Exposure Control Plan

1. Background

    

2. Definitions

    

3. Exposure Determinations

    

4. Methods of Compliance

   1. Responsibilities
   2. Methods of Compliance
   3. Labels/Markings
   4. Training

    

5. Evaluation of Exposure Incidents

    

6. Access to Records

    

7. Annual Policy/Plan Reviews and Updates

    

8. Attachments

    

    

1. BACKGROUND:

The Health Center continues to place the highest priorities on occupational safety and health programs and the protection of the environment.  Managers/supervisors at all levels must assure training of their personnel so that safe work practices are understood and followed.  Employees must follow prescribed safety practices.  This policy implements the Occupational Safety and Health Administration (OSHA) Standard (29CFR1910.1030), Occupational Exposure to Bloodborne Pathogens (OEBP).  All Health Center Activities and employees are responsible for full compliance with the OSHA Standard, this Policy and this Exposure Control Plan.  The OSHA Standard and this Policy applies to employees.  At the Health Center, the control of bloodborne pathogen exposures of non-employees should be consistent with this Health Center Policy.  Other Health Center Policies/Guidelines that may be applicable include:  (1) Guidelines For The Conduct of Activities with Biohazardous Materials At The University of Connecticut Health Center; (2) Policy for the Control of Occupational Exposure to TB; (3) Policy on Selection and Use of Personal Protective Equipment; (4) Regulated Medical Waste Disposal Policy; and (5) the Health Center Infection Control Plan.  If a conflict exists between this policy and such other policies or guidelines and plans, the measures more protective for the employee will be followed. 

Caution: The focus of this Policy is the prevention of bloodborne diseases and compliance with the OSHA Standard.  Other non-bloodborne pathogen biosafety risks may occur in patient care, medical laboratory and research areas (e.g., tuberculosis).  In such cases, additional biosafety/infection control procedures need to be consulted and followed.  The paragraph above lists some important policies, guidelines and plans that address such infectious disease concerns.

2. DEFINITIONS:

Definitions for the purpose of this Policy/Exposure Control Plan are those outlined in paragraph (b) of the OSHA Standard (Attachment 1).  These definitions provide important compliance information.  For example, contaminated sharps means any contaminated object that can penetrate the skin, including, but not limited to needles, scalpels, broken glass, broken capillary tubes, and exposed ends of dental wires.

Supervisors are responsible for identifying on an annual basis, which of their employees are "Occupationally Exposed" to human blood and body fluids as defined in the Standard and this Policy.  Supervisors will keep Human Resources (HR) and the department of Staff and Patient Education informed of such exposure determinations so that the information can be entered into the appropriate data base(s) and to facilitate the accurate assignment of mandated training modules.  In accordance with the Standard, a summary of these exposure determinations for the Health Center is found in Attachment 2.  It includes: (A) a list of all job classifications in which employees in those job classifications have (or are assumed to have) potential occupational exposure; (B) a list of all job classifications in which occupational exposure is unlikely; and (C) a list of tasks and procedures or groups of closely related tasks and procedures in which occupational exposure occurs and that are performed by employees in the job classifications listed.  As required by the Standard, these exposure determinations have been made without regard to the use of personal protective equipment or the frequency of exposure.  This list will be revised, as needed, by the Research Safety Office.

All Health Center activities will comply with the OSHA standard and this Policy.

A.       Responsibilities

Activity Heads:  The head of each major activity (e.g., School of Medicine, School of Dental Medicine, Health System, etc.) is responsible for assuring compliance with the OSHA Standard and this Policy.  This includes identifying any research laboratories/production facilities engaged in the culture, production, concentration, experimentation and manipulation of HIV, HBV and any identified biosafety level 2 bloodborne pathogen and restricting such activities until the principal investigator has prepared a written safety protocol and had it approved by the Institutional Biosafety Committee. 

The Assistant Vice President for Research Administration has the authority to stop such laboratory activities when the Committee's prior approval has not been given and/or when the activities have not been conducted in accordance with the written safety protocol.  Disciplinary action, up to and including termination, may be appropriate for supervisors and employees not complying with the OSHA Standard and this Policy.  Such disciplinary action will be coordinated, in advance, with Human Resources.  Laboratories working with Biosafety Level 2 or above infectious agents must register with the CT Department of Public Health.  Contact the Research Safety Office for assistance.

