Medicare, Medicaid, and CLIA programs; extension of certain effective dates for clinical laboratory requirements under CLIA--CDC, HCFA. Final rule with comment period

This final rule extends certain effective dates for clinical laboratory requirements in regulations published on February 28, 1992, and subsequently revised December 6, 1994, and May 12, 1997, that implemented provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This rule extends the phase-in date of the quality control requirements applicable to moderate and high complexity tests and extends the date by which an individual with a doctoral degree must possess board certification to qualify as a director of a laboratory that performs high complexity testing. These effective dates are extended to allow the Department additional time to issue revised quality control requirements and to determine whether changes are needed in the qualification requirements for individuals with doctoral degrees to serve as directors of laboratories performing high complexity testing. These effective date extensions do not reduce the current requirements for quality test performance.     

Evaluation of Police Training on LGBTQ Issues: Knowledge,Interpersonal Apprehension,and Self-Efficacy

The present study evaluates outcomes of a five-hour training session to prepare law enforcement personnel (LEP) to work effectively with LGBTQ individuals and communities. The training was developed collaboratively with the local police department, an LGBTQ community organization, a group of diversity trainers, and the researchers. Approximately 120 LEP participated in the training, and 81 completed pre- and post-test assessments of knowledge, self-efficacy, and interpersonal comfort with LGBTQ people. Paired-sample t-tests demonstrated significant increases in knowledge and confidence in using LGBTQ-affirming tactics on the job. No significant differences were found in participants’ comfort in working with LGBTQ community members. Implications for LEP training on LGBTQ issues and research in assessing LEP for behavioral and affective change are discussed.     

Medicare,Medicaid, and CLIA programs; laboratory requirements relating to quality systems and certain personnel qualifications. Final rule

This final rule revises and responds to comments on certain laboratory requirements issued pursuant to the Clinical Laboratory Improvement Amendments of 1988 (CLIA), Pub. L. 100-578. Specifically, this final rule sets forth requirements for certain quality control (QC) provisions and personnel qualifications; consolidates and reorganizes the requirements for patient test management, QC, and quality assurance; and changes the consensus required for grading proficiency testing challenges. To ensure a smooth transition to the new provisions for directors of high complexity testing who are not board certified (but who have doctoral degrees), we will not be holding facilities out of compliance with the provisions of the rule concerning directors who are not board certified until the effective date of this new rule, to the extent the facilities are otherwise in compliance with the requirements for laboratory directors.     

Medicare, Medicaid, and CLIA programs; extension of certain effective dates for clinical laboratory requirements under CLIA. Centers for Disease Control and Prevention (CDC) and Health Care Financing Administration (HCFA), HHS. Final rule with comment period

This final rule extends certain effective dates for clinical laboratory requirements in regulations published on February 28, 1992, that implemented provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This rule extends the phase-in date of the quality control requirements applicable to moderate and high complexity tests and extends the date by which an individual with a doctoral degree must possess board certification to qualify as a director of a laboratory that performs high complexity testing. These effective dates are extended to allow the Department to revise quality control requirements and establish the qualification requirements necessary for individuals with doctoral degrees to serve as directors of laboratories performing high complexity testing. These effective date extensions do not reduce the current requirements for quality test performance.     

Public Health Service--Grants for allied health projects. Final rule

These regulations set forth requirements for grants to: (a) Establish regional or State systems to assure that allied health and nursing personnel needs in the area are met by coordinating and managing allied health professions and nursing education and training within and among educational institutions and their clinical affiliates; (b) Establish or improve recruitment, training, and retraining programs for allied health personnel; and (c) Establish career ladders and advancement programs for practicing allied health personnel. These regulations implement section 796 of the Public Health Service Act.     

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.     

