Form 0920-1424 Personal Protective Equipment Survey for Laboratories

[CPR] U.S. National Authority for Containment of Poliovirus Data Collection Tools

Att 7a - PPE Survey_final

Att 7 _Personal Protective Equipment Survey for Laboratories

OMB: 0920-1424

Document [docx]
Download: docx | pdf

FORM APPROVED OMB NO. 0920-1424 EXP DATE: 12/31/2026


Personal Protective Equipment Survey for Laboratories

*This survey is designed to gather specific and detailed information regarding the use of personal protective equipment (PPE) at facilities using or storing infectious microorganisms and hazardous biological materials. You have been asked to complete this survey because:

Introductory question to set survey logic

  • My facility works with or stores [poliovirus] materials

  • My facility works with or stores [poliovirus potentially infectious materials (PIM)]

  • My facility works with or stores biological materials, but does not work with or store poliovirus or PIM


Survey instructions: This survey is intended to gather information regarding PPE and PPE practices used for work and/or storage of infectious materials (or potentially infectious) at your facility. Questions are designed to prompt additional questions if a particular answer is selected. Some questions include the option to select “other” which would prompt a text box to provide additional or explanatory information. The survey is divided into categorized modules and is expected to take 60 to 90 minutes to complete. You may save your progress and return to incomplete questions at any time.


Specific questions regarding brand names, catalog numbers, product protection standards, and PPE procedures are included, please have the product technical or specification sheet or information available when the survey is started. The information collected in the survey will assist the Centers for Disease Control and Prevention (CDC), United States National Authority for Containment of Poliovirus (US NAC), Division of Regulatory Science and Compliance (DRSC), and National Institute for Occupational Safety and Health (NIOSH) with developing guidance and recommendations for PPE selection and use in support of poliovirus containment as well as identify laboratory PPE commonly used to evaluate laboratory PPE performance characteristics in testing studies.


















Public reporting burden: CDC estimates the average public reporting burden for this collection of information as 1.5 hours per response, including the time for reviewing instructions, searching existing data/information sources, gathering and maintaining the data/information needed, and completing and reviewing the collection information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Information Review Office; 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; ATTN: PRA (0920-1424).

Facility Information and Work Practices

Questions in this section will ask about general facility information and work practices. Personal or identifying information will not be collected. Please respond with the BEST answer for each question.

Facility Information (5)

  1. My role/occupation at the facility is (select the BEST answer):

    • Laboratorian

    • Facility manager

    • Occupational health

    • Administrative (e.g., purchasing)

    • Biosafety

    • Shape3

      Click here to enter text.

      Other:

  2. This survey is being completed in response to a request by:

    • National Authority for Containment of Poliovirus (US NAC)

    • Shape4 Division of Regulatory Science and Compliance (DRSC)Other Click here to enter text.

  3. My facility is a:

    • Research laboratory

    • Environmental testing laboratory

    • Clinical or diagnostic laboratory

    • Vaccine manufacturer

    • Storage repository

    • Shape5

      Click here to enter text.

      Other

  4. My facility can be classified as:

    • Government

    • Private (i.e., company or nonprofit organization that is not government owned)

    • Academic

    • Commercial (i.e., facility that performs a commercial activity)

  5. My facility is designated as:

    • Biosafety/Containment/Physical Containment Level 1 (BSL1, CL1, PC1)

    • Animal Biosafety/Containment/Physical Containment Level 1 (Animal BSL1, CL1, PC1)

    • Biosafety/Containment/Physical Containment Level 2 (BSL2, CL2, PC2)

    • Animal Biosafety/Containment/Physical Containment Level 2 (Animal BSL2, CL2, PC2)

    • Biosafety/Containment/Physical Containment Level 3 (BSL3, CL3, PC3)

    • Animal Biosafety/Containment/Physical Containment Level 3 (Animal BSL3, CL3, PC3)

    • Biosafety/Containment/Physical Containment Level 4 (BSL4, CL4, PC4)

    • Animal Biosafety/Containment/Physical Containment Level 4 (Animal BSL4, CL4, PC4)

    • Not applicable/Storage only

Poliovirus specific questions (3)

  1. Does your facility work with or store [poliovirus or PIM or biological materials]?

    • Yes

    • No (if No, return to main menu to start over)

If Yes,

1. Select all applicable [poliovirus or PIM] your facility works with or stores:

    • Wild or vaccine derived polioviruses

    • OPV/Sabin viruses

    • nOPV viruses

    • PV potentially infectious materials (PIM) [e.g., fecal, respiratory, environmental specimens collected in a place and time where PV circulated or OPV was in use]

    • Nucleic acids extracted from the materials listed above

    • Untyped or unknown polioviruses

    • Unsure

2. What region is your facility located in? (Please enter Country)

    • Shape6

      Click here to enter text.

      African

    • Shape7

      Click here to enter text.

      Americas

    • Shape8

      Click here to enter text.

      Eastern Mediterranean

    • Shape9

      Click here to enter text.

      European

    • Shape10

      Click here to enter text.

      South-East Asia

    • Shape11

      Click here to enter text.

      Western Pacific

3. Work Practices (2)

  1. My facility’s standard laboratory procedures with [poliovirus or PIM or biological materials] include: (select all that apply)

    • Cell culture

    • Clinical/diagnostic molecular assays

    • Clinical/diagnostic serology assays

    • Centrifugation

    • Isolation

    • Clarification

    • Concentration

    • Purification (e.g., chromatography, distillation)

    • Formulation

    • Nucleic acid extraction

    • Genomic sequencing

    • Antiviral/antimicrobial testing

    • Animal work

    • Large volumes (>1liter)

    • High concentration (>10^7 infectious units/mL)

    • Pressurized systems (e.g., bioreactors, fermentation, filtration processes)

    • Not applicable/storage only

    • Unsure


  1. My facility’s laboratory experiments with [poliovirus or PIM or biological materials] include volumes (approximate estimate; select the answer that BEST describes the largest amount manipulated/propagated):

    • < 1mL

    • 1mL-10mL

    • 10mL 100mL

    • 100mL 1 Liter

    • 1 Liter < 10 Liters

    • 10 < 50 Liters

    • >50 Liters

    • Unsure

    • Not applicable storage only


PPE Selection, Supply, and Quality

Questions in this section ask general supply and selection questions regarding PPE used only for [poliovirus or PIM] work or storage.

