Attachment_Number_8_-_Infectious_Disease_Control_Policy_Memo_July_12_2010.docx

POLICY AND PROCEDURES MANUAL

OFFICE OF PURCHASING AND CONTRACTS

Contract Series

No. C02-08 Release Date: July 1, 2010

Subject: Control of Infectious Disease under Clinical Center Contracts and Purchase Orders

Purpose

This issuance has been developed to provide the Contract Specialist continued guidance in preparing and monitoring awards requiring infectious disease reporting in accordance with Federal government and NIH regulations for contracted work within the NIH Clinical Center (CC) which includes building 10, ACRF, CRC and the Family Lodge. All awards which require contract personnel to provide services in patient care areas or in close proximity to patients are covered by this policy. This includes but is not be limited to: construction, housekeeping, maintenance and any form of direct patient care such as nursing and respiratory therapy.

Background

The Hospital Epidemiology Service (HES) Department supports the CC by providing the expertise necessary for developing, implementing and coordinating an effective, collaborative infection control program. HES is also responsible for obtaining reported information, ensuring compliance and investigating outbreaks and/or exposures to infectious diseases, as well as conducting periodic risk assessments as part of the CC Tuberculosis Control Plan.

Changes in Tuberculin Skin Testing Requirement for Patient Care Staff:

In the past, all Clinical Center contractors who provided patient care were required to have annual skin test surveillance for tuberculosis. In 2005, CDC issued updated guidelines for preventing tuberculosis in health-care settings. Based upon the criteria for institutional assessment in the revised guidelines, the NIH Clinical Center is categorized as a low risk setting for occupational exposure to Mycobacterium tuberculosis. Consistent with these guidelines, contractors shall continue to have initial two-step tuberculin skin testing (TST) performed for newly hired CC employees. Only health care workers in high-risk occupations will be required to have annual TST (e.g., respiratory therapists, bronchoscopy staff, mycobacteriology lab staff, etc.) OMS shall not perform these or other tests on contractors or contractors’ employees.

Policy

It is the policy of the Office of Purchasing and Contracts (OPC) to work with HES officials to ensure that all appropriate clauses are incorporated into the purchase vehicle and that compliance reports are obtained. The reports shall be made as deliverables under applicable awards regarding outbreaks of M. tuberculosis, measles, hepatitis B, varicella and related issues among contracted employees. The contract specialist shall assure that the reports are delivered by the contractor on time to HES.

Procedures

1. The first step in the award process regarding infectious disease reporting is the receipt of a formal statement of work that is reviewed and concurred by the HES representative for any compliance requirements. The HES representative, with approval of the Project Officer, will determine which portions of the reporting requirements are applicable. This will enable the Contract Specialist to include the required language in the solicitation using the Federal Acquisition Regulation (FAR) Uniform Contract Format and shall be included AS STATED as follows:

a. Section F – Deliveries of Performance.

F.x. Compliance Report Requirements.

The contractor shall submit deliverables and/or compliance reports covering the control of infectious disease for each reporting period. See exhibit B.

Reports shall address each of the applicable infectious diseases (e.g., M. tuberculosis; hepatitis B, measles, and varicella (chicken pox) and related issues (Universal Precautions Training.)) The infectious disease, related issues, work locations and job categories are outlined in the attachments herein. The reports shall be factual and prepared in accordance with the format in Section J, Attachment (enter number).

b. Section H – Special Contract Requirements.

H.x. Control of Infectious Disease.

Contractors must ensure that they comply with all applicable federal and state government regulations regarding control of infectious diseases in health care facilities. Contractors should consult the specific regulations for further details, exemptions, documentation, and record keeping requirements. Specific examples include, but are not limited to:

· Hospital workers must have proof of rubeola (measles) immunity. Workers born after 1956, working at least 20 hours each week, who are newly retained as medical staff, direct or contractual employees, or volunteers shall have documentation of receipt of either one dose of live measles virus vaccination or proof of immunity by blood test for antibody to rubeola. (Immunization of Health-Care Workers: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Hospital Infection Control Practices Advisory Committee (HICPAC) MMWR December 26, 1997 / Vol 46 / RR-18). The contractor shall keep the measles vaccination or immunity status of each worker on file.

