Review of Increased Identification of Clostridium difficile at Ennis General Hospital 2007 Key Findings and Recommendations Dr Mary Hynes Dr Kevin Kelleher April 2008 1
Glossary of Terms ADON Assistant Director of Nursing CDAD Clostridium difficile Associated Diarrhoea CNM Clinical Nurse Manager CDT Clostridium difficile Toxin DON Director of Nursing ECU Elderly Care Unit EMT Executive Management Team HCAI Healthcare Associated Infection ICN Infection Control Nurse IPCC Infection Prevention and Control Committee IV Intravenous MWRH Midwestern Regional Hospital MWRHE Midwestern Regional Hospital Ennis MWRHL Midwestern Regional Hospital Limerick NCHD Non Consultant Hospital Doctor 2
Introduction The authors were asked by the National Directors Population Health and National Hospitals Office to examine the circumstances pertaining to a probable outbreak of Clostridium difficile at the Midwestern Regional Hospital Ennis (MWRHE) in March-April of 2007. The scope of the review covers the time period leading to the recognition of the increased number of cases at MWRHE and ends 20 th December 2007 when the authors visited the hospital. The review focused on the level of C. difficile in the hospital, clinical and non-clinical factors potentially contributing, measures taken to contain the situation and learning for the hospital and healthcare system as a whole as a consequence. Our findings and recommendations are based on the following: Written evidence including reports, correspondence, minutes of meetings, procedures and guidelines provided to us (a listing of all written material is included at Appendix 1). The local epidemiological investigation had not been fully finalised within the timeframe of this review. Interviews and meetings with MWRHE personnel, consultant microbiologist, Population Health Personnel (Appendix 2 lists all those spoken with) A tour of all ward areas including Accident and Emergency Department 20 December 2007 Consideration of relevant publications and documents as set out in Appendix 3. Key Findings When in late October 2007 data were analysed in a Statistical Process Control (SPC) chart showing C. difficile Associated Diarrhoea (CDAD) trends in MWRHE from 2003 to 2007, it was evident there were more cases than would be expected at that hospital for Quarter 1 & 2 of 2007. This trend was markedly different to the trend in other hospitals in the region which were showing a downward trend. Fifty patient episodes of CDAD affecting 46 patients were reported with onset 1 Jan 30 Jun 07. The number of cases per month peaked at 18 cases in April and fell steeply to four cases in May and two in June. Levels remained at baseline for the remainder of the year. The hospital had no effective system for surveillance of C. difficile during the period. As a consequence a probable outbreak that involved 50 episodes of disease was not identified at hospital or ward level. Forty six, mainly elderly, patients were affected, 39 women and seven men. The diagnosis was discussed with either patients or their families as appropriate. Forty one of the 50 episodes occurred in patients 75 years of age or over. Twenty two of the episodes occurred on the female medical ward. Most of the patients had well recognized risk factors for the development of CDAD. Of the 46 patients, 15 died within 30 days of being diagnosed with CDAD. Thirteen of those who died were 75 years or over and two were aged 65-74years. None of the 15 Death Notification Form (DNF) recorded death as directly due to CDAD. Eight of the 15 DNFs contained CDAD as antecedent cause or significant condition in death. Nine patient notes made mention of CDAD as contributory to death. In four of these nine cases there was no mention of CDAD on the Death Notification Form. From information obtained as of December 2007, 21 of the cohort of 46 are deceased. CDAD was mentioned on the DNF of one of these six additional patients. In summary, CDAD was mentioned either on the DNF or in the case notes as being a contributory factor to death in 13 patients; in none of these patients was CDAD the primary cause of death. 3