Supervisors:  Supervisors are responsible for compliance with the OSHA Standard and this Policy.  Supervisor responsibilities include:

1. Identifying their employees that are occupationally exposed and providing Human Resources and Staff and Patient Education with requested information on such exposure determinations;
2. Identifying in advance any change in tasks of a non-occupationally exposed employee that would result in occupational exposure and identifying this change to Human Resources and Staff and Patient Education;
3. Requiring their occupationally exposed employees to promptly complete initial  training prior to performing tasks with potential exposure and training thereafter as required by the Standard (e.g., annual);
4. Requiring that occupationally exposed employees report initially to Employee Health Service to complete their hepatitis B vaccination requirements (at no cost) or sign the OSHA refusal statement (within ten working days);
5. Providing appropriate protective equipment, materials, labels, etc., required by this Policy and Assuring its proper use in accordance with principles of Universal Precautions in order to prevent contact (skin, clothing, eyes and mucous membranes) with human blood or other potentially infectious material;
6. Requiring that employees seek prompt initial medical attention for exposure incidents from Employee Health Service 679-2893, Emergency Department 679-2588 as appropriate and report such incidents promptly to their supervisor and to Human Resources 679-2204.
7. Completing promptly and completely the form(s) provided by the Environmental Health and Safety Office and or Employee Health Service so that the circumstances surrounding exposures/incidents and the corrective actions taken can be properly evaluated;
8. Ensuring compliance with the responsibilities outlined in Attachment 3, Summary Methods of Compliance;
9. Monitoring compliance with this Policy and taking prompt and appropriate corrective actions; and

10. Enforcing compliance, as necessary, by appropriate disciplinary action coordinated with Human Resources.

11. The support of needlestick prevention efforts and to provide engineering controls when the Health Center has determined that the use of such devices is feasible.

Supervisors of laboratory activities that use research laboratory-scale amounts of HIV or HBV or that produce high concentrations of HIV or HBV and/or produce industrial scale volumes of such materials shall not conduct such activities without a written safety protocol approved in advance by the Institutional Biosafety Committee.  See Section IV A in this Policy, Institutional Biosafety Committee and Section IV B, Methods of Compliance (Research Laboratories) for more information.

Occupationally Exposed Employees:  Responsibilities of the occupationally exposed employee include: 

1. Reporting to Employee Health Service within ten working days of first being assigned duties classified as "occupationally exposed" and completing the training on  the benefits of hepatitis B vaccination and receiving the vaccination or signing the declination form;

2. Completing the required initial and annual training;

3. Following the procedures outlined in this Policy and Attachment 3, Methods of Compliance

4. Utilizing the provided protective equipment properly in accordance with the principles of Universal Precautions, and maintaining or disposing of such equipment in accordance with this Policy, the Health Center’s Personal Protective Equipment Policy and the instructions/training received;

5. Reporting promptly to Employee Health Service 679-2893 or the Emergency Department 679-2588, as appropriate, for the initial medical management of an exposure incident and reporting it to both their supervisor and Human Resources 679-2204; a medical evaluation of an exposure should be done within 1-2 hours after the injury. 

6. Disposing of medical waste (red bag waste) in accordance with the Health Center's Regulated Medical Waste Policy; and

7. Reporting problems to their supervisor related to compliance with this Policy or unique activities requiring added evaluation.                   

This Policy is aimed at protecting the employee and complying with CT OSHA compliance requirements.  Failure to comply with the Policy may result in disciplinary action up to and including termination.

Bioengineering/Clinical Engineering/Dental Engineering: These functions, in addition to identifying their occupationally exposed individuals and complying with the supervisor/employee responsibilities of the Policy, will provide to users they support applicable technical assistance on issues related to decontamination of laboratory/clinical equipment as required by paragraph 2n of Attachment 3.

Employee Health Service (EHS):  EHS is the Health Center activity responsible for functioning as the "Licensed Healthcare Professional" defined in the Standard.  For all employees EHS is responsible for providing or arranging for all services, evaluations and recordkeeping specified in paragraphs (f) and (h)(1) of the Standard (hepatitis B vaccination and post-exposure evaluation and follow-up).  Such services will be made available at no cost to the employee and at a reasonable time and place.  EHS will see the new employees identified as "Occupationally Exposed" (or an employee transferred to a job or tasks with "occupational exposure" from a non-occupational exposure position) as soon as possible, but within the first ten working days of Health Center employment/transfer.  EHS will stress the importance of the hepatitis B vaccine, including information on the efficacy, safety, method of administration, the benefits of being vaccinated, and that the vaccination will be offered free of charge.  The employee will be given an opportunity to ask questions on the vaccination.  Hepatitis B vaccination must be made available to occupationally exposed employee within ten work days unless the employee has previously completed the series, antibody testing has revealed that employee is immune, or the vaccine is contraindicated for medical reasons.  Participation in a prescreening program will not be a prerequisite for receiving hepatitis B vaccination.  After the initial 3 doses of Hepatitis B vaccine a Hepatitis B surface Antibody titer will be ordered to document immunity.  A second series of 3 doses of Hepatitis B vaccine be offered if the employee did not develop Hepatitis B surface antibodies following the initial series of the vaccine.  For an employee who declines to accept the hepatitis B vaccination offered, the individual will sign a copy of the declination statement provided in appendix A of the Standard.  EHS will maintain records on such employees and:

