Health Hippo: Labs, Diagnostic Facilities & Telemedicine

"Pursuant to a congressional request, GAO reviewed the steps that the federal government needs to take to realize the full potential of telemedicine and achieve cooperation with the private sector, focusing on: (1) the scope of public and private telemedicine investments; (2) telemedicine strategies among the Department of Defense (DOD), other federal agencies, and the private sector; (3) potential benefits that the public and private sectors may yield from telemedicine initiatives; and (4) barriers facing telemedicine implementation." Telemedicine: Federal Strategy Is Needed to Guide Investments. NSIAD/HEHS-97-67. February 14, 1997.

Not to be outdone, the U.S. Department of Commerce produced its whopper telemedicine report, focusing on the use of advanced telecommunications services for medical purposes.

This report provides a snapshot of the Federal government's activities in the area of telemedicine. Telemedicine is a rapidly evolving field, requiring flexibility and creativity to respond to its challenges. Moreover, telemedicine encompasses many legal, technical and political issues that must be resolved before it can proliferate. Thus, it will become all the more critical that the Federal government have a vehicle for coordinating its telemedicine policies and programs. ...However, Federal government agencies cannot resolve all the issues discussed in this report, alone. Congress, the states, health professionals and associations, and the private sector must come together to make telemedicine a viable health care delivery option for the United States. US DEPT OF COMMERCE: TELEMEDICINE REPORT TO CONGRESS, January 31, 1997.

Both reports provide a nice history of telemedicine and background information before focusing on problems associated with the establishment of telemedicine networks nationwide. The Commerce report outlined six steps for further action: 1) Inventory and evaluation of current telemedicine programs and resources; 2) Development of standards and guidelines for telemedicine; 3) Addressing privacy and security concerns; 4) Licensing and credentialing of telemedicine practitioners; 5) Infrastructure development, including access for rural areas; and 6) Educational opportunities for practitioners and patients. Related Links: Congressional Record 1997: Telemedicine ~ Telemedicine Bills (105th Congress)

Meanwhile, HCFA has issued a report on the availability of Medicaid payments for telemedicine, stating that while the agency "has not formally defined telemedicine, and Medicaid law does not recognize telemedicine as a distinct service.... Medicaid reimbursement for services furnished through telemedicine applications is available as an optional cost effective alternative to direct consultations or examinations, or as an element of any other Medicaid covered service." A late ammendment to the Health Insurance Portability Act requires HCFA to complete a report by March 1, 1997, addressing Medicare reimbursement of telemedicine services.

AMA has reportedly taken the surprising position that state medical boards should require full licensure of physicians who "regularly practice telemedicine" in a state. That position is contrary to the "limited licensure" approach taken by the Federation of State Medical Boards in its report on telemedicine.

• 42 USC Sec. 263a. Certification of laboratories
• 42 USC Sec. 263a-1. Assisted reproductive technology programs
• 42 USC Sec. 263a-2. Certification of embryo laboratories
• 42 USC Sec. 263a-3. Accreditation organizations
• 42 USC Sec. 263a-4. Certification revocation and suspension
• 42 USC Sec. 263a-5. Publication
• 42 USC Sec. 263a-6. Fees
• 42 USC Sec. 263a-7. Definitions
• 42 USC Sec. 263b. Certification of mammography facilities
• 42 USC Sec. 1395nn. Limitation on certain physician referrals
• 42 USC Sec. 1395w-2. Intermediate sanctions for providers or suppliers of clinical diagnostic laboratory tests
• 42 USC Sec. 10001. CONSUMER-PATIENT RADIATION HEALTH AND SAFETY
  • 42 USC Sec. 10002. Statement of purpose
  • 42 USC Sec. 10003. Definitions
  • 42 USC Sec. 10004. Promulgation of standards
  • 42 USC Sec. 10005. Model statute
  • 42 USC Sec. 10006. Compliance
  • 42 USC Sec. 10007. Federal radiation guidelines
  • 42 USC Sec. 10008. Applicability to Federal agencies

• CLIA and the POL There are 13 subparts to the CLIA regulations. Not all subparts are reproduced here.
• 42 CFR PART 493 - LABORATORY REQUIREMENTS
• 42 CFR Sec. 410.32 Diagnostic X-ray tests, diagnostic laboratory tests,

• Congress: Telemedicine
• Telemedicine Bills (105th)
• Search Telemedicine
  • AltaVista ~ Excite! ~ HotBot
• Congress: Mammography
• Mammography Bills (105th)

