UALITY IMPROVEMENT AND PATIENT SAFETY WHAT IS QUALITY ? Appropriate medical application knowledge of with due regard to the balance between the hazard medical inherent intervention in every and the benefits expected from it It is, however more complex than this. WHAT IS QUALITY ASSURANCE Quality assurance as making sure that the services provided by thehospital are the best possible given existing resources and current medical knowledge. QUALITY FROM WHOSE POINT OF VIEW ? Provider of Health care Services Recipient of the Health care services Organizer services of the Health care PROVIDERS CONCERNS To provide care as per established norms Adequate Self resources satisfaction with the final outcome Should contribute to enhancement of skills, competence and add to experience RECIPIENTS CONCERNS Accessibility Affordability Prompt Less Early attention waiting time diagnosis and cure Return to Productivity as early as possible Humane Treatment ie to be treated with empathy , respect and concern ORGANISERS CONCERNS Responsible to the Society for the funds spent on health care To ensure safety of public and prevent inappropriate or suboptimal care To meet the requirements of the recipient and provider of the health care services at Acceptable costs QUALITY IMPROVEMENT APPROACHES Credentialing Licensure Accreditation Certification Chart recognition QUALITY ASSURANCE CYCLE NEW TRENDS IN QUALITY ASSURANCE Quality council Concurrent monitoring High volume case assessment High risk assessment Standard of quality care Inter disciplinary quality assurance Automation of data sources Performance of the staff WHAT IS ACCREDITATION Accreditation is an external review of quality with four It is based on written and published principal components: standards Reviews are professional peers conducted by The accreditation process is administered by an independent body The aim of encourage development. accreditation is to organizational Focus of standards Patient Staff Safety and employee safety Environment and community safety Information Communication Education and Accreditation Process Applications Screening of the Applications Pre-assessment survey Assessment Survey Review of the recommendations of the assessing body by the Accreditation Committee Recommendations to the board Accreditation decision DOCUMENT REVIEW Quality Manual Various Policies and Procedures Minutes of Meetings of various committees Medical Records Medical / Nursing Audit Adverse Events HAI Action Taken Reports Personal Records of Staff OBSERVATIONS Facility Safety Level of compliance with laid down policies and procedures BMW Management Standard Precautions Patient care Fire Safety Equipment Management PROBLEMS AND CHALLENGES HCOs Ill are very enthusiastic prepared Initial preparation is shoddy Resources Benefits period required initially have a longer gestation PROBLEMS AND CHALLENGES Quality Consciousness at all levels will take time Sustenance and consistency of efforts will be required Commitment on a consistent basis High rates of attrition will require repeated and continual training Public Sector will take a longer time to get into the process Quality and consistency of assessors and assessments These May Look Difficult Initially, But the First steps are Never easy. Also Nothing Is Impossible For, Impossible Means I' M Possible Quality Norms and Accreditation?? Response of Medical Fraternity Expected Response THE CURRENT STATUS OF ACCREDITATION IN INDIA Initializing phase is over. Phase The of consolidation. initial steps have been difficult but the journey has begun. The journey has to continue.......... Especially --------------------------- since ACCREDITATION IS A JOURNEY AND NOT A DESTINATION. Risk Management Plan 1 Agenda What is Quality Risk Management Background Initial steps in guideline development The guideline Scope Process Tools Integration of Quality Risk management Next step 2 Quality Risk Management (Q9) Process consisting of well-defined steps which, when taken in sequence, support better Decision Making by contributing to a greater insight into risks and their impacts. It includes elements such as risk identification, assessment, mitigation, elimination and communication. Risk= probability and severity 3 Background 4 Prior dialogue Use of Risk Management in Pharmaceutical Manufacturing A Process Risk Assessment Model The relationship between risk and knowledge and how to apply them pre and post approval (e.g. Regulatory scrutiny, post approval changes and GMP's, etc). 5 OPS objective (April AC meeting) OPS will implement a review quality system and procedures that will: Recognize the level of scientific knowledge supporting product applications, process validation, and process capability Apply a risk based regulatory scrutiny that will relate to level of scientific understanding of how formulation and manufacturing process factors affect product performance the capability of process control strategies to prevent or mitigate risk of poor product performance 6 Background of the Q9 working group July 2003, Brussels: initial meeting to discuss topic and merits of moving ahead November 2003, Osaka: Developed concept paper and received approval March 2004, London: Drafted outline and agreed on general approach June 2004, Washington: Developed the first draft of the guideline 7 Approach 8 Considerations for moving ahead in ICH \"Develop a harmonized pharmaceutical quality system applicable across the life cycle of the product emphasizing an integrated approach to risk management and science.