Methods of compliance | Occupational Exposure to Bloodborne Pathogens

Add a Note HereParagraph (d) sets forth the method by which employers must protect their employees from the hazards of bloodborne pathogens and comply with this standard through the use of universal precautions, engineering controls, work practice controls, personal protective equipment, proper housekeeping and handling of regulated waste.
1.  Add a Note HereUniversal precautions — Paragraph (d)(1). Universal precautions are OSHA’s required methods of control to protect employees from exposure to all human blood and OPIM. The term “universal precautions” refers to a concept of bloodborne disease control which requires that all human blood and OPIM be treated as if known to be infectious for HIV, HBV, HCV or other bloodborne pathogens, regardless of the perceived “low risk” status of a patient or patient population.
Add a Note HereAlternative concepts in infection control are called Body Substance Isolation (BSI) and Standard Precautions. These methods define all body fluids and substances as infectious. These methods incorporate not only the fluids and materials covered by this standard but expands coverage to include all body fluids and substances.
Add a Note HereThese concepts are acceptable alternatives to universal precautions, provided that facilities utilizing them adhere to all other provisions of this standard.
Add a Note HereCitation guidelines: If the employer has a policy of treating the blood or OPIM of some patients as potentially infectious and the blood or OPIM of others (e.g., the elderly or children) as not infectious, a violation of this provision exists.
2.  Add a Note HereEngineering controls and work practices — Paragraph (d)(2)(i). This paragraph requires the employer to institute engineering and work practice controls as the primary means of eliminating or minimizing employee exposure. It conforms to OSHA’s traditional adherence to a hierarchy of controls [See 56 Fed. Reg. 64114-15 (1991)]. OSHA has always required employers to use engineering and work practice controls. Thus the employer must use engineering and work practice controls that eliminate occupational exposure or reduce it to the lowest feasible extent. Preventing exposures requires a comprehensive program, including the use of engineering controls (e.g., needleless devices, shielded needle devices, and plastic capillary tubes) and proper work practices (e.g., no-hands procedures in handling contaminated sharps, eliminating hand-to-hand instrument passing in the operating room). Paragraph 1910.1030(b) provides definitions of engineering controls, safer medical devices, needleless systems, and sharps with engineered sharps injury protection. If engineering and work practice controls do not eliminate exposure, the use of personal protective equipment (e.g., eye protection) is required. The use of sharps containers is not an acceptable means of complying with (d)(2)(i). The specific provisions of (d)(4)(iii)(A) covers sharps containers and thus preempts this section, pursuant to 29 CFR 1905 (specific standard preempts general standard).
Add a Note HereNeedles that will not become contaminated by blood during use (such as those used only to draw medication from vials) are not required to have engineering controls under this standard. The needle used for the actual injection, however, must incorporate engineering controls.
3.  Add a Note HereThe employer must also make changes to its Exposure Control Plan to include the selection and use of these engineering controls. [See discussion of paragraph (c)(1)(iv) above.] Safer medical devices are generally of two types: needleless systems (e.g., needleless IV connectors) and sharps with engineered sharps injury protection (e.g., self-sheathing needles on syringes). Substitution methods such as the use of plastic (instead of glass) capillary tubes are also available. Paragraph (c)(1)(v) requires employers to involve employees in the selection of effective engineering controls to improve employee acceptance of the newer devices and to improve the quality of the selection process.
4.  Add a Note HereWhere engineering controls will reduce employee exposure either by removing, eliminating or isolating the hazard, they must be used. Significant improvements in technology are most evident in the growing market of safer medical devices that minimize, control or prevent exposure incidents.
5.  Add a Note HereIdeally, the most effective way of removing the hazard of a contaminated needle is to eliminate the needle completely by converting to needleless systems. When this is not possible, removal of the hazard as soon as possible after contamination is required. This is best accomplished by using a sharp with engineered sharps injury protection, which shields the sharp from exposure as soon as it is withdrawn from the patient.
6.  Add a Note HereNo one medical device is appropriate in all circumstances of use. Employers must implement the safer medical devices that are appropriate, commercially available, and effective.
7.  Add a Note HereThe FDA is responsible for clearing medical devices for marketing, although this “clearance” alone is not enough to guarantee the device will be effective in the workplace. The employer must rely on further evidence to ensure its effectiveness in the situations it will be used. There are specific design features for recessed needle systems that the Food and Drug Administration (FDA Safety Alert, April 16, 1992 and Draft Supplementary Guidance on the Content of Premarket Notification 510(K) Submissions for Medical Devices with Sharps Injury Prevention Features, March 1995) has published and agrees are important in preventing percutaneous injury. These design features have the following characteristics:
a.    Add a Note HereA fixed safety feature provides a barrier between the hands and the needle after use; the safety feature should allow or require the worker’s hands to remain behind the needle at all times;
b.    Add a Note HereThe safety feature is an integral part of the device and not an accessory;
c.    Add a Note HereThe safety feature is in effect before disassembly and remains in effect after disposal to protect users and trash handlers, and for environmental safety;
d.    Add a Note HereThe safety feature is as simple as possible, and requiring little or no training to use effectively.
Add a Note HereInspection guidelines: The Compliance Officer should determine through interviews or observation of work involving exposure to blood or OPIM whether sufficient engineering controls and work practices are used. While it is generally accepted that an exposure incident can occur at any time or place, a review of the facility records can better direct the Compliance Officer to areas that are more likely to be sites of exposure incidents. Data from The Uniform Needlestick and Sharp Object Injury Report, 77 Hospitals, 1993-1995 (Exposure Prevention Information Network EPINet at show that injuries occurred, in order of frequency, in patient rooms, operating rooms, emergency departments, and intensive/critical care units. The report indicates that nurses (RN’s and LPN’s) were injured more often than any other type of healthcare worker.
Add a Note HereFurthermore, the report finds that an overwhelming majority (93%) of the injuries were caused by items that were not a “safe design with a shielded, recessed, or retractable needle.” The Compliance Officer should determine if there were occasions where injuries were incurred during the same procedure, using the same equipment, in the same location or among similar employees (e.g., housekeepers), and determine whether effective engineering or work practices have been or can be implemented to prevent or minimize future injuries. The Compliance Officer should investigate whether the employer has instituted alternative engineering controls and work practices to eliminate or minimize employee exposure in areas where exposure incidents have been documented.
Add a Note HereCitation guidelines: Paragraph (d)(2)(i) should be cited for failure to use engineering/work practice controls as discussed above. The lack of recorded injuries on the sharps injury log or OSHA 200 (through the end of 2001) or OSHA 300 (effective January 1, 2002) does not exempt the employer from this provision. The Compliance Officer should carefully evaluate the exposure control measures, such as effective engineering controls, that are in use at the facility. Part of this evaluation should include whether other devices that are commercially available were reviewed or considered by the employer and whether there is evidence that other engineering controls would reduce exposures. Such evidence might include CDC studies of efficacy, pilot tests by the employer, or data available in published studies.
