Health Hazard Evaluation Report 2013-0019-3205 Page 1

Evaluation of Chemotherapy Drug Exposure 

in an Outpatient Infusion Center 

Christine West, RN, MSN/MPH, COHN-S

Catherine Beaucham, MPH, CIH 

Report No. 2013-0019-3205

March 2014

U.S. Department of Health and Human Services

Centers for Disease Control and Prevention

National Institute for Occupational Safety and Health
Page 2 Health Hazard Evaluation Report 2013-0019-3205

Contents

Highlights...............................................i

Abbreviations ..................................... iii

Introduction......................................... 1

Methods ............................................... 1

Results and Discussion........................ 3

Conclusions.......................................... 9

Recommendations............................... 9

Appendix A ........................................ 12

Appendix B......................................... 14

References.......................................... 17

The employer is required to post a copy of this report for 30 days at or near the 

workplace(s) of affected employees. The employer must take steps to ensure 

that the posted report is not altered, defaced, or covered by other material.

The cover photo is a close-up image of sorbent tubes, which are used by the HHE 

Program to measure airborne exposures. This photo is an artistic representation that may 

not be related to this Health Hazard Evaluation. Photo by NIOSH.
Health Hazard Evaluation Report 2013-0019-3205 Page i

We evaluated employee 

exposure to chemotherapy 

drugs at an outpatient infusion 

center. We found low levels 

of surface contamination of 

platinum throughout the 

workplace. Handling platinumcontaining compounds 

is the likely source of this 

contamination. Although we 

cannot definitively link all of 

the reported symptoms to 

chemotherapy drug exposures, 

many were consistent with 

those reported in the literature. 

Employees inconsistently used 

personal protective equipment. 

We recommended employees 

use chemotherapy gowns 

and gloves when handling 

chemotherapy drugs, and the 

company implement a medical 

surveillance program for 

employees potentially exposed 

to chemotherapy drugs.

Highlights of this Evaluation

The Health Hazard Evaluation Program received a request from a regional hospital. The 

employer was concerned about possible adverse health effects in employees from handling 

chemotherapy drugs in the outpatient cancer and infusion center.

What We Did

● We visited the infusion center in June 2013.

● We observed how employees received, stored, 

administered, and disposed chemotherapy 

drugs. 

● We talked to employees about their work and 

health concerns.

● We took samples from work surfaces to look 

for several chemotherapy drugs. 

● We evaluated the airflow direction in the 

infusion center and isolator cabinet.

● We reviewed the employer’s workplace injury 

and illness logs and employee health records. 

● We reviewed environmental sampling and 

inspection reports, training documents, and 

standard operating procedures for handling 

hazardous drugs in the infusion center.

What We Found

● Some work surfaces had chemotherapy drugs 

on them.

● Many employees reported that previous 

symptoms had resolved.

● Employees reported inconsistent use of 

personal protective equipment. 

● Procedures for handling hazardous drugs did 

not apply to all personnel who are exposed to 

chemotherapy drugs.

● Procedures for proper storage, routine 

housekeeping, medical surveillance, and the hazardous drug list were incomplete. 

● Air from the pharmacy was not being drawn into the pass-through chamber on the 

isolator cabinet, as employees believed.
Page ii Health Hazard Evaluation Report 2013-0019-3205

What the Employer Can Do

● Require employees to wear chemotherapy gowns and gloves whenever handling 

chemotherapy drugs.

● Advise employees to wear safety goggles rather than prescription glasses when 

cleaning up a drug spill or when chemotherapy drugs might splash.

● Ensure employees who receive the chemotherapy drug shipments are aware of the 

potential for contamination of outer surfaces of drug containers and protect themselves. 

● Start a medical surveillance program for employees who handle chemotherapy drugs.

● Train all employees about the short and long-term health effects of chemotherapy drug 

exposures.

● Update procedures for handling hazardous drugs safely.

● Encourage employees to report work-related illnesses to hospital occupational health 

and safety representatives as soon as possible. 

● Ensure there is employee participation on the infusion center safety committee. 

● Adjust the isolation cabinet height to fit employees.

What Employees Can Do

● Wear all required personal protective equipment when handling chemotherapy drugs.

● Report any workplace health concerns to the employer.
Health Hazard Evaluation Report 2013-0019-3205 Page iii

Abbreviations

μg Microgram

μL Microliter

ACGIH® American Conference of Governmental Industrial Hygienists

ANSI American National Standards Institute

cm2 Centimeter squared

CETA Controlled Environment Testing Association

CFR Code of Federal Regulations

HEPA High efficiency particulate air

HVAC Heating, ventilation, and air-conditioning

IARC International Agency for Research on Cancer

ng Nanogram

NIOSH National Institute for Occupational Safety and Health

OEL Occupational exposure limit

OSHA Occupational Safety and Health Administration

TLV® Threshold limit value

TWA Time-weighted average

WEEL Workplace environmental exposure levels
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Health Hazard Evaluation Report 2013-0019-3205 Page 1

Introduction 

The Health Hazard Evaluation Program received a request from a regional hospital. The 

employer was concerned about health symptoms (burning and itchy eyes, itchy skin, hair 

loss, and metallic taste in the mouth) among outpatient cancer and infusion center (referred 

to in this report as infusion center) employees potentially associated with chemotherapy 

drug exposure in the workplace. We visited the infusion center in June 2013 and shared 

our preliminary findings, observations, and recommendations with employer and employee 

representatives.

The infusion center opened in 2009 in a separate building approximately 1,500 feet from the 

hospital. The center employed 10 clinical and administrative staff and provided outpatient 

treatment to approximately 4 patients per day during the time of our visit which is the typical 

number of patients treated at this clinic.

Methods

Our main objectives of the evaluation were to assess whether (1) the infusion center’s work 

surfaces were contaminated by chemotherapy drugs; (2) the cabinet used to compound 

chemotherapy drugs was operating as designed; (3) employee symptom reports could 

be related to chemotherapy drug exposure; and (4) procedures were adequate to protect 

employees from chemotherapy drug exposures. 

