The purpose of the pilot study was to determine the effectiveness of our revised PASQ, for example, did the revision of the ACSM screening criteria result in fewer physician referrals, were the questions clear and understandable, as well as evaluate other potential benefits from administrative perspectives. As stated previously, the pilot study was conducted in the 2016 fall semester and involved two groups — students and employees.
Exercise Science Students (n = 36)
Since implementing the PASQ several years ago, we always had one to two students each year who needed to obtain medical clearance due to being classified as “high risk” because they indicated a known medical condition or sign/symptom. However, approximately half of the students each year were classified as “moderate risk” because they did not know their values for some of the CV risk factors. The former ACSM criteria recommended that moderate-risk individuals who would be participating in vigorous activity obtain medical clearance — and our students would be participating in vigorous activity in their laboratories/activity courses. Instead of having all these students obtain medical clearance, we had them come to our laboratory for a finger prick test to obtain their blood values (e.g., cholesterol, glucose) and blood pressure if needed. Once these values were determined, virtually all of these students were reclassified as “low risk.” This process required the faculty member (program coordinator who administered the screening) to schedule the tests and then reinterpret the data on each student’s PASQ. It also cost the student $15.00 for the test.
Using the revised PASQ in 2016 resulted in one student who needed to obtain medical clearance because of signs/symptoms, so there was no difference in this regard. However, a major difference occurred because of the elimination of CV risk factors in the new ACSM screening criteria. We did not need to conduct a finger prick tests to obtain CV risk factor data. This simplified the screening process significantly — a major benefit for the program coordinator and students in terms of time and costs.
FIT Employees (n = 20)
In our promotions to recruit employees for this program, we inform them that we cannot enroll anyone with known disease. Under the direction of the course professor, the employee FIT program is designed/delivered by our exercise science seniors in the semester before their internship. At this point, they do not have the necessary knowledge and skills to train clinical populations. They take our clinical exercise course concurrently with the FIT course but would still need more advanced course work in clinical exercise and experience before working with clinical populations.
The course professor conducts the screening before the beginning of the semester. The screening data are reviewed with students before fitness testing and training of the FIT employees. (Note: Students sign a confidentiality agreement indicating they fully understand that FIT employee health/fitness data must be kept private, confidential, and secure at all times. Legal and ethical issues related to protecting individual data, for example, the Health Insurance Portability and Accountability Act (HIPAA) privacy rule, state privacy laws, and professional codes of ethics, are covered in another course also taken by these students concurrently). In the past years, the previous PASQ always resulted in 25% to 35% of the FIT participants needing to obtain medical clearance, primarily because employees had two or more CV risk factors. In 2016 with our revised PASQ that eliminated questions to assess CV risk factors, none of the FIT participants needed to obtain medical clearance. Therefore, one of the major goals of the new ACSM screening criteria was achieved, that is, to reduce excessive physician referrals. It is also important to point out that over the years, we have not had any untoward events occur with FIT participants while exercising and again in 2016, there were none.
In 2016 with our revised PASQ that eliminated questions to assess CV risk factors, none of the FIT participants needed to obtain medical clearance. Therefore, one of the major goals of the new ACSM screening criteria was achieved, that is, to reduce excessive physician referrals. It is also important to point out that over the years, we have not had any untoward events occur with FIT participants while exercising and again in 2016, there were none.
Because this was the first time using the revised PASQ, we wanted to obtain feedback from the FIT participants. After the screening process was complete, they were sent a survey to evaluate the PASQ. Of the 20 participants, 15 (75%) completed the survey including 10 new and 5 returning FIT participants. All participants, except one, indicated “yes” when asked if the terms and questions were clear and understandable in each of all four sections on the PASQ. This one participant indicated that the definitions of moderate and vigorous intensity (in Section 2) were not clear and understandable and commented that there was not much variance in the activity levels. Regarding the level of difficulty (very easy, easy, difficult, very difficult) to complete the PASQ, 10 indicated “very easy” and 5 indicated “easy.”
Time and efficiency were additional administrative benefits. Three of the five returning FIT participants indicated that the revised PASQ was faster and easier to complete than the previous PASQ. The professor who administered/interpreted the revised PASQ also indicated that the administrative process was easier and more time efficient than the PASQ used in the previous years.
Recommendations to Address Screening Challenges
These recommendations are based on the screening challenges identified by the EP-Cs in the national study (5) described previously.