A particularly virulent and highly transmissible strain PCR ribotype 027 was found in 11 of the 19 strains typed by a UK C. difficile typing reference facility. There is one consultant microbiologist in Network 7. MWRHE does not have a designated sessional commitment from either a consultant microbiologist or infectious disease consultant. Telephone advice and support is available from the consultant microbiologist based at the MWRH Limerick. A 0.5 WTE ICN was appointed to the hospital in 2002. An additional 0.5 WTE was appointed in November 06 with an increase to 30 hours per week in January 08. A recently appointed antibiotic liaison pharmacist has 0.2 WTE commitment to MWRHE. There had been ongoing concerns re hygiene levels at the hospital. While focused efforts to improve hygiene achieved improvements, they were not sustained in all areas of the hospital. Female Medical ward was identified as an area of particular concern. On the Female Medical Ward difficulties were experienced with the bed pan washer during the early part of 2007 resulting in leaking, breakdowns and maintenance callouts. At times bedpans were washed by hand. The bedpan washer was replaced in June 07. Occupancy levels on Female Medical Ward Jan-May 07 ranged from a high of 105.9% in February to a low of 99.9% in May. Infection Control Nursing raised ongoing concerns about the level of background C. difficile in the hospital. A range of procedures and guidelines had been developed in response. Adherence to many of these has been patchy with practical difficulties in implementing appropriate patient isolation, adherence to antibiotic prescription guidelines and poor attendance by support staff at infection control training sessions. The hospital Infection Prevention and Control Committee (IPCC) was in abeyance since September 2006 until it reconvened under the Chairmanship of the Hospital General Manager in December 2007. Four meetings have been scheduled for 2008. The Committee does not have input from either a consultant medical microbiologist or an infectious disease consultant. While there was some awareness of an increased level of C. difficile in the hospital in Q1 2007, particularly by ICN and medical consultants, the extent of the problem was not appreciated initially by either management or clinical staff at the hospital, many of whom considered MRSA or norovirus a bigger threat. The main focus was on best management of individual patients. The absence of the Director of Nursing on special assignment from March until October, the absence on sick leave of the Female Medical Ward Manager April 06 2 Apr 07 and the absence on annual leave of the ICN 9 April 23 April may have contributed to the delay in taking definitive action in relation to the increase in cases. The situation was not declared as an outbreak and an Outbreak Control Team was not convened. Other than advice from the consultant microbiologist, help was not sought at Hospital Network level or from the Public Health Department. It is now planned to present Healthcare associated infection (HCAI) surveillance data monthly to the Executive Management Team of the hospital and the IPCC will also function as the Outbreak Control Team as necessary. A range of actions were taken which are likely to have contributed to curtailing the level of C. difficile in the hospital. These included: raising awareness with consultant and nursing staff verbally and in writing, additional intensive cleaning, improved hand hygiene facilities, increased education and training on hand hygiene and infection control, renewed focus on appropriate antibiotic prescribing. Disposable curtains were introduced in one area of the hospital and their use extended subsequently to other 4
areas of the hospital. Cohorting arrangements were not satisfactory and an isolation ward was not established. Difficulties have been experienced in sustaining the levels of cleanliness at ward level and further improvements in hand hygiene facilities are in train. Tazocin 1 has been recommended for broad empiric antibiotic cover in medical wards and elderly patients. There has been little change in the level of Tazocin, Co- Amoxiclav, Zinacef or Ciproxin (400mg/200ml) IV prescribed in the hospital between Jan-Jun 07 and Jul-Dec 07. There was a 70% reduction in Tavanic iv prescribing, a 64% reduction in Rocephin iv, a 62% reduction in Tarivid iv, and a 48% reduction in Ciproxin (200mg/100 ml) iv prescribing between the first six months of 2007 and the 2 nd half of the year. Restricted use of Claforan has been recommended in the hospital since April 2006. It was dispensed on 39 occasions Jan-Jun 07 and this increased to 49 occasions 1Jul-, a 25% increase. A new medication Kardex was introduced in Dec 07 which includes space