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Based on interviews and review of contract staffs' background check status, the facility failed to ensure that 4 out of 5 contract agencies (Agencies KKKK, LLLL, MMMM, and PPPP) utilized for hospital staff, had completed statutorily required background checks. 68 out of 81 (84%) contracted staff failed to have the required background check completed. This had the potential to put at risk every patient, visitor and staff at 3 of 3 hospital locations, (St. Joseph's, Elmbrook and Wisconsin Heart Hospital.)

This condition is NOT MET as evidenced by:

The governing body did not comply with all applicable requirements for employment. 68 out of 81 contracted staff did not have the statutorily required background checks. (A0083)

The governing body failed to ensure the safety of 4 out of 5 contracted services (Agencies KKKK, LLLL, MMMM and PPPP) when it failed to complete the statutorily required background checks for 84% contracted employees. (A0084)

Based on interviews and record reviews, the facility failed to ensure that 4 out of 5 contract agencies (Agencies KKKK, LLLL, MMMM, and PPPP), which provide staff to the facility, had completed Wisconsin's required background checks: - 68 out of 81 (84%) contracted staff did not have the required background check completed. This had the potential to put at risk every patient, visitor and staff at the facility.

Findings include:

The governing body did not ensure that contracted staff had the statutorily required background checks to ensure that no person is hired that has a record of abuse or neglect.

The entity is required to complete background checks on employees and contractors. This includes employees who provide direct care and may also include housekeeping, maintenance, dietary and administrative staff, if those persons are under the entity's control and have regular, direct contact with clients served by the entity. (also see A-0145)

On 5/15/2013, 2:55 PM, review of background check for Director of Food Service F (DF-F) revealed the required check had not been done. On 5/20/2013, further follow-up with Vice President of Human Resources confirmed that background checks have not been done for 68 out of 81 contracted staff.

Based on interviews and record reviews, the facility failed to ensure that 4 out of 5 contract agencies (Agencies KKKK, LLLL, MMMM, and PPPP), which provide staff to the facility, had completed Wisconsin's required background checks. The results were 68 out of 81 (84%) contracted staff that did not have the required background check completed. By not having the statutorily required background checks, the governing body could not ensure that the services performed by contracted staff was provided in a safe and effective manner for every patient, visitor and staff at the facility.

Findings include:

On 5/15/2013, 2:55 PM, review of background check for Director of Food Service F (DF-F) revealed the required check had not been done, which was confirmed by Vice President of Human Resources. On 5/20/2013, further follow-up with Vice President of Human Resources confirmed that Wisconsin's required background checks have not been done for 68 out of 81 contracted staff.

Based on record reviews, observations and staff interviews, the obstetrical nursing service failed to ensure the patient safety in 1 of 1 pts (#24) by overriding their security systems and gave wrong breast milk to the patient, and in 1 of 1 newborns (pt.#6) overrode the transfer security system and put the patient at risk for abduction. This failure had the potential to affect all 47 newborns in the facility on this date.

Findings include:

On 05/02/13 at 8:30 PM RN AAAA overrode the breast milk bar coding security system installed to address the hospital self-identified errors in switching breast milk. After seeing the warning "no medication order found", RN AAAA continued to give the wrong mother's breast milk to newborn infant #24. At the time of exit 05/15/13 AT 5:00 PM, the hospital had not completed action plan for this occurrence on 05/02/2013, with no override monitoring system in place, and no system to prevent nursing staff from overriding the breast milk security system. (A 0142)

On 05/14/13 at 9:29 AM Pt #6 was assigned security transmitter #185. Transmitter #185 did not show up in the L&D system, per interview with charge nurse QQ on 05/14/13 at 10:55 AM, because it was in a "transfer mode." In the transfer mode, a newborn has the potential to be removed from their secured unit without alarming.

The security system for Pt #6 (transmitter #185) was overridden by L&D RN EE. Newborn #6 was placed in a transfer mode on 05/14/13 from 10:47 AM to 12:20 PM (approximately 1 ½ hours), potentially allowing #6 to be removed from the unit and undetected as abducted/missing for the 1 ½ hours the system remains in a transfer mode. (A0142)

On 05/15/13 at 2:30 PM during an interview, Administrative Director (AD) NNN and Manager OOO confirmed an analysis made that L&D supervisors had pulled the override records and nursing staff were overriding this security default time approximately 50% of the time.

On 05/15/13 at 2:30 PM during an interview, AD NNN and Manager OOO stated the hospital had no P&P on using the "transfer" or "escort" mode feature of their infant security system. However, staff should not be overriding security systems put in place to protect its newborn pt. (A 0142)

Based on record reviews, observations and staff interviews, the obstetrical nursing service failed to ensure the pt safety in 1 of 1 pts (#24) by overriding their security systems and gave wrong breast milk to the pt, and in 1 of 1 newborns (pt.#6) overrode the transfer security system and put the pt at risk for abduction.

Findings include:

Medication/Breast milk labeling and coding:

Current 3-page P&P entitled: "Expressed Breast Milk (EBM)", with no policy number documented, last reviewed and revised 5/2013. P&P reviewed on 05/15/13 at 11:00 AM, with Administrative Director (AD) NNN and Women and Infant Service Manager (WISM) OOO states:

"Scan infant ID band and then scan bar code on milk label on both original container and warmer milk given to baby."

"Scanning the incorrect baby's milk will produce a "No Med Order Found."

"STOP"
"There is only 1 reason this message would come up: You have the wrong breast milk and the wrong baby"
"No Med Order Found" message is the "red flag" that identification between infant and label need to be verified."

"If you see this message, 2 RNs must verify (and co-sign electronically) that the patient identifiers (baby name and account number) on the label match the baby's ID band."

"DO NOT use the "Override" feature if you receive a "no med order found" message since this will appear electronically that the baby received the wrong milk."

On 05/15/13 11:00 AM, AD NNN and WISM OOO stated the bar coding security system was initiated as a part of the hospital's self-identification that the wrong breast milk was given to the wrong baby. Utilizing the labeling and coding system like they have for medication administration was to prevent the wrong breast milk from reaching vulnerable infants. Also identified in an earlier (5/13/13 at 11:25 PM) interview with Coordinator PP and NICU Pt Care Coordinator TT that the current labeling, coding and scanning system was put in place as a part of prior hospital initiated corrective action plan.

Clinical Development Coordinator PP and NICU Pt Care Coordinator TT stated on 05/15/13 between 11:25 AM and 12:25 AM, unlike emergency medications overrides, there would not be an emergency need to override the security system to provide breast milk. 05/15/13 during an interview at 11:00 AM, AD NNN and WISM OOO also stated there would not be an urgency or emergent reason to override the security system for breast milk.

A completed incident report was reviewed with AD NNN and WISM OOO on 05/15/13 at 2:30 PM and identified:

On 05/02/13 at 8:30 PM NICU RN AAA overrode the security system when the system gave the alert "no med order found," and failed to follow P&P, and gave the wrong breast milk to Pt #24.

NICU Pt Care Coordinator TT was aware RN AAAA overrode the security system and provided the wrong breast milk to infant #24 on 05/02/12. A type written note was reviewed on 05/15/13 at 2:30 PM that showed the hospital was aware and working on this incident. The note read: "05/03/13 at approx 0730" (7:30 AM) RN AAA "came to speak to TT" . "5/3/13 approx 10:30" (AM) the note indicated "PDA (performance development action) ligation in process."

As of 05/15.13 at 2:30 PM no implemented corrective action was taken to address RN AAAA. The incident was logged into the incident reporting system 05/03/13 at 12:00 AM. On call physician was notified 05/03/13 at 2:00 AM.

Progress notes in the medical record for Pt #24 noted from 05/03/13 at 2100 (9:00 PM): "neonatologist on call" informed the mother of Pt #24 receiving the wrong breast milk.

Additional excerpts from the progress note dated 05/03/13 at 9:00 PM:

"The mother whose breast milk Pt #24 received was CMV+." (herpes virus positive) Cytomegalovirus (CMV) is one of the herpes viruses information retrieved from: . HIV testing was completed for the mother of the breast milk 05/04/13, and was negative.


No testing was completed to determine if the infant had contracted the herpes virus. This was confirmed in a telephone interview with PCP BBB on 05/16/13 at 10:00 AM, who said "no testing had been completed per hospital policy."


On 05/16/13 at 11:45 AM, Director of Quality A confirmed to surveyor the hospital had no policy for not testing for CMV when exposure has occurred.


BBB stated BBB had not done anything about this incident at a medical level however, BBB stated something should be done at a higher level.


PCP BB said, RNs overriding the security systems is a problem, and should be addressed by the medical staff.


On 05/15/13 at 2:30 PM during an interview, AD NNN and WISM OOO confirmed there is still potential to override the system if it alarms "no medication order found" and there is currently no tracking of system overrides for breast milk.


Safe Place Infant Security Alarm System:


Per observation on 05/14/13 at 9:00 AM Pt #6 was born at 9:00 AM.


Per review of online security record for Pt #6 with L&D Charge RN QQ conducted on 05/14/13 at 10:55 AM, QQ confirmed Pt #6 (transmitter #185) was not identified in the L&D floor.


L&D Charge RN QQ said the reason Infant #6 did not show up in L&D unit tracking system is, that newborn #6 is in a "transfer mode."


L&D Charge RN QQ said the transfer mode has a security default of 15 minutes however, staff overrides the 15-minute transfer default time to avoid going into the system multiple times. When questioned about if the overrides were for staff convenience, L&D Charge RN QQ said "yes."


QQ said, "transfer mode was used regularly between maternity/newborn units (3rd floor, 4th floor and 5th floor) for 2 to 4 hour periods. Using the transfer mode prevents the alarms from registering or sounding.


On 05/14/13 at 3:00 PM Supervisor Pt Care L&D SS provided and reviewed the "all activity" report for transmitter #185 (Pt #6). The following review and interview with Supervisor Pt Care L&D SS confirmed, transmitter band #185 for newborn Pt #6 was "enrolled" in the security system at 9:29 AM.


At 10:40 AM newborn #6 was put in a "transfer mode" and was not locked into another security system until 12:20 PM (approximately 1½ hours), potentially allowing #6 to be removed from the unit and undetected as abducted/missing for the 1½ hours the security system remained in a "transfer mode".


Supervisor Pt Care L&D SS provided and reviewed the MFR that identified a 15-minute transfer default time was their recommendation. However, SS stated the hospital had no P&P for the use of transfer and escort modes.


On 03/14/13 at 10:55 AM L&D Charge RN QQ also confirmed the hospital had no P&P for the use of "transfer" or "escort" modes, that were implemented to prevent infant abduction. The system could allow the baby to be removed from the secured department undetected for the the estimated 2-4 hours the newborn is in the transfer mode.


During a walk through of the OB departments on 3rd, and 4th floor with Clinical Educator JJJ, the additional systems' issues were identified. Once OB staff passes the secure archway in the hallway to the pt transport elevator there is no security until the baby reaches either the 4th or 5th floor.


The third floor infant/pt transport elevators are unmarked, unsecured, and directly accessible to the public corridors and the walkway that leads directly outside to the 3rd floor parking structure.


AD NNN and WISM OOO stated their staff is always the first line of defense with the infants. Surveyor discussed an observation completed on 05/13/13 3rd floor between 1:55 PM and 2:30 PM where an RN left two infants in an unsecured area to answer the unit phone. The RN was unable to see either of the two infants or surveyor and PP until returning to the area.


An experiment was conducted to determine the longest time required for transport. Surveyors and Clinical Educator JJJ, left L&D final destination 4th floor OB department. Including a delay forgetting to push the elevator call button to pick us up, it took approximately 3 to 5 minutes to get from the 3rd floor L&D Unit to the 4th floor OB unit.


On 05/15/13 at 11:00 AM during an interview, AD NNN and WISM OOO stated NNN and OOO had not conducted a risk assessment on their current security system to identify potential high-risk abduction possibilities for transport area between maternity/newborn units (3rd floor, 4th floor and 5th floor).


AD NNN and WISM OOO said prior to surveyors identification of security system alarms being overridden by staff, the hospital had not monitored staff overriding their security systems preset 15 minutes default to determine if this would jeopardize the integrity of the security currently in place.


On 05/16/13 at 12:10 PM, surveyor along with RN Clinical Educator CCCC, Bio-medical DDDD and Quality Assurance B conducted a mock security breach drill.


An infant transmitter band was enrolled at 12:10 PM into the security system. The transmitter carried by surveyor was placed in "transfer" mode at the MFR 15-minute default time with the 5th floor OB unit as the final destination.


CCCC, DDDD and B stated that at any given time during this drill, if the transmitter wavered from its defined destination, computer alarms would go off notifying security and OB staff of the security breach.


Surveyor, CCCC, DDDD and B left the L&D unit and walked the designated path to the pt transport elevator.


After passing through the last security-wanded archway, surveyor took a left away from the elevators and then a right to the skywalk that lead to the 3rd floor parking structure instead of going to the pt transport elevator. No one was alerted, and no alarm went off.


Surveyor, CCCC, DDDD and B continued across the skywalk to the doors leading into the parking structure. No one was alerted, and no alarm went off.


The infant security transmitter was then brought back into the building to the patient transport elevators where surveyor, CCCC, DDDD and B intentionally got off on the 4th floor (instead of the 5th floor defined in the security system as the infant destination). No one was alerted, and no alarm went off.


The alarm did activate after the 15-minute default time had passed and the transmitter was still on the 4th floor.


On 05/15/13 at 2:30 PM, Nursing Administrative staff NNN and OOO, acknowledged, that staff overriding two infant security systems that were put in place to protect all infant pt's receiving breast milk and being monitored for safety has the potential to affect every infant born at this hospital.

Based on interviews and record reviews, the facility failed to ensure that 4 out of 5 contract agencies utilized for staff had completed required background checks: Agencies KKKK, LLLL, MMMM, and PPPP - 68 out of 81 contracted staff did not have the required background check completed. This had the potential to put at risk every patient, visitor and staff at the facility.

Findings include:

The entity is required to complete background checks on employees and contractors. This includes employees who provide direct care and may also include housekeeping, maintenance, dietary and administrative staff, if those persons are under the entity's control and have regular, direct contact with clients served by the entity.

On 5/15/2013, 2:55 PM, review of background check for Director of Food Service F (DF-F) revealed the required check had not been done. On 5/20/2013, further follow-up with Vice President of Human Resources confirmed that background checks have not been done for 68 out of 81 contracted staff.

Based on MR review, Pt and staff interview, and observation the facility failed to ensure RN's assess patient needs and provide appropriate interventions in 1 of 30 MR's reviewed (Pt #30). This can potentially affect all patients receiving treatment at this facility.

Findings include:
The following issues were identified at Elmbrook memorial hospital:
Pressure Ulcer Prevention-ob/staff and patient I/ RR:
The 5/15/13 clinical record review of Patient # 30's care plan with RN Staff TTTT, reflects that patient has care planned interventions of pressure relief mattress and heels off bed using pillow. Patient #30 has diagnosis of Peripheral Vascular Disease, with left above the knee amputation.

Interview with Staff RN TTTT at approximately 10:45 a.m. reflects that the turning and repositioning schedule for Patient #30 was not triggered because she is ambulatory and able to move self in bed. Staff RN TTTT stated that Patient #30 is at high risk for skin breakdown leading to pressure ulcer development due to high Braden scores (pressure ulcer prediction scale).

Observation of Patient #30 at approximately 10: 50 a.m. reflects that heel (patient has one leg) is not suspended off the bed, and is exposed to friction and shear from the sheet and mattress.

In interview with this patient at the time of the above observation, she states that she is given no assistance with repositioning/ turning even though she is hospitalized for treatment of hospital acquired pressure ulcer on coccyx. Patient stated in interview that maintaining position changes is difficult with one leg.

Based on interview, MR's and P&P reviews, the hospital failed to individualize Interdisciplinary Plan of Care (IPOC) for 3 of 30 records reviewed, (Pt's #18, 19, and 20). This deficient practice had the potential to affect all inpatients receiving treatment at this facility.

Findings include:

On 05/15/2013 at 1:00 p.m. a review of the P&P titled Interdisciplinary Documentation dated 5/2013 was completed. The P&P stated in part, Procedure: E. 2. Plan of Care: a. All patients will have an interdisciplinary plan of care. F. Interventions are identified and performed to achieve outcomes.

Review of pt. #18's MR on 5/14/13 beginning at 2:45 p.m. - 3:35 p.m. was completed. Pt. #18's Interdisciplinary Plan of Care (IPOC) indicated a risk for injury/falls with the following interventions: "reduce risk factors, and provide education." IPOC does not list individual interventions utilized to prevent falls. Pt. was noted to have a bed alarm in place as falls prevention.

Review of pt. #19's MR on 5/14/13 beginning at 3:40 p.m. - 4:10 p.m. was completed. Pt. #19's IPOC indicated a risk for falls/injury with the following interventions: "reduce risk factors, implement precautions, and alternate interventions." IPOC does not list individual interventions utilized to prevent falls. Assessment dated 5/9/13 at 11:07 p.m. indicated interventions of observation, bed alarm, closer to station, frequent supervision and restful environment; however IPOC does not indicate these interventions being utilized.

Review of pt. #20's MR on 5/15/13 beginning at 8:30 a.m. - 9:00 a.m. was completed. Pt. #20's IPOC indicated a risk for falls/injury with the following interventions: "reduce risk factors, alternative intervention and implement precautions." IPOC does not list individual interventions utilized to prevent falls.

Per interview on 5/14/13 at 2:50 p.m. with RN Edu O indicated that nursing staff selects interventions from a list and in addition staff is able to individualized interventions on the IPOC by adding specific interventions. Findings were confirmed with RN Edu O at time of MR's review.

Based on observation and staff interview the facility failed to ensure confidentiality of patient MR's in 14 of 14 patient records observed, (Pt # 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49). This can potentially affect all patients receiving treatment at this facility.

Findings include:

The following issues were identified at Elmbrook memorial hospital

Medical records confidential -O/I

*) During tour of 6th floor patient care area on 5/15/13 at approximately 8:30 a.m., there were 3 PCA patient assignment sheets for Patients 36, 37 and 38 laying in plain view on the nursing station. There was no one in the immediate area to protect the confidentiality of these medical records.

Interview with Clinical Educator RRRR was conducted at the time of the observation. RRRR states that they will be removed right away and the responsible PCA will be reminded about patient information.

*) Observations in the outpatient laboratory show a large white board (approximate size is 4 foot) posted on the wall in the visitor registration area/ treatment areas. This board is visible to anyone coming into the outpatient lab. This white board has the time of scheduled treatment, the first name and last initial of the patient, the type of service/procedure being received, the doctor's name, the RN assigned and the patients room number assignment; for the following patients: Patient # ' s 39, 40, 41, 42, 43, 44, 45, 46, 47, 48 and 49.

In interview with Clinical Educator RRRR at the time of observations, she stated that she could see how this might be breach of confidential patient information, that did not need to be shared with the public.

Based on observations, policy review, and staff interviews this facility failed to maintain pt confidentiality of medical records by placing them in unlocked cabinets accessible to unauthorized personnel, visitors and other pts. Failure to secure medical records and maintain confidentiality has the potential to affect all pts receiving care in the facility, including all pts present during the course of the survey.

Findings include:

A tour of the Rehabilitation Department was conducted with Rehab director AAA on 05/14/13 at 1:30 PM. During a tour of the "Overflow Gym" in the outpatient rehab department (basement of St. Joe's) it was discovered that clinic files with patient information were kept in unlocked drawers in the documentation/computer area. Insurance charge sheets containing patient information were also found unsecured in both the "balance room" and the conference room of the Overflow Gym" at the time of the tour. A tour of the Living Skills Room" also revealed unsecured, outpatient medical records. These findings were confirmed with Rehab Director AAA at the time of the tour, she also stated that these areas were cleaned after hours by housekeeping personnel.



09948

Issues at the WA WA Campus Mayfair RD

Unsecured medical records

*) Observations of the wound Care clinic on 5/13/13 at 12:10 p.m. reflects that the patient ' s medical records are not secured in a locked area, during after hour cleaning of this area by hospital housekeeping staff.

In interview with Wound care RN ZZZZ at 12:15 p.m. she states that cleaning is done after hours when staff is not present.

Based on MR review, P & P, Medical Staff Rules and Regulations, and staff interview the facility failed to ensure that all entries in the MR are properly authenticated with date, time and/or signature of the practitioner completing the entry in 7 out of 30 MR's reviewed (Pt #4, 7, 8, 14, 18, 19, 20) Failure to properly authenticate orders with signature, date and time has the potential to affect all patients receiving care in this facility.

The Medical Staff Rules and Regulations, dated 8/8/2012, were reviewed on 5/15/2013 at 1:40 p.m.

Page 20, k. Authentication and Legibility states, "All clinical entries in the patient's record must be accurately dated, timed, individually authenticated and legible. Authentication means to establish authorship by written signature, identifiable initials or computer key."

