In 2008, Det Norske Veritas Healthcare, Inc. (DNV Healthcare) was approved by the Centers for Medicare and Medicaid Services (CMS) to deem acute care and critical access hospitals in compliance with the Conditions of Participation (CoPs) for hospitals.
The survey application process took more than four years to complete, and DNV Healthcare was the first company in over 40 years to submit an application and subsequently have it approved. In 2013, DNV Healthcare changed its name to DNV GL - Healthcare (DNV GL) as a result of a merger between two leading organizations in the field: Det Norske Veritas (Norway) and Germanischer Lloyd (Germany).
This is part 4 of an 8-part series on Accreditation Options for Hospitals and Health Systems. Read
Read Part 1: Accreditation: A CEO’s Strategic Choice
Read Part 2: Understanding the Healthcare Facilities Accreditation Program
Read Part 3: Accreditation Options: Understanding the Joint Commission
DNV Healthcare originated in Norway in 1864 as a risk management company. Det Norske Veritas means “The Norwegian Truth.” Their purpose has always been safeguarding life, property, and the environment.
Believing that the current accreditation programs in the United States had little impact on business practices that are responsible for creating quality and controlling costs, DNV purchased TUV Healthcare, a small US company that already had formed and proposed an accreditation model focused on "improvement" and "sustainability" rather than "survival." DNV’s approach to accreditation utilizes the National Integrated Accreditation for Healthcare Organizations (NIAHO®) requirements and ISO 9001:2015.
At the time of this update, approximately 492 acute care hospitals have pursued DNV GL accreditation. DNV GL also provides accreditation services for critical access hospitals and offers certification in the disease management program/centers of excellence for primary and comprehensive stroke center certification, acute stroke ready, managing infection risk prevention, the hip and knee replacement program, and VAD facility credentialing. DNV GL has certified 138 hospitals for primary and comprehensive stroke centers.
Standards
DNV GL’s NIAHO® standards are directly related to the CMS CoPs and apply to hospitals of all sizes. To focus efforts on the fundamental aspects of the Conditions of Participations, the standards are less prescriptive than TJC’s, and the survey process supports CMS’ quality initiatives with focus on continual improvement prioritized by the organization, and allows organizational innovation to determine the most effective means for compliance using best practices. Hospitals must become ISO 9001 compliant within the first three years, and those that wish to go the extra mile become ISO 9001 certified. Currently, about 180 hospitals are now formally ISO 9001 Certified.
There are currently 25 chapters in the NIAHO® manual. Most of the chapter names coincide with many of the section names in the CMS CoPs and departments or functions within a hospital. NIAHO® standards focus on outcomes and are less prescriptive than The Joint Commission. The standards are arranged in a format similar to the one used in the CMS CoPs. First, the standard is listed, then the Standard Requirement, followed by the "Interpretive Guidelines," and lastly, the "Surveyor Guidance."
Changes to the NIAHO® standards can be broken down into two groups: mandatory and discretionary. Mandatory changes occur when NIAHO® standards are altered to conform to a change in the CMS CoPs. Discretionary changes clarify existing standards or incorporate practices and principles to enhance the NIAHO® accreditation program. Such changes occur through a thorough review process, involving input from the field and applicable agencies and review by DNV GL's accreditation management team.
The ISO 9001 Standard was introduced in 2000 and represented a combination of three standards to focus on process management. Minor revisions in 2008 addressed issues faced by facilities in service industries, including healthcare. Generally, ISO changes the standards no more frequently than every six years.
The latest edition of ISO 9001 was published in 2015. A result of over three years of revision work by experts from nearly 95 participating and observing countries, the 2015 edition includes important changes to bring the standard up to date with modern needs.
The earlier versions of ISO 9001 included many requirements for documented procedures and records, whereas ISO 9001:2015 is less prescriptive, focusing instead on performance.
The primary difference is that ISO 9001:2015 requires a clear and dominant commitment to quality, particularly from leadership. As part of that focus, leaders need to demonstrate an understanding of the context in which the organization operates. Consideration must be given to the internal and external issues affecting the organization relevant to its purpose and strategic direction and the results the organization intends to achieve as leaders establish the Quality Management System. Hospitals are given a year after publication of the standards to transition to ISO 9001:2015.
