The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

AURORA ST LUKES MEDICAL CENTER 2900 W OKLAHOMA AVE MILWAUKEE, WI 53215 Jan. 10, 2017
VIOLATION: INFECTION CONTROL Tag No: A0747
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on observation, record review and interview, the hospital's infection control program failed to have an active infection control program for the prevention, control and investigation of [DIAGNOSES REDACTED] (TB), in 2 of 2 hospital infection control programs reviewed (Patient Services and Employee Health).

Findings include:

1) The hospital's infection control patient services program failed to prevent the potential transmission of communicable disease in the hospital's geographic community when it failed to notify Patient #3 of positive TB ([DIAGNOSES REDACTED]) conversion results after Patient #3's exposure to active (infectious) TB during an in-patient hospital stay. This occurred in 1 of 3 TB exposure incidents reviewed (Patient #3).

2) The hospital's infection control patient services program failed to have an infection control program that tracked and documented patient notification of TB test results conducted for the patient population exposed to active TB during their in-patient hospital stay, in 1 of 2 hospital infection control programs reviewed (Patient Services).

In addition to the Immediate Jeopardy:

3) The hospital's infection control patient services program failed to thoroughly investigate a communicable disease exposure event by failing to interview the HCW known to be actively infectious [Index Case RN (Registered Nurse) F] while caring for hospital in-patients, in 1 of 2 hospital infection control programs reviewed (Patient Services).

4) The hospital's infection control employee health program failed to ensure that HCWs (health care workers) having direct contact with their patient population had baseline TB testing and/or appropriate medical follow-up, in review of 3 of 10 employee health files of HCWs having positive TB test (having latent or non-infectious TB) results (Staff F, K and L).

5) The hospital's infection control employee health program failed to ensure that health care staff having latent TB were instructed to report signs and symptoms of [DIAGNOSES REDACTED]

6) The hospital's infection control patient services program failed to report all cases of suspected TB as required by Wisconsin state law, in 2 of 4 TB index cases reviewed (F and G).

7) The hospital's infection control patient services program failed to ensure that hospital staff followed hospital infection control policies in the areas of standard precautions, hand hygiene, aseptic medication preparation, in 4 of 9 observations conducted (Staff B, C, D and E).
(Reference A 749 for examples 1-7)

The cumulative effect of the hospital's failures to investigate, prevent and control the spread of communicable disease (TB) in their patient population and the geographic community resulted in a high potential for harm to the health, safety and welfare of their patients and the public. This has the potential to affect the past and current in-patient hospital censuses and the geographic public community.

Immediate Jeopardy (IJ) was determined on 1/10/17 at 2 p.m., with regard to the hospital's failure to develop an infection control and prevention program which notified patients when communicable diseases were identified. The facility's Administrative Chief Nursing Officer A was notified of the IJ on 1/10/17 at 2:10 p.m. The IJ was removed on 1/10/17 at 5:30 p.m. after the facility presented an IJ plan of correction detailing the immediate notification of Patient #3 of TB (tuberculosis) testing results, development of a procedure of notification and information documentation when communicable disease testing is conducted in the patient population, and development of a systemic compliance monitoring plan for compliance maintenance. The deficient practice remains at the Condition-level.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on observation, record review and interview, the hospital's ICP (infection control program) officers: 1) failed to notify a discharged patient of a positive TB test after that patient suffered infectious TB (Tuberculosis) exposure as an in-patient, in 1 of 13 sampled patients with infections (Patient #3); and 2) failed to have a IC (infection control) system to track and document patient notification of TB test results conducted for the patient population exposed to active TB during their in-patient hospital stay, in 1 of 2 hospital infection control programs reviewed (Patient Services); and 3) failed to thoroughly investigate a communicable disease exposure event by interviewing the HCW known to be actively infectious (index case) in-patient caregiver, in 1 of 4 TB transmission investigations reviewed (Index Case Staff F); and 4) failed to have a TB infection control health program that had baseline TB testing conducted upon hire, in 3 of 11 employees files reviewed (RN F, RN K and Medical Assistant L); and 5) failed to have documentation of counseling to direct staff with latent TB to report signs and symptoms of potentially active TB between annual screening questionnaire, in 10 of 11 employees files reviewed (F, J, K, L, N, O, P, Q, R and S) having latent TB; and 6) failed to report all cases of suspected TB as required by Wisconsin state law, in 2 of 4 TB transmission investigations reviewed (Index Case Staff F and Staff G); and 7) failed to ensure that hospital staff followed hospital infection control policies in the areas of hand hygiene, aseptic medication preparation and standard IC precautions to prevent infections, in 4 of 9 total infection control staff observations conducted (Staff B, C, D and E). This has the potential to affect the past and current in-patient hospital censuses and the geographic public community.