PPE Selection (6)

  1. In your opinion, what is the most important factor when selecting PPE at your facility? (Select the best answer)

    • Worker protection (biohazard)

    • Workplace safety (slips, trip, falls)

    • Established protocol

    • Availability

    • Cost

    • Odor

    • Convenience

    • Public image or perception

    • Worker comfort (i.e., dexterity, breathability)

    • Environmental factors (e.g., wasted resources, pollution)

    • Compliance with applicable performance standards or regulatory requirements

    • Unsure

  2. In your opinion, what is the least important factor when selecting PPE at your facility? (Select the best answer)

    • Worker protection (biohazard)

    • Workplace safety (slips, trip, falls)

    • Established protocol

    • Availability

    • Cost

    • Odor

    • Convenience

    • Public Image

    • Worker comfort (i.e., dexterity, breathability)

    • Environmental factors

    • Compliance with applicable performance standards or regulatory requirements

    • Unsure

  3. Who is responsible for deciding the specific PPE requirements (e.g., types of PPE, performance requirements) for laboratory work at your facility? (Select the best answer)

    • Principal investigator

    • Biosafety officer

    • Laboratory manager

    • Administrative staff

    • Biosafety committee or group

    • There are no specific PPE requirements at my facility

    • Unsure


  1. Who is responsible for selecting the PPE product to be purchased (i.e., selecting product from vendor catalog)? (Select the best answer)

    • Principal investigator

    • Biosafety officer

    • Laboratory manager

    • Laboratorian

    • Administrative staff

    • Biosafety committee or group

    • Other

    • Unsure

      1. Are the purchased PPE products verified to meet the specific PPE requirements (e.g., types of PPE, performance requirements or regulations)?

        • No

        • Yes

        • Unknown

        • Unsure


  1. Select how PPE requirements for laboratorians are determined (select all that apply)

    • Work-based risk assessment

    • Minimal PPE is based on other work that occurs in the laboratory or laboratory suite

    • Individual laboratorians

    • Regulatory authority

    • Principal investigator

    • Lab manager or supervisor

    • Biosafety officer

    • Unsure

  2. Have you had training on PPE standards, ratings, or levels of protection?

    • No

    • Shape12

      Click here to enter text.

      Yes

If yes, what type of training?


PPE Supply (1)

  1. Has your facility experienced supply issues for PPE in the last 5 years (e.g., limited availability, back-ordered, out of stock, delivery problems)?

    • Shape13 Yes

If yes, how have supply issues impacted the normal use of PPE and for how long (months)? Click here to enter text.

    • No

    • Unsure


PPE Quality (3)

  1. Has your facility experienced PPE failures during normal use (e.g., tears, holes, strikethrough/breakage, liquid penetration)?

    • Yes

    • No

    • Unsure If Yes,

      1. PPE failures have included: (select all that apply):

        • Body protection (e.g., gowns, coveralls)

        • Head/face protection (face shields, goggles, etc.)

        • Gloves

        • Foot protection (shoe cover, boot cover)

        • Respirators

        • Masks

      2. Types of PPE failures include: (select all that apply)

        • Puncture or tear

        • Pilling (small balls of fluff on surface)

        • Seam failure

        • Tie failure

        • Strap failure

        • Interface with glove

        • Fabric worn out

        • Rips, holes

        • Repair failure

        • Strikethrough (observed liquid penetration)

        • Shape14 Respirator fit or seal failure

      3. Provide details on the specific type of PPE and how it failed Click here to enter text.

  2. How many standards (e.g., ANSI/AAMI, ISO, ASTM, EN, etc.) directing PPE use in laboratory or health settings, are you aware of for each of the following PPE types:

    • Body protection (gowns, coveralls)

  • 0

  • 1-3

  • 4-5

  • 6-10

  • More than 10

    • Head/face protection (face shields, goggles, etc.)

  • 0

  • 1-3

  • 4-5

  • 6-10

  • More than 10

  • Respirators (N95, KN95, FFP, PAPR, elastomeric, etc.)

    • 0

    • 1-3

    • 4-5

    • 6-10

    • More than 10


  • Masks (medical masks, non-medical masks)

    • 0

    • 1-3

    • 4-5

    • 6-10

    • More than 10

  • Gloves

    • 0

    • 1-3

    • 4-5

    • 6-10

    • More than 10


  • Foot protection (shoe covers, boot covers, etc.)

    • 0

    • 1-3

    • 4-5

    • 6-10

    • More than 10

  1. For the PPE standards that you are aware of (e.g., ANSI/AAMI, ISO, ASTM, EN, etc.), how confident are you in your knowledge about their requirements?

    • Extremely confident

    • Moderately confident

    • Somewhat confident

    • Slightly confident

    • Not at all confident

PPE Training Practices

Questions in this section ask general questions about training practices regarding PPE use and procedures for [poliovirus or PIM] work or storage.