\" July 2003. Requiring consensus among all regions and developing a guideline to be used by all ICH parties. Proceeding with a process oriented, practical, applicable, predictive, flexible, consistent and integrated approach in mind. 9 What is the problem being solved Product may not be available to patients, when needed May increase the potential for the release of unacceptable product to the market New product introductions to the marketplace may be delayed Delays may occur during implementation of changes and improvements to processes Safe and effective drugs may be discarded or recalled from the market Manufacturers may be reluctant to implement new technologies or continuous improvements to the products or processes Scarce resources may not be optimally allocated Lack of appropriate data to evaluate risk most effectively 10 Benefits Enhanced patient confidence in decision making on pharmaceutical quality Promotes more effective use of regulatory agency and industry resources Establishes a systematic, well-informed and thorough method of decision making which leads to greater transparency and predictability Increased knowledge of exposure to risk Fosters quality by design, continuous improvement and new technology introduction, which generally leads to enhanced product quality 11 Scope This guideline provides a framework that may be applied to all aspects of pharmaceutical quality including GMP and submission/review processes throughout the lifecycle of drug substances (API) and drug (medicinal) products, biological and vaccine products, and the use of excipients and packaging materials. This guideline is not intended to apply to risk management used in a pharmacovigilance setting involving safety and efficacy. 12 Process 1. 2. 3. 4. 5. Initiate Process Assess Control Communicate Review 13 Guiding principles The evaluation of the risk should ultimately link back to the potential risk to the patient. The extent of the risk management process should be commensurate with the level of risk associated with the decision. A more robust data set will lead to lower uncertainty. It is essential to have a clear delineation of the risk question. Risk management should be an iterative process. People who apply risk management should have the appropriate training, skills and experience. The risk management process should be appropriately documented and verifiable. 14 Guide to initiating risk Defining specifically the risk management problem management assumptions leading to the or question, including the question. Assembling background information and data on the hazard, harm or human health impact relevant to the assessment. Defining how the assessment information and conclusions will be used by the decision makers. Identifying the necessary resources, members of the team who have the appropriate expertise, with the leader clearly identified. Asking the right risk assessment question(s) Stating clearly the assumptions in the risk assessment Assessing the quality and sufficiency of relevant data Specifying a timeline and deliverables for the risk assessment 15 Risk Assessment What can go wrong? What is the likelihood (probability) it would go wrong? What are the consequences? Risk analysis is a systematic use of information to identify specific sources of harm (hazards) and to estimate the risk. Risk evaluation compares the estimated risk against given risk criteria using a quantitative or qualitative scale to determine the significance of the risk. 16 Risk Control Risk control describes the actions of implementing risk management decisions. What can be done to mitigate and reduce risks? What options for controlling risks are available? What are the impacts of current risk management decisions on future options for risk management? Risk mitigation focuses on a reduction of severity of harm. Risk reduction focuses on the reduction of probabilities of occurrence of harm and detection of harm. Risk acceptance is a decision to accept risk, i.e., no additional risk control activities are necessary at that time. 17 Risk communication Risk communication is the exchange or sharing of information about risk and risk management between the decision maker and other stakeholders. The information can relate to the existence, nature, form, probability, severity, acceptability, treatment, detectability or other aspects of risks to quality. The communication among stakeholders concerning quality risk management decisions can be made through existing channels. 18 Risk monitoring and review All risk management processes are dynamic/iterative. Quality risk management when applied should benefit from new knowledge with each decision cycle and used to enhance future decisions allowing for continuous improvement. 19 Process flow Initiate Risk Management Process Risk Assessment (Resources, Interfaces & Line functions) Risk Management tools & statistic toolbar Risk Analysis Risk Evaluation Risk Control Risk Mitigation (incl. elimination and avoidance) [Severity] Risk Reduction [Probability] Risk Acceptance Risk Communication Output / Results of the Risk Management Process No additional risk Review (e.g. Inspections/Audits, Complaints) 20 Risk management Tools 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Process mapping Preliminary Hazard Analysis (PHA) Hazard Analysis of Critical Control Points (HACCP) Hazard Operability Analysis (HAZOP Fault tree analysis (FTA) Failure Mode Effects Analysis (FMEA) Failure Mode, Effects and Criticality Analysis (FMECA) Risk Ranking and Filtering Informal Risk Management Taguchi, variation risk management method 21 Supporting Statistical Tools Design of experiments (DOE) Process Capability Analysis Control charts: 1. 2. 3. acceptance control charts. Shewart control charts. Accumulative sum charts) 22 Integration of Quality Risk Management into operations 1. 2. 3. 4. 5. Development (e.g. Specification Setting, Test Method Selection and process development). Regulatory scrutiny during pre and post approval. As a component of Quality systems ( e.g. Auditing, Deviations/Discrepancies, Complaints & Recall Management, Change management) Facility systems management ( e.g. Design, Hygiene, Qualification, environmental control, Preventative maintenance and Computerized systems) Materials Management (e.g. Supply chain, Assessment and evaluation of suppliers and contract manufacturers, procurement and release of material) 23 Integration of Quality Risk Management into operations (Continued) 6. 