Improving Questionnaires for Medical Surveillance of Hazardous Drug Exposure: Results of a Pilot Study

Abstract

Background:

Numerous drugs pose harm to healthcare workers. Medical surveillance (MS) questionnaires often do not capture desired information. Social cognitive theory, plain language, and quality improvement were explored to design an MS questionnaire. The goal of this study was to pilot test an MS questionnaire assessing employees’ hazardous drug (HD) exposures consistent with a 2016 public standard addressing safe handling of HDs in health care.

Methods:

A cross-sectional study design was used to conduct qualitative analysis of questionnaire data collected from a convenience sample of three to five employees from each of the four departments at elevated risk of HD exposures in a large tertiary healthcare organization. Key research questions addressed employees’ understanding of questionnaire items and interview completion rates.

Findings:

Fourteen employees (oncology nurses, pharmacy technicians, housekeepers, and laundry workers) participated. None had participated in the organization’s prior hazardous drug medical surveillance (HDMS) activities. For the surveillance process, employees preferred in-person interviews to emailed questionnaires. Challenges for questionnaire comprehension related to employees’ basic skills of literacy and numeracy.

Conclusion/Application to Practice:

Strategies for ensuring employee comprehension of health and safety communications are critical. Questionnaires should be written in plain language employees can understand the first time it is read.

Background

Hospital standards for handling hazardous drugs (HDs) have changed with the adoption of the United States Pharmacopeia (USP) 800 (United States Pharmacopeial Convention, 2018), which is designed to better protect workers handling and preparing drugs across healthcare settings. In response to this policy, the National Institute for Occupational Safety and Health (NIOSH) classified three groups of HDs (U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, 2016) covering 184 drugs, 80% of which pose reproductive risk (McDiarmid, 2018). Unprotected healthcare workers can be exposed to HDs by inhalation, ingestion, and absorption through skin and mucous membranes. Volunteers, trainees, and family members may also be exposed by contaminated work environments (Graeve et al., 2016).

The USP 800 recommends HD risk assessment and medical surveillance (MS) to discover patterns and detect hazardous contact and exposure. The original HD questionnaire did not provide sufficient information for Occupational Health Professionals (OHPs) to identify employees with preventable exposures. The medical center rarely had spill reports and the occupational health nurse used the original HD questionnaire for MS, but few eligible employees completed them. The questionnaire was burdensome as several items could unnecessarily trigger an interview.

Screening questionnaires are widely used by OHPs as a preferred tool for MS. Alternatives to questionnaires such as direct observation of healthcare employees in their work environment or interviews are not feasible, given OHP staffing levels and resource constraints. Biomarkers involving laboratory testing of individual workers for specific exposure is another alternative to questionnaires, but they were not used, given the wide variation in genetic, behavior, and environmental factors (Miller, 2014) as well as the proprietary nature of HD information. Therefore, the team concluded an MS questionnaire remained the most practical tool for assessing exposure.

Formerly, the hazardous drug medical surveillance (HDMS) program invited employees to complete a questionnaire by email delivered through their supervisors. A NIOSH hazard pamphlet (U.S. Department of Health and Human Services, 2004) was also provided. Only 2% of questionnaires were returned over the seven prior attempts. Few employees from higher risk areas completed the questionnaire. Consequently, a lack of information undermined efforts to estimate exposure among higher risk employees and a new questionnaire was needed.

A more quantitative and precise questionnaire was proposed by an OHP’s workgroup in association with their USP 800 medical center change projects. The medical center’s pharmacy and industrial hygiene staff developed an HD new risk assessment tool. They tabulated the drugs, locations, and safety guidance for each HD in the facility. Work groups and higher risk activity were identified. Updated procedures for safe handling of HDs and the approach for OHPs to monitor, conduct surveillance, and respond to exposure concerns were developed as the medical center incorporated USP 800. The new policy drove staff to improve risk assessment and MS components including the employee questionnaire. The questionnaire also served to address Occupational Safety and Health Administration’s (OSHA) Hazard Communication Standard,

The new questionnaire was designed to detect work-related exposures by having employees describe what drugs they handled, how often, and the duration of their contact or potential exposures. The questionnaire and HDMS were informed by program theory and program history. Social cognitive theory (SCT), as described by Kelder et al. (2015), provided a conceptual basis for understanding why volunteers might participate in HDMS surveillance. For example, theory suggests occupational health nurses would engage more employees to complete the HDMS questionnaire if occupational health nurses recognized the influence factors such as peer role modeling (e.g., respected colleagues completing the questionnaire), normative beliefs (e.g., unit leaders encouraging and rewarding employees to complete the questionnaire), and the value of providing relevant support (e.g., paid work time to complete the questionnaire.)