Medicaid Integrity Program; eligible entity and contracting requirements for the Medicaid Integrity audit program. Final rule

Section 1936 of the Social Security Act (the Act) (as added by section 6034 of the Deficit Reduction Act of 2005 (DRA) established the Medicaid Integrity Program to promote the integrity of the Medicaid program by requiring CMS to enter into contracts with eligible entities to: (1) Review the actions of individuals or entities furnishing items or services (whether on a fee-for-service, risk, or other basis) for which payment may be made under an approved State plan and/or any waiver of such plan approved under section 1115 of the Act; (2) audit claims for payment of items or services furnished, or administrative services rendered, under a State plan; (3) identify overpayments to individuals or entities receiving Federal funds; and (4) educate providers of services, managed care entities, beneficiaries, and other individuals with respect to payment integrity and quality of care. This final rule will provide requirements for an eligible entity to enter into a contract under the Medicaid integrity audit program. The final rule will also establish the contracting requirements for eligible entities. The requirements will include procedures for identifying, evaluating, and resolving organizational conflicts of interest that are generally applicable to Federal acquisition and procurement; competitive procedures to be used; and procedures under which a contract may be renewed.     

Medicare, Medicaid and CLIA programs; extension of certain effective dates for clinical laboratory requirements and personnel requirements for cytologists--HCFA. Final rule with comment period

This final rule extends certain effective dates for clinical laboratory requirements in regulations published on February 28, 1992, which implemented provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and announces our approval of a certifying organization for qualifying cytotechnologists. This rule extends the date by which an individual must enroll in an HCFA-approved cytology proficiency testing (PT) program and the date by which an individual with a doctoral degree must possess board certification to qualify as a director of a laboratory that performs high complexity testing. In addition, we are extending the phase-in of the quality control requirements applicable to unmodified, moderate complexity tests cleared for commercial distribution by the Food and Drug Administration (FDA). We are extending the date to meet applicable CLIA QC requirements for laboratories using commercial, nonmodified tests to fulfill certain quality control (QC) requirements. These effective date extensions do not reduce the current requirements for quality test performance. The date extensions are necessary due to the limited number and scope of currently operating cytology PT programs, resource constraints that have prevented commencement of the substantial number of quality control reviews, and inability of many laboratory directors to complete certification requirements within the time period originally specified.     

CLIA program; categorization of tests and personnel modifications--HCFA. Final rule with comment period

In this rule we are responding to some of the comments on categorization of tests and personnel requirements received in response to rules published on February 28, 1992 and January 19, 1993. (In a future rule, we will be responding to the remaining comments.) We are revising our regulations to: Allow dentists and midlevel practitioners to perform tests in the "physician-performed" microscopy (PPM) subcategory of moderate complexity procedures (we now call the subcategory "provider-performed"); include three additional tests in PPM; and expand provisions relating to general supervisor and high complexity testing personnel.     

Barcelona 2002: law, ethics, and human rights. HIV testing for peacekeeping forces: legal and human rights issues

In 2001, the United Nations Security Council established an Expert Panel to study the issue of whether the UN should institute HIV testing of peacekeeping personnel. This article, based on a 9 July 2002 presentation to the XIV International AIDS Conference (abstract TuOrG1173), reports on the findings of a paper prepared for the Expert Panel by the Canadian HIV/AIDS Legal Network. The paper examined whether it is permissible for the UN to implement mandatory HIV testing of its peacekeeping personnel, and whether HIV-positive UN peacekeeping personnel should be excluded or restricted from service on the basis of their HIV status or HIV disease progression. The article describes some of the court cases in which these issues have been considered; discusses the importance of analyzing such issues in the context of a human rights-based approach to the pandemic; and formulates a series of key principles for guiding UN decision-making. The article concludes that a policy of mandatory HIV testing for all UN peacekeeping personnel cannot be justified on the basis that it is required in order to assess their physical and mental capacity for service; that HIV-positive peacekeeping personnel cannot be excluded from service based on their HIV status alone, but only on their ability to perform their duties; and that the UN cannot resort to mandatory HIV testing for all UN peacekeeping personnel to protect the health and safety of HIV-negative personnel unless it can demonstrate that alternatives to such a policy would not reduce the risk sufficiently. In the end, the Expert Panel unanimously rejected mandatory testing and instead endorsed voluntary HIV counselling and testing for UN peacekeeping personnel.     

