Anaesthesia, Pain, Intensive Care and Emergency - Part 7 ppt

PERIOPERATIVE MEDICINE Standards of care in operating theatres F. GRÜNE,T.OTTENS,M.KLIMEK Most clinicians develop “routines”, “protocols”, “standards” or “configurations” for the evaluation and management of diseases they frequently encounter. Espe- cially in anaesthesiology, doctors and nurses are used to working with those standards, dealing with such matters as venous access, spinal anaesthesia and airway management. Where do these standards come from? In many cases, their first drafts were generated by postgraduate trainees and result from “updates” of the advice of their respected teachers, commands received from their consultants and information gleaned from books and congresses. Later, as these trainees gained the ability and freedom to operate in searching and appraising modes, these standards were continuously modified and developed on the basis of the highest level of evidence the operators could find. Furthermore, such evidence is modified by the values accepted by our patients and by our local hospital conditions. For years we have accepted theselocalroutines orstandards orconfigurations.The processof manag- ing our standards costs us a lot of effort, but we consider the time and energy well spent. Today we are confronted with more than local routines: We are invited to read and to follow international or national guidelines, clinical pathways, recommen- dations or disease management programmes—and have the feeling that if we fail to do so this might have bad consequences. Are all of them valid? And what is the role of the “good old standard operating procedure” (SOP)? This article will give an overview of the “jungle” of phrases, definitions and terms concerning standards. In addition, we will describe how SOP can be devel- oped and implemented. Definitions/terminology Every routine, protocol, standard, configuration or pathway for the evaluation and management of illness is based on three questions: 1. What is the best therapy for me (efficacy)? (patient’s view) 2. Which therapy has the best evidence and efficiency for him/her? (physician’s view) 3. Which therapy is most effective/efficient? (hospital economic view) Every health care professional will consider these questions, with the aim of Chapter 25 developing thebest medicaland organisationalpathwayspossible inthe conditions pertaining locally. Increasing shortages of resources in hospitals demand an enhanced economic performance of clinical procedures. This should be achieved by optimising all the work processes involved in the provision of healthcare. Healthcare providers are often confused by the terms used in the field of medical quality improvement. In some countries such terms as “SOP”, “guidelines” and “pathways” are defined by medical societies (Table 1) [1–6]. Table 1. Definition of terms Medical recommendations Are descriptions of diagnostic procedures or therapeutic intervention. Adherence is not legally mandatory, but well reasonable. Are not systematically developed. Standard operating procedures (SOP) SOP can be seen as more specific than guidelines, defined in greater detail. Protocols provide “a comprehensive set of rigid criteria outlining the management steps for a single clinical condition or aspects of organisation”. Clinical guidelines Are “systematically developed statements to assist practitioners and patient decisions about appropriate health care for specific circumstances” [19, 20]. They are sometimes published by international and national medical societies. Clinical pathways Are care paths or managed plans that display goals for patients and provide the sequence and timing of actions necessary to achieve these goals with optimal efficiency [21]. Differences between guidelines and SOPs When we consider the definitions of SOPs and guidelines we have two distinct components (Table 2): first the evidence summary and secondly the detailed in- structions for applying that evidence to our patients [6]. International or national guidelines must be rigorously developed and should pass through an appraisal process using evidence-based medicine criteria. Some authors use the terms SOP and local hospital guideline as synonyms. For the common hospital nurse or physician, nationally produced guidelines still require local adaptation to suit local circumstances and to achieve a feeling of “ownership” in local clinicians, which is a major factor in uptake and use [7]. In their local form, guidelines or SOPs should have three components: a simple algorithm that gives a practical sequence of steps to follow for each patient; an explanation of the contentof thealgorithm; and a detailed summary ofthe evidence that supports such advice (Fig. 1). 