Process-oriented regulatory surveys

Numerous AHJs review and evaluate different types of policies, procedures, rules and regulations.

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Health care facilities professionals must stay on top of a myriad of ever-changing rules and regulations that can have a massive impact on the safety and security of all persons who work, visit and receive care within the walls and corridors of their buildings.

There are numerous authorities having jurisdiction (AHJs) reviewing and evaluating different types of policies, procedures, rules and regulations for effectiveness. AHJs have a purpose, are well-meaning and want to do the right thing. However, compliance with health care rules and regulations can be viewed as a never-ending game of whack-a-mole. Every time something is fixed, repaired or maintained, something else can pop up. Historically, this is a reactive approach to compliance and maintenance.

Naturally, reacting to identified physical environment deficiencies from an AHJ on life safety devices, equipment and levels of protection for necessary correction and/or corrective action plans is a standard operating protocol. However, facilities managers should ask themselves, “How much better can we be if we focus on prevention and process improvement, and not just reaction and correction?”

An ongoing, reasonable and legitimate debate is the best way to determine compliance with rules and regulations while balancing efficient and effective operations within the health care environment.

Process improvement surveys

Not a brand-new concept, the process improvement or process-oriented survey concept began to gain significant traction in 2008, when the Centers for Medicare & Medicaid Services (CMS) granted deeming authority to DNV Healthcare USA Inc. in Katy, Texas. The significance at this time was, and still is, the inclusion of the International Organization for Standardization’s ISO 9001 Quality Management System concepts as part of the accreditation process.

This focus on quality management as part of health care accreditation highlights the focus of communication, customer satisfaction, collaboration, consistency and, most importantly, continual improvement. Continual improvement does not have a destination or end point. Rather, an organization that strives for continual process improvement combines forward-thinking and risk-based thinking concepts with preventive action that bolsters the integrity and strength of an organization. To illustrate, facilities managers may ask themselves, “Is it more beneficial for a health care organization to operate for the sole purpose of passing a checklist or a test, or to strive to continually make the health care environment safer and more secure for everyone?”

The process improvement survey is not a pass/fail test, and there are no traditional scoring systems or tipping points. Accreditation is not granted based on the number of identified issues. Rather, it encourages the successful implementation of sustainable corrective action plans in conjunction with sustainable preventive action plans that focus on the continual improvement of what is identified during the survey.

Appreciating and recognizing the significance of the number of findings during a survey, this approach does not consider the final number or classification of findings. Ultimately, it doesn’t matter if there are two findings, 20 findings or 200 findings. Accreditation is granted based solely on the successful implementation of sustainable corrective action plans. In other words, “What are you doing about it?”

Knowing your nonconformities

The process improvement survey identifies several types of findings and observations. For reference, ISO 9001 uses the term “nonconformities” (NCs) instead of the term “findings.” In addition, ISO 9001 allows for the identification of noteworthy efforts (NWEs) and opportunities for improvement (OFIs), both of which are not formally identified on the final accreditation report but are given verbally at the closing meeting for consideration by the surveyed hospital.

There are four types of NCs, referred to as NC-2 (minor NC), NC-1 (major NC), NC-1 Condition Level (major NC) and NC-1 Immediate Jeopardy (major NC). Accreditation is granted on the successful implementation of sustainable corrective action plans for however many NCs are identified on a final issued report. For example, a hospital could have two NC-1s and four NC-2s. Once corrective action plans are approved, accreditation is issued. Similarly, a hospital could have two NC-1 Condition Level nonconformities, three NC-1s and nine NC-2s. Once corrective action plans are approved, accreditation is issued.

A common question is, “If the number or type of finding or nonconformity doesn’t matter, why the various classifications?” Knowing all NCs will be corrected regardless of the classification, the only reason for the classification is to formalize the timeline for corrective action. While the timeline for the submission of corrective action plans is the same, the validation of those corrective action plans is variable. More specifically, NC-2s are subject to validation during the next annual survey, NC-1s require the submission of objective evidence of implementation within 60 days from the acceptance of the plan, and an NC-1 Condition Level requires an in-person on-site follow-up visit within 60 calendar days from the last day of the survey. (CMS mandates NCs specific to the Life Safety Code^® require validation of complete correction within 60 calendar days from the last day of the survey, absent an approved time-limited waiver or fire safety evaluation system. These are both approved by the accrediting organization as well as the CMS regional office.)

When NCs are identified, baseline questions are asked to determine compliance with a requirement. Is there a process in place to address this requirement? If so, how effective is that process? The following examines and applies the classifications to these questions:

• NWE. An overall effective process that may or may not be unique to the health care facility.
• OFI. An overall effective process in place to address a requirement. However, there may be a “one-off” here or there. No formal corrective action is required. This is sometimes called a one-off or two-off.
• NC-2. This is a minor NC. A process is in place that, for the most part, works well. However, the auditor or surveyor determines if enough examples of NCs exist to require a formalized corrective action plan. This can be subjective.
• NC-1. This is a major NC such as a missing process for a requirement or a broken process. Although it may be correctly planned out in a policy or procedure, the execution does not sufficiently address a rule or regulation reviewed by the AHJ. A formal corrective action plan is required with a follow up of objective evidence supplied to the AHJ.
• NC-1 Condition Level. This is a major NC such as a missing or broken process for a requirement that includes a significant component of patient safety that has the possibility of threat to life.
• NC-1 Immediate Jeopardy. This is a major nonconformity such as a missing or broken process for a requirement that includes a significant component of patient safety that presents an imminent threat to life.

What is the difference between a condition level NC and an immediate jeopardy NC? Facilities managers can compare these two terms with weather warnings. A tornado watch alerts the public to the possibility of a tornado, while a tornado warning warns of an existing tornado.

