Summary:
Summary Statement of Deficiencies D0000 A initial survey was completed on 10-7-2024. The following condition level deficiencies existed: Condition Not Met:: 1. 42 CFR 493.1250 Analytical Systems 2. 42 CFR 493.1409 Technical Consultant- Moderate Complexity 3. 42.CFR 493.1421 Laboratory Testing Personnel D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on lack of documentation, record review and interview the laboratory failed to meet the following analytic system requirements: the laboratory's policy and procedure manual failed to include daily testing of control material and calibration verification procedures for four of four instruments (Abbott I-Stat 1- serial numbers 436917,436920,436992,and 437278) and twelve of twelve analytes (sodium (Na), potassium (K), chloride (Cl), total carbon dioxide (TCO2), ionized calcium (iCa), blood urea nitrogen (BUN), creatinine (Crea), hematocrit (HCT), hemoglobin (Hgb), potential of hydrogen (pH),Glucose(g) and partial pressure of carbon dioxide (PCO2)) tested (Refer to D5403); the laboratory failed to perform two control materials of different concentrations at least once daily for four of four patients (Pt#1-Pt#2) tested (refer to D5447); the laboratory failed to test one sample of control material each 8 hours of testing using a combination of control materials the include both low and high values on each day of testing for three of four patients (Pt#1, PT#2, and Pt#4) tested receiving blood gas testing (pH, pO2, and pCO2) (Refer to D5537); and 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 7 -- laboratory failed to have a written policy or procedure for an ongoing mechanism to monitor, assess, and correct problems in the analytic system from 9-10-2024, when patient testing started, to 10-7-2024, the date of the survey (Refer to 5791). 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)