Thedacare Family Medicine Gateway

Summary Statement of Deficiencies 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 surveyor review of laboratory records and interview a technical supervisor, staff A, the laboratory did not perform calibration verification every six months on one of one Beckman Coulter DxH520 Hematology analyzers. Findings include: 1. Review of Beckman Coulter DxH520 hematology analyzer calibration verification records showed calibration verification was performed December 23, 2023, June 18, 2024, and January 8, 2025 Further review showed no additional calibration verification when due on December 18, 2024. 2. Interview with staff A on March 5, 2025, at 12:20 PM confirmed the laboratory was testing patients on the hematology analyzer between December 18, 2024, and January 8, 2025. Further interviewed 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 -- confirmed the laboratory did not perform calibration verification every six months on the Beckman Coulter DxH520 hematology analyzer. -- 2 of 2 --

Summary Statement of Deficiencies D3029 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(2) Test procedures. Retain a copy of each test procedure for at least 2 years after a procedure has been discontinued. Each test procedure must include the dates of initial use and discontinuance. This STANDARD is not met as evidenced by: Based on surveyor review of procedures and interviews with a technical consultant, the laboratory did not discontinue one of three procedures when the laboratory stopped performing the tests. Findings include: 1. Interview with a technical consultant (staff A) on June 8, 2023, at 9:00 AM revealed the laboratory had discontinued testing samples for microalbumin, hemoglobin A1c, and Prothrombin Time / INR (International Normalized Ratio) since the last survey. 2. Review of procedures showed no indication the laboratory discontinued the 'Prothrombin Time - ACL Top and INR (International Normalized Ratio) ACL-TOP' test procedure. The procedure showed it was in use at the Gateway laboratory. 3. Interview with staff A on June 8, 2023, at 11:20 AM confirmed the prothrombin time / INR test was discontinued at this laboratory and confirmed the procedure had not been discontinued for this location. 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 D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with a technical consultant, staff A, testing personnel used expired potassium hydroxide (KOH) reagent for quality control (QC) and patient testing on November 1, 2021. Findings include: 1. Review of the "KOH QC LOG" revealed testing personnel performed QC on the KOH on November 1, 2021 with KOH lot number 9301 and expiration date of October 28, 2021. 2. Review of the KOH patient log revealed testing personnel performed KOH testing on patient 1 on November 1, 2021. 3. Interview with staff A on December 16, 2021 at 11:25 AM confirmed testing personnel used expired KOH reagent for QC and patient testing on November 1, 2021. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) 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. 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 -- This STANDARD is not met as evidenced by: Based on surveyor review of laboratory record control, and interview with a technical consultant, staff A, the laboratory did not meet their stated Potassium Hydroxide (KOH) Quality Control (QC) requirements for testing external controls daily with patient testing for one of three days in November 2021. Findings include: 1. Review of the KOH patient test log revealed testing personnel performed KOH testing on patient 2 on November 21, 2021. 2. Review of "KOH QC LOG" showed no documentation the laboratory performed QC testing for KOH on November 21, 2021. 3. Interview with staff A on December 16, 2021 at 11:25 AM confirmed the laboratory did not meet their QC requirements for KOH testing on one of three days in November 2021. -- 2 of 2 --