History

9/18/2012 - a case of aspergillus meningitis was reported to the Tennessee Department of Health

Investigation revealed that the initial patient and 7 more patients had received epidural injections of methylprednisolone acetate from a single compounding pharmacy and at the same ambulatory surgical center

9/26/2012 – NECC recalled 3 lots of methylprednisolone acetate

9/28/2012 – Health Departments and facilities that had administered the recalled lots began identifying and notifying patients

History, continued

10/4/2012 – FDA announced that microscopic evaluation of unopened vials of one lot of methylprednisolone acetate revealed fungi

The CDC website disseminates statistics, patient guidance and clinician guidance updated on a daily basis for the initial weeks of the outbreak

10/18/2012 – CDC and FDA announce finding Exserohilum rostratum in 2 lots of the recalled methylprednisolone acetate along with other nonpathogenic fungi

Local history

One facility in the county used the recalled lots of methylprednisolone acetate

463 patients had received injections with the recalled lots including epidural, facet, paraspinous and sacroiliac joint injections

Notification of exposed patients began on 10/2/2012 with a large number of patients notified on 10/4/2012

Patients began presenting to the hospital ED on 10/4/2012 PM with first patients with abnormal spinal fluid results admitted on 10/4/2012 evening

Two patient cases were identified as already admitted by initiating a search using the list of exposed patients

The Hospital

325 bed community hospital Several patients were diagnosed and being admitted

with meningitis on 10/4/2012 late afternoon and evening. Telephone discussions began with nursing administration, ED, pharmacy and the infectious disease physician. Information about the reported initial cases and treatment recommendations from CDC and ISDH were reviewed.

Patients were admitted to the Intermediate Care Center (ICC) and, if needed, the ICU. Patients were placed in isolation for meningitis while bacterial meningitis was ruled out. Initial treatment with IV voriconazole, Ambisome, vancomycin, ceftriaxone and ampicillin was begun. PICC lines were placed.

The Hospital, continued

Multidisciplinary “Huddle” on 10/5/2012 PM to coordinate the response to the large number of patients in ED, need for numerous LPs and multiple admissions with meningitis

Huddles were held each Monday, Wednesday and Friday through the end of October

ISDH, County Health Department and others joined the huddle by teleconference

CDC physicians arrived in mid October to collect data on the outbreak

The Hospital Huddle

Chaired by Nursing Administration Nursing Supervisor and Unit managers: bed

situation on ICC and ICU and nursing concerns ED physician and manager: logistics of overflow of

patients, need for more LP capacity, order sets for CSF, lab and antibiotic orders, staffing

Pharmacy: availability of antifungals, updates on the FDA investigation, placement of dedicated pharmacist on ICC, monitoring drug interactions and levels, patient handouts on the antifungal medications, met with each patient at discharge for medication teaching

Interventional Radiology: LP procedures, staffing

The Hospital Huddle

IV team: PICC placement and supplies Infection Prevention: reporting and

recordkeeping, coordination with County HD, ISDH

Lab: specimen handling and sending specimens to IDSH/CDC, order sets

Supply Dept.: LP trays, PICC kits, laundry Environmental Services Marketing: press releases and interview

requests Clergy: visiting all patients, contacting their

churches and meeting with community clergy to educate them on the outbreak

The Hospital Huddle

Hospitalists: (all new physicians as of Oct.1)keep them updated on the hospital response and outbreak information

Case Management: ongoing case review with insurance companies, review insurance issues with patients, discharge planning for prescription coverage and ECF placement, application for Pfizer drug assistance program, information to ECFs at discharge

Dietary: coordinate mealtimes with voriconazole dosing schedule, nutritional supplements and special diets

Hospital President: encouragement, support and coordination of response

The Hospital Huddle

Infectious Disease physician: Update huddle on current statistics of the

outbreak and new CDC information Update patient status

Initiate and update order sets for lab tests, medications, consultation orders Identify discharge planning needs Attempt to anticipate upcoming patient care needs in the face of rapidly changing

outbreak information

Fungal Infection Census 10/2 -11/15/2012

10/2

/201

2

10/7

/201

2

10/1

2/20

12

10/1

7/20

12

10/2

2/20

12

10/2

7/20

12

11/1

/201

2

11/6

/201

2

11/1

1/20

120

5

10

15

20

25

Total Inpatient CensusReadmissionsExtradural Infection AdmissionsMeningitis Ad-missions

The Hospital - Statistics Outbreak associated ED visits (October) – 168 LPs (10/4 – 11/15/2012) – 180 Outbreak associated hospital days (October) –

322 Cost of Ambisome and voriconazole

(10/5-11/15/2012) - $277,971 Meningitis patient insurance: Medicare

63% Medicaid18% Private ins15% Uninsured 4%

The Doctor

Infectious Disease physician in practice for 25 years

Solo private fee for service practice, on staff at this hospital for 18 years. Also on staff at three other hospitals and Infection Prevention consultant. Rounds at this hospital on Monday, Wednesday, Friday and PRN. Sees outpatients in office two mornings a week.

Only Infectious Disease physician on staff at this hospital

The Doctor and the Outbreak

Faced with a new fungal pathogen not seen in humans before and with little or no information available to guide diagnosis or treatment.

Rapid influx of patients needing complex treatment with toxic antifungal and antibiotic therapy

Patients and families with questions that had no answers: How do you know I have the infection?

What kind of infection do I have?What is the treatment?How long will I be in the hospital?How long will I need to be treated?How will I know that I’m cured?Why should I have to pay for this?

The Doctor and the Outbreak, continued

Lots of time spent on rounds explaining things known and unknown repeatedly to patients and families

Treating a new disease when the patients, their families and their physician simultaneously learn all of the known information on www.CDC.gov updated on a daily basis

Changing practice to round at this hospital all day every day for the month of October

Seemingly endless phone calls and pages, meetings, teleconferences. Hours of time on paperwork and keeping up to date with the latest information and recommendations from the CDC

The Doctor and the Outbreak, continued Experiencing excellent patient care, kindness

and teamwork at the hospital under difficult conditions.

The challenges of arranging and managing complex post-discharge care

Lawsuits and lawyers Mental and physical fatigue Dealing with the unknown

The Patient

Dealing with the unknown Change of lifestyle: In

the hospital for significant duration Off work/unable to work Need for nursing home or rehabilitation facility Driving restrictions Unable to live independently without help Debilitating side effects of voriconazole Complex outpatient care: meds, labs, office followup

Less effective chronic pain management since cannot have further injections or planned spine surgery

Cost of medical bills, deciding about filing lawsuits

Successful Strategies in an Outbreak

Work together Utilize everyone and their expertise Communicate continuously Be flexible Try to anticipate upcoming needs Remain calm (at least on the outside)