Page 20 l. Countersignature. i) states, "All entries in the medical record made by Dependent Allied Health Professionals and students require a countersignature from a member of the Medical Staff."


A MR review was conducted on Pt. # 18's open MR on 5/14/13 from 2:45 p.m - 3:40 p.m.
*Between 5/11/13 and 5/14/13 Pt. # 18 had 2 progress notes that do not include a time the note was written and there were 4 progress notes from the (Physician Assistant) PA that do not include a time the MD co-signed the progress note.

A MR review was conducted on Pt. # 19's open MR on 5/14/13 from 3:40 p.m. - 4:10 p.m.
*Between 5/8/13 and 5/13/13 Pt. # 19 had 7 progress notes that do not include a time the note was written and there were 3 progress notes from the PA that do not include a time the MD co-signed the progress note.

A MR review was conducted on Pt. # 20's open MR on 5/15/13 from 8:30 a.m.- 9:05 a.m.
*Between 5/10/13 and 5/14/13 Pt. # 20 had 3 progress notes that do not include a time the note was written.


26390


Review of pt. #14 ' s record on 5/15/2013 at 7:35 AM revealed a physician progress note with no date or time by the physician signature.


22198

During a medical record review of Pt #7, on 05/14/13 at 10:15 AM Surveyor, along with Clinical Coordinator PP and unit RN RR identified that Pt #7's L&D check list to ensure documentation was completed and on the medical records was incomplete, and the admission consent was not timed.

During a medical record review of Pt #8, on 05/14/13 at 10:45 AM Surveyor, along with Clinical Coordinator PP and unit RN RR identified that Pt #8's medical record release of information for a hearing screening was not timed.


26711

In an interview with Dir of HIM BBB on 5/14/2013 at 1:30 p.m., Dir BBB stated that all entries from Physician Assistants are to be cosigned by the Attending Physician.

A MR review was conducted on Pt. #4's open MR on 5/14/2013 from 1:21 p.m.-2:09 p.m. The review was continued on 5/15/2013 from 7/13:45 a.m.-9:00 a.m. and again from 10:30 a.m.-11:00 a.m.

Between 5/6/13 and 5/10/13 Pt. #4 has 4 progress notes from the PA that do not include a time the MD co-signed them and one MD progress note that does not have the time the MD wrote the note.

Based on MR review in 6 out of 30 MR's reviewed (Pt. #4, 15, 16 18, 19, 20), P & P review, Medical Staff Rules and Regulations and staff interview, the facility failed to ensure that all orders are properly authenticated with date, time and/or signature of the practitioner writing the orders. Failure to properly authenticate orders has the potential to affect all patients receiving care in the facility.

The Medical Staff Rules and Regulations, dated 8/8/2012, were reviewed on 5/15/2013 at 1:40 p.m. On page 8, C. Orders i) states, "All orders must include the date and time the order was issued."

Page 20, k. Authentication and Legibility states, "All clinical entries in the patient's record must be accurately dated, timed, individually authenticated and legible. Authentication means to establish authorship by written signature, identifiable initials or computer key."

Page 20 l. Countersignature. i) states, "All entries in the medical record made by Dependent Allied Health Professionals and students require a countersignature from a member of the Medical Staff."

Findings Include:

A MR review was conducted on Pt. #18's open MR on 5/14/13 from 2:45 p.m.- 3:40 p.m.
*In paper form on a patient order sheet dated 5/11/13, a physician order does not indicate a time in which the order was written.
*In paper form on a patient order sheet dated 5/11/13, a speech therapist wrote an order and requested MD to sign if in agreement. Physician signature is noted but no date or time indicated when physician signature was completed.

A MR review was conducted on Pt. #19's open MR on 5/15/13 from 3:40 p.m.- 4:10 p.m.
*In paper form on a patient order sheet dated 5/9/13, a physician order does not indicate a time in which the order was written.
*In paper form on a patient order sheet dated 5/13/13, a physician order does not indicate a time in which the order was written.

A MR review was conducted on Pt. #20's open MR on 5/15/13 from 8;30 a.m.- 9:05 a.m.
*In paper form on a patient order sheet dated 5/10/13, a physician order does not indicate a time in which the order was written.


26390


Review of Pt. #15's record on 5/15/2013 at 8:05 AM revealed physician orders dated 5/1/2013 with no time next to the physician signature. Discharge order dated 5/1/2013 is without a time next to the physician signature. An order for intra-ocular lens is dated 3/28/2013 and is without a time next to the physician signature.

Review of pt. #16's record on 5/15/2013 at 8:30 AM revealed a order for medication dated 5/2/2013 with no time next to the physician signature and pre-operative physician orders without a time next to the physicians signature.


26711

In an interview with Dir of HIM BBB on 5/14/2013 at 1:30 p.m., Dir BBB stated that all entries from Physician Assistants are to be cosigned by the Attending Physician.

A MR review was conducted on Pt. #4's open MR on 5/14/2013 from 1:21 p.m.-2:09 p.m. The review was continued on 5/15/2013 from 7/13:45 a.m.-9:00 a.m. and again from 10:30 a.m.-11:00 a.m.

*On 5/6/13 there are two pages of MD orders. It is not indicated if one of the pages is a continuation of the previous page. One of the pages dated 5/6/13 does not have a time the MD wrote the orders.

*In paper form there are two MD orders that do not include a time the MD wrote the orders between 5/6/13 and 5/8/13.

Based on MR review and Medical Staff Rules and Regulations the facility failed to ensure verbal orders are authenticated by the physician with in 48 hours in 4 of 30 MR's reviewed (Pt #4, 7, 28, 53). This can potentially affect all patients receiving treatment at this facility.

The Medical Staff Rules and Regulations, dated 8/8/2012, were reviewed on 5/15/2013 at 1:40 p.m. On page 8, C. Orders i) states, "All orders must include the date and time the order was issued."

Page 20, k. Authentication and Legibility states, "All clinical entries in the patient's record must be accurately dated, timed, individually authenticated and legible. Authentication means to establish authorship by written signature, identifiable initials or computer key."

Page 20 l. Countersignature. i) states, "All entries in the medical record made by Dependent Allied Health Professionals and students require a countersignature from a member of the Medical Staff."

Findings include:

Review of Pt #53 ' s MR on 5/15/13 beginning at 1:45 PM reveals the following: Pre-Procedure standing orders dated 5/1/13 have no time and date of physician authentication.

The above finding was confirmed with Clinical Development Coordinator CCC at the time of medical record review.
In an interview with Dir of HIM BBB on 5/14/2013 at 1:30 p.m., Dir BBB stated that all entries from Physician Assistants are to be cosigned by the Attending Physician. Dir BBB also stated that the time frame for the MD to co-sign verbal orders is 48 hours. Dir BBB stated that the current computer system does not allow an alternate provider to co-sign orders for a provider in the event the provider would be unavailable in the 48 hour time frame to sign.

An MR review was conducted on Pt. #4's open MR on 5/14/2013 from 1:21 p.m.-2:09 p.m. The review was continued on 5/15/2013 from 7/13:45 a.m.-9:00 a.m. and again from 10:30 a.m.-11:00 a.m.

*In the paper portion of the MR, from 5/6-5/8/2012 there are 2 verbal orders that do not include a time or date when the MD signed them and 2 verbal orders that do not include a signature, date or time from the MD.

Electronic portion, verbal orders that are not signed within 48 hours:
*written 5/6/13, not signed until 5/9/13--2
*written 5/6/13, not signed until 5/13/13--14
*written 5/7/13, not signed until 5/13/13--5
*written 5/8/13, not signed until 5/13/13--1
*written 5/9/13, not signed until 5/13/13--3

The findings for the electronic MR were confirmed by Dir BBB on 5/14/2013 from 1:21 p.m.-2:09 p.m. Findings for the paper MR were confirmed by RN Edu YY on 5/15/2013 from 7/13:45 a.m.-9:00 a.m.


05409

Per medical record review of Pt. #28 beginning at 12:45 p.m. on 5/15/13, review of physician orders reveal that a telephone order was written on 5/12/13 regarding a change in the Coreg dose. There is no authentication of this order. RN JJJJ said, beleives the order needs to be signed up here on the floor and it was not.


22198


On 05/14/13 at 10:15 AM Surveyor and Clinical Coordinator PP review the medical record for Patient #7. The pre-printed medication reconciliation telephone order dated 05/12/13 at 0330 (3:30 AM) was not authenticated by the physician. Unit Staff RR reviewed and confirmed that the telephone/verbal order did not meet the 48 hour requirement.

Based on observation and staff interview, this facility failed to secure medications in emergency/crash carts from unauthorized access in 3 out of 4 emergency carts ( Family Birth Center, 5 West, and 5 Center) observed on fifth floor and 1 of 1 surgical medication carts(WI heart Hospital) in the clean surgical corridor. Failure to secure medications has the potential to affect all patients receiving treatment at this facility.

Findings include:

According to the facility's medication charge sheet for crash carts, the following medications are in each crash cart: Epinephrine, Vasopressin, Amiodarone, Lidocaine, Magnesium Sulfate, Atropine, Dopamine, Adenosine, Calcium Chloride, Dextrose, Sodium Bicarbonate, Norepinephrine and Naloxone. Syringes and needles are also in the drawers of the carts.

A tour of the Family Birth Center was conducted on 5/13/2013 at 3:30 pm accompanied by RN Edu O. The 5th floor Family Birth Center is currently closed. An Emergency/Crash cart with a plastic breakaway lock is noted in an alcove. Upon entering the locked unit a housekeeper was noted in the area. This would indicate unauthorized persons (housekeeping staff) have access to the medications, needles, and syringes while the cart is unsupervised by staff.

A tour of 5 West was conducted on 5/13/13 at 2:25 pm accompanied by RN Edu O. The Emergency/Crash cart was stored in an alcove out of sight from the nurses ' station with a plastic breakaway lock.

A tour of 5 Center was 5/13/13 at 3:00 pm accompanied by RN Edu O. The Emergency/Crash cart was stored in an alcove out of sight from the nurses ' station with a plastic breakaway lock.


09948


The following issues were found at Wisconsin Heart Hospital

Unsecured Medications and syringes-I /O
*) In a room off the clean surgical corridor on 5/14/13 at approximately 12:20 p.m., the malignant hyperthermia cart was located. This cart was secured with a plastic break-away lock, which could give anyone easy access to the medications (Dantrole), syringes, needles and intravenous solutions stored inside. This room opened to an elevator that could be accessed from a public corridor on the first floor.

In interview with Clinical Educator XXXX at the time of observations, she stated that medications, syringes and needles should be secured.

26711



Based on observations and P & P review the facility failed to ensure that all medications for patient use were appropriately labeled and/or discarded if outdated in 2 of 2 departments (ED, Cardio-Pulmonary) observed. Failure to ensure medications are dated or discarded has the potential to affect all patients receiving services in this facility.

Findings include:

The facility's policy titled, "Labeling Medications and Solutions," dated January 2012, was reviewed on 5/15/2013 at 1:35 p.m. The policy states in part, "Medications and solutions should be labeled anytime they are removed from the original packaging to another container. Medication labels include the medication name, strength, quantity, dilutent and volume (if not apparent from the container), expiration date when not used within 24 hours, expiration time when expiration occurs in less than 24 hours."

During a tour of the Cardio-Pulmonary unit with RN Edu C on 5/13/2013 at 3:45 p.m., in the medication refrigerator there was a vial of Levimir insulin that was open and undated and without a patient label. The label that had been on the vial had been removed and the insulin was not discarded.

RN Edu confirmed this finding at the time of discovery.

During a tour of the Emergency Department (ED) with ED director DDD on 5/14/2013 at 3:00 p.m., in the trauma room outdated culture swabs (dated 04/13) were found on the counter as well as in the Urgent Care clean utility room was found outdated infant formula (4, 2 oz. bottles of Similac Soy dated 01/13 and 1, 2oz. bottle of Similac advance dated 02/13). These observations were confirmed at the time of discovery by ED director DDD.

09948




29302

Based on observations, staff interviews and record reviews, the 3 out of 3 facilities (St. Joseph's, Elmbrook and Wisconsin Heart Hospital) failed to prepare and serve food under sanitary conditions. The totality of the following concerns has the potential to affect all patients, staff and visitors who eat at this facility.


Findings include:


- Food items not labeled and dated
- Dirty equipment and food preparation area for babies
- Improper sanitation of thermometers
- Cleaning tools stored in food areas
- Hair and facial hair not properly restrained
- Not washing hands between tasks
- Improper 3-compartment sink washing
- Not appropriately monitoring internal and external temperature levels of high temperature dishmachine.


FOOD STORAGE
The Director of Food Service F (DF-F) stated the facility follows guidance from the United States Department of Agriculture, Food Safety and Inspection Service (USDA, FSIS) and Wisconsin ' s Food Code. According to these references the storage of food must be done in a manner to prevent foodborne illnesses caused by harmful pathogens and to preserve the quality and nutritional value of food.


Facility's Policy HACCP/Food Safety Program, Food Safety Standards and Requirements, Document #: 1.1.4, Revised date 1/27/2012 states: " 6. All foods prepared in operation must be covered and labeled as to contents and date of preparation prior to storage in refrigerators and freezers. " " Purchased, ready-to-eat foods removed from original container and not served during the next meal must be labeled and dated. "



On 5/13/2013, 11:08 AM - 11:30 AM, in St. Joseph's food storage area, the following concerns were observed and verified by DF-F:
- Rice - no identification of any kind
- Almonds, chicken gravy, noodles - no discard date
- Unidentifiable white package
- Yellow corn meal, Uncle Ben's Rice, and chipotle powder - not sealed and without a discard date
- Partially used container of Stir Fry Sauce which states "refrigerate after opening"
- Dill weed - discolored - No date noted
- Caraway seeds, ground cloves and whole cloves expired 3/2008, 1/2007 and 6/2006 respectively.
- 4 oz. empty container of nectar thickened water sitting on shelf
- Bananas stored directly above individually packed, ready-to-eat Cheez-it crackers

On 5/13/2013, 1:50 PM - 2:00 PM, in St. Joseph's reach-in C-7 cooler, the following concerns were observed, identified and verified by DF-F:
9 small individual containers of steak sauce (no labels)
5 small containers sour cream (no labels)
6 slices chocolate cake (no labels)
5 slices cheese cake (no labels)

On 5/13/2013, 2:19 PM - 2:27 PM, in St. Joseph's retail cooler, the following concerns were observed, identified and verified by DF-F:
Honey dew melon, Pineapple, Cantaloupe, pkg. bologna, open gallon of 2% milk, all had no label/date.

On 5/13/2013, 2:19 PM - 2:27 PM, in St. Joseph's main freezer, the following concerns were observed, identified and verified by DF-F: The following food items were cooling and did not have any type of cover to protect from contamination: 10 containers of chicken noodle soup and 7 meat loaves

On 5/14/2013 at 3:45 PM at Wisconsin Heart Hospital campus observed one package opened, unlabeled and undated food in walk in freezer. Executive Chef B5 identified the item as one-half of a ten-pound bag of chicken breasts. Executive Chef B5 agrees the item does not have a date or label.

On 5/14/3013 at 9:50 AM at Elmbrook campus observed one bag of chicken breasts in plastic bag and two unidentified bags of food items not labeled or dated in the reach in freezer. Director or Nutrition Services EEE said " no " when asked if the items are labeled or dated.

On 5/14/2013 at 10:00 AM at Elmbrook campus observed one 50# bag of open and unsealed Japanese Bread crumbs in dry food storage area. Director of Nutrition Services EEE confirmed the bag did not have a seal.

On 5/15/13, 9:00 AM, Elmbrook campus ICU, observed food thickener not labeled with a date to identify when this food additive was opened or when it will expire. Clinical Educator RRRR states that they are dating the caps instead of dating the bottle, and should be dating the bottle. When the pump is put on the bottle the dated cap is removed and discarded.

DIRTY EQUIPMENT
According to Wisconsin's Food Code, food items and equipment must be properly stored to prevent transmission of foodborne pathogens or contamination. Equipment food-contact surfaces and utensils shall be clean to sight and touch and nonfood-contact surfaces of equipment shall be kept free of an accumulation of dust, dirt, food residue and other debris. According to foodservice management's fact sheets, all managers are trained and certified in safe food handling. The foodservice management group uses the National Restaurant Association Solution's ServSafe® program. This program states there must be an effective cleaning program in place.

On 5/13/13, in St. Joseph's foodservice area, the following observations were made and confirmed by DF-F:
11:36 AM - emergency eye wash very dirty.
11:36 AM - large garbage container's lid, next to handwashing sink is very dirty
11:41 AM - front of microwave and freezer door very dirty - more than one day ' s accumulation of dirt
1:40 PM - fan in dishroom with built-up dust
1:50 PM - tray pans used for baking and storing of food items have in corners and edges built up brown greasy debris
1:56 PM - dietary cart with drawer - inside on bottom of drawer was dirty with debris -bottom shelf of cart very dirty


2:00 PM - area where food/formula preparation is done for babies is very dirty. There is a sign posted saying " please stock and clean baby area. " Inside the stainless steel cabinet are 8-12 oz. plastic cups, uncovered. Bottom shelf has a white powdery substance on it.
2:04 PM - rack inside Alto-Sham (a special type of oven), which facility is using to heat plates, has debris hanging from it.
2:09 PM - oven hood, above 4 burner stove, very greasy in its edges
2:12 PM - top of convection oven is extremely dirty with debris - outside of it is dirty and greasy. DF-F agrees that it is more than one day ' s worth of dirt.
2:12 PM - outside of combi-therm oven is very dirty
2:14 PM - bottom of what was identified as fast food freezer is very dirty with debris over entire area

CROSS CONTAMINATION
On 5/13/13, 11:45 AM in St. Joseph ' s foodservice area, prior to taking temperatures of food, DF-F wiped off thermometer with a cloth from a bucket containing Oasis 144, and proceeded to take temperatures of food without waiting the required contact time for effectiveness of 1 minute per product information. Manufacturer's specifications for Oasis 144 states for sanitizing surfaces exposed to food, the utensil shall be in the sanitizing solution " for a period of not less than 1 minute."

On 5/15/13, 3:49 PM, in Wisconsin Heart Hospital's foodservice area, observed Chef GGG pull thermometer from upper arm sleeve, and without sanitizing the thermometer, proceeded to take temperature of the chicken. Chef GGG agreed should have been sanitized prior to its use. According to facility's document #1.1.4, Rev. Date: 01/27/2012, "HACCP/Food Safety Program," "Food Safety Standards & Requirements," "Thermometers must be sanitized between each food item ... "

Improper storage of equipment:

According to foodservice management's fact sheets, all managers are trained and certified in safe food handling. The foodservice management group uses the National Restaurant Association Solutions' ServSafe® program. According to this program, cleaning tools and chemicals should be placed in a storage area away from food and food-preparation sites.


On 5/13/13, 11:12 AM, in St. Joseph ' s foodservice area, observed a floor mop stored in dry food storage area which was confirmed by DF-F:

On 5/13/13, 11:30 AM, in St. Joseph ' s foodservice area, observed supplements stored on top of a stainless steel cabinet which contained bleach, methanol gel and turbo-chef oven cleaner and the door to the cabinet was open.

HAIR RESTRAINTS/HAND WASHING
Wisconsin Food Code and food safety program, ServSafe®, states food employees are to wear hair restraints to effectively keep hair from contacting exposed food, clean equipment, utensils, linens, and unwrapped single-service/single-use articles. Food employees shall clean their hands and exposed portions of their arms immediately before engaging in food preparation, including working with exposed food, clean equipment and utensils, and unwrapped single-service and single-use articles and before donning single-task disposable gloves.

On 5/13/13, 11:37 AM, in St. Joseph's main kitchen, observed Cook H and Tray Pass Worker I with uncovered facial hair-verified by DF-F

On 5/13/13, 11:37 AM, St. Joseph's main kitchen, observed Tray Pass Worker come into the kitchen, and without washing hands, proceeded to put on disposable gloves.

On 5/13/13, 11:39 AM, St. Joseph's main kitchen, observed Cook J going to large garbage container and then proceeded to throw out numerous items; then observed Cook J proceed to put 2 large (5-6 pounds) beef roasts onto a cart, without washing hands between the two tasks-verified by DF-F.

On 5/14/2013 at 9:10AM at the Elmboork campus, observed Diet Clerk HHH in kitchen with bangs of hair not covered.

On 5/14/2013 at 9:30 AM at the Elmbrook campus, observed Operations Manager III in kitchen with back of hair not covered.

On 5/14/2013 at 9:45AM at the Elmbrook campus, observed Kitchen employee MMM in kitchen with bangs not covered.

During tour of kitchen on 5/14/2013 between 9:00AM and 11:00AM Director of Nutrition Services EEE agreed hair is not properly restrained, then asked Diet Clerk HHH, Operations Manager III and kitchen employee MMM to properly restrain hair.

