Summary:
Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a record review and interview with the laboratory Technical Consultant (TC) #1, the laboratory failed to perform twice annually accuracy verification or proficiency testing for urine protein by sulfosalicylic acid from January 1, 2020 to April 27, 2022. Findings: 1. Review of CMS-116 form on April 27, 2022 at 9:00 AM, revealed the laboratory test/analyte list included urine protein by sulfosalicylic acid. 2. Review of 2020 and 2021 College of American Pathology (CAP) proficiency testing records lacked documentation for urine protein by sulfosalicylic acid. 3. Interview with TC #1, on April 27, 2022, at 12:30 PM, confirmed the laboratory had an annual testing volume for urine protein by sulfosalicylic acid of six for 2021. 4. Interview with TC #1, on April 27, 2022 at 12:35 PM, confirmed the laboratory failed to perform twice annually accuracy verification for urine protein by sulfosalicylic acid from January 1, 2020 to April 27, 2022. 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 hematology record review and interview with the Technical Consultant (TC) 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 -- #1, the laboratory failed to include the normal reference ranges in the patient results report for manual differential Basophils and Variant Lymphocytes. Findings: 1. Review of Manual Differential patient results report (#21-034-3369) lacked normal reference ranges for Basophils and Variant Lymphs. 2. Review of Hema 3 Stain Policy and Procedure BR-006 revealed, "Reference Ranges: A. Leukocytes: (100 cell differential) Basos; Adult ( 0-3), 0-14 day (0-3) and 15 days-4years (0-3)". 3. Interview with TC #1 on April 27, 2022 at 10:30 AM , confirmed the patient results report lacked normal reference ranges for Basophils and Variant Lymphocytes. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on record review and interview with the Technical Consultant (TC) #1, the laboratory failed to have a mechanism to periodically verify the laboratory information system (LIS) accuracy of its calculated data for hemoglobin A1c and reference ranges listed on the patient results report to the laboratory's written policy and procedures for analytes: ionized calcium (iCa), prothrombin time (PT), international normalized ratio (INR), Basophils and Variant Lymphocytes from January 1, 2020 to April 27, 2022. Findings: 1. No documentation was available for review to verify the LIS accuracy of its calculated data for hemoglobin A1c. 2. Review of General Chemistry (Chem 8) patient results report (#20-304-3104), revealed a reference range for Calcium Ionized of 1.10 - 1.30 mmol/L, differed from Policy and Procedure: #BR-011 reference range for iCa of 1.12-1.32 mmol/L. 3. The laboratory lacked data or reference material to support the reference range listed in the patient results report for Calcium Ionized. 4. Review of Coagulation patient results reports, (#20-269-3327 and #21-042-0939) revealed a PT, Whole Blood reference range of 11.0 - 17.9 and INR reference range of 0.88 - 1.22, differed from Policy and Procedure: #PCPOC-485 reference range for PT of 10:54 - 12.92 sec and INR of 0.86 - 1.12. 5. The laboratory lacked data or reference material to support the reference range listed in the Coagulation patient result report for PT and INR. 6. Review of patient results report for Manual Differential lacked reference ranges for Basophiles and Variant Lymphocytes. Cross refer D5807 7. Interview with TC #1 on April 27, 2022 at 10:55 AM, confirmed the laboratory failed to have a mechanism to periodically verify the LIS accuracy of its calculated data for hemoglobin A1c and patient results report's reference ranges from January 1, 2020 to April 27, 2022. -- 2 of 2 --