to record the indication for iv antibiotics and provides prompts for stopping both intravenous and oral antibiotics. MWRHE is an 88 bedded hospital with 8 single rooms and 3 2-bedded rooms. Additional beds are put up regularly. Putting up an additional bed in the Female Medical ward impedes access to the hand basin in one of the rooms. None of the rooms or ward accommodation has ensuite bathroom facilities. The hand basins in the single rooms are standard domestic fittings and are not clinical hand hygiene facilities. Alcohol hand rub is widely available. Toilet facilities for the A & E department are across a corridor from the Department. There is no facility to isolate a patient with diarrhea in the A & E department or the Intensive Care Unit. Distance between beds is less than recommended for good infection control practice and additional hand hygiene facilities are required. Wards have no clinical side-rooms. Storage space on wards is severely limited resulting in a cluttered appearance. There are still extensive areas of wooden flooring not in keeping with a modern hospital environment. All of these factors combined with high occupancy levels contribute to difficulties in limiting the spread of C. difficile in the hospital. Notwithstanding these constraints, it is evident that great efforts have been made in relation to the environment and that these efforts have been more successful and sustained in some ward areas than others 2 C. difficile levels remained at or below baseline from May 07 onwards. An Assistant Director of Nursing has been assigned to have lead responsibility for hygiene in the hospital. The infection control nurse is at CNM2 level, on a par with ward managers. There is some tension arising as a result of the reporting arrangements of infection control staff and these should be reviewed. 1 Antimicrobial trade names were used in the hospital report provided and have been retained in this review. 2 A formal hygiene audit was not carried out by the reviewers. 5
Recommendations For MWRHE The Executive Management Team (EMT) of the hospital must regularly receive information about incidence and trends in healthcare associated infections in the hospital (as has already been agreed). The EMT must ensure rapid identification and notification of outbreaks, establishment of a multidisciplinary outbreak committee which meets regularly, rapid institution of recommended changes, close monitoring of all components of the management of outbreaks including cleanliness, decontamination, the environment for patients, antibiotic regimes, communication with patients, staff, other parts of the HSE (particularly the local Public Health Department) and outside agencies. The re-established Infection Prevention and Control Committee should meet on a regular basis (as had been agreed). The hospital should designate a senior executive with responsibility for infection control. A named individual should be identified in each ward or clinical area with responsibility for implementing recommendations on hygiene and infection control and prevention. Dedicated sessions of a consultant microbiologist should be identified for the hospital. The planned programme of upgrading hand washing facilities should proceed as a matter of urgency (this is currently in train). There should be an intensive programme of hand hygiene education and training of all staff followed by audits of compliance with good practice There should be a systematic programme of infection control education and training of all staff with documented attendance and follow through of non-attendance. Links with the laboratory in MWRHL should be strengthened with provision of regular timely surveillance reports and alerts to ICN in MWRHE Guidelines on appropriate antibiotic prescribing need to be reinforced and their implementation monitored. The recently appointed Antibiotic Liaison Pharmacist must be involved actively in the monitoring and supervision of the Hospital Formulary particularly the Antimicrobials. The hospital needs to ensure effective isolation for those patients who pose a potential or actual high risk of infection to others. The practice of cohort nursing of infected patients on open wards must be reviewed and should be stopped for patients with undiagnosed diarrhoea. Accuracy of death certification - where ever appropriate the death certificate should include HCAIs. In the short term, storage facilities convenient to the ward should be identified for items that are not immediately required at ward level. In the medium term, ward accommodation should be reconfigured or replaced to comply with international best practice in relation to infection control. 6