· Workers with occupational exposure to blood or other potentially infectious materials shall be offered the hepatitis B vaccine unless the employee has previously received the complete hepatitis B vaccination series, antibody testing has revealed that the employee is immune, or the vaccine is contraindicated for medical reasons. Employees who decline to accept the hepatitis B vaccination must sign the mandatory declination, as specified in the OSHA standard. The contractor shall maintain these records for at least the duration of employment plus 30 years, in accordance with the standard. (29 CFR Part 1910.1030, Bloodborne Pathogens).

· Workers with occupational exposure to blood or other potentially infectious materials must receive annual training in Universal Precautions. For workers in the Clinical Center and/or credentialed to provide patient care, this training is routinely offered by the Hospital Epidemiology Service (HES). Contractors must either provide annual training to their employees with occupational exposure or ensure that they receive training through the HES. Contractors must maintain training records for three years, according to the standard. (29 CFR Part 1910.1030).

· Workers with occupational exposure to blood or other potentially infectious materials shall be offered post-exposure evaluation and follow-up. The contractor shall maintain these records for at least the duration of employment plus 30 years, in accordance with the standard. (29 CFR Part 1910.1030) The NIH Occupational Medical Service provides emergency clinical evaluation and treatment to staff and visitors on campus who report an exposure to potentially infectious materials.

· Workers who have the potential for exposure to M. tuberculosis shall receive counseling, screening, and evaluation and shall have a two step tuberculin skin test (TST) at the time of employment. These workers include: persons who routinely have patient contact or who enter patient rooms or examination or treatment rooms; persons who are exposed to M. tuberculosis in a laboratory or morgue; or persons who work in a primate animal care setting. Workers who have positive purified protein derivative (PPD) skin test results, PPD test conversions, or symptoms suggestive of TB should be identified, evaluated to rule out a diagnosis of active TB, and started on therapy or preventive therapy if indicated. The results of pre-placement and periodic TST (if indicated) testing must be kept in a retrievable aggregate database. These data must be reported to the Hospital Epidemiology Service as requested. (Centers for Disease Control and Prevention. Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005. MMWR December 30.2005 / Vol 54/ RR-17).

· Any contract employee physically working in building 10, whether or not he or she has occupational exposure to M. tuberculosis, must have a pre-placement PPD skin test and those with positive PPD tests must be evaluated as described above

Contract workers with patient contact must have a pre-placement titer for varicella zoster. If titer indicates susceptibility receipt of varicella vaccine is recommended. The contractor shall keep the varicella titer and/or vaccination status of each worker on file. (Prevention of Varicella recommendations of the Advisory Committee on Immunization Practices (ACIP) MMWR June 22, 2007 / Vol 56/ RR-04).

2. The concluding step in the contract process phase is the distribution of the final contract or purchase order document. Copies of the new signed executed contract or purchase order are distributed to the Contractor, the NIH Finance Office, the Project Official, the Administrative Officer(s) and Property, if applicable.

The face page of any contract or purchase order that contains infectious disease reporting requirements shall also be forwarded to the attention of:

Hospital Epidemiology Service (HES) Warren G. Magnuson Clinical Center, NIH Attn: MaryAnn Bordner, MS Building 10, Room 2N224 10 Center Drive MSC 1354 Bethesda, MD 20892-1354

E-Mail: MBordner@ cc.nih.gov

Each Contracting Officer shall ensure that all reporting information is received as outlined in the award document and filed accordingly.

3. During the award administration phase, HES will prepare a Summary Status Report of all reporting contractors and forward the report to the Contract Branch’s Chief as follows (See Exhibit B for compliance reporting.):

Initial Report 30 days after award effective date.

Semi-Annual Report 30 days following the due date.

HES dedicate both staffing and administrative resources to ensure compliance with regulatory requirements. Refer to http://www.cc.nih.gov/hes/mission.html for their strategic functions.

4. HES shall be notified by OPC when an award is being renewed or recompeted.

References

1. NIH Manual 1743, “Keeping and Destroying Records,” Part 1 Administration, 2600 A-1, Procurement, Property and Supply Management, General Correspondence Files dated February 1998.

2. CC Tuberculosis Control Plan 1, Based on the Centers for Disease Control and Prevention “Guidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Health-Care Facilities, 2005.”

3. OPC Standard Operating Procedure No. A00-02, Acquisition Plan Process, dated March 2, 2009.

Exhibits A: Acquisition Plan OPC - Transmittal and Approval Form.

