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 surveyor review of Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to retain all records from Throat Culture PT events performed with the American Proficiency Institute in the calendar year 2019. The findings include: 1. The attestation was not retained from the 1-2019 event. 2. The work records were not retained in the 2019 PT events. 3. The TP #1 listed on CMS form 209 confirmed on 12/19/19 at 10:30 am that PT records were not retained. D5002 BACTERIOLOGY CFR(s): 493.1201 If the laboratory provides services in the subspecialty of Bacteriology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1261, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on surveyor review of the Quality Control (QC) records and interview with the Testing Personnel (TP) the laboratory failed to ensure that the quality systems for the analytical phases of Bacteriology testing were monitored from 11/29/17 to the date of survey. The findings include: 1. The laboratory failed to ensure that an acceptable Room Temperature and Incubator range was defined. Cross Refer to D5471. 2. The laboratory failed to ensure that quality control on Bacitracin discs was done. Cross Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- Refer to D5471. 3. The laboratory failed to ensure that quality control on media was performed. Cross Refer to D5477. 4. The laboratory failed to take