Posted by Sten Westgard, MS
My esteemed colleague, good friend, and keen-eyed tracker of all things regulatory. Dr. Sharon Ehrmeyer, alerted me to a HUGE change in US regulations.
In April CMS sent out a memo title "Policy Clarification on Acceptable Control Materials Used when Quality Control (QC) is Performed in Laboratories"
This memo may contain as big a shift in regulatory policy as IQCP was to EQC. More, after the jump...
Here are the key CMS memo paragraphs, with my emphasis added:
"The Clinical Laboratory Improvement Amendments (CLIA) Interpretive Guidelines (IGs) for the regulation at §493.1256(c) state that laboratories have traditionally tested two levels of external control materials daily, and that such testing of external controls meets the requirement for monitoring test system components, environment, and operator performance. External control materials, as described in the IGs, have a similar matrix to that of patient specimens, are treated in the same manner as patient specimens, and go through all analytic phases of testing as applicable, and they may be provided as part of the test system, provided separately, or prepared in-house.
"The IGs do not state that external control materials are the only way to meet the requirement. We believe that on-board control materials, when used as described below, can also fulfill regulatory requirement. However, we believe that electronic function checks or procedural controls, as described below, do not fulfill the regulatory requirement.
"Acceptable control materials
"Control materials that go through all elements of the analytic process must be run for each procedure per §493.1256(d)(3)(i)-(iii). With the advances in technology, certain instruments have introduced the use of on-board controls, that is, ampules or cartridges containing the same QC material that would traditionally be considered as external QC. For example, on-board control materials that have a similar matrix to that of patient specimens, are treated in the same manner as patient specimens, and go through all elements of the analytic process as applicable, will be considered acceptable to meet the regulatory requirement for control materials. The laboratory Director is responsible for the determination of what control materials to use in his/her laboratory. Surveyors will ensure that the laboratory is following its own established policies, specifically its QC procedures, in the context of the Outcome Oriented Survey Process." [Please note: my emphasis added]
Internal calibrators, almost by design and necessity, are traditionally produced by the manufacturer and consist of a matrix that is usually not commutable to a patient sample. The on-board materials are instead built to be long-lasting and easy on the machinery. It's unlikely that manufacturers are going to open up their internal systems to third-party control vendors. As much as CMS asserts that these on-board controls must be just like the external quality control materials that are traditionally run, the economics and logistical architecture will probably mean those on-board materials can only be made by the manufacturer, not by anyone independent.
What I've emphasized is that the responsibility for this shifts to the Laboratory Director. They can choose to determine that these on-board control materials are acceptable, which may or may not be true. Surely the manufacturer should be responsible for assuring that any on-board control materials are sufficiently commutable to be the equivalent of the traditional control materials.
If you're an optimist, this OBQC option means that QC can be incorporated more directly into instruments and may in fact make it easier for laboratories to operate. A more cynical viewpoint might be taken: that OBQC is going to be allowed in order to support the new IQCP regulations, particularly the reductions in QC frequency. If OBQC is acceptable, and internally it's running regularly, then it becomes more professionally palatable to reduce the traditional external QC frequency.
But beyond the immediate implications to US labs and their IQCP, another issue that jumps out at me is whether this new policy sets the US laboratory regulatory apparatus on a collision course with ISO 15189.
Note the notes in ISO 15189:2012
"220.127.116.11 Quality control materials-
Quality control materials shall react to the examination system in a manner as close to patient samples as
Quality control materials should be periodically examined along with patient samples, with a frequency that is
based on the stability of the procedure.
NOTE 1 The laboratory should choose concentrations of control materials, especially at or near clinical decision values
that ensure the validity of decisions made.
NOTE 2 Use of independent third party control materials should be considered, either instead of, or in addition to any
control materials supplied by the reagent or instrument manufacturer."
Here ISO is stating that controls should be from an independent third party, while the OBQC control materials are likely to be provided by the manufacturer directly.
In other words, if we're not careful, we may be heading toward a world where on-board QC is going to be acceptable in the US but unacceptable by any ISO 15189 accreditation system?