INCIDENCE OF NEEDLESTICK AND SHARPS INJURIES AND MEDICAL SAFETY DEVICE AVAILABILITY/USE AMONG NON-HOSPITAL HEALTH CARE WORKERS Release Date: February 28, 2000 RFA: OH-00-004 National Institute for Occupational Safety and Health (NIOSH) Centers for Disease Control and Prevention Letter of Intent Receipt Date: March 28, 2000 Application Receipt Date: April 27, 2000 PURPOSE The National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC), invites cooperative agreement applications for studies that will contribute to the understanding of the risks of exposure to blood borne pathogens among health care workers in non-hospital settings. Such information will contribute significantly to an understanding not only the risk for such injuries but the development of effective intervention strategies. Because little is known about the incidence of this injury in these workers, this RFA has an emphasis on research that examines the incidence of exposures to blood, risk factors associated with such exposures, and the availability and use of medical safety devices. A special feature of this RFA is encouraging applications from researchers and from membership organizations comprised of health care workers, such as unions and professional organizations, and collaboration among these groups. HEALTHY PEOPLE 2010 CDC is committed to achieving the health promotion and disease prevention objectives of Healthy People 2010, a national activity to reduce morbidity and mortality and improve the quality of life. This announcement is related to the focus area of occupational safety and health. For information on the conference on Healthy People 2010, visit the internet site: http://www.health.gov/healthypeople. ELIGIBILITY REQUIREMENTS Applications may be submitted by public and private nonprofit and for-profit organizations and by governments and their agencies; that is, universities, colleges, research institutions, hospitals, other public and private nonprofit and for-profit organizations, State and local governments or their bona fide agents, including small, minority and/or women-owned businesses. Applications from minority and women investigators are encouraged. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be a cooperative agreement (U01), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIOSH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. The awardee will be responsible for the planning, direction, and execution of the proposed project and interrelated activities. The NIOSH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships and governance of the study to be funded under cooperative agreement(s) are discussed later in this document under the section "Terms and Conditions of Award." The total project period for an application submitted in response to this present RFA may not exceed 3 years. The anticipated award date is September 1, 2000. The award and level of support depends on receipt of applications of high scientific merit. Although this program is provided for in the financial plans of NIOSH, the award pursuant to this RFA is contingent upon the availability of funds for this purpose. FUNDS AVAILABLE Approximately $325,000 is available in FY 2000 to fund one award. The maximum amount that maybe requested is $325,000 total cost (direct and facilities and administrative (F&A) costs) per year. Continuation award within an approved project period will be made on the basis of satisfactory progress as evidenced by required reports and the availability of funds. USE OF FUNDS Recipient should allocate funds for travel for two project staff to attend an semi-annual one to two day meeting in Cincinnati, Ohio for each year of the project. PREAPPLICATION CONFERENCE Applicants are invited by NIOSH to attend a pre-application technical assistance conference on Tuesday, March 14, 2000 at 1:00 PM (Eastern time) to discuss: programmatic issues, potential research partners, how to apply; and other questions regarding the content of the RFA. This conference is expected to last approximately two hours. The conference will be held at the NIOSH Alice Hamilton Laboratory located at 5555 Ridge Avenue, Cincinnati, Ohio, 45213. Applicants may also participate by telephone. The conference name is NIOSH Needle Stick Injuries. The telephone bridge number is (800) 311-3437. Participants will need the conference code, 408178, to be connected. RESEARCH OBJECTIVES Background There are nearly seven million health care workers employed in the United States; approximately half work in non-hospital settings. Health care workers are at risk of infection from blood borne pathogens, particularly human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus. As of June 1999, the CDC was aware of 55 health care workers in the U.S. who had been documented as having sero-converted to HIV following occupational exposures. Approximately 83% of exposures to blood reported by hospital-based health care workers are by percutaneous injury (i.e., needlestick and sharps injuries). Mucous membrane exposure accounts for about 13%, skin 3%, and bite 1%. Precise national data are not available on the annual number of needlesticks and other percutaneous injuries among health care workers since it has been estimated that about half of these injuries go unreported. Virtually all of the information on the occurrence of needlestick and sharps injuries is based on hospital workers. However it has been estimated that 600,000 to 800,000 such injuries occur annually. In addition to the serious health consequences of this injury, the emotional impact of a needlestick injury can be severe and long lasting, even when a serious infection is not transmitted. In order to address this public health problem in the context of occupational injuries, past studies have shown that certain information about blood exposures need to be considered in a survey design, including