Chi Health Plainview Laboratory

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) 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. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on surveyor review of quality control records, patient testing records, lack of Individualized Quality Control Plan (IQCP), and interview with the laboratory manager the laboratory failed to performed quality control (QC) each day of patient testing on Clostridium difficile testing from 1/1/2025 - 8/5/2026. Findings are: 1. Review of Clostridium difficile QC records and patient testing records from 1/1/2025 - 8/5/2026, revealed QC was performed with new test kit lot and monthly. 2. Interview with the laboratory manager on 8/5/2026 at 1:17 PM confirmed the laboratory did not perform QC each day of patient testing from 1/1/2025 - 8/5/2026. 3. Interview with the laboratory manager on 8/5/2026 at 1:17 PM confirmed the laboratory did not have an IQCP in place for Clostridium difficile testing. 4. The laboratory performed thirteen Clostridium difficile patient tests in 2025. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and blood products must be stored under 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 -- 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. This STANDARD is not met as evidenced by: Based on surveyor review of the laboratory's Equipment Maintenance Schedule policy, blood bank system alarm check records, and confirmed by interview with the laboratory manager the laboratory failed to inspect, perform, and document quarterly blood bank refrigerator alarm system checks for eight out of ten time periods from 1/1 /2024 - 8/5/2026. Findings are: 1. The laboratory's Equipment Maintenance Schedule policy stated that the alarm for the blood bank refrigerator is checked quarterly. 2. The blood bank refrigerator alarm check records showed refrigerator alarm check performed on 6/16/2025 and 12/15/2025. No alarm checks performed during 1st quarter 2024, 2nd quarter 2024, 3rd quarter 2024, 4th quarter 2024, 1st quarter 2025, 2nd quarter 2025, 1st quarter 2026, and 2nd quarter 2026. 3. Interview with the laboratory manager on 8/5/2026 at 1:28 PM, confirmed the laboratory failed to perform quarterly blood bank refrigerator alarm checks for 1st quarter 2024, 2nd quarter 2024, 3rd quarter 2024, 4th quarter 2024, 1st quarter 2025, 2nd quarter 2025, 1st quarter 2026, and 2nd quarter 2026. -- 2 of 2 --

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 surveyor review of Validation of the Analytical Measurement Range (AMR) Procedure, review of AMR verification documentation performed on the Siemens Dimension ExL, and interview with the technical consultant on 8/15/2024 12:26 PM, the laboratory failed to perform one out of three AMR verification every six months on chloride, potassium, and sodium, and failed to perform three out of three AMR verification every six months on triglycerides from 7/11/2023 - 8/15/2024. Findings 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 -- are: 1. Based on review of the laboratory's Validation of the Analytical Measurement Range (AMR) Procedure, "ExL assays listed below must have six-month AMR verification: Chloride, Potassium, Sodium, Trig". 2. Review of chloride, potassium, and sodium AMR verification records revealed AMR verification was performed on 7 /11/2023 and 6/12/2024. 3. Interview with the technical consultant confirmed the laboratory did not perform one out of three AMR verification on chloride, potassium, and sodium. 4. Review of AMR verification records revealed no triglycerides AMR verification was performed from 7/11/2023 - 8/15/2024. 5. Interview with the technical consultant confirmed the laboratory did not perform three out of three AMR verification on triglycerides. D6055 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing whenever test methodology or instrumentation changes. The individual's performance must be reevaluated to include the use of the new test methodology or instrumentation prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on surveyor review of new instrumentation records, review of competency records, and interview with the technical consultant on 8/15/2024 at 10:40 AM, the laboratory failed to perform competency on two out of two testing personnel prior to reporting patient test results using the new moderate complexity BioRad ToxSee system detection of drugs of abuse. The findings include: 1. Review of new instrumentation records revealed the new moderate complexity BioRad ToxSee system detection of drugs of abuse was put into use on 8/8/2023. 2. Review of competency records from 2023 and 2024 revealed no competency performed on the BioRad ToxSee system detection of drugs of abuse on two out of two testing personnel. 3. Interview with the technical consultant confirmed no competency was performed on the BioRad ToxSee system detection of drugs prior to reporting patient test results. -- 2 of 2 --