Hegg Health Center

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of the Siemens DCA Vantage performance specification records and confirmed by interview with General Supervisor (GS) #1 at 10:15 am on 06/18/2025, the laboratory failed to verify the performance specifications of precision and reportable range prior to testing and reporting patient specimens for the analytes, urine microalbumin and urine creatinine. The findings include: 1. The laboratory installed a new Siemens DCA Vantage instrument and began using it to perform patient urine microalbumin and urine creatinine testing in March 2024. 2. Review of the performance specification verification records for the Siemens DCA Vantage did not include the precision and reportable range for the analytes, urine microalbumin and urine creatinine. 3. At the time of the survey, GS #1 confirmed the laboratory failed to have documentation of performance specification verification records for precision and reportable range for urine microalbumin and urine creatinine testing performed on the Siemens DCA Vantage. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: A. Based on review of chemistry quality control (QC) records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 11:00 am on 3/30/23, the laboratory failed to retain the manufacturer's quality control package inserts for all lot numbers of quality controls used prior to the current lot numbers: qc level 1 lot number 45931, expiration date 7/31/24 and qc level 3 lot number 45933, expiration date 7/31/24. B. Based on review of bacteriology quality control (QC) records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 9:30 am on 3/30/23, the laboratory failed to retain weekly susceptibility quality control records for 11 out of 11 weeks from 9/5/2022 - 11/14/2022 for lot number 2411998503, expiration date 5/17 /23 of gram negative Vitek cards. The laboratory had a power failure that caused the Vitek computer to loose weekly QC susceptibility records from 9/5/2022 - 11/14 /2022. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 on review of the Vitros 5600 chemistry analyzer calibration verification records and confirmed by laboratory personnel identifier #2 (refer to Laboratory Personnel Report) at approximately 10:45 am on 06/22/2021, the laboratory failed to perform calibration verification for the analytes, vitamin D and total iron binding capacity (TIBC), every six months for two out of two time periods from 02/19/2020 through 06 /22/2021. The findings include: 1. Records revealed that laboratory performed 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 -- calibration for vitamin D and TIBC using two calibrators. The laboratory performed calibration verification for vitamin D and TIBC on the Vitros 5600 chemistry analyzer on 02/19/2020. 2. At the time of the survey, the laboratory did not have calibration verification records for the time period between 02/19/2020 and 6/22/2021. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's blood bank refrigerator alarm procedure and

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on review of hematology quality control (QC) records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 11:00 am on 04/10/2019, the laboratory failed to retain hematology complete blood count (CBC) QC records for one out of three lot numbers of QC (lot 370718, expiration 09/05/2018) and 41 out of 62 days from 07/01/2018-08/31/2018. The findings include: 1. The laboratory performed two levels of CBC QC for each 24- hour period of patient testing, rotating between low, normal, and high. The laboratory documented which two levels were performed on the AcTDiff Maintenance Log. 2. At the end of use for each lot number, the laboratory printed the QC files stored on the hematology instrument and kept them as documentation of QC results. 3. The QC records from 07/01/2018- 08/31/2018 contained data for lot numbers 360718, expiration 09/05/2018 (low) and 380718, expiration 09/05/2018 (high), but not 370718 (normal). 4. Review of the July and August 2018 AcTDiff Maintenance Logs indicated the laboratory performed QC with lot number 370718 on the following dates: 07/01, 07/03, 07/04, 07/06, 07/07, 07/09, 07/10, 07/12, 07/13, 07/15, 07/16, 07 /18, 07/19, 07/21, 07/22, 07/24, 07/25, 07/27, 07/28, 07/30, 07/31, 08/02, 08/03, 08 /05, 08/06, 08/08, 08/09, 08/11, 08/12, 08/14, 08/15, 08/17, 08/18, 08/20, 08/21, 08 /23, 08/24, 08/26, 08/27, 08/29, and 08/30. 5. Laboratory personnel identifier #2 stated that the QC file for lot number 370718 had been deleted before it could be printed. 6. At the time of the survey, the laboratory did not have additional QC records for the previously listed dates. 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 -- D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (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. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)