HospitalInspections.org

Based on MR review, review of P&P and interview with staff (B, C, W, JJ, X), in 3 of 30 MR reviewed (4, 11, 26) the facility failed to ensure consents are completed and signed in the MR. This deficiency has the potential to affect all 202 inpatients and 221 ED patients treated during this survey.

Findings include:

Review on 10/2/13 in the AM of facility P&P titled Informed Consent/Informed Refusal, revised 4/13, stated under IV.H.1. "Informed Consent. a. In the event of a suspected Emergency Medical Condition, a Practitioner may proceed with a medical screening examination and/or treatment necessary to alleviate an Emergency Medical Condition without the patient's/representative's consent if the attempt to secure informed consent would result in an unacceptable delay in treatment. If time and circumstances permit, the Practitioner should attempt to secure consent from the patient/representative and consult with another Practitioner regarding the urgency of treatment. Document all such consultations in the patient's medical record. b. Efforts to obtain consent from the patient/representative and information describing the patient's Emergency Medical Condition shall be documented in the patient's medical record. Once the emergency situation has subsided, informed consent for continuing treatment shall be obtained form the patient/representative." Exhibit B includes Specific Treatments/Procedures That Require a Signed Consent Form under Miscellaneous: "certain treatments have unique informed consent requirements, see your facility policies for more information on specific consent requirements for any of these topic areas: Blood/Blood Products..."

Review of Pt #4's MR on 10/1/13 beginning at 1:37 PM revealed the informed consent for exploratory laparotomy, bowel resection, and colostomy is not signed, dated, and timed by the practitioner. Findings confirmed with RN X at the time MR review.


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Pt #11 was seen in the emergency department on 08/21/13, his condition necessitated transfer to another facility. The transfer form required does not have a signature by the patient or a representative. This was confirmed per interview with ED MGR W on 10/01/13 at 10:15 AM. W stated that transfer consent forms should be signed and dated by the patient or their representative.


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Pt #26's MR review on 10/1/13 at 1:45 PM revealed Pt #26 was born on 9/15/13 and admitted to NICU due to respiratory distress and requires tube feeding through a nasogastric tube, and has umbilical lines for intravenous fluids. There is no consent for treatment of Pt #26 signed by Pt #26's representative. There is no evidence in the MR there was verbal consent to treat given by Pt #26's representative. This is confirmed in interview with RN B and MGR C on 10/1/13 at 1:45 PM, adding there should be evidence of a consent for treatment.

Based on MR review, P & P review, and staff interview (X, DD,EE), the facility failed to ensure staff appropriately assessed/reassessed and met patient care needs in response to interventions in 9 of 30 MR reviewed (1, 2, 3, 4, 6, 7, 16, 19 and 20). This deficiency has the potential to affect all 202 inpatients and 221 ED patients receiving services during this survey.

Finding include:

Review on 10/1/13 in the PM of Pain Management using Opioids Delivered by Patient Controlled Analgesia (PCA) P & P, last reviewed 9/2011 reveals the following: "The RN will initiate PCA infusion and complete the pain evaluation monitoring every one hour x 2, followed by every 2 hours and prn (as needed) evaluation for the first 24 hours of PCA therapy including:
1. Pain intensity rating
2. Pain evaluation based on comparing pain assessment with established comfort goals for pain management at rest or with activity.
3. Sedation monitoring including sedation and respiratory status assessment. Note: These assessments should be conducted by the RN. After 24 hours of stable dosing with no adverse effects, the frequency of monitoring is reduced to every 4 hours until the infusion is discontinued."

Review on 10/1/13 in the PM of Fall Prevention P & P, last reviewed 1/2013 reveals the following: "Reevaluate fall risk after the patient has a surgery or procedure requiring sedation, after a room change, when the patient demonstrates a change in clinical condition or a change is noted in any of fall risk variables on the Morse Fall Scale. Falls risk is reassessed daily and as needed with change in condition using the Morse Fall Scale".

The facility's policy titled, "Pain Management", dated 3/10 reviewed on 09/30/2013 at 3:40 PM states pain will be " reevaluated within 30-60 minutes of administering an oral pain medication and within 15-30 minutes of an IV pain medication " . Policy also states " Health care professionals screen each patient for the presence of pain. Based on this screening for each patient who indicates pain, a comprehensive pain assessment is made consistent with scope and services provided and the patient's condition."

The facility's policy titled, "Skin Integrity Alteration-Potential/Actual for adult inpatients", dated 11/11 was reviewed on 10/1/13 at 1:30 p.m. The policy indicated under IV. Assessment/Reassessment C. "Conduct a comprehensive wound assessment, including staging for patients with a pressure ulcer, for a wound of measurable size with visible wound bed at the following times: 1. Admission (within 4 hours of admission to patient unit). 2. 1 week after start of initial treatment."

Review of Pt #1's MR on 9/30/13 beginning at 2:20 PM revealed the following: Pt #1 given Dilaudid IV injection on 9/28/13 at 11:49 am, 6:02 PM, and 10:14 PM and 9/29/13 at 9:16 am; per review of pain monitoring documentation, pain reassessment was not done within 15 to 30 minutes after Dilaudid IV administration to ensure medication is effective as per Pain Management P & P.

Review of Pt #2's MR on 10/1/13 beginning at 10:00 am revealed the following: Pt #2 is a 71 year old who received a bilateral mastectomy on 9/30/13, per review of Pt #2's MR a Morse Falls Scale assessment was not documented post surgery to ensure patient safety and as per Falls Prevention P & P. Per interview with RN X on 10/1/13 at 3:12 PM patients should have falls risk assessment done upon arrival back from surgery. Pt #2 received morphine IV (pain medication) on 9/30/13 at 3:38 PM and 10:28 PM; per review of pain monitoring documentation, pain reassessment was not done within 15 to 30 minutes after Morphine administration.

Review of Pt #3's MR on 10/1/13 beginning at 12:38 PM revealed the following: Pt #3 is a 60 years old patient status post motor vehicle accident with diagnosis of multiple rib and leg fractures admitted on 9/26/13. Per review of Pt #3's MR there is evidence of one Morse Falls Scale assessment documented on 9/27/13 at 9:00 PM. This is not consistent with the Falls Prevention P & P to document falls risk assessment daily and with change in condition. On 9/30/13 beginning at 4:35 PM, continuous IV infusion of Fentanyl (pain medication) was started on Pt #3. Per review of Pt #3's MR pain assessment and sedation monitoring is documented at 4:00 PM and then 7:00 PM, approximately 2 hours and 25 minutes later. This is inconsistent with PCA and continuous infusion P & P.

Review of Pt #4's MR on 10/1/13 beginning at 1:37 PM revealed the following: Dilaudid PCA infusion started on Pt #4 on 9/20/13 beginning at 7:13 PM. Per review of Pt #4's "Opoid induced Sedation Monitoring" documentation and "Pain Evaluation at Rest" documentation from 9/20/13 to 9/21/13 there is no evidence of the RN consistently performing a pain assessment/evaluation and sedation monitoring every hour x 2 then every 2 hours for the first 24 hours post initiation of PCA infusion as per policy.

Review of Pt #6's MR on 10/1/13 beginning at 2:45 PM revealed the following: Morphine PCA infusion started on Pt #6 on 9/30/13 beginning at 12:53 PM. Per review of Pt #6's "Opoid induced Sedation Monitoring" documentation and "Pain Evaluation at Rest" documentation from 9/30/13 to 10/1/13 there is no evidence of the RN consistently performing a complete pain assessment/evaluation and sedation monitoring every hour x 2 then every 2 hours for the first 24 hours post initiation of PCA infusion as per policy.

Review of Pt #7's MR on 10/1/13 beginning at 3:15 PM revealed the following: Dilaudid PCA infusion started on Pt #7 on 9/29/13 beginning at 11:23 PM. Per review of Pt #7's "Opoid induced Sedation Monitoring" documentation and "Pain Evaluation at Rest" documentation from 9/29/13 to 10/1/13 there is no evidence of the RN consistently performing a complete pain assessment/evaluation and sedation monitoring every hour x 2 then every 2 hours for the first 24 hours post initiation of PCA infusion as per policy.

The above findings were confirmed with RN X at the time of the MR reviews, staff should document per P&P.


