In 1970, the Occupational Safety and Health Act [1] created the Occupational Safety and Health Administration (OSHA), a regulatory body commissioned to protect private employees against workplace health and safety hazards. At the time OSHA was created, Congress reported that nearly 14,000 people per year died in job-related accidents. [2] Moreover, workplace injuries had risen precipitously due to new technologies and equipment. Accordingly, OSHA was mandated to:
- Encourage employers to reduce workplace hazards and implement health programs;
- Provide research in occupational safety and health issues;
- Establish responsibilities and rights for employers and employees;
- Maintain a reporting and recordkeeping system to monitor progress;
- Establish training programs to increase the competence of health and safety personnel;
- Develop mandatory job safety and health standards and enforce them effectively; and
- Provide for the development and evaluation of similar state. [3]
In order to bolster workplace safety, OSHA created a wide and far-reaching body of regulations impacting virtually every private employer. Notably, OSHA does not create rules for public employers, such as federal or state governments (although similar requirements are demanded). In the decades since this law was enacted, a myriad of additional regulations have been created and enforced. [4] OSHA provisions have been particularly burdensome on health care providers, as medical practices risk both basic occupational hazard issues such as fire, ergonomic injuries and specific medical hazard issues, including bloodborne pathogens, biological hazards and exposure to drugs, chemicals and other toxic substances. As a result, OSHA compliance for health care providers, while complex and time-consuming, is critically important to the overall compliance success of the practice.[5]
I. State Workplace Safety Provisions:
Through OSHA, the federal government regulates workplace safety standards nationwide. However, all but four states [6] also place additional requirements and restrictions on employers, working in conjunction with federal OSHA provisions to create more stringent regulations. While federal OSHA laws are an important starting point, be sure to research and consider laws specific to your state when developing an effective compliance program. State inspectors are just as active as federal inspectors in investigating OSHA violations and assessing fees and penalties.
II. General Duty Clause:
While OSHA has promulgated more and more regulations over the years related to specific hazardous or unsafe activities, OSHA also has the ability to cite employers for safety violations even if the act, error or failure is not specifically regulated. Because OSHA was established to ensure the safety of every employee and enforce any and all regulations necessary to secure that goal, OSHA inspectors rely on the “General Duty Clause” if they identify a hazard whose removal is necessary to create a working environment “free from recognized hazards that are causing or are likely to cause death or serious physical harm[.]”[7] These may also be referred to as “5(a)(1) citations”, based on the Section in which they are authorized.
A General Duty Clause violation has four specific elements which must be met for an inspector to issue a citation. They are:
- The employer failed to keep the workplace free of a hazard to which employees of that employer were exposed;
- The hazard was recognized;
- The hazard was causing or was likely to cause death or serious physical harm; and
- There was a feasible and useful method to correct the hazard. [8]
While the General Duty Clause looms over employers because it can apply in nearly any situation, proving that a violation occurred requires specific circumstances. Therefore, inspectors only use this clause if they identify an egregious or flagrant hazard. For instance, if an injury or death did not occur, then it is often difficult for inspectors to prove the third element, unless it is clearly obvious that a serious danger exists. Often a danger is not “recognized” until it happens, which may assist in eliminating the second element. Finally, the government may be hard- pressed to show that a “feasible and useful method” existed to correct or avoid the hazard. Frequently, no other feasible method may exist to perform a particular task or function. However, the bottom line is this: If something in your office presents a reasonable, common-sense hazard (e.g., water near electric wires or stairs in disrepair), it is best practice to correct the problem before anything occurs. Take affirmative steps to preemptively identify and address possible hazards. Not only will this shield you from OSHA citations, but it will also shield you from potential workers’ compensation and civil negligence liability.
III. Specific OSHA Requirements for Health Care Providers:
Health care organizations, especially medium to small-sized physician practices, are a prime target for OSHA inspectors. Because of the inherent dangers in working with potentially infectious and life-threatening illnesses, OSHA mandates extremely strict controls and processes to ensure that unnecessary injuries do not occur. Rules about bloodborne pathogens, specific to the health care industry, were the among the most frequently cited violations. Other common violations of OSHA in clinics and doctor’s offices include hazard communication, exit route safety, documentation and the reporting / correction of identified deficiencies.
