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8.1 GENERAL INFORMATION
Medical monitoring and surveillance was discussed primarily at the fifth, seventh, eighth and ninth meetings. A panel of physicians addressing nonmalignant respiratory disease focused on different needs and approaches to address medical monitoring and surveillance. The Health Work Group was charged with developing a best practice document for medical monitoring and surveillance. Although most of the attention was devoted to non-malignant respiratory effects, the group developed strategies for addressing dermatitis as well. Various editions of this document were discussed and the final version is provided at the end of this chapter.
A medical panel consisting of Dr. Kevin Fennelly and Dr. Cecile Rose, both of National Jewish Research and Medical Center, along with committee members, Dr. Lee Newman, Dr. David Wegman and Dr. Henry Anderson addressed the committee (M5:7). They fielded committee questions on respiratory disease and MWFs, and medical monitoring and surveillance. The Health Work Group developed a medical surveillance program that could be either part of a regulation or guideline, and provided extensive input to discussions. Dr. Gordon Reeve, Ford Motor Company, and committee member Ken Kushner provided information on the use of passive surveillance at their companies (M6:1-5). Darryl Mattheis discussed medical surveillance in his description of the ORC Document. More on many of the issues discussed by these speakers is found in Chapter Two. Active discussion and development of the recommendations on medical surveillance began at the fifth meeting of the committee.
The panel of physicians explained that medical monitoring is screening individuals and referring cases to physicians for treatment (M5:7). Monitoring is an individual based activity, while surveillance is population based (M6:25). Medical surveillance goes beyond medical monitoring (M5:7). Medical surveillance helps provide indicators of problems not shown by individual cases (M5:7). Wegman explained that surveillance can elucidate patterns of disease in a population and not just identify cases (M5:7). Medical surveillance can be a safety net so ideally people with early stages of disease can be found and treated (M5:7). Both monitoring and surveillance can help identify work areas that need prevention efforts, according to Newman (M5:7).
Wegman explained that passive surveillance uses existing records that
have been collected for a different reason (M6:25). Active surveillance is the development of records specifically designed to track symptoms and disease related to exposure (M6:25). Passive surveillance can help guide identification of problem areas, according to Wegman (M8:22).
8.4.1 The NIOSH Criteria Document
Medical monitoring is discussed in section 9.4 of the NIOSH Criteria Document (NIOSH, 1998). It cites that the major objective of the recommended medical monitoring is the early identification of workers who develop symptoms of MWF-related conditions such as asthma, HP and dermatitis (NIOSH, 1998). Early identification can result in exposure control and minimization of recurrence of symptoms or exacerbation of disease (NIOSH, 1998). It notes that priority should be given to those with highest risk (NIOSH, 1998). Training workers about identifying symptoms and reporting them is needed (NIOSH, 1998). Qualifications of medical personnel and testing frequency and scheduling recommendations are provided (NIOSH,1998). Questionnaires, spirometry and skin examination are included as recommended tests (NIOSH, 1998). Details on medical exams, reporting, employer action and follow up are found 9.4.4-9.4.8 of the Criteria Document (NIOSH,1998).
The NIOSH Criteria Document for Metalworking Fluids provided the committee with a comprehensive baseline for its consideration of a medical surveillance program. The documentation and recommendations in the criteria document were supplemented by literature provided to the committee by members of the committee and by invited experts.
8.4.2 Discussions Related to Components of a Medical Surveillance Program for MWFs
Wegman and Rose explained that surveillance would include baseline and follow-up testing using a questionnaire and pulmonary function testing (M5:7). Rose thought diffusing capacity might be included as part of the spirometry exam but warned that a qualified lab is needed (M5:7). Rose also recommended considering a baseline radiograph (M5:7). In addition, Fennelly suggested paying attention to upper airway and skin symptoms (M5:7). Infante questioned if case identification guidelines should be included (M5:31).
Rose explained that for HP and other sensitization reactions, the exposure had to be much lower than existing PELs or TLVs (M5:7). She noted the importance of using surveillance tools such as questionnaires (M5:7). A well designed questionnaire and surveillance can capture information, according to Newman (M5:7). Anderson thought that respiratory complaints can help flag problems (M5:7). Rose noted that in HP, the symptoms precede any discernible radiographic or spirometric abnormalities (M5:7).The Government Options Work Group reported that the Michigan SENSOR program uses questionnaires (M5:26). Mirer recommended using a questionnaire similar to what the SENSOR program uses (M5:26). Wegman hoped that the Health Work Group would at least address the type of questionnaire used (M5:31).
Return to work was discussed in the context of medical surveillance. Fennelly explained that there is a lot of overlap between the concerns about returning to work with HP and with asthma (M5:7). Newman recommended that if someone is returning to their work environment, serial exams documenting recurrence or exacerbation are needed (M5:7). These tests would include a questionnaire, spirometry, peak flow for asthma and skin screening for dermatitis (M5:7). Wegman noted that return to work may be difficult for OSHA to address (M5:7).
As a result of discussion, a program, according to the Health Work Group should include: a definition of who is included, baseline medical components, frequency, triggers, sentinel events, use of data and evaluation of surveillance and a questionnaire (M5:31). Pulmonary function and skin exams should be included (M5:31).
