Approval of the Commission on Office Laboratory Accreditation--HCFA. Notice

This notice announces the approval of the Commission on Office Laboratory Accreditation (COLA) as an accrediting organization for clinical laboratories under the CLIA program. We have found that the accreditation process of this organization provides reasonable assurance that the laboratories accredited by it meet the conditions required by Federal law and regulations. Consequently, laboratories that voluntarily become accredited by COLA in lieu of receiving direct Federal oversight and continue to meet COLA requirements would meet the CLIA condition level requirements for laboratories and therefore are not subject to routine inspection by State survey agencies to determine their compliance with Federal requirements. They are, however, subject to validation and complaint investigation surveys.     

The transfer of Federal technology and the community college

The State of Ohio has developed a transfer mechanism using its technical and community colleges. A pilot program began in 1979. The program includes eleven of the State's technical and community colleges and the Ohio State University acting as program manager. This paper reports on a program which is a cooperative effort with the Federal Laboratory Consortium that represents some 200 Federal laboratories and the Ohio technical and community college network. The role of the Ohio Technology Transfer Organization (OTTO) is explained and Federal Laboratory Consortium demonstration projects are discussed.     

Approval of the Commission on Office Laboratory Accreditation for Immunohematology--HCFA. Notice

This notice announces the approval of the Commission on Office Laboratory Accreditation (COLA), which is an accrediting organization for clinical laboratories under the Clinical Laboratory Improvement Amendments (CLIA) program, for the addition of the full specialty of immunohematology. This approval adds immunohematology to the specialties and subspecialties approved by HCFA in a notice published in the Federal Register on December 23, 1993 (58 FR 68148). We have found that the accreditation process of this organization provides reasonable assurance that the laboratories accredited by it for immunohematology meet the conditions required by Federal law and regulations. Consequently, laboratories that voluntarily become accredited by COLA for the specialty of immunohematology in lieu of receiving direct Federal oversight and continue to meet COLA requirements would meet the CLIA immunohematology condition level requirements for laboratories. These laboratories performing immunohematology testing are not subject to routine inspection by State survey agencies to determine their compliance with applicable Federal requirements. They are, however, subject to validation and complaint investigation surveys.     

CLIA program; approval of the College of American Pathologists--HCFA. Notice

This notice announces the approval of the College of American Pathologists (CAP) as an accrediting organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. We have found that the accreditation process of this organization provides reasonable assurance that the laboratories accredited by it meet the conditions required by Federal law and regulations. Consequently, laboratories that voluntarily become accredited by CAP in lieu of receiving direct Federal oversight and continue to meet CAP requirements would meet the CLIA condition level requirements for laboratories and therefore are not subject to routine inspection by State survey agencies to determine their compliance with Federal requirements. They are, however, subject to validation and complaint investigation surveys.     

Maintaining the high-tech edge: Governmentindustry technology transfer and the federal laboratory system in California

One of the important resources to any state, such as California, is the technology that is available from the many federally operated and/or funded laboratories within its borders. In this age of technology a state needs to take advantage of applications of modern technology and innovative exploitation of human and natural resources. This article illuminates the importance of the Federal Government research laboratories. Many examples are presented to support the argument that the Federal Government research laboratories can be and often are substantial contributors to the storehouse of technology that finds its way to the private sector and public sector. Several types of technology transfer are discussed, i.e. primary technology, secondary applications, mission related, technical assistance and cooperative. In addition the article discusses the structure and logic of the Federal Laboratory Consortium for Technology Transfer (FLC). The legislaltion that has helped to make the FLC effective is discussed. Included in the discussion are insights of how the FLC operates and how the private sector and public sector may use the FLC in order to locate process, product and service technology.     

Solicitation of information and recommendations for developing OIG compliance program guidance for certain Medicare+Choice organizations--OIG, HHS. Notice

This Federal Register notice seeks the input and recommendations of interested parties into the OIG's development of a compliance program guidance for Medicare+Choice organizations that offer coordinated care plans (M+CO/CCPs). The OIG has previously developed compliance program guidances for hospitals, clinical laboratories and home health agencies in order to provide clear and meaningful guidance to those segments of the health care industry. In an effort to provide similar guidance to certain M+C organizations, we are soliciting comments, recommendations and other suggestions from concerned parties and organizations on how best to develop compliance program guidance and reduce fraud and abuse within M+CO/CCPs.     