Standard practices (2)

  1. Standard practices used in my facility for PPE use include (select all that apply):

    • PPE requirements are posted in the laboratory

    • PPE in multiple sizes are available to make sure that PPE fits the wearer well

    • The order in which PPE is put on and taken off is posted in the laboratory

    • Training on PPE is required

    • Training on procedures for how to put on and take off PPE is required

    • PPE care and maintenance (e.g., cleaning, decontamination, use) guidance is provided to laboratory personnel

    • Not applicable my facility does not have standard practices for PPE use

    • Unsure

  2. Standard practices used for training laboratorians on PPE procedures include (select all that apply):

    • Review standard operating procedure or work instruction

    • Instructor-led demonstration of procedures

    • Individual practical demonstration of procedures

    • Training video or presentation

    • Unsure

    • Not applicable my facility does not have training for laboratorians on PPE procedures

PPE Worn

Questions in this section ask about specific types of PPE most frequently worn (e.g., routine or standard ensemble) for work or storage at your facility. More specific questions regarding the type of PPE worn based on YES answers in this section will be asked in another section of the survey.

PPE Type & Configuration (8)

  1. Does standard PPE worn include body protection?

    • Yes

If yes, select type: (Select the most frequently used PPE)

      • Solid front gown (solid front with closed back)

      • Front closing lab coat with closures

      • Open-back protective gown or apron (sleeveless or exposed back)



    • No

    • Coverall or overall

    • Sleeve protectors

  1. Does standard PPE worn include head protection?

    • Yes

If yes, select type: (Select the most frequently used PPE)

      • Full head covering (hood or enclosure)

      • Hair covering (bouffant cap or hairnet)

      • Protective head cover

    • No

  1. Does standard PPE worn include foot protection?

    • Yes

If yes,

  1. select type: (Select the most frequently used PPE)

    • Personal street shoes are worn

    • Facility/laboratory specific footwear that remains in the laboratory

    • Safety shoes (e.g., rubber boots, steel-toed)

    • Unsure

  2. Does standard foot PPE include shoe or boot covers?

    • Yes

    • No

    • Unsure

  • No

  1. Does standard PPE worn include head/face protection?

    • Yes

If yes, select type: (Select the most frequently used PPE; select ALL that apply)

      • Safety glasses

      • Safety goggles

      • Face shield

      • Powered Air Purifying Respirator (PAPR)

  • No

  1. Does standard PPE worn include mucus membrane protection?

    • Yes

If yes, select type: (Select the most frequently used PPE)

      • Medical face mask

      • Non-medical face mask (non-medical mask/cloth mask/face covering)

      • Surgical mask

      • Procedure mask

      • Dental mask

      • Respiratory protection (e.g., N95, elastomeric half-mask respirator, KN95, or PAPR)

    • No

  1. Does standard PPE worn include respiratory protection?

    • Yes

If yes, select type: (Select the most frequently used PPE)

      • NIOSH-approved N95 filtering face-piece respirator

      • NIOSH-approved N99 filtering face-piece respirator

      • NIOSH-approved N100 filtering face-piece respirator

      • NIOSH-approved resistant or strongly resistant to oil respirator (R95, R99, R100, P95, P99, P100))

      • NIOSH-approved elastomeric half-mask or full-face respirator

      • NIOSH-approved powered air purifying respirator (PAPR)

      • KN95 filtering facepiece respirator

      • Filtering facepiece (FFP1)

      • Filtering facepiece (FFP2)

      • Filtering facepiece (FFP3)

      • Filtering facepiece (KF94)

      • Non- NIOSH-approved elastomeric half-mask or full-face respirator

      • Non-NIOSH approved powered air purifying respirator (PAPR)

    • No

  1. Does standard PPE worn include gloves (e.g., nitrile examination gloves)?

    • Yes

    • No

  2. If given the opportunity, I would change the type of PPE worn for [poliovirus or PIM or biological materials] work at my facility.

    • Shape15

      Click here to enter text.

      Strongly agree

If strongly agree, explain:

    • Shape16 Agree

If agree, explain: Click here to enter text.

    • Neither agree nor disagree

    • Disagree

    • Strongly disagree

General Facility Practices

This section asks about general practices regarding PPE entry/exit procedures and decontamination at your facility.

General Practices (3)

  1. Do practices include a change out of street clothing into laboratory clothing?

    • No clothing change (street clothes worn when working in the laboratory)

    • Yes, street clothing change into lab clothing (e.g., facility scrubs or uniform)

      1. If yes, select all that apply:

        • Facility cloth scrubs or uniform are worn

        • Complete clothing change (remove all street clothes and undergarments) into facility clothing

        • Partial clothing change (remove shirt, pants) into facility clothing

        • Reusable (washable) facility clothing worn

        • Disposable facility clothing worn


      1. Laboratory clothing is autoclaved before removing from laboratory or containment boundary (e.g.,

gowns, scrubs).

        • Yes

        • No

        • Not applicable

      1. Laboratory clothing is laundered at the facility (e.g., gowns, scrubs).

        • Yes

        • No

        • Not applicable

  1. Do practices include an exit shower when exiting the laboratory or containment boundary?

    • No

    • Yes

If yes, select all that apply:

  • An exit shower when leaving the in vitro laboratory (research laboratory)

  • An exit shower when leaving the in vivo laboratory (animal laboratory)

  • An exit shower is used when leaving containment boundary

  • Unsure

  1. Emergency procedures used in my facility related to PPE include (select all that apply):

    • PPE is available for emergency and first responders in a dedicated location

    • PPE used during an emergency is the same as normal use PPE

    • PPE used during an emergency is different from normal use PPE

    • Unsure

Sequence for putting on and taking off PPE (5)

  1. Do practices include a defined order for putting on PPE?

    • Yes

Shape17 If yes, select the order (first to last, do not select PPE that is not worn)

Shape18 Shape19 Body protection (gown/coverall or similar) Head protection (head cover, hood, bouffant, hairnet, etc.)