relevant demographic information about survey respondents, general information about past exposures to blood, and details about the circumstances of recent exposures. For recent exposures to blood, a least eight critical areas of information have been shown to be important. These include: 1) route of exposure, 2) activity during and timing of exposure, 3) specific medical device being used, 4) relevant characteristics of the source patient, 5) reasons why the exposure either was or was not reported, 6) suggestions on how to improve reporting of injuries, 7) whether respondents obtained post-exposure prophylactic treatment, and 8) precautions that would have prevented the exposure. Another critical area for inclusion in such studies is an assessment of past injuries experienced by employees and, in order to assess under-reporting, the percentage of injuries reported to the worker’s employer via standard procedures. Valuable new information would be contributed by a study that provided a comparison of injury incidence density rates among health care workers in the same occupations (e.g., RNs versus RNs) but employed in either hospital or non-hospital settings by using the same denominator (such as person-hours worked) for both groups. NIOSH has set a goal to describe the occurrence of exposure to blood among non-hospital health care workers in order to subsequently identify appropriate interventions to reduce the future incidence of exposure to blood borne pathogens. This RFA is the first step to accomplish this goal. Research Goals and Objectives The objective of this RFA is to support research on the incidence of and risk factors for exposures to blood among health care workers employed outside hospitals. Among the issues that need to be understood are the significant factors that affect blood exposures such as rate of exposure from needlestick and sharps injuries, other routes of exposure, and the prevalence and use of medical safety devices. Research projects should address this occupational issue in an integrated and comprehensive manner in order for the risk for this injury in non-hospital workers can be understood. In designing their studies, applicants may consider the inclusion of these data elements in the study design: the incidence rate of exposure to blood from needlestick and sharps injuries and other routes of exposure among health care workers who work in non-hospital settings; risk factors for these injuries; and the prevalence of medical safety device availability and usage. Non-hospital settings include, but are not limited to, public and private clinics, nursing homes and other long-term care facilities, non-hospital-based hospices, emergency medical services, home care, and correctional facilities. Because there is little quantitative data on these injuries in non-hospital workers, the applicant should address in the application the basis for the selection of occupations chosen for inclusion in the study. In addition, the applicant should justify the survey sample size. One approach investigators may wish to consider, is to survey, either retrospectively or prospectively, an entire population of non-hospital health care workers or a random sample thereof in order to estimate numbers of injuries and injury/exposure incidence rates by occupation, setting, and medical device, as well as the availability and usage of medical safety devices. An important element that investigators may wish to include in the study design is a comparison of risk factors, rates of injury, and availability/use of medical safety devices between non-hospital and hospital health care workers in the same occupations; however, the focus of this RFA is on non-hospital settings. Investigators may also wish to include in the study design approaches for estimating the availability and usage of medical safety devices in non-hospital institutions. Another element that investigators may wish to consider is the rate of vaccination against hepatitis B virus and compliance with recommendations for post-exposure prophylaxis for hepatitis B virus and human immunodeficiency virus. Because the well-known problem of under-reporting of needlestick injuries could bias a study, applicants should consider in the study design methods for data collection that do not rely solely upon employers or health services records. However, an investigator may wish to supplement a survey of health care workers with a review of injury records kept by employers. USEFUL REFERENCES National Institute for Occupational Safety and Health. National Occupational Research Agenda. Cincinnati, OH: U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No.96-115 (http://www.cdc.gov/niosh/nora.html). SPECIAL REQUIREMENTS Applications should include, at a minimum, descriptions of the following: o The source of recruitment for the population studied and letters of agreement; o A detailed timetable for the proposed study. UNIQUE CAPABILITIES Applicants should highlight unique expertise and/or unusual opportunities related to the purpose of this RFA. TERMS AND CONDITIONS OF AWARD The Terms and Conditions of Award, below, will be incorporated in all awards issued as a result of this RFA. It is critical that each applicant include specific plans for responding to these terms. These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and PHS Grants Policy Statement. The administrative and funding instrument used for this program is a cooperative agreement (U01), an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NIOSH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIOSH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NIOSH Project Scientist where appropriate, including the following. 