Instrument print outs

[Likewine99]

Does anyone know the standard for record retention for printouts from an automated analyzer?

We do not plan to interface our instrument to the BB computer system at this time and for every sample tested we use an analyzer printout with additional clerical check when entering results into our BB computer system.

Any help greatly appreciated. I have posed this question to AABB, waiting for an answer, could be up to 6 weeks before they get back to me.

[Eagle Eye]

in our case we have interface with our LIS so we do not save instrument printout...and also we have all result saved in our instrument and we back up data every month.

[Malcolm Needs ☆]

You're going to love this - NOT!

30 years minimum in the UK!

:(:(

[RR1]

I would say that if you regularly audit the manual transfer of your data into the LIMS, to check for accuracy then the paper records should be kept for the lifetime of your analyser plus an additional few years.

The LIMS ultimately holds the patient blood group and screen results, which could then be held for a longer period. In the UK the fate of all blood components needs to be held for 30yrs, but this does not necessarily mean the blood group has to be held for this period.

What do we achieve by holding loads of paper records for ridiculous lengths of time ( unless they are your primary traceability system)?

[John C. Staley]

We kept the "printouts" for one week. The original electronic data was stored on CDs and kept for what ever length of time either CAP or AABB currently indicated was the longest.

When we retired the ABS2000 Immucor wrote a program for us so we could still read the discs from as far aback as 1999 when we started using the ABS2000. That way we did not have to keep the ABS2000 just in case we needed to reveiw any of those records.

:pcproblem

[clmergen]

We did the same as John while we weren't interfaced. The testing results need to be saved and those are archived on disk from the instrument. We saw no reason to save the paper.

[crldehart]

Does anyone know the standard for record retention for printouts from an automated analyzer?

We do not plan to interface our instrument to the BB computer system at this time and for every sample tested we use an analyzer printout with additional clerical check when entering results into our BB computer system.

Any help greatly appreciated. I have posed this question to AABB, waiting for an answer, could be up to 6 weeks before they get back to me.

----------------------------

I would refer you to the CAP accreditation requirements in the lab general section:

GEN.20377

Phase II

N/A YES NO

Are laboratory records and materials retained for an appropriate time?

NOTE: The following records must be retained for at least 2 years: specimen requisitions (including the patient chart or medical record only if used as the requisition), patient test results and reports, instrument printouts, accession records, quality control records, instrument maintenance records, proficiency testing records, and quality management records. Specimens of serum, heparinized plasma, EDTA plasma, CSF, and body fluids (except urine) should be retained for 48 hours. (The 48 hour retention requirement does not apply to whole blood samples; for example, samples collected for blood gas testing.) Urine specimens should be retained for 24 hours; exceptions may be made at the discretion of the laboratory director. Blood films, permanently stained body fluid slides, and permanently stained microbiology slides prepared from clinical specimens (including blood culture bottles) should be retained for 7 days.

Specimens must be kept under appropriate storage conditions.

Laboratories may wish to retain instrument maintenance records for longer than the 2-year requirement (e.g., for the life of the instrument), to facilitate trouble-shooting.

Records of method performance specifications must be retained while the method is in use, and for at least two years afterwards. For requirements on retaining records of changes to software, the test library, and major functions of laboratory information systems, please refer to the Hardware and Software section of the Laboratory Computer Services section of this checklist.

More stringent requirements for certain laboratory records (e.g., in anatomic pathology, cytopathology, transfusion medicine) may be found in the discipline-specific checklists.

For data directly transmitted from instruments to the laboratory computer system via an interface (on-line system), it is not necessary to retain paper worksheets, printouts, etc., so long as the computer retains the data for at least two years. Manual computer entry of patient result data from worksheets, print-outs, etc. requires retention of all worksheets, printouts, etc. for at least two years. For results that are manually entered into the computer from 1) observation of an electronic display, with no paper print-out available, or 2) manually performed test methods without worksheets, the two-year retention requirement applies to the data within the computer.

In establishing retention requirements, care should be taken to comply with state and federal regulations.

REFERENCES

1)

College of American Pathologists. Guidelines for the retention of laboratory records and materials. Northfield, IL: CAP, current edition

2)

Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1105]

[kate murphy]

Some states have more strigent requirements - what do you do with your manual records? Whatever applies to them, would apply to analyzer paper records.

Our instrument is not interfaced (yet!) and we do what John Staley does -download to a CD or optical disc and store those for the required time.

Just for the record, we keep ours 5 years.

[Bill]

We download to partition of hospital network that has 3 levels of back-up including off site. According to IS manager--cheapest form of record retention with best available back-ups. Instrument printout kept 2 years on network server and auto purged on day 732.