Shape20 Foot protection (booties)

Shape21 Shape22 Face protection (safety glasses, safety goggles, face shield) Face mask or respiratory protection

Shape23 Shape24 Shape25 Gloves (inner) Gloves (outer) Scrubs/uniform

    • No

    • Unsure

  1. Do practices include a defined order for taking off PPE?

    • Yes If yes, select the order (first to last, do not select PPE that is not worn)

Shape26 Shape27 Body protection (gown/coverall or similar) Head protection (head cover, hood, bouffant, hairnet, etc.)

Shape28 Foot protection (booties)

Shape29 Face protection (safety glasses, safety goggles, face shield) Face mask or respiratory protection

Shape30 Shape31 Gloves (inner) Gloves (outer)

Shape32 Scrubs/uniform

    • No

    • Unsure

  1. Is PPE put on in a designated space?

    • Yes

If yes, select the location where PPE is put on?

      • Anteroom

      • Designated zone or taped area in laboratory

      • Outside laboratory door

      • Changeroom

      • Shape33

        Click here to enter text.

        Restroom

      • Other

    • No

    • Unsure

  1. Is PPE taken off in a designated space?

    • Yes

If yes, select the location where PPE is taken off:

      • Anteroom

      • Designated zone or taped area in laboratory

      • Outside laboratory door

      • Changeroom

      • Shape34

        Click here to enter text.

        Restroom

      • Other

    • No

    • Unsure

  1. If given the opportunity, I would change the sequence for putting on or taking off PPE used for [poliovirus or PIM] work at my facility.

    • Shape35

      Click here to enter text.

      Strongly agree

If strongly agree, explain:

    • Shape36

      Click here to enter text.

      Agree

If agree, explain:

    • Neither agree nor disagree

    • Disagree

    • Strongly disagree

Decontamination of PPE (5)

  1. Standard practices used in my facility for the decontamination and disposal of PPE include (select all that apply):

    • Autoclave

    • Chemical

If yes, provide decontamination methods:

      1. Shape37

        Click here to enter text.

        Describe the chemical decontamination used for PPE (active ingredient, concentration, contact time, brand name):

Shape38 Shape39

Click here to enter text.

Click here to enter text.

Brand name: Active ingredient: Concentration:

Contact time: Click here to enter text.

      1. PPE is decontaminated by:

        • Spray bottle

        • Disinfecting wipe

        • Other Click here to enter text.

    • Incineration

    • Used PPE is disposed of in waste/garbage or refuse without prior decontamination

    • Unsure


  1. Does your facility reuse single use or disposable PPE worn for work with infectious materials? (e.g., routine practice even when sufficient supplies of these products are available)

    • Yes

If yes,

      1. Select PPE that is reused: (select all that apply):

        • gown/coverall/overall

        • lab coat

        • booties or boot cover

        • protective head covering (hood or full head covering)

        • hair covering (bouffant cap or hairnet)

        • gloves

        • protective sleeves

        • safety glasses or goggles

        • face shield

        • respiratory protection (e.g., N95, KN95)

        • face mask (non-medical)

        • medical mask

        • dental mask

        • procedure mask

        • surgical mask

      2. Is reused PPE disinfected or decontaminated before reuse?

        • Yes

        • No

        • Unsure

    • No

    • Unsure


  1. Do standard practices include chemical disinfection or decontamination of single use (i.e. disposable PPE)

(e.g., gowns, coveralls) after work with infectious materials for reuse by laboratory staff?

    • Yes

If yes, select method: (select all that apply)

  • Disinfecting spray

    • Chlorine spray (e.g., bleach)

    • Alcohol spray (e.g., ethanol)

    • Oxidizing agent spray (e.g., Oxivir™, Virkon-S™)

    • Quaternary ammonium spray (Roccal™, Lysol™, Clorox™)

    • Shape40 Other Click here to enter text.

    • Unsure

  • Wipes

    • Chlorine wipes

    • Alcohol wipes

    • Oxivir, Virkon-S

    • Quaternary ammonium wipes (e.g., Clorox or Lysol wipes)

    • Other Click here to enter text.

    • Unsure

    • No

    • Unsure


  1. Do standard practices include the use of reusable PPE (excluding facility scrubs/uniform)?

    • Yes

If yes, select the statement that BEST describes standard practices:

  • Prior to reuse, reusable PPE is autoclaved

  • Prior to reuse, reusable PPE is chemically disinfected

  • Prior to reuse, reusable PPE is laundered with detergent

  • No

  • Unsure

  1. My facility uses an antimicrobial spray or antimicrobial PPE for work with [poliovirus or PIM or biological] materials.

    • Yes

If yes, provide the type of spray, coating, or modified PPE: Click here to enter text.

    • No

    • Shape41 Unsure

PPE and Applicable Testing Standards

Questions in this section ask about specific PPE worn for [poliovirus or PIM] work or storage at your facility. The questions are based on responses to answers provided in previous sections of the survey. Specific questions regarding brand names, catalog numbers, product protection standards, and PPE procedures are included, please have the product technical or specification sheet or information available when this section of the survey is started.

Body protection module (If yes to body protection)

These questions relate to the selected response for the use of body PPE. The PPE product information or technical specification sheet may be needed. Select the choice that most closely matches the manufacturer’s specifications.