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A medical record review was completed on Pt. # 16 open medical record on 10/1/13 at 8:20 a.m. in the presence of RN Manager DD. Pt. # 16 was admitted to the hospital on 9/13/13 for acute bacterial peritonitis. Pt. #16 was given a pain medication at 9:55 a.m. and did not have any documentation of a pain reevaluation being completed. Pt. #16 was given a pain medication according to MAR on 9/30/13 at 9:11 p.m. but no pain assessment was documented at the time the medication was given. Pt # 16's MR indicated pressure wounds on admission (9/13/13), however no documentation of measurements of wounds noted until 9/17/13 by WCN EE.

A medical record review was completed on Pt. # 19 open medical record on 10/1/13 at 2:25 p.m. in the presence of RN Manager DD. Pt. # 19 was admitted to the hospital on 9/29/13 for pneumonia. Pt. # 19 was given pain medication on 9/29/13 at 12:00 p.m.; no follow up assessment was documented for a reassessment of the effectiveness of the medication given.

A medical record review was completed on Pt. # 20 open medical record on 10/1/13 at 2:50 p.m. in the presence of RN Manager DD. Pt. # 20 was admitted to the hospital on 9/29/13 for a stroke. Pt. # 20 had a pain assessment completed at 2:00 a.m. and rated his pain at a level 6. Pain medication was administered at 2:44 am. A reassessment of pain was not documented until 8:00 a.m.

These findings were confirmed at the time of the MR reviews by RN MGR DD.

In an interview with RN Manager DD on 10/01/2013 at 8:30 a.m. during MR reviews, RN Manager DD stated that pain re-assessments following medication administration should occur approximately within an hour of giving the medication.

In an interview with WCN EE on 10/1/13 at 2:00 p.m., WCN EE indicated that he usually measures wounds but if patients are admitted on days when he is not working then it is expected that RN's will complete the initial measurements of the wounds.

Based on MR review, review of P&P and interview with staff (B, C, X, II), in 5 of 30 MR (1, 2, 4, 25, 31) the facility failed to ensure CPs are developed with measurable goals, interventions and evaluated based on Pt unique needs. This deficiency has the potential to affect all 202 in patients treated during this survey.

Findings include:

Review on 10/1/13 in the PM of Systems Standards of Nursing Practice P & P #SC-001 last revised 2012 reveals the following:
-The RN will complete and Interdisciplinary Plan of Care (IPOC) within 24 hours of admission.
-Revisions to the plan of care shall be made whenever a new problem is identified, when the patient meets a goal or resolves a problem, when the patient does not meet a goal within the time frame identified, or when goals and interventions are revised.
-The IPOC will be reviewed/revised every 24 hours

Review of Pt #1's MR on 9/30/13 beginning at 2:20 PM reveals the following: Pt #1 admitted on 9/27/13 complaining of severe back pain x 3 days. The pain management CP initiated on 9/28/13 and per review of pt #1's MAR on 9/28/13, 9/29/13, and 9/30/13, Pt #1 was ordered Dilaudid IV (pain medication) every 2 hours for pain control and per pain evaluation at rest Pt #1 complained of pain ranging from 5-10 of 10 with 10 being severe pain. No documentation updating goals, interventions provided, or evaluating interventions on Pt #1's pain care plan prior to 10/1/13.

Review of Pt #2's MR on 10/1/13 beginning at 10:00 am reveals the following: Pt #2 is a post surgical bilateral mastectomy admitted on 9/30/13 at 7:06 am; review of Pt #2's care plans shows no evidence of a Pain management Care Plan initiated post surgery.

Review of Pt #4's MR on 10/1/13 beginning at 1:37 PM reveals the following: Pt #4 admitted for abdominal surgery on 9/16/13 at 4:28 PM received Dilaudid PCA infusion for pain management post surgery. Pain management care plan initiated on 9/17/13, documentation of interventions and evaluation on pain management plan of care on 9/29/13 and 9/30/13. No evidence of pain management care plan being reviewed and/or updated every 24 hours.

The above findings were confirmed with RN X at the time of MR review.


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Pt #25's MR review on 10/1/13 at 1:57 PM revealed Pt #25 was born on 8/26/13. The MD notes dated 8/29/13 reveal Pt #25 lost 9% of birth weight during the first two days of life, and supplemental feedings were initiated. There is no CP in the MR reflecting the change of Pt #25's status for supplemental feedings, including measurable goals, interventions and if Pt #25 met the goals. This is confirmed in interview with RN B and MGR C on 10/1/13 at 1:57 PM, adding a CP should have been done for weight loss and supplemental feedings.


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Review of Pt # 31's MR on 10/2/2013 at 2:00 PM accompanied by Clinical Informatics Educator II revealed Pt # 31 was admitted to the hospital after having a joint replacement surgery. Pt # 31 had problems with urinary retention and was discharged home with information on how to self catheterize (a procedure used to pass a tube into the bladder to drain urine). Pt # 31's CP does not include urinary problems. The CP did not include a urinary problem, intervention or goals per Clinical Informatics Educator II at the time of the chart review.

Based on observation during tour and interview (K) the facility failed to ensure medicals records are secured from unauthorized personal in 1 of 2 off site locations. This deficiency has the potential to affect all patients receiving care at this off site location.

Findings include:

During a tour of the Vince Lombardi Cancer Clinic in Sheboygan on 10/1/2013 at 9:15 AM accompanied by Risk Manager J, Clinic Supervisor U, and Clinic Manager K noted radiology films stored in an unlocked closet with sliding doors in the hallway near Radiation Oncology. Per Clinic Manager K, at the time of discovery, housekeeping cleans the clinic after hours and has access to these records.

Based on MR review, P&P review and interview (II, JJ), in 1 of 7 surgical MR in a total universe of 30 MR, the facility failed to ensure post operative assessment were completed. This deficiency has the potential to affect all patients receiving surgery at this facility.

Findings include:

Per review of facility policy #1016 dated 10/12 titled "Nursing Assessment/Reassessment" on 10/3/2013 at 9:00 AM under Medical/Surgical/Orthopedics/Remote Telemetry, "postoperative surgical patients assessed per unit standards or using standard assessment times (every 15 minutes x 4, every 30 minutes x 2 every 1 hour x 4 and every 4 hours x 24 hours).

Per review of facility policy policy number SC-001 titled "System Nursing Foundational Documents" undated on 10/3/2013 at 9:00 AM revealed "upon receiving a patient from the PACU, vital signs will be obtained a. Immediately b. Every 30 minutes x 1 c. Every hour until stable".

Per interview with CNO JJ on 10/3/2013 at 9:15 AM the "System Nursing Foundational Documents" is considered the floor standards for nursing and does not address postoperative surgical assessments, therefore, the "Nursing Assessment/Reassessment" policy #1016 would be in effect.

Review of Pt # 27 MR on 10/2/2013 at 12:45 PM accompanied by Clinical Informatic Educator II revealed Pt #27 moved from the PACU the 2nd floor at 5:00 PM on 9/30/2013, when full nursing assessment is documented. A pain assessment was documented at 6:45 PM and there is no other assessment documented for 7 hours. Clinical Informatic Educator II confirmed at the time of the MR no other assessments were documented for Pt #27 between 5:00 PM and 12:37 AM.

Based on tour and interview with staff (J, K, DD), in 2 out of 10 patient care areas, the hospital failed to ensure all medications and sharps/needles were not accessible to unauthorized visitors or staff. This deficiency has the potential to affect all patients and visitors at the facility during survey.

Findings include:

During a tour of a medical imaging room on 9/30/13 at 11:15 a.m., it was noted that the unattended unlocked room had a refrigerator that was equipped with a lock, the lock was opened. Inside the unlocked refrigerator was 2 vials of contrast (Optison and Difinity) used to complete stress tests and echocardiograms.

Per interview with RN Manager DD on 9/30/13 at 11:20 p.m., RN Manager DD stated that the refrigerator should be locked at all times as it contains medication used to perform tests.


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During a tour of the Vince Lombardi Cancer Clinic in Sheboygan on 10/1/2013 at 9:45 AM accompanied by Risk Manager J, Clinic Supervisor U and Clinic Manager K noted a drawer containing a box of needles, used for administration of medications in Exam Room 1. Per Clinic Manager K, at the time of discovery, patients could potentially be left unattended in Exam Room 1.

Based on observations, interview (DD) and P & P, review the facility failed to ensure that all medications for patient use were appropriately discarded if outdated in 1 of 10 departments toured (ICU). This deficency has the potiental to affect all patients receiving treatment at this faciltiy.

