Kansas Nephrology Physicians

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 the lack of procedures for review and interview, the laboratory failed to have three written procedures available to and followed by, laboratory personnel at time of survey. Findings: 1. No procedures for the Sysmex Pochi - 100 was made available for review at the time of survey including the following analytes; white blood cell count (WBC), red blood cell count (RBC), hemoglobin (HGB), hematocrit (HCT), mean corpuscular volume (MPV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), platelet count, lymphocyte percentange (LYM %), lyphocyte absolute (LYM #), mixed cell percentange (MXD %), mixed cell absolute (MXD #), neutrophil percentage (NEUT %), neutrophil absolute (NEUT #), red cell distribution weight (RDW) and mean platelet volume (MPV). 2. No procedures for the Siemen Expand was made available for review at the time of survey including the following analytes; glucose, blood urea nitrogen, creatine, potassium, sodium, chloride, carbon dioxide, calcium, magnesium, alanine transaminase, aspartate transferase, direct bilirubin, phosphorus, triglycerides, high density lipoprotein, uric acid, iron, total iron-binding capacity, urine protein, urine creatine, low density lipoprotein, cholesterol, alkaline phospatase, glomerular filtration rate, total protein, protein/creatine ratio, and albumin. 3. No procedures for the Cobas e 411 was made available for review at the time of survey including the following analytes; free thyroxine, ferritin, thyroid stimulatin hormone, intact 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 -- parathyroid hormone and vitamin D. 4. Interview with the laboratory director on 10/27 /22 at 10:00 a.m. confirmed, the laboratory failed to have three written procedures available to and followed by, laboratory personnel. -- 2 of 2 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based upon direct observation during a tour of the laboratory, review of BIO-RAD manufacturer's control sheet and interview with testing personnel #1 and #2 (refer to the Laboratory Personnel Report (CMS-209)) at 10:40 AM on November 6, 2018, the laboratory failed to ensure that controls in use had not exceeded their stability expiration date. Findings were: 1. During a tour of the lab, the surveyor observed the following BIO-RAD Control bottles stored in the refrigerator currently in use had the following open dates. Liquichek Unassayed Chemistry Control --- level 2; lot 31872, unopened frozen expiration date 1/31/2020. Open date: 10/25/2018. Liquichek Urine Chemistry Control --- level 1; lot 66791, unopened refrigerator expiration date 12/31 /2018. Open date: 10/3/2018. --- level 2; lot 66792, unopened refrigerator expiration date 12/31/2018. Open date: 10/2/2018. Liquichek Immunoassay Plus Control, unopened frozen expiration date 6/30/2020. --- level 1; lot 40971, level 2; lot 40972, level 3; lot 40973. Open date for all: 9/27/2018. Liquichek Specialty Immunoassay Control, unopened frozen expiration date 1/21/2020. --- level 1; lot 60231, level 2; lot 60232, level 3; lot 60233. Open date for all: 9/27/2018 2. Review of the BIO-RAD manufacturer's control sheets stated the following stability listed below once thawed and opened or just opened for the urine chemistry controls. Liquichek Unassayed Chemistry Control: this control will be stable thawed and stored refrigerated as follows: Bilirubin (Total), Triglycerides and Phosphorus: 6 days. Liquichek Urine Chemistry Control: this control will be stable stored refrigerated for all analytes for 30 days. Liquichek Immunoassay Plus Control: this control will be stable thawed and stored refrigerated as follows for all analytes tested at this lab for 14 days. Liquichek 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 -- Specialty Immunoassay Control: this control will be stable thawed and stored refrigerated for Parathyroid Intact (PTH intact) for 7 days. 3. Testing personnel #1 and 2 confirmed that the expired control vials were were all used for quality control on November 5, 2018. -- 2 of 2 --