8.4.3 Development of a Medical Monitoring and Surveillance Document
An initial draft of the Health Work Group's Medical Monitoring and Surveillance Document was provided at the sixth meeting (M6:25). Eligibility was based on exceedance of some level, e.g., PEL, or presence of symptoms associated with MWFs even if below a PEL (M6:25). A baseline medical exam would include a questionnaire, physical exam and baseline spirometry and there would be follow-up periodic medical monitoring, e.g., annually (M6:25). At a minimum, the follow-up would include a questionnaire and certain findings on a questionnaire may trigger further medical testing (M6:25). Substantial cross shift pulmonary function changes may trigger further diagnostic exams (M6:25). Exceedance of a PEL in a homogeneous exposure zone may trigger medical monitoring for all workers in this group even if individuals were not above the PEL (M6:25).
In the early stages, the work group was trying to identify medical removal triggers and related issues (M6:25). The work group wanted to relate their program to exposure, and fluid management issues, and determine ways of exempting areas from medical monitoring (M6:25). Howell suggested dividing out those already exhibiting a history of medical problems in a given work place and then extend appropriate testing to others in the area (M6.26).
A new draft of the Health Work Group's Medical Monitoring and Surveillance document was reviewed at the seventh meeting (M7:28-30). The program included: baseline medical monitoring, periodic medical monitoring, medical surveillance, medical removal, incentives and evaluation of the medical surveillance (M7:29). The trigger for baseline medical monitoring would be working in an area above an action level for 30 days per year (M7:29). The 30 day value was an arbitrary choice made by the Health Work Group (M7:29). Another trigger would be working in an area whose MWF management program does not meet set criteria, even if exposure is less than the action level (M7:29).
A third trigger would be that a physician determines the presence of an MWF related condition (M7:29). A fourth trigger would be a veteran worker with previous history of work in an area where the PEL was exceeded for greater than 30 days/year for a minimum of 5 years (M7:29). A special criteria would be working in an area where a sentinel event occurred (M7:29).
For the draft discussed at the seventh meeting, Wegman explained that the baseline exam would include a questionnaire that is similar to the American Thoracic Society's questionnaire and would include respiratory symptoms, work history, smoking, and demographic data (M7:29). The exam would include a physical exam of lung and skin and baseline pulmonary function (M7:29). For the special criteria category, only a questionnaire would be used (M7:29). Minimal periodic medical monitoring would be required for those working in areas where the MWF management program does not meet minimum criteria, or the exposures are between the action level and PEL but the program meets the criteria (M7:29). The minimal periodic monitoring would include a questionnaire (M7:29). The routine periodic medical monitoring would be for those working in areas with exposures between the action level and PEL and the fluid management program does not meet minimum criteria, or those working in areas with exposures above the PEL and the fluid program meets minimum criteria (M7:29). These exams would include a questionnaire and simple spirometry and would be annual exams (M7:29).
According to the draft discussed at the seventh meeting, enhanced periodic monitoring is triggered by an indicated need from periodic or baseline monitoring (M7:29). Those using respirators to reduce exposure to MWF would need enhanced periodic monitoring (M7:29). If abnormalities are found on exams, enhanced monitoring would be needed (M7:29). Those working in areas designated positive on surveillance exams would need enhanced monitoring (M7:29). Other triggers would include abnormal health events such as allergy to MWFs or sickness greater than 3 days due to respiratory disease (M7:29). An unexplained febrile illness occurring more than two times within 6 months would also trigger enhanced monitoring (M7:29). The discretion of the physician can trigger enhanced monitoring (M7:29). Enhanced periodic monitoring adds cross-shift FEV1 and FVC along with environmental evaluation to the routine monitoring requirements (M7:29). The enhanced exams would be annual unless there are abnormal findings (M7:29).
As noted in the seventh meeting draft, for the surveillance component for the employees in periodic medical monitoring, the data would be grouped and a criteria used to prompt action that otherwise would not occur based on individuals (M7:29). Medical removal triggers would include new asthma or a cross-shift drop in FEV1 or FVC or 10 % on three successive exams conducted at monthly intervals (M7:29). Other triggers would be a diagnosis of or exacerbation of asthma, diagnoses of HP or work-associated contact dermatitis (M7:29). A return to work protocol would include an environmental review and for some disorders a minimal removal time (M7:29).
In the seventh meeting draft, the criteria for ceasing medical surveillance would be documentation of exposures below the PEL for more than 11 months and the MWF management program exceeds minimum criteria (MT:30).Triggers that put individuals in medical monitoring also return to normal (M7:30). The pulmonary function data collected for surveillance could be assessed by NIOSH within the first 10 years of implementation (M7:30). NIOSH would determine if the pulmonary function data collection is achieving the intended goal and if not, recommend that OSHA discontinue this testing requirement and only require questionnaires (M7:30).