(1) Bloodborne Pathogens.
Bloodborne pathogens represent a serious and very real risk to the health and safety of employees in medical offices. Bloodborne pathogens or diseases that spread through interpersonal blood contact, include Hepatitis B and C, malaria, syphilis, HIV/AIDS and more recently, Ebola. These diseases can be deadly, and infection is easily spread, should an infected individual’s blood or other bodily fluid come in contact with an opening, including small cuts, of an uninfected individual. Moreover, needles and syringes can hold deadly pathogens and act as a “viral highway” should an accident occur. Therefore, compliance with OSHA’s regulations may not only save money but also save lives.
Compliance with OSHA bloodborne pathogens regulations requires careful planning and effective reporting. Generally, “[u]niversal precautions shall be observed to prevent contact with blood or other potentially infectious materials. Under circumstances in which differentiation between body fluid types is difficult or impossible, all body fluids shall be considered potentially infectious materials.” [9] The best practice is for health care workers and staff to treat all bodily fluids and human tissues, as potentially infectious. In this way, practitioners can greatly reduce the risk of accidental infection. OSHA’s Bloodborne Pathogens Standard [10] includes a myriad of rules. Some of the most critical elements to compliance require that:
- Employers establish, update and make available an Exposure Control Plan, designed to eliminate or minimize employee Occupational Exposure is defined as “reasonably anticipated skin, eye, mucous membrane or parenteral contact with blood or other potentially infectious materials that may result from the performance of an employee’s duties.”
- Employers keep a Sharps Injury Log documenting every incident of a percutaneous injury from contaminated sharp objects, such as a needle
- Non-managerial employees who may be exposed to potentially infectious material be involved in the identification, evaluation and selection of engineering and work practice controls reflected in the Exposure Control
- Employers create an Exposure Determination which contains a list of all job classifications, tasks and procedures (or groups of closely related tasks and procedures) that are performed by employees which have occupational exposure.
- Employers use effective engineering and work practice controls to eliminate or minimize exposure or prevent infection upon exposure, including hand washing facilities, antiseptic cleanser and clean towels. Employers should ensure that employees wash hands and skin as soon as possible after contact with potentially infectious materials, such as blood or
- Contaminated needles and other sharp objects should not be bent, recapped or removed, nor shorn or broken. Needles should be disposed in specially- marked containers, in order to avoid accidental sticks of employees and other professionals, such as waste and disposal pick-up and management
Any contaminated but reusable sharp objects should be kept in puncture resistant, leak-proof and properly labeled containers until processed for reuse. Containers for bio-hazardous waste must be marked with the international biohazard symbol. The containers must be lined with red bags.
- Eating, drinking, smoking, applying lip balm/make-up or touching contact lenses should be prohibited when there is a reasonable likelihood of Break rooms should be kept far away from areas in which medical procedures are performed.
- Food and drink should not be kept in refrigerators, freezers or other areas where potentially infectious material is stored or may be kept. Refrigerators containing biological or infectious material should be properly marked as Refrigerators for food and beverages should be kept in or near a break room and marked appropriately as not for biological materials, e.g., “food and drink only”.
- Personal protective equipment, defined as “specialized clothing or equipment worn by an employee for protecting against a hazard,” is provided to employees free of cost. Personal protective equipment does not consist of normal street clothes, such as jeans, shirts, pants or dresses. Employers must ensure that employees are trained and use personal protective equipment and that appropriate sizes and types be provided and cleaned, repaired and/or replaced. [11]
Understandably, requirements regarding bloodborne pathogens and protective clothing are quite expansive. The list above is not exhaustive but may act as a good starting point for enacting appropriate compliance policies.
(2) Hazard Communications (or “HazCom”).