Findings include:

The facility's policy titled, Medication Storage Inspection Policy # S2.06 dated 10/2011 stated under "1. Purpose: Pharmacy Services shall assure that all areas that store medication are periodically inspected to verify the integrity and security of such medication. B. Expired medications or medications whose integrity is questionable will be returned to pharmacy for disposal."

During a tour of the ICU with RN Manager DD on 9/30/2013 at 10:10 a.m., a box of 22 carpojects of 0.9% Sodium Chloride was found dated 10/10/2012.

RN Manager DD confirmed this finding at the time of discovery.

Based on observation, staff interview and review of maintenance records between 9/30 -10/03/13, the facility failed to construct, install, and maintain the building system to ensure safety to all patients, staff and visitors.

Building #01 Kohler, Center, Lucas and South buildings

1. One doorway of hazardous room not kept clear of an obstruction;
2. Lack of exit signs to direct occupants to exits;
3. One smoke barrier not extended to roof deck above, one cable penetration of smoke barrier not properly sealed and supported, and one HVAC duct penetration of smoke barrier sealed with an expandable foam;.
4. Inadequate clear widths provided by smoke barrier doors;
5. Inadequate clear widths provided by exit access doors;
6. Fire Alarm system was not installed to minimum standards of NFPA 72, trouble signals due to phone line failure not transmitted to and annunciated at a continuously attended location in accordance with NFPA 72 Chapters 1, 5 and 7;
7. Fire alarm system batteries not tested semiannually;
8. Sprinkler piping not maintained free of external loads that are not allowed by NFPA 25 standards, and missing sprinkler head on top of one stair shaft;
9. One corridor used as a return air plenum, and lack of smoke isolation dampers in two air-handling units;
10. Soiled linen/trash receptacles not stored in a room protected as a hazardous area;
11. Lack of medical gas and vacuum area alarm panel in three patient sleeping areas; and
12. Lack of adequate ventilation with proper airflow direction in four clean utility and clean supply storage spaces, and five soiled utility/housekeeping rooms.

See K18, K-22, K-25, K-28, K-40, K-51, K52, K56, K67, K75, K77, and A-726 for detail.


Building #03- Ambulatory Surgery Center, Plymouth

(i) lack of smoke detectors in the fire alarm control unit rooms;
(ii) lack of a remote annunciator to annunciate emergency generator fault conditions; and
(iii) lack of exit sign in one location to direct occupants to exits.

See K-130 for detail.

The cumulative effects of these environmental problems resulted in the hospital's inability to ensure a safe environment for the patients.

Based on observation and interviews (C, D) the facility failed to ensure biohazard storage areas are secured from patients and visitors in 4 out of 10 areas toured (ICU, 3K Medical Unit, OB/Nursery and Surgery Center in Plymouth). This deficiency has the potential to affect all patients and visitors at this facility.

Findings include:

During a tour on 9/30/13 at 9:40 a.m. of the ICU noted a room labeled with a biohazard sign and labeled soiled utility room. The door was unlocked and biohazard containers were stored in this room.

During a tour on 9/30/13 at 10:40 a.m. of 3K Medical Unit noted a room labeled with a biohazard sign and labeled soiled utility room. The door was unlocked and biohazard containers were stored in this room.


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During a tour of Women's Health Services/OB/Nursery/NICU on 9/30/13 at 10:30 AM accompanied by Nursing Unit Manager C and Staff Nurse/Educator B noted room labeled with a biohazard sign and labeled "soiled utility room" unlocked. Nursing Unit Manager C verbalized at time of discovery, the soiled unity room is not a locked room.

During a tour of the Aurora Surgery Center in Plymouth accompanied by CNO/Surgery D and Supervisor I on 10/1/2013 at 7:38 AM noted a soiled unity room near the sleep lab propped open using the bolting mechanism to keep the door from shutting. CNO/Surgery D verbalized the door should not be propped open at the time of discovery.

Based on observation and staff interview, the facility failed to ensure 'life safety from fire' for all patients, staff and visitors.

Findings include:

Building #01 Kohler, Center, Lucas and South buildings

1. Failed to protect the life safety of patients from fire due to one doorway of hazardous room not kept clear of obstruction;
2. Failed to protect the life safety of patients from fire due to lack of exit signs to direct occupants to exits;
3. Failed to protect the life safety of patients from fire due to one smoke barrier not extended to roof deck above, one cable penetration of smoke barrier not properly sealed and supported, and one HVAC duct penetration of smoke barrier sealed with an expandable foam;
4. Failed to protect the life safety of patients from fire due to clear widths provided by smoke barrier doors in two locations not being adequate;
5. Failed to protect the life safety of patients from fire due to clear widths provided by exit access doors not adequate in one location;
6. Failed to protect the life safety of patients from fire due to fire Alarm system not installed to minimum standards of NFPA 72, and trouble signals due to phone line failure not annunciated at a location where it can be easily heard in accordance with NFPA 72 Chapters 1, 5 and 7;
7. Failed to protect the life safety of patients from fire due to fire alarm system batteries not tested semiannually;
8. Failed to protect the life safety of patients from fire due to sprinkler piping not maintained free of external loads, and missing sprinkler head on top of one stair shaft;
9. Failed to protect the life safety of patients from fire due to one corridor used as a return air plenum, and lack of smoke isolation dampers in two air-handling units;
10. Failed to protect the life safety of patients from fire due to soiled linen/trash receptacles not stored in a room protected as a hazardous area; and
11. Failed to protect the life safety of patients due to lack of medical gas and vacuum area alarm panels in three patient sleeping areas.

See K18, K-22, K-25, K-28, K-40, K-51, K52, K56, K67, K75, and K77 for detail.


Building #03- Ambulatory Surgery Center, Plymouth

(i) lack of smoke detectors in the fire alarm control unit rooms;
(ii) lack of a remote annunciator to annunciate emergency generator fault conditions; and
(iii) lack of exit sign in one location to direct occupants to exits.

See K-130 for detail.

Based on observation and staff interview, the facility did not provide adequate ventilation due to (i) lack of positive pressure in 4 clean utility and clean supply storage spaces, and (ii) lack of negative pressure in 5 soiled utility/housekeeping rooms in accordance with CDC and AIA guidelines. This deficient practice had a potential of contaminating air in clean spaces with undesirable contaminants, and causing possible infection.

The CDC guidelines can be found in the website


Findings include:

(i) During a tour of the facility with Staff M1 (senior director of facilities operations), Staff M2 (director of facilities operations), Staff M3(director of facilities operations-south market), and Staff M4(manager of facilities operations), surveyor observed on 10/01/13 between 8:50 am and 12 pm that the 5th Floor clean supply storage room adjacent to the Operation Room 5 did not have ventilation and positive pressure.

(ii) During a tour of the facility with Staff M1, Staff M2, Staff M3, and Staff M4, surveyor observed on 10/01/13 between 8:50 am and 12 pm that the Biohazard/Soiled Utility room on the 5th Floor did not have adequate ventilation, even though the room was slightly under negative pressure when tested with a tissue paper at the door undercut.

(iii) During a tour of the facility with Staff M1, Staff M2, Staff M3, and Staff M4, surveyor observed on 10/01/13 between 8:50 am and 12 pm that the 4th Floor soiled utility room across from Patient Room 468 was not maintained in negative pressure relative to the adjacent spaces. The room was under positive pressure causing airflow in the wrong direction from dirty to a clean environment.

(iv) During a tour of the facility with Staff M1, Staff M2, Staff M3, and Staff M4, surveyor observed on 10/01/13 between 8:50 am and 12 pm that the 4th Floor Clean Utility Room 466 adjacent to the Nourishment Center was not maintained under positive pressure relative to adjacent paces. The room was under negative pressure causing airflow in the wrong direction from dirty to a clean environment.

(v) During a tour of the facility with Staff M1, Staff M2, Staff M3, and Staff M4, surveyor observed on 10/01/13 between 8:50 am and 12 pm that the 3rd Floor clean utility room across the Nurse Station was not maintained under positive pressure and allowed air to flow from the corridor (dirty environment) into the clean space.

(vi) During a tour of the facility with Staff M1, Staff M2, Staff M3, and Staff M4, surveyor observed on 10/01/13 at 1:58 pm that the 2nd Floor Housekeeping Closet across Room 266 in the Kohler building did not have exhaust ventilation, and was thus not maintained in a negative pressure relative to adjacent spaces.