Surface Wipe Samples

We collected surface wipe samples for platinum-containing drugs (cisplatin, carboplatin, 

oxaliplatin), gemcitabine, irinotecan, cyclophosphamide, and 5-fluorouracil (Table 1). We 

selected these drugs on the basis of (1) frequency of use in the infusion center, (2) presence 

on the National Institute for Occupational Safety and Health (NIOSH) hazardous drug list, 

and (3) availability of a sampling and analytical method. We selected wipe sample locations 

based on findings from previous health hazard evaluations and other research [Connor 

and McDiarmid 2006; NIOSH 2012b] and where employees could touch with non-gloved 

hands. We evaluated these surfaces before, during, and after drug administration. For each 

sample, we wore a clean pair of chemotherapy protective gloves and used a new 100 square 

centimeter (cm2

) disposable template to determine the sampling area. We wiped the area 

twice, once with the first texwipe, texwipe swab, or Whatman filter, and then again with a 

second wipe as described in Connor et al. 2010.

Compounding Aseptic Containment Isolator Cabinet and 

General Ventilation Evaluation

We used a TSI Model 8386 VelociCalc®Plus Multi-Parameter Ventilation Meter for all 

ventilation measurements. We evaluated the direction of airflow between the pharmacy and 

the hallway, the infusion room and the hallway, and the hazardous waste storage room and 

the hallway to see if there was a potential for contaminated air to spread to other areas of the 
Page 2 Health Hazard Evaluation Report 2013-0019-3205

Table 1. Sampling and analytical methods for chemotherapeutic agents in surface samples 

Chemotherapeutic Surface wipe/ Surface Analysis method/detection limits

agent wetting agent area 

sampled

Cisplatin Two Alpha® 100 cm2 •	 Inductively coupled plasma/mass 

Carboplatin texwipes, or two 

Alpha texwipe 

spectrometry (Bureau Veritas 

North America)

Oxaliplatin

(all as platinum)

swabs moistened 

with 250 microliters 

(μL) deionized water

•	 Limit of detection = 

0.0009 micrograms (μg) platinum 

(swabs); 

0.003 μg platinum (wipes)

•	 Limit of quantitation = 

0.0029 μg platinum (swabs); 

0.01 μg platinum (wipes)

Gemcitabine

5-Fluorouracil

Irinotecan

Cyclophosphamide 

Two 42 millimeter 

diameter 

Whatman® filters 

moistened with 

250 μL of a 

50% acetonitrile/ 

50% methanol 

solution

100 cm2 •	

•	

Liquid chromatography/mass spectrometry/mass spectrometry (Bureau 

Veritas North America)

A formal limit of detection/limit of 

quantitation study was not performed; 

10 nanograms (ng) per sample of each 

drug were used as a low calibration 

standard. Results are semi-quantitative 

infusion center. We also evaluated the direction and velocity of airflow in the isolator cabinet 

used for mixing chemotherapy drugs. In addition, we reviewed a hospital consultant’s report 

of an isolator cabinet evaluation. 

Employee Interviews, Injury/Illness Logs, and Medical Records

We interviewed nine of 10 employees who worked in the infusion center. During these 

health interviews, we asked about work history, handling of chemotherapy drugs, acute 

and chronic health symptoms, personal cancer history, reproductive health history, use of 

personal protective equipment, and workplace health and safety training. We reviewed the 

Occupational Safety and Health Administration (OSHA) Form 300 Log of Work-Related 

Injuries and Illnesses for years 2008–2012. We reviewed employee records from medical 

evaluations performed by a physician contracted by the hospital’s employee health program 

in October 2012 to evaluate employee health concerns. The medical evaluations included 

physical exams, health histories, urinalyses, blood tests for liver and thyroid function, and 

complete blood counts, including the percentage of each type of white blood cell. 

Review of Hazardous Drug Procedures

We reviewed the infusion center’s standard operating procedures for handling hazardous 

drugs, list of hazardous drugs at the infusion center, isolator cabinet use policies, isolator 

cabinet inspection reports, and list of personal protective equipment required by job title.
Health Hazard Evaluation Report 2013-0019-3205 Page 3

Results and Discussion

Observations 

During our visit, a drug distributor shipped small boxes containing chemotherapy drugs to 

the hospital’s main receiving area. These shipments occurred approximately 3 days a week. 

The infusion center’s pharmacist picked up the drugs and transported them in a personal 

vehicle to the infusion center. The pharmacist unpacked the drugs in the infusion center and 

stored them in a locked Omnicell® cabinet in a room designed for preparing chemotherapy 

drug infusions. The pharmacist compounded the drugs in a compounding aseptic containment 

isolator cabinet designed for compounding sterile hazardous drug preparations (Figure 1). The 

isolator cabinet had a high efficiency particulate air (HEPA) filter air supply and exhausted 

100% of the captured air to the outdoors through a second HEPA filter. Employees reported 

that the pass-through chamber was under negative pressure and that air flowed in from the 

surrounding pharmacy.

Figure 1. Compounding aseptic containment isolator cabinet. 

Photo by NIOSH.

All employees in the infusion center who handled chemotherapy drugs were required to 

wear two pairs of chemotherapy protective gloves (double gloving). We observed some 

employees voluntarily wearing safety glasses to prevent eye contact with the chemotherapy 

drug in the event of a splash. Upon patient arrival, the pharmacist verified the dose and 

delivered the required drug to the nurse to administer in the treatment area. After verifying 

the chemotherapy drug treatment with the patient’s medical record, the nurse administered 

the drug. This was done through a closed system with a needleless intravenous syringe or bag 

with tubing primed with a saline solution. The time it took to administer the chemotherapy 

drugs varied from minutes to hours depending on the treatment protocol. After completing 

the chemotherapy treatment, the nurse removed the intravenous line from the patient and 

disposed of all the chemotherapy drug-contaminated materials into a chemotherapy waste 

container. The nurse then removed both pairs of chemotherapy protective gloves, placed 
Page 4 Health Hazard Evaluation Report 2013-0019-3205

them into the chemotherapy waste container, and washed his or her hands after removing the 

gloves. We observed no food or beverage consumption in the pharmacy or treatment area. We 

observed employees storing and preparing food, and eating in a break area away from where 

employees handled chemotherapy drugs.

