Valley Day And Night Clinic

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (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 upon review of the laboratory's verification study for the Medonic M series hematology analyzer (Serial Number 62348), patient test records and interview of facility personnel, the laboratory failed to verify the reference ranges for the parameters of the Complete Blood Count (CBC) using the Medonic analyzer were appropriate for the patient population before testing patient specimens. The laboratory reported an annual volume of 13,518 Hematology tests. The findings included: 1. Review of the laboratory's verification study found no verification of reference ranges for the Medonic M series hematology analyzer (Serial Number 62348) installed May 2024. Further review found in the letter dated April 12, 2024 (from Medonic) to the Technical Consultant and Laboratory Director :"It is also the responsibility of the Laboratory Director to determine whether the manufacturer's published reference ranges are acceptable for your lab's patient population. I have included a worksheet for you to use. Instructions for evaluation are included in the worksheet." 2. Review of the method validation instructions provided by the manufacturer found: "3. Reference Range Validation: The Laboratory Director must examine all reference ranges provided by the manufacturer and determine if they are appropriate for the lab's patient population. This can be done empirically, or by using the methods outlined in the CLSI Document C28-A2E "How to Define and Determine Reference Intervals in 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 -- the Clinical Laboratory." 3. Review of final patient reports printed from the LIS for male and female patients found the following reference ranges to be the same for both sexes: WBC 3.2 - 10.2 x10^3 RBC 4.08 - 5.48 x10^6 Hgb 12.2 - 16.2 g/dL Hct 37.7 - 47.9 % MCV 80 - 97 fL MCH 27.0 - 31.2 pg MCHC 31.8 -35.4 g/dL RDW 11.5 - 14.5 % Plt 142 - 424 x10^3 MPV 0.0 - 50.0 fL Gran % 37 - 92 % Lymph % 10.0 - 50.0 % Mid % 0.1 - 24.0 % 4. During interview of the technical consultant conducted June 3, 2024, at 3:24 PM, she stated that the reference ranges in the LIS were obtained from a nearby hospital and she did not verify ranges for the new analyzer. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based upon review of the laboratory's verification study for the Medonic M series hematology analyzer (Serial Number 62348), patient test records and interview of facility personnel, the laboratory director failed to ensure the reference ranges for the parameters of the Complete Blood Count (CBC) using the Medonic analyzer were appropriate for the patient population before testing patient specimens. ( See D 5421) -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed on July 10, 2018 and found to be in compliance with the CLIA regulations and recertification is recommended. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a review of laboratory policy, review of the laboratory's American Association of Bioanalysts (AAB) proficiency testing records, and confirmed in interview of facility personnel, the laboratory failed to document remedial action for unacceptable analytes or testing event scores. The findings included: 1. Review of the laboratory's policy titled, "Proficiency Testing" (no laboratory director approval date), stated, " ...The laboratory should document all steps taken in PT performance. All records and reports will be maintained for two years." 2. Review of the laboratory's AAB proficiency testing records from 2016 (event 3), 2017 (events 1, 2, and 3), and 2018 (events 1 and 2) revealed the following unacceptable scores: 2017 (event 3) Erythrocytes = 60% Hematocrit = 60% 3. Review of the laboratory's