Holding
Consultants Accountable
Healthcare professionals and hospitals are all too familiar with
accreditation whether it be from The Joint Commission (TJC), Det Norske Veritas
(DNV) Healthcare Facilities Accreditation Program (HFAP), College of American
Pathologists (CAP) or others. Being
accredited carries with it many benefits such as validation that you are
providing quality care, a competitive edge, and maybe most important is
reimbursement from the Centers of Medicare and Medicaid Services (CMS). But does the importance of accreditation from
one the above mentioned accrediting bodies end there?
While being accredited is important for many reasons, it is
important for hospitals and healthcare systems to think beyond their own
accreditation if they really want to drive performance and patient
outcomes. They need to consider the
accreditation of their vendors and the products and services their vendors provide.
A common practice in healthcare is to use the services of
third party consultants to assist in meeting the requirements of accreditation
and /or certification from accreditation and other regulatory bodies. However if the consultant you just contracted
with is not accredited or certified will this affect your results? And what about the materials and tools the
consultants use, are they recognized by a certification or accreditation
body? For example, ICH's ISO 9001 Lead Auditor for Health Care workshop is the only RABQSA recognized ISO 9001 lead auditor for healthcare course in existence. So, the bigger question is, if
your hospital has to meet a set of requirements in order to be accredited,
shouldn’t the consultant that is assisting you to meet these requirements also
be accredited as well as their materials?
ISO 9001 continues to gain recognition in the healthcare
industry even as its implementation remains foreign and can seem overwhelming
to healthcare professionals. As a
result, we are seeing an increase in the number of ISO 9001 consultants rushing
into the healthcare market. This
competition is good, but it does force hospitals to do their due diligence in
choosing consultants that are certified and use materials that are also
recognized by a certification body.
More importantly it is important that the consultant you
choose practices what they preach.
Within the ISO family of standards there are specific clauses that
prevent certification bodies from also providing consultation: ISO/IEC
17021:2011, clauses 5.2.5, 5.2.6 and 5.2.7 (see clauses below). This
is similar in concept to ISO 9001 clause 8.2.2 Internal Audits that indicates: “The selection of auditors and conduct of
audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own
work.” In other words, accrediting bodies shall not
audit or survey their own work, which means that they cannot consult with
hospitals that they also audit, survey, and/or provide accreditation to.
If your hospital or healthcare system is held to a set of
requirements in order to be accredited shouldn’t the consultants you use also
be accredited/certified and held to meet the requirements of their own
certification?
ISO/IEC 17021:2011, clauses 5.2.5, 5.2.6 and 5.2.7
5.2.5 The
certification body and any part of the same legal entity shall not offer or
provide management system consultancy. This also applies to that part of
government identified as the certification body.
5.2.6 The
certification body and any part of the same legal entity shall not offer or
provide internal audits to its certified clients. The certification body shall
not certify a management system on which it provided internal audits within two
years following the end of the internal audits. This also applies to that part
of government identified as the certification body.
NOTE See
Note to 5.2.2.
5.2.7 The
certification body shall not certify a management system on which a client has
received management system consultancy or internal audits, where the
relationship between the consultancy organization and the certification body
poses an unacceptable threat to the impartiality of the certification body.
NOTE 1 Allowing
a minimum period of two years to elapse following the end of the management
system consultancy is one way of reducing the threat to impartiality to an
acceptable level.
NOTE 2 See
Note to 5.2.2.
5.2.2.
NOTE A relationship that
threatens the impartiality of the certification body can be based on ownership, governance, management, personnel, shared resources, finances, contracts,
marketing and payment of a sales commission or other inducement for the referral of new clients,
etc.