On 5/14/2013 at 3:45 PM at the Wisconsin Heart Hospital campus, observed Executive Chef B5 in kitchen with facial hair not covered. At this time, Operations Manager FFF stated she observed the facial hair not covered.

IMPROPER SANITATON OF KITCHENWARE AND DISHES:
On 5/14/2013 at 10:40AM at the Elmbrook campus observed six stainless steel steam table pans stacked above the water line in the third/sanitizing compartment of the 3-compartment sink. Dietitian and Room service manager LLL stated it was not proper technique for sanitation.

On 5/14/2014 at 10:50 AM at the Elmbrook campus asked Dietitian and Room service manager LLL to test sanitation level for the water in the sink, the level per Dietitian and Room service manager LLL and confirmed by Nutrition Services Director EEE, was in the 0-100ppm range. Per manufacture's product label for Apex Solid Quad dispenser dilution should be 150-400ppm to be effective. Product label states "Mix sanitizing solution 0.053oz - 0.14oz per gallon of water or equivalent of 150-400 ppm active Quat." "Sanitize in a solution of 0.07 oz-0.14 ounces of Apex Solid Quat Broad Range Sanitizer per gallon of water. Immerse all utensils for at least two minutes."
.
On 5/14/2013 at 12:00 PM at the Elmbrook campus during an interview, Director of Nutrition Services EEE stated training was done with kitchen staff in April 2013 regarding the 3-compartment sink washing. Review of training materials with Director of Nutrition Services EEE titled "Topic of the Month, Sanitizing Food Contact Surfaces" is for the use of the Oasis 146 dispenser. Director of Nutrition Services EEE stated they had the Oasis 146 dispenser prior to the Apex Solid Quat dispenser. Director Nutrition Services EEE stated they used the wrong training materials for April 2013 training. On 5/14/2013 at 1:42 PM, reviewed document labeled "Sanitizer Solution Log" with Dietitian and Room service manager LLL. Noted log to be missing data on the following dates in April 2013: April 3,6,7,11,16,20,21,25,30. When asked to see the May 2013 log Dietitian and Room service manager LLL stated there was not a log started for May 2013.

On 5/14/2013 at 10:15 AM at Elmbrook campus, noted the facility uses a Hobart FT900 Series dishwasher. Label on the machine reads "Final rinse temp 180 degrees minimum." Observed temperature log labeled "Dish Machine Temperature log May 2013" next to the dish washing machine. Noted final rinse temperature fell below 180 degrees on the following dates:

Breakfast = May 1,3,6,8,12,13 Lunch = May 1,2,5,7,8,10,11,12,13 Dinner = May 2,6,7,8,11,12.

Interview conducted at the time of the findings with Director of Nutrition EEE, who stated dish machine was new and "staff are probably not writing down the correct temperatures." Asked Director of Nutrition Services EEE what training staff received regarding the new machine. Director of Nutrition Services EEE stated Hobart Corporation did an in-service when they installed the machine. When asked to see the training materials and a list of employees who were trained to use the new dishwashing machine, Director of Nutrition Services EEE stated, "Staff were not required to sign in for the training." Director of Nutrition Services EEE stated they did not have written training documents as Hobart Corporation did the training. Per review of operation manual for FT900 Series Dishwashers received from Director of Nutrition Services EEE on 4/14/2013, document states "recommended minimum temperatures, Final Rinse 180 degrees minimum."

5/14/2013 at 10:35 AM at Elmbrook campus Observed Dietitian and Room Service Manager LLL test the surface temperature of a plate during sanitization. Test strip turned black with indicated dish temperature reached at least 160 degrees. Asked Director of Nutrition Services EEE how often they complete dish surface temperatures using the test strips. Director of Nutrition Services EEE stated they do them weekly. When asked to see temperature strip logs Director of Nutrition Services EEE stated they just started doing them. Received document labeled "Weekly Sticker Temperature Check for Dish Machine" dated May 2013. Entries noted on 5/3/2013 and 5/10/2013. Dietitian and Room Service Manager LLL confirmed they started this log on May 3, 2013.

A Recertification Survey for Life Safety Code compliance was conducted by the Wisconsin Division of Quality Assurance on 05/13/2013 - 05/16/2013. The Wheaton Franciscan Health - St. Joseph Hospital was found to be NOT in compliance with the following regulation:

42 CFR 482.41 Condition of Participation: Physical Environment was NOT MET

The cumulative effect of these deficiencies has the potential to affect the safety of all patients, staff, and visitors at the hospital.

K11: Unreliable separation
K12: Reduced Class of Construction
K14: Interior finishes without flame spread ratings.
K15: Interior room finishes without flame spread ratings.
K17: Smoke tight corridors are not maintained.
K18: Ineffective latching and non-protected openings into the corridor.
K20: Compromised vertical shaft ratings.
K21: Rating doors on hold-open without automatic closing feature.
K22: Access to exits without readily visible signs.
K24: Smoke Compartments with inappropriate configurations.
K25: Smoke Compartment walls were not smoke tight w/ ratings.
K27: Smoke barrier doors were not smoke tight.
K29: Unreliable enclosure of hazardous areas.
K32: Exit were not provided or properly remote from each other.
K33: Exit enclosures open to an unoccupied space.
K34: Stairways were not reliably enclosed or protected.
K38: Access to exits was not accessible.
K39: Egress corridors were undersized.
K40: Egress doors were undersized.
K47: Lacking exit directional signs.
K48: Evacuation plan without all elements.
K50: Fire drills were not conducted under varied conditions.
K51: Fire alarm system was not compliant to NFPA 72 minimum standards.
K52: Fire alarm system was not fully tested to NFPA 72 standards.
K56: Sprinkler system was not compliant to NFPA 13 minimum standards.
K61: Sprinkler valves were not supervised.
K62. Sprinkler system was not properly maintained.
K64: Portable fire extinguishers were not properly distributed.
K67: The ventilation system did not meet NFPA 90A minimum standards.
K69: Kitchen was not properly protected per NFPA 96.
K72: Corridor obstructions were not eliminated.
K74: Loosely hanging fabrics lacked treatment.
K75: Linen receptacles located within rated room enclosures.
K76: Medical gas storage was not protected per NFPA 99.
K77: Piped medical gas and valves was not installed properly.
K78: Smoke removal not provided for an indoor anesthetizing location.
K103: Interior partitions were constructed of combustible materials.
K130: Miscellaneous provisions not found in other K-tags.
K147: Electrical system not to NFPA 70 minimum standards.
K154: Sprinkler outage policy lacked fire watch personnel specific duties.
K155: Fire alarm outage policy lacked fire watch personnel specific duties. (A 0709)

Please refer to the full description and findings within the specific K-tag deficiencies within the appropriate Building found later in this report.

The hospital failed to maintain walls free of damage, counters free of damage, cabinets free of damage, and ceilings free of damage in 2 of 3 hospital locations (St Joseph's and Elmbrook Memorial). (A 0701)

The facility potentially placed all patients, visitors and staff at risk by not keeping the surrounding area of the refuse bins free from debris and covered. (A 0713)

The hospitals equipment and supply maintenance system for 2 of 3 hospital locations (St Joseph's, Wisconsin and Elmbrook Memorial), failed to secure hazardous chemical, failed to have an effective system in place to check, rotate and remove outdated products, and failed to monitor equipment and supplies for safety, integrity and security. (A 0724)
The facility failed to provide proper ventilation that had potential of cross-contamination of air with undesirable contaminants, and causing possible infection for all patients receiving services at this hospital. This observed situation is not consistent with CDC and AIA guidelines. (A 0726)

The facility did not construct, install and maintain a proper ventilation and temperature control system in pharmaceutical, food preparation, and other appropriate areas. (A0726)

The facility did not have and a ventilation system that was installed and maintained in accordance with CDC guideline, AIA guidelines and manufacturer recommendations. This deficient practice could affect all patients, staff, and visitors in 40 of the 92 smoke compartments. (A 0726)

Based on observation and interviews the hospital failed to maintain walls free of damage, counters free of damage, cabinets free of damage, and ceilings free of damage in 2 of 3 hospital locations (St Joseph's and Elmbrook Memorial).

Findings Include:

These observations occurred at St Joseph ' s Hospital
On 05/15/13 at 2:40 pm, observation revealed on the second floor near bathroom 2303 in Smoke Compartment 2-K, that a portion of a wall was damaged and in need of repair. The wheelchair alcove wall, by bathroom 2303, had exposed dry wall due to wall damage. This damage renders this surface porous and non-cleanable.

On 05/16/13 at 8:44 am, observation revealed on the Second floor room N2503 A-N, ICU waiting area, that a portion of a wall was damaged and in need of repair. The walls were noted to be damaged throughout the ICU waiting area. This damage renders this surface porous and non-cleanable.

On 05/16/13 at 9:53 am, observation revealed on the Third floor in the OR2, that a portion of a wall was damaged and in need of repair. The South and North walls were dirty and damaged with drywall exposed in some areas. This damage renders this surface porous and non-cleanable.

On 05/16/13 at 9:35 am, observation revealed on the Third floor in the Room 3214, that a portion of the counter was damaged and in need of repair. The counter-top in the Soil Utility Room was damaged and porous. This damage renders this surface porous and non-cleanable.

On 05/16/13 at 10:41 am, observation revealed on the Third floor in the Room 335C, Smoke Compartment 3A, that a portion of the ceiling was damaged and in need of repair. The ceiling was damaged from water leakage.

On 5/13/2013 at 4:40 pm, observation revealed on the 2nd floor in the OR 15, that a portion of the cabinetry was damaged, showing bare wood, and in need of repair. This damage renders this surface porous and non-cleanable.

The above physical conditions were confirmed at the time of discovery by a concurrent observation and interview with staff M10 (EUA) and staff M11 (Architectural Designer).

During a tour on 05/13/13 from 11:25 AM to 4:00PM with CDC PP, the following concurrent observations and interviews identified damage to the physical environments as follows:
*Clean storage room (#7029) had 7 ceiling tiles falling down.
*Ceiling tiles in clean storage Rm #3218C were falling down.
*Soiled Utility Rm #3214 had chipped counter tops and gouges in the walls making surfaces porous and non-cleanable.
*Clean storage Rm#2319 had gouges in the walls
The above findings were confirmed by CDC PP at the time of discovery.

On 5/13/2013 from 11:21 AM to 11:55 AM, a tour with Nurse Educator L and concurrent observations and interviews identified the following:

*Biohazard room #2223 had a floor with cracked stone tiles, the wall had gouges and the ceiling air vent had dirt/debris on the louvers.
*The hallway leading to the ICU had cracked floor tiles, gouges in the dry wall and areas where the vinyl wall trim was separating away from the floor exposing the sub floor.
*The ICU waiting area had gouges in the dry wall.
*Chairs in rooms #1, 2, 3, 5, 6, 7, 8, 10, and 11.had cracked vinyl coverings.
*The ICU charting station had broken laminate.
*The above findings were confirmed with Nurse Educator L at the time of discovery.

*On 5/13/13 from 1:20 PM to 2:55PM, a tour with Nurse Educator L and concurrent observations and interviews identified the following:
*The hallway of the catheterization lab to Rms 1 & 2 had cracked tile flooring.
*The recovery bay had gouges in the drywall.
*The pre-operative holding area for surgery had a back counter with broken laminate.
*The medication room had holes in the drywall and wall tiles.
*The GI area procedure room #1 had a large hole in the flooring, gouged drywall, a piece of laminate flooring was missing in the storage closet.
*The dictation area within the recovery area had gouges in the drywall.
*Recovery rooms #2, 3, 4, and 6 had gouges in the drywall..
*The day surgery charting station had gouges in the laminate.
*Pt Rms #10, 11, 14, and 17 had vinyl molding coming off the wall exposing underlayment.
*The decontamination room had cabinets that had rust and had chipping, peeling paint throughout the area.
The above findings were confirmed with Nurse Educator L at the time of discovery.

n 5/14/2013 at 7:35 AM, during a tour with CDC BB, and concurrent observations and interviews the following was identified:
*Surgery Rms #4, 5, 6, 7, 8, 9, 10, 11, and 15 had broken wall tiles, broken laminate counters/cabinets and gouges in the drywall.
The above findings were confirmed with Clinical Development Coordinator BB at the time of discovery.

These observations occurred at Elmbrook Memorial Hospital:

*During an observation on 5/15/13 at 9:05 AM, on the 5th floor, the clean storage room had linoleum flooring (approximate 7 inch wide by 2 foot long) that was warped and missing exposing the floor concrete surfaces.

*The same clean storage room had a marred surface exposing porous plaster (approximate 3 foot long gash at the height of between 5-6 feet high) on the wall.

*The 6th floor pt care area on 5/15/13 at 8:15 AM, the storage alcove across from Rms 644/641 had marred gouged walls exposing porous plaster that could not be cleaned.

During an interview with V.P. SSSS on 5/15/13/at 3:00 PM, stated that a work order to fix the flooring was submitted to the maintenance department on 10/17/12.


A tour of the 4th floor was conducted on 5/13/2013 from 11:25 AM-11:55 AM and again from 1:30 PM-3:30 PM accompanied by RN Edu C. The 4th floor consisted of Cardiac, Pulmonary, and Post-Partum units, and a closed short stay Cardiac unit. The following observations were made on these units:

*Laminate on doors and counters was chipped and/or missing in several work areas and patient rooms.
*In several patient rooms and utility rooms there were chips and gouges in the dry wall revealing the porous, non-cleanable surface underneath.
*A large strip of molding along the kick board in room 4153 is missing.



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22198

A Recertification Survey for Life Safety Code compliance was conducted by the Wisconsin Division of Quality Assurance on 05/13/2013 - 05/16/2013. The Wheaton Franciscan Health - St. Joseph Hospital was found to be NOT in compliance with the following regulation:

42 CFR 482.41(b) Standard: Safety from Fire was NOT MET

The cumulative effect of these deficiencies has the potential to affect the safety of all patients, staff, and visitors at the hospital.

K11: Unreliable separation
K12: Reduced Class of Construction
K14: Interior finishes without flame spread ratings.
K15: Interior room finishes without flame spread ratings.
K17: Smoke tight corridors are not maintained.
K18: Ineffective latching and non-protected openings into the corridor.
K20: Compromised vertical shaft ratings.
K21: Rating doors on hold-open without automatic closing feature.
K22: Access to exits without readily visible signs.
K24: Smoke Compartments with inappropriate configurations.
K25: Smoke Compartment walls were not smoke tight w/ ratings.
K27: Smoke barrier doors were not smoke tight.
K29: Unreliable enclosure of hazardous areas.
K32: Exit were not provided or properly remote from each other.
K33: Exit enclosures open to an unoccupied space.
K34: Stairways were not reliably enclosed or protected.
K38: Access to exits was not accessible.
K39: Egress corridors were undersized.
K40: Egress doors were undersized.
K47: Lacking exit directional signs.
K48: Evacuation plan without all elements.
K50: Fire drills were not conducted under varied conditions.
K51: Fire alarm system was not compliant to NFPA 72 minimum standards.
K52: Fire alarm system was not fully tested to NFPA 72 standards.
K56: Sprinkler system was not compliant to NFPA 13 minimum standards.
K61: Sprinkler valves were not supervised.
K62. Sprinkler system was not properly maintained.
K64: Portable fire extinguishers were not properly distributed.
K67: The ventilation system did not meet NFPA 90A minimum standards.
K69: Kitchen was not properly protected per NFPA 96.
K72: Corridor obstructions were not eliminated.
K74: Loosely hanging fabrics lacked treatment.
K75: Linen receptacles located within rated room enclosures.
K76: Medical gas storage was not protected per NFPA 99.
K77: Piped medical gas and valves was not installed properly.
K78: Smoke removal not provided for an indoor anesthetizing location.
K103: Interior partitions were constructed of combustible materials.
K130: Miscellaneous provisions not found in other K-tags.
K147: Electrical system not to NFPA 70 minimum standards.
K154: Sprinkler outage policy lacked fire watch personnel specific duties.
K155: Fire alarm outage policy lacked fire watch personnel specific duties.

Please refer to the full description and findings within the specific K-tag deficiencies within the appropriate Building found later in this report.

Based on observation and record review the facility potentially placed all patients, visitors and staff at risk by not keeping the surrounding area of the dumpsters free from debris and covered for 1(St. Joseph's) out of 3 hospitals.

On 5/13/2013, 10:57 AM, observed outside dumpsters. One dumpster was not covered and along its side, sitting directly on the ground was a stack of cardboard. Also, sitting on the ground, was different types of debris - old milk crate, plastic bags, plastic wrappers and another larger plastic bag behind dumpster. This was confirmed by Staff F and G.

On 5/20/2013, 1:00 PM, review of undated procedure "Sodexo Shine - Waste Receptacle Cleaning," does not address keeping the surrounding area free of debris.

"OUTSIDE RECEPTACLES
Outside receptacles shall be kept covered with tight-fitting lids, doors, or cover and the surrounding area should be free of debris. Area is to be kept clean to prevent infestation of rodents and pests and littering into the environment. "

Based on observations in P&P review, and interviews, the hospital's equipment and supply maintenance system for 2 of 3 hospital locations (St Joseph's, Wisconsin and Elmbrook Memorial), failed to secure hazardous chemical, failed to have an effective system in place to check, rotate and remove outdated products, and failed to monitor equipment and supplies for safety, integrity and security. Failure to maintain the physical environment has the potential to affect all patients, visitors, and staff in this hospital system.

Findings include:

The facility's policy titled, "Environmental Cleaning, Sanitation, and Decontamination," dated August 2012, was reviewed on 5/15/2013 at 1:20 PM. The policy's rationale is to achieve excellence and use best practices which requires them to, "Adhere to environmental cleaning, sanitation, and decontamination by following best practice of CDC guidelines."

The policy's Part A. Summary states in part, "The environment includes but is not limited to: floors, carpeted and uncarpeted, walls, ceilings, doors, office and pt care furniture, wall and ceiling mounted equipment, cabinets, shelves, counters and other work surfaces, air vents, ducts..."

Findings at Elmbrook Memorial Hospital:

Refrigerator Temperatures not monitored:
*During tour of the Elmbrook Hospital location on 5/15/13 at 8:06 AM, during a tour and concurrent observation and interview with Clinical Nurse Educator FFFF Laboratory Staff GGGG, the following was observed:
* In the laboratory area the 4 refrigerators had incomplete temperature logs for the date of 04/28/13, the refrigerator labeled "Biohazard Survey", Chemistry", "Co-ag", and "Urinalysis".
*The refrigerator labeled, "Processing" had a log showing that temperatures were not recorded on 5/12/13 and 5/13/13. When the missing temperatures were pointed out to Staff GGGG, GGGG said, "They must have missed it those days. Monitoring is to be done by the morning shift daily.
*The refrigerator log for the refrigerator in the grossing station room shows that temperatures were not recorded on the following dates from March 1 through May 14, 2013:
March 7, 15, 28, and 29, 2013
April 1, 2, 3, 4, 5, 7, 10, 24, and 28, 2013.
May 8, 9, 10, 11, 12, 13, and 14, 2013.

When Surveyor mentioned that there were numerous temperatures missing, staff GGGG said, "yes" and then provided a copy of the log.

Physical plant observations:

Observations on 5/15/13 at approximately 9:05 a.m., of the 5th floor clean storage room reflects linoleum flooring (approx. 7 inch wide by 2 feet long) is warped and missing,exposing the floor concrete surfaces, that cannot be efficiently disinfected. One wall has a marred surface exposing porous plaster (approx 3 feet long gash at the height of between 5-6 feet high.) The clean storage room should have washable and intact wall surfaces to prevent transmission of infection to clean supplies.

Interview with V.P. SSSS on 5/15/13 at 3:00 p.m. reflects that a work order to fix the flooring was submitted to maintenance on 10/17/12, and has not been responded to yet.

During the tour of 6th floor patient care area on 5/15/13 at 8:15 a.m., the storage alcove across from Rooms 644/641 had marred gouged walls exposing porous plaster that could not be cleaned.

At 9:35 AM on 5/5/15/13 while touring the Cardio-respiratory area of the Elmbrook Hospital, accompanied by Supervisor IIII, the following concurrent observation and interview identified the following:

In Rm #C212, a labeled EMG (Echo-Myogram), had 1 bottle of alcohol 70% sitting on the desk that had expired in July of 2009. When asked Supervisor IIII what the expiration date on the bottle was, IIII replied, "July 2009".

Findings at St Joseph ' S Hospital:
On 05/13/13 from 11:25 AM to 4:00 PM, during a tour and concurrent observations and interview with CDC PP the following areas were identified and confirmed not to have a cleaning schedule or assigned staff accountable for cleaning:
*3rd floor NICU large common wash sinks debris had visible build up on the wall, sinks and sanitizer/cleaner dispensers.
*3rd Prenatal Assessment department and 7th floor kitchenette had ice machines that had white debris built up around the dispensing spout and catch tray. Dust and debris was found on top of and underneath both ice machines.
*3rd floor NICU unit laundering room was also used for storage blocking the hand washing sink.