1. Maintain the signed statement of employees declining the HBV immunization (the statement and training record may be combined for each employee);
2. Provide exposure evaluations and follow-up
3. Conduct laboratory tests in accordance with the standard accomplished by an accredited laboratory at no cost to the employee;
4. Provide the confidential medical evaluation and follow-up required by the Standard, including documentation of the route of exposure under which the incident occurred and other actions required by paragraph (f)(3) of the Standard; and
5. Document that healthcare professionals responsible for providing the HBV program and the healthcare professionals evaluating employee exposures have been provided a copy of the OSHA Occupation Exposure to Bloodborne Pathogens Standard and this Policy. 

The EHS will also ensure that the healthcare professional evaluating an exposure incident has: (1) a description of the exposed employees duties as they relate to the exposure incident; (2) documentation of the exposure and circumstances under which exposure occurred; (3) results of the source individual's blood testing, if available; and (4) all medical records relevant to the appropriate treatment of the employee including vaccination status which are the Health Center's responsibility to keep as the employer.  Items (1) and (2) will be obtained by EHS or the treating healthcare professional during their interview/treatment of the exposed employee.  Within 15 days of the completion of the exposure evaluation, EHS will verify that the written opinion required by the Standard is available and that a copy has been provided to the employee.  The written opinion will provide the information required by (f)(5)(i) or (f)(5)ii of the Standard, as appropriate.  For the hepatitis B vaccination determination {(f)(5)(i)}, the statement signed by an employee refusing vaccination can be annotated to show that the vaccination was indicated (or not indicated for the individual) and a copy provided to the employee and the original placed in the medical record.  EHS will be responsible for arranging the collection and preservation of blood for future testing in accordance with the Standard and other accepted occupational medicine practices/requirements.  EHS will ensure for the Health Center that employee medical records are maintained under their supervision in accordance with paragraph (h) of the Standard.      

EHS shall maintain a sharps injury log for the recording of percutaneous injuries from contaminated sharps.  The information in the log shall be recorded and maintained in such a manner as to protect the confidentiality of the injured employee.  The sharps injury log shall contain at a minimum:

(a)   The type and brand of device involved in the incident.

(b)   The department or work area where the exposure incident occurred, and

(c)   An explanation of how the incident occurred.

Institutional Biosafety Committee (IBC):  Any research laboratories and production facilities engaged in the culture, production, concentration, experimentation, and manipulation of HIV and HBV shall have developed a written safety protocol covering such activities.  (See Methods of Compliance HIV and HBV Research Laboratories and Production Facilities).  This protocol shall be approved by the Institutional Biosafety Committee (IBC).  The special training required by the Safety Protocol or the OSHA Standard will be completed prior to the start of such work with potentially infectious materials.  The supervisor/P.I. (principal investigator) shall require as a condition of employment that personnel accomplishing such tasks comply with this Policy, the OSHA Standard and the written safety protocol approved by the IBC.  Such laboratories must also be registered with the CT Department of Public Health and this registration must be coordinated with the Research Safety Office.  In addition to the normal training required by this Policy and Standard, employees in these HIV and HBV research laboratories and/or production facilities shall demonstrate to the satisfaction of the IBC: 

1. Proficiency in standard microbiological practices and techniques and in the practices and operations specific to the facility before being allowed to work with HIV or HBV,  
2. Prior experience in the handling of human pathogens or tissue cultures before working with HIV or HBV; or  
3. Completion of a Research Safety Office arranged training program for any such employee who has no prior experience in handling human pathoge (for these employees initial work activities shall not include the handling of infectious agents and a progression of work activities shall be assigned as approved by the IBC as techniques are learned and proficiency is developed).