7. 8. 9. Production (e.g. PAT, Validation, in-process sampling, testing, reporting and trending) Laboratory controls (e.g. validation, testing, methods development, stability). Packaging and labeling (e.g. Selection of container closure system and label controls). Regulatory Authority Activities 24 Next steps June 2004, Draft sent out to the Q9 EWG for review by constituents September 2004, Consolidate comments November 2004, Step II document preparation 25 Organizations represented on the Expert Working Group EU regulators: EMEA (European Medicines Evaluation Agency) and the French Health Products Safety Agency (AFSSAPS) EFPIA: F. Hoffmann-La Roche Ltd. And Eli Lilly &Co. Japan regulators: Division of drugs, National Institute of Health Sciences ;and Compliance and Narcotics Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare. Japan Pharmaceutical Manufacturers Association: Eisai Co., Ltd and Mochida Pharmaceutical Co., Ltd. US regulators: Office of Compliance, CDER ;and office of scientific support, CVM, Food and Drug Administration. Pharmaceutical Research and Manufacturers of America: Merck & Co inc. and Centocor, Inc Canada Regulators: Compliance and Enforcement Coordination Division Health Products and Food Branch Inspectorate Health Canada. Swiss regulators (EFTA): Swiss medic, Swiss Agency for Therapeutic Products. World regulators: Quality Assurance & Safety: Medicines, World Health Organization. Generic Industry: Barr Laboratories, Inc. World Self Medication Industry: CHPA Consumer Healthcare Products Association 26 Definitions Decision Maker - process owner of risk management process Dynamic / Iterative Process - TBD Harm - Damage to health, including the damage that can occur from loss of product efficacy, safety, quality or availability Hazard - the source of harm. Can be a chemical, biological or physical substance, or an event that can cause harm. Product Lifecycle - All phases in the life of a product covering both the inherent characteristics of the product and how these may change over time. The lifecycle is from the initial development through pre- and post-approval until the product's discontinuation and includes the associated regulatory processes. Quality - Degree to which a set of inherent characteristics of a product, system or process fulfills requirements Quality System - A formalized system that documents the structure, responsibilities and procedures required to achieve effective quality management. Requirements - Needs or expectations that are stated, generally implied or obligatory by the patients or their surrogates (e.g. health care professionals, regulators and legislators) Risk - Combination of the probability of occurrence of harm and the severity of that harm (from ISO/IEC Guide 51) Risk Management - Process consisting of well-defined steps which, when taken in sequence, support better Decision Making by contributing to a greater insight into risks and their impacts. It includes elements such as risk identification, assessment, mitigation, elimination and communication. Severity - Measure of possible consequence of a potential source of harm Stakeholder - Any individual, group or organization that can affect, be affected by, or perceive itself to be affected by a risk. The decision makers might also be stakeholders. For the purposes of this guideline, the primary stakeholders are the patient, healthcare professional, authority, regulator, industry, business, customer. 27 References Ayyub, B.M. (2002) Elicitation of Expert Opinions for Uncertainty and Risks. Boca Raton, FL: CRC Press. Ayyub, B.M. (2003) Risk Analysis in Engineering and Economics. Boca Raton, FL: Chapman & Hall/CRC Chowdhry, S. (2002). Design for Six Sigma: The Revolutionary Process for Achieving Extraordinary Profits. Dearborn, MI: Dearborn Trade. Davies, J.C. (Ed.), (1996). Comparing Environmental Risks. Tools for Setting Government Priorities. Washington, DC: Resources for the Future. Haimes, Y . (1998). Risk Modeling, Assessment and Management. New York: John Wiley .Y and Sons, Inc. Konisky, D.M. (1999) \"Comparative Risk Projects: A Methodology for Cross-Project Analysis of Human Health Risk Rankings.\" Discussion Paper 99-46, August 1999. Washington, DC: Resources for the Future. Morgan, G.M., and Henrion, M.C. (1990) Uncertainty. A Guide to Dealing with Uncertainty in Quantitative Policy Analysis. Cambridge, England: Oxford University Press. Morgan, G.M., Florig, H.K, DeKay, M.L., and Fischbeck, P. (2000) Categorizing risks for risk ranking. Risk Analysis 2: 49-58. National Research Council (1994). Understanding Risk. Informing Decisions in a Democratic Society. Washington, DC: National Academy Press Ross, T. and Sumner, J. (2002). A simple spreadsheet-based food safety risk assessment tool. Int. J. Food Micro. 77:39-53. Sparrow, M.K. (2000) The Regulatory Craft Thornton, A. C. (2004). Variation Risk Management. Focusing Quality Improvements in Product Development and Production. Hoboken, NJ: John Wiley and Sons, Inc. 28 Risk Management Strategy Guide The patient-centred risk management strategy for multi-resistant organisms (MROs) a guide for hospitals can adapt for local use The guide is not designed for residential care Australian Guidelines for the Prevention and Control of Infection In Healthcare (2010) Based on: Australian Commission on Safety and Quality in Health Care (ACSQHC) Australian Guidelines for the Prevention and Control of Infection In Healthcare (2010) National approach Best available evidence Risk management framework Patient-centred 2 level strategy - Core - Additional strategies Antimicrobial stewardship promotion Risk management framework Risk management principles applied to MROs 1. Avoid risk Not avoidable in healthcare Must be managed Risk management principles applied to MROs 2. Identify risk Who is at risk? What is infectious agent? 