In the seventh meeting draft, tables and figures were provided, including a flow chart (M7:30). Some clarifications were needed on the document. Wegman clarified that if someone under the special criteria has an abnormal questionnaire they move into a baseline exam, but if they have a normal questionnaire, they are out of the medical monitoring program (M7:30). Wegman explained that new onset of symptoms referred to results from a questionnaire, not physician diagnosis (M7:30). Wegman clarified that the seventh meeting document requires a baseline questionnaire and pulmonary function test if the fluid management program does not meet minimum criteria (M7:30). This requirement is independent of air concentration (M7:30). Wegman clarified work history and noted that for veteran employees with 5 or more years of exposure, only a baseline evaluation would be done unless there are abnormalities (M7:30). Wegman explained that NIOSH would determine the sunsetting of the pulmonary function testing based on the overall data set, not on a case by case basis (M7:30). Wegman explained that section lA, 1D refers to individuals who currently work for the company but do not work with MWFs (M7:31). He noted that baseline means the first testing (M7:31).
Comments from the committee on the seventh meeting draft included many compliments on this draft. White questioned if it would be practical in many facilities and if a drop of FEV1.0 of 10% is valid (M7:30). Howell liked the inclusion of a fluid management trigger (M7:30). Howell questioned the use of contact dermatitis as a sentinel event since there may be very different reasons why it would appear than, e.g., respiratory symptoms (M7:30)
Recommendations for improvement of the seventh meeting draft included: improving the flow chart, removing dermatitis as a trigger or developing a different logic route, working on the dermatitis issue, explaining why triggers were chosen, justifying the criteria used in their recommendation, reviewing the new respirator standard's questionnaire, and developing the rationale for the 30 days per year (M7:30). When air sampling was done, and how frequently, needed to be clarified along with a definition of work area (M7:30). These last issues including a definition for work area are included in Chapter Seven on Exposure Assessment (M7:30).
At the eighth meeting, the Health Work Group provided an updated version of the medical surveillance document (M8:13). Anyone exposed to
MWF above a defined action limit for 30 or more days per year or working with an inadequate fluid management program would be eligible for a baseline exam consisting of a questionnaire, pulmonary function test and limited physical exam (M8:13). Normal exam results lead into one of three levels of periodic monitoring depending on the environment (M8:13). Abnormal baseline results send the worker into enhanced periodic monitoring (M8:13). Surveillance exams of a group can also lead into monitoring (M8:13). Environmental review can trigger monitoring and excessively abnormal medical test results can result in a more involved medical exam needs (M8:13). A physician diagnosis of a MWF related condition can place one in surveillance (M8:13). Any worker with a history of working in an area where the PEL was exceeded for greater than 30 days for a minimum of two years will receive a baseline exam (M8:13). If the exam is normal, the individual is removed from the program (M8:13). This approach finds those who may have been affected by MWFs earlier in their work life (M8:13). The questionnaire would focus on respiratory and dermal issues using part of a standard questionnaire (M8:13-14). The pulmonary function testing would include FEV1 and FVC and their ratio determined using standard procedures (M8:14). The physical would focus on the skin and some guidance would be given for it (M8:14) The questionnaire, pulmonary function test and physical would be the baseline exam (M8:14).
As stated in the eighth meeting draft, a combination of below the action level and an inadequate fluid management program would trigger the minimum periodic medical monitoring (M8:14). A combination of between the action level and PEL, plus an adequate fluid management program would also need minimum periodic medical monitoring (M8:14). Minimum periodic monitoring consists of an annual questionnaire (M8:14). Areas between the action level and the PEL, and with an inadequate fluid management system, would need routine periodic monitoring (M8:14). Areas above the PEL and with an adequate fluid management system would also need routine periodic monitoring (M8:14). Routine periodic monitoring consists of an annual questionnaire and pulmonary function test (M8:14). Enhanced monitoring was for those areas with exposure greater than the PEL and the fluid management is inadequate (M8:14). Regardless of environmental conditions or fluid management, those individuals with abnormal baseline exams (e.g., low pulmonary function test measurements, baseline defined symptom abnormalities) would be in the enhanced category (M8:14). Any individual with an abnormal baseline questionnaire alone would be given the questionnaire again in six-months, and if the same result occurs, the individual would be placed in the enhanced category (M8:14). Abnormal minimum or routine periodic exam including new symptoms, cross shift drop or physician diagnosed MWF related disease would place the worker in the enhanced category (M8:14). The enhanced monitoring is done annually and includes routine monitoring plus cross-shift FEV1.0 and FVC on site, and a physical exam of the skin by an appropriate health care professional (M8:14). Two annual cycles of stable results removes the worker from enhanced monitoring and places the worker in a category based on environmental conditions (M8:14). Minimal or routine periodic would be done annually (M8:14). Enhanced periodic would be done annually but if the results are unchanged on resurvey, it would be done monthly or semiannually, or a physician can determine that more than annual testing is needed (M8:14).
For the eighth meeting draft, an approach was developed for population results (M8:14). If population results of periodic medical monitoring indicated a problem with the group, this result would trigger enhanced monitoring for the group (M8:14). Abnormalities including unusual values for a whole group or three individuals for cross shift drops in FEV1 or FVC, a loss in annual FEV1.0 or FVC or new onset of symptoms (M8:14). Sentinel events would include diagnosed conditions of asthma, HP or contact dermatitis associated with exposure to MWFs (M8:14). Triggers and sunsetting were similar to the earlier draft. How to get out of medical surveillance was provided in the eighth meeting version.
