NIH Department of Occupational Health and Safety (DOHS) - Respiratory Protection Program

The National Institutes of Health (NIH) Respiratory Protection Program (RPP) establishes uniform procedures, in accordance with the Occupational Safety and Health Administration (OSHA) Standards, 29 CFR Part 1910.134, Respiratory Protection, for the appropriate selection, use, and care of respiratory protective equipment for NIH employees.  The Office of Research Services (ORS), Division of Occupational Health and Safety (DOHS), Technical Assistance Branch (TAB), provides administrative management for the NIH RPP. The NIH RPP applies to all federal employees at the NIH. 

It is the policy of the NIH to provide, at no cost to the employee, respiratory protection when: the best available engineering controls fail to adequately reduce employee exposure to respiratory hazards; substitution of respiratory hazards with less hazardous elements is not feasible; modifications in hazardous operations fail to reduce exposures to below regulated or acceptable levels; or, national guidelines for minimizing health care associated infections recommend respirator use. Respiratory protection shall be provided during interim periods when engineering controls are being implemented and no other means of worker protection is available.

General Introduction

The NIH Clinical Center (CC) has instituted a strict category of isolation for patients with special respiratory disease, including Severe Acute Respiratory Syndrome (SARS). It is anticipated that emerging infections or smallpox could be managed with this type of isolation.

The CC Infection Control Guidelines, Respiratory Pathology Management, addresses the management, containment and prevention of the spread of respiratory pathogens throughout the clinical center.

The following precautions were developed based on the latest recommendations from the Centers for Disease Control and Prevention (CDC), the World Health Organization (WHO), the Clinical Center Safety Committee, and the Clinical Center Hospital Epidemiology Service (HES). The CDC estimates that several thousand diagnostic specimens from patients with SARS have been processed in routine clinical laboratories and, to date, there have been no reported clusters of SARS illness among laboratory workers. As we learn more about these patients and the best way to handle laboratory specimens, we will likely change this procedure. At present, the only types of samples expected under the new SARS protocol are:

  • Bronchial alveolar lavage (BAL) or other bronchial cytology specimen, placed in formalin.
  • Trans-bronchial biopsy placed in formalin.
  • Other, unexpected specimens, as clinically indicated.
  • Potential autopsy.

Notes:

  1. Frozen sections will not be done on these patients, until more is learned about how to do them safely.
  2. Smears cannot be made at the bedside for Fine Needle Aspirates.
  3. Specimens dedicated for tissue exam or cytopathology exam (not cultures) must be placed directly in formalin (see below).

For questions or problems, contact your supervisor. The supervisor may consult the following resources:

Notification of Special Respiratory Isolation (Including SARS, Smallpox, etc.)

HES will notify certain Laboratory of Pathology (LP) employees of patients with Special Respiratory Isolation via secure e-mail. The e-mail notifications will be printed and stored in a secured notebook in the Histology and Cytology sections.

Specimen Handling Precautions and Personal Protective Equipment
Full Personal Protective Equipment (PPE) is to be used when processing specimens that have not been properly bagged, transported, or inactivated with fixative, or for autopsy procedures.

 In addition to the PPE procedures stated below, follow the NIH Clinical Center (CC) Isolation Guidelines for additional information regarding Respiratory Pathogen Management.

  • Refer to procedure for donning/removing PPE.
  • Double Gloves. For autopsy procedures, use interposed layer of cut-resistant gloves between rubber gloves.
  • Impervious disposable gown, coverall, and/or apron, as appropriate.
  • Disposable surgical cap and shoe covers.
  • All employees must be re-trained to wear the powered air purifying respirator (PAPR) and be fit tested for the N-95 respirator mask prior to handling unfixed specimens from "Special Respiratory Specimens".
  • A full face shield must be worn with an N-95 mask, but is not required when using a PAPR.
  • Autopsy down draft table (autopsy procedures only) in Negative-Pressure Autopsy Suite. See room preparation for autopsy procedure (below).
  • The biosafety cabinet (BSC) located in the Cytology Section (Building 10, Room 2S242) may be used to process specimens, if needed, while wearing full PPE.
  • It is acceptable to wear the N-95 respirator while working at the BSC, but a PAPR should be worn when handling unfixed specimens outside of the BSC (e.g., an autopsy procedure in the Negative-Pressure Autopsy Suite).