3. Analyse risk How is it transmitted? Why can this happen? How likely is it to happen? What are the consequences? Risk management principles applied to MROs 4. Evaluate risk What can be done to reduce or eliminate the risk? 5. Treat risk Who will do it? How will it be monitored? Risk assessment and modified contact precautions Risk assessment and modified contact precautions already in place in many health services to prioritise single rooms Risk factors: Patient population Setting/infrastructure Local experience of MRO Possible endemic MROs Degree of antimicrobial stewardship Patient-centred risk management strategy for multi-resistant organisms Health care services can adapt to their local needs Transmission-based precautions for all MROs Designed for acute care health services 'Routine Practices and Additional Precautions in Health Care Settings'; Health Canada, Revised July 2011 Adapted Provincial Infectious Diseases Advisory Committee (PIDAC) Routine Practices and Additional Precautions in all Health Care Settings revised July 2011 Based on \"chain of infection\" principles infectious agent source patient environment susceptibility of the host Patient-centred risk management strategy for multi-resistant organisms Risk assessment for management of MROs Consider: Patient risks Environmental risks Organisational risks Patient risks Clinical/additional risk factors Colonised/infected Antibiotic exposure/use Decolonisation opportunities Patient population in hospital area/ ward Risk assessment for management of MROs Environmental risks Layout hospital area/ward Environmental cleaning and disinfection Local prevalence of MROs Organisational risks Level of HCW training in infection control principles Background surveillance monitoring strategies Implementation of antimicrobial stewardship Patient-centred risk assessment Using patient-centred risk assessment Emphasizes consistent practice of standard precautions Tailors the use of contact precautions to local conditions Patient-centred risk assessment Advantages Current status of patient considered Low risk patients/settings Improved access to medical care Less demand on single rooms Reduced financial costs (consumables etc) Potentially less cancelled/postponed procedures Patient not feeling \"isolated\" Disadvantages Risk assess at each episode of care Standard precautions must be rigorously followed Patient-centred risk management strategy for multi-resistant organisms MRO working group Infection prevention and infectious disease consultants representing 5 health services Feedback from regional Department of Health infection prevention consultants 4 pilot study hospitals large metro large regional medium sub regional medium private sub regional Outcome measures No increase in clinical specimens of MROs during pilot Number of times tool misinterpreted Pilot Pilot results 6-8 weeks 52 patients with MRO risk assessed 17/52 standard precautions 35/52 transmission-based precautions Feedback No increase in clinical isolates of MROs Flow chart easy to use Uncertainty with terminology (changed) Scenarios helpful Pilot Limited time for pilot Used the experience of 2 large health services who have risk assessment and modified contact precautions in place 1-2 years No increase in clinical isolates Local policies to assist risk assessment - specify which patient populations and which wards require single rooms and contact precautions Patient-centred risk management strategy for multi-resistant organisms Quick guide flow chart Quick guide flow chart Appendix 1 of the strategy is a quick guide flow chart for assessment clinical risk and additional risk factors Set up with tick boxes Can completed for individual patients and filed in medical record Used as a wall chart Adapt locally, for example specify high risk patient populations and areas/wards Where is the guide? Search: Infection prevention in Victoria Patient-centred risk management strategy for multi-resistant organisms Patient-centred Risk-based approach Guide- adapt locally Acute hospitals Transmission based precautions for all MROs Implementation resources- ACSQHC OSSIE toolkit Case studies Checklists Templates/ worksheets Action plans Project plans URL links Additional reading Implementation resources 5 phase approach to change management developed by the Clinical Handover Initiative at ACSQHC O Organisational leadership S Simple solution development S Stakeholder engagement I Implementation E Evaluation and management http://www.health.gov.au/internet/safety/publishing.nsf/Content/home Patient-centred risk management strategy for multi-resistant organisms Acknowledgements: MRO working group members Rural Infection Control Practice Group (RICPRAC) members Infection Prevention in health services Department Health Infection Prevention in health services initial contact: Theresa Williamson Acting Manager, Quality and Safety Programs 9096 7258 who will liaise with the Director, Quality, Safety and Patient Experience regarding who best to advise theresa.williamson@health.vic.gov.au For the moment all infection control advice will be managed from resources within the department. As usual communicable diseases matters: Communicable Diseases Prevention and Control Unit 1300 651160 Risk management and Medical Liability Risk management and medico-legal issues in reproductive healthcare Risk - The likelihood and consequence of something going wrong Risk management - An approach to improving the quality of and safety of health care by identifying circumstances that put patients, staff and organisations at risk and acting to prevent or control those risks Most commonly accepted definition is that of the joint Australia/New Zealand standard 4360:1999 Risk management and medico-legal issues in reproductive healthcare \"...a logical and systematic method of establishing the context, identifying, analysing, evaluating, treating, monitoring and the communication of risks associated with any activity, function or process in a way that will enable organisations to minimise losses and maximise opportunities. Risk management is as much about identifying opportunities as avoiding losses.