The Principles of Clinical Cytogenetics - Extra Materials - Springer

112 Michael Watson and Steven Gersen
including that in a nonelectronic form. There are three main areas of requirement. These include
monitoring and control of the uses and disclosures of protected health information (PHI), providing
patients with certain rights with respect to their PHI, and establishing and implementing certain
administrative polices and procedures to ensure maintenance of privacy. Not all rules apply
equally to clinicians and laboratories. For instance, because the laboratory is considered to have
an indirect treatment relationship with the patient, it is considered exempt from the consent requirements
that require distribution of a Notice of Privacy Practices and from obtaining the
acknowledgement. In order to extend a clinician’s patient privacy protections to third parties, they
might seek to enter into a “Business Associate Agreement.” However, where a geneticist is only
analyzing specimens to provide treatment services, they should not need to sign such an agreement.
There is a wide range of information that could be considered “individually identifiable,” including
names, social security numbers, geographic subdivisions smaller than a state, and so forth.
Care also must be taken in the use of photographs. The HIPAA privacy rules are likely to evolve as
their intent is interpreted over time. They set the floor for the protection of individual’s information.
About half of the states have enacted more specific genetic information privacy statutes.
Consultation with local or institutional compliance officers for one’s specific needs is recommended.
• Compliance training. Many labs, particularly those in commercial settings, find themselves subjected
to an increasing number of restrictions designed to prevent kickbacks” or other potentially
fraudulent finance-related practices. Although the average technologist is unlikely to be faced
with decisions that may involve such regulations, training in this area is becoming common as a
precaution.
ACKNOWLEDGMENTS AND CONTRIBUTORS
The authors would like to sincerely thank the following for their direction and generous contributions
to this chapter:
Christopher McAleer, Cellomics, Inc., Pittsburgh, PA
Renee R. Fordyce-Boyer, M.S., CLSp(CG) of the University of Nebraska Medical Center, Omaha NE
Sandra J. Bomgaars, CLSp (CG), Iowa Methodist Medical Center, Des Moines, IA
Sally J. Kochmar, M.S., CLSp(CG), Magee Women’s Hospital, Pittsburgh PA
Jay W. Moore, Ph. D., Genzyme Genetics, Tampa, FL
In addition, we would also like to thank the following for their contribution to this chapter:
Suzanne Merrick, CLSp(CG), Applied Imaging, Santa Clara, CA
Dennis Hulseberg, CLSp(CG), Denise Wilson, CLSp(CG), and Carol Johnson, CLSp(CG), University
of Iowa Hospitals and Clinics, Iowa City, IA
Matt Williams, CLSp(CG), Stanford University Hospital, Stanford, CA
Patricia Lewin, M.D., Laboratoire cerba, Val d’Oise, France
Raleigh Hankins, Ph.D., Health Sciences Research Institute, Yokohama, Japan
Lola Cartier, McGill University Health Center, Montreal, Canada
Dr. Johji Inazawa, M.D., Ph.D., Tokyo Medical and Dental University, Tokyo, Japan