Medicare, Medicaid, and CLIA programs; clinical laboratory requirements--extension of certain effective dates for clinical laboratory requirements under CLIA--CDC, HCFA. Final rule with comment period

This final rule extends certain effective dates for clinical laboratory requirements in regulations published on February 28, 1992, and subsequently revised December 6, 1994, that implemented provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This rule extends the phase-in date of the quality control requirements applicable to moderate and high complexity tests and extends the date by which an individual with a doctoral degree must possess board certification to qualify as a director of a laboratory that performs high complexity testing. These effective dates are extended to allow the Department additional time to issue revised quality control requirements and to ensure laboratory directors are able to complete certification requirements. These effective date extensions do not reduce the current requirements for quality test performance.     

Establishment of vaccination clinics; user fees for investigational new drug (IND) influenza vaccine services and vaccines. Interim final rule and request for comments

We are amending 42 CFR part 70 to establish vaccination clinics and a user fee in connection with the administration of vaccination services and vaccine. On December 7, 2004, HHS Secretary Tommy G. Thompson announced the purchase of 1.2 million doses of GlaxoSmithKline (GSK) influenza vaccine, Fluarix, for distribution to areas most in need as determined by State public health authorities. The Fluarix vaccine has been approved in seventy-eight foreign countries, and FDA has recently reviewed extensive manufacturing and summary clinical information and conducted an inspection of the GSK manufacturing facility in Germany to determine that this vaccine, although not licensed in the United States, is suitable for use under an Investigational New Drug application (IND). The Food and Drug Administration (FDA) reviewed GSK's IND application as well as the clinical protocol and manufacturing data. CDC and CDC's Institutional Review Board approved the GSK flu vaccine response protocol including the informed consent document. To ensure that the vaccine is properly administered to individuals identified to be most at risk and facilitate compliance with IND requirements, CDC is establishing vaccination clinics. CDC is proceeding without delay because of the unprecedented nature of this season's influenza vaccine shortage caused by contamination problems with Chiron Corporation's production facility in the United Kingdom, which effectively cut in half the expected United States supply of inactivated influenza vaccine. A user fee is being established in order to recoup the costs associated with administering the vaccine and for the vaccine itself. All individuals, other than those who are enrolled in Medicare Part B, will be required to pay the user fee.     

Continuation of benefit payments to certain individuals who are participating in a program of vocational rehabilitation services, employment services, or other support services. Final rule

We are publishing final rules that amend the rules for the continuation of disability benefit payments under titles II and XVI of the Social Security Act (the Act) to certain individuals who recover medically while participating in an appropriate vocational rehabilitation (VR) program with a State vocational rehabilitation agency. We are amending these rules to conform with statutory amendments that extend eligibility for these continued benefit payments to certain individuals who recover medically while participating in an appropriate program of services. These include individuals participating in the Ticket to Work and Self-Sufficiency Program or another program of vocational rehabilitation services, employment services, or other support services approved by the Commissioner of Social Security. We are also extending eligibility for these continued benefit payments to students age 18 through 21 who recover medically, or whose disability is determined to have ended as a result of an age-18 redetermination, while participating in an individualized education program developed under the Individuals with Disabilities Education Act with an appropriate provider of services. Providers of services we may approve include a public or private organization with expertise in the delivery or coordination of vocational rehabilitation services, employment services, or other support services; or a public, private or parochial school that provides or coordinates a program of vocational rehabilitation services, employment services, or other support services carried out under an individualized program or plan.     

Comparing Standard and Selective Degradation DNA Extraction Methods: Results from a Field Experiment with Sexual Assault Kits,

A growing number of U.S. cities have large numbers of untested sexual assault kits (SAKs) in police property facilities. Testing older kits and maintaining current case work will be challenging for forensic laboratories, creating a need for more efficient testing methods. Methods: We evaluated selective degradation methods for DNA extraction using actual case work from a sample of previously unsubmitted SAKs in Detroit, Michigan. We randomly assigned 350 kits to either standard or selective degradation testing methods and then compared DNA testing rates and CODIS entry rates between the two groups. Results and conclusions: Continuation‐ratio modeling showed no significant differences, indicating that the selective degradation method had no decrement in performance relative to customary methods. Follow‐up equivalence tests indicated that CODIS entry rates for the two methods could differ by more than ±5%. Selective degradation methods required less personnel time for testing and scientific review than standard testing.     

