AMARILLO, TX – We are facing an unprecedented challenge. COVID-19 has spread rapidly across the world affecting workforces, global economies, and everyday individuals. While the virus has seemingly turned the world as we know it upside down, good news is on the horizon. Through concerted efforts of social distancing in the United States, it appears that the “curve is flattening” and states are beginning to reopen. With states reopening, DME suppliers need to implement controls that will not only protect the safety and health of its employees, but also its patients.

The motivation for a DME supplier to properly reopen includes: (i) the desire to take care of its patients; (ii) the desire to take care of its employees; (iii) the desire to keep its doors open; and (iv) the desire to protect itself from plaintiffs’ attorneys who will likely come out of the woodwork six months from now and sue DME suppliers for negligence.

The purpose of this article is to provide guidance to suppliers on structuring an appropriate written protocol that implements necessary controls including: (i) what reliable governmental sources a supplier can turn to for COVID-19 guidance; (ii) recommended controls for DME supplier employees; and (iii) recommended controls for DME supplier patients.

Sources for Structuring Protocols
When structuring a protocol, a supplier needs to turn to reliable sources for COVID-19 guidance. One reliable source is the Centers for Diseases Control and Prevention (CDC), which continuously updates its guidelines. The CDC’s published guidelines are available on its website. The Occupational Safety and Health Administration (OSHA) also has general guidelines and interim guidance for specific work groups and their employees. OSHA’s interim guidance for health care workers is available here. Finally, a supplier should consult applicable state governmental agencies for published guidance on how a business may reopen.

While a DME supplier does not need to incorporate every available guideline, it should diligently review and adopt guidelines that fit it the best. Further, a supplier should cite within its protocol the source for an incorporated guideline. Citations to a reliable source provide a DME supplier the argument that it took reasonable steps to protect patients and employees.

Structuring the Protocol: Employees
A DME supplier’s protocol needs to adopt various controls specific to its employees. The protocol should touch on topics such as: (i) what PPE the supplier requires; (ii) how the supplier responds to a sick employee; (iii) cleaning and disinfecting procedures; and (iv) a description of general good hygiene practices employees should adhere to. The following are some example controls that a supplier may incorporate in its protocol:

(i)              Required PPE

A DME supplier may mandate the use of face coverings and gloves for all employees. In doing so, a supplier should ensure to make the PPE available to its employees. The protocol should also address the proper disposal, cleaning, and disinfecting of PPE.

(ii)             Sick Employees

There is no requirement to close a DME supplier facility if an employee is exhibiting symptoms or tests positive for COVID-19. Under its protocol, a supplier should require all employees to notify the supplier if they test positive for COVID-19 or are exhibiting symptoms. Further, a supplier should implement procedures on what to do if it receives notice from an employee that he/she tests positive for, or exhibits symptoms of, COVID-19. For example, a supplier should require the employee to self-quarantine for 14 days or until he/she tests negative for COVID-19. A supplier may also adopt the CDC’s return to work criteria for health care professionals.

In addition to sick employees, the protocol should outline procedures for the treatment of employees who may have been in close contact with a suspected or positive COVID-19 employee. This may include notifying employees of possible exposure and closely monitoring the employees for symptoms.

(iii)            Cleaning and Disinfection

DME suppliers should also incorporate regular cleaning and disinfection procedures in its protocol. For example, the protocol could require that employees routinely clean and disinfect frequently touched surfaces or objects. Separate procedures may also touch on how to clean and disinfect a facility if an employee tests positive for COVID-19. The CDC and OSHA have published guidelines on how to properly clean and disinfect workplaces.

(iv)            Good Hygiene Practices for Employees

While there is constant chatter about the need to practice good hygiene to help limit exposure to COVID-19, it is still in a supplier’s best interest to include these practices in its protocol. The protocol should emphasize the importance of:

• washing hands with soap and water for at least 20 seconds or the use of hand sanitizer;
• avoiding touching the eyes, nose, or mouth; and
• covering a cough or sneeze with an elbow or tissue.

Structuring the Protocol: Patients
A DME supplier’s protocol should also implement controls for patients who will enter the facility. Specifically, the protocol should address (i) how an employee should handle sick patients, (ii) how to protect high-risk patients, (iii) the implementation of communication procedures with prescribing practitioners or with patients and (iv) the implementation of physical controls to encourage social distancing.

(i)              Sick Patients

It is inevitable that a DME supplier will encounter a COVID-19 positive patient on its premises; thus, the protocol should address various situations and applicable controls. For example, if a patient is exhibiting COVID-19 symptoms but does not have a diagnosis, then a supplier should advise the patient to get tested as soon as possible. Employees should also encourage patients to sign up for home delivery if available.

If a patient has a positive diagnosis, then a supplier may implement more stringent controls. Such controls may include directing the positive patient to a private, designated area of a facility (or even to the patient’s car). It may also include minimizing contact between the patient and the employee, and ensuring the employee has proper PPE while interacting with the patient.

After interaction with suspected or confirmed COVID-19 patients, a supplier should require employees to properly clean and sanitize themselves and any possibly contaminated areas after the interaction.

(ii)             High Risk Patients

A DME supplier’s protocol should address how to ensure the safety and health of its high-risk patients. Such controls include posting signs on doors encouraging patients to return to their vehicles and call the supplier for services. A supplier can also send notices to patients either by mail, telephone, or text messaging to inform patients of their options.

(iii)            Communication Procedures

A DME supplier should work with physicians and hospitals to set up a COVID-19 positive patient notification system. Such a system could be set up to help a supplier prepare for a patient needing a product. For example, proper notification could prepare a supplier to have patients receive their products through curbside pickup or home delivery. This will help limit exposure to employees and other patients. A supplier could also work with prescribers to submit orders via telephone or electronically rather than through traditional paper prescriptions. A supplier should incorporate all communication procedures into its protocol.

(iv)            Physical Controls

Physical controls also play a vital role in a supplier’s protocol. The goal in implementing physical controls is to promote social distancing and minimizing the risk of exposure between patients and employees. Physical controls include:

• Installation of sneeze guards at counters.
• Discontinued use of magazines or other shared items in waiting areas.
• Closure of self-serve blood pressure units.
• Limiting the total number of patients inside the premises to prevent crowding.
• Placement of markers six feet apart on the floor for patients waiting in line for service.
• Requiring face coverings for anyone entering the facility.
• Placement of hand sanitizing stations throughout the facility.

Jeffrey S. Baird, JD, is chairman of the Health Care Group at Brown & Fortunato, PC, a law firm with a national health care practice based in Texas. He represents pharmacies, infusion companies, HME companies and other health care providers throughout the United States. Mr. Baird is Board Certified in Health Law by the Texas Board of Legal Specialization, and can be reached at (806) 345-6320 or [email protected].

Bradley W. Howard, JD, is chairman of the Labor and Employment Law Group and a health care attorney at Brown & Fortunato, PC and works with numerous health care clients, handling governmental investigations, business disputes, and litigation involving health care providers including pharmacies, DME companies, home health agencies, and hospitals. Mr. Howard is Board Certified in Labor and Employment Law by the Texas Board of Legal Specialization, and can be reached at (806) 345-6310 or [email protected].