*3th and 7th floors, clean storage areas (Rm #3827C, #3827D, #3831 #3837, #3839C, #3812,#3149, #3219, #3225, #3218A, #3218C, #3214, #3010, #3026, #3050, #3051, #3041, #7029,and 7028) were not on a cleaning scheduled.
*3th and 7th floors soiled and dirty utility rooms (3820B, 3830A, 3835, 3810, #3214, #3043, #3115 and #7009) were not on a cleaning schedule.
*Air ventilation grids (for air flow into the unit) were dusty with gray/black material clinging vent grids on 2 of 7 floors (#3 and #7) for 7 of the 7 pt care areas (Hospice, Oncology, L&D, Antepartum, Pediatric Stepping Stones, Prenatal Assessment Maternal Fetal Medicine & NICU), including their storage rooms.
*7th floor surveyor noted a stained carpet on the floor of a clean supply room. 7th floor RN Manager XX stated, XX was not aware that carpet was not allowed in a clean storage area.
*At the time of discovery, CDC PP acknowledged both clean and dirty storage areas on the 3rd and 7th floor identified above had evidenced of debris and dust build up on the flat surfaces, storage racks storage bins and air vents.

On 05/13/13 from 11:25 AM to 4:00 PM, during a tour and concurrent observations and interview with CDC PP and unit staff, the following supply areas were identified, not to have clearly marked expiration dates and no system to ensure product quality, and out dated products were not being removed from Pt care areas in the following areas:
*3rd floor NICU had 2 shipping boxes labeled " Mission Supplies". In an interview at 12:25 PM on 05/13/13, CDC UU and NICU Supervisor TT said the mission items are no longer useable on the NICU unit. TT and UU said they were unaware that unusable items should be separated from their Pt useable products.
*On 05/13/13 from 1:55 PM to 2:30 PM on a tour of the Antepartum unit Medication Rm #3230, CDCP PP identified outdated blood collection tubes.
*On 2 of 7 floors (#3 and #7) in 6 of 7 (Hospice, Oncology, L&D, Antepartum, Prenatal Assessment Maternal Fetal Medicine & NICU), units, sterile product packaged by a MFR did not have an expiration date on them.

On 05/13/13 during an interview, CDC PP discussed validity of sterility with NICU Pt Care Supervisor TT at 12:25 PM, 3rd floor L&D Supervisor SS at 2:40 PM and 7th floor RN Manager XX at 3:30 PM. TT, SS and XX, acknowledged that PP, TT, SS and XX were not aware that products came from the MFR without an expiration date.
*NICU Pt Care Supervisor TT (12:25 PM), 3rd floor L&D Supervisor SS (2:40 PM) and 7th floor RN Manager XX (3:30 PM) said, the hospital does not have a P&P for rotation of sterile products that come to the hospital without a clearly marked expiration date.
*NICU Pt Care Supervisor TT (12:25 PM), 3rd floor L&D Supervisor SS (2:40 PM) and 7th floor RN Manager XX (3:30 PM), acknowledged, TT, SS and XX were not aware of any monitoring done within the respective departments to ensure sterile packages were maintained at a temperature and humidity to ensure sterility for the sterile products shelf life.
*NICU Pt Care Supervisor TT (12:25 PM), 3rd floor L&D Supervisor SS (2:40 PM) and 7th floor RN Manager XX (3:30 PM), acknowledged, that TT, SS and XX did not know the shelf life for the sterile products identified as not having an expiration date within the respective departments.
*3rd floor NICU on emergency NICU response cart MFRs sterile packages were rubber banded, that include venipuncture needles and intubation tubes. Staff stated they were not aware that rubber banding sterile packages jeopardized the package integrity. At 12:25 PM, NICU Pt Care Supervisor TT said she was unaware that rubber banding sterile packages compromised their integrity and sterility.
*3rd floor NICU surveyor found 4 packages of outdated infant formula. S NICU Pt Care Supervisor TT (12:25PM), said TT acknowledged the outdated infant formula but TT said TT was unsure who was monitoring formula outdates, unit staff nurses or nutritional services.
*Medication Rm #3230, Surveyor and CDC PP identified outdated blood collection tubes.
On 05/13/13 from 11:00 to 4:00 PM, tours of the 3rd and 7th floors with CDC PP and concurrent observations and unit staff interviews identified the following equipment maintenance issues:
*7th floor medication room #7028 had a missing grill at the bottom of the medication refrigerator dust and debris were visible including a syringe cape and a roll of tape. On 05/13/13 at 3:30 PM, RN XX was not sure who was responsible for the maintenance of the refrigerator. However, XX did acknowledged the grill had been missing for a while.
*7th floor room #7029 had a blanket warmer currently being used, but was missing its top and side panels. The insulation was duct taped in place. On 05/13/13 at 3:30 PM the 7th floor RN Manager XX, said, that XX was not aware of why the blanket warmer had no sides or top, or who maintained the blanket warmer or who would have ducted tape the insulation in place.
*3rd and 7th floors, had computers on wheels with dust and debris between the keys and in the housing frame. 3rd floor NICU Pt Care Supervisor TT at 12:25 PM, 3rd floor L&D Supervisor SS at 1:25 PM and RN Manager XX on the 7th floor at 3:30 PM, explained that staff are to wipe them down between pts, however there was no regular cleaning or maintenance scheduled for the computer key boards.

A tour of the 4th floor was conducted on 5/13/2013 from 11:25 AM-11:55 AM and again from 1:30 PM-3:30 PM, accompanied by RN Edu C. The 4th floor consisted of Cardiac, Pulmonary, and Post-Partum units, and a closed short stay Cardiac unit. The following observations were made on these units:
*Rm #4159, designated as a family waiting area, was being used for storage of wheel chair with an oxygen tank attached to them, a vital sign monitor, and other unsecured pt equipment.
*Soiled Utility rooms containing bio-hazard waste and sani-wipes (chemical cleaning wipes that indicate to keep out of reach of children on the label) were unlocked, allowing potential unauthorized access to chemicals and hazardous waste.
*On the post-partum unit, the soiled utility room had dirty surgical instruments in it and the door was unlocked.
*In the hallway outside of rm #4202 in the basket attached to the EKG monitor stand was a container of sani-wipes. There was a visiting child playing in the hallway in this area, who had potential to access the chemical wipes.
These findings were discussed with and confirmed by RN Edu C at the time of discovery on 5/13/2013.

During a tour of the rehabilitation unit at Elmwood on 05/15/13 at 9:20 AM with RN educ. CCCC dirty and scuffed walls were observed as well as dust clogged vents on the radiator/heating unit in both room #466 and room #473. These findings were confirmed by CCCC at the time of the tour.

Per review on 5/15/13 at 1:50 pm of facility policy titled Hazardous Materials and Waste Management Plan, dated 1/2012 indicated under Rationale: The Hazardous Materials and Waste Management Program was developed to coordinate an effective hazardous materials safety program based on organizational experience, applicable laws, and regulations, and accepted practice. This includes maintaining a safe physical environment, inventory and safe handling of hazardous materials, monitoring associate e work areas, reviewing departmental policies and procedures, an implementing a hazardous material waste reduction program.

Per review on 5/15/13 at 1:50 pm of facility policy titled Hazardous Materials and Waste Management Plan, dated 1/2012 indicated under II. A. 2. Those chemicals defined as OSHA/EPA as hazardous are stored in areas accessed only by authorized personnel.

A tour of the 5th floor was conducted on 5/13/2013 from 2:25 PM.-3:40 PM accompanied by RN Edu O. The 5th floor consisted of Medical, Surgical, and Post-Partum units. The following observations were made on these units:
*Soiled Utility rooms housing bio-hazard waste and sani-wipes (chemical cleaning wipes that indicate to keep out of reach of children on the label along with bottles of chemical cleaning supplies) were left unlocked.
*In several pt rooms there were upholstered chairs with cracks or rips in the material revealing a non-cleanable surface underneath.
*In several pt rooms built-in metal closets are utilized for medical supplies and pt belongings on the medical unit. The paint was chipped off and areas are noted to have rust.
*On 5 West in the pt food storage area were white plastic bins used to hold packets of salt, pepper, and sugar; the containers have crumbs, and debris noted at the bottom of the containers. These findings were confirmed at the time of the tour by RN Edu O.

Per tour on 5/13/13 beginning at 11:45 am of the Materials Management area in the basement level revealed the following:
*The room was filled with dirty/full bio-hazardous containers along with clean/unused bio-hazardous container with no distinct separation of clean/unused and dirty/full containers.
*Dirty/full bio-hazardous containers housed on the same wheeled metal cart with Empty/unused bio-hazardous containers.

Per interview with Director of Environmental Services (DEVS) P on 5/13/13 at 11:50 am, DEVS P stated the wheeled metal cart is used to exchange the bio-hazardous containers on the units. The cart is filled with unused containers and when a dirty/full bio-hazardous container is removed from the unit, it is placed on the cart and an empty/clean container is removed from the cart. Clean containers are stored next to contaminated containers increasing the risk of cross contamination.

Per tour on 5/13/13 beginning at 12:00 pm of the Clean Laundry Storage Area revealed a large stainless venting mounted on the ceiling directly above the clean laundry carts, with an opening of approximately 3 ft by 2 ft which had a large accumulation of a thick layer of dust. Directly under the air vents were 8 laundry carts filled with clean linen which was uncovered. At time of tour laundry staff was at lunch.
Findings confirmed with Lead worker of Linen Room LWLR (Q) and RNN Edu O.
Per interview on 5/14/13 at 8:40 am with Director of Supply (DS) TTT indicated, that it is expected that staff would keep linen covered when not working immediately in that area to prevent possible contamination.

Per tour on 5/14/13 at 11:25 am through 11:45 am of the Inpatient Dialysis Area reveled:
*Water room with dirt and debris noted on the floor
*A buildup of white thick substance on top of the pipes leading from the bicarbonate and acid storage containers. Findings confirmed with RN Edu O at time of tour.

Per tour on 5/13/13 beginning at 1:45 PM of the Material Management Room revealed room filled with metal shelving.
*Approximately 38 metal carts had a plastic covering on the bottom level of each shelf. A thick layer of dust noted on all the plastic coverings.
*Boxes of supplies were tipped over and individual packaged supplies were lying in the dust.
*Supplies noted out of original packaging included lab supplies, anesthesia packs, colostomy supplies, tape, intravenous supplies and ventilator supplies. Also noted 3 urinals laying on the floor in between the wood pallets. Findings confirmed with RN Edu O at time of tour.

Per interview with Distribution Attendant (DA) UUU stated that the Housekeeping Staff is responsible to clean the floor and material management staff is responsible to keep the shelving for the supplies clean. DA UUU stated there is no schedule to complete cleaning.

On 5/13/2013, beginning at 11:21 AM a tour with Nurse Educator L was conducted. Biohazard Rm #2223 was observed to be unlocked. The room contained a large biohazard bin with material inside and dirt accumulated in the corners. The air vent had dirt/debris on the louvers.
*The room contained a hopper sink. The sink had a dark brown film on the inside with chunks of brown debris clogging the drain. Nurse Educator L explained the room is used by the dialysis unit and the outpatient unit.

On 5-13-2013 at 1:20 PM a tour with Nurse Educator L was conducted of the catheterization lab. It was observed the medication room had wash cloths stored under the sink.

At 1:55 PM, the post anesthesia care unit (PACU) was observed. Bathroom was observed to have dirty ceiling air vent and floor tiles with accumulated dirt.

Across from pt recovery pod #11 was a large original shipping box. Nurse Educator L explained that original shipping boxes do come to pt care areas to be emptied.

At 2:15 PM the GI area was observed. 34 GI scopes were observed hanging in the hallway outside of procedure room #2 un protected and uncovered exposing them to dust, debris and damage.

Clean storage room #2106 was observed to have storage of diapers, syringes and suction canisters under the hand-washing sink.
*Original shipping box of Bair Paw gowns was observed in the clean storage room.
*Dirty Utility room #2104 was observed to be unlocked and contained a biohazard container.
*Under the sink were pt positioning items.
*Pt rooms #10, 11, 14, and 17 were observed to have dirty floors.
*Pt room # 16 was observed to have no pt in the room and used IV tubing was still attached to a IV bag with the IV catheter inside a glove laying on the floor.
*The door to the laundry chute was unlocked.
*At 2:55 PM the decontamination room was observed. The hopper sink behind the disassembly table was observed to have large amounts of white residue around and on the sink.
The above findings were confirmed with Nurse educator L at the time of discovery.

On 5/14/2013 at 7:35 AM observation of surgery rooms #1, 2 and 3 with CDC BB, are used for currently used to perform surgical procedures are also being used to house unprotected storage.
The above findings were confirmed with CDC BB at the time of discovery.



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26711




29963

Based on observation and staff interview, the facility did not construct, install and maintain a proper ventilation and temperature control system in pharmaceutical, food preparation, and other appropriate areas. The facility did not have and a ventilation system that was installed and maintained in accordance with CDC guideline, AIA guidelines and manufacturer recommendations. This deficient practice could affect all patients, staff, and visitors in 40 of the 92 smoke compartments.

The facility also did not provide proper ventilation due to a lack of positive pressure int hree spaces and a lack of negative pressure in one space. These deficient practices had a potential of cross contamination of air with undersirble contaminants and causing posile infectin for all patients receiving services at this hosptial.

The CDC guidelines can be found in the website


FINDINGS INCLUDE:

1. On 5/14/2013 at 2:00 PM, observation revealed on the 8th floor between the clean room of the infusion pharmacy and the ante room, that the ventilation to the space could not be confirmed to be compliant with accepted standards. The air flow was going from positive to negative and then negative to positive without any apparent reason. They was observed by a tissue under the door.

2. On 5/15/2013 at 10:00 am, observation revealed on the 2nd floor (on the 1st floor roof) by the air handler near the old main entrance, that the ventilation to the space could not be confirmed to be compliant with accepted standards. The air intake was only 8 feet from the air exhaust. The CDC and AIA Guidelines require a separation distance of 25 feet between air intakes and air exhausts. Moss was growing on the roof, 2 feet from an air intake.

3. On 5/16/2013 at 9:58 am, observation revealed on the Basement floor in the sterile processing, that the ventilation to the space could not be confirmed to be compliant with accepted standards. Air flow was from substerile (receive area (dirty)) into sterile processing (clean). This air flow is in the wrong direction. The air shall go from clean to dirty.

4. On 5/16/2013 at 10:05 am, observation revealed on the Basement floor in the sterile processing room, that the ventilation to the space could not be confirmed to be compliant with accepted standards. The air grills between the sterile processing room and behind the sterilizers were covered in dirt and dust.

These conditions were confirmed at the time of discovery by a concurrent observation and interview with staff M3 (HVAC Tradesman), staff M7 (EUA), staff M9 (Mechanic), and staff M13 (Risk Analyst).
______________________________________



12316


5. On 5/14/2013 at 9:10 am, observation revealed that the Clean Equipment & Case Cart Storage room adjacent to the male staff locker Room 2B456 on the 2nd Floor was not under positive pressure relative to adjacent spaces. It was instead under negative pressure causing airflow in the wrong direction from corridor to the clean storage.

6. On 5/14/2013 at 2 pm, observation revealed that the pressure monitor mounted on wall of the Operation Room #3 (OR3) opposite nurse station on the 2nd Floor showed a pressure differential reading of +0.0013 in. of water column, and was not at least +0.01 in. of water column recommended in the CDC and AIA guidelines.

7. On 5/15/2013 at 10:10 am, observation revealed that the Medical Waste Room GA152 in the Lower Level was under positive pressure relative to adjacent spaces, and not under negative pressure when tested with a one-ply toilet paper at the door undercut. The test showed the airflow direction from the waste room GA152 to corridor. The airflow was in a wrong direction from dirty to clean spaces.

8. On 5/15/2013 at 10:20 am, observation revealed that one leaf of the double corridor doors to the Clean Supply Storage GA144 in the Lower Level was held open with an electromagnetic hold-open device, and did not maintain positive pressure in the room relative to adjacent spaces to cause airflow from clean to dirty spaces.

These conditions were confirmed at the time of discovery by a concurrent observation and interview with Staff M4 (Director of Facilities-Elmbrook), Staff M15 (EUA), Staff M16 (Safety Coordinator), and Staff M22 (Mechanic). The above deficiency was also confirmed with Staff M1 (V.P. Facilities) at an exit conference on 05/15/2013 at 4:15 pm.

Based on observation and staff interviews, the facility did not construct, install and maintain a proper ventilation and temperature control system in pharmaceutical, food preparation, and other appropriate areas. This deficient practice could affect all patients, staff, and visitors in 20 of the 92 smoke compartments.

FINDINGS INCLUDE:

1. On 05/16/13 at 8:17 am, observation revealed on the Second floor in Room 2440N, that visible accumulations of dirt and dust were present in this health care environment. A dirty return vent, in the ICU, was noted over an area labeled "clean work area".


2. On 05/16/13 at 8:18 am, observation revealed on the Second floor in Room 2440J, that visible accumulations of dirt and dust were present in this health care environment. Staff Kitchen area had dirty vents.


3. On 05/16/13 at 9:16 am, observation revealed on the Second floor in Stairwell #24 & Stairwell #25, Smoke Compartment 2Q, that visible accumulations of dirt and dust were present in this health care environment. The stairwells were dusty and dirty.

4. On 05/16/13 at 10:12 am, observation revealed on the Third floor in Room 3071, that visible accumulations of dirt and dust were present in this health care environment. A thick layer of dust was visible on top of the lockers where clean surgical gowns were stored on a linen bin. Air supply was also noted to be blackened with dirt.

5. On 05/16/13 at 10:32 am, observation revealed on the Third floor in Room 3094 & Room 3097, Smoke Compartment 3B, that visible accumulations of dirt and dust were present in this health care environment. Recovery Rooms had dusty air vents, ceiling tiles and even dust visible to the eye on top of the wall clock in Recovery Room 2.

6. On 05/16/13 at 12:45 pm, observation revealed on the Fourth floor in Corridor 409C, Smoke Compartment 4E, that visible accumulations of dirt and dust were present in this health care environment. The corridor had a dirty air supply and dirty ceiling tiles. This has been noted throughout Smoke Compartment 4E.

7. On 05/16/13 at 12:50 pm, observation revealed on the Fourth floor in Room 4041, Room 4040, Room 4039 & Room 4029, Smoke Compartment 4C, that visible accumulations of dirt and dust were present in this health care environment. Rooms were noted to have dirty air supplies. This has been noted throughout the rooms on the fourth floor.

These conditions were confirmed at the time of discovery by a concurrent observation and interview with staff M10 (EUA) and staff M11 (Architectural Designer).
______________________________________

Based on observations and interviews with staff and review of nationally accepted standards of practice, the hospital did not ensure that standards of practice were followed and that patients were protected from potential contaminants or the potential spread of microorganisms to patients. This had the potential to affect all patients receiving services at the hospital.

Findings Include:

EXPIRED SUPPLIES
At 9:35 a.m. on 5/5/15/13 while touring the Cardio-respiratory area of the Elmbrook facility, accompanied by Supervisor IIII, room #C212 and labeled EMG (Echo-Myogram), had 1 bottle of alcohol 70% sitting on the desk that had expired in July of 2009. When asked Supervisor IIII what the expiration date on the bottle was, IIII replied, "July 2009.

INFECTION CONTROL WITH INJECTABLE MEDICATION:

Per observation of the colonoscopy procedure performed on Pt. #29 beginning at 10:30 a.m. on 5/15/13, the following was observed:

At 10:45 a.m. and 10:58 a.m. without cleansing the port/membrane of the vial of Versed, RN EEEE drew up Versed medication for sedation and injected the Versed via IV to Pt. #29. Of the 6 opportunities observed of administering IV medications of Zophran, Benedryl, and Versed, RN EEEE did not cleanse the port of the medication vial prior to drawing up the Versed in 2 of 3 occurrences observed.

At 11:37 a.m. on 5/15/13 when Clinical Nurse Educator FFFF, who also observed the procedure, was asked what FFFF observed in regard to when RN EEEE had cleansed medication vial ports prior to drawing up medications, FFFF replied, "I only saw her wipe the port prior to medication administration of Zophran and it should be done before each medication draw."


09948

The following issues were identified at Elmbrook memorial hospital
Infection control/ wound care-ob/I

*) Observations of wound care/ dressing change on Patient #31 by WORN QQQQ on 5/15/13 at approximately 10 a.m. reflects that after handwashing and donning clean gloves, WORN QQQQ approached patient to removed dressing over wound site, and reached with clean gloved right hand to adjust the bed height on the patient ' s upper siderail panel. This action contaminated the glove on WORN QQQQ's right hand. WORN QQQQ did not remove contaminated glove, handwash, nor don clean gloves before removing this patient dressing.
This observation was reported in interview to Clinical Educator RRRR at approximately 3 p.m. on 5/15/13. She stated that this observational information would be added to documentation to share with administrative staff.

