Kota Cancer Clinic ,Pllc

Summary Statement of Deficiencies D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Review of the laboratory's Policy and Procedure for Quality Control (QC)A, quality control results for October 16, 2023 through December 7, 2023, patient result reports for December 5, 2023, and interview with laboratory staff determined that the laboratory reported patient results for hematocrit (Hct) tests on one of thirty-four days of testing reviewed when QC results failed to meet the laboratory's criteria for acceptability. Survey findings follow: A) Review of the Laboratory's Policy for "Quality Control " revealed "QC rules followed for unacceptable QC results were two of three levels of controls outside 2 standard deviation (SD) limits or any single control outside 3 SD limits and "patient results should not be reported if controls exceed acceptable limits". B) Review of the QC report for Hct revealed that on 12/5 /23 at 08:30 a.m. result for level 1 of Sysmex eCheck (XS) hematology control lot # 32619804 was reported as 19.7 with acceptable limits (18.5 to 19.5) and level 2 of Sysmex eCheck (XS) hematology control lot # 32610805 was reported as 37.9 with acceptable limits of (36.0 to 37.8). This represents two of three levels of control exceeding 2 SD. C) Review of patient reports for December 5 , 2023 revealed that Hct assays were performed and reported on twelve patients (identified as 1 through 12 on a separate patient identification list). D) In an interview on 7/25/24 at 11:17 a.m., the laboratory staff members (identified as #2 and #4 form CMS 209) confimed that patient results were released for Hct assays on 12/5/23 against laboratory policy when QC results on two of three levels of control were outside the laboratory's acceptable range.. 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 D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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: Through observation, review of temperature records, lack of documentation and interview it was determined that the laboratory failed to monitor the temperature of one of two rooms in which supplies with storage temperature requirements were stored on each day of operation. Findings follow: A) During a tour of the laboratory on 10/12/22 at 09:15 AM two rooms containing items with a temperature storage requirement , the laboratory and storage room all separated by a closable door, were observed. B) During a review of the laboratory's temperature records it was noted that temperature records for only the laboratory was presented. C) During a tour of the laboratory on 10/12/22 at 11:55 am, two 20L carboys of Sysmex CallPack lot number Y2028 expiration date 2023-09-23 with a storage temperature requirement of 1 degree C. to 30 degrees C. were observed in the storage room. D) Upon request, the laboratory could not present the temperature records for the storage room in which the supplies identified above were stored,. E) In an interview on 10/12/22 at 12:05 pm the laboratory staff member, identified as number two on the CMS 209 form, confirmed that the daily temperature of the storage room in which the supplies, identified above, were stored had not been monitored and recorded.. 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: Through a review of the Operator's Manual for the Sysmex XS-1000i, a review of Certificates of Calibration Verification, and through interviews with laboratory staff, it was determined the laboratory failed to perform calibration verification following manufacturer's instructions. Survey findings include: A. The Operator's Manual for the Sysmex XS-1000i states, "The laboratory must verify calibration every six months or on an as needed basis to ensure accuracy of the system." B. A review of 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 -- Certificates of Calibration Verification for 2016, 2017, and 2018 revealed the following dates of calibration: June 14, 2016; July 14, 2017 (11 months after the previous documented calibration); and March 9, 2018 (8 months after the previous documented calibration). There is no documentation that calibration verification has been performed every six months. C. In an interview at 10:54 on 5/8/2018, the technical consultant (as listed on the form CMS-209) confirmed the laboratory had not performed calibration every 6 months as required by the manufacturer. -- 2 of 2 --