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Medicare, Medicaid, and CLIA programs; Clinical Laboratory Improvement Amendments of 1988 continuance of exemption of laboratories licensed by the State of Washington--HCFA. Notice.

This notice announces that laboratories located in the State of Washington that possess a valid license under the Medical Test Site Licensure Law, Chapter 70.40 of the Revised Code of Washington (RCW), continue to be exempt from the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) until April 30, 2001.

Centers for Medicare and Medicaid Services, U.S.↗

Immigration and Naturalization Service--nonimmigrant alien (H-1) nurses; state license or examination requirements. Final rule.

This final rule requires nonimmigrant nurses to possess a valid state license to practice nursing in the United States or to have successfully passed the screening examination given by the Commission on Graduates of Foreign Nursing Schools in order to qualify for an "H-1" nonimmigrant visa classification. Proof of having met either requirement is necessary before the Service will approve the visa petition. This amendment to the regulations is necessary to ensure that only those nonimmigrant nurses who are fully qualified to perform services of the "exceptional nature" required by section 101(a)(15)(H)(i) of the Act are admitted under this classification.

Emigration and Immigration↗

Compulsory license for cable systems--Copyright Office, Library of Congress. Interim regulations.

This notice is issued to inform the public that the Copyright Office of the Library of Congress is adopting interim amendments to 201.11 and 201.17 as amended on June 27, 1978 and July 3, 1980 respectively. These regulations implement portions of section 111 of the Copyright Act of 1976, title 17 of the United States Code. That section prescribes conditions under which cable systems may obtain a compulsory license to retransmit copyrighted works, including the filing of Notices of Identity and Signal Carriage Complement and Statements of Account, and the submission of statutory royalty fees. The effect of the amendments is to modify the filing requirements and royalty fee calculations necessitated by changes in the rules and regulations of the Federal Communications Commission. The amendments are issued on an interim basis in order to permit their immediate application while allowing full public comment.

Copyright↗

Update on state licensing of radiologic technologists.

The number of states that license radiologic technologists has grown since federal legislation aimed at promoting licensure was passed in 1981. The federal government, however, has played a limited role at best in encouraging states to comply with the law, and many states still do not regulate certification of radiologic technologists.

Government↗

Careful planning of software license agreements deters disputes.

This article, part two of a three-part series on software license agreements, addresses the need to become familiar with the central provisions of such agreements. Healthcare institutions must carefully review proposed agreements to ensure the vendor meets all requirements. The best way to avoid legal disputes over breach of a contract is to carefully investigate vendors and to use an extremely detailed request for proposal. The agreement itself should specify the legal remedy to be used if a term of the contract is breached.

Capital Expenditures↗

Licensing health professionals: quality, competitive health care.

In licensing health professionals, states need to protect the public from unqualified practitioners without limiting price competition or consumer freedom. Attorneys general play a vital role in regulating professions and in protecting consumer interests in health care.

Consumer Advocacy↗

In a different voice: the attitudes of licensed practical nurses towards the future.

In the fall of 1997, the Idaho Commission of Nursing and Nursing Education undertook a survey of Idaho nurses to collect data on future workforce and educational needs. The results of the survey demonstrated substantial attitudinal differences between licensed practical nurses and registered nurses in the areas of educational motivation, role differentiation, skills by type of nurse, trends in nursing supply, and educational preparation. Given that the Idaho workforce is comparable to the national nursing workforce in numbers, educational background, and age, these findings have implications for health policy planners and nursing educators throughout the country. This article presents the findings and then uses the data as a basis for suggesting their implications for nursing education and workforce planning.

Attitude of Health Personnel↗

Pneumococcal vaccination for elderly subjects: license extension. Still no proof of clinical efficacy.

(1) In France the licensed indications of a 23-valent polyoside pneumococcal vaccine called Pneumo 23 degrees have been extended to cover people over 65. (2) The only relevant published double-blind trial showed no reduction in the risk of pneumonia or death after vaccination in this age group. Similarly, a comparative unblinded trial involving more than 26,000 elderly people showed no reduction in the risk of pneumonia. (3) Some retrospective studies suggest that the vaccine may reduce the risk of infection with bacteraemia or meningitis, with no clear protection against the serotypes usually associated with diminished susceptibility to penicillin. (4) Randomised trials have also failed to show that older pneumococcal vaccines reduce the risk of pneumonia or death. (5) The adverse effects of Pneumo 23 degrees are generally mild and local. They occur most frequently after booster injections.

Aged↗

Prediction of student performance on the Comprehensive Osteopathic Medical Licensing Examination Level I based on admission data and course performance.

To predict student performance on the Comprehensive Osteopathic Medical Licensing Examination (COMLEX-USA) Level 1 examination based on academic performance during the first 2 years, stepwise regression analysis of COMLEX-USA Level 1 performance with preadmission grade point averages, Medical College Admission Test scores, and academic performance was performed on the class of 2000 to develop three formulae that were then used to predict performance on COMLEX-USA Level 1 for the class of 2001. Models ranged in accuracy of predicting the pass/fail status from 95.2% (all available data) to 96.8% (first-year grades and admissions data). A predictive model for student performance on COMLEX-USA Level 1 can be developed and has a high degree of accuracy. The model with the most variables available to choose from predicts the most failures.

