ASM Poses Questions to CMS on Implementation of IQCP

Sept. 8, 2015


Andrew Slavitt, Acting Administrator
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244
RE: IQCP Impact on Clinical Microbiology Laboratories

Dear Mr. Slavitt:

The American Society for Microbiology (ASM) strongly supports quality improvement measures which have the potential to impact patient care positively and the services that clinical microbiology laboratories offer.  However, it is difficult to see how the new Individualized Quality Control Plan (IQCP) will affect positive outcomes for our patients with most tests performed in the clinical microbiology laboratory.   Consequently, as ASM assists clinical microbiology laboratories in the development of their IQCPs, many concerns have been raised and brought to our attention as outlined below.  We would appreciate responses to the questions below to enable the ASM to guide clinical laboratories that need advice in implementation of IQCP. 

Questions for CMS Response:

1.  The IQCP program seems to have been developed to address quality issues that occur primarily with the non-microbiology sub-specialty areas of the laboratory.  The unique tests in clinical microbiology such as media quality control, identification testing, and susceptibility testing are not improved or enhanced with the addition of IQCP.
 
Question:  Are there any data or other information available specifically related to clinical microbiology tests to demonstrate that IQCP would improve patient outcomes?  As clinical scientists, we rely on evidence-based medicine to guide our practice.  Having these data is critical to help laboratories understand the value of IQCP and to further motivate them to allocate their already limited resources to this time consuming effort.  If there are no clinical data to support that IQCP helps to effect positive patient outcomes for clinical microbiology tests, requiring clinical microbiology laboratories to implement this alternative QC or return to default CLIA QC in lieu of equivalent QC, cannot be supported. 

2.  The reason why CMS removed references to the CLSI documents for antimicrobial susceptibility testing (CLSI M100-S25, M02-A11, M07-A10), streamlined QC of identification tests (CLSI M50-A) and QC of media (NCCLS M22-A3) is understood.  However, it is unlikely that the development of IQCPs for these tests will discover that additional QC (above that recommended by the CLSI, which is evidence-based and statistically proven) will lead to improved patient care.  For decades, the QC recommendations in the CLSI documents have been demonstrated to adequately identify system problems, and such issues have been thoroughly vetted by experienced members of CLSI comprised of doctorate level scientists and other members.  To have to justify the reliability of the CLSI QC recommendations now seems little more than an “exercise.” 

Question:  Are there plans for CMS to reexamine the amount of QC required according to CLIA ’88 for antimicrobial susceptibility testing, QC of identification tests and commercially prepared media?   

Question:  Most clinical microbiology laboratories have access to the CLSI documents.  Why is continuation of their use not an option for laboratories with access to these documents? Following the CLIA regulations or development of an IQCP could be an alternative for laboratories that elect not to purchase CLSI documents or follow the recommendations of the CLSI.  Laboratories must allocate resources to educational materials/activities, and it would be their choice as to whether or not to procure CLSI documents and/or pursue IQCP for the testing systems.

3. It appears IQCP is focused on the number of and frequency at which QC samples must be tested.  There are many tests in clinical microbiology where additional QC does nothing to prevent reporting erroneous results on patient isolates or samples.  For example, daily QC testing with antimicrobial susceptibility tests will not prevent a laboratory from reporting results from testing a mixed population of organisms.  Similarly, testing commercially prepared “exempt” media with QC strains will not prevent a technologist from choosing a poor portion of a sputum sample for plating onto a blood agar plate.  Also, daily external QC of self-contained molecular tests that have internal controls does not mitigate the risk of cartridge-specific errors or inadequate specimen collection. 

Question:  During the IQCP development process, did CMS discuss other measures that might be of greater benefit to clinical microbiology than generating an IQCP?  Analogous to tests performed in anatomic pathology and cytology, is it possible to exempt clinical microbiology tests from IQCP?  We recommend that CMS consider alternative approaches to IQCP for clinical microbiology, and ASM is more than willing to have its members assist CMS in this endeavor.

We appreciate your time and attention to this letter and hope that CMS will reconsider IQCP for clinical microbiology laboratory testing and work with ASM member experts on the important issue of improving patient care through quality efforts in clinical microbiology testing. 

The American Society for Microbiology is the world's largest scientific Society, comprised of over 40,000 professionals in the microbiological sciences.  ASM members work in educational, research, industrial, and government settings on issues such as the environment, the prevention and treatment of infectious diseases, laboratory and diagnostic medicine, and food and water safety.  Many of ASM’s members have primary involvement in clinical laboratory medicine including individuals directing clinical microbiology, immunology and molecular diagnostic laboratories.

Please send any requests for clarification in care of Kimberly Walker at kwalker@asmusa.org for immediate attention.

Sincerely,

Melissa B. Miller, Ph.D., D(ABMM), Chair, ASM Committee on Laboratory Practices