Please note, this newsletter applies to the following programs: OPT
In recent years, the topic of the two person rule has gained momentum in various fields for enhancing safety and accountability. The concept has made its way into the healthcare sector, specifically in outpatient physical therapy settings. QUAD A standard 15-K-9 states: The facility must ensure that at least two persons are on duty on the premises of the organization whenever a patient is being treated. The two person rule in outpatient physical therapy is a requirement that necessitates the presence of two organization staff during treatment sessions. The QUAD A standard is crosswalked to the Centers for Medicare & Medicaid (CMS) and is part of the facility’s Provider Agreement entered into with CMS. This information can be found at 42 CFR 485.723(a)(6). The aim of this rule is to increase patient safety and enhance the quality of care.
QUAD A is often contacted to clarify the requirement, as implementing the regulation comes with its own set of challenges, particularly with staffing. It can also be a significant challenge for smaller clinics, private practices, and at extension sites. The State Operations Manual (SOM) Chapter 2 – The Certification Process developed by CMS provides some additional information related to this requirement.
SOM Chapter 2, Section 2292B – Providers of Outpatient Physical Therapy and/or Outpatient Speech Pathology Services Specified in 485.701-485.729 (Rev.224. Issued: 06-28-24)
Two person duty requirement: Organizations must always have at least two persons (either of its own personnel or its contracted personnel) on duty on the premises anytime rehabilitation treatment is being provided to a patient. The two person requirement does not specify which staff must be on duty (in other words, professional staff or a combination of professional staff and support staff), but the organizations must consider the supervision required of support staff.
The SOM provides further guidance for facilities that provide services in a patient’s residence, such as an Independent Living or Assisted Living Facility.
Services provided in a patient’s residence are exempt from the two person duty requirement. Additionally, services provided in a patient’s room within an assisted living facility (ALF), or independent living facility (ILF) may be considered to be a patient’s residence and therefore also exempt from the two person on duty requirement. A common or general use area of the facility, such as a hallway, may be considered to be an extension of the patient’s room and residence and also exempt from the two person on duty requirement.
This requirement is for the safety of the patients. It is not a new requirement, but is sometimes overlooked, particularly at a rehabilitation agency’s extension location(s). Refer to Interpretive Guidance Tag I-118 in Appendix E of the SOM.
Successful implementation of the two person rule in outpatient physical therapy requires thoughtful planning and communication. Suggestions for best practices that healthcare facilities can consider include: Policy Development and Communication, and Training and Sensitivity. Develop clear policies around the two person rule, including when it is necessary and how it will be implemented. Communicate these policies to both staff and patients to build confidence, understanding, and compliance and if applicable, to the ALF or ILF. Further, provide training for staff on the rationale behind the two person rule and how to maintain professionalism and sensitivity to patient comfort and privacy during treatment sessions.
The implementation of the two person rule in outpatient physical therapy is a CMS requirement, yet it also represents a proactive approach to enhancing patient and staff safety, improving the quality of care, and maintaining the highest standards of practice. Together we can improve patient safety!
Since 1980, QUAD A (a non-profit, physician-founded and led global accreditation organization) has worked with thousands of healthcare facilities to standardize and improve the quality of healthcare they provide – believing that patient safety should always come first.