Surface Wipe Samples

Appendix A, Tables A1 and A2 contain detailed surface wipe sample results. We detected 

platinum in 4 of the 50 surface wipe samples and gemcitabine, irinotecan, cyclophosphamide, 

and/or 5-fluorouracil in 18 samples. Of the detectable platinum results, levels ranged from 

0.005–0.63 μg/100 cm2

. We measured the highest platinum level (0.63 μg/100 cm2) inside 

the storage cabinet where vials were stored prior to compounding. A sample collected in the 

pharmacy in front of a computer touch screen used to track quantity and create vial labels 

contained detectable levels of all four of the other chemotherapy drugs: 1 ng/100 cm2

 of 

irinotecan, 2 ng/100 cm2

 cyclophosphamide, 50 ng/100 cm2 5-fluorouracil, and 140 ng/100 

cm2

 gemcitabine. The highest level of 5-fluorouracil (690 ng/cm2) was found in the sample 

from the isolator cabinet pass-through after 5-florouracil was used. We measured the highest 

level of gemcitabine (600 ng/100 cm2

) in front of the pharmacist’s computer keyboard. Other 

locations that had detectable levels of chemotherapy drugs included the inner doorknob of the 

pharmacy, inside a vehicle used to transport chemotherapy drugs, the pharmacy counter left 

of the sink where intravenous bags were stored prior to carrying them to the infusion room, in 

the bin where chemotherapy drugs were stored prior to administration in the infusion room, 

and inside the isolator cabinet’s gloves. We also found detectable levels of chemotherapy 

drugs on the outside of drug vials including 430 ng/100 cm2

 of 5-fluorouracil on the outside 

of the never opened 5-fluorouracil vial, and on the shelves where the vials were stored. The 

drug transport boxes did not test positive for chemotherapy drugs. 

Although surface wipe samples detected the presence of platinum, likely from platinum 

containing chemotherapy drugs, and cyclophosphamide on some surfaces inside the infusion 

center, these contaminants were present in relatively low levels when compared to other 

NIOSH evaluations in similar environments [NIOSH 2012b,c]. The infusion center did not 

administer cyclophosphamide during our visit, yet it was detected in surface wipe samples. 

This suggests that cyclophosphamide was stable in the environment and that housekeeping 

procedures were not effectively removing this chemotherapy drug. We saw similar results 

in a previous evaluation at an oncology clinic. In that evaluation, the surface samples for 

cyclophosphamide remained positive for 3 days, even after housekeeping staff cleaned 

the surfaces [NIOSH 2012b]. Currently no occupational exposure limits (OELs) exist for 

chemotherapy drugs on surfaces or in the air. However, considering the carcinogenicity of 

these chemotherapy drugs [IARC 2004], precautions to eliminate or minimize exposures are 

appropriate. 

Housekeeping

Although we did not observe housekeeping procedures, the employer reported that cleaning 

was conducted “in house” by hospital employees throughout the day as needed and after 
Health Hazard Evaluation Report 2013-0019-3205 Page 5

hours. The hospital did not have a specific procedure for housekeeping services in the 

infusion center but it was reported that cleaning staff wore gloves. 

The infusion center managers did not give employees formal guidance on avoiding takehome contamination with chemotherapy drugs. Shoe bottoms may carry traces of drugs that 

can be tracked outside the infusion center. If employees follow proper procedures while 

working, it is unlikely they will carry the drugs home. However, items such as the totes 

used to transport chemotherapy drugs between the main hospital and the infusion center 

could become contaminated and potentially contaminate areas outside of the pharmacy and 

treatment stations such as personal cars.

Review of Hazardous Drug Handling Procedures and 

Ventilation Evaluation Reports

The facility’s standard operating procedures for handling hazardous drugs provided adequate 

guidance to pharmacy and nursing personnel on safe techniques in preparing, administering, 

and disposing of hazardous drugs as well as managing chemotherapy drug spills. The 

standard operating procedures, however, did not apply to other hospital employees with the 

potential for exposure, such as shipping and receiving personnel, custodial workers, laundry 

workers, and waste handlers. The standard operating procedures for the pharmacist and 

pharmacy technicians included guidance on the use of chemotherapy gloves and gowns when 

handling chemotherapy drugs; however, we observed that employees did not always follow 

this guidance. We found no information about proper storage, routine housekeeping, or 

medical surveillance for employees exposed to hazardous drugs. The hazardous drug list was 

incomplete. It included drugs and items that are not hazardous such as plastic bags and did 

not contain criteria for determining whether a drug is hazardous. 

The isolator cabinet inspection testing was last performed in September 2012 (within 1 

year of our evaluation) in accordance with the Controlled Environment Testing Association 

(CETA) Compounding Isolator Testing Guide CAG-002-2006, a consensus document of 

minimum testing criteria appropriate for all compounding isolators. The report found that 

the airflow in the main chamber was within acceptable limits; however, the consultant did 

not evaluate airflow in the pass-through chamber. We determined the air velocity inside the 

pass-through to the main chamber of the isolator cabinet to be 10 to 30 feet per minute in this 

location, which was similar to ambient air movement outside the chamber and was not under 

negative pressure. The report also found that the exhaust duct static pressure was within 

appropriate limits. The consultant collected a particle count and performed a smoke pattern 

test in the main chamber and pass-through chamber; both met the recommended guidelines. 