B: 5-5-10 Compliance Reporting for Clinical Center Control of Infectious Disease.

Attachments 9.1: Itemized Compliance Report for Clinical Center Control of Infectious Disease.

9.1a: New Employee Report 9.2: Summary of Compliance Report for Clinical Center Control of Infectious Disease.

9.3: Work Locations and Job Categories.

EXHIBIT A

Acquisition Plan, OPC Part I –Transmittal and Approval Form To:

From:

Project Title:

RFP Number:

This document transmits the required Acquisition Plan (AP) for the proposed solicitation and award of the above-referenced project. The AP complies with HHS Acquisition Regulation (HHSAR) Subpart 307.71, Acquisition Plan, and applicable OPDIV guidance. The AP consists of the following parts:

1. Part I: Transmittal and Approval Form

1. Part II: Summary Sheet

1. Part III: Project Considerations and Information

1. Part IV: Clearance/Approval Checklist

1. Part V: Acquisition Milestone Schedule

1. Part VI: Independent Government Cost Estimate

1. Part VII: Attachments Signature by the Division Director or Designee and other AP signatories verifies that the AP has been reviewed and, as required by HHSAR 307.7104, certifies that the AP provides all required information in the prescribed format and the following:

· Vague and ambiguous language has been eliminated;

1. A thorough technical review of the Statement of Work/Specification has been completed;

1. The project is structured by phases or tasks, as appropriate;

1. Methods are available to assess the contractor’s performance;

1. The acquisition mechanism is appropriate (i.e., the principal purpose of the project is to acquire supplies or services for the direct benefit or use of the Government); and

1. The planned obligation of appropriated funds for the project satisfies a bona fide need of the requiring office arising in the fiscal year for which the appropriation was made.

PROJECT OFFICER (PO/COTR) *

* Signature by the Project Officer listed above certifies in accordance with HHSAR 307.170 and the Acquisition Workforce Training and Certification Handbook (June 2007), that they have met the training requirements for appointment as Project Officer for this Acquisition.

PO/COTR IMMEDIATE SUPERVISOR

DIVISION DIRECTOR OR

DESIGNEE

HOSPITAL EPIDEMIOLOGY SERVICE

CONTRACTING OFFICER (CO)

CONTRACT SPECIALIST (NBS BUYER)

Funding Official’s Certification:

FUNDS CERTIFICATION OFFICIAL

EXHIBIT B

Compliance Reporting Schedule Control of Infectious Diseases

1. Initial Report Itemized compliance information on each current employee working on the contract (Attachment 9.1) 1 copy to

2. HES

3. Contracting Officer

4. Project Officer Due 30 days after contract is effective

2. New Employee Report Itemized compliance report shall be submitted as new employees are hired (Attachment 9.1a) 1 copy to

5. HES

6. Contracting Officer

7. Project Officer Due within 30 days of hire date

3. Semi-Annual Report Cumulative report for each current employee working on the contract (Attachment 9.2) 1 copy to

8. HES

9. Contracting Officer

10. Project Officer Due on or before April 15 (for October 1 to March 31) October 15 (for April 1 to September 30)

4. Immediate report for possible transmission for any contract employee identified with pulmonary or laryngeal tuberculosis

Contact HES immediately by phone 301-496-2209 office 301-496-1211 page Hospital Epidemiology Service person on call

Office of purchasing and Contracts (OPC) 6707 Democracy Blvd (Suite 106) Bethesda, MD 20892

Hospital Epidemiology Service (HES) National Institutes of Health Building 10/Room 2N 224 10 Center Drive Bethesda, MD 20892

ATTACHMENT 9.1

Initial Compliance Report for Clinical Center Control of Infectious Diseases

Employee Name

Occupational TB Exposure[footnoteRef:1] [1: Workers with potential for exposure to M. tuberculosis = persons who routinely have patient contact or who enter patient rooms, examination, or treatment rooms; persons who are exposed to M. tuberculosis in a laboratory or morgue; or persons who work in a primate animal care setting.

Baseline TST – 2 step Measles[footnoteRef:2] [2: Workers born after 1956 working at least 20 hours/week in Bldg. 10 must comply. Compliance = either 1) Documentation of receipt of 1 dose live measles virus vaccination or 2) Proof of immunity by blood test for antibody to rubeola.