(vii) During a tour of the facility with Staff M1, Staff M2, Staff M3, and Staff M4, surveyor observed on 10/02/13 between 10:45 am and 11:30 am that the Soiled Utility Room in the C-Section Suite on the 2nd Floor was not maintained in a negative pressure relative to the adjacent spaces. The pressure in the room was instead positive causing air flow in a wrong direction.

(viii) During a tour of the facility with Staff M1, Staff M2, Staff M3, and Staff M4, surveyor observed on 10/02/13 at 11:36 am that the Housekeeping Closet across Room 23 and adjacent to the stair in the emergency department on the 1st Floor did not have exhaust ventilation to maintain a negative pressure relationship.

(ix) During a tour of the facility with Staff M1, Staff M2, Staff M3, and Staff M4, surveyor observed on 10/02/13 at 2:05 pm that the Clean Utility room adjacent to the Nurse Station in the 1st Floor behavioral patient unit was not maintained under positive pressure. The space was under a negative pressure relationship to adjacent spaces.

This deficiency was acknowledged by the senior director of facilities operations, director of facilities operations, director of facilities operations-south market, and manager of facilities operations at the time of discovery, and confirmed with Staff JJ (chief nursing officer) at the exit conference on 10/03/13 at 4 pm.

Based on observation, tour, review of P&P, review of manufacturer's instructions, review of WI Food Code, AORN standards of practice, MR review (#16) and interview with staff (D, E , DD, FF, W, M, Y, X, G, K, J, V), in 9 of 9 staff observations (N, R, Q, S, GG, Z, AA, F, L), the facility failed to ensure a safe and sanitary environment to prevent and control contamination and/or cross-contamination. This deficiency has the potential to affect all patients and visitors at this facility.

Findings include:

Review on 10/1/13 in the AM of facility P&P titled Cleaning, Environmental, revised 11/12, states under Procedure c.h.(sic) "The horizontal surfaces of the furniture and equipment that have been involved in the surgical procedure are cleaned with disinfectant solution which is left in place for ten minutes (or as recommended by the manufacturer)."

Review on 10/1/13 in the AM of facility P&P titled Cleaning of Reusable Items, revised 10/12, states under General Guidelines: "3. Remove gross soil from instruments with cool or tepid water. 4. Pre-soak grossly soiled items in enzymatic solution for two to ten minutes prior to cleaning...8. Rinse items thoroughly."

Review on 9/30/13 at 1:15 PM of V. Mueller Enzymatic Cleaner label it states "Recommended soak time 5 minutes or longer..."

Review on 10/2/2013 in the PM policy entitled "Laundry Services" dated 04/13 states: "Clean Linen shall be stored on covered carts, in cabinets or covered on shelved (sic)."

Per review on 10/1/13 in the PM of Hand Hygiene/Surgical Hand Antisepsis P & P #183 last reviewed 8/12, Hand hygiene should be performed in the following situations:
-Before and after patient contact
-Before preparing and administering medication.
-After contact with body fluids, or excretions, mucous membranes, non intact skin, or wound dressing.
-Moving from contaminated body site to a clean body site during patient care
-After removing gloves
-After contact with inanimate objects in the immediate vicinity of the patient

Example of cleaning surgical instruments:

On 9/30/13 at 1:15 PM SPT N pre-cleaned surgical instruments, placing multiple instruments in a basin of water with premeasured V. Mueller Enzymatic Cleaner, immediately scrubbing the instruments with a brush, placing in the sink to the left then into the rigid container for running through the washer prior to sterilization. SPT N repeated this process with another set of instruments. When asked how long the instruments soak, SPT N stated "No soak time, just brush under water."

Observation of the contents of the rigid container holding instruments ready for the high powered washer, there was a dark red nickel sized "clot" in the corner, a closed surgical clamp, with visible red substance in the "teeth" of the clamp, and a visible read substance on the handles of at least 2 instruments.

SPT N was not observed to rinse any instruments prior to placing the in the rigid container, and did not allow instruments to soak at least 5 minutes per manufacturer instructions.

CNO D, ICC M and CNS E were present during the observation of surgical instrument cleaning by SPT N on 9/30/13 at 1:15 PM. CNO D, ICC M and CNS E stated the instruments should be cleaned per manufacturer's instructions and facility policy.

Example of cleaning OR:

On 9/30/13 between 2:15 PM and 2:40 PM, RN G, H R and AT S were observed cleaning OR 4 after an orthopedic surgery. RN G, H R and AT S each used one cleaning cloth soaked with the EPA approved disinfectant HB QUAT, that requires a 10 minute contact time, per manufacturer's instructions.

RN G wiped down the foot pedal controls for equipment then proceeded to clean the "tower" containing electronic equipment. H R wiped down an arm board, that was on a mayo stand (instrument table), placed it on a cart that had not been cleaned, contaminating the arm board. RN G did not change out cleaning cloths when moving from bottom to the top of another piece of equipment.

H R wiped down the mayo stand and placed the contaminated arm board on the stand. H R wiped down one side of a pillow, turned it over on the table it was on, contaminating the clean side of the pillow and wiped down the other side. H R picked up an IV irrigation bag off a cart, wiped down the cart and replaced the IV irrigation bag, recontaminating the cart.

AT S wiped down the anesthesia cart, and began setting up the anesthesia equipment for the next surgical case, without waiting a full 10 minutes for QUAT contact time.

On 9/30/13 at 2:40 PM, CNO D was informed of the above observations and stated equipment should be cleaned from top to bottom, clean items should not be placed on dirty items and the equipment must have a 10 minute contact time before setting up for the next procedure.


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Examples in the ED:

During a tour of the ED on 10/01/13 at 9:12 AM with ED manager W the following was observed; The linen cabinet in the ambulance bay which was filled with clean linen was open. The linen was unprotected from dust and dirt in the atmosphere.


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Examples in OB/Nursery:

During a tour of Women's Health Services/OB/Nursery/NICU accompanied by Nursing Unit Manager C and Staff Nurse/Educator B on 9/30/2013 at 10:30 AM noted labor/exercise ball on the floor in the labor room. Nursing Unit Manager C verbalized at the time of discovery it was a clean item and should be kept off the floor.

Examples in the GI Lab:

During a tour of the GI Lab accompanied by CNS E and CNO/Surgery D on 9/30/2013 at 12:40 PM noted scrapes and holes on the walls in Procedure Room C making these surfaces non cleanable. CNO/Surgery D verbalized agreement with the findings at the time of discovery.

Examples at the Plymouth Surgery Center:

During a tour of the Aurora Surgery Center in Plymouth accompanied by CNO/Surgery D and Supervisor I on 10/1/2013 at 7:38 AM noted scrapes and holes on the walls in OR 1 and chipped and missing tiles inside the OR corridor doors making these surfaces non cleanable. CNO/Surgery D verbalized agreement with the findings at the time of discovery.

Examples at the Vince Lombardi Cancer Clinic:

During a tour of the Vince Lombardi Cancer Clinic in Sheboygan on 10/1/2013 9:15 AM accompanied by Risk Manager J, Clinic Supervisor U and Clinic Manager K noted the Emergency Cart covered in thick dust. Clinic Manger K acknowledged need to have the cart cleaned at the time of discovery.

On 10/1/2013 at 9:27 AM observed RN L palpate Pt # 32's skin with bare hands and then proceed to put on gloves without performing hand hygiene. RN L then inserted a needle to access Pt # 32's Port A Cath (a device implanted under the skin to allow intermittent venous access). After accessing the Port A Cath RN L removed gloves and discarded trash then preceded to the nursing station without performing hand hygiene. Clinic Manager K acknowledged at the time of the observation, RN L should have preformed hand hygiene before donning gloves and after removing gloves

During a tour of the Vince Lombardi Cancer Clinic in Sheboygan on 10/1/2013 at 9:15 AM accompanied by Risk Manager J, Clinic Supervisor U and Clinic Manager K noted cardboard between the seat and the legs of the lab chair making this a non cleanable surface. Clinic Manager K stated the cardboard was used to prevent the chair from squeaking. Risk Manager J asked staff verbalized the cardboard should not be used and asked staff to remove the cardboard at the time of discovery.

Examples in the Kitchen:

The 2009 Wisconsin Food Code states under 4-601.1 that:" nonfood-contact surfaces of equipment shall be kept free of an accumulation of dust, dirt, food residue and other debris. "

Per review on 10/1/13 in the AM, the "Master Monthly Cleaning List", included the "cooks area" staff are to "wipe down fronts of all ovens".

During a tour of the kitchen on 10/01/13 at 11:00 AM with Dietary Manager V it was observed that the door handles for the ovens were covered with grease and dirt.