\" Risk management and medico-legal issues in reproductive healthcare Input into risk management - - - - - - FFPRHC evidence-based guidelines RCOG evidence based guidelines NICE Guidelines WHO Medical eligibility Criteria Clinical governance Quality Assurance schemes (cervical screening, Colposcopy etc) - Legal sources (CNST, NHSLA, Defence Societies) Risk management and medico-legal issues in reproductive healthcare Responsibility of all staff Part of quality improvement programme Individual roles and responsibilities need to be clearly understood Ongoing training in quality improvement and risk management is important for all professionals working in this field Need to strike a balance between overprotection that inhibits progress and innovation , and insufficient protection which can lead to unnecessary injury, loss or damage. Care and safety of patients, staff and organisation should be of primary concern Risk management in reproductive healthcare - Strategy A structured approach to clinical risk management within a clinical governance framework that meets the needs of patients, staff and organisation Risk management group with a multidisciplinary membership should be in place to provide strategic direction A risk register should be established and systems should be in place to communicate effectively with all staff Risk management in reproductive healthcare - Process Risk management in reproductive healthcare - Risk identification Formal processes should be in place using internal and external data to identify risks to delivery of safe, high quality service Internal sources - - - - - - - - - Incident reports Near miss reports Complaints Claims Patient satisfaction surveys Staff surveys and consultations Clinical audit Risk assessment exercise in all clinical areas Risk management in reproductive healthcare - Risk identification External sources - - - - - National Patient Safety Agency (NPSA) Alerts Healthcare Commission reports Medico-legal Defence Body data Training, accreditation and acquisition of competencies mandatory for practice in the field (DFFP, MFFP, LOCs Risk management in reproductive healthcare - Risk identification Incident reports Missed diagnosis (ectopic pregnancy, missed abortion) Failed operations (TOP, Laparoscopic sterilization, vasectomy) Omission of planned procedures (insertion/removal of IUD, Implanon) Incorrect drug therapy - - - - Omission Wrong drug Wrong dose Wrong regimen Risk management in reproductive healthcare - Risk analysis and evaluation Establish the likelihood of an incident or risk and the consequences that follow Assign a risk score for each risk or incident Risk management in reproductive healthcare - Risk Treatment Identify and consider range of options for dealing with the risk Formulate and Action Plan to be implemented to reduce or eliminate the risk of similar incidents occurring again Risk management in reproductive healthcare - Monitoring, Review and Feedback Risks identified through earlier processes should be entered into a risk register. Escalation to different levels can take place based on present thresholds - Risk management group should meet regularly to monitor and review incidents within the service Regular dialog between protocol and risk management groups Feedback through appropriate means to individuals and within the service Communication to relevant external bodies (CNST, NPSA, MHRA) Medico-Legal issues in reproductive healthcare The Duties Of A Doctor Make the care of your patient your first concern; Treat every patient politely and considerately; Respect patients' dignity and privacy; Listen to patients and respect their views; Give patients information in a way they can understand Respect the rights of patients to be fully involved in decisions about their care; Respect and protect confidential information; Medico-Legal issues in reproductive healthcare Confidentiality Patients have a right to confidentiality Protection against improper or unintentional disclosure Sharing of personal information - within the health care team, (unless patient objects). - with other organisations/agencies providing health /social care. Data Protection Act Medico-Legal issues in reproductive healthcare Disclosure Disclosure without consent may be justified where failure to do so may expose the patient or others to risk or death or serious harm Personal information may be disclosed in the public interest - E.G. Where a disclosure may assist in the prevention or detection of a serious crime. If you believe a patient to be a victim of neglect or physical, sexual or emotional abuse THE NATIONAL HEALTH SERVICE ACT 1977, The NHS Trusts and Primary Care Trusts (Sexually Transmitted Diseases) Directions 2000 Every NHS trust and Primary Care Trust shall take all necessary steps to secure that any information capable of identifying an individual obtained by any of their members or employees with respect to persons examined or treated for any sexually transmitted disease shall not be disclosed except(a) for the purpose of communicating that information to a medical practitioner, or to a person employed under the direction of a medical practitioner in connection with the treatment of persons suffering from such disease or the prevention of the spread thereof, and (b) for the purpose of such treatment or prevention. Medico-Legal issues in reproductive healthcare Consent Agreement for a health professional to provide care Patients can change their minds and withdraw consent at any time. For