Clarifications about the eighth meeting draft were given that 30 days exposure did not mean sampling for 30 days but that someone works in this environment more than 30 days (M8:14). Airborne levels without reduction for respirator use would be used (M8:14). Simple respiratory function and simple spirometry were synonyms (M8:14). Population changes only changed the monitoring, while sentinel events triggered an investigation (M8:14). There was an effort to include smoking status as part of the way symptoms were interpreted (M8:17). The changes in lung function noted in the table on page 3 of draft 6 (eighth meeting draft) of the medical surveillance document would not usually occur in a smoker, according to Anderson (M8:17).
Howell noted that without the fluid management approach, the work group's product would look like any normal medical surveillance program and including the fluid management aspect can make the program less burdensome (M8:15,17). Wegman urged development of criteria for the fluid management so there would be reasonable relief from spirometry testing while protecting the workers' health (M8:15).
Burch was concerned with how small business could accomplish what was presented in this draft and more on this issue is provided in the issues and concerns section of this chapter (M8:15). White noted that as a best practice document, the proposed medical surveillance program is elegant, limited and targeted although some of the triggers could be debated (M8:15). Burch noted one burden was the complexity of the 8 pages of the program (M8:16).
Some discussion of improvements and corrections of the eighth meeting document were noted such as making the program more user friendly, determining how to handle someone with dermatitis so these individuals would not have to take a pulmonary function test, and exempting workplaces with no risk (M8:15,17). Other concerns were the development of algorithms for asthma
and HP to help physicians discriminate between the two, and how to conduct an investigation of a sentinel event (M8:14). Other issues of concern about the draft reviewed at the eighth meeting included: how to handle skin and colo-rectal cancer, who should conduct the testing, medical record retention, and how to encourage companies to also do passive surveillance (M8:22).
A revised version of the Health Work Group's Medical Monitoring and Surveillance Document (draft #8) was discussed at the ninth meeting (M9:9). The document was similar in content to the version reviewed at the eighth meeting (M9:9). Some improvements were recommended by Sherman to provide better decision links (M9:9). Wegman noted a change that was needed on the draft description of the time interval for baseline test (M9:9). The revision should state: for current employees - within six months of starting a medical surveillance program; for new employees - within two weeks of starting the job (M9:9). Another item to change was the eligibility could be 30 days working in an environment where the sample indicates that the exposure is at this, or greater than this level (M9:9). Wegman noted that depending on the outcome of the Exposure Assessment Group, the eligibility trigger could be as soon as you document an area is over the PEL (M9:9). The work group decided that if an abnormal spirometry test result occurred, a repeated spirometry test should be done within two months (M9:9). If an abnormal symptom was found, the symptom survey would be repeated within two months (M9:9). Wegman noted the term dermatitis will be used throughout instead of skin disease and, "dermatologist" will be replaced with "physician familiar with occupational skin disease" (M9:9).
Wegman clarified that the word volunteer on page 4, IV C (2) (c) of the version discussed at the ninth meeting, referred to employees in the sentinel event area (M9:9). These individuals will be asked to participate in a survey (M9:9). Mirer clarified that OSHA only requires that testing be offered to designated employees and Sherman agreed (M9:9).
Continuing with the changes in the ninth meeting edition, individuals can be returned to areas below the action level but at the discretion of a physician for areas between the action level and PEL (M9:9). Wegman explained that worker removal would be for a maximum of a year (M9:10). White clarified that a shorter time may be listed for dermatitis (M9:10).
Wegman wanted to include non-mandatory guidance for searching for change among groups of individuals (M9:10). Mirer recommended using economic protection language from the formaldehyde standard for medical removal protection benefits (M9:10).
Newman explained algorithms 1 and 2 as part of the ninth meeting draft of the document (M9:10). These are guidelines for physicians (M9:11).
Other than the algorithms, diagrams were removed from this draft. Wegman explained that the fluid management triggers were removed from the ninth meeting edition due to lack of a defined evaluation scheme for fluid management (M9:10). Wegman noted that a good fluid management program only dropped out a questionnaire (M9:10). There was discussion of dropping from enhanced to basic periodic monitoring with a good fluid management program (M9:10).
8.4.4 Passive Medical Surveillance
Kushner noted that the worker's compensation carriers for some of his plants did not classify claims by industry type or track diseases (M8:16). He explained a data source he found called NCCI which is a national compensation group that gathers data but they did not classify by industry or disease (M8:16). Kushner found a private service that reviews health care claims for employees and families and provides information on inpatient and outpatient health care (M8:16). Any diagnosis can be accessed (M8:16). Reeve provided information from Ford at the sixth and seventh meetings and most of this was discussed in Chapter Two on Health Issues. Kushner also provides some surveillance data at the sixth meeting and this is noted in Chapter Two. Additional information is in Kushner's handout from the tenth meeting (Kushner, 1999).
