Retaining patient test records

As a previous CLIA inspector, our office verified with our CMS Regional Office that maintaining the info on the instrument w/o hard copies was acceptable. This was several years ago so I would verify with your CLIA office as thoughts change often.  I would highly recommend though that the instrument be backed up regularly. I had numerous facilities that would lose instrument data, examples: 1) by getting rid of instrument; 2) in a storm (flooding, power surge, etc); 3) by someone accidentally/intentionally deleting the info. I wrote numerous deficiencies in labs that failed to appropriately maintain data in their instruments by one of the above examples. Of course, hard copy data can also be lost so nothing is 100% guaranteed. 

It's great that you're being thorough with the retention requirements! According to the CLIA 493.1105 Standard, laboratories must retain patient test records, including instrument printouts, for at least 2 years 

1. This requirement ensures that all relevant data is available for review and compliance purposes.

The question about whether storing results electronically on the instrument for 2 years is acceptable is indeed valid. While the CLIA standard specifies the retention of records, it does not explicitly state the format in which these records must be kept. Therefore, if the instrument can securely store the results for the required period and these records can be retrieved and reviewed as needed, it might be considered compliant. However, it's always best to get confirmation directly from CLIA to ensure there are no specific stipulations regarding the format of record retention.

The CAP GEN.20377 requirement also emphasizes the importance of maintaining records for the specified duration 

2. Ensuring that the records are accessible and retrievable is key to meeting these standards.

Thank you all for your feedback.  I just finished a call with CLIA and was told, since they are doing waived testing, the only regulations that need followed are from the manufacturers instructions. Non-waived (mod or high complexity) tests are the only tests that require the printed results to be saved.  I didn't realize there were different record retention regulations between waived and non waived testing.