Most medical practices utilize a variety of drugs and potentially dangerous chemicals, including ethylene oxide and formaldehyde, which present a hazard to employees if used improperly. For this reason, OSHA mandates that employers ensure that all items used for storage, including containers and bottles, are properly marked with their contents and that staff are made aware of the contents and their potential danger if misused. Employers must develop and promulgate a policy regarding communication of hazardous materials. At a minimum, each employee should be trained on what each container and/or label means, a specific way to read them (should there be technical information), potential adverse effects from exposure to these chemicals, how to treat them and what steps to take in an emergency. [12]
A list of hazardous chemicals used in the practice should be prepared and should correspond to the Safety Data Sheets (SDS) [13] book. SDS sheets for each product can be obtained from the manufacturer.
(3) Respiratory Protection.
In some instances, employees in medical offices may be working with gases, fumes or chemicals which are noxious or poisonous. Moreover, many illnesses may be transferred simply through the air by way of coughing. To prevent “atmospheric contamination,” including infection, serious injury or possibly even death, OSHA requires employers to utilize appropriate engineering, such as proper ventilation or containment of hazardous gases in a room with proper warning signs, to the extent feasible to minimize risk to employees. Additionally, should there still be risk from particular chemicals, employers must provide respirators free of charge to employees and must establish and implement a respiratory protection program. Such a program should encompass, at a minimum, gases, fumes and chemicals used by the practice which may be potentially hazardous, how to recognize the presence of such materials, how to avoid injury, harm or death upon exposure and proper usage of ventilators. [14]
(4) Lockout/Tagout.
Lockout and tagout require employers to ensure that employees secure the power switch of electrical devices in the “off” position before performing maintenance or repair activities. In a health care context, this may include diagnostic imaging equipment, such as CT scans and x-ray machines or other medical equipment, including centrifuges for blood testing and lasers. When a technician is working on a piece of machinery in which an electrical surge or other hazardous power event could occur, the technician should “lockout” (i.e., render inoperable) the power source, such as an outlet and “tagout” (i.e., affix a warning regarding the situation). Lockout may be done by having exclusive control over the switch mechanism or by putting an actual physical restraint on the power source or switch. Tagout should be done by affixing a red tag that has clear and visible markings indicating potential danger. This requirement is designed to ensure that hazardous power sources do not cause injury or death when an employee is working on them.[15]
(5) Exit Route Safety.
A simple but often overlooked requirement, the Exit Route Safety regulations mandate that employers develop and communicate facility-wide exit procedures in the event of an emergency, such as a fire, flood or violence. An instructional program that walks employees through emergency procedures and protocols should be implemented. Explain to employees what signs may indicate an emergency, emphasizing the best escape route and avoiding dangerous conditions. Additionally, employers must ensure that exit routes are available for the safe exit of all employees from all work areas and that fire doors are used, and walls of emergency routes are made with fire-resistant materials. The exit route(s) must lead out to safe areas, such as sidewalks, streets or open spaces and must always be unlocked when employees may be in the facility. [16] Additionally, fire prevention programs [17] and emergency actions plans [18] must be implemented.
(6) Document, Document, Document . , ,
Above all else, OSHA requirements generally call for written documentation of compliance-related activities. Nearly every OSHA regulation begins with establishing a plan or procedure and unwritten verbal orders or ideas are not enough to comply with those basic requirements. For instance, even if you explain to your employees the steps regarding lockout/tag-outs or exit route safety, regulators want to see that this requirement is documented. When conducting training sessions, save a copy of all training materials and have employees sign certifications that they received training regarding the relevant topics. Moreover, written policies, plans and procedures and a log of the date these materials were distributed to employees are critical in demonstrating compliance. These policies and their respective logs should be accurate and timely.
(7) Ergonomics.
According to the U.S. Department of Labor Occupational Safety and Health Administration, ergonomics is defined as “the science of fitting workplace conditions and job demands to the capabilities of the working population.”[19] Proper ergonomics can result in increased productivity, increased employee satisfaction and decreased illness and injury. Ergonomics is one of the most important OSHA concerns, as physical activity, including stressful or repetitive motion, can lead to musculoskeletal disorders, a leading cause in missed work days and workers’ compensation costs. These disorders are highly prevalent, but also highly preventable.
