Grundy County Primary Care Center

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 on observation of the laboratory, review of final patient test reports, review of test system records, and staff interview, the laboratory failed to verify the reference ranges that were in use at the time of the survey (10/10/23) for complete blood count (CBC) patient testing. The findings include: 1. Observation of the laboratory on 10/10 /2023 at 8:05 am revealed a Horiba ABX Micros 60 instrument (SN# 206C591730) in use for CBC patient testing. 2. Review of three final patient test reports revealed the following CBC analyte reference ranges in use for patient evaluation: -White Blood Cell count (WBC): 4-10.5 -Red Blood Cell count (RBC): 4.1-5.6 -Hemoglobin (HGB): 12.5-17 -Hematocrit (HCT): 36-50 -Platelet count (PLT): 140-415 -Mean corpuscular volume (MCV): 80-98 -Mean corpuscular hemoglobin (MCH): 27-234 - Mean corpuscular hemoglobin concentration (MCHC): 32-36 -Red cell distribution width (RDW): 4.1-5.6 -Absolute granulocyte count (GRA#): 1.8-7.8 -Relative granulocyte count (GRA%): 40-74 -Absolute lymphocyte count (LYM#): 0.7 - 4.5 - Relative lymphocyte count (LYM%): 14-46 -Absolute monocyte count (MON#): 0.1- 1 -Relative monocyte count (MON%): 4-13 3. Review of system records for CBC testing revealed no normal range validation of the reference intervals that were in use for evaluating the laboratory's patient test results. 4. Interview with the lab coordinator on 10/10/23 at 12:25 pm confirmed there was no documentation of validation of the 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 -- reference ranges that were in use for patient evaluation with an annual testing volume of 6002 CBC test results. -- 2 of 2 --

Summary Statement of Deficiencies D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of the 2019 American Association of Family Physicians (AAFP) PT manual, 2018-2019 proficiency testing (PT) records, quality assurance (QA) plan & assessments and interview with the lab's QA nurse coordinator, the lab director failed to ensure the PT of the regulated analyte, Hemoglobin, was reported in 2018 AAFP PT Events A, B, & C (Refer to D6016) and failed to ensure the QA plan & assessments monthly identified the missing regulated analyte, Hemoglobin, during the 2018 AAFP PT Events A, B, & C. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a review of the 2018-2019 AAFP PT manual & assessments, PT records, and an interview with the QA nurse coordinator, the the laboratory director failed to 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 -- ensure the regulated analyte, Hemoglobin, was not enrolled/reported during all 3 hematology events (A, B, & C) in 2018. Findings include: 1. Review of the 2019 AAFP PT manual, page 22, for CLIA Regulated Analytes stated: the requirement for the laboratory "must be enrolled" for "Hematology" including regulated analyte, Hemoglobin (excluding HemaCue). 2. Review of the 2018-2019 AAFP PT assessments for CMS Performance Summary, Regulated Analytes, for 3 of 3 events (A, B, & C) revealed no enrollment/reporting for Hemoglobin during 2018. 3. Review of 2018-2019 PT records revealed the regulated analyte for hematology, Hemoglobin, was not reported in 3 of 3 2018 AAFP PT events. 4. In an interview, on June 6, 2019, at 10:00am, the QA nurse coordinator confirmed the laboratory director failed to ensure the hematology regulated analyte, Hemoglobin, was enrolled/reported during the 3 of 3 2018 AAFP PT events. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the Laboratory's Quality Assurance & Assessments (QA) Plan, review of the Director's monthly QA for the 2018 proficiency testing (PT) program for hematology regulated analytes and an interview with the QA nurse coordinator, determined the Laboratory Director did not ensure quality of laboratory services were maintained for the 2018 year time period per QA plan. The findings include: 1. A review of the QA Plan stated: "The Lab Director will ensure that Quality Control and Quality Assurance Plans are established and maintained by review to assure the quality of the laboratory services and identify failures as they occur. 2. The documentation of Director review for Quality Controls or Qualtiy Assessments for 2018 did not ensure the hematology regulated analyte, Hemoglobin, was enrolled /reported for the 2018 AAFP PT events A, B, & C. 3. An interview with the QA nurse coordinator at approximately 11:00 a.m. June 6, 2019 confirmed the Director review of the quality quality assessment records to ensure the quality of the laboratory services were maintained for the 2018 year time period -- 2 of 2 --