Recommendations from the report included storing the hazardous drugs separately from 

nonhazardous drugs and verifying negative pressurization of the pharmacy. 

We reviewed a consultant’s October 2012 report of indoor air quality testing for radon, 

aldehydes, organic vapors, spore trap analysis, carbon dioxide, and carbon monoxide. The 

report also contained platinum and fluorouracil analysis of the filters from the air filtration 

units. The consultant concluded that airborne contaminant levels were “below the most 
Page 6 Health Hazard Evaluation Report 2013-0019-3205

protective regulatory and nuisance levels.” They recommended increasing the number of 

indoor air changes to improve the overall indoor air quality in the infusion center.

General Ventilation Evaluation

We used the VelociCalc® to evaluate the direction of airflow between the rooms; we found 

that air flowed as designed according to ANSI/ASHRAE/ASHE Standard 170-2013. We 

did not collect indoor relative humidity or temperature measurements; however, 50% of 

interviewed employees commented on the variable nature of the heating, ventilation, and 

air-conditioning (HVAC) system. In the United States, ASHRAE and American National 

Standards Institute (ANSI) recommend maintaining indoor relative humidity below 60% 

and temperatures between 70°F–75°F [ANSI/ASHRAE/ASHE 2013; ASHRAE 2013] for 

chemotherapy infusion rooms. ASHRAE guidelines provide specific details on ventilation 

system design for hospitals and clinics [ASHRAE 2013]. ANSI/ASHRAE Standard 170-

2013: Ventilation of Health Care Facilities specifies controlling indoor relative humidity and 

temperature is an important factor in comfort in an occupational environment. ASHRAE 

states, “Acceptable air quality is defined as air in which there are no known contaminants at 

harmful concentrations as determined by cognizant authorities and with which a substantial 

majority (80% or more) of exposed employees do not express dissatisfaction [ANSI/

ASHRAE 2010].”

Employee Interviews, Injury/Illness Logs, and Health Records 

We interviewed nine out of 10 employees, including administrative and clinical personnel, 

working in the infusion center. The average length of employment at the infusion center was 

7 years. Five infusion center staff reported handling chemotherapy drugs; of these employees, 

three reported eye and nose irritation, or headache that improved on their days off work, and 

a metallic taste while at work. 

None of the interviewed employees reported any chronic conditions that have been found in 

the scientific literature to be associated with exposure to chemotherapy drugs. Employees 

reported receiving adequate training about the safe preparation, administration, and disposal 

of chemotherapy drugs. A few employees reported they did not receive enough training on 

the potential occupational health risks of handling chemotherapy drugs. Employees reported 

consistently double gloving with chemotherapy gloves and wearing disposable gowns when 

preparing or administering chemotherapy drugs. Most employees reported they thought the 

gowns were protective against chemotherapy drugs. A few employees reported they would 

wear safety goggles and disposable booties in the event of a chemotherapy drug spill but 

were unclear about what other occasions, such as drug splashes, would warrant use of safety 

goggles and disposable booties. 

Regarding comfort issues unrelated to chemotherapy administration, employees 

reported fluctuating temperature changes throughout the day. Employees reported being 

uncomfortably warm when wearing personal protective equipment (gowns, gloves) when 

room temperatures were high. 
Health Hazard Evaluation Report 2013-0019-3205 Page 7

No entries on the OSHA Logs of injuries or illnesses were recorded for infusion center 

employees. There was no medical surveillance program for those handling chemotherapeutic 

drugs. We reviewed employee health records from the medical evaluations and laboratory 

testing done in October 2012. All nine employees in the infusion center were asked by 

management to participate in these evaluations. Most physical exam findings and laboratory 

tests were within normal limits, but four out of the nine employees reported mucous 

membrane irritation, nausea, metallic taste, and tiredness intermittently in the past year while 

at work. One employee had a borderline low white blood cell count. We also obtained records 

of white blood cell counts from tests performed in 2009, 2011, and 2013 for this employee. 

All results fell below the normal range for the testing laboratory except for a result in 2013, 

which showed white blood cell counts within the reference range. The examiner did not 

make a determination if the symptoms reported by employees or the abnormal lab result were 

related to exposures at work. Employees received their individual exam results in writing. 

Aside from upper respiratory symptoms and metallic taste, the symptoms reported during the 

October 2012 examinations were not reported to us in June 2013. 

The routes of exposure to chemotherapy drugs in healthcare settings are primarily inhalation 

and dermal, though ingestion could occur from contaminated surfaces and hand-to-mouth 

contact, as well as unintentional injection through a needle-stick or sharps injury. Inhalation 

exposure may occur from airborne droplets, vapors, or dust from tasks such as crushing 

tablets. We observed the risk of inhalational exposure to be low. Dermal exposure may occur 

when employees touch contaminated surfaces, and oral exposure may occur from hand-tomouth transmission. Dermal exposure for most employees in the infusion center appeared 

to be minimal because of their use of gloves, including chemotherapy gloves. However, 

the potential for dermal exposure was greater in the pharmacy and receiving area where 

chemotherapy drugs were handled; here we found evidence of surface contamination and 

observed less consistent use of chemotherapy gloves. 