  1. Based on your selected response for type of body protection, (select the choice that most closely matches the manufacturer’s specifications):

Is the selected body PPE:

    1. (Reusability):

      • Single use or disposable

      • Reusable or washable

      • Unsure

    2. (Type):

      • Isolation

      • Surgical

      • Fluid resistant

      • Fluid impermeable or impervious

      • Unsure

    3. (Material):

      • Woven, Polyester, Cotton/Polyester

      • Nonwoven (paper like, spunbond, spunbond-meltblown-spunbond (SMS), polypropylene, polyester, composite)

      • Film or plastic-like

      • Unsure

  1. The most important factor affecting the selection of body PPE is: (select your preference)

  • Level of protection provided by PPE

  • Reusability

  • Full body coverage

  • Fabric thickness

  • Fabric material

  • Fabric/garment design

  • Fabric/garment durability

  • Fabric color

  • Cost

  • Quality

  • Comfort

  • Conformance to performance standards/regulations

  • Availability

  1. Do you know the PPE standards for the body protection PPE used at your facility?

  • No

  • Unsure

  • Unknown there are no standards listed on the PPE used

  • Yes (If Yes, go to next question)


  1. Standard PPE used for body protection meets standards for (select all that apply):

  • ANSI/AAMI PB70, (if yes, select level)

    • Level 1

    • Level 2

    • Level 3

    • Level 4

    • Unsure

  • EN13795: Surgical clothing and drapes, (if yes, select level)

    • High performance

    • Standard performance

    • Unsure

  • EN14126: Protective clothing against infective agents, (if yes, select level)

    • 3B

    • 4B

    • 5B

    • 6B

    • Unsure

  • EN 13982: Protective clothing against airborne solid particulates

  • ISO811/EN20811: Hydrostatic pressure test/water penetration resistance, (if yes, add test result in box) Click here to enter text.

  • ISO16603: Blood penetration resistance, (if yes, select level)

    • Class 1 or 0 kPa (EN 14126)

    • Class 2 or 1.75 kPa (EN 14126)

    • Class 3 or 3.5 kPa (EN 14126)

    • Class 4 or 7 kPa (EN 14126)

    • Class 5 or 14 kPa (EN 14126) 

    • Class 6 or 20 kPa (EN 14126)

    • Unsure 

  • ISO16604: Bloodborne pathogen resistance, (if yes, select level)

    • Class 1 or 0 kPa  (EN 14126)

    • Class 2 or 1.75 kPa (EN 14126)

    • Class 3 or 3.5 kPa (EN 14126)

    • Class 4 or 7 kPa (EN 14126)

    • Class 5 or 14 kPa (EN 14126) 

    • Class 6 or 20 kPa (EN 14126)

    • Unsure 

  • ASTM F1670: Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood

  • ASTM F1671: Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System

  • EN 13034/EN 14605/EN 943: Protective clothing against liquid chemicals

  • ASTM F739: Permeation of Liquids and Gases through Protective Clothing

  • ASTM F3352: Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities

  • ASTM F2407: Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities

  • ISO 22610: Resistance to wet bacterial penetration, if yes, select level

    • Class 1

    • Class 2

    • Class 3

    • Class 4

    • Class 5

    • Class 6

    • Unsure

  • ISO 22611/ISO 22612: Resistance to dry microbial penetration, (if yes, select level)

    • Class 1

    • Class 2

    • Shape42 Class 3

  • AATCC 127: hydrostatic pressure test, if yes, add test result in box Click here to enter text.

  • Shape43

    Click here to enter text.

    AATCC 42/ISO 18695: Water Resistance: Impact penetration test if yes, add test result in box

  • EN 14325 - Protective clothing against chemicals - Test methods and performance classification of chemical protective clothing materials, seams, joins and assemblages


  • ISO 6530 Protective clothing — Protection against liquid chemicals — Test method for resistance of materials to penetration by liquids (if yes, select level)

    • Class 1

    • Class 2

    • Class 3



  • Shape44 Unknown there are no standards listed on the PPE used

  • Unsure – add all of the standards mentioned in the label in the box



Head protection module (if yes to head protection)

These questions relate to the selected response for the use of head PPE. The PPE product information or technical specification sheet may be needed. Select the choice that most closely matches the manufacturer’s specifications.

  1. Based on your selected response for type of head protection, (select the choice that most closely matches the manufacturer’s specifications):

Is the selected Head PPE:

    1. (Reusability):

      • Single use or disposable

      • Reusable or washable

      • Unsure

    2. (Type):

      • Fluid resistant

      • Fluid impermeable or impervious

      • Unsure

    3. (Material):

      • Woven, Polyester, Cotton/Polyester

      • Nonwoven (paper like, spunbond, spunbond-meltblown-spunbond (SMS), polypropylene, polyester, composite)

      • Film or plastic-like

      • Unsure

    4. (Configuration for head covering):

      • Integrated head covering attached to the protective body clothing

      • Elastic seal around face opening

      • Integrated plastic face shield

      • Unsure

    5. (Configuration for hair covering):

      • Bonnet

      • Bouffant

      • Skull cap

      • Unsure

  1. Do you know the PPE standards for the head protection PPE used at your facility?

  • No

  • Unsure

  • Unknown there are no standards listed on the PPE used

  • Yes (If Yes, go to next question)

  1. Standard PPE used for head protection (protective head or hair covering) meets standards for (select all that apply):

  • EN14126: Protective clothing against infective agents, if yes, select level

    • 3B

    • 4B

    • 5B

    • 6B

    • Shape45 Unsure

  • ISO/EN20811: Water penetration resistance, if yes, add test result in box Click here to enter text.

