| Monday, January 01, 0001
We intend to go entirely paperless in our lab over the next year. How does CLIA feel about electronic records vs. paper records?
All regulatory agencies and accreditation agencies are struggling a bit with this. It really boils down to three points.
1. Security – Are the records safe from unwanted access? Are the records password protected? Your operating system should employ encryption software and effective firewalls to keep the data secure.
2. Accessibility – Can the lab retrieve patients records, QA data, QC data, etc. when it is needed or on demand? If records are not accessible, then the lab cannot meet the CLIA requirements.
3. Retention – Are all records retained for two years electronically and are they located in more than one system for redundancy? The records must be maintained for at least two years (longer for some specialties such as a blood bank). The records also need to be located in two different systems. For example, if the instrument retains an electronic copy of the patient report and the original printout is scanned into the EMR patient record, then the record is considered “backed up”.
For inspection purposes, the inspector will want to be able to review all required documentation. If all documentation is in an electronic format, the inspector may need help in navigating your EMR or instrument records.
My daughter is considering going into the lab field and studying to be an MT. Do you think this is a good idea with the state of the economy, etc.?
Absolutely! The lab field is in a bad situation. The nationwide shortage of qualified MTs and MLTs is reaching a critical level. Laboratory training programs are shutting down nationwide. The outcome of this will be increased salaries as the competition to retain qualified techs heats up. I would suggest she pursue a Masters in Medical Technology. This would set her apart from the rest of the field, and probably propel her into a great career.
The doctors group I work for does not want to renew the service contract for our hematology machine after the first year. Are we required to have a contract?
Technically, no. CLIA regulations require that the instrument be serviced and maintained according to the manufacturer’s guidelines. So, if the manufacturer requires preventive maintenance be performed on the instrument every six months, that maintenance must be done and it must meet the manufacturer’s guidelines. You may be able to find another company to perform the required maintenance or develop the expertise to perform the maintenance in-house, but there are risks associated with this. The necessary parts may only be available from the manufacturer and improper maintenance can void the warranty on the equipment. If the equipment ever breaks and requires service, the cost for the service outside of a maintenance contract will far outweigh cost of the contract itself. So, while it is not technically required to have a contract, it is usually in the best interest of the lab to maintain one.