consent to be valid patient must - Be competent to make decision - Have received sufficient information to make it - Not be acting under duress Medico-Legal issues in reproductive healthcare Consent Consent must be given voluntarily, not under - any form of duress - undue influence from health professionals, family or friends. You should: - give a balanced view of the options; - explain the need for informed consent. - you must declare any potential conflicts of interest Medico-Legal issues in reproductive healthcare Types of Consent Consent can be - written - oral - implied A signature on a consent form does not itself prove the consent is valid Beware of a patient's apparent compliance Medico-Legal issues in reproductive healthcare Competence A patient will be competent if he or she can: comprehend information, which has been presented to them in a clear way; believe it; retain it long enough to weigh it up and make a decision. Seek legal advice if in doubt. Medico-Legal issues in reproductive healthcare Who is competent? Adults are always assumed to be competent unless demonstrated otherwise A competent pregnant woman may refuse any treatment, even if this would be detrimental to the fetus. Young people aged 16 and 17. Younger children who understand fully what is involved in the proposed procedure Medico-Legal issues in reproductive healthcare Young People The Children Act 1989 defines a young person as \"a person who has not yet reached 18 years of age\" The age of consent in England Wales and Scotland is 16 and in Northern Ireland it is 17. This applies to both hetero and homosexual sex Medico-Legal issues in reproductive healthcare The Fraser Ruling The young person understands the doctors advice The doctor cannot persuade the young person to inform his/her parents and will not allow the doctor to inform his/her parents that the young person is seeking contraceptive advice The young person is very likely to begin or continue having sexual intercourse with or without contraceptive treatment Unless s/he receives contraceptive advice or treatment the young person's mental or physical health or both are likely to suffer The young person's best interests require the doctor to give contraceptive advice or treatment or both without parental consent Medico-Legal issues in reproductive healthcare The Children Act The best interests of the child are paramount Duty of disclosure to Child Protection Services - With agreement if possible The need of the young person for a confidential sexual health service vs. the need for protection from sexual abuse and exploitation The law permits the disclosure of confidential information necessary to safeguard a young person. Legal advice should be taken in doubtful cases Medico-Legal issues in reproductive healthcare Child protection Issues Risk of Sexually transmitted infections Past and continuing sexual abuse/assault Undiagnosed mental health problems including self-harm, eating disorders, alcohol and substance misuse Risk of or involvement in prostitution/commercial sex work Vulnerability of those living away from home/accommodated by the local authority Vulnerability of disabled young people/ or those with learning difficulties irrespective of age Medico-Legal issues in reproductive healthcare Child Protection issues Be alert to the possibility of child abuse and neglect Be aware of local area child protection committee procedures and protocols Know the names of relevant named professionals Be aware of your local under 16s guidelines Be familiar with local procedures for checking the child protection register Receive appropriate training to recognise and act on child welfare concerns Medico-Legal issues in reproductive healthcare Record keeping Write legibly Print your name Date and sign all entries Ensure that identifier is at the top of all continuation sheets together with the date. Keep contemporaneous complete, clear, accurate and appropriate record of all consultations including telephone consults Information should be factual- relevant clinical findings, decisions made, information drugs or other treatment prescribed; A copy of all letters should be retained in notes All correspondence and investigations should be filed in date order Use the medical records as a source of information Improve Patient & Staff Safety Objectives Understand the importance of Leadership in successfully implementing TeamSTEPPS Explain the importance of early metrics selection Describe 3 pilot site selection criteria for successful TeamSTEPPS implementation State 3 implementation success factors for TeamSTEPPS and how they can be applicable to your healthcare system or hospital 2 Texas Health Resources 24 centers in North Texas (14 wholly owned hospitals) Over 4,100 licensed beds 133,903 inpatient discharges 1,238,929 outpatient encounters 5,500 active physicians 469,309 ER visits 21,775 employees 89,452 surgeries 27,200 deliveries 3 Importance of Effective Communication Communication failure has been identified as a leading root cause of sentinel events over the past 10 years (Joint Commission) Communication failure is a primary contributing factor in almost 80% of more than 6000 root cause analyses of adverse events and close calls (VA Center for Patient Safety Patient Safety Movement Institute for Healthcare Improvement 100K lives Campaign National Implementation of JCAHO National Patient Safety Goals \"To Err is Human\" IOM Report TeamSTEPPS TeamSTEPPS DoD MedTeams ED Study 1995 Executive Memo from President 1999 2001 2003 2004 2005 Patient Safety and Quality Improvement Act of 2005 2006 Adoption by Military Health System from 2007-2011 2008 2011 Medical Team Training 5 Medical Team Training Johns Hopkins Johns Hopkins Beth Israel Deaconess Medical Center OB/GYN 6 WHO Surgical Checklist \"Checklist Manifesto\" Annals of Surgery, Sept 2010 Medical Team Training Supports Improvement in Dept