Findings include:

1) The 1/9/17 at 2 p.m. record review of " Tuberculosis Control Plan Policy #EH-014, effective 6/94, revised 5/15" revealed "Post exposure protocols will follow the Centers for Disease Control and Prevention (CDC) and the State of Wisconsin Department of Health Services guidelines". Under "Exposures to Active TB, ... B. Infection Prevention will be responsible for addressing exposed patients. Following the Centers for Disease Control and Prevention (CDC) 'Guidelines for the Investigation of Contacts of Persons with Infectious TB', patients identified as falling under the definition of contact with the index patient, and their attending physician as noted in the patient's medical file, will have notification provided within 5 business days from the date of positive lab confirmation".

During interview with hospital IC Preventionist H on 1/10/17 at 1:30 p.m., H identified Patient #3, a [AGE] year old oncology patient, as having a positive TB blood test (QFT=QuantiFeron-TB Gold) result reported to the hospital's ICP (infection control program) on 12/31/16. Patient #3 was one of 268 hospital in-patients that had direct care contact exposure to staff RN (registered nurse) F, who was identified as having active (infectious) TB from 5/31/16 through 11/27/16. H stated Patient #3 had no known history of prior TB tests before the 12/30/16 blood draw, and therefore was considered an "exposure conversion" patient. H stated that no contact had been made with Patient #3 to inform patient of "positive" TB test result as of 1/10/17 at 1:50 p.m., and stated that on 1/9/17 at 8 a.m., an email was sent to Patient #3's oncologist to inform the oncologist of the test result, and that notification that email being read by the recipient (oncologist) was not received as yet.

2) The 1/9/17 at 5:30 p.m. record review of the CDC Guidelines for the Investigation of Contacts of Persons with Infectious Tuberculosis, 12/16/2005, Volume 54/ No. RR-15" revealed under "Table 5. Minimal data recommended concerning each contact of persons with TB" lists "... previous history of TB disease or latent infection and documentation...". Under "Data Management and Evaluation of Contact Investigations" it reflects "Data collection related to contact investigations has three broad purposes: 1) management of care and follow-up for individual index patients and contacts, 2) epidemiologic analysis of an investigation in progress and investigations overall, 3) program evaluation using performance indicators that reflect performance objectives. A systematic, consistent approach to data collection, organization, analysis, and dissemination is required."

During interview with hospital IC Preventionist H on 1/10/17 at 1:50 p.m., regarding the infectious TB index case (staff RN F) contact investigation, H stated that the hospital did not have information showing that the 49 patients coming back for TB exposure blood testing were given their test results. H stated that the TB exposure investigation had no method to assess prior TB history or signs and symptoms of TB before exposure testing was given to the 49 of 268 hospital in-patients exposed to active TB.

3) The 1/9/17 at 5:30 p.m. record review of The CDC Guidelines for the Investigation of Contacts of Persons with Infectious Tuberculosis, 12/16/2005, Volume 54/ No. RR-15" revealed under "Investigating the Index Patient and Sites of Transmission" that "Comprehensive information regarding an index patient is the foundation of a contact investigation.", and revealed under "Interviewing the Patient (Index case)... A minimum of two interviews is recommended... the second interview is conducted 1-2 weeks later... The number of additional interviews required depends on the amount of information needed...".

Record review on 1/10/17 at 9 a.m. of the hospital IC preventionist H's investigative case notes for infectious TB index case (staff RN F) revealed no documented evidence of interview with staff RN F to determine details of course of illness. There is no documented interview evidence to determine when signs and symptoms of illness developed, if RN F was compliant to hospital standard precautions of wearing a mask during cough, or if there were any potential hospital exposures that occurred outside of the assigned work areas.

