Ballinger Memorial Hospital/Laboratory

Summary Statement of Deficiencies D0000 An onsite recertification survey conducted March 25 & 26, 2025, found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. . D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: A. Based on review of the Vidas 3 instrument operator's manual, laboratory maintenance logs, and interview with laboratory personnel, the laboratory failed to perform and document required monthly maintenance for 12 of 12 months in 2024 for the Vidas 3 analyzer. The findings included: 1. Based on review of the Vidas 3 operator's manual (PRN 052733 - Rev.01.A), on pages 3.2 and 3.3, the manual describes a monthly maintenance procedure for cleaning the SPR Blocks. 2. Based on review of maintenance records for 2024, there were no records of the laboratory performing the monthly SPR cleaning maintenance. 3. In an interview at 09:19 hours on March 26, 2025, the Laboratory Manager stated the laboratory cleaned the SPR blocks as necessary but did not realize the cleaning was monthly requirement. B. A. Based on review of the Siemens Dimension EXL instrument operator's manual, laboratory maintenance logs, and interview with laboratory personnel, the laboratory failed to perform and document required monthly maintenance for four of four months between September through December in 2024 for the Siemens Dimension chemistry analyzer. The findings included: 1. Based on review of the Siemens Dimension EXL operator's manual, on pages 5-8 through 5-20, the manual describes required monthly maintenance procedures including: Cleaning the Clot Check Drain on the IMT Port Replacing IMT Pump Tubing Cleaning the IMT System Replacing Instrument Air filters Styletting HM Wash Probes Replacing HM Pump Heads on the wash station Cleaning the R1, R2, and R3 (if RMS Equipped) Drains. 2. Based on a review of 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 -- maintenance records from September 2024 to December 2024, the laboratory did not document required monthly maintenance procedures for four of four months. 3. In an interview at 11:47 hours on March 26, 2025, the Laboratory Manager confirmed the findings. D5783

Summary Statement of Deficiencies D0000 An onsite survey conducted February 13, 2023 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of 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 proficiency testing records and interview with facility personnel, the laboratory failed to evaluate ungraded scores for two of two events in 2022 for the assay cholinesterase. The findings included: 1. Based on review of American Proficiency Institute (API) performance evaluations for the first and second events of 2022, the instructions stated "Laboratories should review the Performance Summary and Comparative Evaluation thoroughly for failures or 'not graded' analytes. Laboratories are responsible for documenting and performing

Summary Statement of Deficiencies D2098 ENDOCRINOLOGY CFR(s): 493.843(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a review of the laboratory's American Proficiency Institute (API) endocrinology proficiency testing results and interview of facility personnel found that the laboratory failed to attain a satisfactory score for the analyte of TSH (thyroid stimulating hormone) in the 2018 1st testing event. The findings included: 1. A review of the laboratory's API proficiency testing results from the 1st Chemistry testing event of 2018 found that the facility failed to attain a satisfactory score. The laboratory submitted unacceptable responses for 4 of 5 specimens resulting an unsatisfactory score of 20% for TSH. Further review of the laboratory's