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A. Based on Medical Staff Bylaws, Rapid Response Team policy, Sentinel Events policy, clinical record review and staff interview, it was determined that for 1 of 11 clinical records reviewed (Pt. #1), the Governing Body failed to ensure the Medical Staff took action i.e. root cause analysis/sentinel event when variation in medical staff performance was identified in peer review activities.

Findings include:

1. On 12/8/11 at approximately 9:30 AM, the Medial Staff Bylaws (Approval date 2005 were reviewed. The Bylaws included," The Medical Staff Performance Improvement Committee shall... B... analyze and review results of Medical Staff monitoring activities and make recommendations concerning the overall performance of the Medical Staff and processes that affect their outcomes pt performance. These reports include but are not limited to:departmental peer review activities, sentinel events review (as relative to the clinical performance of Members)..."

2. On 12/8/11 at approximately 9:45 AM, facility policy #05 titled,"Rapid Response" (effective 8/21/05) was reviewed. The policy included,"The rapid response team consist of a Nurse with current critical care or emergency room experience and a Respiratory Therapist...calling criteria acute changes in heart rate less than 40 or greater than 130...SPO2 less than 87%, respiratory rate less than 8 or greater than 28 or respiratory distress, sudden fall in level of consciousness... the team will assess the patient,communicate with the patient's primary care physician, assist in stabilizing the patient based on physician orders, educate and support the unit clinician, assist with transfer."

3. On 12/08/11 at approximately 10:00 AM, the "Sentinel Events" policy (effective 3/2/06) was reviewed. The policy included,"IV. Definitions: A: Sentinel Event: An unexpected occurrence involving death... E. Root Cause Analysis: A process for identifying the basic factors that may trigger variation in the performance of tasks... V. Guidelines... F... Root Cause Analysis (RCA) is performed on all sentinel events and those "near misses" which have potential for reoccurrence and/or adverse outcome..."

4. On 12/8/11 at approximately 11:00 AM, the clinical record for Pt. #1 was reviewed. Pt. #1, a 75 year old female, presented to the emergency department on 11/18/08 at approximately 9:29 PM with complaints of abdominal pain. Pt. #1 was admitted to a medical surgical unit (E3) on 11/18/08 with diagnoses of Right Upper Quadrant Abdominal Pain/ Biliary Colic.

On 11/19/08 at 11:14 PM, Pt. #1 required assistance from the Rapid Response Team. The Rapid Response Record contained documentation that on 11/19/08 at 11:17 PM, the team arrived because Pt. #1 had an episode of decreased mentation for which Narcan (sedation reversal agent) was administered. Pt. #1's vital signs were: BP 106/62, heart rate 144 respiratory rate of 36 and no recorded SPO2. The primary care physician (E#1) was contacted by the Rapid Response Nurse (E#8).The primary care physician ordered Digoxin 0.5 mgs IV (administered at 12:15 AM on 12/20/08), a chest x-ray,blood work and increased IV fluids. The Team was onsite with Pt. #1 for 23 minutes without stabilization of the Pt's condition or plans to transfer Pt. #1 to a higher level of care. Vital signs documented prior to the Response Team leaving Pt. #1 at 11:40 PM, were outside the acceptable range not requiring rapid response team intervention (BP 117/66, heart rate 142, respiratory rate 30 and no recorded SPO2). The team documented,"Pt. remains lethargic, BP somewhat improved. Dr. awaiting results of chest Xray and blood work and will make further treatment decisions."

A Code Blue (initiated for respiratory arrest, cardiac arrest or other life threatening situation according to policy) was called 42 minutes later (12:22 AM). Pt. #1 required intubation. Pt. #1's heart rate as documented on the Code Blue Record was between 143 and 146. At approximately 12:38 AM on 11/20/08, Pt. # required emergency transfer to the intensive care unit.

Forty eight (48) minutes later (1:10 AM) while Pt. #1 was in ICU, another code was called and CPR was initiated due to asystole (no heart rate) resuscitative measures were unsuccessful resulting in brain anoxia. Pt. #1 was pronounced dead on 11/20/08 at 2:10 PM approximately one day and 16 hrs after admission.

5. On 12/08/11 at approximately 12:00 PM, the Director of Claims Risk Management and VP of Quality, with the hospital's attorney in attendance, were asked if the medical record for Pt. #1 was evaluated as a sentinel event. The VP stated that a sentinel event review was not needed per policy and only a peer review was conducted.

6. A peer review document regarding E #1's performance related to Pt. #1 dated 12/5/08, included, "Variation is questionable and unexpected, marginal deviation from standards. This can also include variation in process measures transfusions, infection rates, medication use, efficiency in practice patterns."

7. During the interview with the Director of Claims Risk Management and VP of Quality, the Hospital representatives failed to share any specifics on potential quality of care breaches regarding Pt. #1 or an explanation of "marginal deviations". The VP of Quality stated that Digoxin should not have been given to Pt. #1.

