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Abstract
Purpose – Hospital cleaning and healthcare associated infections (HCAIs) continue to attract adverse
media attention and consumer concern. Parallels exist with similar publicity relating to cleaning and
food safety in the food industry almost 13 years earlier. This paper examines some of the management
solutions developed in the food industry, and discusses their application to healthcare delivery.
Design/methodology/approach – The food industry is managing food safety by adopting a dual
approach based on pre-requisite programmes and Hazard Analysis Critical Control Points (HACCP).
How these differ is described and how the approaches and terminology can be adapted for use in
healthcare is discussed.
Findings – The food industry is moving towards external certification of safety using national and
international standards. The HACCP approach, a management tool and a central requirement of these
standards, is evolving and there is interest worldwide from the healthcare community. Its application
to the decontamination of endoscopes, using conventional HACCP, is presented, as well as suggestions
for a simplified format for managing patient-related procedures. Taking this type of approach to the
management of HCAIs could provide greater transparency, reduce infection rates and increase
consumer confidence.
Practical implications – Potential problems in adopting HACCP, including cost and human
resource, are discussed.
Originality/value – The HACCP method/approach has previously been mentioned in the medical
literature but this paper is one of the few to examine, from basic principles, its infection control
application within a broader approach to quality assurance.
Keywords Hospitals, Cleaning, Quality management
Paper type General review
Background
Healthcare delivery, especially the UK National Health Service, has undergone massive
change (Scrivens, 2005). This includes political/managerial changes, as well as
developments in the diagnosis and treatment of illnesses. Although not immediately
obvious, there are some similarities as well as differences between healthcare delivery
and the food industry (a broad term concerning all stages in the food chain, from
production, processing, transport via retailing and food service, up to and including,
activities of the consumer) (Table I).
One point of similarity, although separated by time, includes considerable adverse International Journal of Health Care
media attention. In the late 1980s (Brownsell et al., 1989) newspaper headlines, TV Quality Assurance
Vol. 19 No. 4, 2006
documentaries and even political resignations related to concerns over food safety and pp. 351-367
the cleanliness and management of food operations. Approximately 15 years later q Emerald Group Publishing Limited
0952-6862
super-bugs, healthcare associated infections (HCAIs) and hospital cleanliness are also DOI 10.1108/09526860610671409
19,4
352
Table I.
IJHCQA
manufacturing and
Comparison of food
healthcare industries
Food manufacturing Healthcare
Size media attention Started late 1980s, continues today Started late 1990s, continues today, possibly
overtaken food in importance as media topic
Quality attributes Many food quality attributes, e.g. taste, smell, Many attributes to quality of patient experience, e.g.
nutrition Food safety and food hygiene prime convenience, caring atmosphere. Patient safety and
importance infection control prime importance
Philosophical approach underpinning safety Precautionary principlea Evidence-based research
Approach to safety management Statutory food hygiene inspections External New statutory hygiene code to be introduced, linked
national/international management procedural to inspections. Infection control policies are expected
standards, e.g. BRC, ISO 22000 which are regularly to conform to national guidelines. Maybe internally
externally audited as part of the standard audited or inspected. Standards tend to be
performance rather than procedural. Subject to
random external checks
Approach to assessing cleanliness Routine microbiology/rapid tests used in Little routine monitoring of the environment. Visual
environmental monitoring, often linked to data assessment primary component of inspections
storage and trend analysis
Note: aThe precautionary principle has been defined as: “when an activity raises threats of human health or the environment, precautionary measures
should be taken even if some cause-and-effect relationships are not fully established scientifically”
Source: Tickner et al. (2000)
regular major news items (Unison, 2005). Central to both, as with many other industries, HACCP and the
is a concern over quality. Quality can be defined in many ways, although the American management of
Society for Quality definition as “the totality of characteristic of a product or service that
bear on its ability to satisfy a stated or implied need” indicates quality is not a single HCAIs
issue but made up of a number of components or attributes (Dillon and Griffith, 1997).