  • ISO16603: Blood penetration resistance, (if yes, select level)

    • Class 1 or 0 kPa (EN 14126)

    • Class 2 or 1.75 kPa (EN 14126)

    • Class 3 or 3.5 kPa (EN 14126)

    • Class 4 or 7 kPa (EN 14126)

    • Class 5 or 14 kPa (EN 14126) 

    • Class 6 or 20 kPa (EN 14126)

    • Unsure 

  • ISO16604: Bloodborne pathogen resistance, (if yes, select level)

    • Class 1 or 0 kPa (EN 14126)

    • Class 2 or 1.75 kPa (EN 14126)

    • Class 3 or 3.5 kPa (EN 14126)

    • Class 4 or 7 kPa (EN 14126)

    • Class 5 or 14 kPa (EN 14126) 

    • Class 6 or 20 kPa (EN 14126)

    • Unsure 


  • ASTM F1670: Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood

  • ASTM F1671: Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System

  • EN 13034/EN 14605/EN 943: Protective clothing against liquid chemicals

  • ASTM F739: Permeation of Liquids and Gases through Protective Clothing

  • ASTM F3352: Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities

  • ASTM F2407: Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities

  • ISO 22610: Resistance to wet bacterial penetration, if yes, select level

    • Class 1

    • Class 2

    • Class 3

    • Class 4

    • Class 5

    • Class 6

    • Unsure

  • ISO 22612: Resistance to dry microbial penetration, if yes, select level

    • Class 1

    • Class 2

    • Class 3

    • Shape46 Unsure

  • AATCC 127: hydrostatic pressure test, if yes, add test result in box

  • AATCC 42/ISO 18695: Water Resistance: Impact penetration test if yes, add test result in box



  • EN 14325 - Protective clothing against chemicals - Test methods and performance classification of chemical protective clothing materials, seams, joins and assemblages


  • ISO 6530 Protective clothing — Protection against liquid chemicals — Test method for resistance of materials to penetration by liquids (if yes, select level)

    • Class 1

    • Class 2

    • Class 3



  • Shape47 Unknown there are no standards listed on the PPE used

  • Unsure – add all of the standards mentioned in the label in the box


Foot protection module (if yes to foot protection)

These questions relate to the selected response for the use of foot PPE. The PPE product information or technical specification sheet may be needed. Select the choice that most closely matches the manufacturer’s specifications.

  1. Based on your selected response for type of foot protection, select the choice that most closely matches the manufacturer’s specifications:

Is the selected foot PPE:

    1. (Reusability):

      • Single use or disposable

      • Reusable or washable

      • Unsure

    2. (Type):

      • Fluid resistant

      • Fluid impermeable or impervious

      • Unsure

    3. (Material):

      • Woven, Polyester, Cotton/Polyester

      • Nonwoven (paper like, spunbond, spunbond-meltblown-spunbond (SMS), polypropylene, polyester, composite)

      • Film or plastic-like

      • Unsure

    4. If yes to shoe or boot cover: (Configuration):

      • Shoe cover

      • Boot cover

      • Other: enter text

      • Unsure

  1. Do you know the PPE standards for the foot protection PPE used at your facility?

  • No

  • Unsure

  • Unknown there are no standards listed on the PPE used

  • Yes (If Yes, go to next question)


  1. Standard PPE used for foot protection (shoe or boot covers) meets standards for (select all that apply):

  • EN14126: Protective clothing against infective agents, if yes, select level

    • 3B

    • 4B

    • 5B

    • 6B

    • Unsure

  • Shape48

    Click here to enter text.

    ISO811 Hydrostatic pressure test, if yes, add test result in box

  • EN20811: Water penetration resistance, if yes, select level

    • Type 1

    • Type 2

    • Unsure

  • ISO16603: Blood penetration resistance, (if yes, select level)

    • Class 1 or 0 kPa (EN 14126)

    • Class 2 or 1.75 kPa (EN 14126)

    • Class 3 or 3.5 kPa (EN 14126)

    • Class 4 or 7 kPa (EN 14126)

    • Class 5 or 14 kPa (EN 14126) 

    • Class 6 or 20 kPa (EN 14126)

    • Unsure 

  • ISO16604: Bloodborne pathogen resistance, (if yes, select level)

    • Class 1 or 0 kPa  (EN 14126)

    • Class 2 or 1.75 kPa (EN 14126)

    • Class 3 or 3.5 kPa (EN 14126)

    • Class 4 or 7 kPa (EN 14126)

    • Class 5 or 14 kPa (EN 14126) 

    • Class 6 or 20 kPa (EN 14126)

    • Unsure 

  • ASTM F1670: blood penetration resistance

  • ASTM F1671: blood penetration resistance

  • EN 13034/EN 14605/EN 943: Protective clothing against liquid chemicals

  • ASTM F739: Permeation of Liquids and Gases through Protective Clothing

  • ASTM F3352: Performance and Labeling of Isolation gowns

  • ASTM F2407: Performance, documentation, labeling of surgical gowns

  • ISO 22610: Resistance to wet bacterial penetration, if yes, select level

    • Class 1

    • Class 2

    • Class 3

    • Class 4

    • Class 5

    • Class 6

    • Unsure

  • ISO 22612: Resistance to dry microbial penetration, if yes, select level

    • Class 1

    • Class 2

    • Class 3

    • Unsure

  • Shape49 AATCC 127: hydrostatic pressure test, if yes, add test result in box

  • AATCC 42/ISO18695: Water Resistance: Impact penetration test if yes, add test result in box



  • EN 14325 - Protective clothing against chemicals - Test methods and performance classification of chemical protective clothing materials, seams, joins and assemblages


  • ISO 6530 Protective clothing — Protection against liquid chemicals — Test method for resistance of materials to penetration by liquids (if yes, select level)

    • Class 1

    • Class 2

    • Class 3



  • Shape50 Unknown there are no standards listed on the PPE used

  • Unsure – add all of the standards mentioned in the label in the box



Head/face protection module (if yes to head/face protection)

These questions relate to the selected response for the use of head or face PPE. The PPE product information or technical specification sheet may be needed. Select the choice that most closely matches the manufacturer’s specifications.