These observations were confirmed by staff V at the time of the kitchen tour. V stated that they would be cleaned immediately.

Hospital policy entitled; "Food Safety and Quality" dated 01/13 was reviewed on 10/01/13 at 1:30 PM, it states under "3. Food Quality"; "Items that are expired should be thrown away."

A tour of the food storage area of the kitchen was conducted on 10/01/13 at 11:00 AM with Dietary Manager V. During this tour it was observed that outdated tube-feeding formulas were on the shelves of the food storage area. These included; 9, 1 liter bags of "novasource renal" with expiration dates of 07/20/13 and 6, 1 liter bags of "peptamen" with expiration dates of 07/10/13.

These findings were confirmed at the time of the observation by staff V who stated outdated food and tube feedings should be removed and discarded.















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Examples of hand hygiene:

Per observation on 10/1/13 at 11:10 a.m. of RN GG providing dialysis to pt. #14, RN GG initiated dialysis on pt.# 14's right arm fistula. RN GG inserted needles, applied tape to fistula needles, and removed gloves. RN GG gathered more supplies and then reapplied gloves without the benefit of hand hygiene. RN GG continued to change gloves 3 times without the benefit of hand hygiene.

The above findings were confirmed and observed by RN Manager DD on 10/1/13 at 11:30 a.m.

Observation of CNA Z checking Pt #8's blood glucose on 9/30/13 beginning at 11:10 am, revealed the following: CNA Z had to be reminded by RN X to wash hands prior to gloving. CNA placed box containing blood sugar supplies and glucometer on to Pt #8's bedside tray table. CNA Z then proceeded to grab Pt #8's hand to scan Pt bracelet and then reached into clean supplies to obtain lancet and test strip potentially contaminating clean supplies. CNA Z checked Pt #8's blood sugar then disposed of lancet and test strip. CNA Z removed gloves and sanitized hands and then picked up box containing blood sugar supplies and glucometer potentially recontaminating hands. CNA Z then returned box to common area and placed glucometer on docking station without first cleaning and disinfecting equipment. RN X confirmed and witnessed the above observations. Per RN X, CNA Z should have cleaned and disinfected the glucometer and outside of box containing supplies prior to leaving Pt #8's room. Per "POCT NOVA STATSTRIP GLUCOSE" guidelines for use reference #6210, Version #1, the Nova StatStrip Meter must be disinfected after every patient test.

Observation of RN AA performing wound care on Pt #4's abdominal surgery site on 9/30/13 beginning at 11:20 am revealed the following: RN AA pulled tray table closer to Pt #4's bed then proceeded to don gloves without performing hand hygiene. RN AA then removed Pt #4's abdominal dressing, removed gloves, performed hand hygiene, then proceeded to grab phone out of pocket and give to RN X to make a phone call. RN AA then proceeded to open supplies and don sterile gloves without first performing hand hygiene. RN X confirmed and witnessed the above observations.

On 9/30/2013 at 1:40 PM observed General Surgeon F in OR 1 remove a soiled dressing from Pt # 27's left breast without gloves on then preceded to exit OR 1 without washing hands. Supervisor of Surgical Services G acknowledged General Surgeon F did not wear gloves or wash hands a the time of the observation.


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On 9/30/2013 beginning at 9:45 am, during tour with RN J and RN X observed the following infection control issues:

Examples from the 4th floor tour:

-Room 461---Commode toilet seat surface is chipped and bubbling.
-Patient rooms throughout the 4th floor contain multiple pillows in pillow cases sitting on plastic containers in unoccupied rooms exposing pillow cases to potential dust and debris contamination. Per interview with CNA Y at the time of the tour, the pillows are used for positioning patients post surgeries such as hip and knee surgeries; this deficient practice could allow for potential cross contamination.
-Room 464---Ceiling vent in bathroom contains large dust particles.
-Nourishment Center---dust and debris in cabinets above and below sink.
-Room 457---wash cloth and towel hanging in bathroom in clean unoccupied room.

Examples from the 2nd Floor tour:

-linen room--- microwave contains food debris and residue; multiple towels on floor under linen cart.
-Nourishment room---dust and debris in cabinets; layer of dust on shelving units.
-Restroom 2k west wing---drywall chipping and peeling behind toilet not allowing for surface to be cleaned and disinfected.
- Soiled utility room---white residue on counter tops; dust, debris, and rust in cabinets, laminate separating on counter tops exposing under surface.
-House keeping closet---staff members purse sitting on floor next to cleaning supplies, mop, and floor drain.
-Room 273--rust on grab bar connected to toilet seat, not allowing for cleaning and disinfection of surface.

Examples in the Laundry Department:

On 9/30/2013 beginning at 1:25 PM, during tour with RN X observed the following infection control issues:

-Broken and missing laminate on counter top where laundry is sorted; surface cannot be properly cleaned and disinfected.
-Wash cloths not completely covered next to labeler machine; labeler machine contains large dust particles, exposing wash clothes to potential cross contamination.

Based on observation, MR review, P&P review, review of manufacturer's instructions, AORN Standards of Practice and interview with staff (D, E, G), in 1 of 1 observation of staff performing skin prep for surgery (G) the facility failed to ensure the alcohol based skin prep is dry prior to draping to prevent potential fire hazard and burns to Pt. And in 4 of 6 staff observed (B, F, G, LL) the facility failed to ensure staff followed the surgical attire policy This deficiency has the potential to affect all patients receiving surgery at this facility.

Findings include:

Review on 10/2/13 in the PM of facility P&P titled Skin Preparation-Intraoperatively, revised 11/12, it states under Surgical Prep Technique Recommendations 5.b. "Chloraprep must be completely dry prior to draping to minimize the risk of fire when electrocautery or lasers are used."

A review of facility policy titled PM titled "SUR-042 Surgical Attire" was conducted on 9/30/2013 at 3:45 PM. The policy states under Procedure: B. " Head and facial hair, including sideburns and neckline, should be covered when in the semi-restricted and restricted areas of the surgical suite. 1. Head gear should be clean, low lint and confine all hair. 2. Bouffant and hood style covers are preferred."

Per interview with CNO/Surg D on 9/30/2013 at 3:30 PM this facility follows AORN standards of practice. Per AORN Perioperative Standards and Recommended Practices 2013 Edition, all hair is to be covered, long sleeved jackets should be worn to cover exposed skin if not gowning.

Example of alcohol skin based preparation:

On 9/30/13 at 2:07 PM, RN G applied Chloraprep (alcohol based skin prep) to Pt #27's left breast in preparation for a mastectomy. After 30 seconds of dry time MD F began applying drapes to Pt #27's left arm, by 2:09 PM the entire surgical site was draped. There was no verbal statement the Chloraprep was dry prior to draping and the dry time of the prep was not included in the "time out" prior to incision. In interview with CNO D on 9/30/13 at 2:40 PM, CNO D stated the skin prep should be dry prior to draping. Review of Pt #27's MR on 10/1/13 at 12:45 PM revealed the Intra-operative record includes box checked next to the statement "Verified alcohol based prep dry before draping." This is confirmed in interview with CNS E on 10/1/13 at 12:45 PM, adding the box should be checked only if the prep was dry prior to draping.


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Examples of surgical attire:

On 9/30/2013 at 1:40 PM noted CRNA LL wearing a hair bonnet which left the hair on the back of the head uncovered in OR 1. Supervisor of Surgical Services G acknowledged all hair was not restrained at the time of discovery.

On 9/30/2013 at 1:40 PM noted General Surgeon F, Supervisor of Surgical Services G, CRNA LL and CNO/Surgery D in OR 1 while sterile fields were being prepared without long sleeve surgical attire. Per interview with CNO/Surgical services D at 3:30 PM the policy does not address the need to wear long sleeves in the OR.

Based on MR review, review of P&P and interview with staff (B, C, W, JJ, X), in 3 of 30 MR reviewed (4, 11, 26) the facility failed to ensure consents are completed and signed in the MR. This deficiency has the potential to affect all 202 inpatients and 221 ED patients treated during this survey.