282 F. Grüne, T. Ottens, M. Klimek Table 2. The two distinct components of any guideline Evidence component Detailed instructional component Bottom line “Here is the typical effect of this diagnostic/therapeutic/preventative intervention on the typical patient” “Here is exactly what to do / not do with this patient!” Underlying requirements Validity; importance; contemporariness Local relevance Expertise required by those executing this component Human biology, clinical sciences, consumerism, database searching, clinical epidemiology, biostatistics Clinical practice; local patients’ values; local current practice; local geography; local economics; local sociology; local politics; local tradition Site where this component should be generated Clinical guideline: national or international Standard operating procedure: local Form of output Level of evidence Grades of recommendation and detailed instructions, flowcharts Fig. 1. What is a Standard Operation Procedure (SOP)? Standards of care in operating theatres 283 SOPs are a modular instrument of clinical pathways Clinical pathways should only be defined by departments that are responsible for organising and providing healthcare services for the patient from the point of hospital admission to discharge. They must be developed in a multidisciplinary approach and with close cooperation between the different specialties and profes- sions involved.The SOPis aninstrument that is included asone modulein aclinical pathway (Fig. 2) [8, 9]. Legal and political consideration of SOPs When they read SOPs or national guidelines, physicians and nurses are often concerned about their legal status. 1. Are guidelines advisory or mandatory? 2. Do doctors who deviate from guidelines place themselves at increased risk of being found liable for negligence if patients suffer injury as a result? 3. Can compliance with guidelines protect healthcare workers from liability in such circumstances? 4. What legal responsibility do the developers and issuers of guidelines have if their guidance is found to be faulty? Fig. 2. SOP as a modular instrument of clinical pathways 284 F. Grüne, T. Ottens, M. Klimek In a case of medical malpractice, judges and lawyers are looking at medical and organisational aspects of wrong diagnostic or therapeutic procedures. Courts have to assess the applicablestandard of care, the causation (theconnection between the alleged wrongful conduct and the harm suffered by the plaintiff) and the damage, which often involves a medical prognosis. Medical expert testimony helps the court to ascertain what is accepted “state of the art” and proper practice in a particular case. The definition of state of the art is based on medical textbooks, and the expert should be a graduate in a medical specialty. International experience shows that guidelines or SOPs are regarded as “just another form of expert evidence” [10]. For consideration of the state of the art in medicine in the future, printed medical textbooks willbereplaced byinternet-based knowledgeresources. Medical societies are asked to develop guidelines based on the best evidence. When the organisational aspects of medical malpractice are considered, hospital boards will be asked to define their clinical pathways so as to reduce the frequency of adverse events consequent on negligence. For example: A young doctor fails in an attempt to intubate a patient. Hypoxia leads to cardiac arrest and death. In this situation the medical expert would be able to explain to the court the state of the art in difficult airway management and resuscitation, basing this explanation on the guidelines of the American Society of Anesthesiologists or the European Resuscitation Council. The defendant doctor would explain why a specific action was taken, or why one was not. If clinical guidelines are meant to enhance the quality of clinical care, then the courts might enquire why such guidelineswere not followed andwhether adecisionnot to follow them was reasonable. But the judge would also ask the hospital board about the organisation of resuscitation officers and the level of education among young doctors and the support available to them, and whether SOPs were in place in the hospital concerned. Effectiveness of SOPs In contrast to the relatively limited data and review of clinical pathways, there has been more carefulappraisal ofclinical protocols andSOPs in themedical literature. When we consider the steps in a patient’s journey through the operating depart- ment, itis obviousthat SOPsare aimed at improving the process qualityand patient outcomes (Table 3). The product of an operation theatre—the surgical procedure performed on a patient successfully,time-efficiently and without complications—is based on three relevant processes: 1. Technical process (instruments, equipment, rooms) 2. Organisational process (workflow, time, methods of work) 3. Social process (knowledge, skills, attitude, motivation, level of cooperation). Standards of care in operating theatres 285 On the basis of these processes, the operating theatre management team can and should produce: 1. SOP for the process (steps in induction of anaesthesia, steps in surgical preparation) 2. SOP for the organisation (set of surgical