Publication of the OIG compliance program guidance for hospitals--OIG. Notice

This Federal Register notice sets forth the recently issued compliance program guidance for hospitals developed by the Office of Inspector General (OIG) in cooperation with, and with input from, several provider groups and industry representatives. Many providers and provider organizations have expressed an interest in better protecting their operations from fraud and abuse through the adoption of voluntary compliance programs. The first compliance guidance, addressing clinical laboratories, was prepared by the OIG and published in the Federal Register on March 3, 1997. We believe the development of this second program guidance, for hospitals, will continue as a positive step towards promoting a higher level of ethical and lawful conduct throughout the health care industry.     

Solicitation of information and recommendations for developing OIG compliance program guidance for the durable medical equipment industry--HHS. Notice

This Federal Register notice seeks the input and recommendations of interested parties into the OIG's development of a compliance program guidance for the durable medical equipment (DME) industry, its providers and suppliers. Many providers and provider organizations have expressed an interest in better protecting their operations from fraud and abuse. Previously, the OIG has developed compliance program guidances for hospitals, clinical laboratories and home health agencies. In order to provide clear and meaningful guidance to those segments of the health care industry involved in the supply and distribution of DME, we are soliciting comments, recommendations and other suggestions from concerned parties and organizations on how best to develop compliance program guidance and reduce fraud and abuse within the DME industry.     

Lessons from history: Origins of the federal laboratory consortium for technology transfer

Editor’s Note: The Federal Laboratory Consortium today consists of over 600 member research laboratories and centers from 16 federal departments and agencies. The FLC brings these laboratories together with potential users of government-developed technologies in the private sector and state and local governments. The FLC also develops and tests transfer mechanisms, addresses barriers to the transfer process, provides training, highlights grass-roots transfer efforts and focuses on national initiatives where technology transfer has a role. The author played a pivotal role in establishing the Consortium and managing the network during its early years.     

Meeting state and local government needs by transfer of Federal laboratory technology

The need of State and local governments to deal with an increasing range of technological problems has led to the development of relatively new ways to call on Federal laboratories. This paper discusses the structure of these mechanisms for technology transfer, organizations involved in the systems that have developed, trends that affect these organizations and current problem areas.     

Technology transfer legislation: An overview

This article provides an overview of the Federal legislation on technology transfer beginning with the Bayh-Dole and Stevenson-Wydler acts of 1980 and ending with the 1987 Executive Order, “Facilitating Access to Science and Technology.” The legislation and Executive Order provide the context for Federal laboratory technology transfer activities. The article covers the historic development of transfer legislation, the authorities given to laboratories, incentives for technology transfer provided by legislation, and the mandated duties and responsibilities of ORTAs, organizations, and agencies.     

Promoting small business through public-sector technology transfer

It is generally concluded that small businesses are the most effective institutional mechanism for the execution of technological innovation in the United States. Federal legislation provides for special considerations to be rendered to small businesses when public-sector technology is to be transferred to the private sector. Nevertheless, the activities of many federal laboratories lag in the transfer of technology to small businesses relative to large businesses. This paper examines the reasons for the current low level of interaction between federal laboratories and small businesses including the constraints typically encountered in working with small businesses. Recommendations are made to enhance the lab/small-business relationship. Finally, a sample program at Sandia National Laboratory for assistance to small businesses is described.     

The FAA's postmortem forensic toxicology self-evaluated proficiency test program: the first seven years

Existing proficiency-testing (PT) programs do not address the complexity of postmortem forensic toxicology. These programs do not include decomposed samples and solid tissues. Therefore, the Federal Aviation Administration in July 1991 started such a needed PT program. This program is used to: (i) professionally develop and maintain technical currency on a voluntary, interlaboratory, and self-evaluation basis, and (ii) quantifiably assess methods in the absence and presence of interfering substances. There are currently about 30 laboratories in the program. Functioning under various governmental/non-governmental agencies and academic institutions, these laboratories represent a broad cross-section of the country. PT samples are distributed quarterly, and result summaries are sent to the participants, while maintaining their anonymity. Since the inception of the program, 28 PT samples encompassing whole blood, plasma, urine, kidney, or liver, with (or without) drugs, metabolites, and common chemicals (nicotine, caffeine, beta-phenylethylamine, etc.) have been analyzed by the participants. Analytical findings were generally consistent with the anticipated values, but they were dependent on the nature and conditions of the specimens and types of the added analytes. Some incidences of false positives of concern were noted, as well. This PT program is one of the few programs recommended by the American Board of Forensic Toxicology in which laboratories may participate for their accreditation by the Board. It is anticipated that this PT program will continue to play a critical part in supporting the quality assurance/quality control (QA/QC) component of forensic toxicology, thereby enhancing operational performance.     