  1. Standard PPE used for head/face protection (safety glasses, goggles, face shields) meets standards for (select all that apply):

    • ANSI/ISEA Z87.1: Occupational and Educational Personal Eye and Face Protection Devices

    • EN 166: Personal Eye Protection

    • ISO 4007: Eye and Face Protection

    • Unknown there are no standards listed on the PPE used

    • Unsure


Mucus membrane protection module (if yes to mucus membrane protection)

These questions relate to the selected response for the use of mucus membrane PPE. The PPE product information or technical specification sheet may be needed. Select the choice that most closely matches the manufacturer’s specifications.

  1. Select the practice that best describes use of mucus membrane protection (masks, respirators):

    • Used for all laboratory procedures

    • Not used when working in primary containment (e.g., biosafety cabinet)

    • Not used when there is no risk of splash or spray

    • Not used

    • Unsure

  2. Based on your selected response for type of mucus membrane protection, (select the choice that most closely matches the manufacturer’s specifications):

Is the selected mucus membrane protection PPE:

  1. (Reusability):

    • Single use or Disposable

    • Reusable or Washable

    • Unsure

  2. (Type):

    • Medical

    • Non-medical

    • Unsure

  3. (Material):

    • Woven, Polyester, Cotton/Polyester

    • Nonwoven (paper like, spunbond, spunbond-meltblown-spunbond (SMS), polypropylene, polyester, composite)

    • Film or plastic-like

    • Other

    • Unsure

  4. (Configuration):

    • Ear loops

    • Head straps

    • Ties

    • Powered air purifying respirator (PAPR)

    • Unsure

  1. Do you know the PPE standards for the mucus membrane protection PPE used at your facility?

    • No

    • Unsure

    • Unknown there are no standards listed on the PPE used

    • Yes (If Yes, go to next question)

  2. When selecting mucus membrane protection (masks, respirators), the most important factor (in your opinion) affecting the selection is: (Select the best answer)

    • Level of protection provided by mask/respirator

    • Mask/respirator thickness/number of layers

    • Mask/respirator material

    • Mask/respirator head suspension system (head straps, ties, ear loops)

    • Mask/respirator color

    • Cost of mask/respirator

    • Quality or performance standard of mask/respirator

    • Comfort

    • Durability

    • Unsure

  3. Standard PPE used for mucus membrane protection (masks/respirators) that provide mucosal protection, meets standards for (select all that apply):

    • NIOSH approved (Code of Federal Regulations 42 CFR 84); filtering facepiece respirator

      • N95

      • N99

      • N100

      • P95 or R95

      • P99 or R99

      • P100 or R100

    • EN 149: filtering half masks

      • FFP1

      • FFP2

      • FFP3

      • GB 19083: protective face masks for medical use

        • Grade/Level/Class 1

        • Grade/Level/Class 2

        • Grade/Level/Class 3

      • GB 2626: Respiratory protective equipment-Non-powered air-purifying particle respirator

        • KN90

        • KN95

        • KN100

        • KP90

        • KP95

        • KP100

    • ISO 16975

    • EN 14683: medical face masks

      • Type I

      • Type II

      • Type IIR

    • ASTM F2100: Performance of materials used in medical face masks

    • Level 1

    • Level 2

    • Level 3

  • Shape51

    Click here to enter text.

    ASTM F2101: Bacterial filtration efficiency of medical face mask materials Enter the percentage of bacterial filtration efficiency

  • ASTM F3502: Standard specification for barrier face coverings Enter the level of performance

    • Level 1

    • Level 2

Shape52

Click here to enter text.

Enter the percentage of sub-micron particulate filtration efficiency Enter the inhalation resistance Click here to enter text.

Enter the percentage of bacterial filtration efficiency Click here to enter text.

  • Shape53 Shape54

    Click here to enter text.

    ASTM F2299: Efficiency of materials used in medical face masks to penetration by particulates Enter the percentage of particulate filtration efficiency

  • YY 0469: Medical surgical masks

Enter the percentage of bacterial filtration efficiency Click here to enter text.

  • YY/T 0969: Single-use medical face masks

Shape55

Click here to enter text.

Enter the percentage of bacterial filtration efficiency

  • Shape56 KMOEL-2017-64: filtering facepiece respirators

Enter the percentage of filtration efficiency Click here to enter text.

  • KMOEL-2017-64: filtering facepiece respirators

  • KMOEL-2014-4

  • Respirator provides mucous membrane protection (e.g., Powered air purifying respirator, elastomeric respirator)


Glove module (if yes to glove protection)

These questions relate to the selected response for the use of gloves. The PPE product information or technical specification sheet may be needed. Select the choice that most closely matches the manufacturer’s specifications.

  1. Based on your selected response for the use of gloves, select the choice that most closely matches the manufacturer’s specifications:

Is the selected glove:

    1. (Reusability):

      • Single use or disposable

      • Reusable or washable

      • Unsure

    2. (Material):

      • Latex

      • Polyisoprene

      • Nitrile

      • Vinyl

      • Unsure

    3. (Type): (select all that apply)

      • Examination gloves

      • Surgical gloves

      • Standard cuff

      • Extended cuff

      • Unsure

  1. Standard practices used at my facility for gloves include:

  • Single layer gloves

  • Double layer gloves (inner and outer gloves)

  • Unsure

  1. My facility uses tape to seal/secure gloves to sleeves of PPE.

  • Yes

If yes, for taping gloves, select all practices used-:

    1. Gloves are taped:

      • Inner gloves to sleeves (if double gloved)

      • Outer gloves to sleeves (if double gloved)

      • Single gloves to sleeves

      • Unsure

    2. Gloves are secured by:

      • Masking tape

      • Autoclave tape

      • Painter’s tape

      • Duct tape

      • Colored lab tape

      • Unsure

    3. How many times is the tape wrapped around the wrist?

      • Once

      • Twice

      • Three or more

      • Unsure

    4. When removing the tape, do you observe any holes/rips/tears in the sleeves or gloves?

      • Yes

      • No

      • Unsure

  • No, my facility does not secure glove to sleeves

  • My facility uses PPE with thumb loops

  • Unsure

  1. In my opinion, the most important factor affecting the selection of gloves is: (Select the best answer)

  • Level of protection provided by PPE

  • Material (latex, nitrile, etc.)