Studies have documented adverse health effects such as nausea, headaches, vomiting, upper 

airway irritation, skin rash, hair loss, and dizziness in oncology staff handling chemotherapy 

drugs [McDiarmid and Egan 1988; Valanis et al. 1993; Krstev et al. 2003]. In addition 

to acute adverse effects, the literature has indicated an association of chemotherapy drug 

exposure in health care staff who work in oncology settings with the following long-term 

adverse effects: adverse reproductive health outcomes, genetic damage, and cancer [Skov 

et al. 1992; Valanis et al. 1999; Ratner et al. 2010; McDiarmid et al. 2014]. The overall 

health risk from hazardous drugs depends on toxicity of the drug, how much exposure 

an employee has to these drugs, and individual variation [NIOSH 2004]. Much of the 

literature documents these associations with symptoms in health care workers who handle 

chemotherapy drugs based on exposure group or job task but individual drugs were typically 

not identified. Although the literature is unclear in specifically associating the symptoms of 

upper respiratory symptoms and headache reported by employees with the drugs we found 

in surface wipe samples, these drugs are considered hazardous as listed in the 2012 NIOSH 

List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings [NIOSH 2012a]. In 

order to minimize potential acute or long term health effects, it is recommended to prevent or 

reduce inadvertent exposure to these drugs as much as feasible [NIOSH 2004]. 
Page 8 Health Hazard Evaluation Report 2013-0019-3205

Metallic taste and other taste changes have been documented in patients who receive 

treatment with chemotherapy drugs such as 5-fluorouracil, cisplatin, carboplatin, 

cyclophosamide, and methotrexate [Wickham et al. 1999]. Oncology staff have also been 

noted to report metallic taste changes when working with chemotherapy drugs [Connor 

2013]. Pharmaceutical testing has shown that contact between small amounts of bitter active 

pharmaceutical ingredients and taste buds can result in metallic taste sensations [Gittings 

et al. 2014]. Given the presence of metal-containing hazardous drugs in the infusion center, 

staff reports of metallic taste may have been related to exposure to chemotherapy drugs in 

the infusion center. However, metallic taste or other change in taste perception is a symptom 

that is subject to inter-individual variation; its presence is difficult to validate and may not 

necessarily be associated with adverse health effects [Cowart 2011]. 

In our review of the laboratory reports from employees of the infusion center, there were 

laboratory values that showed borderline low white blood cell counts among one employee. 

Upon repeat testing, the values returned to within the normal range for the laboratory. With 

borderline abnormal laboratory values on one employee, we are unable to speculate on the 

cause of this result. Altered (decreased and or elevated) white blood cell counts have been 

documented as an effect in patients who received oral or intravenous chemotherapy drugs as a 

treatment for cancer [Yang et al. 2012]. One study of hematologic changes in oncology nurses 

who handle chemotherapy drugs did not find a statistically significant decrease in white blood 

cell count [Jochimsen et al. 1988]. No other evidence of altered white blood cell count from 

occupational exposure was found in the published scientific literature for employees handling 

chemotherapy drugs [Harrison 2001; Heron and Pickering 2003; Dranitsaris et al. 2005; Martin 

2005; Connor et al. 2010; Fransman et al. 2014; McDiarmid et al. 2014] including those 

chemotherapy drugs used in this facility. Many factors can cause abnormal white blood cell 

counts, such as viral infections, certain medications, and vitamin deficiencies, and some healthy 

individuals have mild neutropenia (a low white blood cell count). 

Routine or annual complete blood count testing is not currently recommended for employees 

handling chemotherapy agents [NIOSH 2013b]. This testing is only recommended for 

employees who have an acute exposure, such as a chemotherapy drug spill or needle 

stick injury [ONS 2011]. However, a medical surveillance program should be created for 

employees who handle hazardous materials and are therefore at risk of adverse health 

effects from exposure. Medical surveillance involves collecting and interpreting data to 

detect changes in the health status of working populations potentially exposed to hazardous 

substances. The elements of a medical surveillance program are used to establish an 

initial baseline of workers’ health and then monitor their future health as it relates to their 

potential exposure to hazardous agents. Early identification of health problems can lead to 

the recognition of deficiencies in exposure controls and can also benefit individual workers 

[NIOSH 2013b]. 

Because many employees we spoke with had concerns about thermal discomfort and 

other indoor environmental quality issues, it is important to mention that poor indoor 

environmental quality has been associated with the types of upper respiratory symptoms 

reported to us. Studies have attributed these symptoms to problems with building airflow 
Health Hazard Evaluation Report 2013-0019-3205 Page 9

and temperature as well as the presence of low levels of chemicals from office furnishings, 

office machines, cleaning products, personal hygiene products, and the building’s structural 

components [EPA 2012]. We did not evaluate these factors. 

Conclusions

We found low but detectable levels of chemotherapy drugs in surface wipe samples 

collected throughout the infusion center. This contamination included platinum-containing 

drugs (cisplatin, oxaliplatin, and carboplatin), gemcitabine, irinotecan, cyclophosphamide, 

and 5-fluorouracil in various areas around the pharmacy and infusion room. We detected 

cyclophosphamide even though it was not in use during our visit. Based on our review of 

available evidence and existing guidance, we do not recommend routine complete blood 

count tests for employees other than for acute exposure follow-up. Although we cannot 

definitively link the reported symptoms to chemotherapy drug exposures many symptoms 

were consistent with those reported in the scientific literature. Because chemotherapy drugs 

are hazardous, protective measures and controls should be followed to minimize the health 

risk to employees. 

Recommendations

On the basis of our findings, we recommend the actions listed below. Use the existing 

regional hospital labor-management health and safety committee, with employee/

management representation from the infusion center, to discuss our recommendations and 

develop an action plan. 

Our recommendations are based on an approach known as the hierarchy of controls 

(Appendix B). This approach groups actions by their likely effectiveness in reducing or 

removing hazards. In most cases, the preferred approach is to eliminate hazardous materials 

or processes and install engineering controls to reduce exposure or shield employees. Until 

such controls are in place, or if they are not effective or feasible, administrative measures and 

personal protective equipment may be needed. 

Engineering Controls

Engineering controls reduce employees’ exposures by removing the hazard from the process or by 

placing a barrier between the hazard and the employee. Engineering controls protect employees 

effectively without placing primary responsibility of implementation on the employee. 

1. Evaluate the HVAC system and make changes necessary to attain the ANSI/ASHRAE/

ASHE standard 170-2013 indoor relative humidity and temperature levels for 

healthcare facilities [ANSI/ASHRAE/ASHE 2013; ASHRAE 2013].