Principles and best practices of plain language recommended by the Minnesota Department of Health were used to ensure the questionnaire would be easy for employees to understand (Minnesota Department of Health, n.d.). Best practices called for the use of simple terms and fewer choices in questionnaires. In addition, Microsoft^® Office Word was used to evaluate documents for readability. Ultimately, the HDMS relied upon expert judgment of OHPs supported by evidence of spills and subjective exposure histories acquired by the new questionnaire.

The principal investigator (PI) applied quality improvement (QI) principles (Langley et al., 2009) to the overall change project while concentrating on the readability and acceptability of the new questionnaire. The first task was to identify purpose: to improve employee health and safety, follow corporate directives and USP 800, to increase participation in HDMS, and to evaluate a new questionnaire. Second, a plan for employee feedback was developed involving employee interviews conducted by the PI to understand their experience with the original questionnaire. Third, a change was projected to result in improvement. A new questionnaire that employees could easily understand and complete was created; the PI constructed and pilot-tested this questionnaire and a new cover letter on a sample of end-users. Finally, the change was implemented; the PI recommended revisions for the new questionnaire. The purpose of this study was to test a new HDMS questionnaire among a group of higher risk employees. The two key questions were as follows: Was the new questionnaire understood by employees in key job classes handling HDs, and to what extent would the new questionnaire be completed by employees in the key job classes? The answers would inform the improvement of the next steps in the renewed HDMS.

Methods

This project was conducted in an urban, tertiary, medical center in the Midwestern United States with a workforce exceeding 4,500 individuals including dedicated occupational health and safety professionals. A cross-sectional design was used and a convenience sample of three to five employees from each of the four highest risk positions for exposure to HDs: housekeepers (HAs), laundry workers (LWs) who routinely handle soiled linen from the oncology infusion center, oncology nurses (ONs), and pharmacy technicians (PTs). Individuals were drawn from a population of 264. The study’s PI contacted 14 employees to invite their participation in the study. Employee interviews were conducted in the workplace for 2 days during the day shift.

Private interviews were conducted in department lounges during 2019. The PI introduced the study to employees and supplied a written explanation of the study. Standardized questions were asked in a conversational manner and responses were written. Oral responses were reflected to the participant to ensure accuracy. The estimated employee time burden was 10 to 15 minutes.

Quantitative variables included participant age, sex, educational requirements for entry into their job, job tenure, and position. Participants were asked the following questions: duration on the job, knowledge of patient medications, source of knowledge about patient medications, previous participation in screening, opinion of the previous questionnaire, which included personal willingness and expectation of coworkers to complete the questionnaire, and whether questions could be improved. The analyses described participants’ demographic and job characteristics.

The qualitative analysis aggregated and coded interview responses, derived themes, and interpreted and summarized responses (Ulin et al., 2005). The new questionnaire was produced through collaborative occupational health practitioners’ workgroup discussion. The readability and acceptance of the questionnaire was assessed using plain language tools (Minnesota Department of Health, n.d.).

This study met University of Minnesota and Veterans Administration institutional exemption criteria for protection of human participants in research. Participant information was kept confidential.

Findings

Fourteen of the 264 eligible employees were named by their supervisors as potential study participants and all 14 invited workers (100%) participated in the study. Among the interviewees, five were ONs in the oncology infusion center, three were PTs in the compounding area, three were HAs, and three were LWs. The average age of employees was 43.5 years (range: 27–64 years), while eight were male and six were female. Tenure on the job averaged 4.9 years (range: 3.2–6.7 years). Employees’ interviews revealed the following themes: varying knowledge of HDs, no experience with HDMS, unequal training about HDs, and confusion about certain terms.

Varying Knowledge

Respondents described how they came to know about working with or around HDs. An HA1 reported he can find information in the policy and procedure manual and by seeing precaution signs in different areas. He has standard operating procedures for cleaning in the departments. Consistent adherence to standard operating procedures would be necessary for safety. A PT1 described extensive learning on the job over the years and a greater concern for exposures since USP 800. Pharmacy technicians acknowledged a need for and valued knowing how to protect themselves during this high-risk work and the value of this knowledge. An LW1 indicated not knowing much. She described wearing puncture-proof gloves when dumping bags of linens. She knew of nearby sharps containers whenever something is found. This LW spoke of limited knowledge, but reported using personally protective gloves, and knowing the place to take needles and tubing they found while doing laundry. An ON4 indicated confidence and reported access to policy and procedures, completion of a comprehensive orientation, and resources on necessary precautions. She also had a booklet from their professional society’s USP 800 meeting. Oncology nurses were expected to know most about protecting themselves relative to workers in other occupations, given their proximity to patients and their comparatively higher level of education; this expectation was supported by interviews. In addition, they reported relying on access to manuals, on the job training, and professional development opportunities. Personal commitment to self-protection was necessary among the respondents.