8. The VP of quality stated that the case was in litigation. The Surveyor made two requests for minutes from the Medical Staff Performance Improvement Committee or any Quality Minutes that would ensure a complete hospital investigation was conducted in accordance with facility policy and Medical Staff Rules and Regulations to include a summary of events and identification of opportunities for improvement. The Minutes were not available for review.

9. The above findings were discussed with the Administrative staff during the exit interview on 12/08/11 at approximately 2:00 PM.

A. Based on Hospital's policy, clinical record review, and staff interview, it was determined that for 3 of 3 patients (Pt#s 1, 2, and 3) who required Patient Controlled Analgesia (PCA) the hospital failed to ensure a nursing patient assessments were conducted which could potentially place 203 patients on census at risk.

Findings include:

1. On 12/08/11 at approximately 9:30 AM, the Hospital's policy titled, Patient Controlled Analgesia (PCA): Assessment/Maintenance of Patient on PCA" (last reviewed April 2008), was reviewed and required, "Assess and document the patient's respiratory rate, level of sedation, and pain score along with attempts (Denied Doses) and injections (Completed Doses) every hour x 4 hours, then a minimum of every 4 hours".

2. On 12/8/08 at approximately 10:00 AM, the clinical record of Pt#2 was reviewed. Pt#2 was a 63 year old male admitted on 12/3/11 with a diagnosis of Left Acetabular Fracture. The clinical record contained a physician's order dated 12/5/11 at 8:37AM for," Dilaudid PCA dose 0.2mgs, delay 10 minutes, loading dose as needed 1mgs x 1." The medication was initiated on 12/3/11 at 9:45AM. Vital signs documented at 10:45AM, 12:45PM and 4:30PM failed to include a pain assessment as required by policy.

3. On 12/8/11 at approximately 10:30 AM, the clinical record of Pt#3 was reviewed. Pt#3 was a 50 year old male admitted on 11/23/11 with a diagnosis of Possible Aspiration Pneumonia. The clinical record contained a physician's order dated 12/2/11 at 2:45PM for,"Dilaudid PCA pump 0.2mgs every fifteen minutes as needed. No basilar rate. No loading dose." The medication was initiated on 12/2/11 at 2:46PM. The clinical record lacked a documented respiratory rate at 5:00PM . Vital signs documented at 7:20PM and 9:30PM failed to include a pain assessment as required per policy .

4. On 12/8/11 at approximately 11:00AM, the clinical record for Pt. #1 was reviewed. Pt. #1, a 75 year old female, was admitted to a medical surgical unit on 11/18/08 with a diagnoses of Right Upper Quadrant Abdominal Pain/ Biliary Colic. The clinical record contained a physician's order, dated 11/19/08, to "Initiate PCA Therapy Via Pump "with a dose of Dilaudid 0.5mg and continuous rate of 0.5mgs for 24 hrs with a delay interval every 20 minutes. The medication was initiated on 11/19/08 at 12:30PM without documentation of the Pt.'s sedation level. Pt. #1's pain score was not assessed or documented on 11/19/08 at 2:30PM (2hrs after initiation of the medication) as required by policy.

5. On 12/8/11 at approximately 1:00 PM the above findings were verified with the Vice President of Nursing Services (VPNS).

B. Based on facility stated policy, personnel file review and staff interview, it was determined that the hospital failed to ensure, for 4 of 6 RN personnel files reviewed ( E#s 1, 2, 3 and 4), staff competency for use of PCA (Patient Controlled Analgesia) medication administration pumps potentially placing 203 patients on census at risk.

Findings include:

1. On 12/8/11 at approximately 10:00 AM, the Vice President of Nursing Services (VPNS) was interviewed. The VPNS stated that it is facility stated policy to have staff PCA competency upon hire.

2. On 12/08/11 at approximately 11:00AM, personal files were reviewed.

* E#1 was hired on 3/5/08 (no longer employed). The file lacked staff PCA competency.
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* E#2 was hired 6/2007 (no longer employed). The file lacked staff PCA competency.

* E#3 was hired 3/13/08 (active employee). The file lacked staff PCA competency.

*E#4 was hired 1/3/06 (active employee). The file lacked staff PCA competency.

3. On 12/8/11 at approximately 12:30PM, the Vice President of Nursing Services (VPNS)was interviewed. The Vice President stated that nurses (E#s 1-4) received PCA competency during orientation however, the general orientation skills check list did not specifically indicate PCA training although competency was completed..

4. The above findings were confirmed with the VPNS during an interview on 12/08/11 at approximately 1:00PM and discussed with Administrative staff during the exit interview on 12/08/11 at approximately 2:00PM.