  • Cuff length (standard, extended)

  • Type (surgical, examination, etc.)

  • Quality or performance standard of PPE

  • Glove thickness

  • Glove regulations

  • Reusability

  • Durability

  • Cost

  • Comfort

  • Personal preference

  • Unsure

  1. Do you know the PPE standards for the gloves used at your facility?

  • No

  • Unsure

  • Unknown there are no standards listed on the PPE used

  • Yes (If Yes, go to next question)


  1. Gloves used at my facility meet standards for (select all that apply):

  • EN388: Mechanical Risks for Hand Protection

  • EN 455: Single use medical work gloves, if yes, select level:

    • EN 455-1

    • EN 455-2

    • EN 455-3

    • EN 455-4

  • EN ISO 374: Chemical resistance

  • ISO2895: statistical sampling scheme

  • ISO 10282: Single-use sterile rubber surgical gloves

  • ISO 11193-1: Single-use medical examination gloves, rubber latex or rubber solution

  • ISO 11193-2: Single-use medical examination gloves, poly(vinyl chloride)

  • EN ISO 11607: Packaging for terminally sterilized medical devices

  • ANSI/ISEA 105: Hand protection

  • NFPA 1999: Protective Clothing and Ensembles for Emergency Medical Operations

  • ANSI/ADA 76: non-sterile natural rubber latex gloves for dentistry

  • ASTM D3577: Rubber Surgical Gloves

  • ASTM D3578: Rubber Examination Gloves

  • ASTM D5250: Poly(vinyl chloride) gloves for medical application

  • ASTM D6977: Polychloroprene examination gloves for medical application

  • ASTM D5151: Detection of holes in medical gloves

  • ASTM D6319: Nitrile examination gloves

  • ASTM F739: Permeation of Liquids and Gases through Protective Clothing

  • GB10213: single-use medical rubber examination gloves

  • AS/NZS 4011.1: Single-use medical examination gloves, rubber latex or rubber solution

  • AS/NZS 4011.2: Single-use medical examination gloves, poly(vinyl chloride)

  • JIS T9107: Single-use sterile rubber surgical gloves

  • JIS T9115: Single-use sterile rubber examination gloves

  • MS 1155: Single-use medical examination gloves


Respiratory protection module (if yes to respiratory protection)

These questions relate to the selected response for the use of respiratory protection. The PPE product information or technical specification sheet may be needed. Select the choice that most closely matches the manufacturer’s specifications.

  1. Based on your selected response for type of respiratory protection, select the BEST choice: The selected respiratory protection meets the following criteria:

    1. (Reusability):

      • Single use or disposable

      • Reusable or washable

      • Unsure

    2. (Configuration):

      • Ear loops

      • Head straps

      • Ties

      • Powered air purifying respirator (PAPR)

      • Unsure

    3. Is fit testing required to use a respirator?

      • Yes

      • No

      • Unsure

  2. Select the practice that best describes the use of respiratory protection (e.g., N95 or N100 filtering facepiece respirator, elastomeric half mask respirator, or PAPR):

  • Used for all laboratory procedures

  • Not used when working in primary containment

  • Not used when there is no risk of splash or spray

  • Used for incidents only (e.g., spill response)

  • Unsure

  1. When selecting respiratory protection (respirators), the most important factor affecting the selection is: (Select the best answer)

  • Level of protection provided by respirator

  • Respirator thickness/number of layers

  • Respirator material

  • Respirator head suspension system (head straps, ties, ear loops)

  • Respirator color

  • Respirator fit

  • Cost

  • Quality or performance standard of respirator

  • Comfort

  • Durability

  • Unsure

  1. Do you know the PPE standards for the respiratory protection PPE used at your facility?

  • No

  • Unsure

  • Unknown there are no standards listed on the PPE used

  • Yes (If Yes, go to next question)


  1. Which of the following products that provide varying levels of respiratory protection do you typically use (select all that apply)?

  • NIOSH approved (Code of Federal Regulations 42 CFR 84): respirators

    • N95

    • N99

    • N100

    • P95 or R95

    • P99 or R99

    • P100 or R100

    • Elastomeric half-mask or full-face respirator

    • Powered air purifying respirator (PAPR) (tight fitting or loose fitting)

  • EN 149: filtering half masks

    • FFP1

    • FFP2

    • FFP3

  • GB 19083: protective face masks for medical use

    • Grade/Level/Class 1

    • Grade/Level/Class 2

    • Grade/Level/Class 3

  • GB 2626: Respiratory protective equipment-Non-powered air-purifying particle respirator

    • KN90

    • KN95

    • KN100

    • KP90

    • KP95

    • KP100

  • KMOEL-2017-64: filtering facepiece respirators

Enter the percentage of filtration efficiency Click here to enter text.

  • Unknown there are no standards listed on the PPE used

  • Unsure


PPE Summary

The table below has answers from previous sections. Please review this information. Additionally, if manufacturer, product, or catalog numbers are available, enter in the table.



Body Part Protected


Configuration


Reusability


Type


Material


Standards

Manufacturer/ product number


Catalog #

Body








Head








Foot








Head/Face








Mucus Membrane








Respiratory








Gloves









Shape1 Shape2

2

NAC.AUDIT.EXT.017.01


File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
File TitlePersonal Protective Equipment Survey for Laboratories
AuthorGustin, Kortney M. (CDC/DDPHSIS/CPR/DSAT)
File Modified0000-00-00
File Created2025-11-25

© 2025 OMB.report | Privacy Policy