It is important that new participants (or members) understand the purpose of screening and the steps involved. This can be achieved by providing them with a short “cover letter” as shown in Figure 3. Regarding honesty issues, the privacy-confidentiality-security section in the cover letter may enhance honesty if participants believe their answers will be kept private (of course, the fitness facility needs to have these procedures in place and have their staff members well informed of these procedures). Also related to honesty, see Section 4 in the PASQ (Figure 1). Although this signed acknowledgement does not guarantee that participants were honest when answering the questions, it helps them understand that it is their responsibility.
This acknowledgement also states that the participant is responsible to inform a staff member if his/her health status changes at any time. When this is brought to the attention of a staff member, the screening process should be repeated. ACSM (18) does provide some guidance as to how often screening should be done, for example, preferably once annually. This reflects a realistic, practical approach but does not account for an individual’s change in health status that can occur overnight.
Even after sharing/explaining the cover letter and the PASQ, some new participants may still refuse to go through the screening process. Fitness facilities have a couple of policy options to consider when this occurs: (a) exclude individuals from participation or (b) have individuals sign a refusal form or waiver (release). In the national study (5), 51% of the facilities excluded participation and 38% had participants sign a refusal form. The remaining 11% indicated some other approach. A competent lawyer is needed when making these decisions, for example, excluding individuals may increase the risk of a discrimination lawsuit and waivers must be written and administered carefully to be an effective defense and are not enforceable in all jurisdictions. An example of a screening refusal form is available elsewhere (8). This form should include several sections including a description of the benefits of completing the screening process and the risks of not completing the screening process.
Medical Clearance Issues
As shown from our pilot study, the number of individuals needing medical clearance was lowered significantly by using the new PASQ. We believe this will be the case in most fitness facilities if they opt to follow the new ACSM screening guidelines when developing and implementing their screening procedures. However, there will be individuals who will need to obtain medical clearance because many Americans are inactive, have known disease, and/or have signs/symptoms suggestive of disease.
First, it is important to communicate with these individuals why medical clearance is important, as described in the cover letter in Figure 3. Next, it is necessary to make this process as quick and simple as possible for all parties. It will likely be delayed if the exercise professional attempts to obtain clearance directly from the participant’s medical provider, that is, it is difficult to get medical offices to respond to these requests. It is quicker to have the participant obtain the clearance directly from his/her medical provider because of their existing relationship. We provide a copy of our medical clearance form (see Figure 4) and attached a copy of the participant’s completed PASQ and then ask the participant to take/send this form to his/her provider to complete/sign and then return it back to us. It is also wise to explain to the medical provider why this clearance is being requested (see paragraph at the top of the form in Figure 4). We have not had any issues/problems with this form, and medical providers seem to appreciate that it is quick and easy to complete. For participants who indicate that they do not have a medical provider, the facility may want to provide a list of medical providers in the area that are accepting new patients.
As demonstrated in our pilot study, our revised PASQ and procedures to administer it resulted in a more streamlined approach — it is quicker and easier for both participants and staff members. Too time-consuming for staff members was one of the main reasons for not conducting screening (see Table 2), and this also was one of the challenges articulated by EP-Cs in the national study (5). By establishing efficient administrative procedures as well as quick, easy forms to complete, the staff time needed should be quite minimal even for a professionally guided screening program. However, some facilities may not want to adopt a professionally guided program for all new participants and maybe only for structured programs such as personal fitness training. Although not ideal, self-guided screening is an option to consider and we have developed a self-guided PASQ that incorporates the new ACSM screening criteria and is available upon request. ACSM (2,11,18) also provides examples of self-guided questionnaires such as the PARQ and You. When making decisions regarding screening options/procedures, it is best for fitness managers and exercise professionals to consult with medical and legal experts (discussed next) and review the standards/guidelines published by professional organizations such as ACSM so they are well informed of professional practices.
Legal Liability Issues
Every fitness facility should have a risk management advisory committee (RMAC) made up of experts (e.g., lawyer, physician, insurance agent, and clinical exercise physiologist or clinical exercise physiologist with clinical experience and background) that fitness managers and exercise professionals can consult with on a variety of medical-legal issues. Some of these issues related to screening have already been described previously (privacy-confidentiality-security issues and refusal policies/procedures), but there are a few more to discuss with the members of the RMAC as follows:
Type of Screening
The lawsuits described in Table 4 involved negligent claims against the defendants for the failure to conduct screening. It is clear from these case law examples that screening should be conducted to help avoid these types of claims. Therefore, the legal advice that some fitness facilities have received to not conduct screening (see Table 2) perhaps is not good advice. It is speculated that this advice was given because the facility does not employ exercise professionals who are qualified to perform the screening procedures. In these situations, a self-guided screening program could be considered. Although the type of screening that is needed is not clear from case law, the best approach would be to conduct professionally guided screening. In lawsuits involving claims regarding the failure to screen, it is likely that expert witnesses will testify that professionally guided screening was needed to meet the standard of care.