Add a Note HereThe Record Summary indicated that over 87% of the respondents who provided information on device usage were already using needleless or shielded needle IV line access in 1998. Other popular devices include blunt suture needles, safer syringes, and safer phlebotomy devices. This is not an exhaustive list of effective engineering controls that are available. Appendix B provides some examples of forms an employer might use for evaluation of engineering controls.
Add a Note HereCompliance with this paragraph should take into consideration that the availability or use of an engineering control is not enough to guarantee that an employee cannot be injured. Employee acceptance and employee training are necessary for an engineering control to be effective. The Compliance Officer should evaluate the training in accordance with paragraph (g)(2)(vii). A citation for the appropriate paragraph of (g)(2)(vii) should be grouped with paragraph (d)(2)(i), if the Compliance Officer determines that inadequate training caused the failure to use such controls.
Add a Note HereCitations for paragraph (d)(2)(i) should be issued when these criteria are met:
§  Add a Note HereIf no engineering controls are being used to eliminate or minimize exposure, a citation should be issued.
§  Add a Note HereIf a combination of engineering and work practice controls used by the employer does not eliminate or minimize exposure, the employer shall be cited for failing to use engineering and work practice controls.
§  Add a Note HereWhen the compliance officer finds that an employer is using an engineering control, but believes another device would be clearly more effective than the one in use, the compliance officer should document how the device was being used and how it was selected. The compliance officer should consult with the Regional Bloodborne Pathogens Coordinator to determine if a violation of (d)(2)(i) exists.
Add a Note HereThe citation should state that the employer failed to use engineering controls or work practices that would “eliminate or minimize exposures” and identify particular engineering controls, such as self-sheathing needles, and particular work practice controls, such as no-hand procedures in handling contaminated sharps, which should have been used. After each particular control mentioned in the citation, the words “among other controls” should be added unless it is clear that there are no other controls.
Add a Note HereParagraph (d)(2)(i) should not be cited where another provision of the standard mandates a specific engineering or work practice control (e.g., paragraph (d)(4)(iii)(A) for sharps containers and paragraph (d)(2)(vii) for the prohibition of recapping).
3.  Add a Note HereParagraph (d)(2)(ii). This paragraph requires that engineering controls be examined and maintained or replaced on a regular schedule to ensure their effectiveness. Regularly scheduled inspections are required to confirm, for instance, that engineering controls such as safer devices continue to function effectively, that protective shields have not been removed or broken, and that physical, mechanical or replacement-dependent controls are functioning as intended.
Add a Note HereCitation guidelines: It is the employer’s responsibility to regularly examine and repair and/or replace engineering controls as often as necessary to ensure that each control is maintained and that it provides the protection intended. If the Compliance Officer finds that there is no system for regular checking of the engineering controls or that regular checking is not done, paragraph (d)(2)(ii) should be cited.
4.  Add a Note HereParagraphs (d)(2)(iii) through (d)(2)(vi). These paragraphs require employers to provide hand-washing facilities which are readily accessible to employees. Handwashing with soap and at least tepid running water must be performed as soon as feasible, particularly in cases of gross contamination, to adequately flush contaminated material from the skin.
a.    Add a Note HereParagraph (d)(2)(iv). This paragraph allows the use of alternative handwashing methods as an interim measure when soap and water are not a feasible means of washing the hands or other parts of the body. In such cases, the employer must provide either antiseptic hand cleaner and clean cloth/paper towels, or antiseptic towelettes.
Add a Note HereWhen these types of alternatives are used, employees must wash their hands (or other affected area) with soap and running water as soon as feasible thereafter.
Add a Note HereThe Compliance Officer may see these types of alternative washing methods used by ambulance-based paramedics and emergency medical technicians (EMT’s), fire fighters, police, and mobile blood collection personnel who are exposed to blood or OPIM but have no means of washing up with running water at the site of the exposure (e.g., a crime scene, traffic accident, fire).
b.    Add a Note HereParagraph (d)(2)(v). This paragraph requires employers to ensure that employees wash their hands immediately or as soon as feasible after removal of gloves or other PPE. There is no requirement for handwashing upon leaving the work area unless contact with blood or OPIM has occurred or gloves/PPE have been removed.
Add a Note HereCitation guidelines: If the compliance officer finds that required handwashing facilities are not being provided, paragraph (d)(2)(iii) should be cited unless the employer demonstrates that handwashing facilities are not feasible. If infeasibility is demonstrated, paragraph (d)(2)(iv) should be cited when the required alternatives are not used. If handwashing is not performed by the employees immediately or as soon as feasible after exposures or removal of gloves, paragraphs (d)(2)(iv), (v), or (vi) should be cited. A citation for one or more of these paragraphs may be grouped with the pertinent training paragraphs of (g)(2) if employees have not been adequately trained in handwashing procedures.
Add a Note HereAt a fixed establishment, if handwashing facilities are not readily accessible, i.e., within a reasonable distance from the area where the employee is exposed, (d)(2)(iii) should be cited. For example, if an employee must leave the work area and thread his/her way through doorways and/or stairs to wash, there is a reasonable chance of resultant environmental surface contamination. This situation is a violation.
5.  Add a Note HereParagraph (d)(2)(vii). Shearing or breaking of contaminated sharps is completely prohibited by this paragraph. Bending, recapping, or removing contaminated needles is prohibited as a general practice. The practice of removing the needle from a used blood-drawing/phlebotomy device is rarely, if ever, required by a medical procedure. Because such devices involve the use of a double-ended needle, such removal clearly exposes employees to additional risk. Devices with needles must be used and immediately discarded after use, un-recapped, into accessible sharps containers. Certain circumstances may exist, however, in which recapping, bending, or removing needles is necessary (e.g., administering incremental doses of a medication such as an anesthetic to the same patient).
a.    Add a Note HereIn these procedures, if the employer can demonstrate that such action is required by a specific medical procedure, or that no alternative is feasible, recapping must be performed by some method other than the traditional two-handed procedure, e.g., by means of a mechanical device or forceps.
b.    Add a Note HereThe use of the properly performed one-hand scoop method (in which the hand holding the sharp is used to scoop up the cap from a flat surface) for recapping is a recognized and acceptable method; however, the scoop method must be performed in a safe manner and must also be limited to situations in which recapping is necessary.
c.    Add a Note HereIf the employer claims that no alternative to bending, recapping, or removing contaminated needles is feasible or that such action is required by a specific medical procedure, the compliance officer should review the exposure control plan for a written justification supported by reliable evidence. This justification must state the basis for the employer’s determination that no alternative is feasible or must specify that a particular medical procedure requires, for example, the bending of the needle and the use of forceps to accomplish this.
6.  Add a Note HereParagraph (d)(2)(viii). Since reusable sharps, such as large bore needles, scalpels, and saws, pose the same percutaneous exposure hazard as disposable sharps, they must be contained in a manner that eliminates or minimizes the hazard until they are reprocessed. Therefore, the containers for reusable sharps must meet the same requirements as containers for disposable sharps, with the exception that they are not required to be closable since it is anticipated that containers used for collecting and holding reusable sharps will, themselves, be reused.
