Summary:
Summary Statement of Deficiencies 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: Findings: 1. Review of the patient reports from the EMR revealed that the male normal range for three analytes and female normal ranges for four analytes did not correlate with the normal ranges stated in the procedure manual with regards to Complete Blood Counts (CBCs) at time of survey. 2. Review of the procedure manual for Mean Corpuscular Hemoglobin (MCH) found the male expected values or normal range was 27.0 - 31.7 pg; the MCH on a patient report for a 65 year old male was 27.0 - 31.2 pg. 3. Review of the procedure manual for granulocyte percentage (GRAN%) found the male expected values or normal range was 0.1 - 1.8 %; the GRAN% on a patient report for a 65 year old male was 37.0 - 92.0 %. 4. Review of the procedure manual for MID Absolute (MID #) found the male expected values or normal range was 2.0 - 15.0 K/ul; the MID # on a patient report for a 65 year old male was 0.1 - 1.8 K/ul. 5. Review of the procedure manual for granulocyte percentage (GRAN%) found the female expected values or normal range was 0.1 - 1.8 %; the GRAN% on a patient report for a 84 year old female was 37.0 - 92.0 %. 6. Review of the procedure manual for Hemoglobin (HGB) found the female expected values or normal range was 12.2 - 16.2 g/dL: the HGB on a patient report for a 84 year old female was 11.7 - 13.8 g/dL. 7. Review of the procedure manual for Hematocrit (HCT) found the female expected values or normal range was 37.7 - 47.0 %: the HCT on a patient report for a 84 year old female was 37.7 - 47.9 %. 8. Review of the procedure manual for Mean Corpuscular Hemoglobin (MCH) found the female expected values or normal range was 27.0 - 31.7 pg; the MCH on a patient report for a 84 year old female was 27.0 - 31.2 pg. 9. Interview with the technical consultant on 4/7/22 at 9:00 a.m. confirmed, 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 laboratory failed to ensure the male normal ranges for three analytes and female normal ranges for four analytes did not match the normal range section in the procedure manual with regards to CBCs at time of survey. -- 2 of 2 --