Findings include:

Review on 10/2/13 in the AM of facility P&P titled Informed Consent/Informed Refusal, revised 4/13, stated under IV.H.1. "Informed Consent. a. In the event of a suspected Emergency Medical Condition, a Practitioner may proceed with a medical screening examination and/or treatment necessary to alleviate an Emergency Medical Condition without the patient's/representative's consent if the attempt to secure informed consent would result in an unacceptable delay in treatment. If time and circumstances permit, the Practitioner should attempt to secure consent from the patient/representative and consult with another Practitioner regarding the urgency of treatment. Document all such consultations in the patient's medical record. b. Efforts to obtain consent from the patient/representative and information describing the patient's Emergency Medical Condition shall be documented in the patient's medical record. Once the emergency situation has subsided, informed consent for continuing treatment shall be obtained form the patient/representative." Exhibit B includes Specific Treatments/Procedures That Require a Signed Consent Form under Miscellaneous: "certain treatments have unique informed consent requirements, see your facility policies for more information on specific consent requirements for any of these topic areas: Blood/Blood Products..."

Review of Pt #4's MR on 10/1/13 beginning at 1:37 PM revealed the informed consent for exploratory laparotomy, bowel resection, and colostomy is not signed, dated, and timed by the practitioner. Findings confirmed with RN X at the time MR review.


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Pt #11 was seen in the emergency department on 08/21/13, his condition necessitated transfer to another facility. The transfer form required does not have a signature by the patient or a representative. This was confirmed per interview with ED MGR W on 10/01/13 at 10:15 AM. W stated that transfer consent forms should be signed and dated by the patient or their representative.


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Pt #26's MR review on 10/1/13 at 1:45 PM revealed Pt #26 was born on 9/15/13 and admitted to NICU due to respiratory distress and requires tube feeding through a nasogastric tube, and has umbilical lines for intravenous fluids. There is no consent for treatment of Pt #26 signed by Pt #26's representative. There is no evidence in the MR there was verbal consent to treat given by Pt #26's representative. This is confirmed in interview with RN B and MGR C on 10/1/13 at 1:45 PM, adding there should be evidence of a consent for treatment.

Based on MR review, P & P review, and staff interview (X, DD,EE), the facility failed to ensure staff appropriately assessed/reassessed and met patient care needs in response to interventions in 9 of 30 MR reviewed (1, 2, 3, 4, 6, 7, 16, 19 and 20). This deficiency has the potential to affect all 202 inpatients and 221 ED patients receiving services during this survey.

Finding include:

Review on 10/1/13 in the PM of Pain Management using Opioids Delivered by Patient Controlled Analgesia (PCA) P & P, last reviewed 9/2011 reveals the following: "The RN will initiate PCA infusion and complete the pain evaluation monitoring every one hour x 2, followed by every 2 hours and prn (as needed) evaluation for the first 24 hours of PCA therapy including:
1. Pain intensity rating
2. Pain evaluation based on comparing pain assessment with established comfort goals for pain management at rest or with activity.
3. Sedation monitoring including sedation and respiratory status assessment. Note: These assessments should be conducted by the RN. After 24 hours of stable dosing with no adverse effects, the frequency of monitoring is reduced to every 4 hours until the infusion is discontinued."

Review on 10/1/13 in the PM of Fall Prevention P & P, last reviewed 1/2013 reveals the following: "Reevaluate fall risk after the patient has a surgery or procedure requiring sedation, after a room change, when the patient demonstrates a change in clinical condition or a change is noted in any of fall risk variables on the Morse Fall Scale. Falls risk is reassessed daily and as needed with change in condition using the Morse Fall Scale".

The facility's policy titled, "Pain Management", dated 3/10 reviewed on 09/30/2013 at 3:40 PM states pain will be " reevaluated within 30-60 minutes of administering an oral pain medication and within 15-30 minutes of an IV pain medication " . Policy also states " Health care professionals screen each patient for the presence of pain. Based on this screening for each patient who indicates pain, a comprehensive pain assessment is made consistent with scope and services provided and the patient's condition."

The facility's policy titled, "Skin Integrity Alteration-Potential/Actual for adult inpatients", dated 11/11 was reviewed on 10/1/13 at 1:30 p.m. The policy indicated under IV. Assessment/Reassessment C. "Conduct a comprehensive wound assessment, including staging for patients with a pressure ulcer, for a wound of measurable size with visible wound bed at the following times: 1. Admission (within 4 hours of admission to patient unit). 2. 1 week after start of initial treatment."

Review of Pt #1's MR on 9/30/13 beginning at 2:20 PM revealed the following: Pt #1 given Dilaudid IV injection on 9/28/13 at 11:49 am, 6:02 PM, and 10:14 PM and 9/29/13 at 9:16 am; per review of pain monitoring documentation, pain reassessment was not done within 15 to 30 minutes after Dilaudid IV administration to ensure medication is effective as per Pain Management P & P.

Review of Pt #2's MR on 10/1/13 beginning at 10:00 am revealed the following: Pt #2 is a 71 year old who received a bilateral mastectomy on 9/30/13, per review of Pt #2's MR a Morse Falls Scale assessment was not documented post surgery to ensure patient safety and as per Falls Prevention P & P. Per interview with RN X on 10/1/13 at 3:12 PM patients should have falls risk assessment done upon arrival back from surgery. Pt #2 received morphine IV (pain medication) on 9/30/13 at 3:38 PM and 10:28 PM; per review of pain monitoring documentation, pain reassessment was not done within 15 to 30 minutes after Morphine administration.

Review of Pt #3's MR on 10/1/13 beginning at 12:38 PM revealed the following: Pt #3 is a 60 years old patient status post motor vehicle accident with diagnosis of multiple rib and leg fractures admitted on 9/26/13. Per review of Pt #3's MR there is evidence of one Morse Falls Scale assessment documented on 9/27/13 at 9:00 PM. This is not consistent with the Falls Prevention P & P to document falls risk assessment daily and with change in condition. On 9/30/13 beginning at 4:35 PM, continuous IV infusion of Fentanyl (pain medication) was started on Pt #3. Per review of Pt #3's MR pain assessment and sedation monitoring is documented at 4:00 PM and then 7:00 PM, approximately 2 hours and 25 minutes later. This is inconsistent with PCA and continuous infusion P & P.

Review of Pt #4's MR on 10/1/13 beginning at 1:37 PM revealed the following: Dilaudid PCA infusion started on Pt #4 on 9/20/13 beginning at 7:13 PM. Per review of Pt #4's "Opoid induced Sedation Monitoring" documentation and "Pain Evaluation at Rest" documentation from 9/20/13 to 9/21/13 there is no evidence of the RN consistently performing a pain assessment/evaluation and sedation monitoring every hour x 2 then every 2 hours for the first 24 hours post initiation of PCA infusion as per policy.

Review of Pt #6's MR on 10/1/13 beginning at 2:45 PM revealed the following: Morphine PCA infusion started on Pt #6 on 9/30/13 beginning at 12:53 PM. Per review of Pt #6's "Opoid induced Sedation Monitoring" documentation and "Pain Evaluation at Rest" documentation from 9/30/13 to 10/1/13 there is no evidence of the RN consistently performing a complete pain assessment/evaluation and sedation monitoring every hour x 2 then every 2 hours for the first 24 hours post initiation of PCA infusion as per policy.

Review of Pt #7's MR on 10/1/13 beginning at 3:15 PM revealed the following: Dilaudid PCA infusion started on Pt #7 on 9/29/13 beginning at 11:23 PM. Per review of Pt #7's "Opoid induced Sedation Monitoring" documentation and "Pain Evaluation at Rest" documentation from 9/29/13 to 10/1/13 there is no evidence of the RN consistently performing a complete pain assessment/evaluation and sedation monitoring every hour x 2 then every 2 hours for the first 24 hours post initiation of PCA infusion as per policy.

The above findings were confirmed with RN X at the time of the MR reviews, staff should document per P&P.


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A medical record review was completed on Pt. # 16 open medical record on 10/1/13 at 8:20 a.m. in the presence of RN Manager DD. Pt. # 16 was admitted to the hospital on 9/13/13 for acute bacterial peritonitis. Pt. #16 was given a pain medication at 9:55 a.m. and did not have any documentation of a pain reevaluation being completed. Pt. #16 was given a pain medication according to MAR on 9/30/13 at 9:11 p.m. but no pain assessment was documented at the time the medication was given. Pt # 16's MR indicated pressure wounds on admission (9/13/13), however no documentation of measurements of wounds noted until 9/17/13 by WCN EE.

A medical record review was completed on Pt. # 19 open medical record on 10/1/13 at 2:25 p.m. in the presence of RN Manager DD. Pt. # 19 was admitted to the hospital on 9/29/13 for pneumonia. Pt. # 19 was given pain medication on 9/29/13 at 12:00 p.m.; no follow up assessment was documented for a reassessment of the effectiveness of the medication given.