7.  Add a Note HereParagraphs (d)(2)(ix) and (x). These paragraphs are intended primarily to eliminate or minimize indirect transmission of bloodborne pathogens from contaminated environmental surfaces.
Add a Note HereHand cream is not considered a “cosmetic” and is permitted. It should be noted that some petroleum-based hand creams can adversely affect glove integrity, and the hand washing requirements of paragraph (d)(2)(v) and (d)(2)(vi) must be followed.
Add a Note HereThe term “work area” means the area where work involving exposure or potential exposure to blood or OPIM exists, along with the potential contamination of surfaces. Employees are permitted to eat and drink in an ambulance cab, for example, as long as the employer has implemented procedures to permit employees to wash up and change contaminated clothing prior to entering the ambulance cab, and to ensure that patients and contaminated material remain behind the separating partition.
Add a Note HereInspection guidelines: In addition to direct contamination of food or drink by blood or OPIM, the Compliance Officer must keep in mind that containers of food and beverage may also become contaminated, resulting in unsuspected contamination of the hands. The purpose of this paragraph is to prevent food and drink from being contaminated by the leakage/spilling of specimen containers, contact with contaminated items, or the performance of activities (e.g., laboratory analysis) that could generate splashes, sprays, or droplets of blood or OPIM.
Add a Note HereCitation guidelines: Deficiencies of paragraphs (d)(2)(iv) through (x) should be cited in conjunction with the appropriate paragraph of (g)(2) if inadequate training exists.
8.  Add a Note HereParagraph (d)(2)(xi). The intent of this paragraph is not only to decrease the chances of direct employee exposure through spraying or splashing of infectious materials onto employees, but also to reduce contamination of surfaces in the general work area.
Add a Note HereSurgical power tools, lasers, and electrocautery devices may generate aerosols as well as be a source for splashing and spattering. Some of these devices include labeling recommendations such as local exhaust ventilation. The employer is responsible for appropriate operation of these devices, including controls recommended by the manufacturer.
Add a Note HereTypically, reasonably anticipated spattering or generation of droplets would necessitate use of eye protection and mask or a face shield to prevent contamination of the mucous membranes of the eyes, nose, and mouth.
Add a Note HereCitation guidelines: The use of sprays, brushes, and high pressure in equipment lines is particularly hazardous. A citation should normally be issued for paragraph (d)(2)(xi) if cleaning procedures cause unnecessary splashing, spraying, spattering, or generation of droplets of blood or OPIM.
9.  Add a Note HereParagraph (d)(2)(xii). While this paragraph prohibits mouth pipetting/suctioning, the agency allows a recognized emergency care method of clearing an infant’s airways called “DeLee suctioning” in the following situation: in an emergency; when no other method is available, and a trap which prevents suctioned fluid from reaching the employee’s mouth is inserted in-line between the infant and the employee.
10.  Add a Note HereParagraphs (d)(2)(xiii)-(d)(2)(xiii)(C). These paragraphs deal with the containerization and labeling of specimens with the intent to eliminate or minimize the possibility of inadvertent employee contact with blood or OPIM which have leaked out of the container, contaminated exterior surfaces of the container, and/or surrounding surfaces. The labeling requirement warns employees that these substances are present so that proper handling precautions can be taken.
Add a Note HereThe labeling exemption listed in paragraph (d)(2)(xiii)(A) applies to facilities which handle all specimens (not just those specimens which contain blood or OPIM) with universal precautions. This exemption applies only while these specimens remain within the facility. All employees who will have contact with the specimens must be trained to handle all specimens with universal precautions. If the specimens leave the facility (e.g., during transport, shipment, or disposal) a label or red color-coding is required.
Add a Note HereExtracted teeth which are being discarded or used as specimens are subject to the containerization and labeling provisions of the standard. However, OSHA does not issue citations to dentists and doctors for non-employee exposures. Extracted teeth, gall stones and kidney stones may be given to the patients. In these situations, the teeth and stones are not subject to the containerization and labeling provisions of the standard.
Add a Note HereThe use of pneumatic tube systems for transport of small materials in hospitals now includes transmittal of laboratory specimens and other more fragile items. The primary concern in the transportation of clinical specimens in a pneumatic tube system is leakage of the specimen into the carrier and potentially into the system tubing. Some systems have virtually eliminated breakage as a cause of leakage by means of padded inserts for carriers and soft delivery of the carrier. Leakage generally results from improper packaging and/or the use of primary containers that do not prevent leakage during transport.
Add a Note HereAll employees who might potentially open a carrier must be trained to regard the contents as biohazardous in nature. Employees who open biohazard carriers must wear gloves in accordance with paragraph (d)(3) when removing specimens from the tube system carrier, because it may be contaminated with leakage. They must be trained in decontamination of the carrier and, if need be, the tube system in accordance with paragraph (g)(2).
Add a Note HereAll precautions and standards for manual transport of specimens also apply to the automated transport of specimens (e.g., containerization and tagging/labeling).
Add a Note HereInspection guidelines: The Compliance Officer must observe or document work practices to determine whether a secondary container is being used when necessary. If a bloody glove contaminates the outside of a primary container while the employee is placing a specimen, the employee would need to use a secondary container. Also, primary containers which may be punctured by their contents, including such items as pointed bone slivers, must be placed in a puncture-resistant secondary container.
11.  Add a Note HereParagraph (d)(2)(xiv). When it is not possible to decontaminate equipment prior to servicing or shipping (e.g., highly technical or sensitive equipment and/or limited access to contaminated parts), at least partial decontamination, such as flushing lines and wiping the exterior, must be accomplished.
Add a Note HereInspection and citation guidelines: The Compliance Officer should ensure that the employer’s program makes provision for the required equipment labels. A label must be attached to equipment stating which portions of the equipment remain contaminated in order to inform downstream servicing/repair employees of the hazard and precautions they need to take.
Add a Note HereBefore citing paragraph (d)(2)(xiv), the Compliance Officer should document that equipment is being shipped and/or serviced. Compliance Officers should observe or document work practices used when employees are decontaminating equipment. When decontaminating reusable equipment that is heavily soiled, the employee will have to perform some prewashing before proceeding with decontamination because most disinfectants/sterilants cannot sufficiently penetrate the organic material that may remain on such heavily soiled equipment.
12.  Add a Note HerePersonal protective equipment — Paragraph (d)(3). When there is occupational exposure, PPE must be provided at no cost to the employee to prevent blood or OPIM from passing through to, or contacting, the employees’ work or street clothes, undergarments, skin, eyes, mouth, or other mucous membranes.
13.  Add a Note HereParagraph (d)(3)(i). The type and amount of PPE must be chosen to protect against contact with blood or OPIM based upon the type of exposure and quantity of these substances reasonably anticipated to be encountered during the performance of a task or procedure.
Add a Note HereInspection and citation guidelines: The financial responsibility for purchasing and providing PPE rests with the employer. The employer is not obligated under this standard to provide general work clothes to employees, but is responsible for providing PPE. If laboratory coats or uniforms are intended to protect the employee’s body from contamination, they are to be provided by the employer at no cost to the employee.