While ergonomics is not specifically regulated by OSHA, it is important for employers to be aware, nonetheless. Should an accident occur, OSHA inspectors may cite an employer under the General Duty Clause if standards were obviously unreasonable and inappropriate. Moreover, employees may lose valuable working hours with injuries and illness due to improper working conditions. In order to avoid such events, your Compliance Plan should work to achieve the following ergonomics goals:
- Informing employees about musculoskeletal disorders and the risk factors that can cause or aggravate them;
- Promoting consistent improvement in workplace ergonomic protection;
- Encouraging utilization of new technology and innovation in ergonomic protection; and
- Ensuring ongoing and consistent management leadership and employee involvement.
As part of this, you should conduct a review of each employee’s duties and daily activities to identify potential problems and possible remedies. In modern offices, computer usage represents one of the greatest ergonomic challenges. You should review:
- PC displays (monitors) including focus, flickering and brightness;
- Keyboards including wrist support;
- Eyestrain;
- Chairs and back support; and
- Proper levels for computer
Computer workstations, such as those for receptionists, billers or data entry personnel, should be adjustable for each individual. This may be done with adjustable chairs and tilting or swiveling monitors. Every employee who uses a workstation should be able to achieve a physical balance and comfort while performing their duties.
(8) The Parking Lot Rule.
We recommend that you conduct an internal audit before drafting or redrafting an OSHA compliance plan. OSHA encourages workplace-specific procedures, so walking through your facility as if you were a critical and independent third party is the best way to identify potential risk areas. To do this, use the “Parking Lot Rule.” Begin your audit in the parking lot where employees arrive and follow employees’ daily routine, including tasks, duties and break room activity. Finish the audit back in the parking lot when employees are leaving the facility for the day. When conducting your review, consider the worst-case scenario for each circumstance, including power outages or surges, fires, floods, violence or biological emergencies and identify how these events may affect your facility and your employees. This will allow you to identify how your facility functions in all compliance-related activities.
IV. OSHA Fines and Penalties:
OSHA penalties can be hard on a health care practice. The Field Operations Manual states that,
[OSHA penalties are] designed primarily to provide an incentive for preventing or correcting violations voluntarily, not only to the cited employer, but [also] to other employers. While penalties are not designed as punishment for violations, Congress has made clear its intent that penalty amounts should be sufficient to serve as an effective deterrent to violations. [20]
Below are the maximum penalty amounts that may be assessed after January 15, 2020:
Type of Violation | Penalty |
Serious / Other-than-Serious / Posting Requirements | $13,494 per violation |
Failure to Abate | $13,494 per day beyond the abatement date |
Willful or Repeated | $134,937 per violation |
V. Different Types of OSHA Violations:
- What is Meant by a “Serious” Violation? OSHA defines a “Serious” violation as a situation in which a workplace hazard could cause an accident or illness that would most likely result in death or serious physical harm, unless the employer did not know or could not have known of the violation.
- What is Meant by an “Other-Than-Serious” Violation? OSHA defines an “Other-Than-Serious” violation” as one in which the violation has a direct relationship to job safety and health but is not serious in nature.
- What is Meant by a “Failure to Abate”? A “Failure to Abate” charge can be levied by regulators after a health care provider or supplier receives a “Notice of Unsafe or Unhealthful Working Conditions” (notice) is by the government and a follow-up inspection finds that you have failed to correct (abate) one or more of the hazards previously identified and cited by OSHA in its notice.
- To Avoid a “Failure to Abate” Citation, What Can You Do? Subsequent to an inspection by OSHA, you may be issued a “Notice of Unsafe or Unhealthful Working Conditions.” To avoid a “Failure to Abate” citation, upon receipt of a notice, you should: (a) Post the OSHA note, as required by the agency; (b) Take action to correct the violations that have been identified in OSHA’s notice; and (c) Take action to protect employees from any of the violations that have been identified while corrective action is being taken.
- What is a Willful Violation? OSHA defines a “Willful Violation” as one in which an employer has either knowingly failed to comply with a legal requirement (purposeful disregard) OR acted with plain indifference to employee safety.