National Recommendations Implementation of the Healthcare Associated Infection and Antimicrobial Resistance National Action Plan (available on www.hse.ie). Key elements of the plan include 1. A public education campaign 2. Standard setting and audits 3. Healthcare worker education and training 4. Focused target areas for surveillance 5. Antimicrobial prescribing 6. Improving personnel and physical infrastructure 7. Governance and performance management The serious risk that C. difficile poses to the health of the public is being increasingly recognised. National guidelines should be developed for surveillance, including case definitions, prevention and control of C. difficile infections. The Health Protection Surveillance Centre is currently preparing guidelines for publication in May of this year. Such guidelines need to be implemented across the entire health care system including acute hospitals, community facilities, nursing homes and general practice. A system should be put in place to ensure that serious adverse incidents associated with infection are reported in a standardized format, are monitored locally and reports collated to provide a national picture. Such incidents would include incidents resulting in death or serious sequelae, outbreaks and ward closures. Measures to ensure that lessons learnt are disseminated across the healthcare system must be put in place. Awareness sessions are required to ensure Managers are aware of the serious and significant impact of HCAIs including C. difficile. In the light of the emergence of the C. difficile 027 strain and the difficulty in getting molecular typing carried out in Ireland, a reference laboratory facility for the organism should be developed. Action plans must be developed for compliance with national hygiene standards and infection prevention and control standards (when published). For Department of Health and Children C. difficile is not a notifiable disease under current Irish Infectious Disease legislation. It is recommended that legislation is amended to include C. difficile as a notifiable infection. 7
Appendix 1 Schedule of information provided to the reviewers Document Date Letter to nurse manager Female Medical ward 10 Sep 03 from ICN re cleaning audit Operational/Service Plans Infection Control Undated Service 2004 Letter addressed Dear Colleagues from ICN 1 Oct 04 re Clostridium difficile toxin and costs of HCAI Operational/Service Plans Infection Control Undated Service 2005 Letter to Hospital Administrator from Infection 7 Mar 05 Control Nurse re environmental cleaning audit Memo to Director of Nursing, Infection Control 8 Mar 05 Nurse, Domestic Superviser, Assistant DON from Hospital Administrator re environmental cleaning audit Memo to Director of Nursing, Infection Control 9 Mar 05 Nurse, Domestic Supervisor, Assistant DON from Hospital Administrator re environmental cleaning audit Letter to all heads of discipline from ICN re Undated infection control training Jan-Mar 05 and Training Day planned for 27 Apr 05 Empiric Antibiotic Guideline Formulary Jul 05 3 rd Edition Minutes Risk Management Steering Group Dec 05 Clare Acute Services Letter to CNM2 Female Medical, all 23 Dec 05 consultants, pharmacist, Hospital Administrator, Director of Nursing, Domestic Supervisor and Clinical Risk Adviser from ICN re higher than usual incidence of Clostridium difficile Toxin, risk factors and recommendations Level II Business Plan 2006 MWRHE Undated (Extract) Summary Infection Control Activities 2005 6 Jan 06 Memo to Hospital Administrator and Director 28 Apr 06 of Nursing, copied to Consultant Microbiologist, Pharmacist, Clinical Risk Advisor, all consultants and CNM2s from ICN re Clostridium difficile toxin Letter to Hospital Administrator, Director of Undated Nursing, all consultants, NCHDs, CNM2s, Clinical Risk Adviser, Clinical Audit from ICNs 8