NOTES:

  1. DO NOT add fixative to active specimens delivered to the LP, in the grossing hood or down draft table. Use the BSC for this purpose.
  2. ALL EMPLOYEES MUST BE RE-TRAINED TO WEAR THE PAPR AND FIT TESTED FOR THE N95 RESPIRATOR PRIOR TO HANDLING SPECIAL RESPIRATORY ISOLATION SPECIMENS THAT ARE NOT FIXED. Contact CC Safety at (301) 496-5281 to arrange for an N-95 mask fit test and/or PAPR training in advance of performing the procedures.
  3. Personnel who cannot wear a fitted N-95 face mask must wear a PAPR.
  4. Pay careful attention to procedures for hand hygiene, disposable waste, particulate aerosols, and environmental cleaning (see below for more details)
Personal Protective Equipment (PPE) is to be used when processing formalin fixed, or otherwise inactivated specimens.

  • Follow universal precautions when handling the specimen throughout the remainder of the testing.
  • Wear gloves and lab coat.
  • Employees may wear additional PPE and a PAPR or N-95 mask if desired, but these are not necessary for inactivated specimens.

 A. Cytology/Surgical Pathology Pathology Specimens:

 Verify specimen was collected, transported, and labeled properly. If not, do the following:

  1. Notify your supervisor immediately and complete an Occurrence Reporting System (ORS) report.
  2. The supervisor will notify the Hospital Epidemiology Service (HES) and contact the Hot Seat or Autopsy Resident to assist with placing the sample on fixative in the BSC located in the Cytology Section (Building 10, Room 2S242), while wearing full PPE.
  3. Transfer the specimen directly into a properly labeled container containing 10% neutral buffered formalin, or add the fixative to the specimen. Tighten lid securely. Double-check to make sure it does not leak.
  4. Wipe with CC-approved disinfectant (Dispatch or 95% EtOH).
  5. Change gloves.
  6. Place specimen in bag.
  7. Place bagged specimen in secondary bag.
  8. Dispose of gloves, gowns, shoe covers, empty specimen container, and any other biomedical waste as instructed below.

    1. All specimens must be fixed for at least 24 hours prior to additional handling. A longer time period is required if the specimen is greater than 3 mm thick. Larger specimens should be sectioned as thin as possible by the resident wearing full personal protection equipment (see above), under the biological safety cabinet (BSC) in the Cytology Lab (Building 10, Room 2S242), and placed in 20 volumes of 10% neutral buffered formalin.

    2. All cytology specimens will be processed as a cell block.

B. All Other Laboratory of Pathology Specimens:

  • Collection, retrieval, transport, and processing of specimens should be carefully coordinated with the Section Chief and study investigators.

C. Autopsy:

 IMPORTANT:  STRICT PROCEDURES MUST BE ADHERED TO BY ALL STAFF PARTICIPATING IN THE AUTOPSY.

  1. Before starting the autopsy, refer to the  Center for Disease Control and Prevention (CDC) website for the latest recommendations. Prepare Autopsy Suite by clearing unneeded items from counter tops and draping desks and unneeded equipment. Verify air pressure differential is not in alarm status.
  2. Set up a specimen cart by placing absorbent pads on each shelf.
  3. Before transporting the body to the autopsy suite, drape all benches within 10 feet from the table with linen drapes.
  4. Deactivate door, so people can not push button for entrance.
  5. Place signs in front of door:
    1. Hexagon magnetic stop sign: “STOP DO NOT ENTER, SPECIAL RESPIRATORY ISOLATION AUTOPSY IS IN PROGRESS THANKS”
    2. Hang banner across the doors to the suite to prevent entrance. This banner states “STOP DO NOT ENTER, SPECIAL RESPIRATORY ISOLATION AUTOPSY IS IN PROGRESS.”
  6. Only the Section Chief, the Resident, and the Autopsy Assistant will be present to perform the autopsy. No others will be permitted in the suite without prior discussion with the Section Chief.
  7. Use the same protocol that is used for multidrug-resistant tuberculosis (MDR TB).
  8. Don all PPE (see above) before opening the body bag. Save the outer bag, but discard the inner bag into biohazard waste.
  9. The extent of the autopsy and the approach used in dissection will be limited based on the autopsy permission and the discretion of the Section Chief.
  10. Use an autopsy head drape (under evaluation) to contain particulate matter. The drape is easily adjusted for use over the head or torso. Entry ports are available on all four sides with cover flaps. Minimize the number of ports entered at one time. If possible, enter only one port at a time.
  11. Use the bone dust collector attachment with HEPA filter on the Stryker saw.
  12. Do not cut rib cage with clippers. Use the Stryker with bone dust collector to cut rib cage.
  13. Specimen Collection:
    1. Collect clinical autopsy specimens directly into containers of formalin.
    2. Collect specimens for the CDC following the CDC's Specimen Collection Guidelines. 