Limited Experience

Respondents discussed how they dealt with HDs at their jobs and whether they took part in HDMS, which none had. An HA3 reported having hazardous material containers to use. He described tying bags and securing lids before taking trash away from the area. He had never seen the original questionnaire. The HA was trained on the job to anticipate hazardous material in their work area. An LW1 had found needles, bags of needles, vials, and drug wrappings. He responded by tossing them into sharps container. He did not know about HDMS. A PT3 indicated she followed precautions when preparing HDs. She had never seen the original questionnaire. She had a past injury at work and her work restriction was not accommodated, so she lost trust in their employer. An ON3 described feeling annoyed when patients are admitted, and had no record of when their last chemotherapy was taken, (and) then not knowing how to protect themselves. She had not completed the original questionnaire.

Varying Training

Respondents reported having been trained, except for LWs, who did not recall specific training on HDs. An HA3 indicated she learned through job orientation, then department meetings. She had accompanied people in different areas learning what to do. A PT2 took a 10-month course in Arizona before their present job. He stated they knew more than their coworkers. This person represents someone prepared to influence coworkers. An ON4 completed her professional society’s continuing education sessions and earned certification. This represented the highest level of formal job-related training. Reported training ranged from none to highly formal corresponding with work proximity to patients.

Confusing Vocabulary

Most respondents indicated two terms in the new questionnaire were unknown. An HA did not know what “antineoplastic” meant. He also stated some of the questions did not apply to him. Oncology nurses and PTs found some questions unreasonable. An LW2 asked whether a past medical history question was about them personally suggesting a need for definitions in the new questionnaire. She also asked the meaning of antineoplastic and “radiopharmaceutical.” Workers with the lowest entry-level education had the most questions on the meaning of technical terms. A PT1 asked whether the term drug spills includes needlestick accidents. An ON2 indicated it would be impossible for him to quantify their time per week with a drug. He suggested using a categorical question design instead of fill-in-the-blank which would require further pilot-testing. Interviews revealed that workers closest to the environmental HDs and byproducts did not readily comprehend various terms and structure in the new questionnaire and experienced problems with some item formats.

Discussion

The pilot study affirmed the feasibility of using questionnaires to conduct MS of HD exposure. Interviews with workers revealed varying levels of knowledge about HDs by position consistent with the entry level of education and training. Knowledge by PTs and nurses was greatest, as other studies have shown (Fuller et al., 2007). While not surprising that knowledge of HDs was lower among HAs and LWs, the finding raised important questions about how best to assess exposure levels among these groups, and the possible need for outreach and education interventions to ensure their protection. The study findings can be used to improve HDMS. To the extent that SCT informs HDMS, it can be used to improve methods enhancing employee participation across a range of workplace hazards. Social cognitive theory explained health behaviors such as the use of safer work practices, use of personal protective equipment, and voluntary participation in occupational health and safety programs such as HDMS. Occupational health nurses can tailor tools, refine methods, and wisely choose materials for employees that improved the effectiveness of HDMS questionnaires.

A strength of this pilot study was the strategy of engaging employees in interviews to better understand their ability to complete a new MS questionnaire to assess employee HD exposures. The findings revealed changes were needed to the terminology and questionnaire format. Without a proper pilot test, occupational health nurses would risk rejection and potentially alienate the very groups in need of protection. The limitation of this pilot study was the small convenience sample. While suitable for the PI’s purpose to test the questionnaire, the sample was not representative of the institution’s workforce and lacks generalization to similar work groups at other organizations.

Occupational health nurses may increase rates of HDMS participation by recognizing and focusing on social roles in the workplace. Group cohesion based on knowledge and peer role modeling such as train-the-trainer may boost workers’ attention and improve precautionary practices at work. Informal work group leaders can be taught to model to their coworker’s proper personal protective gear and safe handling. Occupational health nurses may experience increased survey participation by hand-delivering questionnaires and discussing the questionnaire with work groups.

Applications to Professional Practice

This pilot study established the importance of testing a questionnaire before use. Furthermore, questionnaires are best written at the reading level of those least educated. In addition, to maximize employee response rates to a questionnaire, occupational health nurses can employ strategies building on social roles and relationships at work such as peer education and role modeling to communicate that workers’ participation in the survey will promote their protection from hazardous drugs in the occupational setting.