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In Office Analysis

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For in office labs the specimen is prepared for the appropriate analyzer.

The testing technician performs the analysis.

Waivered Testing

For waivered testing the results are recorded on a paper form and signed/initialed by the technician.

The results are recorded in the waivered lab testing log.

The result is reported to the ordering practitioner.

Most of the time these are done in real time with the patient on site. In our office the practitioner signs off on the waivered lab and notifies the patient.

Traditionally, Two copies must be maintained. One copy is required to be maintained in the laboratory and one copy goes to the patient medical record. In our office the paper report is scanned into the system and uploaded into the individual EMR. The original paper copy is returned to the laboratory and held in storage for a minimum of two years.

Medium and High Complexity

The medium and high complexity analyzers frequently maintain their own internal result logs and can be printed on a periodic basis.

The result is verified as valid and printed.

The result is initialed by the technician.

The result is reported to the ordering practitioner.

This copy initialed by the technician and signed by the practitioner is then scanned into the system and then uploaded into the patient EMR.

One hard copy is kept in the laboratory for future reference. This copy must contain the contact information for the laboratory including the name, address and telephone number of the laboratory, the name of the medical director, and the initials of the technician.

In the traditional lab and office. The office is required to keep a copy of the laboratory report as part of the medical record according to statute. With the advent of electronic health reocrds this has been replaced by a scanned image or when possible by discrete data that can then be statistically analyzed to assist the practitioner with clinical and disease management.

The second copy was kept by the laboratory in the event the practitioner lost their copy or the lab was somehow lost or misdirected during transport, and for outside review by (for office laboratories) CLIA. In this way the lab could be easily reproduced and reported to the practitioner. With the advent of electronic systems this requirement is also changing. The original intent was for record keeping for outside review (in our case by CLIA) and easy reporting in the event a lab did not reach its intended ordering practitioner. If the system can maintain the means to easily reproduce the laboratory result to the original ordering practitioner then a daily log of the results can satisfy the dual record requirement.

As records become more and more electronic it is necessary for the laboratory to maintain adequate electronic back-up strategies to prevent potential data loss. This is required of both the the physician's electronic health records, laboratory records and the reference laboratory.