Summary:
Summary Statement of Deficiencies D0000 A CERTIFICATION SURVEY was performed at North Caddo Medical Center (RESP) - CLIA # 19D1094011 on May 21, 2018 through May 25, 2018. The laboratory 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 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 include the specimen collection time for Arterial Blood Gas testing. Refer to D5305. 2. The laboratory failed to ensure the procedure manual contained complete policies and procedures. Refer to D5403. 3. The laboratory failed to ensure quarterly maintenance for the Opti-CCA was performed and documented as required. Refer to D5429. 4. The laboratory failed to perform Quality Controls every thirty (30) days as required by the Individulized Quality Contol Plan (IQCP) for Arterial Blood Gas testing. Refer to D5445. 5. The laboratory's Quality Assurance monitors failed to identify and correct quality issues in Routine Chemistry. Refer to D5791. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 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 -- As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to ensure written policies and procedures to address competency for the Clinical Consultant were complete. Findings: 1. Review of the laboratory's CMS-209 form (Laboratory Personnel Report) revealed Personnel 16 serves as the laboratory's Clinical Consultant. 2. Review of the laboratory's policies and procedures revealed the laboratory did not have a policy for competency assessment of Clinical Consultant. 3. Review of personnel records for Personnel 16 revealed a competency assessment for duties as Clinical Consultant was not performed. 4. In interview on May 22, 2018 at 11:26 am , Personnel 1 stated the laboratory did not have a policy and there is not a competency assessment for Personnel 16's duties as Clinical Consultant. D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on observation, record review and interview with personnel, the laboratory failed to document the specimen collection time for Arterial Blood Gas testing. Findings: 1. Observation by surveyors during laboratory tour on May 21, 2018 revealed the laboratory utilizes the Opti CCA-TS2 analyzer for Arterial Blood Gas (ABG) testing. 2. Review of the Opti CCA-TS2 procedure manual revealed "Whole blood samples should be collected in a heparinized syringe, ComfortSampler, or capillary and analyzed as soon as possible, ideally within 5 minutes after collection." 3. Review of the laboratory's Sampling Procedure revealed "The specimen must be tested as soon as possible after collection and within the time frame specified in the testing method." 4. Review of patient records revealed the laboratory did document the analyze time; However, they did not document the actual collection time for the following patients: Patients 39 - 59 5. In interview on May 22, 2018 at 11:37 am, Personnel 2 stated the testing personnel writes the collection time on the samples but does not document them anywhere else. Personnel 2 confirmed the specimen collection times were not included for the above patients. D5403 PROCEDURE MANUAL -- 2 of 7 -- 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)