Summary:
Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on reviews of the Quality Control (QC) Plan specified in the IQCP (Individualized Quality Control Plan), the Abbott I-Stat QC records, and an interview with Testing Personnel #15, the facility failed to perform QC as specified in the IQCP, one month in 2020 and one month in 2021. The findings include: 1. A review of the QC Plan in the Abbott I-Stat IQCP revealed two levels of QC (Level 1 and Level 3) should be run every 30 days during the first five days of the month. 2. A review of the August 2020 thru April 2021 I-Stat QC records revealed two levels of QC were performed on 8/4/2020, 9/4/2020, 11/4/2020 (this QC was labeled as the "October QC"), 11/14/2020, 12/3/2020, 1/15/2021, 2/5/2021, 3/9/2021, and 4/2/2021. 3. During an interview on 4/8/2021 at 1:55 PM, Testing Personnel (TP) #15 confirmed I-Stat QC should be performed every 30 days during the first five days of the month, as per the IQCP and their Technical Consultant's instructions. The surveyor then requested the October 2020 I-Stat QC; TP #15 stated the testing personnel failed to perform QC until 11/4/2020. The surveyor then asked about the QC performed 1/15/2021 and 3/9 /2021. TP #15 confirmed the January 2021 QC was performed late, however the March QC was not performed because the reagent cartridges were on backorder, and were not received until 3/9/2021. (Documentation was provided.) 4. As the interview 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 -- continued on 4/8/2021, the surveyor asked how many patient tests were performed from 10/4 thru 11/3/2020, and from 1/3 thru 1/14/2021. After reviewing the billing records at 2:15 PM, TP #15 stated 46 patient tests were performed 10/4 - 11/3/2020, and 17 patients from 1/3 - 1/14/2021. SURVEYOR ID#32558 Licensure and Certification Surveyor -- 2 of 2 --