Shocking Variances Between Private Practice and Rehab Agencies
Part One of this Two-Part Series: Mary R. Daulong, PT, CHC, CHP
As you know, a comprehensive compliance program should address all areas of vulnerability related to federal, state, and local laws governing. However, this article will only focus on federal regulations issued by the Occupational Safety and Health Administration (OSHA) and the Centers for Medicare and Medicaid (CMS). We will tackle private practice and rehabilitation agency requirements separately to give you an idea of the vast differences in regulatory obligations regarding Emergency Preparedness Plans (EPP). The U.S. Department of Health and Human Services and the U.S. Department of Labor triggered the EPP guidances and requirements as an endeavor to prevent the spread of the Coronavirus-19.
It is common knowledge that all healthcare entities must have internal and external emergency policies and procedures to comply with OSHA, CMS, and many other state and federal regulators. Of course, the fundamental reason to have safety processes is to prevent injuries and illness and protect our patients and workforce members. But did you know our safety program demands have grown massively over the past few years? The explosion of guidelines and requirements is due to the advent of the EPP. While private practices operate under recommended EPP guidelines, rehabilitation agencies must comply with a federally mandated Emergency Preparedness Standard that originated in 2016. The “shocking variances” will be introduced later in this article.
Most private practices developed a COVID-19 Emergency Preparedness Plan (EPP) during the pandemic, and dozens of states ordered such a Plan while waiting for OSHA to promulgate rules and regulations related to COVID-19. In June of 2021, OSHA adopted an Emergency Temporary Standard (ETS) with a January 2022 effective date. However, the Supreme Court overturned the ETS prior to implementation. We have learned OSHA intends to write rules to address most of the content of the ETS and will enforce the General Duty Clause stringently until a final Standard is approved. For a quick overview, see the ETS Summary. It is paramount that employers maintain their EPP, making modifications as conditions and circumstances change; this will help mitigate the risk of a General Duty Clause citation or violation.
The General Duty Clause (GDC) is very broad; it obligates an employer to protect its workforce from severe and recognized workplace hazards even where there is no OSHA Standard. The GDC also requires that employees follow all OSHA standards, rules, regulations, and orders. In short, this previously sleep giant is now awake and needs feeding. OSHA’s Field Operations Manual (FOM) states that the General Duty Clause will normally not be used to impose a stricter requirement than that imposed by the OSHA standards. This expansion of the GDC seems contradictory to the statement in the previous paragraph since there is no Standard specific to the Coronavirus Pandemic or an associated EPP.
To issue a General Duty Clause citation, OSHA must be able to show:
- The employer failed to keep the workplace free of a hazard to which employee of the employer was exposed
- The employer or its industry recognized the hazard
- 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
Like any other Plan, the EPP is only effective if it has current policies and procedures for each Plan element. Ongoing staff education and Plan adjustments will improve the likelihood of generating a Plan that provides a safe and healthy environment and concurrently complies with OSHA’s General Duty Clause. Minimally the Emergency Preparedness Plan should have processes in place for:
- Appointing an EPP officer/coordinator
- Educating the workforce
- Screening patients, visitors, and employees for signs and symptoms of COVID-19 or other infectious diseases
- Enforcing proper hand-washing and respiratory etiquette
- Providing personal protective equipment
- Applying engineering and administrative controls for social distancing, etc.
- Requiring enhanced cleaning, disinfecting, decontamination, and ventilation
- Monitoring the practice for exposures and Plan effectiveness
- Enforcing EPP compliance
- Monitoring federal, state, and local conditions and orders
- Maintaining communication with managers and personnel
As noted before, all healthcare entities have had to have internal and external policies and procedures specific to their site. OSHA has a one-hundred and thirty-nine (139) page Standard Operating Procedure Manual to serve as a template for employers. These written documents and processes must demonstrate conscientious implementation, monitoring, enforcement, and updating. The practice must appoint a safety/compliance officer, educate its employees, investigate deficiencies, and take corrective action, as applicable. Full compliance with OSHA’s recordkeeping, reporting, and posting of notices is also mandated.
Below are the most common policies and procedures that should be in place in all therapy settings to assure compliance with OSHA Standards and other agency requirements.
Infectious Disease Control & Management (Bloodborne Pathogens, Personal Protective Equipment, and Recording and Reporting Standards)
- Reportable Diseases & Conditions
- Symptoms Requiring Immediate Reporting
- Conditions Requiring Immediate Reporting
- COVID-19 Conditions Requiring Logging
- Conditions Requiring Work Restrictions/Limitations
- Conditions Requiring Treatment Restrictions/Limitations
- Exemption Options for Personal Protective Equipment and Vaccinations
Safety and Internal & External Disaster Preparation & Training (Recording and Reporting and General Industry Standards)
Include written policies and procedures, employee training and drills, and recording and reporting on the following internal and external disasters:
- Medical Emergencies
- Bomb Threats
- Natural Disasters (Internal & External)
- Man-Made Incidents
- Equipment Maintenance, Calibration, Repair, and Proper Utilization
Exposure Control (Bloodborne Pathogens Standard)
- Written Exposure Control Plan
- Exposure Risk Determination
- Workforce Orientation and Annual Education
- Standard Precautions
- Exposure Barriers & Engineering and Work Practice Controls
- Hepatitis B Education and Vaccination Option
- Recordkeeping and Reporting
Hazard Communication and Safety Data Sheet Plan (Hazard Communication Standard)
- Written Hazard Communication Program
- Hazard & PPE Assessment
- Personal Protective Equipment Education and Provision
- Hazardous Substance List
- Safety Data Sheets
- Container Labeling
- Workforce Orientation and Education
- Recordkeeping and Reporting
Personal Protective Equipment (PPE) Standard
- PPE Assessment Based on Duties
- PPE Education:
- Types of PPE and When to Use PPE
- How to Donn and Doff PPE
- How to Maintain or Dispose of PPE
- PPE Provision-Size Appropriate
Recording, Reporting, and Posting Standard
- Illness and Injury Reporting Criteria
- OSHA 300 & 301 Recording and Report Logs (Partial Exemptions for Therapy Practices and Employers with ≤ 10 Employees in most states)
- Needlestick and Sharps Injuries Reporting
- COVID-19 Reporting Log
Respiratory Protection Standard (is not applicable unless respirators (N-95 and greater) are required to be worn in the facility).
- Written Program
- Hazard Evaluation and Respirator Selection
- Respirator Fit Test & Seal Checks
- Medical Evaluation for Wearers
- Respirator Training
- Program Evaluation
Besides being a professional duty to protect personnel, patients, and visitors from hazards and injuries, practice owners must be mindful of the potential to incur significant sanctions for lack of compliance with OSHA and other health and safety regulators. It would be a shortfall not to mention that providers who received Provider Relief Funds under the CARES Act are obligated to comply with OSHA’s regulations throughout the entirety of the loan or face repayment and potential fines and penalties.
If there are not enough motivators for compliance, please note that there are seven types of OSHA citations, six of which can result in financial penalties, criminal penalties, or both. The most serious are “willful” violations; they have severe consequences.
Penalties start at $5,000 and go up to $7,000 per violation.
It is time to move on to Part II which illustrates the significant variances between requirements for private practitioners and rehab agencies. In the words of Sean Connery, “Shocking, simply shocking.”