The following issues were found at Wisconsin Heart Hospital -
BIOHAZARDOUS WASTE - OB
*) Observation in the PACU unit on 5/14/13 at approximately 11:50 a.m. reflects Anesthesiologist UUUU at the automated drug dispensing unit returning medications used for surgical procedures. After leaving the automated dispensing, Anesthesiologist UUUU was observed to throw a syringe in the waste paper basket. There was no biohazard bin at the drug dispensing station for which to properly dispose of these syringes.
In interview with Clinical Educator RRRR at the time of observations, she stated that syringes should be disposed of in a biohazardous bin.

Aseptic Medication technique ob/ practice standards/I -
Observation of care in ICU for the surgical recovery of Patient #52 on 5/14/13 at 1:25 p.m. through 2:10 p.m. reflects that RN Staff VVVV did not use alcohol wipe to clean bladder of Albumin glass vial before puncture with intravenous infusion set.

APIC guidance reflects that single and multidose vials should have their access diaphragm cleansed using friction and 70% alcohol. Allow to dry before inserting a device. Cleanse the access diaphragm of vials using friction and 70% alcohol. Allow to dry before inserting a device.

In interview with Clinical Educator XXXX at 2:12 p.m. this information was shared, without rebuttal comment from Clinical Educator RRRR .



22198

In 7 of 7 patient care areas of St. Joseph Hospital (Hospice, Oncology, L&D, Antepartum, Pediatric Stepping Stones, Prenatal Assessment Maternal Fetal Medicine & NICU) infection control issues were found as follows:

NICU

On 05/13/13 between 11:25 AM and 12:25 PM while on tour of the NICU department with NICU Pt Care Supervisor TT and Clinical Development Coordinators PP and UU observed the following:

Clean storage rooms #3827, 3827D, 3831, 3837, 3830A contained dust and debris on the floors, counter, and storage racks and bins. Rms #3830C and # 3831 had porous un-washable surfaces. Shipping boxes were being stored with supplies in these clean storage areas
Clean storage rooms #3827, 3827D, 3831, 3837, 3830C and 3812 contained clean, sterile and dirty storage without separation.

Rm# 3837A a clean storage room contained respiratory humidifiers for neonatal intensive care infant patients that were not clean. Five (5) of 7 neonatal humidifiers were set up and ready for use with humidifier tubing connected to the 5 of 7 humidifiers. Connection ports were not covered allowing for dust and debris to collect in the connect ports. The hospital airflow vents in the room above the 7 humidifiers had visible dust and debris build up.

NICU Pt Care Supervisor TT and Clinical Development Coordinator UU stated, opening up clean humidifier tubing and setting up the neonatal humidifiers ahead of time was not a good practice if they were not going to monitored and maintained to ensure dust would not build up in the 5 of 7 humidifiers set up for use.

Room# 3812 (clean storage) had 7 boxes of data storage, items used on the unit for families (toys and clothes), 2 transport isolates visibly dirty and other clean and dirty storage items.

Clean storage rooms #3827, 3827D, 3831, 3837, 3830A contained dust and debris on the floors, counter, and storage racks and bins. Rms #3830C and # 3831 had porous un-washable surfaces. Shipping boxes were being stored with supplies in these clean storage areas

NICU soiled utility rooms #3835, 3830A contained dirty, clean and sterile supplies (sample of sterile items: boxes of suture and hospital processed peal packs of OBGYN equipment).

Unit Clerk WW identified the sink in Rm 3830A as an equipment-cleaning sink. The sink counter top contained stacks of clean cleaning towels, numerous peel packs of sterilized OBGYN equipment, gloves and writing materials. Also in the room were additional racks of clean and dirty items and a desk and computer. Chemical hung on a storage rack of clean and dirty items. This room was dusty and dirty with debris.

NICU Pt Care Supervisor TT and Development Coordinator UU stated, TT and UU had not thought about the water spray from cleaning equipment could affect the clean and sterile items on the sink counter or in close proximity.

Soap dispensers and hand gel dispensers throughout the unit had residue built up of dust, and dark debris.

On 05/13/13 during an end of tour discussion of findings and interview, NICU Pt Care Supervisor TT and Clinical Development Coordinator UU stated they observed and acknowledged all infection control findings within the NICU department and there was no current cleaning schedule.

TT and UU agreed that potential for significant cross contamination related to no separation of clean, dirty and sterile was identified throughout the NICU clean and dirty storage rooms

NICU Pt Care Supervisor TT and Clinical Development Coordinator UU stated that they had not involved Infection Control for assistance and oversight to storage and equipment and separation of clean, dirty and sterile items to ensure they were stored in rooms with appropriate airflow, ventilation and humidity.

PRENATAL ASSESSMENT:
On 05/13/13 between 1:55 PM and 2:30 PM during a tour of 3rd floor Antepartum unit with Clinical Coordinator and RN VV the following was observed:

Bio hazardous Rm #3810 had no sink or hand washing availabilities within close proximity to the room. The hand-washing sink in the corridor had soap and dark debris build up at the spout.

ANTEPARTUM:
On 05/13/13 from 1:55 PM to 2:30 PM, tour with Clinical Coordinator PP observed the following:

Clean storage Rm #3219 had chipped counter top, gouges in the walls and clean supplies sitting on the sink countertop.

Between Rm # 3226G and 3226 A were 4 fetal monitor that are taken into patient rooms. Two (2) of the 4 monitors were housed on wooden carts with worn and gouged surfaces, making this cart surface porous and unclean able. Three (3) computers on wheels that had key boards visibly dirty.

Clean storage Rm # 3225 an umbilical line cart used in urgent and emergent situations, contained zip lock bags with emergency with expired blood collection tubes, a Manufacturer packaged Arterial blood sampling kit that expired 03/2012 Lot #1766941 and a hospital sterilized peel pouch with sterile cotton swabs that was visibly stain and on the emergency cart for use.

Equipment and clean storage Rm #3218A had no door and open to a common hallway. The room contained clean, sterile storage, patient use items (clothing). The storage racks were both wood and metal and were visibly dirty. All clean and sterile supplies housed in the room were accessible to patients, and visitors.
Clean utility Rm 3218C housed clean and dirty items.

During an interview after the tour of the antepartum unit, Clinical Coordinator PP agreed that potential for significant cross contamination related to no separation of clean, dirty and sterile was identified throughout the Antepartum Unit in the clean and dirty storage rooms.

L&D
On 05/13/13 between 2:40 PM and 3:20 PM while on tour of the L&D department with Clinical Development Coordinator PP and Supervisor SS observed the following:

Clean storage rooms #3010, 3026, 3050, 3051 and 3041 contained dust and debris on the floors, counter, storage racks and bins. Rms #3041 and 3051 had 6 wooden portable stands, that the finish was worn away and chipped, leaving 6 of 6 wooden stands used for patient rooms, porous and un-washable.

Shipping boxes were being stored with supplies in these clean storage Rms# 3010, 3026, 3050, 3051 and 3041.

Clean storage rooms #3827, 3827D, 3831, 3837, 3830C and 3812 contained clean, sterile and dirty storage without separation.

HOSPICE/ONCOLOGY:
On 05/13/13 between 3:25 PM and 4:00 PM along with RN Manager XX and Clinical Coordinator TT, observed in Rm #7029 identified by XX as clean storage during a tour on 7th floor Hospice and Oncology units. Rm #7029 had a visibly stained carpet in room designated for clean storage area. In an interview at 3:30 PM, RN Manager XX stated that XX was not aware of any carpet-cleaning schedule.
In an interview at 3:30 PM, RN Manager XX stated that they were not sure if a clean storage room could have carpeting.

On 05/13/13 between 3:25 PM and 4:00 PM, along with RN Manager XX and Clinical Coordinator TT observed clean, dirty and sterile storage in Rm #7029. There were desk spaces and paper materials and paper storage materials, paper signs taped to the walls and wire racks of supplies, a sink that had leaked (evidenced by stain on the carpeting and build up on the exposed pipes) decoration on a patient food refrigerator that was not cleaned (evidenced by spilled liquid dried on racks and flat surfaces inside the refrigerator).

Rm #7029 had clean, dirty and sterile storage within one space and no separation. The cleaned equipment available for pts. use was visibly dirty. Shipping boxes were maintained in a clean storage room.
Air vents blowing air into utility rooms #7029 7028, 7009, 7026, 7022, 7022 and pt room 7017 had visible debris hanging from them.

C-SECTION SUITE:
On 05/14/13 between 7:30 AM and 9:45 AM surveyor observed the preparation and C-section for Pt #5.
RN EE went into the sterile procedure area with a mask tied only at the top leaving the bottom strings hanging when she went for blood products.
Orienting student nurse FF had a mask tied around FF's neck from the time since the beginning of observation. The same mask hanging from FF's neck for approximately 1 hour, was then tied up by orientation student nurse FF and used for the C-section of Pt #5.

Surgical light switch had tape and tape residue and darkened tape residue and clinging debris on walls of the OR suite.

Clean and sterile equipment and storage racks were stored open in the C-section suite, exposing clean and sterile products during every C-section case performed in that room, to fluid spray and cautery plume.

Observed RN EE, student nurse FF, MD KK and Resident JJ, removing gloves and not performing hand-hygiene before touching other surfaces or donning new gloves as follows:

RN EE multiple times during the procedure observation, removed dirty and bloody gloves without hand hygiene between glove changes touching sterile items requested during the procedure, the sub sterile door multiple times and reached into the pocket of the scrubs EE had on, to take out a zone phone.

Orientation nurse FF removed bloody gloves without hand hygiene between glove changes.

MD KK immediately after removing bloody gloves without performing hand hygiene took the cell phone from KKs waste clip to make or answer a call.

Resident JJ immediately after removing bloody gloves prior to hand hygiene took Pt #5s paper chart.

MD GG wore personal glass for PPE eye protection.

Respiratory staff MM, Neonatology staff LL, and OO and OB RN NN failed to tie and don PPE per hospital policy:
MM, LL and NN failed to tie the donned gown at the waste. OO failed to tie the top or waste of the donned.

On 05/15/15 at 9:45 AM Infection Control Coordinators U and V provided 2010 hospital education materials and current hospital P&P entitled; "Surgical Attire (3 pages reviewed/revised April, 2013 and "Personal Protective Equipment" (PPE) (last reviewed/revised Aug 2012).
On 05/15/15 at 9:45 AM Infection Control Coordinators U and V, reviewed the materials, in conjunction with an interview.
Infection Control Coordinators U and V, stated staff are trained and have P&P that follow current evidenced based standards of practice, and should not carry things in their scrub pockets.

Infection Control Coordinators U and V, stated that the policy entitled "surgical attire" states under section "D" subsection "b:" "Masks are not to be worn hanging down from the neck," and subsection.
Infection Control Coordinators U and V, stated that PPE P&P states under section "E" subsection "c" "Protective eyewear consists of goggles, enucleated goggles, mask/shield units, or full face shield. Eyeglasses are not adequate eye protection."
On 05/15/15 at 9:45 AM Infection Control Coordinators U and V, confirmed that hand hygiene between glove changes is not a part of the current hand hygiene policy. However, policy does state, "when in doubt perform hand hygiene." U and V stated that hand hygiene is required between glove changes.


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On 5/13/2013 beginning at 11:21 AM a tour with Nurse Educator L was conducted. Biohazard room #2223 was observed to be unlocked. The room contained a large biohazard bin with material inside. The stone tile floor was cracked and had an accumulation of dirt in the corners. The drywall had gouges and the ceiling air vent had dirt/debris on the louvers. The room contained a hopper sink. The sink had a dark brown film on the inside with chunks of brown debris clogging the drain. Nurse Educator L explained the room is used by the dialysis unit and the outpatient unit. The hallway to the ICU was observed to have cracked floor tiles, gouges in the dry wall and areas where the vinyl wall trim was separating away from the floor exposing the sub floor. The waiting area for the ICU was observed to have gouges in the dry wall and chairs with cracked vinyl covering in rooms #1,2,3,5,6,7,8,10,and 11. At 11:55 AM the ICU was observed to have broken laminate at the charting station.

On 5-13-2013 at 1:20 PM a tour with Nurse Educator L was conducted of the catheterization lab. It was observed the hallway to rooms 1 & 2 had cracked tile flooring. The recovery bay had gouges in the drywall. At 1:40 PM the holding area for surgery was observed. The back counter was observed to have broken laminate. The medication room was observed to have wash cloths stored under the sink, holes in the drywall and wall tiles. At 1:55 PM The post anesthesia care unit (PACU) was observed. Bathroom was observed to have dirty ceiling air vent and floor tiles with accumulated dirt. Across from patient recovery pod #11 was a large original shipping box. Nurse Educator L explained that original shipping boxes do come to patient care areas to be emptied.

At 2:15 PM the GI area was observed. Procedure room #1 was observed to have a large hole in the flooring, gouged drywall, a piece of laminate flooring was missing in the storage closet. Area for dictation within the recovery area had gouges in the drywall. GI scopes (34) were observed hanging in the hallway outside of procedure room #2 and the scope cleaning room. Gouges in the drywall were noted in this area and recovery rooms #2, 3, 4, and 6. At 2:30 PM the day surgery area was observed. Clean storage room #2106 was observed to have storage of diapers, syringes and suction canisters under the hand washing sink. Original shipping box of Bair Paw gowns was observed in the clean storage room. Charting station was observed to have gouges in the laminate. Dirty Utility room #2104 was observed to be unlocked and contained a biohazard container. Under the sink were patient positioning items.

Patient rooms #10, 11, 14, and 17 were observed to have dirty floors, vinyl molding coming off the wall exposing underlayment. Patient room # 16 was observed to have no patient in the room and the IV tubing still attached to a IV bag with the IV catheter inside a glove laying on the floor. The door to the laundry chute was unlocked. At 2:55 PM the decontamination room was observed. Cabinets under the counter tops were noted to have rust and chipping, peeling paint throughout the area. The hopper sink behind the disassembly table was observed to have large amounts of white residue around and on the sink.

The above findings were confirmed with Nurse educator L at the time of discovery.

On 5/14/2013 at 7:35 AM observation of surgery rooms was started with Clinical Development Coordinator BB. The following rooms were observed to have broken wall tiles, broken laminate counters/cabinets and gouges in the drywall; #4, 5, 6, 7, 8, 9, 10, 11, and 15. Operating rooms #1, 2 and 3 are used for storage.

The above findings were confirmed with Clinical Development Coordinator BB at the time of discovery.

On 5/14/2013 at 8:40 AM Anesthesiologist AA was observed to draw medication from 3 vials into 3 syringes. Before entering the vials with a syringe Anesthesiologist AA failed to use alcohol on the vials.

At 8:55 AM Anesthesiologist AA administered medication to pt. #14 without using alcohol on the IV hub first.

At 9:05 AM Anesthesiologist AA was observed to touch pt. #14 with gloved hands and then open the drawer of the anesthesia cart and touch the items in the drawer without removing gloves and washing hands first.

The above observations were confirmed with Clinical Development Coordinator BB at 9:28 AM.


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The facility's policy titled, "Hand Hygiene/Handwashing Agents," dated August 2012, was reviewed on 5/15/2013 at 1:25 p.m. The policy references the CDC as a source for information in the policy among many other institutions. The policy states in part on page 2, "4. Personnel should always perform hand hygiene: a. before patient contact, b. before aseptic task, c. after body fluid exposure, d. after patient contact, e. after contact with patient's surroundings. When in doubt, perform hand hygiene."

The facility's policy titled, "Environmental Cleaning, Sanitation, and Decontamination," dated August 2012, was reviewed on 5/15/2013 at 1:20 p.m. The policy's rationale is to achieve excellence and use best practices which requires them to, "Adhere to environmental cleaning, sanitation, and decontamination by following best practice of CDC guidelines."

The policy's Part A. Summary states in part, "The environment includes but is not limited to: floors, carpeted and uncarpeted, walls, ceilings, doors, office and patient care furniture, wall and ceiling mounted equipment, work surfaces, refrigerators, microwaves, ice machines, air vents, ducts..."

In an interview with the Coordinators of the Infection Control Program at the 3 facilities surveyed during this investigation (Coord U, V, and W) on 5/14/2013 at 9:07 a.m. it was determined that the facilities adhere to the standards of practice and guidelines for the following organizations: CDC, APIC (Association for Professionals in Infection Control), NHSN (National Healthcare Safety Network), AORN (Association of Operating Room Nurses), WHO (World Health Organization), ACOG (American Congress of Obstetricians and Gynecologists), SGNA (Society of Gastroenterology Nurses and Associates), AAMI (Association for the Advancement of Medical Instrumentation), and OSHA (Occupational Safety and Health Administration).

The Centers for Disease Control recommendations for hand hygiene and glove use, published in the October 25, 2002 addition of the WMMR (Weekly Morbidity and Mortality Report, www.cdc.gov) are as follows:

IV. Standard Precautions
Assume that every person is potentially infected or colonized with an organism that could be transmitted in the healthcare setting and apply the following infection control practices during the delivery of health care.

IV.A. Hand Hygiene
IV.A.1. During the delivery of healthcare, avoid unnecessary touching of surfaces in close proximity to the patient to prevent both contamination of clean hands from environmental surfaces and transmission of pathogens from contaminated hands to surfaces.
IV.A.3.a. Before having direct contact with patients.
IV.A.3.b. After contact with blood, body fluids or excretions, mucous membranes, nonintact skin, or wound dressings.
IV.A.3.c. After contact with a patient's intact skin (e.g., when taking a pulse or blood pressure or lifting a patient).
IV.A.3.e. After contact with inanimate objects (including medical equipment) in the immediate vicinity of the patient .
IV.A.3.f. After removing gloves.

IV.B.2. Gloves
IV.B.2.b.ii. Wear disposable medical examination gloves or reusable utility gloves for cleaning the environment or medical equipment.
IV.B.2.c. Remove gloves after contact with a patient and/or the surrounding environment (including medical equipment) using proper technique to prevent hand contamination. Do not wear the same pair of gloves for the care of more than one patient. Do not wash gloves for the purpose of reuse since this practice has been associated with transmission of pathogens.
IV.B.2.d. Change gloves during patient care if the hands will move from a contaminated body-site (e.g., perineal area) to a clean body-site (e.g., face).

Observations of Care:
An observation of Phlebotomist D was conducted on 5/13/2013 at 1:12 p.m. accompanied by RN Edu C. As Phlebotomist D was entering Pt. #1's room to obtain a blood sample, D did not wash hands prior to gloving and setting up equipment for the task. RN Edu C stated C did not see that D did not wash hands as D entered two persons ahead of C.

In an interview with Coord U, V, and W on 5/14/2013 at 9:07 a.m. regarding the above observation, U, V, and W stated that hands should be washed upon entry to a patient's room.

An observation of PCA X administering a bed bath to Pt. #4 was conducted on 5/14/2013 at 8:40 a.m. accompanied by RN Edu C. After washing hands PCA X donned two pairs of gloves to each hand and began setting up for the bath. PCA X removed one glove from the right hand to answer the portable phone (paging system for employees). When finished on the phone PCA X removed the remaining glove on the right hand and without washing hands applied two more gloves to the right hand which X retrieved from X's pocket (pockets are considered an unclean area per APIC).

After cleansing the front peri-area and performing catheter care on Pt. #4, with the same gloves PCA X touched Pt. #4s clean arm and blankets then removed one glove from the right hand to adjust the pillow.

With the left double gloved hand (gloves on left hand since entry to the room) PCA X entered the left pocket of X's uniform to retrieve another glove to apply to the right hand thereby contaminating the glove and anything touched by the glove after this point.

PCA X cleaned Pt. #4s incontinent stool and with the same gloves handled clean bedding and blankest, applied sensi-care skin protectant to the region surrounding the rectal area thereby contaminating all of these items.

PCA X then removed the gloves from the right hand, applied a new glove to the right hand without washing, and discarded stool soiled linens into laundry bag. PCA X then removed the right hand glove and handled clean bedding without washing hands. PCA X then removed gloves on the left hand and changed a pillow case.

PCA X did not wash hands throughout the bath procedure, went from a dirty site on Pt. #4 to a clean site with the same gloves on, and contaminated equipment, bedding, and pockets with dirty gloves.

RN Edu C was present for the procedure and was witness to the cares. When asked what RN C thought about the cares C replied, "I'll let you talk," and agreed with findings as stated above.

Also noted during the bath procedure, yellow/brown fluid had dripped down the inside of the lower right bedrail at some point previous to this observation and was completely dry. The origin of the fluid is not known but Pt. #4 has a foley catheter for urine, a chest tube, and is incontinent of stool. PCA X stated, "Yes, I saw that." RN C viewed this when it was pointed out.

In an interview with Coord U, V, and W on 5/14/2013 at 9:07 a.m. regarding the above observation, W stated, "We have no double gloving protocol," and stated that staff should remove gloves after peri-care and wash hands before going on to the next task.
Coord V stated, "We frown on keeping gloves in pockets, masks [as in surgical or air filtration masks] either."

