Hill Medical Services Llc

Summary Statement of Deficiencies D0000 A Validation survey was performed at Hill Medical Services LLC, CLIA ID 19D2054424, on March 30, 2026. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard deficiencies were cited. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 by surveyor, review of laboratory policy and temperature records as well as interview with personnel, the laboratory failed to monitor temperature and humidity levels on weekend and office closure days from July 2025 through January 2026. Findings: 1. Observation by surveyor during the laboratory tour on March 30, 2026 at 10:10 am revealed the laboratory monitors temperature and humidity for the following: a) upright refrigerator/freezer for storage of chemistry quality control, reagents and calibrators b) room temperature for storage of supplies and chemistry analyzers c) humidity for storage of chemistry analyzers 2. Review of the laboratory policy for General Maintenance revealed "Record temperatures on a daily basis. If temperature is out of the acceptable range, note this on the daily temperature chart then: Check for the source of the problem, Adjust thermostat if necessary, Check temperature later (same day)". 3. In interview on March 30, 2026 at 12:47 pm, the Laboratory Director stated the laboratory does not monitor temperature 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 -- and humidity levels when the laboratory is closed. 4. Review of the laboratory's temperature logs from July 2025 through January 2026 revealed the laboratory did not document temperature and humidity levels for the following days: a) July 4, 2025 b) July 5, 2025 c) July 6, 2025 d) July 12, 2025 e) July 13, 2025 f) July 19, 2025 g) July 20, 2025 h) July 26, 2025 i) July 27, 2025 j) August 2, 2025 k) August 3, 2025 m) August 9, 2025 n) August 10 2025 o) August 16, 2025 p) August 17, 2025 q) August 23, 2025 r) August 24, 2025 s) August 30, 2025 t) August 31, 2025 u) September 1, 2025 v) September 6, 2025 w) September 7, 2025 x) September 13, 2025 y) September 14, 2025 z) September 20, 2025 aa) September 21, 2025 bb) September 27, 2025 cc) September 28, 2025 dd) October 4, 2025 ee) October 5, 2025 ff) October 11, 2025 gg) October 12, 2025 hh) October 18, 2025 ii) October 19, 2025 jj) October 25, 2025 kk) October 26, 2025 ll) November 1, 2025 mm) November 2, 2025 nn) November 8, 2025 oo) November 9, 2025 pp) November 15, 2025 qq) Novemer 16, 2025 rr) November 22, 2025 ss) November 23, 2025 tt) November 27, 2025 uu) November 28, 2025 vv) November 29, 2025 ww) November 30, 2025 xx) December 6, 2025 yy) December 7, 2025 zz) December 13, 2025 aaa) December 14, 2025 bbb) December 20, 2025 ccc) December 21, 2025 ddd) December 24, 2025 eee) December 25, 2025 fff) December 27, 2025 ggg) December 28, 2025 hhh) December 31, 2025 iii) January 1, 2026 jjj) January 3, 2026 kkk) January 4, 2026 lll) January 10, 2026 mmm) January 11, 2026 nnn) January 17, 2026 ooo) January 18, 2026 ppp) January 24, 2026 qqq) January 25, 2026 rrr) January 26, 2026 sss) January 27, 2026 ttt) January 28, 2026 uuu) January 30, 2026 vvv) January 31, 2026 5. In interview on March 30, 2026 at 12:47 pm, the Laboratory Director confirmed the laboratory did not monitor the temperature and humidity levels for the identified days. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (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 by surveyor, review of laboratory policy, calibration verification records and interview with personnel, the laboratory failed to perform calibration verification procedure for Hemoglobin A1C at least every six (6) months for the Tosoh G-8 analyzer in 2025. Findings: 1. Observation by surveyor during the laboratory tour on March 30, 2026 at 10:10 am revealed the laboratory utilizes a Tosoh HPLC G-8 analyzer for Hemoglobin A1C patient testing. 2. Review of the -- 2 of 3 -- laboratory's policy "Linearity and Calibration Verification" revealed "For analyzers and analytes that are not calibrated with a minimum of three calibrators verifying the low, midpoint and high end of the reportable range, a calibration verification must be performed to substantiate the continued accuracy of the monitors throughout the reportable range, after inital validation studies are performed with the setup of the analyzer. Calibration verification is performed every six months". 3. Review of the laboratory's calibration verification records revealed the laboratory did not have documentation of calibration verification for Hemoglobin A1C at least every six (6) months in 2025. 4. In interview on March 30, 2026 at 11:52 am, the Laboratory Director confirmed the calibration verification for Hemoglobin A1C was not performed in 2025. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results; This STANDARD is not met as evidenced by: Based on observation by surveyor, review of laboratory policy and records, and interview with personnel, the Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Findings: 1. The laboratory failed to monitor temperature and humidity levels on weekend and office closure days from July 2025 through January 2026. Refer to D5413. 2. The laboratory failed to perform calibration verification procedure for Hemoglobin A1C at least every six (6) months for the Tosoh G-8 analyzer in 2025. Refer to D5439. -- 3 of 3 --