Friday, July 17, 2009

Where is proficiency testing for information systems?

In the laboratory, there are several components to bringing up and subsequently maintaining a laboratory test for patient care.

  1. Validation: Laboratories are required to perform validation testing on prior samples to ensure that the new test or new method is performing in a clinically meaningful manner.
  2. Post Implementation monitoring: In the initial period after a test becomes available for prospective testing on clinical patients, most laboratories perform a higher than normal level of monitoring of test performance in order to ensure that there are no problems or that any problems are resolved.
  3. Proficiency testing: Laboratories are required by College of American Pathologists and CLIA to perform periodic testing of the performance of the assay to ensure that the test that was initially validated is still performing as expected for the samples tested.
With Information Systems, regulations and accreditation hold information system support staff and faculty responsible for validation and for post-implementation (go-live) monitoring of any change to the Information systems.

However, where is the proficiency testing? We can show logs of what we have done to validate and monitor our systems, but how does any regulatory agency know that any information system is adequate for its use?
  • Can the information system handle the volume of information that it is currently being given? What if there is a sudden increase in volume?
  • What are the disaster recovery plans for the information system? Do they have backups? How quickly are those backups able to be restored? Do they have redundant hardware in case of a hardware failure?
  • How many downtimes does a system have? Why? How long are they? Is this reasonable?
  • Is the system business-continuous? Shouldn't all systems have some impetus to gain true business-continuity since healthcare is a 24/7 business with frequent time-sensitive needs to gain information?
  • How does a test order look in the entry system? Does the system require that certain fields be completed before the order is sent? Does the provider have an easy way to get help if the order that he/she is looking for is not available in the order catalog?
  • For paper orders, does the information system flag the person entering the order into the system to gather any missing information, effectively preventing them from going further until the information is acquired?
  • For non-CPOE systems, does the system allow a user to attach an order to a generic "non" physician in the ordering provider field? If it does, is there some sort of reminder to the user at a later time to update the information when possible so that the specimen can be processed in the immediate term but still reminds them to get the correct provider in a timely manner? For communication about critical or unexpected results, it is imperative to know with whom to communicate.
  • For interfaced systems, what are the limitations of the interface? What results are not crossing and cause medical staff to have to search for results on paper rather than in the LIS or EMR?
  • Do providers (including pathologists) have access to all retrospective data on all patients and not just a small subset of laboratory or other history?
These are just a few things that a well-designed proficiency testing program could objectively evaluate and grade. Grading and accrediting these systems according to best practices, regulations and standards (HIPAA, HL7, barcoding, etc.) could provide impetus for vendors to improve their software products to gain certification/accreditation that could then be used for marketing while improving the tools that laboratorians and others have to use to provide needed care to patients in an efficient and meaningful manner.


  1. It is a interesting point you raise with regards to change control when it coes to IT systems. As one of the most regulated professions in europe, IT systems aren't exempt.

  2. Hi there! great post. Thanks for sharing some very interesting and informative content it is a big help to me as well, keep it up!!!

    proficiency testing service

  3. Thank you. This is obviously a topic near and dear to my heart.