SANITARY ENVIRONMENT:
A tour of the 4th floor was conducted on 5/13/2013 from 11:25 a.m.-11:55 a.m. and again from 1:30 p.m.-3:30 p.m. accompanied by RN Edu C. The 4th floor consisted of Cardiac, Pulmonary, and Post-Partum units, and a closed short stay Cardiac unit. The following observations were made on the Cardio-Pulmonary and Post-partum areas:

*Keyboards on portable computers were dusty and dirty, some with sticky residue on them. Many of these were being stored in unoccupied rooms that had been cleaned.
*On the water machines there was a build up of calcium deposit on spigots and the grates where the cup would sit making a porous surface for contaminants to adhere to. There was a build up of dust along the wall behind the water machines, as well as on the pipes.
*On the Cardio/Pulmonary floor there was a build up of dust in the ceiling air vents as well as some of the wall vents in the corridors.
*On the Cardio/Pulmonary floor the insides of drawers that held packaged food products and plastic dinnerware were dirty and contained crumbs. Some of the drawers had sticky residue on them.
*Tears and rips in vinyl furniture and plastic pillow coverings allowing for contaminants to get into the batting/cotton lining which is not cleanable.

On the Cardiac Short Stay floor, which has been unoccupied since October 2012, there was evidence of beds having been layed on, bathrooms being used, trash in garbage cans and on floors in rooms that had been previously cleaned by housekeeping, and tears and rips in vinyl furniture allowing for contaminants to get into the batting used to fill the chairs which is not cleanable.

Also on this unit, in rooms indicated as Utility Room and Storage Room there were housekeeping carts with cleaning supplies on them being stored in the same area as clean equipment and supplies. Some of these supplies were in sterile wraps dated January 2013 and were placed on top of a cardboard shipping container. There is potential for cross-contamination when clean and dirty items are stored in the same space.

RN Edu C, who was present during all of these observations, confirmed these findings at the time of their discovery.


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Observation of care:

Per review on 5/15/13 at 1:50 p.m of facility policy titled Infection Control in the Hospital Dialysis setting, #7-03-01, dated 4/13, under "Teammate personal protection equipment (PPE) 6. Appropriate PPE will be worn whenever there is the potential for contact with body fluids, hazardous chemicals, contaminated equipment and environmental surfaces. 7. Gloves should be worn when: Touching the blood lies, dialyzer, or dialysis delivery system during or after a dialysis treatment.

Requested facility policy related to staff providing a bed bath for patients on 5/15/13 at 1:00 pm. NE O stated the facility provides bed bath care per Perry and Potter 2008. Page 431, under " Implementation: 1. o. 4. Cleanse buttocks and anus, washing from front to back. Cleanse, rinse and dry area thoroughly. P. Remove gloves. "

Per observation on 5/14/13 at 10:45 am, Patient Care Assistant (PCA) WWW completed a bed bath on pt. # 18. With gloved hands, PCA WWW provided cleansing of buttocks with a wash cloth, then with same gloves, touched side rails and proceeded to wash the back of pt. #18.

Observations were confirmed with NE O on 5/14/13 at 10:55 am, at completion of bed bath.

Requested facility policy related to staff completing a dressing change on 5/15/13 at 1:00 pm. NE O stated the facility provides wound care per Perry and Potter 2008. Page 1016, under " Implementation: 5. Remove old dressing. 6. Dispose of soiled dressing..., remove disposable gloves ... and perform hand hygiene. "

Per observation on 5/15/13 at 11:20 am, Wound Care Nurse (WCN) PPP completed a dressing change on Pt. #23. WCN PPP applied ointment to base of wound with gloved hands and 4 x 4 gauze pad, removed gloves, reapplied gloves without the benefit of hand hygiene. As WCN PPP completed dressing change, with contaminated gloved hands touched VAC (vacuum assisted closure) buttons to turn on machine.

Per observation of PCT WWW on 5/14/13 at 11:15 am, PCT SSS was observed touching the dialysis machine without the protection of gloves. Finding were discussed with Acute Clinical Service Specialist RRR on 5/14/13 at 11:45 pm.


Requested Policy and or Procedure for administration of Dexamethosone on 3/13/13 at 3:30 p.m. and facility presented policy titled Iontophoresis with Dexamethosone Sodium Phosphate dated 7/12/12. Policy does not address the administration of the medication. Policy titled Medication Administration- General , dated 3/2013 states under procedure: B. Medications shall be prepared and administered in accordance with the orders of the prescriber or practitioner responsible for the patients care and accepted standards of practice.

Per tour on 5/13/13 at 2:10 p.m. of the Outpatient Therapy Department revealed a locked cupboard which held 5 vials (multi- use) of the medication Dexamethasone (medication used with a small electrical charge to deliver through the skin) along with patches and 2 used syringes. No packaged syringes noted in cupboard.

In an interview with Manager of Rehabilitation Services (MRS) S on 5/13/13 at 2:10 p.m. stated the same syringe is re-used for multiple patients but the syringe never reaches the patient. The medication is drawn up by the locked cabinet and directly placed on the patch. Findings confirmed with RN Edu O at time of tour.

Based on MR review, P&P review and staff interview, this facility failed to appropriately document contact to the Organ Procurement Organization (OPO) upon death/imminent death of a patient in 2 out of 4 death MRs (Pt. #10 and 12) reviewed. Failure to appropriately document contact to the OPO has the potential to affect all patient in the facility including all patients present during the course of the survey. In addition, based on observation of the hyperbaric exam room, and one staff interview (AAAAA), the facility does not have a policy to govern the use, storage or shelf life of medications that are shared between patients at the wound care clinic. This has the potential of affecting all patients presenting for service at this clinic.

Issues at the WA WA Campus Mayfair RD
No policy for medications shared between patients. OB/ I
*) Observations of Hyperbaric exam room on 5/13/13 at 12:20 p.m. reflects that there are opened and previously used jars and tubes of the following topical skin medications laying on the counter: Eucerin cream-original healing cream, Sensi Care skin protectant barrier cream, Midline Remedy skin protectant cream and Saf-Gel Hydrating wound cream with alginate. There is no date nor time of original opening on these containers.
In interview with RN AAAAA at the time of this observation, she states that there is no facility policy to govern the use, storage or shelf life of these medications that shared between patients at the wound care clinic.



26711

The facility's policy titled "Organ/Tissue Donation," dated December 2011, was reviewed on 5/15/2013 at 1:30 p.m. On page 5, J. 1. states, "The RN is responsible to document that a call was placed to the WDN-OPO." [WDN-Wisconsin Donor Network]

A MR review was conducted on Pt. #10's closed MR on 5/14/2013 at 2:24 p.m. assisted by Dir of HIM BBB. Pt. #10 was pronounced brain dead on 9/5/12 and was determined suitable for organ donation. There is no evidence in the MR that the OPO was contacted regarding imminent or actual death.
Dir BBB confirmed these findings during MR review.

A MR review was conducted on Pt. #12's closed MR on 5/14/2013 at 3:06 p.m. assisted by RN Edu CCC. Pt. #12 expired on 10/17/2012. The facility did document the first name of the OPO contact, however there is no evidence in the MR of the date or time this was completed.
RN CCC confirmed these findings during the MR review.

An interview with Dir of Quality A was conducted on 5/15/2013 in the a.m. regarding the above findings. Dir A stated that per the OPO direction last names of the OPO contact should not be used and agreed that the time and date was not indicated on the paper documents from the MR that were reviewed.

Based on record reviews, observations and staff interviews, the obstetrical nursing service failed to ensure the pt safety in 1 of 1 pts (#24) by overriding their security systems and gave wrong breast milk to the pt, and in 1 of 1 newborns (pt.#6) overrode the transfer security system and put the pt at risk for abduction.

Findings include:

Medication/Breast milk labeling and coding:

Current 3-page P&P entitled: "Expressed Breast Milk (EBM)", with no policy number documented, last reviewed and revised 5/2013. P&P reviewed on 05/15/13 at 11:00 AM, with Administrative Director (AD) NNN and Women and Infant Service Manager (WISM) OOO states:

"Scan infant ID band and then scan bar code on milk label on both original container and warmer milk given to baby."

"Scanning the incorrect baby's milk will produce a "No Med Order Found."

"STOP"
"There is only 1 reason this message would come up: You have the wrong breast milk and the wrong baby"
"No Med Order Found" message is the "red flag" that identification between infant and label need to be verified."

"If you see this message, 2 RNs must verify (and co-sign electronically) that the patient identifiers (baby name and account number) on the label match the baby's ID band."

"DO NOT use the "Override" feature if you receive a "no med order found" message since this will appear electronically that the baby received the wrong milk."

On 05/15/13 11:00 AM, AD NNN and WISM OOO stated the bar coding security system was initiated as a part of the hospital's self-identification that the wrong breast milk was given to the wrong baby. Utilizing the labeling and coding system like they have for medication administration was to prevent the wrong breast milk from reaching vulnerable infants. Also identified in an earlier (5/13/13 at 11:25 PM) interview with Coordinator PP and NICU Pt Care Coordinator TT that the current labeling, coding and scanning system was put in place as a part of prior hospital initiated corrective action plan.

Clinical Development Coordinator PP and NICU Pt Care Coordinator TT stated on 05/15/13 between 11:25 AM and 12:25 AM, unlike emergency medications overrides, there would not be an emergency need to override the security system to provide breast milk. 05/15/13 during an interview at 11:00 AM, AD NNN and WISM OOO also stated there would not be an urgency or emergent reason to override the security system for breast milk.

A completed incident report was reviewed with AD NNN and WISM OOO on 05/15/13 at 2:30 PM and identified:

On 05/02/13 at 8:30 PM NICU RN AAA overrode the security system when the system gave the alert "no med order found," and failed to follow P&P, and gave the wrong breast milk to Pt #24.

NICU Pt Care Coordinator TT was aware RN AAAA overrode the security system and provided the wrong breast milk to infant #24 on 05/02/12. A type written note was reviewed on 05/15/13 at 2:30 PM that showed the hospital was aware and working on this incident. The note read: "05/03/13 at approx 0730" (7:30 AM) RN AAA "came to speak to TT" . "5/3/13 approx 10:30" (AM) the note indicated "PDA (performance development action) ligation in process."

As of 05/15.13 at 2:30 PM no implemented corrective action was taken to address RN AAAA. The incident was logged into the incident reporting system 05/03/13 at 12:00 AM. On call physician was notified 05/03/13 at 2:00 AM.

Progress notes in the medical record for Pt #24 noted from 05/03/13 at 2100 (9:00 PM): "neonatologist on call" informed the mother of Pt #24 receiving the wrong breast milk.

Additional excerpts from the progress note dated 05/03/13 at 9:00 PM:

"The mother whose breast milk Pt #24 received was CMV+." (herpes virus positive) Cytomegalovirus (CMV) is one of the herpes viruses information retrieved from: . HIV testing was completed for the mother of the breast milk 05/04/13, and was negative.


No testing was completed to determine if the infant had contracted the herpes virus. This was confirmed in a telephone interview with PCP BBB on 05/16/13 at 10:00 AM, who said "no testing had been completed per hospital policy."


On 05/16/13 at 11:45 AM, Director of Quality A confirmed to surveyor the hospital had no policy for not testing for CMV when exposure has occurred.


BBB stated BBB had not done anything about this incident at a medical level however, BBB stated something should be done at a higher level.


PCP BB said, RNs overriding the security systems is a problem, and should be addressed by the medical staff.


On 05/15/13 at 2:30 PM during an interview, AD NNN and WISM OOO confirmed there is still potential to override the system if it alarms "no medication order found" and there is currently no tracking of system overrides for breast milk.


Safe Place Infant Security Alarm System:


Per observation on 05/14/13 at 9:00 AM Pt #6 was born at 9:00 AM.


Per review of online security record for Pt #6 with L&D Charge RN QQ conducted on 05/14/13 at 10:55 AM, QQ confirmed Pt #6 (transmitter #185) was not identified in the L&D floor.


L&D Charge RN QQ said the reason Infant #6 did not show up in L&D unit tracking system is, that newborn #6 is in a "transfer mode."


L&D Charge RN QQ said the transfer mode has a security default of 15 minutes however, staff overrides the 15-minute transfer default time to avoid going into the system multiple times. When questioned about if the overrides were for staff convenience, L&D Charge RN QQ said "yes."


QQ said, "transfer mode was used regularly between maternity/newborn units (3rd floor, 4th floor and 5th floor) for 2 to 4 hour periods. Using the transfer mode prevents the alarms from registering or sounding.


On 05/14/13 at 3:00 PM Supervisor Pt Care L&D SS provided and reviewed the "all activity" report for transmitter #185 (Pt #6). The following review and interview with Supervisor Pt Care L&D SS confirmed, transmitter band #185 for newborn Pt #6 was "enrolled" in the security system at 9:29 AM.


At 10:40 AM newborn #6 was put in a "transfer mode" and was not locked into another security system until 12:20 PM (approximately 1½ hours), potentially allowing #6 to be removed from the unit and undetected as abducted/missing for the 1½ hours the security system remained in a "transfer mode".


Supervisor Pt Care L&D SS provided and reviewed the MFR that identified a 15-minute transfer default time was their recommendation. However, SS stated the hospital had no P&P for the use of transfer and escort modes.


On 03/14/13 at 10:55 AM L&D Charge RN QQ also confirmed the hospital had no P&P for the use of "transfer" or "escort" modes, that were implemented to prevent infant abduction. The system could allow the baby to be removed from the secured department undetected for the the estimated 2-4 hours the newborn is in the transfer mode.


During a walk through of the OB departments on 3rd, and 4th floor with Clinical Educator JJJ, the additional systems' issues were identified. Once OB staff passes the secure archway in the hallway to the pt transport elevator there is no security until the baby reaches either the 4th or 5th floor.


The third floor infant/pt transport elevators are unmarked, unsecured, and directly accessible to the public corridors and the walkway that leads directly outside to the 3rd floor parking structure.


AD NNN and WISM OOO stated their staff is always the first line of defense with the infants. Surveyor discussed an observation completed on 05/13/13 3rd floor between 1:55 PM and 2:30 PM where an RN left two infants in an unsecured area to answer the unit phone. The RN was unable to see either of the two infants or surveyor and PP until returning to the area.


An experiment was conducted to determine the longest time required for transport. Surveyors and Clinical Educator JJJ, left L&D final destination 4th floor OB department. Including a delay forgetting to push the elevator call button to pick us up, it took approximately 3 to 5 minutes to get from the 3rd floor L&D Unit to the 4th floor OB unit.


On 05/15/13 at 11:00 AM during an interview, AD NNN and WISM O

Based on observations, policy review, and staff interviews this facility failed to maintain pt confidentiality of medical records by placing them in unlocked cabinets accessible to unauthorized personnel, visitors and other pts. Failure to secure medical records and maintain confidentiality has the potential to affect all pts receiving care in the facility, including all pts present during the course of the survey.

Findings include:

A tour of the Rehabilitation Department was conducted with Rehab director AAA on 05/14/13 at 1:30 PM. During a tour of the "Overflow Gym" in the outpatient rehab department (basement of St. Joe's) it was discovered that clinic files with patient information were kept in unlocked drawers in the documentation/computer area. Insurance charge sheets containing patient information were also found unsecured in both the "balance room" and the conference room of the Overflow Gym" at the time of the tour. A tour of the Living Skills Room" also revealed unsecured, outpatient medical records. These findings were confirmed with Rehab Director AAA at the time of the tour, she also stated that these areas were cleaned after hours by housekeeping personnel.



09948

Issues at the WA WA Campus Mayfair RD

Unsecured medical records

*) Observations of the wound Care clinic on 5/13/13 at 12:10 p.m. reflects that the patient ' s medical records are not secured in a locked area, during after hour cleaning of this area by hospital housekeeping staff.

In interview with Wound care RN ZZZZ at 12:15 p.m. she states that cleaning is done after hours when staff is not present.

Based on MR review, P & P, Medical Staff Rules and Regulations, and staff interview the facility failed to ensure that all entries in the MR are properly authenticated with date, time and/or signature of the practitioner completing the entry in 7 out of 30 MR's reviewed (Pt #4, 7, 8, 14, 18, 19, 20) Failure to properly authenticate orders with signature, date and time has the potential to affect all patients receiving care in this facility.

The Medical Staff Rules and Regulations, dated 8/8/2012, were reviewed on 5/15/2013 at 1:40 p.m.

Page 20, k. Authentication and Legibility states, "All clinical entries in the patient's record must be accurately dated, timed, individually authenticated and legible. Authentication means to establish authorship by written signature, identifiable initials or computer key."

Page 20 l. Countersignature. i) states, "All entries in the medical record made by Dependent Allied Health Professionals and students require a countersignature from a member of the Medical Staff."


A MR review was conducted on Pt. # 18's open MR on 5/14/13 from 2:45 p.m - 3:40 p.m.
*Between 5/11/13 and 5/14/13 Pt. # 18 had 2 progress notes that do not include a time the note was written and there were 4 progress notes from the (Physician Assistant) PA that do not include a time the MD co-signed the progress note.

A MR review was conducted on Pt. # 19's open MR on 5/14/13 from 3:40 p.m. - 4:10 p.m.
*Between 5/8/13 and 5/13/13 Pt. # 19 had 7 progress notes that do not include a time the note was written and there were 3 progress notes from the PA that do not include a time the MD co-signed the progress note.

A MR review was conducted on Pt. # 20's open MR on 5/15/13 from 8:30 a.m.- 9:05 a.m.
*Between 5/10/13 and 5/14/13 Pt. # 20 had 3 progress notes that do not include a time the note was written.


26390


Review of pt. #14 ' s record on 5/15/2013 at 7:35 AM revealed a physician progress note with no date or time by the physician signature.


22198

During a medical record review of Pt #7, on 05/14/13 at 10:15 AM Surveyor, along with Clinical Coordinator PP and unit RN RR identified that Pt #7's L&D check list to ensure documentation was completed and on the medical records was incomplete, and the admission consent was not timed.

During a medical record review of Pt #8, on 05/14/13 at 10:45 AM Surveyor, along with Clinical Coordinator PP and unit RN RR identified that Pt #8's medical record release of information for a hearing screening was not timed.


26711

In an interview with Dir of HIM BBB on 5/14/2013 at 1:30 p.m., Dir BBB stated that all entries from Physician Assistants are to be cosigned by the Attending Physician.

A MR review was conducted on Pt. #4's open MR on 5/14/2013 from 1:21 p.m.-2:09 p.m. The review was continued on 5/15/2013 from 7/13:45 a.m.-9:00 a.m. and again from 10:30 a.m.-11:00 a.m.

Between 5/6/13 and 5/10/13 Pt. #4 has 4 progress notes from the PA that do not include a time the MD co-signed them and one MD progress note that does not have the time the MD wrote the note.

Based on MR review in 6 out of 30 MR's reviewed (Pt. #4, 15, 16 18, 19, 20), P & P review, Medical Staff Rules and Regulations and staff interview, the facility failed to ensure that all orders are properly authenticated with date, time and/or signature of the practitioner writing the orders. Failure to properly authenticate orders has the potential to affect all patients receiving care in the facility.

The Medical Staff Rules and Regulations, dated 8/8/2012, were reviewed on 5/15/2013 at 1:40 p.m. On page 8, C. Orders i) states, "All orders must include the date and time the order was issued."

Page 20, k. Authentication and Legibility states, "All clinical entries in the patient's record must be accurately dated, timed, individually authenticated and legible. Authentication means to establish authorship by written signature, identifiable initials or computer key."

Page 20 l. Countersignature. i) states, "All entries in the medical record made by Dependent Allied Health Professionals and students require a countersignature from a member of the Medical Staff."

Findings Include:

A MR review was conducted on Pt. #18's open MR on 5/14/13 from 2:45 p.m.- 3:40 p.m.
*In paper form on a patient order sheet dated 5/11/13, a physician order does not indicate a time in which the order was written.
*In paper form on a patient order sheet dated 5/11/13, a speech therapist wrote an order and requested MD to sign if in agreement. Physician signature is noted but no date or time indicated when physician signature was completed.

A MR review was conducted on Pt. #19's open MR on 5/15/13 from 3:40 p.m.- 4:10 p.m.
*In paper form on a patient order sheet dated 5/9/13, a physician order does not indicate a time in which the order was written.
*In paper form on a patient order sheet dated 5/13/13, a physician order does not indicate a time in which the order was written.

A MR review was conducted on Pt. #20's open MR on 5/15/13 from 8;30 a.m.- 9:05 a.m.
*In paper form on a patient order sheet dated 5/10/13, a physician order does not indicate a time in which the order was written.


26390


Review of Pt. #15's record on 5/15/2013 at 8:05 AM revealed physician orders dated 5/1/2013 with no time next to the physician signature. Discharge order dated 5/1/2013 is without a time next to the physician signature. An order for intra-ocular lens is dated 3/28/2013 and is without a time next to the physician signature.