Survey process
Similar to the processes of CMS, as well as The Joint Commission and other accrediting organizations, NIAHO® surveys are conducted through tracer methodology, in combination with staff and patient interviews and review of medical records. While surveying the hospital to the criteria of the CoPs, DNV GL surveyors also ensure that hospitals are compliant with the ISO 9001:2015 standards throughout clinical and non-clinical areas.
At a minimum, DNV GL sends a nurse or physician surveyor and a physical environment surveyor. This survey team may be complemented by a generalist or additional clinical or physical environment surveyors, depending on the size and complexity of the hospital.
DNV GL does not aggregate the scoring of a survey. In other words, there is no "magic number" of findings or "tipping point" that will cause a hospital to be denied accreditation. Rather, after survey, hospitals receive a preliminary report from the survey team, followed within 10 business days by a final report. The organization is responsible for developing and implementing corrective action plans to address all nonconformities identified. Category 1 Condition-level findings require re-survey.
• For Category 1 nonconformities, the hospital also submits root cause analysis within 10 calendar days to determine what led to the nonconformity, and the actions taken to correct it, including performance measure(s) data, findings, results of internal audits or other supporting documentation, and timelines to attest that correction action measures have been implemented.
Upon the approval of an acceptable corrective action plan, and follow-up survey when applicable for Condition-level nonconformities, the accreditation committee will then make the decision for approval or denial of accreditation. The accreditation will be valid for three years from the effective date subject to annual surveys.
• For Category 2 nonconformities, validation of implementation of corrective measures occurs at the next annual survey. Upon approval of the plan, DNV GL's accreditation committee makes a final accreditation decision, and the hospital's accreditation goes into effect on the last day of the survey.
DNV GL accommodates new members by phasing in the ISO 9001 standards, while requiring compliance with all CoPs/NIAHO® standards. Hospitals have three years in which to achieve compliance.
Full compliance is assured through a series of annual surveys that roughly follow this timeline:
• Year 1 – NIAHO® accreditation and high-level introduction to ISO 9001
• Year 2 – NIAHO® accreditation and ISO 9001 pre-assessment survey (much like a mock survey, the pre-assessment survey measures readiness and identifies any gaps in compliance)
• Year 3 – NIAHO® accreditation and stage one ISO 9001 surveys (to confirm hospital readiness for an ISO 9001 Compliance/Certification Audit).
• Year 4 – NIAHO® accreditation and ISO 9001 compliance/certification audit. ISO 9001 compliance is a requirement for DNV Healthcare accreditation. ISO 9001 certification is not a requirement.
• Year 5 – NIAHO® accreditation and ISO 9001 periodic audit
• Year 6 – NIAHO® accreditation and ISO 9001 periodic audit
It should be noted that survey teams visiting an organization for the periodic audit are doing a routine check-up of the organization’s success. If the team identifies Condition-level findings during the survey, corrective action plans appropriate for the Condition level will need to be developed and implemented with required data submission expectations to support correction of Condition-level findings. Successful implementation of corrective action plans will be assessed at the next review.
Benefits
DNV GL's approach to accreditation is designed to allow organizations to be innovative, as the standards are less prescriptive and best practice is encouraged. Through testimonials on the DNV GL website, some organizations appear to be seeing a transformational change to their quality management system as well as improved communication between leaders, staff, and physicians. Hospitals report that the most helpful ISO standards concern internal auditing, making the quality oversight committee central to hospital functioning, analysis (not just collection) of data, and required contract review. Because hospitals are given leeway to achieve compliance over time, they can avoid the rush to make corrections that are not sustainable.
One myth that has circulated is that DNV GL disregards patient safety goals. In reality, their philosophy is that hospitals should develop individualized programs to address their particular safety issues. Thus, NIAHO® accreditation requires hospitals to be accountable to ensure that quality management processes are planned, managed, measured, documented and improved.
