Summary:
Summary Statement of Deficiencies D3041 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(6) Test reports. Retain or be able to retrieve a copy of the original report (including final, preliminary, and corrected reports) at least 2 years after the date of reporting. (i) In addition, retain immunohematology reports as specified in 21 CFR 606.160(d) (ii) and pathology test reports for at least 10 years after the date of reporting. This STANDARD is not met as evidenced by: Based on review of Mohs surgery map reports and interview with Testing personnel (TP) #2, the laboratory failed to retain copies of pathology test reports for at least 10 years after the date of reporting from 11/2012 to 08/2016. Findings include: 1. On the day of survey, 12/19/2018, the laboratory could not provide documentation of Mohs map reports from the initial start of patient testing (11/26/2012) to a recent split of the company (08/2016). 2. TP #2 was able to retrieve documentation of Mohs surgery map reports from 08/04/2016 to the date of survey. 3. TP #2 confirmed the findings above on 12/19/2017 at around 10:45 am. D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) The laboratory must retain cytology slide preparations for at least 5 years from the date of examination (see 493.1274(f) for proficiency testing exception). The laboratory must retain histopathology slides for at least 10 years from the date of examination. The laboratory must retain pathology specimen blocks for at least 2 years from the date of examination. The laboratory must preserve remnants of tissue for pathology examination until a diagnosis is made on the specimen. This STANDARD is not met as evidenced by: 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 -- Based on review of laboratory records, observation of tissue pathology slides and interview with Testing personnel (TP) #2, the laboratory failed to retain histopathology slides for at least 10 years from the date of examination from 11/2012 to 08/2016. Findings include: 1. On the day of survey, 12/19/2018, the laboratory could not retrieve slides from the initial start of patient testing (11/26/2012) to a recent split of the company (08/2016). 2. TP #2 was able to retrieve slides from 08/04 /2016 to the date of survey. 3. TP #2 confirmed the findings above on 12/19/2017 at around 10:50 am. -- 2 of 2 --