8.4.5 Other Sources of Information
Many of the items discussed in this chapter relate to Chapter Two on Health Effects. An additional resource is an article by Bai et al entitled Questionnaire Items that Predict Asthma and Other Respiratory Conditions in Adults (1998). Additional references are found later in this Chapter in the section on rationale and in the proposed medical surveillance document as well as in Attachment #6.
8.5.1 Size of Business
The appropriateness of the different versions of the medical surveillance document was debated. Wegman explained that the program was developed by the Health Work Group to be appropriate for small or large business (M5:31). Cox questioned how practical the seventh meeting version of the medical surveillance document would be for small business (M7:30). Burch explained that with the methylene chloride standard, the companies he represents could avoid medical surveillance by changing solvents (M8:15). With MWFs, as stated in the eighth meeting version, there would be no option (M8:15).
Mattheis noted a very simple approach for small business would be to have employees with a health problem inform their employer (M8:10) Potential problems could be outlined (M8:10). ORC may use the program developed by the MWFSAC Health Work Group (M8:10).
Wegman thought the draft provided at the eighth meeting would not be too burdensome because it only included pulmonary function tests and a questionnaire (M8:15). He viewed the program as reasonable if a problem such
as asthma or HP exists (M8:16). Wegman noted that pulmonary function tests for e.g., 29 workers would not be burdensome (M8:16). Wegman agreed that cross, shift testing would be burdensome but a need for these tests would indicate an out of control situation (M8:16). The Health Work group did not think that the program as presented in the eighth meeting would be affected by business size (M8:22). They noted that the mechanisms for delivery may be different (M8:22).
White explained that as best practice, the program could be done by a large company, but questioned how to adapt it to small companies (M8:16). Howell questioned how burdensome it would be for small business, noting whatever is set for a PEL or action level would also influence the burden (M8:17). How a different PEL for different fluids would affect medical surveillance concerned Howell; this would affect different industries in different ways depending on fluid type used (M8:22).
Burch stated that he did not see how the medical surveillance could work for a small business with no resources (M8:15). Even if no one had a serious problem, the infrastructure would have to be put in place (M8:15). Burch noted that a big industry can have someone track the medical data, while a small company cannot (M8:23). Burch urged the group to make this process do-able for small business with the goal of identifying people at risk so small business can take care of those employees with their limited resources (M8:16). Burch wanted to see the health effects in his industry group before requiring this type of effort (M8:15)
Cox explained a scenario in a small business in which an employee develops a cough, rash or any symptom and goes to a physician (M8:16). Any follow-up required by the physician as well as the original exam are covered by insurance (M8:16). Estimating this employee's exposure to MWFs when his job covers many areas would be difficult (M8:16).
Anderson did not think the program was very burdensome (M8:16). If exposures are low, no one is sick and the business is not having any trouble, only a periodic questionnaire is required (M8:16). Anderson stressed that the questionnaires could be very useful to help characterize lost work day problems and solve them (M8:16). Anderson questioned if Burch could guarantee that no one in small business has been sick due to MWFs (M8:16). Anderson thought that the questionnaire would help with awareness of problems (M8:16). Mirer wanted to know what percentage of facilities already do the testing, lessening the additional burden (M7:31)
Kushner explained that small and middle sized business would like to be able to identify MWF related respiratory disease in their workplaces (M8:16). Kushner believed these cases would be small or else they would be more obvious in data sources such as OSHA 200 logs, self-reported cases to medical and workman's compensation (M8:16).
8.5.2 Effectiveness and Validity of Test Methods
Fennelly noted that more validation of the measurement tools is needed (M5:8). Wegman recommended focusing on the potential yield of any test (M5:8). Hoffman noted that medical tests need to be reliable, valid, repeatable and accurate (M5:10).
Rose noted that the effectiveness of questionnaires has not been proven (M5:7). Hoffman explained that questionnaires need to be validated, or one should use an existing validated questionnaire such as the American Thoracic Society's or the Medical Research Council's instruments (M5:10). Newman explained that the questionnaire should include questions from already developed questionnaires with established reliability (M8:15). The Health Work Group hoped to have a product with the best reliability and validity without being onerous (M8:15). Wegman noted that an American Thoracic Society (ATS) questionnaire plus additional questions from, e.g., the International Union Against Tuberculosis and Lung Disease, which has good questions on asthma, may be appropriate (M8:15). Wegman explained that there is not any questionnaire for HP (M8:15). Wegman stated that it may be impossible to validate such a questionnaire (M8:15).
Newman was concerned about the rare asymptomatic individual or someone who denies the relationship between symptoms and work (M5:7). Newman questioned if a questionnaire would detect this individual, but he and Rose agreed that some of the baseline testing probably would (M5:7). Anderson questioned who would evaluate questionnaires (M5:87).
Burch thought that baseline tests may have some merit, but questioned the value of questionnaires (M5:8). Later, Burch thought questionnaires might be very useful for small business (M5:8). Other benefits of questionnaires were noted by Howell and Rose (M5:8). Individuals with TB, fungal disease and Mycobacterial diseases could be found and helped (M5:7). Shortell thought the questionnaires may be more useful than the medical tests (M5:8).