During interview with hospital IC preventionist H on 1/10/17 at 9 a.m., H stated there was no investigative interview of the index case conducted.

4) The 1/9/17 at 5:30 p.m. record review of The CDC Guidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Health-care Setting, 2005, 12/30/2005, Volume 54/ No. RR-17" revealed under "TB screening procedures for setting (or HCWs) classified as low risk" that "All HCWs should receive baseline TB screening upon hire, using two step TST (TB skin test) or a single BAMT (Blood assay for Mycobacterium tuberculosis) to test for infection with TB... HCWs with a baseline positive or newly positive test result for TB infection or documentation of treatment of latent TB or TB disease should receive one chest x-ray result to exclude TB disease (or an interpretable copy within a reasonable time frame, such as 6 months)...".

The 1/9/17 at 2 p.m. record review of " Tuberculosis Control Plan Policy #EH-014, effective 6/94, revised 5/15" revealed under "IV. Screening of Caregivers, A. At time of pre-placement screening all applicants, including those with a history of a positive TB test or of vaccinations with Bacillus of Calmette and Guerin (BCG), will complete QFT and a TB screening questionnaire. 1. Applicants with a documented history of a positive TB test who have had adequate treatment for the disease or adequate preventive therapy for infection will: a) provide chest x-ray results to Employee Health by: 1) Submitting a copy of a negative chest x-ray done within 12 months from the date of the pre-employment exam...".

a) The 1/10/17 at 10:50 a.m. record review of the employee health files for RN F (infectious index case) revealed a hire date of 5/31/16. QFT testing reflects a positive lab result for latent TB disease on 5/16/16. Results of the 5/16/16 TB screening questionnaire revealed no signs or symptoms of TB disease. Review of RN F's chest x-ray report in F's employee file reflects a date of 3/26/14 (two years before hire).

b) The 1/10/17 at 10:50 a.m. record review of the employee health files for RN K, who has a hire date of 11/8/1984, revealed no documented evidence of baseline TB testing by use of TST or BAMT upon hire.

c) The 1/10/17 at 10:50 a.m. record review of the employee health files for Medical Assistant L, who has a hire date of 2/22/1999, revealed no documented evidence of baseline TB testing by use of TST or BAMT upon hire.

During interview on 1/10/17 at 10:50 a.m. with Employee Health RN Coordinator M, M stated that "there is no pre-employee x-ray done if they (staff) have a positive QFT and no symptoms." This M stated that there was no additional information regarding identification of baseline hire testing for staffs F, K or L at 3 p.m. on 1/10/17.

5) The 1/9/17 at 2 p.m. record review of " Tuberculosis Control Plan Policy #EH-014, effective 6/94, revised 5/15" revealed under "XI. Latent TB Infection, ...B. ...The Employee Health Specialist however will counsel the caregiver about the risks of developing active TB. Counseling will also include a risk assessment of their job duties, and they will be instructed to follow up with Employee Health Services if symptoms of TB develop."

The 1/10/17 at 10:46 a.m. record review of the hospital's annual infection control training program revealed under "Caregiver TB testing and Screening" that "All caregivers are tested for TB at time of hire... caregivers and volunteers that work in facilities that are in low risk category will not be required to complete an annual TB test... Caregivers with a history of previous positive TB test must complete an annual questionnaire from Employee Health." This annual staff education reflects no documented information requiring the latent TB employee to report suspected signs and symptoms of potentially infectious TB to Employee Health. The lack of education about this requirement was verified in interview with Safety Officer U at 1/10/17 at 10:46 a.m.

Record review on 1/9/17 at 3:30 p.m. revealed a list of 54 currently employed staffs with current latent TB (positive TB testing) results. This list was verified by IC Preventionist H on 1/9/17 at 3:30 p.m..

The 1/10/17 at 10:50 a.m. record review of the employee health files for hospital staff F, J, K, L, N, O, P, Q, R and S, selected from the above list, revealed no documented evidence of education or counseling to report sign and symptoms of potentially active TB disease to employee health/hospital when occurring between annual TB screenings.

During interview with Employee Health Coordinator RN M at 3 p.m. on 1/10/17, M stated there was no additional information.