Performance, Reduced Complications, Increased Staff and Physician Communication & Satisfaction 7 Metrics Selection Patient Safety Culture Survey pre implementation results vs post implementation results Direct on site observations pre and post implementation using the TS observation tool - THR added to each metric observation criteria or questions to ask during the interview process to provide consistency and observer reliability Pre and post implementation HCAHPS scores Stories sell - collect them and share 8 TeamSTEPPS framework builds on team skills Performance Leadership Communication Situation monitoring Mutual support Knowledge Skills Attitudes The TeamSTEPPS tools include many things we already do... but also adds new team skill sets to assure effective communication 9 Learning the Language Leadership Situation Monitoring 1. Briefs 2. Huddles 3. Debriefs 4. Situational awareness - Cross monitoring Mutual Support 5. Task assistance 6. CUS Communication 7. SBAR 8. Call-outs 9. Check-backs 10.Hand-offs 10 10 IMPLEMENTATION PLAN 11 Approach Overview 10 Months 90 days Baseline and pilot preparation 2 years Pilot implementation Large scale rollout Vision Setting Pilot Selection Comprehensive baseline Pre observations PS Culture Survey Satisfaction Results Pilot execution Pilot preparation and design Pilot monitoring and refinement Large scale rollout plan Rollout - Wave 1 Rollout - Wave 2 Pre Obs Corp Approval Leadership meetings Pre Observations Pilot Launch Pilot Mid year Check Pilot Mst Ed Post Obs Trainer Ongoing monitoring and refinement Non-Clinical PSC Progress Post 2012 Obs Survey check Pilot Site Selection Criteria Criterion considered Description Leadership (Sr.) Svc Line/Dept Size Variables Needs to be large enough for multiple team players Department Culture Culture open to change Positioned for success Nurse leadership & support Likelihood of broad nursing participation / support and availability of local champions Willingness to communicate openly Must haves Leadership ready, willing and able to support initiative Encourage feedback as to what works well, and what changes are needed Dept open to honest feedback Safety culture scores Strength of safety culture as measured by PSC survey Adverse Events Willingness to report Positive staff attitude Indicator of being open to team training and use of tools Educator support Dedicated resource to train and reinforce tool utilization 13 Direct Observation Tool Observer - Master or Champion trained Developed to ensure observer objectivity and consistency When completing a Service Line takes 4-6 hours When completing a Dept takes 2-3 hours Complete all shifts so the staff understand this is not just for one shift Perinatal Pilot Champion training - Formal and informal leaders from each shift - Educators to maintain the focus Staff Education slides with talking points Mid year sampling observations Champion meeting connecting the dots between patient safety programs and TeamSTEPPS Shared stories with Leadership and staff End of year post implementation observations 15 Pilot Results Strengths Effectively using TS tools in critical situations in early implementation Successful shift briefs with dept leaders in the service line Consistent use of SBAR and handoffs Improved intercollaborative discharge briefings in certain departments Use of the word \"concern\" stops the line Opportunities for Improvement Early Sr. leadership engagement Improve physician engagement Ensuring use of the TS common language Consistent debriefings Good leadership needed in the service line to set the expectation that TS is 24/7 Shorten length of pilot 16 0 = expected but not observed or found in discussions with staf 1 = observed/discussions but poor 2 = observed/discussions but marginal 3 = observed/discussions and acceptable 4 = observed/discussions and good 17 PG Patient Satisfaction Scores Post TeamSTEPPS Implementation OB/GYN System Implementation 19 Operationalize TeamSTEPPS Develop education for several levels Need a committed leader Physician engagement - elevator speech for brief conversations or info in lounges Large hospitals - implement per Service Line Small hospitals - Single kick off as staff are cross trained to different departments Implement clinical and non-clinical 20 Levels of TeamSTEPPS Education Facilitator Education (Master Trainer Level) Master Trainers (system Super Users) Champions Training (4 hours session) Staff Training - 1 hour by Champion, all received the TeamSTEPPS Pocket Guide Executive Training (1 hour, basic concepts) Physician Training (20 minutes, what is needed the most for their participation) 21 TeamSTEPPS Language Definitions Leadership Brief: Planned, assign roles, establish expectations, anticipate outcomes Huddle: Gather as needed to discuss critical issues & emerging events Debrief: End of activity, discuss what went well and what we can do better Situation monitoring Situation awareness: Know what is going on around you, including cross monitoring your team members Mutual support Task assistance: Ask for and offer support with all team members ONCERNED! CUS: When appropriate, use a CUS word: I am I am NCOMFORTABLE! This is a AFETY ISSUE! Communication SBAR: Summarize your critical messages in a standard format - Situation, Background, Assessment, Recommendation Call-out: Communicate important information and inform team members simultaneously during emergency situations Check-Back: Verbally confirm instructions - "closing the loop" Handoff: During transitions in care, clearly transfer both information and accountability - make sure to offer opportunity for questions Improvement National Strategy & Governance For Quality ?What is clinical governance 'a system through which all of the organizations in the health system are accountable for continuously improving the quality of their clinical services and ensuring high standards of patient care by