Rose noted that asthma and HP may not be very different in a surveillance program but are handled differently in medical management (M5:8). The common denominator of removal from cause is needed in both, according to Rose (M5:8).
Triggers were discussed by the committee in the context of debating the merits of the Medical Surveillance Program proposed by the Health Work Group. Specific triggers are noted in the section above on the development of the program.
The committee needs to provide the triggers for OSHA, according to Wegman (M5:8). Compared to agents like lead, MWFs do not have clear triggers, according to White (M5:8). Teitelbaum cautioned that an airborne exposure concentration may not work as a trigger (M5:8). White stated that there has to be some exposure trigger for baseline testing and Wegman agreed (M5:8). Wegman explained that some characterization of exposure or some supplemental information would drive the initial eligibility for a baseline medical test (M6:25). White noted that if an action level was the trigger instead of a PEL, many more tests would be needed (M6:25).
Other issues discussed included the use of individual cases pointing to a need to check other cases in a group and loss claims or hospitalizations or a certificate to go back to work acting as a trigger (M5:7). If the work environment improves, more workers would be in a low risk group and less testing would be needed according to Newman (M5:8).
Cox, Wegman and Newman agreed that information dissemination was a problem (M5:8). Information on medical surveillance, in general, along with testing, symptoms and diagnosis are needed by medical personnel (M5:8). Newman and Lick noted that any medical surveillance program should include education (M5:31). Fennelly explained that education of workers, management and medical staff is a necessary component of any medical surveillance program (M5:8). More on education and training is discussed in Chapter Nine.
8.5.5 Use of Data
Lick emphasized that we need to know how the data would be used (M5:8). He was concerned that it would just be stored and not used effectively (M5:8,15). Wegman agreed with Lick, noting the committee needs to recommend how the data are used (M5:16). White explained that we need to know what to do with the information so it will allow us to intervene and protect workers (M5:8).
Wegman stated that nothing has been done with OSHA required medical surveillance data (M5:8). Wegman noted that capturing health information may be difficult as shown by Reeve (M7:29) Claims data analysis for hospitalization and general medical care utilization is rapidly evolving and there may be a way of identifying risk in the future (M7:29).
8.5.6 Separating MWF Related Symptoms or Disease from Background Levels
Kushner expressed his concern about the natural background level of asthma and how would workers with asthma unrelated to MWFs be handled in the proposed medical surveillance program (M8:15). Kushner did not see the burden in the questionnaire or pulmonary function test, but because respiratory disease is so prevalent, some people who have exposure to MWFs will be identified in medical surveillance although their illness is not related to MWF exposure (M8:16). Wegman agreed that this is a problem and noted that HP is not just related to MWFs (M8:15). Wegman stated a medical surveillance system that includes questionnaires and spirometry will focus on and find those asthmatics who don't know their problem is work related (M8:17).
Wegman explained that being asthmatic did not mean the individual will react to MWFs (M8:15). Medical monitoring appropriate for the environment will show whether the person is reacting and requires additional monitoring or medical removal (M8:15). Asthmatics would not be in monitoring forever (M8:15). Newman added that the first tier of medical monitoring would flag an asthmatic and the second tier would identify if it was work related (M8:15). Teitelbaum explained that pre-existing asthma would not trigger a group action unless the condition deteriorated due to MWFs (M8:15). Teitelbaum noted that some asthmatics will probably react to MWFs and may voluntarily leave this workplace (M8:15).
8.5.7 Other Issues
Burch recommended consideration of what the appropriate reaction of an employer should be to a prospective employee's respiratory problems noted on the baseline test (M6:25). Sheehan felt that the baseline test would identify preexisting disease and protect the current employer from responsibility due to exposure at another workplace (M8:30). Wegman noted that his group had not discussed using a baseline test to exclude someone from a job (M9:10). Wegman explained there is no condition that de novo would exclude an individual from the MWF environment, if they could pass a pre-placement medical exam (M9:10).
Related to this issue, Burch was concerned about the fairness of the approach that employers have requirements while employees are volunteers for medical testing (M9:10). Sherman and Mirer clarified that OSHA has written that medical exams will be "made available" (M9:10).
How cancer would change medical surveillance was noted in a general discussion of the implications of cancer being a main health endpoint (M7:10). Anderson explained that more surveillance would be needed (M7:10). Howell suggested including cancer history as part of a questionnaire (M7:11). Medical testing may include colo-rectal exams and there would be a question on the level of medical professional needed (M7:11).
Recordkeeping and similar issues were discussed. Sherman noted that the retention of record is linked to the type of disease (M8:22). Mirer thought the re-review of data idea was excellent and should be applied to other provisions of any standard (M7:31).
The cost of medical testing and surveillance are discussed in Chapter Four. The discussion of symptoms versus disease is found in Chapter Two. A discussion of who would pay for tests and the differences between insurance carriers' interpretations of coverage of diagnostic tests vs. screening tests was noted by Burch, Wegman and Mirer (M8:22).
Smoking cessation as part of a medical surveillance document was discussed, and smoking history would be included in questionnaires (M7:30). More on smoking is found in Chapter Two on Health Issues.