Add a Note HereLaboratory coats, uniforms and the like that are used as PPE must be laundered by the employer and not sent home with the employee for cleaning.
Add a Note HereScrubs are usually worn in a manner similar to street clothing, and normally should be covered by appropriate gowns, aprons or laboratory coats when splashes to skin or clothes are reasonably anticipated.
Add a Note HereIf a pullover scrub (as opposed to scrubs with snap closures) becomes minimally contaminated, employees should be trained in accordance with paragraph (g)(2)(vii)(G) to remove the pullover scrub in such a way as to avoid contact with the outer surface, e.g., rolling up the garment as it is pulled toward the head for removal.
Add a Note HereHowever, if the amount of blood exposure is such that the blood penetrates the scrub and contaminates the inner surface, not only is it impossible to remove the scrub without exposure to blood, but the penetration itself would constitute skin exposure. Even though wearing scrubs for protection against exposures of this magnitude is inappropriate, it may also be prudent to train employees on the proper methods to remove grossly contaminated scrubs and prevent exposure to the face.
Add a Note HereA gown which is frequently ripped or falls apart under normal use would not be considered “appropriate PPE.”
Add a Note HereResuscitator devices are to be readily available and accessible to employees who can reasonably be expected to perform resuscitation procedures. Emergency ventilation devices also fall under the scope of PPE and hence must be provided by the employer for use in resuscitation (e.g., masks, mouthpieces, resuscitation bags, shields/overlay barriers). Improper use of these devices should be cited as a violation of paragraph (d)(3)(ii). In addition, paragraph (g)(2)(vii)(G), which requires employees to be trained in the types, proper use, location, etc., of the PPE should be cited if inadequate training exists. Improper use includes failure to follow the manufacturer’s instructions and/or accepted medical practice.
Add a Note HereThe American Society for Testing and Materials (ASTM) has several complete testing and evaluation methods which can be used for assessing the resistance of materials used for PPE for medical use. (ASTM-F1819-98, ASTM-F-1671-97b, and ASTM-F1670-97).
14.  Add a Note HereParagraph (d)(3)(ii). This paragraph requires the use of PPE. It also provides for a limited exemption from the use of PPE, based on situations in which use of PPE would prevent the proper delivery of healthcare or public safety services, or would pose an increased hazard to the personal safety of the worker or coworker. The following represent examples of when such a situation could occur:
a.    Add a Note HereA sudden change in patient status occurs such as when an apparently stable patient unexpectedly begins to hemorrhage profusely, putting the patient’s life in immediate jeopardy;
b.    Add a Note HereA fire fighter rescues an individual who is not breathing from a burning building and discovers that his/her resuscitation equipment is lost/damaged and he/she must administer CPR;
c.    Add a Note HereA bleeding suspect unexpectedly attacks a police officer with a knife, threatening the safety of the officer and/or coworkers.
Add a Note HereAn employee’s decision not to use PPE is to be made on a case-by-case basis and must have been prompted by legitimate and truly extenuating circumstances. In such cases, no citation should be issued when the employee temporarily and briefly abandons use of PPE. This does not relieve the employer of the responsibility to ensure that PPE is readily accessible at all times. The employer must investigate and document why PPE was not used in each case and evaluate the circumstances surrounding the incident to reduce the likelihood of a future (unprotected) incident.
15.  Add a Note HereCitation guidelines: Paragraph (d)(3)(ii) should be cited if PPE is not being used properly. Improper use would include wearing the wrong PPE (e.g., wearing a laboratory coat when a rubber apron is needed) or wearing the wrong size glove.
16.  Add a Note HereIn addition, paragraph (g)(2)(vii)(G) should also be cited if the employees have not been adequately trained.
17.  Add a Note HereUnless all elements of the exemption, including the documentation requirement, are met, the employer should not receive the benefit of this exemption and paragraph (d)(3)(ii) should be cited.
15.  Add a Note HereParagraph (d)(3)(iii). This paragraph requires that the employer provide PPE in appropriate sizes and accessible locations. In addition, “hypoallergenic” gloves (see Note below), glove liners, powderless gloves, or other similar alternatives must be readily available and accessible at no cost to those employees who are allergic to the gloves normally provided. Similar alternatives must supply appropriate barrier protection and must be approved by the FDA for use as a medical glove. The compliance officer should review the employer’s program and, through employee interviews and inspection of places where PPE is kept, ensure that these provisions have been met.
Add a Note HereIn accordance with a notice published in the Federal Register, Volume 62, No. 189, effective September 30, 1998, the FDA now requires labeling statements for medical devices which contain natural rubber and prohibits the use of the word “hypoallergenic” to describe such products. Additional information on the incidence of hypersensitivity reactions to natural rubber latex can be found in the following documents: NIOSH Alert, Preventing Allergic Reactions to Natural Rubber Latex in the Workplace (Publication No. 97-135) published in June 1997; Directorate of Technical Support, Technical Information Bulletin: Potential for Allergy to Natural Rubber Latex Gloves and other Natural Rubber Products,
16.  Add a Note HereCitation guidelines: If PPE is not provided at no cost to the employee, the Compliance Officer should cite paragraph (d)(3)(i). If PPE is not being used properly or the wrong PPE is used (e.g., wearing a laboratory coat when a rubber apron is needed) or wearing the wrong size PPE, paragraph (d)(3)(ii) should be cited. If PPE is not available in appropriate sizes or readily accessible, the Compliance Officer should cite paragraph (d)(3)(iii). For example, the clothing of paramedics out on an emergency call may become blood soaked. If they are unable to change before the next emergency call because a second set of clothing is located at the ambulance’s home base, and the ambulance does not return to base for prolonged periods, a violation of paragraph (d)(3)(iii) would exist.
17.  Add a Note HereIf it is common practice that PPE is not utilized during certain situations or procedures where exposure to blood or OPIM is anticipated, then a violation of paragraph (d)(3)(ii) would exist. If inaccessibility of PPE exists, paragraph (d)(3)(iii) should also be cited.
16.  Add a Note HereParagraph (d)(3)(iv). It is the employer’s responsibility not only to provide PPE, but to clean, maintain, and/or dispose of it. Home laundering is not permitted since the employer cannot guarantee that proper handling or laundering procedures are being followed.
Add a Note HereWhile many employees have traditionally provided and laundered their own uniforms or laboratory coats or the like, if the item’s intended function is to act as PPE, then it is the employer’s responsibility to provide, clean, repair, replace, and/or dispose of it.
Add a Note HereHome laundering by employees is not permitted since the standard requires that the laundering be performed by the employer at no cost to the employee. Home laundering is unacceptable because the employer cannot ensure that proper handling or laundering procedures are being followed and because contamination could migrate to the homes of employees.
Add a Note HereIf the employee wishes to choose, wear, and maintain his/her own uniform or laboratory coat, then he/she would need to don additional employer-handled and employer-controlled PPE when performing tasks where it is reasonable to anticipate exposure to blood or OPIM.
