Summary:
Summary Statement of Deficiencies D0000 An Initial Survey was performed at Union Carbide Corp-Taft Medical Department on June 13, 2019. Union Carbide Corp-Taft Medical Department was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1215 CONDITION: Hematology 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing, Laboratory Director 42 CFR 493.1409 CONDITION: Laboratories performing moderate complexity testing, Technical Consultant 42 CFR 493.1417 CONDITION: Laboratories performing moderate complexity testing, Clinical Consultant 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 observation, record review, and interview with personnel, the laboratory failed to ensure the quality of testing for the specialty of Hematology. Findings: 1. The laboratory failed to ensure written policies and procedures to assess competency for the Clinical Consultant were complete. Refer to D5209 I. 2. The laboratory failed to establish written policies and procedures to assess competency for testing personnel. Refer to D5209 II. 3. The laboratory failed to establish a laboratory policy and procedure manual. Refer to D5401. 4. The laboratory failed to have a complete policy and procedure manual. Refer to D5403. 5. The laboratory failed to document the temperature of the collection area where laboratory supplies are stored per manufacturer requirements. Refer to D5413. 6. The laboratory failed to ensure blood collection supplies have not exceeded their expiration date. Refer to D5417. 7. The laboratory failed to have complete performance specification verification studies for the Beckman Coulter ACT diff Hematology analyzer. Refer to D5421. 8. 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 14 -- laboratory failed to ensure quality control for Complete Blood Counts (CBC) met acceptability criteria per laboratory policy prior to patient testing. Refer to D5481. 9. Tthe laboratory failed to establish procedures to monitor, assess, and correct problems, identified with the analytic system. Refer to D5791. 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: I. Based on record review and interview with personnel, the laboratory failed to ensure written policies and procedures to assess competency for the Clinical Consultant were complete. Findings: 1. Review of the laboratory's records revealed the laboratory did not have a policy for competency assessment of the Clinical Consultant, including frequency of performance. 3. Review of personnel records for the Clinical Consultant revealed a competency assessment for duties as Clinical Consultant was not performed. 3. In interview on June 12, 2019, the Laboratory Director stated she did not perform a competency assessment for the Clinical Consultant. The Laboratory Director stated she did not have competency assessment policies. II. Based on record review and interview with personnel, the laboratory failed to establish written policies and procedures to assess competency for testing personnel. Findings: 1. Review of the laboratory's records revealed the laboratory did not have written policies and procedures for competency that included the following six (6) procedures as a minimal requirement for assessing the competency of all personnel performing laboratory testing: a) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b) Monitoring the recording and reporting or test results. c) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records. d) Direct observation of performance of instrument maintenance and function checks. e) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. f) Assessment of problem solving skills. 2. In interview on June 12, 2019, the Laboratory Director stated she did not have policies for personnel competency. The Laboratory Director further stated she was unsure of what was needed since she is the only personnel that performs the Hematology testing. 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 record review and interview with personnel, the laboratory failed to establish a laboratory policy and procedure manual. Findings: 1. Review of the -- 2 of 14 -- laboratory's documents and records revealed the laboratory did not have written polices and procedures that included: a)