Childrens Mercy-Premier Pediatrics, Inc

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of iStat chemistry quality control (QC) and interview with the technical consultant the laboratory failed to perform two levels of chemistry QC, 31 out of 32 testing days. Findings: 1. Review of IStat chemistry QC for sodium, potassium, chloride, calcium, TCO2, glucose, BUN and creatinine showed laboratory failed to perform QC, 31 out of the last 32 testing days. 2. Interview with the technical consultant on October 26, 2018 at 10:00 AM confirmed the laboratory failed to perform two levels of chemistry controls on each day of testing. 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 hematology procedure manual, patient reports and interview with the technical consultant, the laboratory failed to follow hematology procedure for normal ranges. Findings: 1. Review of the procedure manual normal ranges for males 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 -- shows: WBC 4.6-10.2, RBC 4.69-6.13, HGB 14.1-18.1, HCT 43.5-53.7, MCV 80-97, MCH 27.0-31.2, MCHC 31.8-35.4, PLT 142-424 2. Review of the procedure manual normal ranges for females shows: WBC 4.6-10.2, RBC 4.04-5.48, HGB 12.2-16.2, HCT 37.7-47.9, , MCV 80-97, MCH 27.0-31.2, MCHC 31.8-35.4, PLT 142-424 3. Review of the patient report for males and females shows: WBC 3.5-13.5, RBC 3.50- 5.50, HGB 11.0-16.5, HCT 35-55, MCV 75-100, MCH 25-35, MCHC 31-38, PLT 100-400 4. Interview with the technical consultant on October 26, 2018 at 10:00 AM confirmed the laboratory failed to follow hematology procedure for normal ranges. -- 2 of 2 --