As evidenced by the media attention, within these quality attributes key to
consumers in both healthcare delivery and the food industry is “safety”. Managing 353
food safety and managing patient safety both have a long history; however, their
respective media coverage has resulted in them attracting increased consumer
scrutiny. Patient safety has many dimensions but the one receiving particular media
attention and concerns relates to reducing the level of hospital acquired infections
(National Audit Office, 2004).
In an attempt to bolster flagging confidence in food safety, the Richmond Report
(Richmond, 1991) endorsed the greater application of Hazard Analysis Critical Control
Point (HACCP) as a risk management approach. Details of HACCP, originally
developed for the US space programme, were first published nearly 20 years earlier but
although widely discussed had not been extensively implemented. Since, the early
1990s (Table II), HACCP has emerged worldwide as the basis for managing food
safety.
Date
Figure 1.
Codex logic sequence
IJHCQA HCAIs and bed shortages but also because of increasing concerns over multi-drug
resistant organisms, limited availability of new antibiotics and effective treatment of
19,4 patients.
Figure 2.
Factors influencing
patient quality and safety
The question is, can existing HACCP, or an adapted form, ensure healthier patients? HACCP and the
Before concentrating on HACCP, it is worthwhile examining PRPs in slightly more management of
detail. Definitions from the food industry have been modified for healthcare in
Tables IV and V and Figure 3 and examples of PRP related hospital procedures
HCAIs
include:
357
Term Definition
PRPs Describes all those activities other than specific HACCP plans, which affect food
(patient) safety. Universal steps or procedures that control the operational activities
within a food establishment allowing production of safe food (clinical environment to
minimise patient infection). Managed and documented Table IV.
Clinical HACCP Conduct hazard analysis The process of collecting and evaluating information on Definition of HACCP,
hazards and conditions leading to their presence to decide which are significant for PRPs, etc. – food and
patient safety and therefore should be addressed in the HACCP plan clinical
PRPs HACCP
Indirectly with food safety (patient’s health) Directly with food safety (patient health)
General Product: process specific (procedure specific) Table V.
Lower risk food poisoning (HAI) High risk food poisoning (HAI) PRPs versus HACCP
Figure 3.
PRPs, HACCP and
healthcare
IJHCQA .
design (layout), siting, construction of premises;
19,4 .
Siting, construction of equipment;
.
pest control;
. cleaning/sanitation;
.
raw materials (including water/consumables);
358 .
traceability and recall;
.
personal hygiene; and
.
training.
Cleaning wards/hospital rooms, etc. a subject of much media attention, would in most
cases, be regarded as a PRP rather than as part of HACCP. The precise role of cleanliness
in HCAIs is the subject of debate. One view is that “the inanimate environment is of little
importance in endemic hospital infections but may occasionally have a role in
outbreaks” (Ayliffe et al., 2000), although this view has been questioned (Griffith et al.,
2000; Dancer, 2002). Classified as a PRP, rather than part of HACCP, does not mean the
subject is ignored or unmanaged. The food manufacturing industry certainly places
great importance on cleaning as a means of pathogen control and uses routine
microbiological and ATP testing (a measure of residual organic soil) in cleaning
validation and verification (Griffith, 2005). Considered beneficial for monitoring the
cleaning effectiveness in the food industry, in general these techniques are little used in
healthcare, except possibly microbiological surface testing in outbreak investigations.
Reliance in hospitals is based on simple visual inspection of surfaces, which is known to
be flawed (Griffith et al., 2000; Cooper et al., 2006). In both food and healthcare, the subject
of pathogen reservoirs, survival and prolonged environmental persistence is receiving
increased attention (Griffith, 2005; Griffith, 2006; Sexton et al., 2006; Dancer, 1999; Sattar,
2004; Lemmen et al., 2004). Recent studies (Griffith et al., 2000; Malik, et al., 2002)
highlighted hospital cleaning method inadequacies and how simple changes, along the
lines of food industry good practice, can give significantly better results.
Systems such as HACCP have been mentioned occasionally in the medical literature
(Table VI), although reference to it in winning ways (Department of Health, 2003) has
probably provided the greatest impetus for reviewing its applicability. Included in
action area 1, it would probably have been more accurately located in action area 2
with cleaning equivalent to action area 3/4. Clinical applications of HACCP to date
(Table VI) have tended to concentrate on the prevention of gastrointestinal problems or
be concerned with medical devices. This is perhaps not so surprising given the food
origins of HACCP and the “safe product” orientation of both food processing and the
manufacturing of medical devices.