Review of pt. #16's record on 5/15/2013 at 8:30 AM revealed a order for medication dated 5/2/2013 with no time next to the physician signature and pre-operative physician orders without a time next to the physicians signature.


26711

In an interview with Dir of HIM BBB on 5/14/2013 at 1:30 p.m., Dir BBB stated that all entries from Physician Assistants are to be cosigned by the Attending Physician.

A MR review was conducted on Pt. #4's open MR on 5/14/2013 from 1:21 p.m.-2:09 p.m. The review was continued on 5/15/2013 from 7/13:45 a.m.-9:00 a.m. and again from 10:30 a.m.-11:00 a.m.

*On 5/6/13 there are two pages of MD orders. It is not indicated if one of the pages is a continuation of the previous page. One of the pages dated 5/6/13 does not have a time the MD wrote the orders.

*In paper form there are two MD orders that do not include a time the MD wrote the orders between 5/6/13 and 5/8/13.

Based on MR review and Medical Staff Rules and Regulations the facility failed to ensure verbal orders are authenticated by the physician with in 48 hours in 4 of 30 MR's reviewed (Pt #4, 7, 28, 53). This can potentially affect all patients receiving treatment at this facility.

The Medical Staff Rules and Regulations, dated 8/8/2012, were reviewed on 5/15/2013 at 1:40 p.m. On page 8, C. Orders i) states, "All orders must include the date and time the order was issued."

Page 20, k. Authentication and Legibility states, "All clinical entries in the patient's record must be accurately dated, timed, individually authenticated and legible. Authentication means to establish authorship by written signature, identifiable initials or computer key."

Page 20 l. Countersignature. i) states, "All entries in the medical record made by Dependent Allied Health Professionals and students require a countersignature from a member of the Medical Staff."

Findings include:

Review of Pt #53 ' s MR on 5/15/13 beginning at 1:45 PM reveals the following: Pre-Procedure standing orders dated 5/1/13 have no time and date of physician authentication.

The above finding was confirmed with Clinical Development Coordinator CCC at the time of medical record review.
In an interview with Dir of HIM BBB on 5/14/2013 at 1:30 p.m., Dir BBB stated that all entries from Physician Assistants are to be cosigned by the Attending Physician. Dir BBB also stated that the time frame for the MD to co-sign verbal orders is 48 hours. Dir BBB stated that the current computer system does not allow an alternate provider to co-sign orders for a provider in the event the provider would be unavailable in the 48 hour time frame to sign.

An MR review was conducted on Pt. #4's open MR on 5/14/2013 from 1:21 p.m.-2:09 p.m. The review was continued on 5/15/2013 from 7/13:45 a.m.-9:00 a.m. and again from 10:30 a.m.-11:00 a.m.

*In the paper portion of the MR, from 5/6-5/8/2012 there are 2 verbal orders that do not include a time or date when the MD signed them and 2 verbal orders that do not include a signature, date or time from the MD.

Electronic portion, verbal orders that are not signed within 48 hours:
*written 5/6/13, not signed until 5/9/13--2
*written 5/6/13, not signed until 5/13/13--14
*written 5/7/13, not signed until 5/13/13--5
*written 5/8/13, not signed until 5/13/13--1
*written 5/9/13, not signed until 5/13/13--3

The findings for the electronic MR were confirmed by Dir BBB on 5/14/2013 from 1:21 p.m.-2:09 p.m. Findings for the paper MR were confirmed by RN Edu YY on 5/15/2013 from 7/13:45 a.m.-9:00 a.m.


05409

Per medical record review of Pt. #28 beginning at 12:45 p.m. on 5/15/13, review of physician orders reveal that a telephone order was written on 5/12/13 regarding a change in the Coreg dose. There is no authentication of this order. RN JJJJ said, beleives the order needs to be signed up here on the floor and it was not.


22198


On 05/14/13 at 10:15 AM Surveyor and Clinical Coordinator PP review the medical record for Patient #7. The pre-printed medication reconciliation telephone order dated 05/12/13 at 0330 (3:30 AM) was not authenticated by the physician. Unit Staff RR reviewed and confirmed that the telephone/verbal order did not meet the 48 hour requirement.

Based on observation and staff interview, this facility failed to secure medications in emergency/crash carts from unauthorized access in 3 out of 4 emergency carts ( Family Birth Center, 5 West, and 5 Center) observed on fifth floor and 1 of 1 surgical medication carts(WI heart Hospital) in the clean surgical corridor. Failure to secure medications has the potential to affect all patients receiving treatment at this facility.

Findings include:

According to the facility's medication charge sheet for crash carts, the following medications are in each crash cart: Epinephrine, Vasopressin, Amiodarone, Lidocaine, Magnesium Sulfate, Atropine, Dopamine, Adenosine, Calcium Chloride, Dextrose, Sodium Bicarbonate, Norepinephrine and Naloxone. Syringes and needles are also in the drawers of the carts.

A tour of the Family Birth Center was conducted on 5/13/2013 at 3:30 pm accompanied by RN Edu O. The 5th floor Family Birth Center is currently closed. An Emergency/Crash cart with a plastic breakaway lock is noted in an alcove. Upon entering the locked unit a housekeeper was noted in the area. This would indicate unauthorized persons (housekeeping staff) have access to the medications, needles, and syringes while the cart is unsupervised by staff.

A tour of 5 West was conducted on 5/13/13 at 2:25 pm accompanied by RN Edu O. The Emergency/Crash cart was stored in an alcove out of sight from the nurses ' station with a plastic breakaway lock.

A tour of 5 Center was 5/13/13 at 3:00 pm accompanied by RN Edu O. The Emergency/Crash cart was stored in an alcove out of sight from the nurses ' station with a plastic breakaway lock.


09948


The following issues were found at Wisconsin Heart Hospital

Unsecured Medications and syringes-I /O
*) In a room off the clean surgical corridor on 5/14/13 at approximately 12:20 p.m., the malignant hyperthermia cart was located. This cart was secured with a plastic break-away lock, which could give anyone easy access to the medications (Dantrole), syringes, needles and intravenous solutions stored inside. This room opened to an elevator that could be accessed from a public corridor on the first floor.

In interview with Clinical Educator XXXX at the time of observations, she stated that medications, syringes and needles should be secured.

26711



Based on observations and P & P review the facility failed to ensure that all medications for patient use were appropriately labeled and/or discarded if outdated in 2 of 2 departments (ED, Cardio-Pulmonary) observed. Failure to ensure medications are dated or discarded has the potential to affect all patients receiving services in this facility.

Findings include:

The facility's policy titled, "Labeling Medications and Solutions," dated January 2012, was reviewed on 5/15/2013 at 1:35 p.m. The policy states in part, "Medications and solutions should be labeled anytime they are removed from the original packaging to another container. Medication labels include the medication name, strength, quantity, dilutent and volume (if not apparent from the container), expiration date when not used within 24 hours, expiration time when expiration occurs in less than 24 hours."

During a tour of the Cardio-Pulmonary unit with RN Edu C on 5/13/2013 at 3:45 p.m., in the medication refrigerator there was a vial of Levimir insulin that was open and undated and without a patient label. The label that had been on the vial had been removed and the insulin was not discarded.

RN Edu confirmed this finding at the time of discovery.

During a tour of the Emergency Department (ED) with ED director DDD on 5/14/2013 at 3:00 p.m., in the trauma room outdated culture swabs (dated 04/13) were found on the counter as well as in the Urgent Care clean utility room was found outdated infant formula (4, 2 oz. bottles of Similac Soy dated 01/13 and 1, 2oz. bottle of Similac advance dated 02/13). These observations were confirmed at the time of discovery by ED director DDD.

09948




29302

Based on observations, staff interviews and record reviews, the 3 out of 3 facilities (St. Joseph's, Elmbrook and Wisconsin Heart Hospital) failed to prepare and serve food under sanitary conditions. The totality of the following concerns has the potential to affect all patients, staff and visitors who eat at this facility.


Findings include:


- Food items not labeled and dated
- Dirty equipment and food preparation area for babies
- Improper sanitation of thermometers
- Cleaning tools stored in food areas
- Hair and facial hair not properly restrained
- Not washing hands between tasks
- Improper 3-compartment sink washing
- Not appropriately monitoring internal and external temperature levels of high temperature dishmachine.


FOOD STORAGE
The Director of Food Service F (DF-F) stated the facility follows guidance from the United States Department of Agriculture, Food Safety and Inspection Service (USDA, FSIS) and Wisconsin ' s Food Code. According to these references the storage of food must be done in a manner to prevent foodborne illnesses caused by harmful pathogens and to preserve the quality and nutritional value of food.


Facility's Policy HACCP/Food Safety Program, Food Safety Standards and Requirements, Document #: 1.1.4, Revised date 1/27/2012 states: " 6. All foods prepared in operation must be covered and labeled as to contents and date of preparation prior to storage in refrigerators and freezers. " " Purchased, ready-to-eat foods removed from original container and not served during the next meal must be labeled and dated. "



On 5/13/2013, 11:08 AM - 11:30 AM, in St. Joseph's food storage area, the following concerns were observed and verified by DF-F:
- Rice - no identification of any kind
- Almonds, chicken gravy, noodles - no discard date
- Unidentifiable white package
- Yellow corn meal, Uncle Ben's Rice, and chipotle powder - not sealed and without a discard date
- Partially used container of Stir Fry Sauce which states "refrigerate after opening"
- Dill weed - discolored - No date noted
- Caraway seeds, ground cloves and whole cloves expired 3/2008, 1/2007 and 6/2006 respectively.
- 4 oz. empty container of nectar thickened water sitting on shelf
- Bananas stored directly above individually packed, ready-to-eat Cheez-it crackers

On 5/13/2013, 1:50 PM - 2:00 PM, in St. Joseph's reach-in C-7 cooler, the following concerns were observed, identified and verified by DF-F:
9 small individual containers of steak sauce (no labels)
5 small containers sour cream (no labels)
6 slices chocolate cake (no labels)
5 slices cheese cake (no labels)

On 5/13/2013, 2:19 PM - 2:27 PM, in St. Joseph's retail cooler, the following concerns were observed, identified and verified by DF-F:
Honey dew melon, Pineapple, Cantaloupe, pkg. bologna, open gallon of 2% milk, all had no label/date.

On 5/13/2013, 2:19 PM - 2:27 PM, in St. Joseph's main freezer, the following concerns were observed, identified and verified by DF-F: The following food items were cooling and did not have any type of cover to protect from contamination: 10 containers of chicken noodle soup and 7 meat loaves

On 5/14/2013 at 3:45 PM at Wisconsin Heart Hospital campus observed one package opened, unlabeled and undated food in walk in freezer. Executive Chef B5 identified the item as one-half of a ten-pound bag of chicken breasts. Executive Chef B5 agrees the item does not have a date or label.

On 5/14/3013 at 9:50 AM at Elmbrook campus observed one bag of chicken breasts in plastic bag and two unidentified bags of food items not labeled or dated in the reach in freezer. Director or Nutrition Services EEE said " no " when asked if the items are labeled or dated.

On 5/14/2013 at 10:00 AM at Elmbrook campus observed one 50# bag of open and unsealed Japanese Bread crumbs in dry food storage area. Director of Nutrition Services EEE confirmed the bag did not have a seal.

On 5/15/13, 9:00 AM, Elmbrook campus ICU, observed food thickener not labeled with a date to identify when this food additive was opened or when it will expire. Clinical Educator RRRR states that they are dating the caps instead of dating the bottle, and should be dating the bottle. When the pump is put on the bottle the dated cap is removed and discarded.

DIRTY EQUIPMENT
According to Wisconsin's Food Code, food items and equipment must be properly stored to prevent transmission of foodborne pathogens or contamination. Equipment food-contact surfaces and utensils shall be clean to sight and touch and nonfood-contact surfaces of equipment shall be kept free of an accumulation of dust, dirt, food residue and other debris. According to foodservice management's fact sheets, all managers are trained and certified in safe food handling. The foodservice management group uses the National Restaurant Association Solution's ServSafe® program. This program states there must be an effective cleaning program in place.

On 5/13/13, in St. Joseph's foodservice area, the following observations were made and confirmed by DF-F:
11:36 AM - emergency eye wash very dirty.
11:36 AM - large garbage container's lid, next to handwashing sink is very dirty
11:41 AM - front of microwave and freezer door very dirty - more than one day ' s accumulation of dirt
1:40 PM - fan in dishroom with built-up dust
1:50 PM - tray pans used for baking and storing of food items have in corners and edges built up brown greasy debris
1:56 PM - dietary cart with drawer - inside on bottom of drawer was dirty with debris -bottom shelf of cart very dirty


2:00 PM - area where food/formula preparation is done for babies is very dirty. There is a sign posted saying " please stock and clean baby area. " Inside the stainless steel cabinet are 8-12 oz. plastic cups, uncovered. Bottom shelf has a white powdery substance on it.
2:04 PM - rack inside Alto-Sham (a special type of oven), which facility is using to heat plates, has debris hanging from it.
2:09 PM - oven hood, above 4 burner stove, very greasy in its edges
2:12 PM - top of convection oven is extremely dirty with debris - outside of it is dirty and greasy. DF-F agrees that it is more than one day ' s worth of dirt.
2:12 PM - outside of combi-therm oven is very dirty
2:14 PM - bottom of what was identified as fast food freezer is very dirty with debris over entire area

CROSS CONTAMINATION
On 5/13/13, 11:45 AM in St. Joseph ' s foodservice area, prior to taking temperatures of food, DF-F wiped off thermometer with a cloth from a bucket containing Oasis 144, and proceeded to take temperatures of food without waiting the required contact time for effectiveness of 1 minute per product information. Manufacturer's specifications for Oasis 144 states for sanitizing surfaces exposed to food, the utensil shall be in the sanitizing solution " for a period of not less than 1 minute."

On 5/15/13, 3:49 PM, in Wisconsin Heart Hospital's foodservice area, observed Chef GGG pull thermometer from upper arm sleeve, and without sanitizing the thermometer, proceeded to take temperature of the chicken. Chef GGG agreed should have been sanitized prior to its use. According to facility's document #1.1.4, Rev. Date: 01/27/2012, "HACCP/Food Safety Program," "Food Safety Standards & Requirements," "Thermometers must be sanitized between each food item ... "

Improper storage of equipment:

According to foodservice management's fact sheets, all managers are trained and certified in safe food handling. The foodservice management group uses the National Restaurant Association Solutions' ServSafe® program. According to this program, cleaning tools and chemicals should be placed in a storage area away from food and food-preparation sites.


On 5/13/13, 11:12 AM, in St. Joseph ' s foodservice area, observed a floor mop stored in dry food storage area which was confirmed by DF-F:

On 5/13/13, 11:30 AM, in St. Joseph ' s foodservice area, observed supplements stored on top of a stainless steel cabinet which contained bleach, methanol gel and turbo-chef oven cleaner and the door to the cabinet was open.

HAIR RESTRAINTS/HAND WASHING
Wisconsi

Based on observation and interviews the hospital failed to maintain walls free of damage, counters free of damage, cabinets free of damage, and ceilings free of damage in 2 of 3 hospital locations (St Joseph's and Elmbrook Memorial).

Findings Include:

These observations occurred at St Joseph ' s Hospital
On 05/15/13 at 2:40 pm, observation revealed on the second floor near bathroom 2303 in Smoke Compartment 2-K, that a portion of a wall was damaged and in need of repair. The wheelchair alcove wall, by bathroom 2303, had exposed dry wall due to wall damage. This damage renders this surface porous and non-cleanable.

On 05/16/13 at 8:44 am, observation revealed on the Second floor room N2503 A-N, ICU waiting area, that a portion of a wall was damaged and in need of repair. The walls were noted to be damaged throughout the ICU waiting area. This damage renders this surface porous and non-cleanable.

On 05/16/13 at 9:53 am, observation revealed on the Third floor in the OR2, that a portion of a wall was damaged and in need of repair. The South and North walls were dirty and damaged with drywall exposed in some areas. This damage renders this surface porous and non-cleanable.

On 05/16/13 at 9:35 am, observation revealed on the Third floor in the Room 3214, that a portion of the counter was damaged and in need of repair. The counter-top in the Soil Utility Room was damaged and porous. This damage renders this surface porous and non-cleanable.

On 05/16/13 at 10:41 am, observation revealed on the Third floor in the Room 335C, Smoke Compartment 3A, that a portion of the ceiling was damaged and in need of repair. The ceiling was damaged from water leakage.

On 5/13/2013 at 4:40 pm, observation revealed on the 2nd floor in the OR 15, that a portion of the cabinetry was damaged, showing bare wood, and in need of repair. This damage renders this surface porous and non-cleanable.

The above physical conditions were confirmed at the time of discovery by a concurrent observation and interview with staff M10 (EUA) and staff M11 (Architectural Designer).

During a tour on 05/13/13 from 11:25 AM to 4:00PM with CDC PP, the following concurrent observations and interviews identified damage to the physical environments as follows:
*Clean storage room (#7029) had 7 ceiling tiles falling down.
*Ceiling tiles in clean storage Rm #3218C were falling down.
*Soiled Utility Rm #3214 had chipped counter tops and gouges in the walls making surfaces porous and non-cleanable.
*Clean storage Rm#2319 had gouges in the walls
The above findings were confirmed by CDC PP at the time of discovery.

On 5/13/2013 from 11:21 AM to 11:55 AM, a tour with Nurse Educator L and concurrent observations and interviews identified the following:

*Biohazard room #2223 had a floor with cracked stone tiles, the wall had gouges and the ceiling air vent had dirt/debris on the louvers.
*The hallway leading to the ICU had cracked floor tiles, gouges in the dry wall and areas where the vinyl wall trim was separating away from the floor exposing the sub floor.
*The ICU waiting area had gouges in the dry wall.
*Chairs in rooms #1, 2, 3, 5, 6, 7, 8, 10, and 11.had cracked vinyl coverings.
*The ICU charting station had broken laminate.
*The above findings were confirmed with Nurse Educator L at the time of discovery.

*On 5/13/13 from 1:20 PM to 2:55PM, a tour with Nurse Educator L and concurrent observations and interviews identified the following:
*The hallway of the catheterization lab to Rms 1 & 2 had cracked tile flooring.
*The recovery bay had gouges in the drywall.
*The pre-operative holding area for surgery had a back counter with broken laminate.
*The medication room had holes in the drywall and wall tiles.
*The GI area procedure room #1 had a large hole in the flooring, gouged drywall, a piece of laminate flooring was missing in the storage closet.
*The dictation area within the recovery area had gouges in the drywall.
*Recovery rooms #2, 3, 4, and 6 had gouges in the drywall..
*The day surgery charting station had gouges in the laminate.
*Pt Rms #10, 11, 14, and 17 had vinyl molding coming off the wall exposing underlayment.
*The decontamination room had cabinets that had rust and had chipping, peeling paint throughout the area.
The above findings were confirmed with Nurse Educator L at the time of discovery.

n 5/14/2013 at 7:35 AM, during a tour with CDC BB, and concurrent observations and interviews the following was identified:
*Surgery Rms #4, 5, 6, 7, 8, 9, 10, 11, and 15 had broken wall tiles, broken laminate counters/cabinets and gouges in the drywall.
The above findings were confirmed with Clinical Development Coordinator BB at the time of discovery.

These observations occurred at Elmbrook Memorial Hospital:

*During an observation on 5/15/13 at 9:05 AM, on the 5th floor, the clean storage room had linoleum flooring (approximate 7 inch wide by 2 foot long) that was warped and missing exposing the floor concrete surfaces.

*The same clean storage room had a marred surface exposing porous plaster (approximate 3 foot long gash at the height of between 5-6 feet high) on the wall.

*The 6th floor pt care area on 5/15/13 at 8:15 AM, the storage alcove across from Rms 644/641 had marred gouged walls exposing porous plaster that could not be cleaned.

During an interview with V.P. SSSS on 5/15/13/at 3:00 PM, stated that a work order to fix the flooring was submitted to the maintenance department on 10/17/12.


A tour of the 4th floor was conducted on 5/13/2013 from 11:25 AM-11:55 AM and again from 1:30 PM-3:30 PM accompanied by RN Edu C. The 4th floor consisted of Cardiac, Pulmonary, and Post-Partum units, and a closed short stay Cardiac unit. The following observations were made on these units:

*Laminate on doors and counters was chipped and/or missing in several work areas and patient rooms.
*In several patient rooms and utility rooms there were chips and gouges in the dry wall revealing the porous, non-cleanable surface underneath.
*A large strip of molding along the kick board in room 4153 is missing.



12187





22198

Based on observations in P&P review, and interviews, the hospital's equipment and supply maintenance system for 2 of 3 hospital locations (St Joseph's, Wisconsin and Elmbrook Memorial), failed to secure hazardous chemical, failed to have an effective system in place to check, rotate and remove outdated products, and failed to monitor equipment and supplies for safety, integrity and security. Failure to maintain the physical environment has the potential to affect all patients, visitors, and staff in this hospital system.