Document Date Clostridium difficile 1 Jan 06-30 Apr 06 Audit of Infection Control Standards Female 17 Jun 06 Medical Ward Environment Enteric Infection Control Care Plan Jul 06 Letter to Hospital Administrator, Director of 22 Aug 06 Nursing, all CNM2s from ICN re surveillance figures and care plans for MRSA and Enteric Infections.. Minutes of Regional Communicable Disease 20 Sep 06 Control Meeting Audit of Infection Control Standards ECU 9 Jan 07 Ward Environment Audit of Infection Control Standards Surgical 9 Jan 07 Ward Environment Audit of Infection Control Standards Female 10 Jan 07 Medical Ward Environment Letter to Domestic Supervisor copied to 10 Jan 07 Hospital Administrator, Director of Nursing, all CNM2s and Clinical Risk Adviser from ICN re cleaning audits Audit of Infection Control Standards Male 11 Jan 07 Medical Ward Environment Letter to Director of Nursing from Hospital 15 Jan 07 Administrator copied to nurse managers, assistant Directors of Nursing, Domestic Supervisor and Risk Management re cleaning audits Letter to Hospital Administrator from ICN re 26 Jan 07 cleaning Audit of Infection Control Standards Female 30 Jan 07 Medical Hand Hygiene Letter to Hospital Administrator copied to 12 Feb 07 nurse managers, Domestic Supervisor, Risk Management and Assistant Directors of Nursing from Director of Nursing re cleaning audits Annual report Infection Control Activities 2006 2 Mar 07 Letter to Hospital Administrator from ICN re 1 May 07 disposable curtains Letter to all consultants, nurse managers, 18 May 07 Clinical Risk Adviser, NCHDs from Infection Control Nurses re C. difficile and appropriate antibiotic prescribing Letter to nurse manager Female Medical 8 Jun 07 Ward and Domestic Supervisor copied to Hospital Administrator re C. difficile and cleaning audit on ward from ICNs Letter to consultant surgeon from ICNs re Undated 9
Document Date surveillance figures Jan, Feb, Mar 2007. Identical personalized letter sent to all consultants. Letter to consultant surgeon from ICN re 9 Aug 07 surveillance figures Q2 E-mail to Acting DON from ICN 13 Jun 07 Presentation entitled Clostridium difficile: An 22 Sep 07 Emerging Threat by Infection Control Nurse and Clinical Audit Letter to Clinical Audit copied to Drug and 29 Sep?year Therapeutics Committee from ICN re new drug Kardex Memo to all hospital consultants from 9 Nov 07 Consultant Microbiologist re review of C. difficile patients Draft report Preliminary Analysis Clostridium 3 Dec 07 difficile associated diarrhea cases chart review at Ennis General Hospital MWRHE Infection Prevention and Control 5 Dec 07 Committee Minutes Alcohol gel consumption data 12 Dec 07 Antimicrobial consumption rate Letter and Training Proposal Support Staff to Hospital Administrator, copied to ICN, ADON, and Network Manager from Director of Nursing Data on CDAD MWRHE and Network 7 Undated Hospitals Report Infection Control Department Escalation of Clostridium difficile Toxin (CDT) at MWRHE April 2007 Letter to all Department Heads from ICN re doctors induction in infection control issues Report on C. difficile in MWRHE 14 Dec 07 CDT Surveillance January-December 2007 Undated Medication Record Mid-Western Regional Undated Hospital (Ennis) Draft annual infection control report 2007 and 10 Jan 08 annual infection control plan 2008 Female Medical Ward Bed Occupancy Jan- Undated May Female Medical Staffing Levels 2007 Undated Length of Stay by Consultant 2006 and 2007 Undated 10
Pharmacy Reports Report Summary Cost Centre within Drug Group Analysis Antibiotics 1/1/07 to 30/6/07 and 1/7/07 to 6/12/07 Summary Cost Centre within Drug Group Analysis 1/1/07 to 30/6/07 and 1/7/07 to 6/12/07 Male Medical Surgical Department ICU Geriatric Services Female Medical Dispensed report Tazocin 4.5g injection 1/1/07 to 30/6/07 and 1/7/07 to 13/12/07 Dispensed report Claforan 1g inj vial 1/1/07 to 30/6/07 and 1/7/07 to 13/12/07 Dispensed report Claforan 1g inj vial 1/1/07 to 13/12/07 Dispensed report Zinacef 750mg injection 1/1/07 to 30/6/07 and 1/7/07 to 13/12/07 Dispensed report Rocephin 1g powder for iv/im 1/1/07 to 30/6/07 and 1/7/07 to 13/12/07 Dispensed report Ciproxin 200mg/100ml iv 1/1/07 to 30/6/07 and 1/7/07 to 13/12/07 Dispensed report Ciproxin 400mg/200ml iv 1/1/07 to 30/6/07 and 1/7/07 to 13/12/07 Dispensed report Co-Amoxiclav 1.2g iv 1/1/07 to 30/6/07 and 1/7/07 to 13/12/07 Dispensed report Tarivid iv infusion 200mg/100 ml 1/1/07 to 30/6/07 and 1/7/07 to 13/12/07 Dispensed report Tavanic iv infusion 500mg 1/1/07 to 30/6/07 and 1/7/07 to 13/12/07 Date 11
