Summary:
Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of hematology procedure, quality control (QC), patient reports and interview with the laboratory director the laboratory failed to follow hematology quality control procedure. Findings: 1. Review of laboratory hematology procedure states "Three commercial controls are run each morning". 2. Review of QC and patient reports shows on 3/14/18 and 3/22/18 laboratory reported out patient results and failed to run QC. 3. Interview with the laboratory director on April 11, 2018 at 3: 00 PM confirmed the laboratory failed to follow hematology quality control procedure. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on review of Medonic hematology analyzer validation and interview with the laboratory director on April 11, 2018 at 3:00 PM confirmed the laboratory failed to verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient test reports and interview with the laboratory director the laboratory failed to include positive patient identification on patient test reports. Findings: 1. The laboratory scans complete blood count (CBC) results (a print out from analyzer) into patient charts. 2. Review of patient CBC result's test report from 3 /22/18 from the patient's chart shows only the last name of the patient is on the test report. 3. Interview with the laboratory director on April 11, 2018 at 3:00 PM confirmed the laboratory failed to include positive patient identification on laboratory reports. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of patient test report , Medonic hematology procedure and interview with the laboratory director the complete blood count (CBC) normal values on the patient report did not match the normal values in the procedure. Findings: 1. Review of patient test report shows normal range of CBC: WBC: 3.5-10 Gra%: 35-80 Mid%: 2-15 Lym%: 15-50 RBC: 3.5-5-5 HGB: 11.5-16.5 MCV: 75-100 HCT: 35-55 MCH: 25-35 MCHC: 31-38 PLT: 100-400 MPV: 8-11 2. Review of Medonic hematology procedure shows: WBC: 4.6-10.2 LYM%: 10-50 GRAN%: 37-80 MID%: 0-12 RBC: males 4.69-6.13 female 4.04-5.48 HGB: males 14.1-18.1 female 12.2-16.2 HCT: males 43.5-53.7 female 37.7-47.9 MCV: males 80-97 female 80-97 MCH: 27-31.2 MCHC: 31.8-35.4 PLT: 142-424 3. Interview with the laboratory director on April 11, 2018 at 3:00 PM confirmed the laboratories CBC normal values for patient test reports did not match the procedure. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) -- 2 of 4 -- (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on review of Medonic hematology analyzer quality control (QC), hematology procedure and interview with the laboratory director the technical consultant failed to establish parameters for acceptable levels of analytic performance and ensure these levels were maintained. Findings: 1. Review of QC for complete blood counts (CBC) for April 2018 showed on 4/3/18, 4/4/18 and 4/5/18 hemoglobin was not within acceptable limits for the normal and high controls. Laboratory performed no