Add a Note HereCitation guidelines: If PPE is not cleaned, laundered, and disposed of by the employer, or if the employer cleans the PPE but there is a charge to the employee, then paragraph (d)(3)(iv) should be cited. If PPE is not repaired and/or replaced by the employer at no cost to the employee, then paragraph (d)(3)(v) should be cited.
Add a Note HereIf a garment is not removed as soon as possible when penetrated by blood or OPIM, the Compliance Officer should cite paragraph (d)(3)(vi).
Add a Note HereIf the PPE is not changed, and additional PPE was available, paragraph (g)(2)(vii)(G) may also be cited if employees have not been adequately trained.
17.  Add a Note HereParagraph (d)(3)(vii). To minimize migration of contamination beyond the work area, employees must remove any contaminated clothing before leaving a work area (i.e. before they may enter designated lunchrooms or break rooms). Failure to wash up would be cited under (d)(2)(iv), (v) or (vi).
Add a Note HereInspection and citation guidelines: While “work areas” must be determined on a case-by-case basis, a work area is generally considered to be an area where work involving occupational exposure occurs or where the contamination of surfaces may occur. The standard would not require employees to change PPE when traveling, for example, from one hospital laboratory area to another, provided the connecting hallway is also considered to be a work area. The Compliance Officer should evaluate on a case-by-case basis whether the employee received adequate training in accordance with paragraph (g)(2)(vii)(F) to ensure that no surface contamination occurs during the employee’s movement. A violation would exist for the following:
Add a Note HereAn employee wearing contaminated gloves exits from a pathology laboratory to use a public telephone located in a public hallway of the hospital. Under such circumstances, it can be reasonably anticipated that another employee, without benefit of gloves or knowledge of the potential surface contamination, could use the phone and unwittingly become contaminated.
18.  Add a Note HereParagraph (d)(3)(ix)(A)-(C). These paragraphs discuss the use of gloves. Gloves of appropriate sizes must be made available in accordance with paragraph (d)(3)(iii). Studies have shown that gloves provide a barrier, but that neither vinyl nor latex procedure gloves are completely impermeable. Thus, hand washing after glove removal is required. Disposable gloves must be replaced as soon as practical or as soon as feasible when contaminated.
Add a Note HereWhile disposable gloves must be replaced as soon as practical when contaminated, obviously some critical procedures (i.e., surgery, delivery) cannot be interrupted to change gloves. The key words to evaluate are “practical” and “feasible.”
Add a Note HereDisinfecting agents may cause deterioration of the glove material; washing with surfactants could result in “wicking” or enhanced penetration of liquids into the glove via undetected pores, thereby transporting blood or other potentially infectious materials into contact with the hand. For this reason, disposable (single use) gloves may not be washed and reused.
Add a Note HereThe Compliance Officer should note that certain solutions, such as iodine, may cause discoloration of gloves without affecting their integrity and function.
Add a Note HereAt a minimum, gloves must be used where there is reasonable anticipation of employee hand contact with blood, OPIM, mucous membranes, or non-intact skin; when performing vascular access procedures; or when handling or touching contaminated surfaces or items.
Add a Note HereGloves are usually not necessary when administering intramuscular or subcutaneous injections as long as bleeding that could result in hand contact with blood or OPIM is not anticipated.
Add a Note HerePlastic film food handling gloves (“cafeteria” or “baggie” gloves) are not considered to be appropriate for use in exposure-related tasks. They would not fit the employee as required by paragraph (d)(3)(iii) of the standard.
19.  Add a Note HereParagraph (d)(3)(ix)(D). The exemption regarding the use of gloves during phlebotomy procedures applies only to employees of volunteer donor blood collection centers, and does not apply to phlebotomy conducted in other settings such as plasmapheresis centers or hospitals.
Add a Note HereInspection guidelines: Where an employer in a volunteer donor blood collection center does not require routine gloving for all phlebotomies, the Compliance Officer should document that the employer has fulfilled the requirements of paragraphs (d)(3)(ix)(D)(1) through (d)(3) (ix)(D)(4)(iii), and that employees have received the training necessary to make an informed decision on the wearing of gloves.
Add a Note HereCitation guidelines: Paragraph (d)(3)(ix)(D) should not be cited. Rather, the other paragraphs of (d)(3) should be cited if such an employer violates them and if the employer has not demonstrated fulfillment of all the requirements of the exemptions.
20.  Add a Note HereParagraph (d)(3)(x). This paragraph requires protection for the mucous membranes of the face and upper respiratory tract from exposure. Depending on the degree and type of anticipated exposure, protection for the face would consist of a surgical mask in conjunction with goggles or eye glasses with solid side shields or, alternatively, a chin length face shield.
Add a Note HereThe employer would not necessarily have to provide prescription eyewear for employees. He/she could provide and mandate the use of side shields, goggles, and/or protective face shields, and provide proper training in decontamination procedures.
Add a Note HereDuring microsurgery, when it is not reasonably anticipated that there would be any splattering, a surgeon would not be required to wear eye protection while observing surgery through the microscope.
21.  Add a Note HereParagraphs (d)(3)(xi)-(xii). Requirements for the use of protective body clothing, such as gowns, aprons, laboratory coats, clinic jackets, surgical caps, or shoe covers, and the degree to which such PPE must resist penetration, are performance based. The employer must evaluate the task and the type of exposure expected and, based on the determination, select the “appropriate” personal protective clothing in accordance with paragraph (d)(3)(i). For example, laboratory coats or gowns with long sleeves must be used for procedures in which exposure of the forearm to blood or OPIM is reasonably anticipated to occur.
Add a Note HereInspection guidelines: The Compliance Officer will need to evaluate the task being performed and the degree of anticipated exposure by direct observation, employee interview, or review of written standard operating procedures.
22.  Add a Note HereHousekeeping (d)(4). The term “worksite” in this paragraph refers not only to permanent fixed facilities such as hospitals, dental/medical offices, clinics, etc., but also covers temporary non-fixed workplaces. Examples of such facilities include but are not limited to ambulances, bloodmobiles, temporary blood collection centers, and any other non-fixed worksites which have a reasonable possibility of becoming contaminated with blood or OPIM.
Add a Note HereParagraph (d)(4)(i). Cleaning schedules and methods will vary according to the factors outlined in this paragraph. While extraordinary attempts to disinfect or sterilize environmental surfaces such as walls or floors are rarely indicated, routine cleaning and removal of soil are required.
Add a Note HereThe employer must determine and implement an appropriate written schedule of cleaning and decontamination based upon the location within the facility (e.g., surgical operatory versus patient room), type of surface to be cleaned (e.g., hard-surfaced flooring versus carpeting), type of soil present (e.g., gross contamination versus minor splattering), and tasks and procedures being performed (e.g., laboratory analyses versus routine patient care).
Add a Note HereThe particular disinfectant used, as well as the frequency with which it is used, will depend upon the circumstances in which the housekeeping task occurs.