DNV GL is working to change the "culture of accreditation" by creating partnerships with their accredited hospitals to collaboratively work together to focus on continual improvement, apply innovative methods for compliance and patient safety, and ensure the quality of care provided to their patients. At the same time, DNV GL aims to hold hospitals accountable to ensure they are compliant with their standards that also meet the CMS CoPs. This unique approach to the accreditation process has been very well received and is attributable to their growth.
Costs
Costs of NIAHO® accreditation by DNV GL fall into two general categories: preparation costs and survey costs. Preparation costs derive mainly from standards manuals and human resources necessary for achieving readiness. (NIAHO® Standards, Interpretive Guidelines, and Accreditation Process can all be downloaded for no charge at dnvglhealthcare.com. The ISO 9001 standards can be purchased at www.iso.org.) Because the NIAHO® survey process involves yearly, on-site surveys to encourage readiness, DNV GL argues that hospitals will be able to avoid the "ramp-up" costs normally associated with other forms of accreditation. The thinking here is that more surveys lead to a better understanding of organizational readiness, and therefore fewer surprises and less need to quickly assign resources to address concerns.
In addition, DNV GL asserts that there are no indirect costs associated with NIAHO® accreditation. In fact, their literature cites, by way of contrast, the model of Joint Commission Resources, affiliated with The Joint Commission, which sells consulting and publications to hospitals to help them prepare and maintain Joint Commission standards.
DNV GL offers various free training resources, including webinars. The company also provides, at a cost, day- and week-long training programs, on-site programs for individual organizations, and personal training and updates at any given hospital. These may, in fact, be considered indirect preparation costs. DNV GL does provide a unique program not provided by other accreditation organizations: one person from the organization can attend a training program on the NIAHO® and ISO 9001 standards at no charge.
As a note, DNV GL can serve an advisor, including training and education, for ISO 9001 certification, but they cannot write hospital policies and procedures that DNV GL would then assess through their accreditation and certification process. In short, DNV GL cannot “certify” their own work.
Survey costs, as quoted by DNV GL, address the survey fees plus any travel expenses associated with actual on-site survey activities. The number of “survey days” (2 surveyors x 2 days = 4 survey days) is based on the number of surveyors and the length of the survey, which are usually determined by the following factors:
• Size of the facility, based on average daily census and number of FTEs
• Complexity of services offered, including outpatient services
• Type of survey to be conducted
• Presence of special care units or off-site locations, and the distance from the main campus
All in all, NIAHO® accreditation by DNV GL provides a compelling option for hospitals seeking flexibility in meeting compliance standards, as it is designed to enable more innovative practices but also still hold hospital accountable. The goal of NIAHO® accreditation by DNV GL is to widen the scope of the quality management system to encompass the entire organization.
More information about NIAHO® accreditation can be found at www.dnvglhealthcare.com.
In the next article in the Accreditation Options series, we discuss the Center for Improvement in Healthcare Quality.
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This article was previously published in Becker’s Hospital Review. Compass Clinical Consulting has updated the content to reflect the myriad of changes in the Accreditation Options since previous publication in 2014.
Victoria Fennel, PhD, RN-BC, CPHQ has more than 20 years of healthcare leadership experience. She has spent the majority of her career in nursing leadership roles and brings expertise in evidence-based practice, nursing education, quality management, performance improvement, accreditation, risk management, patient safety, and patient-centered care. As Director of Accreditation and Clinical Compliance for Compass Clinical Consulting, Victoria manages accreditation and compliance engagements, directs client education and advisement, and has led Compass’ efforts to help healthcare organizations prepare for scrutiny from accrediting bodies such as the Centers for Medicare and Medicaid Services (CMS), the Joint Commission (TJC), and Healthcare Facilities Accreditation Program (HFAP).
The views, opinions and positions expressed within these guest posts are those of the author alone and do not represent those of Becker's Hospital Review/Becker's Healthcare. The accuracy, completeness and validity of any statements made within this article are not guaranteed. We accept no liability for any errors, omissions or representations. The copyright of this content belongs to the author and any liability with regards to infringement of intellectual property rights remains with them.