November 15, 2011 - ASM Comments on CLIA Program and HIPAA Privacy Rule

Centers for Medicare and Medicaid Services (CMS), HHS
Centers for Disease Control and Prevention (CDC), HHS
Office for Civil Rights (OCR), HHS

Re: File Code CMS-2319-P

The American Society for Microbiology (ASM) appreciates the opportunity to provide written comments to CMS, CDC, and OCR on the proposed rule “CLIA Program and HIPAA Privacy Rule; Patients’ Access to Test Reports.”  The ASM is the largest educational, professional and scientific society dedicated to the advancement of the microbiological sciences and their application for the common good with over 38,000 members worldwide. Its 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. The ASM’s mission is to advance the microbiological sciences as a vehicle for understanding life processes and to apply and communicate this knowledge for the improvement of health, environmental, and economic well being worldwide.

Many of ASM’s members have primary involvement in clinical laboratory medicine including individuals directing clinical microbiology, immunology and molecular diagnostic laboratories, individuals licensed or certified to perform such testing, industry representatives marketing products for use, and researchers involved in developing and evaluating new technologies.  Therefore, the ASM has significant interest in all proposals pertaining to the regulation of clinical laboratory medicine.

With regard to the proposed changes, the ASM would like to offer the following comments:

  1. We applaud HHS for proposing federal regulatory changes that will allow patients the right to obtain the essential healthcare information presented as laboratory data from CLIA-certified diagnostic laboratories. Personal access to healthcare data is a cornerstone of patient centered healthcare. Given that a significant proportion of medical decision making is based on laboratory data, access to laboratory data on request is an important component of patient awareness. Harmonization of currently varying state regulations to a single federal standard will insure universal patient access to laboratory data.

  2. We encourage HHS and its regulatory entities to provide guidance to CLIA-certified laboratories to ensure all aspects of privacy and security guaranteed by HIPAA are met. Issues including mechanism for laboratories to receive requests, methods for transmitting data, approaches to verifying receipt by an authorized individual other than a healthcare provider, and interpretation of data by recipients are all critical to insure laboratory reports are used as intended, that is, to inform consumers regarding their personal health. To this end, we suggest that HHS specifically survey CLIA-certified laboratories located in states in which direct patient reporting is already allowed to assess current mechanisms that are in place. This information should then serve as the basis for HHS to develop a written regulatory guidance document for clinical laboratories to use in establishing a program that is in compliance with all applicable transfederal regulations

  3. Laboratory data provided by clinical laboratories using microbiologic, immunologic, or molecular diagnostic methods tend to be relatively complex and there is at present no standardization of data elements. Further, a single report may include multiple inter-related findings that cannot be easily interpreted. While the complexity of reports should not be a deterrent to patient access, it does suggest a need for a reliable mechanism to provide interpretation. We recommend that language be included in the proposed changes to CLIA that requires that direct patient communication initiated by the patient for the express purpose of understanding a report (i.e. a request for an interpretation) be provided by individuals meeting CLIA requirements for Laboratory Director including certification by an HHS-approved board. The ASM certifies laboratory directors through two such Boards, the American Board of Medical Microbiology and The American Board of Medical Laboratory Immunology.

  4. A complete understanding of laboratory data, particularly data provided by laboratory scientists represented by The ASM, can only be appreciated through collaborative efforts between a patient requesting laboratory data, the laboratory providing the data, and the healthcare provider initially ordering laboratory tests. The process of requesting laboratory procedures and receiving and responding to data by an ordering provider is incredibly complex in the current healthcare system. It has been documented that there is a significant risk of failure to inform patients of clinically significant tests results due to the complexity (Casalino, et al; Arch Int Med 2009; 169: 1123-9 and Hickner et al; Qual Saf Health Care 2008; 17: 194-200). Thus, a process that allows patients to directly follow-up on results of laboratory testing provides another system checkpoint. However, it seems advisable for laboratories to inform ordering providers of release of data directly to patients as yet another system checkpoint. As suggested previously, The ASM would strongly encourage HHS to survey CLIA-certified laboratories in states in which provider notification of results release is required to determine how this is accomplished and whether the approach is considered essential.

  5. Lastly, ASM stakeholders have expressed concern over the assumptions regarding impact and costs presented in the proposal. Laboratories not already engaged in issuing direct patient reports will have to expend significant resources on developing a compliant process. This comes at a time when laboratories are already challenged by IT requirements for implementation of ICD-10 elements. In addition, laboratories are operating under a workforce shortage imposed by both lack of qualified personnel and economic restrictions. A requirement making laboratories responsible for insuring direct patient access to reports does represent another unfunded mandate. We encourage HHS to determine specific costs and resources expended from states and laboratories already releasing data to patients. In addition, the proposal should allow for flexibility for responsibility in providing reports. For example, the proposed CLIA language might be altered slightly as “Upon a patient’s request, the laboratory or an authorized medical record representative, may provide access to completed test reports…”

Once again, The ASM would like to thank HHS and its regulatory agencies for the opportunity to comment on this proposed change. Clearly, patient access to data, including laboratory data, is an important facet of patient centered healthcare and consumer awareness. ASM has been involved for over a decade through the Lab-Tests-On-Line program with insuring that consumers have access to general educational information about laboratory tests and the data they provide. The ASM stands ready to assist HHS on request in implementing patient access to data in a protected and reliable manner.


Vickie Baselski, Ph.D., Chair, Professional Affairs Committee
Public and Scientific Affairs Board