1. Recipient (Applicant) Responsibilities The applicant will coordinate project activities, scientifically and administratively, at the awardee institution and at other sites that may be supported by sub-contractors to this award. The applicant will have primary authority and responsibility to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of studies conducted under the terms and conditions of the cooperative agreement award. Recipient will a. enroll and follow-up the study participants and establish and maintain mechanisms to ensure that data collection and management procedures have necessary quality control and confidentiality of data, b. provide study participants with individual notification letters when medical tests are performed, c. develop and submit semiannual progress reports in a standard format that is agreed upon at the initial planning meeting after an award is made, d. disseminate the scientific findings, e. provide program management and oversight for the project, f. notify study participants of the overall study results, and g. participate in semi-annual meetings to provide information on program status. 2. NIOSH Responsibilities The NIOSH Project Scientist may, at the request of the recipient, provide substantial scientific-programmatic involvement during conduct of this activity, through technical assistance, advice, and coordination. a. provide technical assistance as a scientific liaison between the awardee and other program staff at NIOSH who have experience in the occupational health issues of health care workers, infection control, and epidemiology; b. provide expert consultation in the area of occupational epidemiology; c. provide technical advice on monitoring of field data collection, developing operating guidelines, quality control procedures, and developing policies/protocols for dealing with recurrent situations; d. facilitate collaborative efforts to compile and disseminate program results through presentations and publications, e. assist in the development of human subjects protocols for the CDC Institutional Review Board (if required) and in the preparation of OMB clearances that may be required during the conduct of the study. PAPERWORK REDUCTION ACT Projects that involve the collection of information from 10 or more individuals and funded by cooperative agreement will be subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act. HUMAN SUBJECTS REQUIREMENTS If a project involves research on human subjects, assurance (in accordance with Department of Health and Human Services Regulations, 45 CFR Part 46) of the protection of human subjects is required. In addition to other applicable committees, Indian Health Service (IHS) institutional review committees also must review the project if any component of IHS will be involved with or will support the research. If any American Indian community is involved, its tribal government must also approve that portion of the project applicable to it. Unless the awardee holds a Multiple Project Assurance, a Single Project Assurance is required, as well as an assurance for each subcontractor or cooperating institution that has immediate responsibility for human subjects. The Office for Protection from Research Risks (OPRR) at the National Institutes of Health negotiates assurances for all activities involving human subjects that are supported by the Department of Health and Human Services. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the Centers for Disease Control and Prevention (CDC) to ensure that individuals of both sexes and the various racial and ethnic groups will be included in CDC-supported research projects involving human subjects, whenever feasible and appropriate. Racial and ethnic groups are those defined in OMB Directive No. 15 and include American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or Other Pacific Islander. Applicants shall ensure that women, racial and ethnic minority populations are appropriately represented in applications for research involving human subjects. Where clear and compelling rationale exist that inclusion is inappropriate or not feasible, this situation must be explained as part of the application. This policy does not apply to research studies when the investigator cannot control the race, ethnicity, and/or sex of subjects. Further guidance to this policy is contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951, and dated Friday, September 15, 1995. NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by NIH, unless there are clear and compelling reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. This policy will be followed by NIOSH for this announcement. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators may also obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by March 28, 2000, a letter of intent that includes a descriptive title of the proposed research, name, address, and telephone number of the principal investigator, identities of other key personnel and participating institutions, and number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information allows NIOSH staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Ann M. Cronin National Institute for Occupational Safety and Health (NIOSH) Centers for Disease Control and Prevention 1600 Clifton Road, NE Mailstop D40 Building 1, Room 3070B Atlanta, GA 30333 Telephone: 404/639-2277 Fax: 404/639-0035 Email: axc2@cdc.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for this cooperative agreement. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, E-mail: grantsinfo@nih.gov. Applications are also available on the web at: grants.nih.gov/grants/forms.htm. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Submit a signed, original of the application, including the Checklist, and three signed photocopies, in one package to: CENTER FOR SCIENTIFIC REVIEW (CSR) NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must also be sent to: Ann M. Cronin National Institute for Occupational Safety and Health (NIOSH) Centers for Disease Control and Prevention 1600 Clifton Road, NE Mailstop D40 Building 1, Room 3070B Atlanta, GA 30333 Applications must be received by April 27, 2000. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such an application must follow the guidance in the PHS Form 398 application instructions for the preparation of revised applications, including an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by NIOSH. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Those applications that are complete and responsive, will undergo further scientific merit review in accordance with the criteria stated below for scientific/ technical merit by an appropriate peer review group convened by NIOSH. The second level of review will be provided by the NIOSH Secondary Review Panel. All applications will be judged on the basis of the scientific merit of the proposed project and the documented ability of the investigators to meet the RESEARCH OBJECTIVES of the RFA. Although the technical merit of the proposed protocol is important, it will not be the sole criterion for evaluation of a study. Access to the study population and ability to achieve the initiative’s goals will also be part of the evaluation criteria. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the NIOSH Secondary Review Panel. PEER REVIEW CRITERIA Applicants are encouraged to submit and describe their own ideas about how best to meet the goals of the RFA, and are expected to address issues identified under "SPECIAL REQUIREMENTS FOR THE RFA." The peer review group will assess the merit of the applications and related factors as follows: Significance: Does the proposed research project satisfy an important public health, occupational health, or infection control need? Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative approaches? Will the research project be able to provide reliable estimates of the incidence rate of exposure to blood, particularly needlestick and sharps injuries? Will the research project be able to identify risk factors for exposures to blood? Will the research project be able to estimate the availability and use of medical safety devices among the facilities employing the respondents? Does the applicant include health care workers in occupations with potentially the highest incidence rates of needlestick injury? Does the applicant demonstrate access to health care workers who are at high risk of occupational exposure to blood, including letters of support from organizations facilitating access to these workers? Does the applicant justify the proposed sample size and statistical power calculations? Innovation: Does the project employ novel concepts, approaches, or methods? Is the project original and innovative? Does the project develop new methodologies? Investigators: Are the principal investigator and her/his collaborators appropriately trained and well suited to carry out this work? Do they have adequate experience in the areas of occupational health, infection control, epidemiology, and project management to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and her/his collaborators? Environment: Are the applicant’s facilities, equipment, and other resources adequate for the performance of this project? Is there evidence of institutional support? Are the methods for assuring privacy and maintaining confidentiality of participant records, including specific protections for Internet-based data systems adequate? In addition to the above criteria, all applications will also be reviewed with respect to the following: The reasonableness of the proposed budget and duration in relation to the proposed research. The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. AWARD CRITERIA Applications recommended by the NIOSH Secondary Review Panel will be considered for award based upon (a) scientific and technical merit, (b) availability of funds and (c) prevalence of these injuries in the study population. SCHEDULE Letter of Intent Receipt Date: March 28, 2000 Application Receipt Date: April 27, 2000 Anticipated Award Date: September 1, 2000 INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Michael J. Galvin, Jr. Ph.D. Research Grants Program National Institute for Occupational Safety and Health Centers for Disease Control and Prevention 1600 Clifton Road, N.E. Building 1, Room 3053, MS D-30 Atlanta, GA 30333 Telephone: 404/639-3343 FAX: 404/639-4616 Email: mtg3@cdc.gov Direct inquiries regarding fiscal matters to: Sheryl L. Heard, Grants Management Specialist Grants Management Branch, Procurement and Grants Office CDC Announcement Number 00038 Centers for Disease Control and Prevention 2920 Brandywine Road, Mail Stop E-13 Atlanta, Georgia 30341 Telephone: 770-488-2723 Email address: slh3@cdc.gov LOBBYING RESTRICTIONS Applicants should be aware of restrictions on the use of HHS funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients (and their sub- tier contractors) are prohibited from using appropriated Federal funds (other than profits from a Federal contract) for lobbying congress or any Federal agency in connection with the award of a particular contract, grant, cooperative agreement, or loan. This includes grants/cooperative agreements that, in whole or in part, involve conferences for which Federal funds cannot be used directly or indirectly to encourage participants to lobby or to instruct participants on how to lobby. In addition no part of CDC appropriated funds, shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself. No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No.93.262. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under CDC grants policies and Federal Regulations 42 CFR Parts 52 and 45 CFR Part 74 [and Part 92 when applicable for State and Local governments]. SMOKE-FREE WORKPLACE The CDC strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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