23.  Add a Note HereParagraph (d)(4)(ii). Since environmental contamination is an effective method of disease transmission for HBV (the CDC states that HBV can survive for at least one week in dried blood on environmental surfaces or contaminated needles and instruments), paragraph (d)(4)(ii) provides the minimum requirements for the cleaning and decontamination of equipment and environmental and working surfaces that come into contact with blood or OPIM.
Add a Note HereUnder paragraph (d)(4)(ii)(A), cleaning of contaminated work surfaces after completion of procedures is required to ensure that employees are not unwittingly exposed to blood or OPIM remaining on a surface from previous procedures. This paragraph requires contaminated work surfaces to be cleaned with an “appropriate disinfectant.” Appropriate disinfectants include a diluted bleach solution and EPA-registered tuberculocides (List B), sterilants registered by EPA (List A), products registered against HIV/HBV(List D) or Sterilants/High Level Disinfectants cleared by the FDA. The lists of the EPA Registered Products are available from the National Antimicrobial Information Network on its website at or at (800) 447-6349. The sterilants and high level disinfectants cleared by FDA can be found at Any of the above products are considered effective when used according to the manufacturer’s instructions, provided the surfaces have not become contaminated with agents or volumes of or concentrations of agents for which higher level disinfection is recommended.
Add a Note HereThe EPA lists contain the primary registrants’ products only. The same formulation is frequently repackaged and renamed and distributed by other companies. These renamed products will not appear on the list, but their EPA Registration number must appear on the label. Products cleared solely by the FDA will not have an EPA number.
Add a Note HereInspection guidelines: Compliance Officers should check the product label for EPA registration and/or consult the Environmental Protection Agency (EPA) lists of registered sterilants (representing the highest level of antimicrobial activity that destroys all viruses), tuberculocidal disinfectants (effective against tuberculosis bacteria and the specific viruses named on the product label as well as the hepatitis B virus), and antimicrobials with HIV/HBV efficacy claims for verification that the disinfectant used is appropriate. The employer must follow the label instructions regarding the amount of disinfectant and the length of time it must remain wet on the surface. Since the effectiveness of a disinfectant is governed by strict adherence to the instructions on the label, Compliance Officers should also interview employees to ensure that the disinfectants are being used according to the manufacturer’s instructions. If employees have not been trained in the proper use of the disinfectant, a violation of the appropriate paragraph in (g)(2)(vii) should be cited.
Add a Note HereFresh solutions of diluted household bleach made up daily (every 24 hours) are also considered appropriate for disinfection of environmental surfaces and for decontamination of sites following initial cleanup (i.e., wiping up) of spills of blood or other potentially infectious materials. Contact time for bleach is generally considered to be the time it takes the product to air dry. Solutions of bleach should not be stored in glass containers, but in material such as the plastic in which the bleach, the consumer product, is packaged in. Household bleach (5.25% sodium hypochlorite) diluted to the appropriate strength for the clean up job at hand is also an effective disinfectant, although bleach may cause damage to some medical instruments and therefore cannot be used in all cases. In addition, gross contamination must be cleaned up first with a soap and water solution, to ensure the disinfectant is completely effective.
Add a Note HereWhere procedures are performed on a continual basis throughout a shift or a day, as may be the case with a clinical laboratory technician performing blood analyses, it is not the agency’s intent for the work surface to be decontaminated before the technician can proceed to the next analysis; rather the intention is for contaminated work surfaces to be decontaminated after the procedures are completed which, in the above example, would include a set of analyses. The completion of procedures might also occur when the employee is going to leave the work area for a period of time.
Add a Note HereDecontamination is not automatically required after each patient care procedure, but is required only after procedures resulting in surface contamination.
Add a Note HereThere may be some instances in which “immediate” decontamination of overt contamination and spills may not be practical as in, for example, an operating table during surgery.
Add a Note HereThe work surface decontamination is to be performed at the end of the work shift if the work surface may have become contaminated since the last cleaning by, for example, setting down contaminated instruments or specimens on the work surface. This requirement is based upon the existence of a contaminated work surface rather than a particular worksite location. It does not, for example, encompass desks, countertops, and so forth that remain uncontaminated.
Add a Note HereThe use of protective coverings described in paragraph (d)(4)(ii)(B) is an acceptable alternative for protecting items and surfaces against contamination and is particularly useful in situations in which a piece of equipment would be difficult to decontaminate but could be protected by a cover.
Add a Note HereIf this option is chosen, the covering must be removed and replaced at the stated minimum intervals, i.e., as soon as feasible following overt contamination or at the end of a workshift if it may have become contaminated during the shift.
Add a Note HereMore stringent decontamination rules, such as cleaning equipment or changing coverings between patients, may be prudent infection control policy but do not fall under OSHA’s mandate to safeguard employee (not patient) health.
24.  Add a Note HereParagraph (d)(4)(ii)(C) requires both the inspection and decontamination, on a regularly scheduled basis, of cans, bins, pails, and so forth which are intended for reuse.
Add a Note HereSince these containers may be used in a manner which presents the potential for their becoming contaminated with blood or OPIM, they must be cleaned immediately or as soon as feasible upon visible contamination. For example, a reusable metal trash can could have been lined with a disposable plastic regulated waste bag which leaks and contaminates the can. In addition, regular decontamination will prevent the can from leaking, spilling, or contaminating the outside of successive bags. Disinfection of these containers is not necessary to ensure their safety for their intended use; it may be possible to achieve their proper decontamination by means of a soap and water wash.
Add a Note HereSince contaminated broken glass (e.g., glass capillary tubes, lab specimen dishes, phlebotomy tubes) is capable of inflicting percutaneous injury and direct inoculation of bloodborne pathogens into the bloodstream, paragraph (d)(4)(ii)(D) stipulates that broken glassware which may be contaminated must not be picked up directly with the hands. The tools which are used in cleanup (e.g., forceps) must be properly decontaminated or discarded after use and the broken glass placed in a sharps container, and employees must be given specific information and training with respect to this task in accordance with the requirements of paragraph (g)(2). Vacuum cleaners are not appropriate for cleanup of contaminated broken glass.
25.  Add a Note HereParagraph (d)(4)(ii)(E) prohibits employers from allowing employees to place their hands into containers whose contents include reusable sharps contaminated with blood or OPIM. The intent is to prevent conditions of use in which the contents cannot be seen and safely handled. For example, employees must not reach into sinks filled with soapy water into which sharp instruments have been placed; appropriate controls in such a circumstance would include the use of strainer type baskets to hold the instruments and forceps to remove the items.
Add a Note HereThe final standard recognizes that proper decontamination of reusable equipment, such as glassware or hand instruments, cannot be achieved in the presence of organic debris (e.g., blood) because it interferes with the efficacy of the disinfecting/sterilizing process, and the number of products which can successfully penetrate a heavy bioburden is limited.