Because it is important to keep protected health information (PHI) private, confidential, and secure, participants should sign a medical release form before any PHI is shared with another party. For example, if an exercise professional wants to obtain medical records (e.g., graded exercise testing, lab reports) from a client’s physician or physical therapist, a medical release form signed by the client is needed. This signed form authorizes the release of the medical records. The reverse also is true, for example, if an exercise professional wants to share exercise progress reports with a client’s physician, it is best to have the client first sign a release form. The Exercise is Medicine® (EIM) initiative encourages more interaction between medical providers and exercise professionals, but precautions such as using medical release forms should be considered to protect an individual’s PHI. Examples of both general and HIPAA compliant medical release forms are available elsewhere (8).
Retention of Screening Documents
As stated previously, concerted efforts are needed to establish procedures to keep screening documents private, confidential, and secure. However, how long should these documents be retained? The general rule is the time period specified in the statutes of limitations, but legal counsel also should be involved when making this decision. These statutes, that vary from state to state, allow individuals to file a lawsuit years after an injury occurs, for example, 1, 2, or more years. Documentation of records helps provide evidence that the standard of care was followed and thus effective in refuting (defending) negligent claims.
Additional Issues — ACSM’s New Screening Guidelines
The new ACSM algorithm did not address “high intensity” exercise — only moderate and vigorous intensity levels. However, high-intensity programs such as high intensity interval training (HIIT) are very popular in fitness facilities (21). Risk management strategies to consider are as follows: (a) for participants who needed to obtain medical clearance, and are not cleared by their medical provider to participate in high-intensity exercise (see Figure 3), it will be important to direct them to lower-intensity exercise activities until they are cleared and (b) for HIIT programs that are structured classes in which participants need to register, it may be a good idea to have these individuals first perform fitness tests (after screening) to help determine their fitness level and if it is not sufficient, direct them to other activities until they are ready for high-intensity exercise. A variety of precautions need to be taken such as conducting screening and fitness assessments before having individuals participate in high-intensity exercise activities because of an increased risk of serious injuries (7). The injuries that occurred in the Rostai, Proffitt, and Baldi-Perri negligence cases (see Table 4) resulted from high-intensity exercise activities before the client was screened and had obtained a sufficient fitness level to participate safely.
A variety of precautions need to be taken such as conducting screening and fitness assessments before having individuals participate in high-intensity exercise activities because of an increased risk of serious injuries (7). The injuries that occurred in the Rostai, Proffitt, and Baldi-Perri negligence cases (see Table 4) resulted from high-intensity exercise activities before the client was screened and had obtained a sufficient fitness level to participate safely.
Other medical conditions (e.g., musculoskeletal problems, recent surgeries, pregnancy, cancer, hypertension, medications, etc.) that are not included in the new ACSM screening criteria also may be important to screen for, especially in structured exercise programs such as personal fitness training. When designing and delivering an exercise program, knowledge of these additional medical conditions will be important to obtain so that a safe and effective program can be implemented. Fitness managers and exercise professionals should discuss this topic with their RMAC and determine if any of these other medical conditions also warrant medical clearance.
As presented in this article, the major revisions in the new ACSM screening criteria (algorithm) were shown to be beneficial from two perspectives: (a) reducing the number of physician referrals and (b) making the administrative procedures more time efficient and easier than the previous ACSM screening criteria. Adopting the new ACSM screening guidelines should be considered by all fitness facilities especially in those settings (e.g., commercial and community) where there is a high percentage not conducting screening. By implementing the new guidelines and the forms/procedures described in this article, many of the screening challenges as described by EP-Cs can be resolved. This article also presented important legal issues that need to be considered when adopting screening procedures. Similar future evaluations of the new screening criteria are encouraged along with investigations to determine if they are adequate to help prevent untoward events. Readers of this article can request copies of the forms (Figures 1–4) by emailing the lead author. Facilities are welcome to use/adapt these forms at no cost.
BRIDGING THE GAP
Research has shown that many fitness facilities are not implementing preactivity screening procedures as recommended or required by ACSM. As shown in our pilot study, implementing the new ACSM screening criteria (algorithm) resulted in fewer physician referrals and made the screening process more time efficient and easier to perform than when we used the previous ACSM criteria. We believe that these major screening revisions will lead to an increase in the number of fitness facilities conducting screening and thus enhance the safety of participants and professionalism in the field.
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Keywords:© 2017 American College of Sports Medicine.
Pre-activity Screening; ACSM Guidelines; Medical Clearance; Screening Procedures; Legal Liability