• Mammography Services: Initial Impact of New Federal Law Has Been Positive (Letter Report, 10/27/95, GAO/HEHS-96-17). Pursuant to a legislative requirement, GAO examined whether the Food and Drug Administration's (FDA) implementation of the Mammography Quality Standards Act has had any effect on the: (1) quality of mammography services; and (2) access to such services.
• FDA's Mammography Inspections: While Some Problems Need Attention, Facility Compliance Is Growing (Letter Report, 01/27/97, GAO/HEHS-97-25). Pursuant to a legislative requirement, GAO reviewed the Food and Drug Administration's (FDA) program for implementing the requirements of the Mammography Quality Standards Act of 1992
• Publication of the OIG Model Compliance Plan for Clinical Laboratories, [Federal Register: March 3, 1997 (Volume 62, Number 41)] [Notices] [Page 9435-9441]. This Federal Register notice sets forth the recently issued model compliance plan for clinical laboratories developed by the Office of Inspector General in cooperation with, and input from, several provider groups and industry representatives.
• FDA Laboratories: Magnitude of Benefits Associated With Consolidation Is Questionable (Letter Report, 03/19/96, GAO/HEHS-96-30). Pursuant to a congressional request, GAO reviewed the Food and Drug Administration's (FDA) plan to consolidate its Office of Regulatory Affairs' (ORA) 18 field laboratories for product testing.
• HHS: Survey Shows Promise and Challenge of Rural Telemedicine
• Exploratory Evaluation of Rural Applications of Telemedicine
• Administration-Sponsored Report on Telemedicine Now Available
• AHCPR To Demonstrate Use Of Computerized Decision-Support Software In Clinical Practice
• American Association of Clinical Chemistry Clinical chemistry is the use of chemical processes in a clinical setting to evaluate patient health. It is one of several specialties -- such as microbiology, pathology, molecular biology or hematology.
• American Association of Electrodiagnostic Medicine The primary goal of the AAEM is to increase the quality of patient care by contributing to steady improvement in the methods of electrodiagnostic medicine.
• American Institute of Ultrasound in Medicine The American Institute of Ultrasound in Medicine is dedicated to advancing the art and science of ultrasound in medicine and research. Its activities are professional, educational, literary and scientific.
• Computers and Health's Hospital Information: listserv@usa.net National Report on Computers and Health's Hospital Information Systems Issues. Send the following message: subscribe nrch yourfirstname yourlastname
• Listing of FDA Certified Mammography Facilities If you click on Search for FDA Certified Mammography Facilities in your area you can access a listing by state and zip code of all mammography facilities certified by the Food and Drug Administration (FDA) as meeting baseline quality standards for equipment, personnel and practices under the Mammography Quality Standards Act of 1992 (MQSA).
• FDA Consumer Reprint--Mammography Facilities Must Meet Quality Standards Last December, the Food and Drug Administration published in the Federal Register interim final regulations intended to ensure that all mammography done in the United States is safe and reliable.
• Global Health Network, Laboratory Page The laboratory home page has been designed for academic, commercial, government and hospital biomedical laboratories.
• Mammography Basic Principles Mammography has been used in clinical practice since 1927 in the diagnosis of breast abnormalities.
• NCI/PDQ Cancer Facts: NCI Director Stresses Importance of Mammography - Updated 12/95 An estimated 182,000 women in the United States will be newly diagnosed with breast cancer this year alone, and some 46,000 women will die from the disease.
• NOKLUS: External quality assurance in Norwegian primary health care In 1992 the Norwegian health authorities and the Norwegian Medical Association made a joint project to secure the quality of laboratory analyses performed in primary health care.
• Quality Standards Compliance for Mammography Facilities By October 1, 1994, all U.S. mammography facilities, except those managed by the Department of Veterans Affairs, must be certified by the Food and Drug Administration (FDA) to legally continue to provide mammography services.
• REINHART, BOERNER: HCFA INVESTIGATES PHYSICIANS' OFFICE LABORATORIES Physicians who perform laboratory tests in their offices will face increasing scrutiny from the Health Care Financing Administration ("HCFA") in the coming months.
• RULES GOVERNING QUALITY ASSURANCE FOR IDAHO CLINICAL LABORATORIES "Laboratory" means not only facilities for biological, serological, biophysical, cytological and pathological tests but, also facilities for the chemical or other examinations of material from water, air or other substances.
• Subscribe to MEDLAB-L To subscribe, send e-mail to LISTSERV@ubvm.cc.buffalo.edu and in the body of the message, type:subscribe MEDLAB-L Your Name
• Tulane: Clinical Laboratory Electronic Reference Department of Pathology and Laboratory Medicine Tulane Hospital Clinical Laboratories.
• Y-ME National Breast Cancer Organization Y-ME National Breast Cancer Organization has a commitment to provide information and support to anyone who has been touched by breast cancer.

• Telemedicine: Federal Strategy Is Needed to Guide Investments (Chapter Report, 02/14/97, GAO/NSIAD/HEHS-97-67). Pursuant to a congressional request, GAO reviewed the steps that the federal government needs to take to realize the full potential of telemedicine and achieve cooperation with the private sector
• Information Security: Computer Hacker Information Available on the Internet (Stmnt. for the Rec., 06/05/96, GAO/T-AIMD-96-108). GAO discussed the importance of computer security and hacker information available on the Internet.
• Arent Fox Telemedicine Welcome to Telemedicine & the Law. This site, developed by Arent Fox, systems, computerized decision support technologies and telemedicine.
• Arent Fox: Health Information Systems and Telemedicine Still the best for legal aspects telemedicine.
• Georgia Statewide Academic and Medical System "No other state has invested as much in distance learning and telemedicine as has Georgia."-- Governor Zell Miller
• Hardin Meta Directory of Internet Sources - Telemedicine Metatelemedicine!
• TIE home page TIE attempts to provide an all-inclusive platform without bias for all information on telemedicine. Inclusion of items in the TIE does not necessarily infer endorsement by the Telemedicine Research Center.
• US DEPT OF COMMERCE: TELEMEDICINE REPORT TO CONGRESS Congress has asked the Secretary of Commerce, in consultation with the Secretary of Health and Human Services and other appropriate departments and agencies, to submit a report on the use of advanced telecommunications services for medical purposes.
• TeleSCAN : Telematics Services in Cancer TeleSCAN provides links and information for the general public, for medical professionals, and researchers.
• Telemedicine Glossary We have tried to define most terms of importance in this arena of rapidly changing technologies.
• An Act to Regulate the Practice of Medicine Across State Lines
• <STAT> Magazine Alaska Telemedicine Projects.
• Telemedicine: Legal & Ethical Issues Telemedicine Information Exchange Database Search Results
• CommonHealthNet
• Medical Informaticians and Telemedicalists Telemedicine links.
• The OUHSC Cardiovascular Section EINTHOVEN system for analyzing electrocardiograms (EKGs).