Varicella titer[footnoteRef:3] [3: Workers with patient contact must comply. Compliance = record of titer results for varicella (Persons with negative titer should consider varicella vaccine)

Hepatitis B Vaccine[footnoteRef:4] [4: Workers with possible occupational exposure to human blood or other potentially infectious materials must comply. Compliance = any of the following: 1)received 3 doses hepatitis B vaccine, 2) immunity documented by anti-HBs testing, 3) vaccine offered but contraindicated for medical reasons, or 4) vaccine offered at no cost, but employee signed mandatory declination, as specified in OSHA standard. Workers who begin vaccine series of 3 doses are classified “Enrolled” until their 3rd dose at 6 months. If series is not completed within 6 months, worker is “Noncompliant.”

Universal Precautions Training[footnoteRef:5] [5: Workers with possible occupational exposure to human blood or other potentially infectious materials must receive annual training. ]

1/12/11

*See Attachment 9-3 for job categories and job locations/abbreviations.

ATTACHMENT 9.1a New Employee Compliance Report for Clinical Center Control of Infectious Diseases

Employee Name

Occupational TB Exposure[footnoteRef:6] [6: Workers with potential for exposure to M. tuberculosis = persons who routinely have patient contact or who enter patient rooms, examination, or treatment rooms; persons who are exposed to M. tuberculosis in a laboratory or morgue; or persons who work in a primate animal care setting.

Baseline TST – 2 step Measles[footnoteRef:7] [7: Workers born after 1956 working at least 20 hours/week in Bldg. 10 must comply. Compliance = either 1) Documentation of receipt of 1 dose live measles virus vaccination or 2) Proof of immunity by blood test for antibody to rubeola.

Varicella titer[footnoteRef:8] [8: Workers with patient contact must comply. Compliance = record of titer results for varicella (Persons with negative titer should consider varicella vaccine)

Hepatitis B Vaccine[footnoteRef:9] [9: Workers with possible occupational exposure to human blood or other potentially infectious materials must comply. Compliance = any of the following: 1)received 3 doses hepatitis B vaccine, 2) immunity documented by anti-HBs testing, 3) vaccine offered but contraindicated for medical reasons, or 4) vaccine offered at no cost, but employee signed mandatory declination, as specified in OSHA standard. Workers who begin vaccine series of 3 doses are classified “Enrolled” until their 3rd dose at 6 months. If series is not completed within 6 months, worker is “Noncompliant.”

Universal Precautions Training[footnoteRef:10] [10: Workers with possible occupational exposure to human blood or other potentially infectious materials must receive annual training. ]

3/8/10

ATTACHMENT 9.2

Summary Compliance Report for Clinical Center Control of Infectious Diseases

Employee Name

Occupational TB Exposure[footnoteRef:11] [11:

Workers with potential for exposure to M. tuberculosis = persons who routinely have patient contact or who enter patient rooms, examination, or treatment rooms; persons who are exposed to M. tuberculosis in a laboratory or morgue; or persons who work in a primate animal care setting.

Baseline TST – 2 step Measles[footnoteRef:12] [12: Workers born after 1956 working at least 20 hours/week in Bldg. 10 must comply. Compliance = either 1) Documentation of receipt of 1 dose live measles virus vaccination or 2) Proof of immunity by blood test for antibody to rubeola.

Varicella titer[footnoteRef:13] [13: Workers with patient contact must comply. Compliance = record of titer results for varicella zoster virus (Persons with negative titer should consider varicella vaccine)

Hepatitis B Vaccine[footnoteRef:14] [14: Workers with possible occupational exposure to human blood or other potentially infectious materials must comply. Compliance = any of the following: 1)received 3 doses hepatitis B vaccine, 2) immunity documented by anti-HBs testing, 3) vaccine offered but contraindicated for medical reasons, or 4) vaccine offered at no cost, but employee signed mandatory declination, as specified in OSHA standard. Workers who begin vaccine series of 3 doses are classified “Enrolled” until their 3rd dose at 6 months. If series is not completed within 6 months, worker is “Noncompliant.”

Universal Precautions Training[footnoteRef:15] [15: Workers with possible occupational exposure to human blood or other potentially infectious materials must receive annual training. ]

1/12/11

ATTACHMENT 9.3

Work Locations and Job Categories in Building 10

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CC-Imaging Department CT, Radiology, Nuclear Medicine, PET, MRI 10/1C626

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Suggested Job Categories

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