Summary:
Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: . Based on proficiency testing records review, lack of documentation, and interview with staff, the laboratory failed to retain complete blood count (CBC) proficiency testing instrument printouts at least 2 years for 3 of 6 proficiency testing events reviewed (2nd and 1st events of 2017 and the 3rd event of 2016). Findings include: 1. Proficiency testing records review for American Proficiency Institute (API) 2nd hematology event of 2017 failed to include documentation instrument printouts corresponding to the test results reported to the API testing agency for: API Event Analyte Reported Lab Record 2nd 2017 Platelets 547 555 (Sp# HEM08) 2nd 2017 Red Blood Cells 6.48 6.59 (Sp# HEM10) 2nd 2017 Granulocytes % 81.0 81.4 (Sp# HEM08) 2. Proficiency testing record review failed to include proficiency test records of instrument printouts for all the results reported for the 1st hematology event of 2017. 3. . Proficiency testing records review for American Proficiency Institute (API) 3rd hematology event of 2016 failed to retain documentation of instrument printouts that matched the test results reported to the API testing agency for: API Event Analyte Reported Lab Record 3rd 2016 Platelets 138 132 (Sp# HEM11) 3rd 2016 White Blood Cells 11.8 12.1 (Sp# HEM14) 4. In an interview conducted on 03/30/2018 at approximately 12 :30 P.M., the laboratory testing personnel confirmed the laboratory had not maintained all CBC proficiency testing records, including instrument printouts for all proficiency testing performed. D5461 CONTROL PROCEDURES CFR(s): 493.1256(d)(6)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Perform control material testing as specified in this paragraph before resuming patient testing when a complete change of reagents is introduced; major preventive maintenance is performed; or any critical part that may influence test performance is replaced. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on calibration test record review, lack of documentation, and interview with staff, the laboratory failed to perform quality control following ABX Micros 60 cell counting instrument calibration for 1 of 4 calibration events reviewed, (10/14/2017), prior to reporting patient test results. The laboratory performed approximately 5 complete blood counts per day. Findings include: 1. Calibration test records document the laboratory perform an instrument calibration on 10/14/2017. 2. The laboratory lacked documentation quality control was performed following instrument calibration prior to testing patient samples on 10/14/2017. 3. In an interview with staff on 03/30 /2018 at approximately 12:15 P.M., the laboratory technical supervisor stated the laboratory did not have documentation of quality control performance following instrument calibration on 10/14/2017. The technical supervisor confirmed patient testing was performed on 10/14/2017 following the instrument calibration. -- 2 of 2 --