A medical record review was completed on Pt. # 20 open medical record on 10/1/13 at 2:50 p.m. in the presence of RN Manager DD. Pt. # 20 was admitted to the hospital on 9/29/13 for a stroke. Pt. # 20 had a pain assessment completed at 2:00 a.m. and rated his pain at a level 6. Pain medication was administered at 2:44 am. A reassessment of pain was not documented until 8:00 a.m.

These findings were confirmed at the time of the MR reviews by RN MGR DD.

In an interview with RN Manager DD on 10/01/2013 at 8:30 a.m. during MR reviews, RN Manager DD stated that pain re-assessments following medication administration should occur approximately within an hour of giving the medication.

In an interview with WCN EE on 10/1/13 at 2:00 p.m., WCN EE indicated that he usually measures wounds but if patients are admitted on days when he is not working then it is expected that RN's will complete the initial measurements of the wounds.

Based on MR review, review of P&P and interview with staff (B, C, X, II), in 5 of 30 MR (1, 2, 4, 25, 31) the facility failed to ensure CPs are developed with measurable goals, interventions and evaluated based on Pt unique needs. This deficiency has the potential to affect all 202 in patients treated during this survey.

Findings include:

Review on 10/1/13 in the PM of Systems Standards of Nursing Practice P & P #SC-001 last revised 2012 reveals the following:
-The RN will complete and Interdisciplinary Plan of Care (IPOC) within 24 hours of admission.
-Revisions to the plan of care shall be made whenever a new problem is identified, when the patient meets a goal or resolves a problem, when the patient does not meet a goal within the time frame identified, or when goals and interventions are revised.
-The IPOC will be reviewed/revised every 24 hours

Review of Pt #1's MR on 9/30/13 beginning at 2:20 PM reveals the following: Pt #1 admitted on 9/27/13 complaining of severe back pain x 3 days. The pain management CP initiated on 9/28/13 and per review of pt #1's MAR on 9/28/13, 9/29/13, and 9/30/13, Pt #1 was ordered Dilaudid IV (pain medication) every 2 hours for pain control and per pain evaluation at rest Pt #1 complained of pain ranging from 5-10 of 10 with 10 being severe pain. No documentation updating goals, interventions provided, or evaluating interventions on Pt #1's pain care plan prior to 10/1/13.

Review of Pt #2's MR on 10/1/13 beginning at 10:00 am reveals the following: Pt #2 is a post surgical bilateral mastectomy admitted on 9/30/13 at 7:06 am; review of Pt #2's care plans shows no evidence of a Pain management Care Plan initiated post surgery.

Review of Pt #4's MR on 10/1/13 beginning at 1:37 PM reveals the following: Pt #4 admitted for abdominal surgery on 9/16/13 at 4:28 PM received Dilaudid PCA infusion for pain management post surgery. Pain management care plan initiated on 9/17/13, documentation of interventions and evaluation on pain management plan of care on 9/29/13 and 9/30/13. No evidence of pain management care plan being reviewed and/or updated every 24 hours.

The above findings were confirmed with RN X at the time of MR review.


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Pt #25's MR review on 10/1/13 at 1:57 PM revealed Pt #25 was born on 8/26/13. The MD notes dated 8/29/13 reveal Pt #25 lost 9% of birth weight during the first two days of life, and supplemental feedings were initiated. There is no CP in the MR reflecting the change of Pt #25's status for supplemental feedings, including measurable goals, interventions and if Pt #25 met the goals. This is confirmed in interview with RN B and MGR C on 10/1/13 at 1:57 PM, adding a CP should have been done for weight loss and supplemental feedings.


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Review of Pt # 31's MR on 10/2/2013 at 2:00 PM accompanied by Clinical Informatics Educator II revealed Pt # 31 was admitted to the hospital after having a joint replacement surgery. Pt # 31 had problems with urinary retention and was discharged home with information on how to self catheterize (a procedure used to pass a tube into the bladder to drain urine). Pt # 31's CP does not include urinary problems. The CP did not include a urinary problem, intervention or goals per Clinical Informatics Educator II at the time of the chart review.

Based on tour and interview with staff (J, K, DD), in 2 out of 10 patient care areas, the hospital failed to ensure all medications and sharps/needles were not accessible to unauthorized visitors or staff. This deficiency has the potential to affect all patients and visitors at the facility during survey.

Findings include:

During a tour of a medical imaging room on 9/30/13 at 11:15 a.m., it was noted that the unattended unlocked room had a refrigerator that was equipped with a lock, the lock was opened. Inside the unlocked refrigerator was 2 vials of contrast (Optison and Difinity) used to complete stress tests and echocardiograms.

Per interview with RN Manager DD on 9/30/13 at 11:20 p.m., RN Manager DD stated that the refrigerator should be locked at all times as it contains medication used to perform tests.


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During a tour of the Vince Lombardi Cancer Clinic in Sheboygan on 10/1/2013 at 9:45 AM accompanied by Risk Manager J, Clinic Supervisor U and Clinic Manager K noted a drawer containing a box of needles, used for administration of medications in Exam Room 1. Per Clinic Manager K, at the time of discovery, patients could potentially be left unattended in Exam Room 1.

Based on observation and interviews (C, D) the facility failed to ensure biohazard storage areas are secured from patients and visitors in 4 out of 10 areas toured (ICU, 3K Medical Unit, OB/Nursery and Surgery Center in Plymouth). This deficiency has the potential to affect all patients and visitors at this facility.

Findings include:

During a tour on 9/30/13 at 9:40 a.m. of the ICU noted a room labeled with a biohazard sign and labeled soiled utility room. The door was unlocked and biohazard containers were stored in this room.

During a tour on 9/30/13 at 10:40 a.m. of 3K Medical Unit noted a room labeled with a biohazard sign and labeled soiled utility room. The door was unlocked and biohazard containers were stored in this room.


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During a tour of Women's Health Services/OB/Nursery/NICU on 9/30/13 at 10:30 AM accompanied by Nursing Unit Manager C and Staff Nurse/Educator B noted room labeled with a biohazard sign and labeled "soiled utility room" unlocked. Nursing Unit Manager C verbalized at time of discovery, the soiled unity room is not a locked room.

During a tour of the Aurora Surgery Center in Plymouth accompanied by CNO/Surgery D and Supervisor I on 10/1/2013 at 7:38 AM noted a soiled unity room near the sleep lab propped open using the bolting mechanism to keep the door from shutting. CNO/Surgery D verbalized the door should not be propped open at the time of discovery.

Based on observation, tour, review of P&P, review of manufacturer's instructions, review of WI Food Code, AORN standards of practice, MR review (#16) and interview with staff (D, E , DD, FF, W, M, Y, X, G, K, J, V), in 9 of 9 staff observations (N, R, Q, S, GG, Z, AA, F, L), the facility failed to ensure a safe and sanitary environment to prevent and control contamination and/or cross-contamination. This deficiency has the potential to affect all patients and visitors at this facility.

Findings include:

Review on 10/1/13 in the AM of facility P&P titled Cleaning, Environmental, revised 11/12, states under Procedure c.h.(sic) "The horizontal surfaces of the furniture and equipment that have been involved in the surgical procedure are cleaned with disinfectant solution which is left in place for ten minutes (or as recommended by the manufacturer)."

Review on 10/1/13 in the AM of facility P&P titled Cleaning of Reusable Items, revised 10/12, states under General Guidelines: "3. Remove gross soil from instruments with cool or tepid water. 4. Pre-soak grossly soiled items in enzymatic solution for two to ten minutes prior to cleaning...8. Rinse items thoroughly."

Review on 9/30/13 at 1:15 PM of V. Mueller Enzymatic Cleaner label it states "Recommended soak time 5 minutes or longer..."

Review on 10/2/2013 in the PM policy entitled "Laundry Services" dated 04/13 states: "Clean Linen shall be stored on covered carts, in cabinets or covered on shelved (sic)."

Per review on 10/1/13 in the PM of Hand Hygiene/Surgical Hand Antisepsis P & P #183 last reviewed 8/12, Hand hygiene should be performed in the following situations:
-Before and after patient contact
-Before preparing and administering medication.
-After contact with body fluids, or excretions, mucous membranes, non intact skin, or wound dressing.
-Moving from contaminated body site to a clean body site during patient care
-After removing gloves
-After contact with inanimate objects in the immediate vicinity of the patient

Example of cleaning surgical instruments:

On 9/30/13 at 1:15 PM SPT N pre-cleaned surgical instruments, placing multiple instruments in a basin of water with premeasured V. Mueller Enzymatic Cleaner, immediately scrubbing the instruments with a brush, placing in the sink to the left then into the rigid container for running through the washer prior to sterilization. SPT N repeated this process with another set of instruments. When asked how long the instruments soak, SPT N stated "No soak time, just brush under water."