A. Based on clinical record review and staff interview, it was determined that for 1 of 3 patients (Pt. #1) who required measurement of nasogastric drainage, the hospital failed to ensure staff document nasogastric drainage (output) as ordered by the physician.

Findings include:

1. On 12/08/11 at approximately 1:00PM the clinical record for Pt. #1 was reviewed. Pt. #1, a 75 year old female, was admitted to a medical surgical unit on 11/18/08 with diagnoses of Right Upper Quadrant Abdominal Pain/ Biliary Colic. The clinical record contained a physician's order, dated 11/19/08 at 1:15 AM, to measure and record Pt. #1's intake and output. Upon review of the "graphic record" and "medical surgical flow sheet" dated 11/19/08, there was inconsistent intake/output documentation.

Examples:

* The "graphic record" documentation for the nasogastric drainage output for a 16 hr period on 11/19/08 (10PM to 6AM and 6AM to 2:00PM) was recorded as 500ccs. The "medical surgical flowsheet" documentation for the same date and time period contained the nasogastric drainage as 1200cc ( a 700cc difference).

2. The Vice President of Nursing Services (VPNS) was interviewed on 12/08/11 at approximately 1:00PM. The VPNS verified the above findings.

B. Based on clinical record review and staff interview, it was determined that for 1 of 3 patients (Pt. #1) who required Patient Controlled Analgesia (PCA), the hospital failed to ensure accurate documentation of medication administration.

Findings include:

1.On 12/8/11 at approximately 11:00AM, the clinical record for Pt. #1 was reviewed. Pt. #1, a 75 year old female, was admitted to a medical surgical unit on 11/18/08 with diagnoses of Right Upper Quadrant Abdominal Pain/ Biliary Colic. The clinical record contained a physician's order, dated 11/19/08, to initiate PCA Therapy via pump with a dose of Dilaudid 0.5mg and a continuous rate of 0.5mgs for 24 hrs with a delay interval every 20 minutes. The medication was initiated on 11/19/08 at 12:30PM. Documentation dated 11/19/08 from the minute by minute digital print out from the PCA pump was compared to the PCA pain flowsheet. According to documentation obtained from the digital print out, Pt. #1 received a total of 8.125mgs.of Dilaudid over an 8hr and 21 minute period. The PCA flowsheet "lockout" column was recorded in milligrams instead of time at 12:30PM (8mgs) and 2:30PM(8mgs). The number of completed doses self administered was listed as four (4) at 2:30PM and seven (7) doses at 7:30PM. This did not correspond with the digital print which listed a total of 3 self administered doses. A critical care nurse reviewed the PCA pain flowsheet at the surveyor's request on 12/8/11 at approximately10:30AM. The nurse calculated the total amount Pt. #1 received from 12:30PM until 8:00PM on 11/19/08 as 9.5mgs. This was a difference of 1.375mgs as compared to the digital printout.

2. The medication dose comparisons were verified with the Vice President of Quality on 12/8/11 at approximately 11:30AM and stated that the medication was administered in accordance with the physician's order.

C. Based on clinical record, "Affiliation Agreement", "Clinical Expectations" document review, and staff interview, it was determined that for 1 of 11 records reviewed (Pt. #1), the hospital failed to ensure contracted Nursing Faculty co-sign all student nurse (E#4) entries in the medical record.

Findings include:

1. On 12/8/11 at approximately 11:00AM, the clinical record for Pt. #1 was reviewed. Pt. #1, a 75 year old female, was admitted to a medical surgical unit on 11/18/08 with diagnoses of Right Upper Quadrant Abdominal Pain/ Biliary Colic. The clinical record contained Pt.#1 assessments by a student nurse (E#4) dated 11/19/08 at 7:30AM, 8:00AM, 8:40AM, 9:45AM, and 12:00PM without a co-signature from Nursing Faculty.

2. On 12/08/11 at approximately 1:30PM, an "Affiliate Agreement" between the hospital and a college dated 8/2005 was reviewed. The Agreement included, "The Facility and College agree that the Facility will provide educational experience to College Students. Students shall work with Facility employees and College Faculty who are directing the program in the department(s) and/ or unit(s) assigned by Facility. Students shall work under the direction of the Faculty and may be present in the Department only at such times when supervising Faculty is present..."

3. On 12/08/11 at approximately 1:40 PM a document titled,"Northwest Illinois Health Care Collaborative Clinical Coordination Affiliated Schools 2011-2012 Clinical Expectations" was reviewed. The document included," The Faculty will be expected to:...review and/or co-sign all student entries in the medical record for completion of documentation for each student prior to leaving the floor."

4. On 12/08/11 at approximately 1:45PM the Vice President of Nursing (VPNS) was interviewed. The VPNS stated that all entires made by a student nurse needs a co-signature from the clinical instructor. The above findings were verified by the VPNS at approximately 2:00PM and discussed with Administrative staff during the exit interview on 12/08/11 at approximately 2:00PM.