The Codex approach to food HACCP is based upon the following seven principles,
which are subdivided into 12 steps/logic sequence (Figure 1) (Codex Alimentarius
Commission, 1997):
(1) conduct hazard analysis;
(2) determine CPPs;
(3) establish critical limits;
(4) establish monitoring procedures;
HACCP and the
Year Area Application
management of
1995 Airborne contamination Clean rooms HCAIs
1999 Gastrointestinal infection Expressed breast milk
1999 Gastrointestinal infection Infant formula
2000 General infection control Work flow: minimising cross infection
2000 Gastrointestinal infection Enterobacterial feeds 359
2001 Specific infection control problem Post operative endophthalmitis
2001 Gastrointestinal infection Hospital food
2002 Infection Control Guidelines for Main application to reprocessing of instruments
Acupuncture in Victoria, Australia
2002 Risk management in infection control Various, e.g. management of intravenous lines
2003 Clinical engineering Repair of specific devices
2003 Respiratory infection SARS
2003 Pharmaceutical production Management of specific products, e.g. antibiotics
2004 Specific infection control problems Cystic-fibrosis patient Table VI.
2005 Prevention of MRSA Cleaning Examples from the
2005 Medical devices and infection control Endoscopes literature of clinical
in general applications of HACCP
These principles and steps can be directly applicable to some clinical applications, for
example, the decontamination of endoscopes. Providing a full worked example of a
HACCP plan is beyond our scope, but some examples of how Codex principles could be
adapted for the construction of an endoscopy decontamination HACCP plan are
provided. HACCP starts with assembling a team, which could include:
. nurses;
.
specialist practitioners;
.
administrators/domestic managers;
.
doctors;
.
infection control/microbiologists; and
. external consultants (?)
360
Figure 4.
Endoscopy
decontamination flow
diagram
HACCP and the
Cleaning Disinfection Rinsing Automated Contaminated processing
Bacteria procedure process process processor or water bottle management of
P aeruginosa X X X X X
HCAIs
Klebsiella sp. X X
Enterobacter sp. X X
Serratia X X 361
marcesns
Salmonella sp. X X X
Incl. typhi
Helocobacter X X X
pylori
Bacillus sp. X X
Proteus sp. X X
Mycobacterium X X
tuberculosis
Atypical X X X X
mycobacteria
Fungi
Trichosporon sp. X X X
Rhodotorula sp. X X X
Parasite Table VII.
Strongyloides X X Microogranisms
Virus transmitted by (or shown
Hepatitis B X X to contaminate)
Hepatitis C X X X endoscopes
Decision Tree
Questions
Process step Hazard Control measures 1 1a 2 3 4 CCP Y/N
Clinicians may argue that hazards associated with endoscopies are well recognised and
numerous sets of decontamination guidelines exist (British Society of Gastroenterology,
2003). However, these are “sets of guidelines” and do not describe how the whole process
should be managed, which can cause problems (Hine, 2005). A comparison of an
endoscopy HACCP plan with the current management processes in two existing
endoscopy units is presented in Table IX. This illustrates a critical message about
HACCP that needs to be communicated to clinicians “HACCP does not tell you new
control measures, but how to manage their implementation”. The knowledge base
concerning appropriate/relevant control measures still lies with clinical staff/medical
microbiologists but the change relates to the application of new management skills.
IJHCQA
HACCP LS Unit A Unit B
19,4
LS1 No Partial
LS2 No Partial
LS3 No No
LS4 No No
362 LS5 No No
LS6 No Partial
LS7 Partial Partial
Table IX. LS8 Partial Partial
Comparison between LS9 No No
HACCP and management LS10 No No
systems in two LS11 No Partial
endoscopy units LS12 No Partial
Catering/IC Manufacturing/sterilised
363
Figure 5.
Evolution of HACCP
Figure 6.
Cost balance of HACCP
introduction
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Corresponding author
Chris Griffith can be contacted at: cgriffith@uwic.ac.uk