Findings include:

The facility's policy titled, "Environmental Cleaning, Sanitation, and Decontamination," dated August 2012, was reviewed on 5/15/2013 at 1:20 PM. The policy's rationale is to achieve excellence and use best practices which requires them to, "Adhere to environmental cleaning, sanitation, and decontamination by following best practice of CDC guidelines."

The policy's Part A. Summary states in part, "The environment includes but is not limited to: floors, carpeted and uncarpeted, walls, ceilings, doors, office and pt care furniture, wall and ceiling mounted equipment, cabinets, shelves, counters and other work surfaces, air vents, ducts..."

Findings at Elmbrook Memorial Hospital:

Refrigerator Temperatures not monitored:
*During tour of the Elmbrook Hospital location on 5/15/13 at 8:06 AM, during a tour and concurrent observation and interview with Clinical Nurse Educator FFFF Laboratory Staff GGGG, the following was observed:
* In the laboratory area the 4 refrigerators had incomplete temperature logs for the date of 04/28/13, the refrigerator labeled "Biohazard Survey", Chemistry", "Co-ag", and "Urinalysis".
*The refrigerator labeled, "Processing" had a log showing that temperatures were not recorded on 5/12/13 and 5/13/13. When the missing temperatures were pointed out to Staff GGGG, GGGG said, "They must have missed it those days. Monitoring is to be done by the morning shift daily.
*The refrigerator log for the refrigerator in the grossing station room shows that temperatures were not recorded on the following dates from March 1 through May 14, 2013:
March 7, 15, 28, and 29, 2013
April 1, 2, 3, 4, 5, 7, 10, 24, and 28, 2013.
May 8, 9, 10, 11, 12, 13, and 14, 2013.

When Surveyor mentioned that there were numerous temperatures missing, staff GGGG said, "yes" and then provided a copy of the log.

Physical plant observations:

Observations on 5/15/13 at approximately 9:05 a.m., of the 5th floor clean storage room reflects linoleum flooring (approx. 7 inch wide by 2 feet long) is warped and missing,exposing the floor concrete surfaces, that cannot be efficiently disinfected. One wall has a marred surface exposing porous plaster (approx 3 feet long gash at the height of between 5-6 feet high.) The clean storage room should have washable and intact wall surfaces to prevent transmission of infection to clean supplies.

Interview with V.P. SSSS on 5/15/13 at 3:00 p.m. reflects that a work order to fix the flooring was submitted to maintenance on 10/17/12, and has not been responded to yet.

During the tour of 6th floor patient care area on 5/15/13 at 8:15 a.m., the storage alcove across from Rooms 644/641 had marred gouged walls exposing porous plaster that could not be cleaned.

At 9:35 AM on 5/5/15/13 while touring the Cardio-respiratory area of the Elmbrook Hospital, accompanied by Supervisor IIII, the following concurrent observation and interview identified the following:

In Rm #C212, a labeled EMG (Echo-Myogram), had 1 bottle of alcohol 70% sitting on the desk that had expired in July of 2009. When asked Supervisor IIII what the expiration date on the bottle was, IIII replied, "July 2009".

Findings at St Joseph ' S Hospital:
On 05/13/13 from 11:25 AM to 4:00 PM, during a tour and concurrent observations and interview with CDC PP the following areas were identified and confirmed not to have a cleaning schedule or assigned staff accountable for cleaning:
*3rd floor NICU large common wash sinks debris had visible build up on the wall, sinks and sanitizer/cleaner dispensers.
*3rd Prenatal Assessment department and 7th floor kitchenette had ice machines that had white debris built up around the dispensing spout and catch tray. Dust and debris was found on top of and underneath both ice machines.
*3rd floor NICU unit laundering room was also used for storage blocking the hand washing sink.

*3th and 7th floors, clean storage areas (Rm #3827C, #3827D, #3831 #3837, #3839C, #3812,#3149, #3219, #3225, #3218A, #3218C, #3214, #3010, #3026, #3050, #3051, #3041, #7029,and 7028) were not on a cleaning scheduled.
*3th and 7th floors soiled and dirty utility rooms (3820B, 3830A, 3835, 3810, #3214, #3043, #3115 and #7009) were not on a cleaning schedule.
*Air ventilation grids (for air flow into the unit) were dusty with gray/black material clinging vent grids on 2 of 7 floors (#3 and #7) for 7 of the 7 pt care areas (Hospice, Oncology, L&D, Antepartum, Pediatric Stepping Stones, Prenatal Assessment Maternal Fetal Medicine & NICU), including their storage rooms.
*7th floor surveyor noted a stained carpet on the floor of a clean supply room. 7th floor RN Manager XX stated, XX was not aware that carpet was not allowed in a clean storage area.
*At the time of discovery, CDC PP acknowledged both clean and dirty storage areas on the 3rd and 7th floor identified above had evidenced of debris and dust build up on the flat surfaces, storage racks storage bins and air vents.

On 05/13/13 from 11:25 AM to 4:00 PM, during a tour and concurrent observations and interview with CDC PP and unit staff, the following supply areas were identified, not to have clearly marked expiration dates and no system to ensure product quality, and out dated products were not being removed from Pt care areas in the following areas:
*3rd floor NICU had 2 shipping boxes labeled " Mission Supplies". In an interview at 12:25 PM on 05/13/13, CDC UU and NICU Supervisor TT said the mission items are no longer useable on the NICU unit. TT and UU said they were unaware that unusable items should be separated from their Pt useable products.
*On 05/13/13 from 1:55 PM to 2:30 PM on a tour of the Antepartum unit Medication Rm #3230, CDCP PP identified outdated blood collection tubes.
*On 2 of 7 floors (#3 and #7) in 6 of 7 (Hospice, Oncology, L&D, Antepartum, Prenatal Assessment Maternal Fetal Medicine & NICU), units, sterile product packaged by a MFR did not have an expiration date on them.

On 05/13/13 during an interview, CDC PP discussed validity of sterility with NICU Pt Care Supervisor TT at 12:25 PM, 3rd floor L&D Supervisor SS at 2:40 PM and 7th floor RN Manager XX at 3:30 PM. TT, SS and XX, acknowledged that PP, TT, SS and XX were not aware that products came from the MFR without an expiration date.
*NICU Pt Care Supervisor TT (12:25 PM), 3rd floor L&D Supervisor SS (2:40 PM) and 7th floor RN Manager XX (3:30 PM) said, the hospital does not have a P&P for rotation of sterile products that come to the hospital without a clearly marked expiration date.
*NICU Pt Care Supervisor TT (12:25 PM), 3rd floor L&D Supervisor SS (2:40 PM) and 7th floor RN Manager XX (3:30 PM), acknowledged, TT, SS and XX were not aware of any monitoring done within the respective departments to ensure sterile packages were maintained at a temperature and humidity to ensure sterility for the sterile products shelf life.
*NICU Pt Care Supervisor TT (12:25 PM), 3rd floor L&D Supervisor SS (2:40 PM) and 7th floor RN Manager XX (3:30 PM), acknowledged, that TT, SS and XX did not know the shelf life for the sterile products identified as not having an expiration date within the respective departments.
*3rd floor NICU on emergency NICU response cart MFRs sterile packages were rubber banded, that include venipuncture needles and intubation tubes. Staff stated they were not aware that rubber banding sterile packages jeopardized the package integrity. At 12:25 PM, NICU Pt Care Supervisor TT said she was unaware that rubber banding sterile packages compromised their integrity and sterility.
*3rd floor NICU surveyor found 4 packages of outdated infant fo

Based on observation and staff interview, the facility did not construct, install and maintain a proper ventilation and temperature control system in pharmaceutical, food preparation, and other appropriate areas. The facility did not have and a ventilation system that was installed and maintained in accordance with CDC guideline, AIA guidelines and manufacturer recommendations. This deficient practice could affect all patients, staff, and visitors in 40 of the 92 smoke compartments.

The facility also did not provide proper ventilation due to a lack of positive pressure int hree spaces and a lack of negative pressure in one space. These deficient practices had a potential of cross contamination of air with undersirble contaminants and causing posile infectin for all patients receiving services at this hosptial.

The CDC guidelines can be found in the website


FINDINGS INCLUDE:

1. On 5/14/2013 at 2:00 PM, observation revealed on the 8th floor between the clean room of the infusion pharmacy and the ante room, that the ventilation to the space could not be confirmed to be compliant with accepted standards. The air flow was going from positive to negative and then negative to positive without any apparent reason. They was observed by a tissue under the door.

2. On 5/15/2013 at 10:00 am, observation revealed on the 2nd floor (on the 1st floor roof) by the air handler near the old main entrance, that the ventilation to the space could not be confirmed to be compliant with accepted standards. The air intake was only 8 feet from the air exhaust. The CDC and AIA Guidelines require a separation distance of 25 feet between air intakes and air exhausts. Moss was growing on the roof, 2 feet from an air intake.

3. On 5/16/2013 at 9:58 am, observation revealed on the Basement floor in the sterile processing, that the ventilation to the space could not be confirmed to be compliant with accepted standards. Air flow was from substerile (receive area (dirty)) into sterile processing (clean). This air flow is in the wrong direction. The air shall go from clean to dirty.

4. On 5/16/2013 at 10:05 am, observation revealed on the Basement floor in the sterile processing room, that the ventilation to the space could not be confirmed to be compliant with accepted standards. The air grills between the sterile processing room and behind the sterilizers were covered in dirt and dust.

These conditions were confirmed at the time of discovery by a concurrent observation and interview with staff M3 (HVAC Tradesman), staff M7 (EUA), staff M9 (Mechanic), and staff M13 (Risk Analyst).
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5. On 5/14/2013 at 9:10 am, observation revealed that the Clean Equipment & Case Cart Storage room adjacent to the male staff locker Room 2B456 on the 2nd Floor was not under positive pressure relative to adjacent spaces. It was instead under negative pressure causing airflow in the wrong direction from corridor to the clean storage.

6. On 5/14/2013 at 2 pm, observation revealed that the pressure monitor mounted on wall of the Operation Room #3 (OR3) opposite nurse station on the 2nd Floor showed a pressure differential reading of +0.0013 in. of water column, and was not at least +0.01 in. of water column recommended in the CDC and AIA guidelines.

7. On 5/15/2013 at 10:10 am, observation revealed that the Medical Waste Room GA152 in the Lower Level was under positive pressure relative to adjacent spaces, and not under negative pressure when tested with a one-ply toilet paper at the door undercut. The test showed the airflow direction from the waste room GA152 to corridor. The airflow was in a wrong direction from dirty to clean spaces.

8. On 5/15/2013 at 10:20 am, observation revealed that one leaf of the double corridor doors to the Clean Supply Storage GA144 in the Lower Level was held open with an electromagnetic hold-open device, and did not maintain positive pressure in the room relative to adjacent spaces to cause airflow from clean to dirty spaces.

These conditions were confirmed at the time of discovery by a concurrent observation and interview with Staff M4 (Director of Facilities-Elmbrook), Staff M15 (EUA), Staff M16 (Safety Coordinator), and Staff M22 (Mechanic). The above deficiency was also confirmed with Staff M1 (V.P. Facilities) at an exit conference on 05/15/2013 at 4:15 pm.

Based on observations and interviews with staff and review of nationally accepted standards of practice, the hospital did not ensure that standards of practice were followed and that patients were protected from potential contaminants or the potential spread of microorganisms to patients. This had the potential to affect all patients receiving services at the hospital.

Findings Include:

EXPIRED SUPPLIES
At 9:35 a.m. on 5/5/15/13 while touring the Cardio-respiratory area of the Elmbrook facility, accompanied by Supervisor IIII, room #C212 and labeled EMG (Echo-Myogram), had 1 bottle of alcohol 70% sitting on the desk that had expired in July of 2009. When asked Supervisor IIII what the expiration date on the bottle was, IIII replied, "July 2009.

INFECTION CONTROL WITH INJECTABLE MEDICATION:

Per observation of the colonoscopy procedure performed on Pt. #29 beginning at 10:30 a.m. on 5/15/13, the following was observed:

At 10:45 a.m. and 10:58 a.m. without cleansing the port/membrane of the vial of Versed, RN EEEE drew up Versed medication for sedation and injected the Versed via IV to Pt. #29. Of the 6 opportunities observed of administering IV medications of Zophran, Benedryl, and Versed, RN EEEE did not cleanse the port of the medication vial prior to drawing up the Versed in 2 of 3 occurrences observed.

At 11:37 a.m. on 5/15/13 when Clinical Nurse Educator FFFF, who also observed the procedure, was asked what FFFF observed in regard to when RN EEEE had cleansed medication vial ports prior to drawing up medications, FFFF replied, "I only saw her wipe the port prior to medication administration of Zophran and it should be done before each medication draw."


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The following issues were identified at Elmbrook memorial hospital
Infection control/ wound care-ob/I

*) Observations of wound care/ dressing change on Patient #31 by WORN QQQQ on 5/15/13 at approximately 10 a.m. reflects that after handwashing and donning clean gloves, WORN QQQQ approached patient to removed dressing over wound site, and reached with clean gloved right hand to adjust the bed height on the patient ' s upper siderail panel. This action contaminated the glove on WORN QQQQ's right hand. WORN QQQQ did not remove contaminated glove, handwash, nor don clean gloves before removing this patient dressing.
This observation was reported in interview to Clinical Educator RRRR at approximately 3 p.m. on 5/15/13. She stated that this observational information would be added to documentation to share with administrative staff.

The following issues were found at Wisconsin Heart Hospital -
BIOHAZARDOUS WASTE - OB
*) Observation in the PACU unit on 5/14/13 at approximately 11:50 a.m. reflects Anesthesiologist UUUU at the automated drug dispensing unit returning medications used for surgical procedures. After leaving the automated dispensing, Anesthesiologist UUUU was observed to throw a syringe in the waste paper basket. There was no biohazard bin at the drug dispensing station for which to properly dispose of these syringes.
In interview with Clinical Educator RRRR at the time of observations, she stated that syringes should be disposed of in a biohazardous bin.

Aseptic Medication technique ob/ practice standards/I -
Observation of care in ICU for the surgical recovery of Patient #52 on 5/14/13 at 1:25 p.m. through 2:10 p.m. reflects that RN Staff VVVV did not use alcohol wipe to clean bladder of Albumin glass vial before puncture with intravenous infusion set.

APIC guidance reflects that single and multidose vials should have their access diaphragm cleansed using friction and 70% alcohol. Allow to dry before inserting a device. Cleanse the access diaphragm of vials using friction and 70% alcohol. Allow to dry before inserting a device.

In interview with Clinical Educator XXXX at 2:12 p.m. this information was shared, without rebuttal comment from Clinical Educator RRRR .



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In 7 of 7 patient care areas of St. Joseph Hospital (Hospice, Oncology, L&D, Antepartum, Pediatric Stepping Stones, Prenatal Assessment Maternal Fetal Medicine & NICU) infection control issues were found as follows:

NICU

On 05/13/13 between 11:25 AM and 12:25 PM while on tour of the NICU department with NICU Pt Care Supervisor TT and Clinical Development Coordinators PP and UU observed the following:

Clean storage rooms #3827, 3827D, 3831, 3837, 3830A contained dust and debris on the floors, counter, and storage racks and bins. Rms #3830C and # 3831 had porous un-washable surfaces. Shipping boxes were being stored with supplies in these clean storage areas
Clean storage rooms #3827, 3827D, 3831, 3837, 3830C and 3812 contained clean, sterile and dirty storage without separation.

Rm# 3837A a clean storage room contained respiratory humidifiers for neonatal intensive care infant patients that were not clean. Five (5) of 7 neonatal humidifiers were set up and ready for use with humidifier tubing connected to the 5 of 7 humidifiers. Connection ports were not covered allowing for dust and debris to collect in the connect ports. The hospital airflow vents in the room above the 7 humidifiers had visible dust and debris build up.

NICU Pt Care Supervisor TT and Clinical Development Coordinator UU stated, opening up clean humidifier tubing and setting up the neonatal humidifiers ahead of time was not a good practice if they were not going to monitored and maintained to ensure dust would not build up in the 5 of 7 humidifiers set up for use.

Room# 3812 (clean storage) had 7 boxes of data storage, items used on the unit for families (toys and clothes), 2 transport isolates visibly dirty and other clean and dirty storage items.

Clean storage rooms #3827, 3827D, 3831, 3837, 3830A contained dust and debris on the floors, counter, and storage racks and bins. Rms #3830C and # 3831 had porous un-washable surfaces. Shipping boxes were being stored with supplies in these clean storage areas

NICU soiled utility rooms #3835, 3830A contained dirty, clean and sterile supplies (sample of sterile items: boxes of suture and hospital processed peal packs of OBGYN equipment).

Unit Clerk WW identified the sink in Rm 3830A as an equipment-cleaning sink. The sink counter top contained stacks of clean cleaning towels, numerous peel packs of sterilized OBGYN equipment, gloves and writing materials. Also in the room were additional racks of clean and dirty items and a desk and computer. Chemical hung on a storage rack of clean and dirty items. This room was dusty and dirty with debris.

NICU Pt Care Supervisor TT and Development Coordinator UU stated, TT and UU had not thought about the water spray from cleaning equipment could affect the clean and sterile items on the sink counter or in close proximity.

Soap dispensers and hand gel dispensers throughout the unit had residue built up of dust, and dark debris.

On 05/13/13 during an end of tour discussion of findings and interview, NICU Pt Care Supervisor TT and Clinical Development Coordinator UU stated they observed and acknowledged all infection control findings within the NICU department and there was no current cleaning schedule.

TT and UU agreed that potential for significant cross contamination related to no separation of clean, dirty and sterile was identified throughout the NICU clean and dirty storage rooms

NICU Pt Care Supervisor TT and Clinical Development Coordinator UU stated that they had not involved Infection Control for assistance and oversight to storage and equipment and separation of clean, dirty and sterile items to ensure they were stored in rooms with appropriate airflow, ventilation and humidity.

PRENATAL ASSESSMENT:
On 05/13/13 between 1:55 PM and 2:30 PM during a tour of 3rd floor Antepartum unit with Clinical Coordinator and RN VV the following was observed:

Bio hazardous Rm #3810 had no sink or hand washing availabilities within close proximity to the room. The hand-washing sink in the corridor had soap and dark debris build up at the spout.

ANTEPARTUM:
On 05/13/13 from 1:55 PM to 2:30 PM, tour with Clinical Coordinator PP observed the following:

Clean storage Rm #3219 had chipped cou

Based on MR review, P&P review and staff interview, this facility failed to appropriately document contact to the Organ Procurement Organization (OPO) upon death/imminent death of a patient in 2 out of 4 death MRs (Pt. #10 and 12) reviewed. Failure to appropriately document contact to the OPO has the potential to affect all patient in the facility including all patients present during the course of the survey. In addition, based on observation of the hyperbaric exam room, and one staff interview (AAAAA), the facility does not have a policy to govern the use, storage or shelf life of medications that are shared between patients at the wound care clinic. This has the potential of affecting all patients presenting for service at this clinic.

Issues at the WA WA Campus Mayfair RD
No policy for medications shared between patients. OB/ I
*) Observations of Hyperbaric exam room on 5/13/13 at 12:20 p.m. reflects that there are opened and previously used jars and tubes of the following topical skin medications laying on the counter: Eucerin cream-original healing cream, Sensi Care skin protectant barrier cream, Midline Remedy skin protectant cream and Saf-Gel Hydrating wound cream with alginate. There is no date nor time of original opening on these containers.
In interview with RN AAAAA at the time of this observation, she states that there is no facility policy to govern the use, storage or shelf life of these medications that shared between patients at the wound care clinic.



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The facility's policy titled "Organ/Tissue Donation," dated December 2011, was reviewed on 5/15/2013 at 1:30 p.m. On page 5, J. 1. states, "The RN is responsible to document that a call was placed to the WDN-OPO." [WDN-Wisconsin Donor Network]

A MR review was conducted on Pt. #10's closed MR on 5/14/2013 at 2:24 p.m. assisted by Dir of HIM BBB. Pt. #10 was pronounced brain dead on 9/5/12 and was determined suitable for organ donation. There is no evidence in the MR that the OPO was contacted regarding imminent or actual death.
Dir BBB confirmed these findings during MR review.

A MR review was conducted on Pt. #12's closed MR on 5/14/2013 at 3:06 p.m. assisted by RN Edu CCC. Pt. #12 expired on 10/17/2012. The facility did document the first name of the OPO contact, however there is no evidence in the MR of the date or time this was completed.
RN CCC confirmed these findings during the MR review.

An interview with Dir of Quality A was conducted on 5/15/2013 in the a.m. regarding the above findings. Dir A stated that per the OPO direction last names of the OPO contact should not be used and agreed that the time and date was not indicated on the paper documents from the MR that were reviewed.