June 11, 2025, 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: Laboratory Director, moderate complexity 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the laboratory's College of American Pathologists (CAP) proficiency testing (PT) reports, the laboratory failed 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 -- achieve satisfactory performance in two consecutive events in 2025 for the analyte of hematocrit (HCT) (refer to D2130) resulting in an initial unsuccessful performance. 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 the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and College of American Pathologists (CAP) proficiency testing (PT) reports, the laboratory failed to achieve satisfactory performance in two consecutive testing events in 2025 for the analyte of hematocrit (HCT) resulting in an initial unsuccessful performance. The findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile report, the laboratory received the following unsatisfactory scores for HCT in two consecutive testing events: 2025 CAP 1st event 20% 2025 CAP 2nd event 40% 2. Based on review of the laboratory's College of American Pathologists (CAP) proficiency testing reports, the laboratory received the following unsatisfactory scoares for hematocrit in two consecutive events: 2025 CAP 1st event 20% 2025 CAP 2nd event 40% 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 the laboratory's College of American Pathologists (CAP) proficiency testing reports, the laboratory director failed to provide overall management and direction of laboratory services when the laboratory failed the analyte of hematocrit for the 1st and 2nd testing events in 2025. Refer to 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 a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the laboratory's College of American Pathologists (CAP) proficiency testing reports, the laboratory director failed -- 2 of 3 -- to ensure successful participation in an HHS approved proficiency testing program for the analyte of hematocrit (HCT) (refer to D2130) for two consecutive events in 2025, resulting in an initial unsuccessful performance. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. Standard level deficiencies were cited. 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)

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. 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 observation, review of manufacturer's instructions, and interview, the laboratory failed to store Bio-Rad Liquichek Diabetes Control material in a non frost- free freezer for one of one freezer. Findings follow. A. During a tour of the laboratory on February 14, 2023, at 1450 hours, the surveyor observed Bio-Rad Liquichek Diabetes Controls in a Frigidaire frost-free freezer: 1. One unopened box of each Lot 55771 and 55772, 6 x 1 mL, 2. One opened box of each Lot 55771 and 55772, 3 x 1 mL. B. Review of the package insert for the Bio-Rad Liquichek Diabetes Control, 07 /2022 5250-00, under Storage and Stability stated, "This product will be stable until the expiration date when stored unopened at -10 to -70 degrees Celsius. Thawed Unopened: When thawed and stored unopened at 2 to 8 degrees Celsius, this product will be stable as follows: - All analytes: 6 months Make a note of the date when storage at 2 to 8 degrees Celsius begins. Do not use past expiration date. Thawed Opened: Once thawed, opened, and stored tightly capped at 2 to 8 degrees Celsius, this product will be stable as follows: - All analytes: 14 days Once thawed, do 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 4 -- refreeze this product. Discard the remaining material. This product is shipped under frozen conditions." C. Interview with Technical Consultant #2, as listed on the CMS form 209, on February 15, 2023, at 1330 hours in the laboratory confirmed the freezer was a frost-free freezer, and agreed, the freezer goes through freeze thaw cycles to prevent ice buildup. 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 manufacturer's instructions, calibration verification, and interview, the laboratory failed to assess failures in linearity using the Roche Cobas Integra 400 Plus analyzer for two of two events reviewed. Findings follow. A. Review of the Maine Standards Validate GC1 Calibration Verification/Linearity Test Kit, 05- 000211-07/05-200585-00, under Calculation of Results stated, "After theoretical values are calculated, for each analyte plot the expected (Theoretical) value or the x- axis versus the Recovered value on the y-axis using standard linear graph paper. If the system is linear, the plot should approximate a straight line. The point at which the line is no longer straight can be used to determine the limit of linearity or the reportable range. Data reduction is available from LGC Maine Standards. Commercially available linear regression software may also be used. The software should provide data point display and x-y graphical presentation. Linear regression should be interpreted using standard statistical analysis and the results should be compared with the instrument manufacturer's claims for linearity or with individual laboratory performance requirements. The degree of acceptable nonlinearity is an individual judgement based on methodology, clinical significance and medical decision levels of the test analyte." B. Review of calibration verification reports from August 2022 showed 6 out of 22 failures in linearity: Date Analyte Vial % diff % Limit 1. 08/19/22 Na 5 2.0 1.6 2. 08/19/22 Cl 2 2.8 2.5 3. 08/19/22 Ca 4 5.2 4.2 5 6.0 4.2 4. 08/19/22 Crea 4 11.3 7.5 5 13.1 7.5 5. 08/19/22 Alb 5 9.2 5 6. 08/19/22 TP 5 6.2 5 Review of calibration verification reports from February 2022 showed 4 out of 22 failures in linearity: Date Analyte Vial % diff % Limit 1. 02/10/22 Cl 5 2.8 2.5 2. 02/10/22 Crea 4 10.2 7.5 5 11.5 7.5 3. 02/10/22 Alb 5 6.5 5 4. 02/10/22 TP 5 6.0 5 C. Interview with the Laboratory Director acknowledged after speaking with technical support for the product, that failures should be evaluated based on the allowable error, peer data, clinical significance, or trends in quality control. KEY: Na = Sodium Cl = Chloride Ca = Calcium Crea = Creatinine Alb = Albumin TP = Total Protein D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) -- 2 of 4 -- 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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of reference materials and interview, the laboratory failed to provide photomicrographs of sediment for performing microscopic urinalysis for two of two years reviewed. Findings follow. A. Photomicrographs for urine sediment were requested on February 15, 2023, at 1520 hours but not provided. B. Interview with Technical Consultant #2, as listed on the CMS form 209, on February 15, 2023, at 1520 hours acknowledged she used google to search for unknown sediment and did not have reference material in the laboratory. D5783

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative at the entrance and exit conferences. The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the