Burch was concerned about ADA regulations and this topic is discussed more fully in Chapter Five (M7:31). Burch recommended determining if a questionnaire is considered a medical exam under the ADA (M9:10).
Wegman thought the committee needs to advise OSHA about the type and frequency of medical exams and other tests (M5:8). Sherman noted that the committee needs to provide a rationale for the frequency of testing since it is more frequent than usual OSHA regulations (M8:15). Teitelbaum noted that the frequency was not out of step with standards such as the lead standard (M8:15). Teitelbaum explained that the Health Work Group was very careful to note that all tests could be done by an appropriate health care professional until the problem reaches a diagnosis stage (M8:15). Licensing becomes an issue with a diagnosis (M8:15).
Who to include is a question. Newman noted that HP can occur in offices as well as on the line (M5:8). Newman stated that medical surveillance is a safety net to help prevent health effects (M8:11).
White explained that industry will question the benefit and cost of medical surveillance (M7:30). Lick noted that he did not like medical surveillance, but without it how are you going to dispute the problems presented by labor (M6:41).
The committee provided extensive input into the Health Work Group's Medical Monitoring and Surveillance Document. No formal vote was taken, however the general consensus was that it was a comprehensive, best practice document. There were reservations about how small business would accomplish the actions provided in the document. The final version of the committee's Best Practice for Medical Monitoring and Surveillance is at the end of this chapter.
As indicated in section 8.5, the committee was concerned that medical surveillance data should be used. The committee recommends that annually, with the assistance of the Bureau of Labor Statistics (BLS), OSHA will identify a nationally representative sample of plants covered by the MWF rule. These plants will provide OSHA surveillance results without personal identifiers. These surveillance results will be forwarded to NIOSH for a review of the MWF surveillance findings and a report prepared for general distribution. Any plant identified through surveillance analysis to have a potential health problem not evident on the plant's OSHA 200 logs, will be informed in accordance with established policies.
The Health Work Group developed a rationale for including medical surveillance in a standard. The rationale is provided in the remaining paragraphs of this section, followed by the best practice document for medical surveillance.
There are established health effects from exposure to MWFs that warrant medical surveillance as an integral component of an OSHA action or rule. These health effects are asthma, HP and dermatitis (Greaves, 1995a & b; Sprince, 1997; Kennedy, 1999; Kennedy, 1989; Kriebel, 1997; Fox, 1999; Kreiss, 1997: MMWR,1996). There is sufficient medical evidence for each of these conditions provided in the NIOSH Criteria Document and the general medical literature which has been provided to the committee. Each of these health effects is a significant risk and represents material impairment of health. These adverse health effects have been demonstrated to occur throughout the industry. Studies and testimony provided to the committee demonstrate these diseases in large and small industry and associated with all types of fluids.
There are other health conditions related to MWF exposure for which the evidence is still evolving. These include cancer at various anatomical sites, other forms of respiratory disease and respiratory infections. These health effects are a significant risk and represent material impairment of health and are detailed in Chapter Two.
There is evidence that the adverse health effects may be mitigated so that the risk is reduced and impairment of health is minimized or eliminated. Since control of MWF exposures below the recommended PEL and appropriate systems management of the MWF environment cannot eliminate all material impairment or harm for the lung or skin, an active medical surveillance program is an essential component of a rule. Active medical surveillance mitigates risk in at least three ways:
Active medical surveillance allows early detection of adverse health outcomes and leads to better health outcomes. Key characteristics of an effective medical surveillance program are that the elements are beneficial to the worker, simple to administer, non-invasive, cost effective, and acceptable to workers, physician and employer (Halperin, 1992; Teutsch, 1994; Rutstein, 1983; Mullan, 1991; Halperin, 1985; Balmes, 1991; Mastrangelo, 1997; Meredith, 1994; Ross, 1997; Gannon, 1993; Roos, 1996; Rosenman, 1997; Timmer, 1993; Reilly, 1995). With these considerations in mind, the following elements of an active medical surveillance program were incorporated.
Questionnaires eliciting history and symptoms of respiratory illness, including asthma and HP, have been demonstrated to be effective tools for the detection of respiratory disease in general, and occupational respiratory disease in particular (Jones, 1992; Abramson, 1991; Venables, 1993; Donoghue, 1993; Ferris, 1978; Smith, 1989; Toren, 1993; Samet, 1978; Brodkin, 1993; Burney, 1989; Burney, 1996). These questionnaires are of demonstrated utility in identifying pre-existing and co-existing non-occupational causes of respiratory illness. Such questionnaires have been demonstrated to have reasonably high sensitivity, specificity and reliability and validity. They are simple, efficient, and inexpensive to adminster and are non-invasive as well as acceptable to workers, physicians and employers with appropriate privacy protection.