2. Contact the manufacturer of the isolator cabinet and clarify the design specifications for 

the pass-through chamber. Examine the airflow of the isolator cabinet’s pass-through 

chamber and ensure it is operating as designed. 
Page 10 Health Hazard Evaluation Report 2013-0019-3205

3. Make the isolator cabinet adjustable to employee’s shoulder height to prevent upper 

extremity discomfort for the primary user and improve visibility inside the isolator cabinet.

Administrative Controls

The term administrative controls refers to employer-dictated work practices and policies 

to reduce or prevent hazardous exposures. Their effectiveness depends on employer 

commitment and employee acceptance. Regular monitoring and reinforcement are necessary 

to ensure that policies and procedures are followed consistently.

1. Train staff who may be exposed to chemotherapy drugs about safe handling techniques 

and about the potential health effects associated with exposure to chemotherapy drugs. 

2. Implement a medical surveillance program for staff who directly handle chemotherapy 

drugs. Use the information obtained through medical surveillance to help affected 

workers and to identify and correct any system failures that may have resulted in 

harmful exposures. More information about specific elements of the program can 

be found in the NIOSH Workplace Solutions document, “Medical Surveillance for 

Healthcare Workers Exposed to Hazardous Drugs” at http://www.cdc.gov/niosh/docs/

wp-solutions/2013-103/ [NIOSH 2013b] and OSHA Technical Manual on “Controlling 

Occupational Exposure to Hazardous Drugs” at https://www.osha.gov/dts/osta/otm/

otm_vi/otm_vi_2.html [OSHA 1999].

3. Wash hands after removal of gloves used to handle chemotherapy drugs.

4. Discontinue the use of personal vehicles to transport hazardous drugs from the main 

hospital to the infusion center. 

5. Use a tote specific to chemotherapy drugs to transport them to the infusion center from 

the hospital. Clean it thoroughly after each use.

6. Ensure employees who receive chemotherapy drug shipments are aware of the 

potential for contamination of outer surfaces of drug containers and of precautions for 

protecting themselves.

7. Include the employees who receive shipments of chemotherapy drugs in hazard 

communication training and revise the policy and procedures for handling hazardous 

drugs to include all employees who may have contact with chemotherapy drugs.

8. Update the hazardous drug list and make it available to the employees. The OSHA 

hazard communication standard [29 CFR 1910.1200] requires employers to develop 

a hazard communication program appropriate for their workplace. An essential part 

of the program is the identification of all hazardous chemicals an employee may be 

exposed to in the facility. Drug manufacturers and importers are required to evaluate 

the hazards of the chemicals they produce or import and prepare labels and safety data 

sheets to convey the hazard information. The employers are required to (1) determine if 

these drugs meet one or more of the criteria defining hazardous drugs; (2) maintain an 

inventory of hazardous drugs; and (3) provide information and training to all employees 

potentially exposed. NIOSH provides additional guidance on how to develop your own 

list of hazardous drugs http://www.cdc.gov/niosh/docs/2012-150/pdfs/2012-150.pdf

[NIOSH 2012a].
Health Hazard Evaluation Report 2013-0019-3205 Page 11

9. Develop a standard operating procedure for housekeeping. Good housekeeping 

procedures include: (1) cleaning work surfaces with an appropriate deactivation 

agent (if available) and cleaning agent before and after each activity and at the end 

of each work shift; (2) wearing two pairs of protective gloves and disposable gown 

if an employee must handle linens, feces, or urine from patients who have received 

hazardous drugs within the last 48 hours; (3) disposing of the gown after each use or 

whenever it becomes contaminated; (4) wearing face shields if splashing is possible; 

(5) removing the outer gloves and the gown by turning them inside out and placing 

them into the yellow chemotherapy waste container, repeating the procedure for the 

inner gloves; and (6) washing hands with soap and water after removing the gloves 

[NIOSH 2004].

Personal Protective Equipment

Personal protective equipment is the least effective means for controlling hazardous 

exposures. Proper use of personal protective equipment requires a comprehensive program 

and a high level of employee involvement and commitment. The right personal protective 

equipment must be chosen for each hazard. Supporting programs such as training, changeout schedules, and medical assessment may be needed. Personal protective equipment should 

not be the sole method for controlling hazardous exposures. Rather, personal protective 

equipment should be used until effective engineering and administrative controls are in place.

1. Wear chemotherapy gowns and gloves when handling chemotherapy or other hazardous 

drugs. If the gowns and gloves are chemotherapy protective, the box will have a label 

stating “chemotherapy protective.” The gowns should not have seams or closures that 

allow drugs to pass through and should be changed every 2–3 hours if no permeability 

information is available. Gowns made of polyethylene-coated polypropylene or other 

laminate materials offer sufficient protection from chemotherapy or other hazardous 

drugs. Further guidance on personal protective equipment for healthcare workers 

who work with hazardous drugs can be found at http://www.cdc.gov/niosh/docs/wpsolutions/2009-106/ [NIOSH 2009]. 

2. Wear shoe covers to prevent tracking chemotherapy drugs through the infusion center.

3. Instruct all employees, including shipping and receiving personnel, to wear appropriate 

personal protective equipment including chemotherapy gloves when handling 

chemotherapy drugs.
Page 12 Health Hazard Evaluation Report 2013-0019-3205

Table A1. Surface wipe samples for chemotherapy drugs

L

Appendix A: Tables

ocation Platinum 

(μg/100 cm2)

