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Subj: Improving Diagnostic Quality and Safety: Draft Report

Dear Sir/Madam:

The American Association for Clinical Chemistry (AACC) welcomes the opportunity to comment on the National Quality Forum’s (NQF’s) Diagnostic Quality and Safety Committee’s draft framework for measuring diagnostic quality and safety. AACC commends the panel for its well-designed, thoughtful approach for gathering and evaluating patient and clinical data that can be used to improve the delivery of care.

AACC is a global scientific and medical professional organization dedicated to clinical laboratory science and its application to healthcare. AACC brings together more than 50,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of progressing laboratory science. Since 1948, AACC has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation.

Patient, Families, and Caregivers
AACC agrees that patients need to understand the diagnostic information pertaining to their condition. Developing measures that assess whether patients comprehend their medical situation is important to engaging them in decisions affecting their health.

Diagnostic Process
AACC agrees that further evaluation of diagnostic management teams is warranted. Studies indicate that many providers are uncertain about what laboratory tests to order1 or how to interpret test results.2 Initial reports indicate the inclusion of laboratory professionals within diagnostic management teams can minimize these problems, while improving patient care and reducing healthcare costs.3 AACC urges the committee to add laboratory professionals to the list of experts comprising these teams. For example, the fourth measure concept in the table on page 11 should read: “Proportion of diagnostic evaluations with appropriate patient and inter-professional team involvement (e.g., nurses, physicians, pharmacists, laboratory professionals).”

Relatedly, AACC agrees that disease specific measures need to be developed to ensure that the appropriate tests are ordered in accordance with evidence-based guidelines. We agree that measures should also be developed to assess the underutilization of laboratory tests—this may be as serious a problem as overutilization.4 We also concur that processes should be in place to ‘reconcile’ conflicting results/interpretations for a health condition.

AACC strongly supports the development of measures that promote clinicians receiving test results, particularly abnormal findings, in a timely manner. This has been a problem in newborn screening, where results have delayed due to administrative and staffing issues.5 Putting quality measures in place may spur providers to create a process for ensuring test results are performed and reported without undue delay.

Organizational and Policy Issues
AACC agrees that measures should be developed to evaluate whether individuals have appropriate access to testing for common conditions, including rapid or point-of-care testing to help in critical diagnostic decision making.

We also support assessing whether healthcare providers have sufficient employees available to perform critical diagnostic specialties, such as laboratory testing. A study of the British National Health Service reported that a shortage in laboratory personnel contributed to an “increased error rate, poor team spirit, diminished productivity and suboptimal laboratory service delivery.”6 Adequate numbers of personnel are vital to providing quality, patient care.

We look forward to continuing to work with you on this important issue. If you have any questions, please email Vince Stine, PhD, AACC Director of Government Affairs, at [email protected].


Michael J. Bennett PhD, FRCPath, FACB, DABCC
President, AACC


1 Marques MB, Hickner J, et al. Primary Care Physicians and the Laboratory. Am J Clin Pathol 2014; 142:738-740

2 Hickner J, Thompson PJ, et al. Primary Care Physicians’ Challenges in Ordering Clinical Laboratory Tests and Interpreting Results. JABFM 2014; 27:268-274

3 Laposata M. How Can a Diagnostic Management Team Improve Patient Care and Save Money? Long-Standing and Rapidly Worsening Problem of Obtaining An Accurate Diagnosis Quickly. CLN June 4, 2014; Seegmiller A, Kim A (2013) Optimizing Personalized Bone Marrow Testing Using an Evidence-based, Interdisciplinary Team Approach. Am J Clin Pathol; 140(5): 643– 650. doi:10.1309/AJCP8CKE9NEINQFL.

4 Zhi M, Ding EL, Theisen-Toupal J, Whelan J, Arnaout R (2013) The Landscape of Inappropriate Laboratory Testing: A 15- Year Meta-Analysis. PLoS ONE 8(11): e78962. doi:10.1371/journal.pone.0078962

5 Government Accountability Office. Newborn Screening Timelines: Most States Had Not Met Screening Goals, but Some are Developed Strategies to Address Barriers. December 2016.

6 Chima, Erhabor Osaro Njemanze (2014). Challenges of a negative work load and implications on morale, productivity and quality of service delivered in NHS laboratories in England. Asian Pacific journal of tropical biomedicine. (6), p. 421 - 429. (ISSN: 2221-1691)