Labeling and effectiveness testing; sunscreen drug products for over-the-counter human use; delay of compliance dates. Final rule; delay of compliance dates; request for comments

The Food and Drug Administration (FDA) is delaying the compliance dates for the final rule for over-the-counter (OTC) sunscreen drug products that published in the Federal Register of June 17, 2011 (76 FR 35620). The final rule establishes labeling and effectiveness testing for certain OTC sunscreen products containing specified active ingredients and marketed without approved applications. It also amends labeling claims that are not currently supported by data and lifts the previously-published delay of implementation of the Drug Facts labeling requirements for OTC sunscreens. The 2011 final rule's compliance dates are being delayed because information received after publication of the 2011 final rule indicates that full implementation of the 2011 final rule's requirements for all affected products will require an additional 6 months. This final rule is part of FDA's ongoing review of OTC drug products.     

Labeling and effectiveness testing; sunscreen drug products for over-the-counter human use. Final rule

The Food and Drug Administration (FDA) is issuing this document to address labeling and effectiveness testing for certain over-the counter (OTC) sunscreen products containing specified active ingredients and marketed without approved applications. This document addresses labeling and effectiveness testing issues raised by the nearly 2,900 submissions that we received in response to the sunscreen proposed rule of August 27, 2007 (2007 proposed rule). The document also identifies specific claims that render a product that is subject to this rule misbranded or would not be allowed on any OTC sunscreen product marketed without an approved application. The document does not address issues related to sunscreen active ingredients or certain other issues regarding the GRASE determination for sunscreen products. The document requires OTC sunscreen products to comply with the content and format requirements for OTC drug labeling contained in the 1999 Drug Facts final rule (published in the Federal Register of March 17, 1999, by lifting the delay of implementation date for that rule that we published on September 3, 2004).     

Administration of grants and agreements with institutions of higher education, hospitals, and other non-profit organizations; direct grant programs--DoE. Final regulations

The Secretary amends 34 CFR parts 74 and 75 to add the Office of Management and Budget (OMB) control numbers to certain sections of the regulations. Those sections contain information collection requirements approved by OMB. The Secretary takes this action to inform the public that these requirements have been approved.     

The Masculine Yardstick of Physical Competence: U.S. Police Academy Fitness Tests

State and local law enforcement training academies differ in a myriad of ways, including the content of their classes, the type of instruction received, and the tests mandated for graduation. The focus of this study is the physical fitness test and how it affects the proportion of women to men matriculating from these academies. A predictive model of academy completion rates is derived from a sample of 96 police training academies. The presence of gendered physical testing requirements was found to be positively related to the proportion of women to men graduating from training. In addition to the empirical models, data on the specific content of these tests are provided. The variability of tests suggests that gendered physical requirements are an illusionary panacea, as they do not address the fundamental assumptions of the tests themselves.     

The training of New Jersey emergency service first responders in autism awareness

This study investigated the extent and adequacy of training among New Jersey first responders (e.g. police, firefighters, emergency medical technicians) specifically as relates to a 2008 state law mandating that autism and hidden disability recognition and response training be conducted. The results show that a significant percentage of emergency service personnel have not completed the state mandated training. Recommendations for improving the training, such as by involving parents, advocates, and field and training personnel as a part of the training process, are discussed.     

Medicaid program; correction and reduction plans for intermediate care facilities for the mentally retarded--HCFA. Final rule

This final rule amends the portions of the Medicaid regulations under which an intermediate care facility for the mentally retarded (ICF/MR) with substantial deficiencies that did not pose an immediate jeopardy to the health and safety of clients could continue participation in the Medicaid program. These regulations gave State Medicaid agencies the option of submitting written plans to either correct deficiencies or permanently reduce the number of beds in the certified portion of the facility. This rule removes all requirements for submitting, approving, and monitoring correction plans for ICFs/MR. The requirements for submitting and approving correction plans are being removed because the time limit for submission of these plans has passed. The provisions for monitoring correction plans are being removed because there are no remaining facilities for which these provisions apply. This final rule also removes requirements for submitting and approving reduction plans for ICFs/MR because the time limit for submitting these plans has passed. It retains and updates the requirements for monitoring and compliance that apply to those ICFs/MR for which reduction plans were approved by January 1, 1990.