5-fluorouracil

(ng/100 cm2)*

Gemcitabine 

(ng/100 cm2)*

Irinotecan 

(ng/100 cm2)*

Cyclophosphamide 

(ng/100 cm2)*

File/Breakroom

Table 1§ ND ND ND ND ND

Table 2 ND ND ND ND ND

Photocopier ND ND ND ND ND

Pharmacist desk

Front of keyboard ND ND ND ND ND

On keyboard‡ ND ND ND ND ND

Reception area, on 

checkout keyboard‡

ND ND ND ND ND

Hall floor from pharmacy to 

infusion center

Sample 1¶ ND ND ND ND ND

Sample 2 0.052 ND ND ND ND

Infusion room

Nurse station

Keyboard‡ ND ND ND ND ND

Floor ND ND ND ND ND

Computer, pre ND

administration

ND ND ND ND

Exit door knob‡ ND ND ND ND ND

Bin, storing chemotherapy before 

administration

Sample 1 ND ND ND ND ND

Sample 2 ND ND 2† ND 3†

Hazardous waste storage room

Enter doorknob‡ ND ND ND ND ND

Floor by biohazard ND

waste bins

ND 2† ND 1†

Other

Pharmacist car

Passenger seat ND ND ND ND ND

Agent transport 

case

ND 4† 4† ND ND

Steering wheel‡ ND ND ND ND ND

ND = Not detected above the limit of detection (see Table 1 for detection limits) 

*Semiquantitative results

†Uncertainty is associated with these sample concentrations because they were above the detection limit, but 

below the low calibration standard of 10 ng/sample.

‡Estimated surface area of 100 cm2

§Wipe sample used three Whatman filters instead of two

¶Wipe sample taken with Alpha texwipes instead of Whatman filters
Health Hazard Evaluation Report 2013-0019-3205 Page 13

Table A2. Surface wipe samples for chemotherapy drugs in the pharmacy

Location Platinum

(μg/100 cm2)

5-fluorouracil

(ng/100 cm2)*

Gemcitabine

(ng/100 cm2*)

Irinotecan

(ng/100 cm2)*

Cyclophosphamide

(ng/100 cm2)*

Pharmacy

In glovebox gloves‡ ND 110 ND 1† ND

Pharmacy storage cabinet

5-fluorouracil vials ND 430 ND 0.7† ND

5-flourouracil 

boxes‡

ND ND ND ND ND

Before handling platins, storage cabinet 

handle‡

0.0048 ND ND ND ND

In vial storage cabinet 0.63 ND ND ND ND

Surface, agents are 

stored, left of sink

ND 14 4† ND 7†

Exit doorknob‡ ND 4† 4† ND ND

Next to sink, drug 

storage

ND ND ND ND ND

Glovebox handle‡ ND ND ND ND ND

Center, pharmacy 

floor

ND ND ND ND ND

In front of computer, 

before any chemo 

ND 65 600 1† 4†

Pass-through chamber 

deck, before handling 

drugs

Sample 1 ND ND 240 ND 13

Sample 2 0.01 ND ND ND ND

Counter, before any 

chemo by computer

ND ND ND ND ND

Outside oxyplatin 

box‡

ND ND ND ND ND

Vial of oxyplatin‡ 0.004 ND ND ND ND

Pharmacy phone‡ ND ND ND ND ND

Pass-through after 

5-fluorouracil processed

ND 690 76 0.4† 1†

Exit doorknob after

5-fluorouracil‡

ND 14 6† ND ND

In front of touch 

screen

ND 50 140 1† 2†

ND = Not detected above the limit of detection (see Table 1 for detection limits)

*Semiquantitative results

†Uncertainty is associated with these sample concentrations because they were above the detection limit, but 

below the low calibration standard of 10 ng/sample.

‡Estimated surface area of 100 cm2
Page 14 Health Hazard Evaluation Report 2013-0019-3205

Appendix B: Occupational Exposure Limits and 

Health Effects

NIOSH investigators refer to mandatory (legally enforceable) and recommended OELs for 

chemical, physical, and biological agents when evaluating workplace hazards. OELs have 

been developed by federal agencies and safety and health organizations to prevent adverse 

health effects from workplace exposures. Generally, OELs suggest levels of exposure that 

most employees may be exposed to for up to 10 hours per day, 40 hours per week, for a 

working lifetime, without experiencing adverse health effects. However, not all employees 

will be protected if their exposures are maintained below these levels. Some may have 

adverse health effects because of individual susceptibility, a pre-existing medical condition, 

or a hypersensitivity (allergy). In addition, some hazardous substances act in combination 

with other exposures, with the general environment, or with medications or employee’s 

habits to produce adverse health effects. Most OELs address airborne exposures, but some 

substances can be absorbed directly through the skin and mucous membranes.

Most OELs are expressed as a time-weighted average (TWA) exposure. A TWA refers to 

the average exposure during a normal 8- to 10-hour workday. Some chemical substances 

and physical agents have recommended short term exposure limit or ceiling values. Unless 

otherwise noted, the short term exposure limit is a 15-minute TWA exposure. It should not be 

exceeded at any time during a workday. The ceiling limit should not be exceeded at any time.

In the United States, OELs have been established by federal agencies, professional 

organizations, state and local governments, and other entities. Some OELs are legally 

enforceable limits; others are recommendations. 

● The U.S. Department of Labor OSHA permissible exposure limits (29 CFR 1910 

[general industry]; 29 CFR 1926 [construction industry]; and 29 CFR 1917 [maritime 

industry]) are legal limits. These limits are enforceable in workplaces covered under the 

Occupational Safety and Health Act of 1970. 

● NIOSH recommended exposure limits are recommendations based on a critical review 

of scientific and technical information and the adequacy of methods to identify and 

control the hazard. NIOSH recommended exposure limits are published in the NIOSH 

Pocket Guide to Chemical Hazards [NIOSH 2010]. NIOSH also recommends risk 

management practices (e.g., engineering controls, safe work practices, employee 

education/training, personal protective equipment, and exposure and medical 

monitoring) to minimize the risk of exposure and adverse health effects.