Publication of OIG compliance program guidance for clinical laboratories--HHS. Notice

This Federal Register notice sets forth the OIG's recently-issued Compliance Program Guidance for Clinical Laboratories. The OIG had previously developed and published a model compliance plan for the clinical laboratory industry on March 3, 1997. This Compliance Program Guidance for Clinical Laboratories is intended to be more consistent with compliance program guidances issued by the OIG with respect to the hospital industry and to home health agencies, and serves to clarify various aspects of the original model plan. As with previously-issued compliance program guidances, we believe that the development of this guidance for clinical laboratories will continue as a positive step towards promoting a higher level of ethical and lawful conduct throughout the entire health care community.     

Federal Employees Health Benefits Program improving carrier performance; conforming changes--OPM. Final rule

The Office of Personnel Management (OPM) is issuing a final regulation that implements OPM's initiative to ensure high quality customer service to its enrollees in the Federal Employees Health Benefits (FEHB) Program by establishing a performance evaluation program that will hold community-rated carriers accountable for their performance. The regulation would enable OPM to better manage carriers' performance in key contract areas, including customer service measures, information and reporting requirements, and significant events that might affect service to enrollees.     

Hazardous waste management programs; Florida: authorization for interim authorization phase I--Environmental Protection Agency. Notice of final determination

The State of Florida has applied for interim Authorization Phase I. EPA has reviewed Florida's application for Phase I and has determined that Florida's hazardous waste program is substantially equivalent to the Federal program covered by Phase I. The State of Florida is, hereby, granted Interim Authorization for Phase I to operate the State 's hazardous waste program, in lieu of the Federal program.     

Current list of laboratories which meet minimum standards to engage in urine drug testing for federal agencies--ADAMHA. Notice

The Department of Health and Human Services notifies Federal agencies of the laboratories currently certified to meet standards of subpart C of Mandatory Guidelines for Federal Workplace Drug Testing Programs (53 FR 11986). Starting this month, a similar notice listing all currently certified laboratories will be published monthly, and updated to include laboratories which subsequently apply and complete the certification process. If any listed laboratory fails to maintain its certification, it will be omitted from updated lists until such time as it is restored to full certification under the Guidelines.     

Evaluation of technology transfer by peer review

We report the outcome of an experiment in the field of program evaluation. Because of the rapid outward growth of technology transfer from federally funded laboratories, it was judged necessary to devise a new, yet effective, way of evaluating technology transfer programs and comparing them to conventional research and development projects. Specifically, technology transfer projects within the High-Temperature Superconductivity program of the Department of Energy were subjected to peer review evaluation by a panel of researchers who themselves conduct technology transfer activities. The evaluation criteria and procedures resembled those used for peer review of basic research, but were adapted to the characteristics of technology transfer projects. We include both the viewpoints of a laboratory being evaluated and of the panel chairman. We comment on the degree of success of this evaluation, and draw some conclusions about how it might be modified for the future.     

The hair analysis proficiency testing program of the French Society of Analytical Toxicology

In an effort to improve laboratories performing hair analysis in forensic cases, the French Society of Analytical Toxicology (S.F.T.A.) has implemented a proficiency testing program since 1992. Actually about 10 laboratories are participating. Each survey is dedicated to one analyte or one pharmacological class: opiates (6-monoacetylmorphine, morphine and codeine), cocaine and benzoylecgonine, tetrahydrocannabinol, buprenorphine and norbuprenorphine, beta-blockers (metoprolol, atenolol), beta 2-agonists (salbutamol, clenbuterol). Animal hair was tested for clenbuterol. Prior to sending, hair samples were reduced to a powdered form, well mixed to ensure homogeneity, and then tested by GC/MS or HPLC/MS. Results confirm those obtained in a preliminary study on opiates and cocaine analysis in hair: a common analytical procedure has to be used by all the participants, including hydrolysis of hair. It is essential to work on authentic drug-positive hair samples and not on spiked samples. Participation at this program is free of charge and considered as an educational tool. Comparison of the results with those of other laboratories in Europe and USA shows that the analytical methods used during this program are in accordance with all the other procedures.