Summary:
Summary Statement of Deficiencies D0000 A recertification survey was performed was performed at Mid City Specialty Center, LLC - CLIA ID 19D2142233 on April 21-22, 2021. Mid City Specialty Center was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1210 CONDITION: Routine Chemistry 42 CFR 493.1403 CONDITION: Laboratories Performing Moderate Complexity Testing; Laboratory Director 42 CFR 493.1409 CONDITION: Laboratories Performing Moderate Complexity Testing; Technical Consultant D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on observation, record review, and interview with personnel, the laboratory failed to ensure the quality of testing in the specialty of Routine Chemistry. Findings: 1. The laboratory failed to obtain a written request from the physician for two (2) of two (2) patients reviewed. Refer to D5301. 2. The laboratory failed to ensure the policy manual contained complete policies and procedures. Refer to D5403. 3. The laboratory failed to perform complete reference range studies for the EPOC analyzer. Refer to D5421. 4. The laboratory failed to have a complete Individualized Quality Control Plan (IQCP) to support the reduction in frequency of quality control (QC). Refer to D5445 I. 5. The laboratory failed to follow the Individualized Quality Control Plan (IQCP) for one (1) of four (4) months of testing reviewed. Refer to D5445 II. 6. The laboratory failed to establish complete procedures to monitor, assess, and correct problems, identified with the analytic system. Refer to D5791. 7. The laboratory failed to establish complete procedures to monitor, assess, and correct problems, identified with the preanalytic system. Refer to D5391. 8. The laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- failed to ensure appropriate reference ranges were available on the final report. Refer to D5807. D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to obtain a written request from the physician for two (2) of two (2) patients reviewed. Findings: 1. Review of a random selection of patient test requisitions revealed the laboratory failed to acquire a written request from the physician on for following two (2) of two (2) patients for whom had EPOC testing: a) Patient 000300002403 for Sodium (NA), Potassium (K), Calcium (CA), Chloride (CL), Hematocrit (Hct), Hemoglobin (Hgb), Glucose (Glu), Blood Urea Nitrogen (BUN), Creatinine (Creat), and Carbon Dioxide (CO2) b) Patient 000300002401 for Blood Gases (pH, pCO2, pO2, cHCO3, BE(b), cSO2), Sodium (NA), Potassium (K), Calcium (CA), Chloride (CL), Hematocrit (Hct), Hemoglobin (Hgb), Glucose (Glu), Blood Urea Nitrogen (BUN), Creatinine (Creat), and Carbon Dioxide (CO2) 2. Interview with the Technical Consultant and the Respiratory Manager on April 22, 2021 at 2:00pm confirmed the laboratory did not obtain a written requests for patient testing. Personnel revealed all EPOC testing is performed during surgery and upon request of the physician; however, the charts did not reflect the physician request of test performance or the specific analyte or panels to be performed. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to establish procedures to monitor, assess, and correct problems, identified with the preanalytic system. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory failed to have a Quality Assurance Policy to identify any of the deficiencies identified with the preanalytic system. 2. The laboratory failed to obtain a written request from the physician for two (2) of two (2) patients reviewed. Refer to D5301. 3. In interview on April 27, 2021 at 2:35 pm, the Technical Consultant confirmed the laboratory did not have written quality assurance policies and procedures specific to the preanalytic system for EPOC testing. 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 -- 2 of 10 -- 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)