Summary:
Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of quality control records and interview with Testing Personnel #1 (TP1), the laboratory failed to retain all blood gas instrument printouts of quality control testing. Findings include: 1. Comparison of the daily quality control (QC) logs against the blood gas instrument QC printouts from January 1, 2017 to December 30, 2017 demonstrate that the all QC printouts were not retained. 2. The only printouts found from 1/1/17 - 12/31/17 include: 3/5, 3/7, 27, 4/ 5, 4/19, 4/25, 5/2, 5/9, 5/11, 6/6 and 12/23, all others 2017 QC printouts were missing. The QC logs and patient testing frequency demonstrated patient testing being conducted at a more frequent basis. 3. On 8/28/2018 at approximately 12:30PM, the TP stated that she did not know where the other printouts were located. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of blood gas proficiency testing (PT) records and interview with testing personnel #1 (TP1), the laboratory failed to document