Because accreditation surveys from the Centers for Medicare & Medicaid Services (CMS) are public, they can make or break an organization’s reputation. This means healthcare leaders are on constant alert for accreditation and regulatory surveyors to arrive at their facilities, as they often do unannounced.
Whether it’s a national accrediting organization such as The Joint Commission or the state department of health walking through the door, these regulatory bodies focus on numerous factors during their surveys. They talk to patients, staff and doctors, and examine everything from disaster preparedness plans and the safe handling of drugs to airflow, ventilation and quality processes that prevent medical errors.
They are also on the lookout for compliance with new standards and regulations issued by federal agencies. The Joint Commission alone accredits hospitals on more than 250 standards, and noncompliance puts organizations at risk for citations or immediate jeopardy, a status that could result in a loss of reimbursement from Medicare and/or Medicaid.
It’s essential for providers to be ready at any time. To adequately prepare, providers need to understand new regulations on the horizon, compliance expectations, staff and evaluator competencies, and leadership responsibilities.
Surveys from The Joint Commission aim to detect known or unknown risks to quality and patient safety as they try to help organizations improve the care and services they provide. In 2017, The Joint Commission changed its approach to accreditation through the launch of Project REFRESH, which has increased the severity and number of findings on survey reports. High-risk standards, which are frequently cited, may result in a follow-up survey by The Joint Commission within 45 days. More severe citations like “immediate threat to life” or “immediate jeopardy” will also result in a follow up survey by CMS.
USP <800> Hazardous Drugs Regulations Now in Effect
As of Dec. 1, 2019, all hospitals are expected to comply with new hazardous drug regulations known as USP <800> or they risk citations from regulatory bodies. These standards center on safe handling, mixing and administration of hazardous medications. They affect not just the hospital pharmacy, but also nursing and ancillary staff such as housekeeping and linen services.
Upgrading facilities to comply with the standards is necessary to help ensure organizations are compliant. An industry expert audit on hospital preparedness would focus on capabilities in three key areas.
- Hazardous drug review. USP <800> requires a facility-level review of all hazardous drugs on the National Institute for Occupational Safety and Health’s list. Depending on the scope of services provided by a hospital, more than 1,000 drugs and dosage forms may need to be evaluated for proper handling or containment methods. This review should be interdisciplinary and drive the hospital’s strategy for USP <800> compliance.
- Facilities and engineering controls. Some hospitals may need to build or upgrade their negative pressure rooms or IV hoods, which will be required for receipt, storage and compounding of certain hazardous drugs going forward. For hospitals for which this is not an option, industry experts can help evaluate alternatives such as consolidation of services, outsourcing or third-party support.
- Policies, procedures and personnel. USP <800> requires the development of standard operating procedures in multiple safety categories including safe handling of hazardous drugs, use of personal protective equipment and spill prevention and cleanup. Existing policies may need to be tweaked or rewritten to fit the new standards, and staff will need to be trained on them – a process that could take several months.
Are you compliant? Download Premier’s USP <800> readiness checklist.
Be Prepared for Immediate Jeopardy
Immediate jeopardy is an unfortunate reality, but one that hospitals should proactively plan for given the potential impacts. If surveyors find conditions to be unsafe, the facility risks losing all CMS reimbursement within 23 -90 days unless the safety concerns are handled within the given timeframe. The facility will have 10 calendar days to submit a corrective action plan, which should include three common elements.
- Leadership roles. Advance planning should identify the right leaders and establish their roles to save time during an immediate jeopardy event. The designated leaders should be prepared to quickly identify the root cause of the issue, and plans must delineate how peers will be kept informed of corrective actions planned. For facility-wide communications, consider using committees such as quality steering councils as well as facility leadership forums, and decide ahead of time how the executive suite and board will be kept updated.
- An education plan. Applicable clinical staff, including providers, will need to hear updates on policy changes and attend educational programs. Having situational, ready-to-go templates of educational materials, updated email lists and an information distribution plan will ensure effective and quick communication. This proactive plan should anticipate educating applicable staff on an as-needed basis and should avoid blanket phrases like “all staff” – does the organization truly need to educate ancillary employees or staff members who are out on leave, disability or a sabbatical?
- Documentation. Think through how to collect and organize all the documents required – and who will be responsible for collecting them – to demonstrate that the facility performed a thorough assessment and took appropriate actions. Required documentation must be presented in a binder to surveyors prior to their revisiting the facility.
It’s important that any action plan be realistic, as a facility will have 18-45 days to show proof of changes and demonstrate compliance with the new plan. For example, if a corrective action plan outlines replacing a piece of costly medical equipment, leaders should consider whether this would be doable within 18 days – given the research, cost and approval process – and consider alternatives to include in the plan, if needed.
Staff and Evaluator Competencies
In addition to standard compliance issues, accrediting bodies and CMS are looking closely at staff competencies. Perhaps the surveyor witnesses an emergency department nurse admixing a medication? The surveyor will more than likely ask for the nurse’s competency file to see if he or she has documented medication admixing training.
Surveyors might ask a central sterile technician to demonstrate or verbalize how to clean surgical instruments. They will also review human resource and departmental competency files to see if training is documented. Staff who oversee performance are expected to be competent to be an evaluator. For example, USP <800> requires a facility to have a designated person who is responsible for developing and implementing appropriate procedures and oversees compliance with the regulations.
Having the right people in the right position with the proper competency and accountability is essential for leaders to create a safe environment. In doing so, they should provide adequate resources, have a general understanding of standards and continuously hold their staff accountable for compliance with regulations and standards.
Standards and regulations necessitate what organizations must do at a minimum, but leading providers strive to excel beyond them.
In Premier’s experience working with organizations to thrive through accreditation survey season, providers that follow three key readiness guidelines see success.
- Prepare for the survey in advance and test readiness with mock surveys. Successful organizations schedule time for internal patient tracer activities and budget for annual mock surveys performed by external consultants.
- Provide resources, such as an accreditation coordinator, to manage rapid changes in survey processes. This person can project-manage, coordinate progress toward goals and ensure all required documents are updated and available at a moment’s notice.
- Sanction a regulatory/accreditation leadership committee to review survey changes and provide assessment results for compliance issues. This committee should also engage the medical staff leadership to alert them of compliance issues, and assign accountability among staff to oversee compliance in their respective units.
The result of a successful survey isn’t just passing it. A successful survey means that an organization effectively demonstrated to surveyors that it provides the best possible care to every patient, every time.
Premier® can help assess and accelerate your readiness for surveys, accreditation and regulations.