● Other OELs commonly used and cited in the United States include the threshold limit 

values (TLVs), which are recommended by the American Conference of Governmental 

Industrial Hygienists (ACGIH), a professional organization, and the Workplace 

environmental exposure levels (WEELs), which are recommended by the American 
Health Hazard Evaluation Report 2013-0019-3205 Page 15

Industrial Hygiene Association, another professional organization. The TLVs and 

WEELs are developed by committee members of these associations from a review of 

published, peer-reviewed literature. These OELs are not consensus standards. TLVs are 

considered voluntary exposure guidelines for use by industrial hygienists and others 

trained in this discipline “to assist in the control of health hazards” [ACGIH 2013]. 

WEELs have been established for some chemicals “when no other legal or authoritative 

limits exist” [AIHA 2013].

Outside the United States, OELs have been established by various agencies and organizations 

and include legal and recommended limits. The Institut für Arbeitsschutz der Deutschen 

Gesetzlichen Unfallversicherung (Institute for Occupational Safety and Health of the German 

Social Accident Insurance) maintains a database of international OELs from European Union 

member states, Canada (Québec), Japan, Switzerland, and the United States. The database, 

available at http://www.dguv.de/ifa/Gefahrstoffdatenbanken/GESTIS-InternationaleGrenzwerte-für-chemische-Substanzen-limit-values-for-chemical-agents/index-2.jsp, 

contains international limits for more than 1,500 hazardous substances and is updated 

periodically. 

OSHA requires an employer to furnish employees a place of employment free from 

recognized hazards that cause or are likely to cause death or serious physical harm 

[Occupational Safety and Health Act of 1970 (Public Law 91–596, sec. 5(a)(1))]. This is 

true in the absence of a specific OEL. It also is important to keep in mind that OELs may not 

reflect current health-based information.

When multiple OELs exist for a substance or agent, NIOSH investigators generally 

encourage employers to use the lowest OEL when making risk assessment and risk 

management decisions. NIOSH investigators also encourage use of the hierarchy of controls 

approach to eliminate or minimize workplace hazards. This includes, in order of preference, 

the use of (1) substitution or elimination of the hazardous agent, (2) engineering controls 

(e.g., local exhaust ventilation, process enclosure, dilution ventilation), (3) administrative 

controls (e.g., limiting time of exposure, employee training, work practice changes, medical 

surveillance), and (4) personal protective equipment (e.g., respiratory protection, gloves, 

eye protection, hearing protection). Control banding, a qualitative risk assessment and risk 

management tool, is a complementary approach to protecting employee health. Control 

banding focuses on how broad categories of risk should be managed. Information on control 

banding is available at http://www.cdc.gov/niosh/topics/ctrlbanding/. This approach can be 

applied in situations where OELs have not been established or can be used to supplement 

existing OELs.

Currently no OELs exist for the chemotherapy drugs for which we sampled. Limited 

information exists that describes specific health effects due to occupational exposure of the 

drugs we tested. Some have been classified as carcinogenic by the International Agency for 

Research on Cancer (IARC). Cisplatin is categorized as a Group 2A Carcinogen, (inadequate 

evidence to designate it as a human carcinogen); cyclophosphamide is categorized as a 
Page 16 Health Hazard Evaluation Report 2013-0019-3205

Group 1 Carcinogen (carcinogenic to humans) and 5-fluorouracil has been categorized as a 

Group 3 Carcinogen (not classifiable as to its carcinogenicity to humans) by IARC [IARC 

2004]. Collectively these drugs can be irritating to the eyes and respiratory tract and some 

are considered a reproductive hazard and harmful to the fetus [Murff 2012]. Healthcare 

personnel who prepare and administer parenteral chemotherapy may be at risk due to 

potential mutagenicity, teratogenicity, and/or carcinogenicity of these materials if workplace 

exposures are not properly controlled; it would be prudent to maintain exposures as low as 

possible.
Health Hazard Evaluation Report 2013-0019-3205 Page 17

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Keywords: North American Industry Classification System 622110 (General Medical 

and Surgical Hospitals), sensory system, chemotherapy drugs, oncology clinic
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Health Hazard Evaluation Report 2013-0019-3205 Page 23

The Health Hazard Evaluation Program investigates possible health hazards in the workplace 

under the authority of the Occupational Safety and Health Act of 1970 (29 U.S.C. § 669(a)

(6)). The Health Hazard Evaluation Program also provides, upon request, technical assistance 

to federal, state, and local agencies to investigate occupational health hazards and to prevent 

occupational disease or injury. Regulations guiding the Program can be found in Title 42, Code 

of Federal Regulations, Part 85; Requests for Health Hazard Evaluations (42 CFR Part 85).

Disclaimer

The recommendations in this report are made on the basis of the findings at the workplace 

evaluated and may not be applicable to other workplaces.

Mention of any company or product in this report does not constitute endorsement by the 

National Institute for Occupational Safety and Health (NIOSH).

Citations to Web sites external to NIOSH do not constitute NIOSH endorsement of the 

sponsoring organizations or their programs or products. NIOSH is not responsible for the 

content of these Web sites. All Web addresses referenced in this document were accessible as 

of the publication date.

Acknowledgments

Desktop Publishers: Greg Hartle and Shawna Watts 

Editor: Ellen Galloway 

Industrial Hygiene Field Assistance: David Lipton, North Carolina Department of Health

Logistics: Donnie Booher 

Medical Field Assistance: Sheila Higgins and Rickey Langley, North Carolina 

Department of Health

Availability of Report

Copies of this report have been sent to the employer and employees at the facility. The state and 

local health department and the Occupational Safety and Health Administration Regional Office 

have also received a copy. This report is not copyrighted and may be freely reproduced. 

This report is available at http://www.cdc.gov/niosh/hhe/reports/pdfs/2013-0019-3205.pdf.

Recommended citation for this report:

NIOSH [2014]. Health hazard evaluation report: evaluation of chemotherapy drug exposure 

in an outpatient infusion center. By West C, Beaucham C. Cincinnati, OH: U.S. Department of 

Health and Human Services, Centers for Disease Control and Prevention, National Institute 

for Occupational Safety and Health, NIOSH HHE Report No. 2013-0019-3205.
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