Education, Medical, Undergraduate↗

Prescribing patterns of optometrists newly licensed in therapeutic drug use in New York State.

PURPOSE: As part of the New York State law authorizing optometrists to use Therapeutic Pharmaceutical Agents (TPAs), the New York State Education Department commissioned a study to monitor and assess the prescribing patterns and competence of optometrists newly licensed to use TPAs. This report summarizes the findings of that study. METHODS: The database was obtained from more than 11,000 Patient Data Reporting Forms (PDRFs) returned by 535 optometrists, listing diagnosis, type(s) of medication(s) prescribed, treatment outcome, and possible adverse effects. RESULTS: Of the more than 11,000 forms returned by 535 optometrists, 8,936 were first visits, with 5,828 follow-up visits scheduled. For all reported initial visits, only 89 patients required ophthalmological referral for secondary or tertiary care. No adverse drug reactions requiring intervention were reported. The most-frequent diagnoses treated by optometrists were related to allergies, superficial trauma, conjunctivitis (unspecified), and then blepharitis. The most commonly prescribed ophthalmic preparations as actually reported on the PDRFs were Polytrim (trimethoprim/ polymixin B), tobramycin (brand name and generic), TobraDex (tobramycin/dexamethasone), and Livostin (levocabastine). CONCLUSIONS: When analyzed according to diagnosis, the data indicate that the prescribing patterns of the prescribing optometrists adhered to currently accepted clinical guidelines. Based on the available data and the lack of observed side effects, the use of topical medications to treat anterior-segment disease by optometrists in New York State appears to be safe, and should be of benefit to patients who seek care from optometrists.

Drug Prescriptions↗

Correlation of scores for the Comprehensive Osteopathic Medical Licensing Examination with osteopathic medical school grades.

The authors evaluated construct validity of scores for the Comprehensive Osteopathic Medical Licensing Examination (COMLEX-USA), the examination used to evaluate osteopathic physicians for licensure. They computed correlations between students' grades in the first 2 years of osteopathic medical school and their scores on the COMPLEX-USA Level 1 (N = 187) and Level 2 (N = 86), as well as correlations between third- and fourth-year clerkship grades and the COMLEX-USA Level 2. Correlations of Level 1 scores with grades for years one, two, and the first 2 years combined were .74, .80, and .81, respectively; for Level 2, correlations were .59, .70, and .71. Correlation between clerkship grades and scores for the COMLEX-USA Level 2 was .26. The strong correlation between COMLEX-USA results and grades for the didactic curriculum in the first 2 years of medical school provides evidence for the construct validity of scores for the COMLEX-USA Levels 1 and 2.

Adult↗

Residential care supply, nursing home licensing, and case mix in four states.

Simulation analyses quantify admission and continuing physical and cognitive impairment patient case-mix changes under two scenarios: with increases in residential care supply and with all nursing homes licensed only as skilled care facilities. Findings raise caution about the assumed interplay between residential care supply and nursing home use. The proportion of nursing home patients with only physical and cognitive impairment likely to be affected by current and emerging long-term care (LTC) policy was well under 25 percent of the nursing home population in each of the four study States. States varied in LTC supply and utilization controls.

Aged↗

Postmarketing studies for approved human drug and licensed biological products; status reports. Food and Drug Administration, HHS. Final rule.

The Food and Drug Administration (FDA) is revising the requirements for annual postmarketing status reports for approved human drug and biological products, and is requiring applicants to submit annual status reports for certain postmarketing studies of licensed biological products. This rule describes the types of postmarketing studies covered by these status reports, the information to be included in the reports, and the type of information that FDA would consider appropriate for public disclosure. This action will implement the Food and Drug Administration Modernization Act of 1997 (FDAMA).

Drug Approval↗

Revision to requirements for licensed Anti-Human Globulin and Blood Grouping Reagents. Food and Drug Administration, HHS. Direct final rule.

The Food and Drug Administration (FDA) is amending the biologics regulations applicable to microbiological controls for licensed Anti-Human Globulin (AHG) and Blood Grouping Reagents (BGR). FDA is amending the regulations to remove the requirements that the products be sterile. FDA is publishing this direct final rule because the requirement that these products be sterile is not necessary for the products to be safe, pure, and potent. FDA is issuing these amendments directly as a final rule because they are noncontroversial and there is little likelihood that FDA will receive any significant comments opposing the rule. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule under FDA's usual procedures for notice and comment in the event the agency receives any significant adverse comments. If FDA receives any significant adverse comment that warrants terminating the direct final rule, FDA will consider such comments on the proposed rule in developing the final rule.

Blood Banks↗