Summary:
Summary Statement of Deficiencies D0000 A scheduled initial survey was conducted 10/9/19 at Fayetteville Heart Center, PC. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Clinical Laboratories. Based on survey findings, an Immediate Jeopardy situation was identified. The laboratory was notified at approximately 1:15 p.m. 10/9/19. The laboratory failed to validate the performance specifications of the ACT analyzer in use before beginning patient testing and had not performed quality control for the ACT testing performed since April of 2017. The following Conditions were not met: D5024-Hematology 493.1215 D6000-Laboratories performing moderate complexity testing; laboratory director 493.1403 D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory records, review of operator's manual, review of manufacturer's instructions (package inserts), and interviews with testing personnel number one (TP #1) and laboratory owner 10/9/19, the laboratory failed to meet all specified requirements for the performance of activated clotting time (ACT) testing in the speciality of Hematology. Findings: The laboratory performs ACT testing on the Hemochron Signature Elite analyzer using Low Range Activated Clotting Time (ACT- LR) cuvettes. The laboratory began testing in April of 2017. 1. The laboratory failed to have a complete and current procedure manual. See D5403. 2. The laboratory failed to define, monitor and document essential storage conditions for reagents and essential temperature conditions for the operation of the Hemochron Signature Elite analyzer. See D5413. 3. The laboratory failed to establish and verify performance specifications for the ACT testing on the Hemochron Signature Elite analyzer. See 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 -- D5421. 4. The laboratory failed to perform and document calibration verifications every 6 months as required for the ACT testing performed. See D5439. 5. The laboratory failed to establish quality control procedures, and failed to perform and document quality control for the ACT testing performed as required. See D5545. Based on TP #1 and laboratory owner interviews, the laboratory performs ACT testing during peripheral angiogram procedures. The facility performs the peripheral angiogram procedures two days a week, two patients a day for a total of approximately 16 patients a month. Total number of patients tested since April of 2017 until time of survey, 30 months, is approximately 480 patients. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 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 review of laboratory records, review of testing personnel (TP) records, and interview with TP #1 10/9/19, the laboratory failed to establish competency policies and procedures that meet the regulations as stated in section 493.1413(b)(8) of the 42 CFR Part 493 Requirements for Laboratories. Section 493.1413(b)(8) states: "The procedures for evaluation of the competency of the staff (testing personnel) must include, but are not limited to.... Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; Monitoring the recording and reporting of test results; Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records; Direct observation of performance of instrument maintenance and function checks; Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and Assessment of problem solving skills; Review of laboratory records revealed no competency procedures for the assessment of TP. Review of TP records revealed no competency records were available for previous TP. TP#1 had started employment in May of 2019 and has not had a competency assessment at time of survey. Interview with TP #1 at approximately 10:45 a.m. confirmed she began employment in May of 2019. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with TP #1 and laboratory owner 10/9/19, the laboratory failed to verify the accuracy of the ACT testing as least twice annually. Findings: Review of laboratory records revealed no documentation that the laboratory had verified the accuracy of the ACT testing at least twice annually since testing began in April of 2017 until time of survey, a period of approximately 30 months in which verification of accuracy had not been performed. Interview with TP #1 at approximately 12:45 p.m. confirmed the laboratory had not performed a -- 2 of 10 -- verification of the accuracy of the ACT testing. She stated she began employment in May of 2019 and had been unable to find any record documenting a performance of a verification of accuracy and was unaware that it was required until preparing for the survey. Interview with laboratory owner at approximately 2:00 p.m. confirmed the laboratory began testing on the Hemochron Signature Elite analyzer in April of 2017. 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)