creating a facilitative environment in which excellence will flourish ' \"clinical governance is a way of making sure that everyone who passes through health system is well cared for\" or System that enable staff to work in the best possible way + Staff performing to the highest possible standards What might that mean in practice Put patients /clients/customers first and last Improve standards of working Learn from experience Enable staff and team Use information effectively The following components have been identified as necessary Clear national standards Mechanisms for ensuring local delivery of these standards Mechanisms for monitoring the delivery of these standards Identify standards Apply standards Monitor standards Evidence-based medicine Manpower planning Clinical audit Clinical standard Continuing professional development and lifelong learning National inquiries job plan Risk management Complaints Monitoring and evaluation Whistle-blowing Research and development key components 1. 2. 3. 4. 5. 6. 7. 8. Clinical audit (individual and service ) National confidential inquiries Evidence-based medicine (? Apply to practice ) Clinical standards (NSFs, NICE, local ) Manpower planning (including retention ) Continuing professional development and lifelong learning Research and development ( including evaluation of care ) Clinical care quality integrated with organizational quality Other components Clinical risk ( self and program (s)) Complaints Job plan and individual performance Critical appraisal Whistle-blowing EB M D & R n co ty ali ti en fid al ic d in dar s Cl n F a st NS s al ic in dit Cl u A rin onito M g& io aluat Ev n PD C t in a pl om s c M a an National confidential inquiries e ow p an r ing M nn a pl Job p t sk men Ri ge lan B W n io t za ty i an ali rg Qu O 1. Clinical audit An audit is an examination or review that assesses and reports on the extent to which a condition, process or performance matches predetermined standards or criteria. It is concerned with resource allocation, financial and general administrative management and, to a certain extent, . substantive issues Considered as tool not goal 2. Evidence-based medicine The process of systematically finding, appraising, and using contemporaneous research findings as the basis for clinical decisions Being health professional you should aim to do only those medical activity that you have evidence it will work successfully Clinical standards. 3 Bounds by which all practices in a given area will be carried out, in achieving the goals and objectives for that area Research and Development. 4 This forms the basis for evidence-based medicine. The NHS Research and Development strategy was launched in 1991 to develop a knowledge-based NHS in which decisions (clinical, policy and managerial ) would have a sound base. This strategy will continue to have pivotal role in collecting new evidence, with support from the Horizon Scanning Center and the National Prescribing Center in identifying new and existing interventions. Risk management. 5 The process of minimizing risk to an organization by developing systems to identify and analyze potential hazards to prevent accidents, injuries , and other adverse occurrences, and by attempting to handle events and incidents which do occur in such a manner that their effect and cost are minimized. Effective risk management has its greatest benefits in application to insurance in order to avert or minimise financial liability. Monitoring and Evaluation. 6 Process of regularly reviewing achievements and progress towards the goals (day to day ) Process measuring the degree to which objectives and targets are fulfilled and the quality to the result are obtained Evaluation and audit requires the assessment of effectiveness and efficiency and the formulation of recommendations to promote improvement. In appraising these elements, however, audit differs from evaluation in orientation or objectives National confidential inquiries. 7 The four existing national confidential inquiries preoperative death, stillbirths and deaths in infancy, maternal deaths and suicides overseen by NICE. 8. Job plan and individual performance This will highlight areas in the job that are not being met, both presently and as the job develops. Continuing Professional Development (CPD). 9 This is about developing a culture that encourages lifelong learning ( the learning organization ) and is an integral part of the job plan. Health organization should commit, plan and act on 'investment in people' if they are truly interested in delivering quality clinical care complaints. 10 Complaints will be monitored both externally and internally. There will have to be an effective local system in place to deal with complaints. Documentation will be particularly important in order to facilitate external scrutiny. Manpower planning. 11 This will establish the required staffing levels to achieve acceptable standards of care. However, this is not just about recruiting the appropriate staff, but also about retaining them. Whistle-blowing. 12 This is to be encouraged. If poorly performing work colleagues are not dealt with/reported, responsibility will be shared. This balance between collective and individual responsibility must be appreciated. Critical appraisal. 13 our ability to critically appraise the strength of the evidence available and its application should be part of our routine practice. peer-review. 14 both internal and external peer-review will be an important tool for assessing the effectiveness of the clinical governance culture and in creating a facilitative environment in which excellence can flourish success For clinical governance to be successful, the following must be in place: Clear lines of responsibility and accountability A program of quality improvement activities Clear policies aimed at managing risk Procedures to identify and remedy poor performance