- What is a “Repeated Violation”? OSHA guidance notes that a Federal agency can be cited for a “Repeated Violation” if the “agency has been cited previously for the same or a substantially similar condition and, for a serious violation, OSHA's regionwide . . . inspection history for the agency lists a previous OSHA Notice issued within the past five years; or, for an other-than-serious violation, the establishment being inspected received a previous OSHA Notice issued within the past five years.”[21]
VI. After an OSHA Inspection:
Understandably, an onsite OSHA inspection is typically a stressful event. After the inspection is inspected, if OSHA’s Compliance Safety and Health Officer (CSHO) has identified violations, you will be issued a formal “Notice of Unsafe or Unhealthful Working Conditions” (OSHA Notice).[22] (OSHA Notice) that explains in detail the exact nature of the alleged violation(s). The OSHA Notice you will receive is required to detail the alleged violations that have been identified. The specific points covered in the OSHA Notice will include:
- The nature of the violation,
- Possible abatement measures you may take to correct the violative condition, and
- Possible abatement dates you may be required to meet.
Should you receive an OSHA Notice, you are required to post a copy of the document “at or near the place where each violation occurred” so that employees and others can be made aware of the alleged hazards that have been identified by the CSHO.[23] o make employees aware of the hazards to which they may be exposed. The OSHA Notice must remain posted for 3 working days or until the hazard is abated, whichever is longer. (Saturdays, Sundays and Federal holidays are not counted as working days).
VII. Responding to an OSHA Notice:
If your health care organization receives an OSHA Notice outlining one or more alleged violations, you have two options:
Option #1: You can promptly take steps to remedy the alleged violation(s) within the correction date set out in the OSHA Notice. This is accomplished by sending a letter to the OSHA Area Director that lays out the specific actions you have taken to correct the violation(s). The letter should also document when corrective actions were taken.
Option #2: Should you believe that the alleged violations set out in the OSHA Notice are unfounded, you can request an Informal Conference with the OSHA Area Director to present your arguments. A request for an information conference must be filed within 15 working days from the time you received the OSHA Notice.
[1] President Richard Nixon signed into law the Occupational Safety and Health Act on December 29, 1970. See 29 U.S.C. § 651 et seq.
[2] Reflections on OSHA’s History, OSHA 3360 (January 2009).
https://www.osha.gov/history/OSHA_HISTORY_3360s.pdf
[3] Id.
[4] In 2000, the United States Postal Service (a quasi-governmental organization) came under the jurisdiction of OSHA and was forced to comply with these regulations.
[5] In our opinion, the definitive guide for small and mid-sized physician practices is the modestly titled “OSHA Compliance Manual,” by D.K. Everitt. The manual is available for purchase from The Compliance Division, L.L.C.The Compliance Division, L.L.C. Bookstore, available at www.thecompliancedivision.com.
[6] These states include Connecticut, New York, New Jersey and Illinois.
[7] 29 U.S.C. § 654(a)(1).
[8] OSHA, OSHA Field Operations Manual, Chapter 4, Section III A.
[9] See 29 C.F.R. §1910.1030(d)(1) and OSHA’s Fact Sheet on standards related to bloodborne pathogens.
[10] 29 C.F.R.§1910.1030.
[11] 29 C.F.R.§1910.132.
[12] 29 C.F.R.§1910.1200.
[13] Formerly referred to as Material Safety Data Sheets (MSDS).
[14] 29 C.F.R. §1910.134.
[15] 29 C.F.R. §1910.147.
[16] 29 C.F.R. §1910.136.
[17] 29 C.F.R. §1910.139.
[18] 29 C.F.R. §1910.138.
[19] Ergonomics, United States Department of Labor: Occupational Safety & health Administration, available at: https://www.osha.gov/SLTC/ergonomics/
[20] U.S. Department of Labor: Occupational Health & Safety Administration, OSHA Field Operations Manual (FOM), Ch. 6, § I (Nov. 9, 2009) available at https://www.osha.gov/OshDoc/Directive_pdf/CPL_02-00-148.pdf.
[21] OSHA’s guidance regarding the types of violations that may be assessed is available at:
https://www.osha.gov/Publications/fedrites.html
[22] OSHA-2H Form. A sample of this OSHA Notice can be found at the following link: https://www.osha.gov/sites/default/files/citations/63rdRSCArmyReserve_1318218.pdf
[23] The OSHA Notice must be posted for a minimum of 3 days or for as long as the hazard exists, which ever is longer.