Observation of the contents of the rigid container holding instruments ready for the high powered washer, there was a dark red nickel sized "clot" in the corner, a closed surgical clamp, with visible red substance in the "teeth" of the clamp, and a visible read substance on the handles of at least 2 instruments.

SPT N was not observed to rinse any instruments prior to placing the in the rigid container, and did not allow instruments to soak at least 5 minutes per manufacturer instructions.

CNO D, ICC M and CNS E were present during the observation of surgical instrument cleaning by SPT N on 9/30/13 at 1:15 PM. CNO D, ICC M and CNS E stated the instruments should be cleaned per manufacturer's instructions and facility policy.

Example of cleaning OR:

On 9/30/13 between 2:15 PM and 2:40 PM, RN G, H R and AT S were observed cleaning OR 4 after an orthopedic surgery. RN G, H R and AT S each used one cleaning cloth soaked with the EPA approved disinfectant HB QUAT, that requires a 10 minute contact time, per manufacturer's instructions.

RN G wiped down the foot pedal controls for equipment then proceeded to clean the "tower" containing electronic equipment. H R wiped down an arm board, that was on a mayo stand (instrument table), placed it on a cart that had not been cleaned, contaminating the arm board. RN G did not change out cleaning cloths when moving from bottom to the top of another piece of equipment.

H R wiped down the mayo stand and placed the contaminated arm board on the stand. H R wiped down one side of a pillow, turned it over on the table it was on, contaminating the clean side of the pillow and wiped down the other side. H R picked up an IV irrigation bag off a cart, wiped down the cart and replaced the IV irrigation bag, recontaminating the cart.

AT S wiped down the anesthesia cart, and began setting up the anesthesia equipment for the next surgical case, without waiting a full 10 minutes for QUAT contact time.

On 9/30/13 at 2:40 PM, CNO D was informed of the above observations and stated equipment should be cleaned from top to bottom, clean items should not be placed on dirty items and the equipment must have a 10 minute contact time before setting up for the next procedure.


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Examples in the ED:

During a tour of the ED on 10/01/13 at 9:12 AM with ED manager W the following was observed; The linen cabinet in the ambulance bay which was filled with clean linen was open. The linen was unprotected from dust and dirt in the atmosphere.


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Examples in OB/Nursery:

During a tour of Women's Health Services/OB/Nursery/NICU accompanied by Nursing Unit Manager C and Staff Nurse/Educator B on 9/30/2013 at 10:30 AM noted labor/exercise ball on the floor in the labor room. Nursing Unit Manager C verbalized at the time of discovery it was a clean item and should be kept off the floor.

Examples in the GI Lab:

During a tour of the GI Lab accompanied by CNS E and CNO/Surgery D on 9/30/2013 at 12:40 PM noted scrapes and holes on the walls in Procedure Room C making these surfaces non cleanable. CNO/Surgery D verbalized agreement with the findings at the time of discovery.

Examples at the Plymouth Surgery Center:

During a tour of the Aurora Surgery Center in Plymouth accompanied by CNO/Surgery D and Supervisor I on 10/1/2013 at 7:38 AM noted scrapes and holes on the walls in OR 1 and chipped and missing tiles inside the OR corridor doors making these surfaces non cleanable. CNO/Surgery D verbalized agreement with the findings at the time of discovery.

Examples at the Vince Lombardi Cancer Clinic:

During a tour of the Vince Lombardi Cancer Clinic in Sheboygan on 10/1/2013 9:15 AM accompanied by Risk Manager J, Clinic Supervisor U and Clinic Manager K noted the Emergency Cart covered in thick dust. Clinic Manger K acknowledged need to have the cart cleaned at the time of discovery.

On 10/1/2013 at 9:27 AM observed RN L palpate Pt # 32's skin with bare hands and then proceed to put on gloves without performing hand hygiene. RN L then inserted a needle to access Pt # 32's Port A Cath (a device implanted under the skin to allow intermittent venous access). After accessing the Port A Cath RN L removed gloves and discarded trash then preceded to the nursing station without performing hand hygiene. Clinic Manager K acknowledged at the time of the observation, RN L should have preformed hand hygiene before donning gloves and after removing gloves

During a tour of the Vince Lombardi Cancer Clinic in Sheboygan on 10/1/2013 at 9:15 AM accompanied by Risk Manager J, Clinic Supervisor U and Clinic Manager K noted cardboard between the seat and the legs of the lab chair making this a non cleanable surface. Clinic Manager K stated the cardboard was used to prevent the chair from squeaking. Risk Manager J asked staff verbalized the cardboard should not be used and asked staff to remove the cardboard at the time of discovery.

Examples in the Kitchen:

The 2009 Wisconsin Food Code states under 4-601.1 that:" nonfood-contact surfaces of equipment shall be kept free of an accumulation of dust, dirt, food residue and other debris. "

Per review on 10/1/13 in the AM, the "Master Monthly Cleaning List", included the "cooks area" staff are to "wipe down fronts of all ovens".

During a tour of the kitchen on 10/01/13 at 11:00 AM with Dietary Manager V it was observed that the door handles for the ovens were covered with grease and dirt.

These observations were confirmed by staff V at the time of the kitchen tour. V stated that they would be cleaned immediately.

Hospital policy entitled; "Food Safety and Qualit

Based on observation, MR review, P&P review, review of manufacturer's instructions, AORN Standards of Practice and interview with staff (D, E, G), in 1 of 1 observation of staff performing skin prep for surgery (G) the facility failed to ensure the alcohol based skin prep is dry prior to draping to prevent potential fire hazard and burns to Pt. And in 4 of 6 staff observed (B, F, G, LL) the facility failed to ensure staff followed the surgical attire policy This deficiency has the potential to affect all patients receiving surgery at this facility.

Findings include:

Review on 10/2/13 in the PM of facility P&P titled Skin Preparation-Intraoperatively, revised 11/12, it states under Surgical Prep Technique Recommendations 5.b. "Chloraprep must be completely dry prior to draping to minimize the risk of fire when electrocautery or lasers are used."

A review of facility policy titled PM titled "SUR-042 Surgical Attire" was conducted on 9/30/2013 at 3:45 PM. The policy states under Procedure: B. " Head and facial hair, including sideburns and neckline, should be covered when in the semi-restricted and restricted areas of the surgical suite. 1. Head gear should be clean, low lint and confine all hair. 2. Bouffant and hood style covers are preferred."

Per interview with CNO/Surg D on 9/30/2013 at 3:30 PM this facility follows AORN standards of practice. Per AORN Perioperative Standards and Recommended Practices 2013 Edition, all hair is to be covered, long sleeved jackets should be worn to cover exposed skin if not gowning.

Example of alcohol skin based preparation:

On 9/30/13 at 2:07 PM, RN G applied Chloraprep (alcohol based skin prep) to Pt #27's left breast in preparation for a mastectomy. After 30 seconds of dry time MD F began applying drapes to Pt #27's left arm, by 2:09 PM the entire surgical site was draped. There was no verbal statement the Chloraprep was dry prior to draping and the dry time of the prep was not included in the "time out" prior to incision. In interview with CNO D on 9/30/13 at 2:40 PM, CNO D stated the skin prep should be dry prior to draping. Review of Pt #27's MR on 10/1/13 at 12:45 PM revealed the Intra-operative record includes box checked next to the statement "Verified alcohol based prep dry before draping." This is confirmed in interview with CNS E on 10/1/13 at 12:45 PM, adding the box should be checked only if the prep was dry prior to draping.


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Examples of surgical attire:

On 9/30/2013 at 1:40 PM noted CRNA LL wearing a hair bonnet which left the hair on the back of the head uncovered in OR 1. Supervisor of Surgical Services G acknowledged all hair was not restrained at the time of discovery.

On 9/30/2013 at 1:40 PM noted General Surgeon F, Supervisor of Surgical Services G, CRNA LL and CNO/Surgery D in OR 1 while sterile fields were being prepared without long sleeve surgical attire. Per interview with CNO/Surgical services D at 3:30 PM the policy does not address the need to wear long sleeves in the OR.