6) The 1/9/17 at 2 p.m. record review of "Tuberculosis Control Plan Policy #EH-014, effective 6/94, revised 5/15" revealed under "II. Policy, C. Post exposure protocols will follow CDC and State of Wisconsin Department of Health Services guidelines."

The 1/9/17 at 5:30 p.m. record review of the Wisconsin Department of Health Services Chapter DHS 145, Appendix A- Communicable Diseases and other notifiable Conditions revealed tuberculosis as a Category I disease. Category I "diseases are of urgent public health importance and shall be reported IMMEDIATELY by telephone or fax to the patient's local health officer upon identification of a case or suspected case. In addition to the immediate report, complete and mail an Acute and Communicable Disease Case Report (form DOH 4151) to the address on the form or enter the data into the Wisconsin Electronic Disease Surveillance System, within 24 hours...".

a) During interview with hospital IC Preventionist H on 1/9/17 at 3 p.m. H was asked to provide all information regarding the investigation of infectious index case RN F. As exit interview on 1/10/17 at 5:30 p.m., there was no documented evidence that H submitted a DOH 4151 case report to the state public health agency as required by state of Wisconsin law.

b) During interview with Hospital IC Preventionist H and IC Medical Officer T on 1/10/17 at 3 p.m., H and T were asked to provide all information regarding the potentially infectious index case for Medical Resident G.
At 4 p.m. on 1/10/17, a case report written by T was reviewed and revealed no documented evidence of the time or date that the local health department was notified. As of exit on 1/10/17 at 5:30 p.m., no additional information was provided by the hospital.






7) The 1/10/17 at 3 p.m. review of hospital policy and procedure titled, "Hand Hygiene..." last reviewed 5/15 states, hand hygiene using alcohol based waterless hand sanitizer should be performed before preparing or administering medication, after removing gloves, after contact with body fluids, and after contact with inanimate objects. Gloves are required when contact with blood or other potentially infectious materials, mucous membranes, or non-intact skin is anticipated.

The 1/10/17 at 3 p.m. review of hospital policy and procedure titled, "Safe Injection Practices" last reviewed 5/15, states the rubber septum on a medication vial should be disinfected with 70% alcohol and allowed to dry prior to piercing.

Observations on 1/10/17:

a) At 11:10 a.m. observation of Environmental Service staff "B" cleaning Patient room. While mopping patient room, "B" moved and reorganized patient equipment and lifted up the bathroom garbage cans without wearing gloves.

Per interview with Director of Inpatient Services "A" at the time of observation, "A" stated environmental service staff should wear gloves while cleaning patient rooms.

b) At 11:20 a.m., observation of Certified Nursing Assistant "C" performing a blood sugar check on Patient #4. "C" washed hands, typed on computer keyboard and entered Patient #4's room. "C" donned gloves that were pulled out of "C's" pocket and proceeded to obtain Patient #4's blood sugar using a glucometer; "C" did not perform hand hygiene prior to donning gloves. "C" removed gloves, then brought the "dirty" glucometer to the nurse's station and set it down on the counter, "C" donned glove on one hand and proceeded to clean the glucometer with a disinfectant wipe potentially contaminating the other hand. "C" did not disinfect counter top after cleaning the glucometer.

Per interview with "A" at the time of the observations, "A" stated staff should not carry gloves in pockets, staff should perform hand hygiene then obtain "clean" gloves from glove box located in patient room. "A" revealed staff should wear gloves on both hands while cleaning "dirty" patient equipment.

c) At 11:45 a.m. observation of Emergency Department Technician "D" inserting Patient 5's intravenous catheter. "D" donned gloves, inserted Patient 5's intravenous catheter, removed gloves, and did not perform hand hygiene. "D" then obtained pen from pocket and picked up blood tubes and urine specimen to label, without wearing gloves; "D" placed potentially contaminated pen back into pocket without cleaning and disinfecting. "D" then proceeded to retrieve clean linen from cabinet in patient room and clean supplies from supply cart without performing hand hygiene first, allowing for potential cross contamination.

d) At 12:00 p.m. observation of Registered Nurse "E" administering intravenous medications to Patient 5. "E" did clean the rubber septum of the Reglan and Benadryl medication vials prior to piercing and drawing up medication into syringes.

Per interview with "A" at the time of the observation, "A" stated staff should clean the rubber septum with alcohol wipe prior to piercing the medication vial.