instruments, operation room equip- ment, teamwork) 3. SOP for calculation the costs (cost of hospital staff, instruments, medicine). This means the clinical pathway–SOP system has the following advantages in operating theatres [11]: 1. Optimised process 2. Implemented best evidence-based medicine 3. Cost-effectiveness 4. Improved education 5. Improved induction of new hospital staff 6. Integrated quality control 7. Transparency 8. Protection from malpractice Table 3. Patient’s path through a surgical department and the role of SOP 1. Risk evaluation SOP for cardiac evaluation, preoperative beta blockade 2. Preparation prior to the surgical procedure SOP for preoperative antibiotic prophylaxis 3. Admission to the operating theatre SOP for preparation prior to operation 4. Induction of anaesthesia SOP for anaesthetic technique 5. Surgical procedure SOP for instruments, disinfection, technique 6. Postoperative care SOP for pain therapy, PONV 7. Discharge from the operating theatre SOP for report Local guidelines or SOPs lead for example to a significant improvement in preoperative antibiotic prophylaxis. Wolterset al.demonstrated that the percentage of cases in which antibiotics were indicated but not administered was reduced from 15.5%to 8.4%.Comparedwith theresultof the retrospectiveanalysis,theprospective study showed a significantly higher percentage of adequately administered antibio- tics (35.7% vs. 63.5%) [12]. Even in such difficult situations as weaning from mecha- nical ventilation the use of SOPs was effective [13]. Rivers et al. provided impressive evidence of the beneficial effect of early goal-directed therapy for patients in septic shock when emergency department care was carried out according to a predefined SOP or protocol. The in-hospital mortality rate was 38% in the early goal-directed protocol group and 59% in the standard care group (P=0.009) [14]. 286 F. Grüne, T. Ottens, M. Klimek Introducing SOPs in your hospital in ten steps Development of SOPs is a structured process [15]. The management team of an anaesthesiology department should ask questions covering matters ranging from the choice of topics through authorisation and membership to the form of reports to be submitted (Table 4). Table 4. Developing SOPs in 10 steps Step Question 1. Choose your topic Which topic is most important and most urgent? Which are our high-cost diagnoses or procedures? Are our nurses and doctors interested in a solution? Is the topic measurable? 2. Authorisation Who will give us support? Every working group needs support an approval from the board of the anaesthesiology department (anaesthesiological topics) or from the board of hospital directors (multidisciplinary topics). This is especially needed in the phase of SOP implementation, in order to break down obstacles. 3. Team Should we invite everybody? It is important to develop a multidisciplinary team for development of critical SOP or pathways. This means including representatives of all groups that would be affected by the pathway (house staff, physiotherapists, dietitians). 4. Moderation Do we expect conflicts among professionals? How difficult is the topic? Moderation should be: neutral and goal orientated. For difficult topics external professional moderators are advisable. 5. The power of the first meeting The first meeting should consider several points: Introduction to auditing Rules of communication Visions and goals (top-down) Expectations and perceptions (bottom-up) 6. Scheduling When will we reach what? Workgroups on SOP should work in a goal-orientated manner with predefined period of times to reach their goals 7. Set standards What is the best evidence? Do we have national guidelines? What are our local conditions? After developing SOPs the team has to define the period of validity (2 years)! Standards of care in operating theatres 287 8. Evaluation Measuring what and for how long? The SOP team has to define indicators. These could be factors of outcome, differences in time or number of personnel. They should follow R.U.M.B.A. principles: Relevant for the selected problem Understandable for providers and patients Measurable with reliability and validity Behavioural, i.e. changeable by behaviour Achievable and feasible 9. Implementation Which implementation techniques are suitable for my hospital? Systematic reviews of rigorous studies provide the best evidence on the effectiveness of different strategies to promote the implementation of research findings Consistently effective interventions are [22]: Educational outreach visits Reminders (manual or computerised) Multifaceted interventions (a combination that includes two or more of the following: audit and feedback, reminders, local consensus processes, or marketing) Interactive educational meetings (participation of healthcare providers in workshops that include discussion or practice) 10. Reports What, when and how? SOPs could be published on paper or on internet/intranet. It depends on the level