Add a Note HereViolations of paragraphs (d)(4)(ii) and (d)(4)(ii)(A)-(E) may result from a failure to adequately train employees in proper housekeeping procedures. If the Compliance Officer determines this is the case, violations should be grouped with the appropriate paragraph(s) of paragraph (g)(2).
26.  Add a Note HereRegulated waste (d)(4)(iii). This paragraph requires regulated waste to be properly contained and disposed of, so as not to become a source of transmission of disease to employees.
Add a Note HereTo eliminate the implication that OSHA has determined the “infectivity” of certain medical wastes, the bloodborne pathogens standard uses the term “regulated waste” to refer to the following categories of waste which require special handling, at a minimum: liquid or semi-liquid blood or OPIM; items contaminated with blood or OPIM and which would release these substances in a liquid or semi-liquid state if compressed; items that are caked with dried blood or OPIM and are capable of releasing these materials during handling; contaminated sharps; pathological and microbiological wastes containing blood or OPIM.
Add a Note HereInspection and citation guidelines: The compliance officer should not use the actual volume of blood to determine whether or not a particular material is to be considered regulated waste, since 10 ml of blood on a disposable bed sheet would appear as a spot (not regulated waste) while the same amount of blood on a cotton ball would likely cause saturation and dripping (regulated waste). Similarly, an item may adequately contain these materials when in a static state yet liberate them when compacted in the waste container. Instead, the compliance officer should consider the potential for generation of bulk blood (i.e through dripping or flaking off of material that may contain either blood or OPIM). Under no circumstances should a bag of waste be squeezed or shaken to determine this. The compliance officer should exercise professional judgment to make a determination based on visual factors such as a pool of liquid in the bottom of the container or dried blood flaking or falling off during handling, or based on employee interviews.
Add a Note HereThe Compliance Officer should keep in mind that, while OSHA specifies certain features of the regulated waste containers, including appropriate tagging, the ultimate disposal method (landfilling, incinerating, and so forth) for medical waste falls under the purview of the EPA and possibly State and local regulations.
Add a Note HereLacking information to the contrary, the Compliance Officer should consider a used needle to be contaminated.
27.  Add a Note HereParagraph (d)(4)(iii)(A)(1). This provision should be cited if contaminated sharps are not discarded in containers immediately or as soon as feasible. If containers are located too far away from the point of use, then (d)(4)(iii)(A)(2)(i) should be cited. See below.
28.  Add a Note HereParagraph (d)(4)(iii)(A)(1)(i)-(iv). The construction of the sharps containers must meet at least four criteria, two of which will be easily discernible. The Compliance Officer should examine a container, preferably empty, to check that it is closable and color-coded or labeled. Sharps containers are made from a variety of products, from cardboard to plastic. As long as they meet the criteria for a sharps container, the Compliance Officer should consider them to be acceptable no matter what the composition. If questions arise, the Compliance Officer should consult the manufacturer’s literature or contact the manufacturer directly to determine if the container is leak-proof on the sides and bottom, as well as puncture resistant. The NIOSH publication, “Selecting, Evaluating and Using Sharps Disposal Containers” is also a good resource.
Add a Note HereIf the container is considered puncture resistant by the manufacturer, but there is evidence, through observation or employee statements, that sharps have been protruding through a container, paragraph (d)(4)(iii)(A)(1)(ii) should be cited.
Add a Note HereThe sharps container should not create additional hazards. Some sharps containers have unwinders that are used to separate needles from reusable syringes or from reusable blood tube holders. The use of these are generally prohibited. However, if a medical procedure requires needle removal, the design of the sharps container and the location of the unwinder must allow the needle removal to be accomplished in a safe, one-handed manner. If this situation is encountered, the Compliance Officer should determine if the circumstances warrant needle removal. If they do not, paragraph (d)(2)(vii)(A), which prohibits needle removal unless no alternative is feasible or it is required by a specific medical procedure, should be cited. If needle removal must be accomplished, the employee must be trained in the correct procedure as required by paragraph (g)(2)(vii)(F).
Add a Note HereThe needle sheath on a self-sheathing needle is not to be considered a “waste container” because it is viewed as a temporary measure. Self-sheathing needle products and other SESIPs, even after activation, must be disposed of in a sharps container which conforms to the requirements of paragraph (d)(4)(iii)(A)(1).
Add a Note HereDuct tape may be used to secure a sharps container lid, but tape is not acceptable if it serves as the lid itself.
29.  Add a Note HereParagraph (d)(4)(iii)(A)(2)(i). The Compliance Officer should ensure that the sharps container is as close as feasible to where sharps are used or can be reasonably anticipated to be found.
Add a Note HereIf an employee must travel to a remote location to discard a sharp, it will increase the possibility of an accidental needlestick and increase the chances that needles and sharps will be improperly discarded and create potential hazards for other staff members.
Add a Note HereAreas such as correctional facilities, psychiatric units, pediatric units, or residential homes may have difficulty placing containers in the immediate use area. Alternatives include using containers which are lockable or which are designed to prevent removal of syringes while maintaining easy accessibility for discarding. Containers may also be locked onto a mobile cart if one is used by healthcare workers in these units, or they may be brought to the site and removed by the employee upon leaving.
Add a Note HereThe determination of whether or not the container is as close as feasible should be made on a case-by-case basis. After interviewing employees, if the Compliance Officer believes there is a better location for the container, management should be given the opportunity to explain the reasons for the present location of the container. The acceptability of the new site should also be discussed. The Compliance Officer should then decide if a violation of this paragraph exists.
Add a Note HereLaundries must also have sharps containers easily accessible because of the high incidence of needles being mixed with laundry. Facilities that handle shipments of waste which may contain contaminated sharps must also have sharps containers available in the event a package accidentally opens and releases sharps.
30.  Add a Note HereParagraph (d)(4)(iii)(A)(2)(iii). The Compliance Officer should ensure that sharps containers are being replaced routinely to prevent overfilling. The Record Summary states that overfilling of sharps containers is an often reported problem. Overfilling is often associated with containers that were too small to accommodate the volume of sharps, limited ability to see the contents in order to determine the remaining capacity, and lax procedures for container maintenance. Examples of methods by which sharps containers can be examined to determine a need for replacement, are the use of sharps containers which have a transparent window or are placed at a height which allows employees to see if the container needs to be replaced. Overfilling of sharps containers should be cited under paragraph (d)(4)(iii)(A)(2)(iii). A citation for inadequate training on work practices, paragraph (g)(2)(vii)(F), should be grouped with the citation for this paragraph if the over-filled containers are present because of lack of training.
Add a Note HereThe Exposure Prevention Information Network (EPINet) study, Uniform Needlestick and Sharp Object Injury Report (77 Hospitals, 1993-1995) reports that 717 injuries occurred in this time period when an employee was putting an item into a disposal container. The Compliance Officer should closely inspect sharps disposal containers at the site to ensure containers are not overfilled. Additional information on sharps disposal containers is available in the NIOSH publication, Selecting, Evaluating and Using Sharps Disposal Containers, January 1998, DHHS (NIOSH) Publication No. 97-111.