List of Policies and Procedures Title Date of issue Date of revision Untitled refers to Infection Prevention and n/a Control Structures Procedure for the control of antimicrobial 1 Jul 05 1 Jul 06 treatment in Ennis General Hospital Procedure for the management of suspected enteric infections 1 Oct 03 1 Oct 05 1 Jan 06 Source Isolation 1 Jan 06 1 Jan 06 Procedure for terminal cleaning following source isolation 1 May 03 1 May 05 1 Jan 06 Domestic Services Infection Control Notification 1 May 03 1 Jan 06 Management of Risk of Infection to Employees 3 Feb 06 3 Jul 06 Procedure for handling linen/laundry 15 May 03 1 Jan 06 1 Jan 08 Guidelines on control measures for 1 Apr 04 1 Jan 06 Legionnaire s Disease Procedure for the flushing of taps, showers, 1 Apr 04 1 Jan 06 toilets and sluices, cleaning/changing of showerheads Procedure for the cleaning of Nebulisers 1 Apr 04 1 Jan 06 Procedure for the appropriate use of cleaning 1 Apr 04 1 Jan 06 equipment Procedure for the appropriate use of a cleaning 1 Apr 04 1 Jan 06 schedule for general areas Procedure for the use of a cleaning schedule for 1 Apr 04 1 Jan 06 patient equipment Building, Refurbishment, Purchasing 1 Jan 06 n/a Procedure for hand hygiene 1 May 03 1 Jan 06 Procedure for use of glove in patient care 1 May 03 1 Jan 06 Procedure for use of plastic aprons/gowns 1 May 03 1 Jan 06 Procedure for use of masks and eye protection 1 May 03 1 Jan 06 Procedure for screening a patient for MRSA 1 Oct 05 1 Jan 06 Procedure for treatment of MRSA 1 Aug 03 1 Jan 06 Pharmacy pack for the treatment of MRSA 1 Aug 03 1 Jan 06 Procedure for the decontamination of health 13 Feb 06 n/a care equipment prior to inspection, service or repair Procedure for Asepsis 1 Oct 03 1 Jan 06 Procedures outlining the basic precautions in 1 Oct 03 1 Jan 06 dealing with exposure to infective materials (standard precautions) Procedure for the safe use and disposal of 1 Oct 03 1 Jan 06 sharps/needles Procedure for the management of suspected airborne/droplet infections 1 Oct 03 1 Jan 06 12
Title Date of issue Date of revision Procedure for the management and treatment 1 Jan 04 1 Jan 06 of Mycobacterium Tuberculosis (non-hiv, non- MDR) Patient Information Leaflet on Tuberculosis 1 Jan 04 1 Jan 05 The Infection Control precautions required in the management and treatment of a patient with 1 Nov 03 1 Nov 04 1 Jan 06 a blood borne disease i.e. HIV, Hepatitis B, C etc. Procedure for the management of blood and 1 Dec 03 1 Jan 06 body fluid spillages Procedure for the insertion and maintenance of 1 Dec 03 1 Jan 06 urinary catheters The Infection Control management of a patient 1 Apr 04 1 Jan 06 with possible /probable/ confirmed Severe Acute Respiratory Syndrome The appropriate segregation and packaging of 1 Apr 04 1 Apr 06 Healthcare Risk Waste from Healthcare Non- Risk Waste Procedure for the notification of infection to staff 1 Jan 06 n/a Procedure for the prevention of Nosocomial 20 Mar 07 n/a invasive Aspergillosis during construction /renovation activities Procedure for the insertion of a Central Venous Catheter 27 Oct 06 n/a 13
Appendix 2 List of persons interviewed or spoken with Individual Title J Doyle Hospital Administrator J Hennessy Network Manager J Somers Meaney Director of Nursing Mr. G. Byrnes Consultant Surgeon and member of Executive Management Team G Quinn Infection Control Nurse M. Cahir Assistant DON; Acting DON B Collins CNM2 D. O Brien Staff nurse; Acting CNM2 G. Carty Hospital pharmacist Dr. N. O Connell Consultant Microbiologist Dr. M. Mannix Specialist in Public Health Medicine Dr. T. Greally A/Director of Public Health Dr. M. Boland Consultant in Medicine of the Elderly Dr. Rahman Consultant Physician 14
Appendix 3 List of other relevant documents A Strategy for the Control of Antimicrobial resistance in Ireland. Report of the Subgroup of the Scientific Advisory Committee of the National Disease Surveillance Centre. 2001. Draft Standards for Infection Control and Prevention. HIQA. To be published in 2008. Guidelines for Hand Hygiene in Irish Health Care Settings. HPSC, 2005. Hygiene Services Assessment Scheme. www.hiqa.ie/hygiene_standards/index.html Investigation into outbreaks of Clostridium difficile at Stoke Mandeville Hospital, Buckinghamshire Hospitals NHS Trust. Healthcare Commission, July 2006. Management of Infection Related Incidents. A reflexive education programme for core members of Incident Management Teams. Health Protection Scotland. Glasgow, 2006. Investigation into outbreaks of Clostridium difficile at Maidstone and Tunbridge Wells NHS Trust. Healthcare Commission, October 2007. The Control and Prevention of MRSA in Hospitals and in the Community. NDSC, 2005. 15