Facilities Management (FM):  FM is responsible for:

1. Disposal of medical waste as required by the UCHC Regulated Medical Waste Policy; 
2. Routine housekeeping of public rest rooms/handwashing facilities and providing hand cleaners and clean single use cloth/paper towels for such areas or for other areas as agreed to with the user; 
3. Examining any facility, research or other non-patient care equipment that may have become contaminated with human blood or other potentially infectious materials for visible signs of contamination prior to Facilities Management's maintenance/repair/servicing, and/or having the equipment user/owner verify that it has been decontaminated (or otherwise appropriately marked in accordance with the Standard) prior to such service;  
4. Maintaining the work areas where they provide housekeeping in a clean sanitary condition in accordance with a written schedule approved, as it pertains to this Standard, by Health Center Epidemiology, Research Safety and the activity (the schedule will list the areas covered, cleaning schedule and cleaning method); 
5. Maintaining all their bins, pails, carts and similar receptacles (e.g. medical waste cart, step-on regulated waste receptacles) intended for reuse which have a reasonable likelihood for becoming contaminated with blood or other potentially infectious material by having the housekeeper visually inspect the interior and exterior surfaces for visible human blood/body fluid contamination after each emptying and prior to reuse and  clean and decontaminate the item whenever contamination is identified (additionally such items will be cleaned/ decontaminated on a periodic basis as indicated on the cleaning schedule);  
6. Making sure that mechanical means (e.g., brush and dust pan) are used to collect broken glassware which may be contaminated (gloves will also be used as a secondary method of exposure control);  
7. Making sure that all regulated medical waste containers used by the facility are constructed, used, marked and disposed of in accordance with this Policy, the OSHA Standard and the Regulated Medical Waste Policy; and  
8. Complying with this Policy and enforcing for their occupationally exposed employees the full provisions of this Policy.

Department of Epidemiology:  This department will act as a Health Center infection control information resource for activity heads, supervisors and occupationally exposed employees on the clinical, Health System and patient care aspects of the OSHA Bloodborne Pathogen Standard.  The Department of Epidemiology will provide the training support outlined in paragraph 5b(8) of Attachment 3 including:

1. Participation in monthly, initial and annual training session for Health Center personnel on Bloodborne Disease Prevention and Biosafety.

2. On a loan basis provide training videos, copies of the Standard, etc., for major activities and supervisors accomplishing their own initial and annual training of exposed employees in accordance with the Standard. 

The Department of Epidemiology will also assist supervisors with the technical aspects of determining when clinical equipment cannot be decontaminated in accordance with paragraph 2n of Attachment 3. 

 

The Department of Epidemiology, in collaboration with the Research Safety Office, shall solicit input from non-managerial employees    

responsible for direct patient contact who are potentially exposed to injuries from contaminated sharps in the identification, evaluation and

selection of effective engineering and work practice controls.  Such solicitation will be documented and an annual summary presented to

the Infection Control Committee.

        The Department of Epidemiology in collaboration with the Research Safety Office shall evaluate and consider for implementation appropriate commercially

        available and effective safer medical devices or technological changes designed to eliminate or minimize occupational exposures to bloodborne pathogens.

        Effectiveness of such devices or changes in technology will be determined by evaluation of institutional accident statistics and determination of the likelihood

        that implementation of technological devices will reduce the occurrence of injuries.

A summary of such evaluation will be provided to the Infection Control Committee on an annual basis.  The Infection Control Committee will   

determine if a new safety device or technology is effective and whether it should or should not be implemented.  Such deliberations

will be documented.

 

Human Resources (HR): Prior to processing for new and transferred employees, HR will require an exposure evaluation form from the supervisor.  This form will indicate whether or not the individual is occupationally exposed to human blood/body fluids.  This determination will be entered into the HR bloodborne pathogen database.  Epidemiology/Research Safety/Employee Health Service will provide the criteria to be used for such exposure determinations to HR and the activity heads.  Human Resources will complete for the injured/exposed employees the report of occupational injury/illness.  Copies of all such reports will be provided to the Office of Research Safety. 

Organization and Staff Development (OSD):  OSD has a major responsibility for coordinating and assuring compliance with regulatory training requirements (e.g., bloodborne pathogens.  Thus, training accomplished as part of this Policy will be developed in coordination with OSD by the content experts (Department of Epidemiology and Research Safety Office).

Purchasing Department:  This department is responsible for assuring that all users have access to the supplies {including protective equipment, clothing, labels, sharps containers, liquid soap dispensers, disinfectants, etc.} and services (such as laundry) required by the Standard and this Exposure Control Plan.  Such supplies and services must be available in the quantities, sizes and types required by the user.  The vendor providing laundry services for contaminated linen/clothing described in Attachment 3 will be required to follow universal precautions in handling all such items received from the Health Center, irrespective of markings.