        1. Fixed Tissue:  all major organs (e.g., lung, heart, spleen, liver, brain, kidney, adrenals)
        2. Frozen Tissue:  lung and upper airway (e.g., trachea, bronchus)
        3. Upper Respiratory:  nasopharyngeal aspirate; nasopharyngeal and oropharyngeal swabs
        4. Lower Respiratory:  broncheoalveolar lavage (BAL), tracheal aspirate or pleural tap
        5. Blood: serum, whole blood
        6. Stool
    3. Collect research tissue for National Institute of Allergies and Infectious Diseases (NIAID), as specified, if requested.
    4. If tissue cannot be fixed, carefully coordinate collection requirements, bagging, and transportation between the Principal Investigator, CC/Department of Laboratory Medicine (DLM), and/or CDC. Wipe with a CC-approved disinfectant (Dispatch or 95% EtOH). Change gloves. Place specimen in bag. Place bagged specimen in secondary bag. Arrange for transportation of the samples.
    5. Wipe down all formalin-fixed tissue containers with a CC-approved disinfectant (Dispatch or 95% EtOH). Place in double bags if possible. Place all large containers on the cart covered with absorbent pads, and cover with clear plastic. Allow samples to fix for 24 hours before further processing.
  14. After the autopsy is complete, prepare the body for transportation according to the latest CDC recommendations for handling remains of SARS patients. After placing the body back into the body bag, disinfect outer surface with Dispatch disinfectant. Place the shrouded body in a new (clean) secondary body bag, before transporting back to the morgue. Place a “Special Respiratory Isolation” sticker on the outside of the new body bag.
  15. Disinfect all work surfaces and instruments with disinfectant (Dispatch, 95% EtOH, TB Quat2) using a two step cleaning method.

NOTE:  DO NOT USE BLEACH PRODUCTS. AS A PRECAUTION, ADHERE TO THE MANUFACTURER’S RECOMMENDATIONS FOR THE LONGER CONTACT TIME (USUALLY 3 MINUTES).

  1.  Clean surfaces with disinfectant and allow disinfectant to remain on surfaces for at least three (3) minutes, or the longest contact time recommended by the disinfectant man.
  2. Change gloves and repeat.
  • Housekeeping after autopsy is critical because of the potential for mite transmission. Notify Housekeeping  to send staff who have been specifically trained in "Special Respiratory Isolation" procedures to clean floors and walls and pick-up MPW waste, wearing full personal protective gear.
  • An LP employee will transport samples. Patient Escort Services will NOT transport these specimens. Package samples for the CDC in accordance with the CDC Web site.
  • The Admissions Office should inform the funeral home that this is a "Special Respiratory Isolation" case. Please remind the Admissions Office to notify the funeral home that the patient has a specific disease (SARS, smallpox, etc).
Disposable Waste

 All waste will be placed in a double autoclave bags, LOOSELY sealed with autoclave tape and labeled with the date, location and isolation category. Wipe the secondary bag with disinfectant (Dispatch or 95% EtOH). Allow disinfectant to remain in contact with outer bag for at least three (3) minutes. Change gloves. Wipe the bag again. Place “Special Respiratory Isolation” stickers (available through HES) on the outer bags. Contact housekeeping (5-3075) to send staff who have been specifically trained in Special Respiratory Isolation procedures to pick up the waste and transfer it to CC/DLM where it will be autoclaved before it is transported off campus for incineration.

Environmental Cleaning

 Work surfaces and equipment must be disinfected using a CC-approved disinfectant, after infectious specimens are processed. Disinfectants need to be mycobactericidal and effective against lipid-enveloped viruses (e.g., Dispatch, 95% EtOH, TB Quat2).  Clean surfaces with disinfectant and allow disinfectant to remain on surfaces for at least three (3) minutes, or the longest contact time recommended by the manufacturer. Change gloves and repeat.

NOTE: DO NOT USE BLEACH PRODUCTS. AS A PRECAUTION, ADHERE TO THE MANUFACTURER’S RECOMMENDATIONS FOR THE LONGER CONTACT TIME (USUALLY 3 MINUTES).

CDC Website:

Severe Acute Respiratory Syndrome (SARS)

WHO Website:

Guidance on Severe Acute Respiratory Syndrome (SARS)

Hospital Epidemiologist:

Office: 301-496-3515
Cell: 240-602-8375

Hospital Epidemiology Service (HES):

Office: 301-496-2209
Evenings/Weekends (page): 301-496-1211

SARS Investigators:

John Beigal: 301-435-2292
Cliff Lane: 301-496-7196

LP Clinical Manager:

Joseph Chinquee: 301-480-7177
Last updated by Lumelski, Victoria (NIH/NCI) [E] on Sep 12, 2022