31.  Add a Note HereParagraphs (d)(4)(iii)(A)(3)(i) and (ii). If work practice violations of these paragraphs exist (e.g., not closing the container prior to movement or not placing the container in a secondary container if leakage is possible), the citations should be grouped with paragraph (g)(2)(vii)(F) if employees have not received adequate training.
32.  Add a Note HereParagraph (d)(4)(iii)(A)(3)(ii)(B). It is reasonable to presume that some sharps containers will contain residual liquids. If the container cannot be sealed to prevent leakage, it must be placed in a secondary container.
33.  Add a Note HereParagraph (d)(4)(iii)(A)(4). A reusable sharps container system for disposable sharps will be acceptable if it does not expose employees to the risk of percutaneous injury. No system involving the manual opening, emptying, or cleaning of the containers will be allowed. The only acceptable system is a fully automated container cleaning system that eliminates employee exposure to sharps.
34.  Add a Note HereParagraph (d)(4)(iii)(B). While this paragraph requires that regulated waste containers be closable, simply being closed does not ensure that waste will be contained. Waste-containing bags may break and spill their contents, including liquid blood, while, for example, being loaded onto incinerator hoppers, thus contaminating both the employees and the work area. Also, small medical offices which generate only a small volume of regulated waste may place that waste in a large holding container until the container is filled. In such a case, the design of the container must be such that it is able to retain the waste over an extended period of time between pickups by a specialized waste service. The Compliance Officer should, therefore, check for visual signs of leakage of fluids during handling, storage, transport, or shipping.
Add a Note HereAny failures to comply with the container construction requirements would be cited under this paragraph. If the compliance officer determines that the employee was not properly trained to recognize the problem or use the containers correctly, a citation for the appropriate paragraph of paragraph (g)(2) should be grouped with violations of paragraph (d).
35.  Add a Note HereParagraphs (d)(4)(iii)(B)(1)(iii) and (2)(iii). Regulated waste containers are required to be labeled with the biohazard symbol or color-coded to warn employees who may have contact with the containers of the potential hazard posed by their contents.
Add a Note HereEven if a facility considers all of its waste to be regulated waste, the waste containers must still bear the required label or color-coding in order to protect new employees, employees who would not normally come into contact with wastes, and employees from outside the facility. This requirement is in contrast to the labeling alternative allowed when laundries use universal precautions for the handling of all soiled laundry.
Add a Note HereRegulated waste that has been decontaminated need not be labeled or color-coded. The compliance officer in such a case should verify that the employer’s exposure control plan states the decontamination procedures to be followed. In order to ensure that the decontamination process is successful, the employer must monitor factors such as the content, volume, density, configuration, and organic content of the load of waste. The temperature needed for incineration is sufficient to decontaminate regulated waste. Autoclave efficiency can be verified by means of biological or chemical indicators. While most disposal bags used will contain an indicative color strip, if this is not the case a review may be made of the documentation kept for the sterilizer. Such documentation should include (1) date, time, and operator of each run, (2) type and approximate amount of waste tracked, (3) post-treatment reading of temperature-sensitive tape, (4) dates and results of calibration of the sterilizer, and (5) results of routine spore testing. Although these paragraphs contain label requirements, failure to label can also be cited under paragraph (g)(1)(i).
36.  Add a Note HereParagraph (d)(4)(iii)(B)(2). A second container is required to be used when outside contamination of the first waste container occurs. This provision does not require routine double-bagging but rather requires double-bagging in such circumstances as a waste container being splashed with blood during surgery or autopsy, when a container has been handled by an employee with bloody gloves, or when a waste bag leaks blood or OPIM onto an adjacent bag.
37.  Add a Note HereParagraph (d)(4)(iv). This paragraph reduces employee exposure to bloodborne pathogens by reducing the amount of manual handling of contaminated laundry. Restricting the sorting to the laundry area will also reduce contamination of additional surfaces.
Add a Note HereInspection and citation guidelines: Paragraphs (d)(4)(iv)(A) and (A)(1) limit the handling of laundry to removal and bagging or containerization. The compliance officer should check the laundry collection program as well as the training of the employees assigned to these tasks.
38.  Add a Note HereParagraph (d)(4)(iv)(A)(2). The employer has been given the choice, by this paragraph, to either: label or color-code according to paragraph (g)(1)(i), or to utilize universal precautions in the handling of all soiled (i.e., used) laundry.
Add a Note HereIf universal precautions are used for handling all soiled laundry, the employer may use an alternative color or label for the bags/containers, as long as all employees are trained to recognize them as containing soiled laundry which requires the use of universal precautions.
Add a Note HereTraining violations would be cited under the appropriate paragraph of (g)(2)(vii).
39.  Add a Note HereParagraph (d)(4)(iv)(A)(3). The material for the bags or containers used in laundry collection must prevent soak-through or leakage of fluids to the exterior, if the contaminated laundry is wet and presents a reasonable likelihood of soak-through or leakage. Not all contaminated laundry must be placed in such bags or containers; only laundry wet enough to leak or soak through and expose workers handling the bags/containers to blood or OPIM, or contaminate other surfaces should be considered contaminated laundry.
40.  Add a Note HereParagraph (d)(4)(iv)(B). Employees having direct contact with contaminated laundry must wear protective gloves (e.g., utility gloves) and any other appropriate personal protective equipment, in order to prevent or reduce contact exposure to blood or OPIM. Any other personal protective equipment required must be determined on a case-by-case basis. Gowns, aprons, eyewear, and masks may be necessary to prevent employee exposure.
41.  Add a Note HereParagraph (d)(4)(iv)(C). The employer generating the laundry must have determined if the facility to which it is shipped utilizes universal precautions in the handling of all laundry. If not, all bags or containers of contaminated laundry must be labeled or color-coded in accordance with paragraph (g)(1)(i). In this instance, if the employer generating the laundry chooses to color-code rather than label, the color of the bag must be red.
Add a Note HereInspection and citation guidelines: The Compliance Officer should check the employer’s program to determine if laundry is shipped to another facility for cleaning and should evaluate the methods used to ship contaminated laundry (CL) to a facility that does not utilize universal precautions in the handling of all soiled laundry.
Add a Note HereThe following are unacceptable shipment methods and constitute violations of this paragraph:
§  Add a Note HereThe CL is not shipped labeled or in a red bag, paragraph (d)(4)(iv)(C) would be cited and grouped with the applicable subparagraph of paragraph (g)(1)(i);
§  Add a Note HereThe CL is shipped with an improper label, paragraph (d)(4)(iv)(C) would be cited and grouped with the applicable subparagraphs of paragraphs (g)(1)(i) (B), (C) and/or (D);
§  Add a Note HereThe CL is shipped in a bag color-coded for in-house use (in a color other than red), paragraph (d)(4)(iv)(C) would be cited and grouped with citations for paragraph (g)(1)(i)(E).
Add a Note HereCDC has published Guidelines for Laundry in Health Care Facilities. Current recommendations for the laundering of contaminated linen stipulate only that normal laundering methods be used according to the manufacturer’s recommendations.

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