Office of Research Safety:  The Office of Research Safety will assist

supervisors with the technical aspects of determining when laboratory equipment cannot be decontaminated in accordance with paragraph 2n of Attachment 3.  The Research Safety Office, through the Biological Safety Officer (BSO), will act as a Health Center safety information resource for activity heads and supervisors and occupationally-exposed employees on the laboratory aspects of the OSHA Bloodborne Disease Standard, this Policy and Universal Precautions.  The BSO and/or other qualified staff of the Environmental Health and Safety Office will provide the training support outlined in paragraph 5b(8) of Attachment 3 including:

1. Participation in monthly, initial and annual training session for Health Center personnel on Bloodborne Disease Prevention and Biosafety.

2. On a loan basis provide training videos, copies of the Standard, etc., for major activities and supervisors accomplishing their own initial and annual training of  exposed employees in accordance with the Standard.  The Director of the Office of Research Safety or a designated representative will serve on the Committee on Institutional Safety and Environmental Health.

The Research Safety Office in collaboration with The Department of Epidemiology, shall solicit input from non-managerial employees responsible for direct patient contact who are potentially exposed to injuries from contaminated sharps in the identification, evaluation and selection of effective engineering and work practice controls.  Such solicitation will be documented and an annual summary presented to the infection Control Committee. 

The Research Safety Office in collaboration with the Department of Epidemiology shall evaluate and consider for implementation appropriate commercially available and effective safer medical devices or technological changes designed to eliminate or minimize occupational exposures to bloodborne pathogens.

         Effectiveness of such devices or changes in technology will be determined by

         evaluation of institutional accident statistics and determination of the likelihood that

         implementation of technological devices will reduce the occurrence of injuries.

A summary of such evaluation will be provided to the Infection Control Committee on an annual basis.  The Infection Control Committee will determine if a new safety device or technology is effective and whether it should or should not be implemented.  Such deliberations will be documented.

UCHC Infection Control Committee (UCICC):  The UCICC provides professional oversight of infection control issues including those related to bloodborne pathogens.  It reviews, approves and coordinates recommendations with the UCHS Safety and Emergency Preparedness Committee and as needed, the Institutional Biosafety Committee.   

The Infection Control Committee shall on an annual basis determine if new safety devices/technology will be effective in reducing injures in a specific application and determine if the use of such devices should be implemented.  Such deliberations will be documented.

University of Connecticut Health System Safety and Emergency Preparedness Committee:  The UCHS Committee is primarily responsible for patient and/or staff safety issues within the UCHC Health System, including the John Dempsey Hospital.  This Committee coordinates any recommendations made regarding bloodborne pathogen safety within the Health System.

B.  Methods of Compliance

General:  Universal Precautions shall be observed to prevent contact with blood or other potentially infectious materials.  Specific methods of compliance that must be followed by supervisors and employees are outlined in Attachment 3.

HIV and HBV Research Laboratories and Production Facilities:  In addition to all other requirements of this Policy and the OSHA Standard, research laboratories and production facilities engaged in the culture, production, concentration, and manipulation of HIV and HBV shall comply with the requirements of paragraphs (e) and the additional training requirements of paragraph (g)(2)(ix) in the OSHA Standard, as applicable.  (These additional requirements do not apply to clinical or diagnostic laboratories engaged solely in the analysis of blood, tissue, or organs.  They also do not apply to research laboratories using unconcentrated blood or blood components as the source of HIV or HBV, if this is the only source of the virus in the laboratory.)  In addition:

1. Research laboratories and production facilities shall not engage in the culture, production, concentration, and manipulation of HIV and HBV until a detailed written safety protocol has been formally approved by the Institutional Biosafety Committee (IBC);

2. No employee shall conduct such activities the IBC has formally acknowledged that the individual has met the special training mandates of paragraph (g)(2)(ix) of the OSHA Standard and that this has been documented;

3. The research laboratory investigator/supervisor shall review and update the written Safety Protocol, as needed.

4. The Institutional Biosafety Committee approvals of such safety protocols shall require: (a) submission by the investigator of any safety changes for the Subcommittee's advanced approval; (b) acknowledgment by the investigator that the protocol will be reviewed and resubmitted to the IBC so that it can be evaluated for re-approval , if necessary.

5. The investigator/supervisor will cease such activities: (a) if the safety protocol has significantly changed and has not been re-approved within twelve months; (b) if the approved safety protocol requirements cannot be complied with; and/or (c) the IBC cancels the approval.

6. The investigator/supervisor will register the laboratory with the CT Department of Public Health and coordinate this registration with the Biological Safety Officer.