of implementation All SOP must be coded. The code should include: SOP number, version and period of validity! ThemosturgentandimportanttopicsforSOPdevelopmentcanbefoundinrisk factor studies r elating to anaesthesia management. Arbous et al., in a case-control study, described a n incidence of 24-h postoperative death of 8.8 (95% confidence interval 8.2–9.5) per 10,000 anaesthetics. After mult ivariate analysis they identified equipment check, direct availability ofan anaesthesiologist, presence of a n anaesthetic nurse and no intraoperative changeover of anaesthesiologist as factors associated with a d ecreased riskof death [16]. Kendallet al.showed that60–82.5% ofmachines checked had at least one fault, and 11–18% of these were deemed serious [17]. Montasser cited another example of identified malpractice. Based on the standards of the American Society of Anesthesiologists (ASA), a spreadsheet was d eveloped for documenting features of pre-, intra- and postanaest hetic care. The s preadsheet enabled the re- searcher to document all equipment, supplies and personnel involved from the prea- naesthetic evaluation to discharge. Even in developing nations this evaluation of structure, processes and outcome of a naesthetic practice has improved the identifica- tion of risk factors leading to perioperative death [18]. All these findings support the need for SOPs used as modules in clinical pathways. 288 F. Grüne, T. Ottens, M. Klimek Conclusions 1. Standard operating procedures (SOPs) are a vital component in any quality management system. Written instructions on standardised processes provide guidance to ensure that activities are conducted in a consistent way, leading to reliable product and service quality. SOPs should be prepared in full com- pliance with guidelines and regulations and must mirror current organisatio- nal practices. 2. SOPs can and should be used to decrease variation in care, improve guideline compliance, and potentially improve overall quality of care. 3. Development of SOPs should follow a structured and transparent process. 4. Implementation of SOPs should be backed up by a mixture of dissemination techniques (manuals, intranet, interactive educational meetings). References 1. National Guideline Clearinghouse™ (NGC), sponsored by the Agency for Healthcare Research and Quality (AHRQ), U.S. Department of Health and Human Services, USA. URL: http://www.guideline.gov/ 2. Agency for Quality in Medicine aqumed (Aerztliches Zentrum für Qualität in der Medizin aezq), Berlin, Germany, owned by the German Medical Association (BAEK) and the National Association of Statutory Health Insurance Physicians (KBV), Germa- ny. URL: http://www.aezq.de 3. Programma Nazionale Linee Guida, from Piano nazionale per le linee guida (PNLG), Italy URL: http://www.pnlg.it 4. National Institute for Health and Clinical Excellence (NICE), England, UK. URL: http://www.nice.org.uk 5. Guidelines International Network – G.I.N., Scotland, UK. URL: http://www.g-i-n.net 6. Sackett DL, Straus ES, Richardson WS et al (2000) Evidence-based Medicine. How to practice and teach EBM. Churchill Livingstone, London 7. Grimshaw JM, Russell IT (1993) Effect of clinical guidelines on medical practice: a systematic review of rigorous evaluations. Lancet 342:1317–1322 8. Martin J, Schleppers A, Kastrup M et al (2003) Development of standard operating procedures in anaesthesiology and critical care medicine. Anästhesiol Intensivmed 44:871–876 9. Every NR, Hochman J, Becker R et al (2000) Critical pathways: a review. Circulation 101:461–465 10. Pelly JE, Newby L, Tito F et al (1998) Clinical practice guidelines before the law: sword or shield? Med J Aust 169: 330–333 11. Busse T (1998) OP-Management. R. v. Decker’s Verlag, Hüthig, Heidelberg 12. Wolters U, Schrappe M, Mohrs D et al (2000) Do guidelines bring an improvement in the preoperative course? A study of preoperative antibiotic prophylaxis. Chirurg 71:702–706 13. 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In the United Kingdom’s healthcare system, clinical audit is one part of the “Clinical Governance” project, a project intended to improve the standards of clinical practice in all fields of care Other aspects of Clinical Governance are clinical effectiveness, research and development, openness, risk management and education and training Audit and research—what audit is, and what it isn’t – – – Clinical . documenting features of pre-, intra- and postanaest hetic care. The s preadsheet enabled the re- searcher to document all equipment, supplies and personnel involved from the prea- naesthetic evaluation. patient care and outcomes through systematic review of care against explicit criteria and the implementation of change. Aspects of the structure, processes, and outcomes of care are selected and. 342:13 17 1322 8. Martin J, Schleppers A, Kastrup M et al (2003) Development of standard operating procedures in anaesthesiology and critical care medicine. Anästhesiol Intensivmed 44: 871 – 876 9.