An NC-1 Condition Level indicates that conditions exist where a threat to life is possible. An NC-1 Immediate Jeopardy indicates that not only does the condition exist, but also the threat to life is imminent if corrective action is not taken immediately. A common example would be a dedicated behavioral health room with ligature risk present without a patient in the room compared to the same room with a patient present without supervision.

Again, regardless of the quantity and classification of these types of NCs, accreditation is granted based solely on the effective implementation of sustainable corrective action plans.

A comprehensive and sustainable corrective action plan addresses six core open-ended questions: Who is responsible for the plan? What is the plan? When does the plan take effect, and how long will it last? How does the hospital intend to implement the plan? Why did the deficiency or nonconformity occur? Where does the plan apply?

When each of these six core areas of a formalized comprehensive plan are identified, implemented and monitored, there will be a high rate of success to ensure the corrective action plan will not only work as intended but also will have long-term sustainability and prevent recurrence of the original deficiency. This forces the owner of the plan to evaluate all other areas where similar occurrences may appear.

Risk-based thinking

The basis and intent of the process audit (survey) approach is to utilize risk-based thinking methods and techniques to determine how to identify, monitor, manage and address various forms of risk. By using risk-based thinking, an organization can determine the highest risk vulnerabilities and create custom corrective action plans that are unique to ensure compliance, as long as these corrective action plans meet the intent of the listed requirement.

Health care facilities professionals employ process audits to ensure the consistent application of management plans, that staff members are working off the same set of instructions, and to verify competencies and ensure consistent outputs.

For example, consider a large health care organization that employs 5,000 staff members, 200 of whom are facilities engineers and support staff.

The size of the campus is vast and multiple buildings require five emergency generators placed in different areas of the main facility and at certain support buildings that are not attached to the main building.

The engineering staffing plan outlines an electrician assigned to each building to maintain each generator. How does the health care organization ensure that each of the five electricians are maintaining the generators the same way? What are their competencies? What is the verification process of weekly inspections? Who verifies the records of preventive maintenance?

Process audits can ensure communication, customer satisfaction, collaboration, consistency and, most importantly, continual improvement.

A wider range

Checklists are an important component of the overall operations of a health care facility. However, when the checklist approach is primary, health care facilities professionals tend to allow their hospital to operate and run with the goal of meeting and passing the checklist.

This can narrow the review of the health care facility. Tunnel vision can occur as facilities staff allocate their time and resources to items outlined in the checklist.

While checklists serve a very important purpose, risk-based thinking with a continual improvement mindset allows the combination of information from checklists to be included within process audits.

Thus, the scope of responsibilities opens a wider range of monitoring, review and preventive action plans that can help capture a wider range of possible NCs.

Related article // Adopting risk-based evaluations

An auditor who utilizes risk-based thinking with a process audit will evaluate whether formalized processes are in place, verify evidence of staff training, and validate evidence of inspections completed and the conditions present at the time of the survey to make the final determination of whether a nonconformity (NC) exists and then classify it.

For example, the 2010 edition of the National Fire Protection Association’s NFPA 10, Standard for Portable Fire Extinguishers, states, “Fire extinguishers shall be conspicuously located where they are readily accessible and immediately available in the event of fire.” This will cause an auditor to apply the following classifications to scenarios discovered during a hypothetical audit:

• Noteworthy effort. All extinguishers are readily accessible and properly maintained, and all inspection paperwork is in order.
• Opportunity for improvement. All extinguishers are readily accessible and properly maintained, but monthly inspection was missed once.
• NC-2. Workstation on wheels is blocking two extinguishers in the emergency room (ER), one in the intensive care unit (ICU) and three in the medical-surgical unit.
• NC-1. Workstation on wheels is blocking two extinguishers in the ER, one in the ICU and three in the medical-surgical unit. Additionally, annual inspection was not completed, three monthly inspections were missed, and a fire extinguisher is missing from a cabinet in the ER.
• NC-1 Condition Level. Workstation on wheels is blocking two extinguishers in the ER, one in the ICU and three in the medical-surgical unit. Annual inspection was not completed, three monthly inspections were missed, and a fire extinguisher is missing from a cabinet in the ER. Additionally, extinguisher cabinets were locked on the second floor and only security has the keys, and smoking is allowed in the second-floor patient care unit. There is objective evidence of missed fire safety training by staff in the second-floor patient care unit.
• NC-1 Immediate Jeopardy. Workstation on wheels is blocking two extinguishers in the ER, one in the ICU and three in the medical-surgical unit. Annual inspection was not completed, three monthly inspections were missed, and a fire extinguisher is missing from a cabinet in the ER. Additionally, extinguisher cabinets were locked on the second floor and only security has the keys, and smoking is allowed in the second-floor patient care unit. There is objective evidence of missed fire safety training by staff in the second-floor patient care unit. Further, the fire suppression system is red tagged by the local fire marshal as inoperable, and patients and staff were observed smoking on the second-floor patient care unit.

The checklist approach is an important component of ensuring all applicable areas are touched on. Ideally, checklists are an excellent starting point to establish a baseline, as well as ensure all required areas are compliant. However, when combined with risk-based thinking, the full utilization of checklists is maximized.

About this article

This article is one of a series contributed to Health Facilities Management (HFMmagazine.com) by DNV Healthcare USA Inc. (dnv.com/healthcare)

Brennan P. Scott, CHFM, CHOP, is program manager for acute care/critical access hospital services, head of surveyor development and educator/trainer for DNV Healthcare USA Inc. in Katy, Texas. His email is brennan.p.scott@dnv.com.