Simple spirometry complements questionnaire information and both supplements and confirms respiratory disease in general and occupational respiratory disease in particular (Smith, 1989; Hankinson, 1999; American Thoracic Society, 1995; American Thoracic Society, 1991; Kennedy, 1999; Becklake, 1993; Becklake, 1992, Oxman, 1993). When used as baseline tests they provide an objective reference point for subsequent comparisons. These tests have demonstrated utility in identifying occupational as well as preexisting or co-existing non-occupational causes of respiratory illness and in providing an objective measure of disease severity and impairment. These tests are readily available, well standardized, and when administered by a NIOSH certified technician provide reliable data on respiratory status for interpretation. Such tests have been demonstrated to have reasonably high sensitivity, specificity and reliability and validity. They are simple, efficient, and inexpensive to administer and are non-invasive as well as acceptable to workers, physicians and employers with appropriate privacy.
The combination of a dermatologic questionnaire and physical examination of the skin constitute the standard of practice for early detection of both occupational and non-occupational dermatitis (Adams, 1990; Marks, 1992; Nethercott, 1994). They are simple, efficient, and inexpensive to administer and are non-invasive as well as acceptable to workers, physicians and employers with appropriate privacy.
Studies have demonstrated that all workers who are exposed to MWFs are at potential risk of the above health effects. Consequently, both initial and ongoing surveillance of exposed workers is indicated. Cases of MWF-related respiratoryand skin illnesses have occurred within 30 days of first exposure. Exposure has been defined as work with MWFs at or above the action level for 30 days or more in accordance with established OSHA procedures. Delaying eligibility until 30 days increases the likelihood of identifying only those individuals with exposure-related disease. Basic periodic medical surveillance should be required no more frequently than annually. The rate of development of abnormal symptoms or pulmonary function in the general population can be detected with this frequency of testing. While abnormalities may develop in the year between annual tests, it is expected that unapparent disease will be efficiently detected at this interval and that individuals with more obvious disease or illness will seek medical attention which will trigger enhanced surveillance through the sentinel event response. When an abnormality has been detected, resurveying within a minimum of two months of detection of the abnormality is prudent practice and allows sufficient time for acute non-occupational illnesses to resolve.
In order to improve likelihood of detecting adverse health effects in the highest risk individuals enhanced periodic monitoring is indicated for those who show evidence of abnormality or have experienced prolonged exposure above the PEL. Eligibility for enhanced periodic monitoring, however, is contingent upon demonstrating the repeatability of the abnormality. This is in keeping with standard medical practice and reduces the likelihood of inappropriate action on transient non-work related illnesses or laboratory error. In the presence of abnormality, increased periodicity of testing is justified in order to mitigate material impairments of health. The frequency recommended is consistent with the known natural history of MWF health effects.
Cross shift simple spirometry, as an added component of enhanced medical surveillance, provides a specific measure of work-relatedness (Bernstein, 1993; Newman, 1995; Chan-Yeung, 1995; Chan-Yeung, 1996; Venable, 1997; Wagner, 1998, Milton, 1998; Rose, 1998). This information would not be obtained in any other fashion. An acute drop in FEV1.0 or FVC following exposure is a sensitive indicator of asthma or HP (Chan-Yeung, 1995; Rose, 1998). A cross-shift decrement of 10% or greater is unlikely to occur by chance and in exposed workers is indicative of an acute work-related respiratory health effect which should be immediately resurveyed. From a health perspective it would be inappropriate to delay such resurveying for more than one month. Repeated abnormality on cross-shift spirometry testing is strong indication of a work-related disease warranting special examination because it is essential to intervene before irreversible damage occurs.
Even a single case of occupational respiratory disease or dermatitis is important as a sentinel event. Sentinel events are a well-recognized indicator of potential presence of a hazard to the remainder of a workforce which may be amenable to control before other workers are affected (MMWR, 1996; Rutstein,1989; Mullah, 1991; Bernstein, 1993). A sentinel event may indicate a failure in fluid management and occupational hygiene controls. Thus, any single sentinel event warrants a series of response actions for the individually affected worker, for all other workers in that environment, and for the environment itself.
Medical removal protection and multiple physician review are important components of an effective medical surveillance program, more so for MWFs than for several other chemical agents for which OSHA has provided this provision. Diagnosis of MWF related respiratory illness depends heavily on employee's accounts of symptoms or time course of objective signs of illness. The proposed standard requires, and occupational medical practice frequently employs temporary removal from exposure as a diagnostic tool, to see whether the illness resolves on removal from exposure. Temporary restrictions may be needed while controls are installed, and in a few instances permanent restrictions may also be necessary to protect individuals with advanced illness. Employees will be reluctant to reveal this information if they fear it will lead to job restriction and attendant loss of self-esteem or compensation. The committee heard direct testimony on this point and there is extensive evidence of this from personal experience of some committee members. Machining jobs were also recognized to be the higher paying and higher skilled jobs in many MWF using facilities, which would provide incentives for employees not to disclose symptoms. Medical removal protection is needed for maximum effectiveness of medical surveillance. Multiple physician review is another best practice, mirroring procedures from the general health care system. An example of regulatory text for medical removal protection and multiple physician review is provided in Attachment #10.
Goals of Proposed Medical Surveillance Program:
Control of MWF exposures below a PEL of 0.5 mg/m3 will reduce but not eliminate all impairment or material harm to the lungs or skin due to MWF exposure.
Proposed Medical Surveillance System