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A. Based on observation and staff interview, it was determined the Hospital failed to ensure Emergency Department (ED) patients were not left unattended and or without the ability to call for assistance. This has the potential to effect all ED patients who receive radiology services.

Findings include:

1. During a tour of the Hospital on 7/17/12 at 11:00 am with the Director of the ED and the Director of the Radiology Department, it was determined that ED patients were left unattended, in the hallway, outside the Computed Tomography (CT) room next to the ED. There was no call light system observed for the ED patients to call for assistance if needed and there were no nursing stations within line of site where ED patients were awaiting radiological services.

2. During an interview with the Director of Radiology on 7/17/12 at 11:00, it was confirmed that it has been past practice, by Hospital staff, to leave ED patients, unattended, with no call light system, or ability to call for assistance outside the CT room.

A. Based on a review of the Hospital's Quality Assessment Performance Improvement (QAPI) and staff interview, it was determined the Hospital failed to ensure it analyzed the information it gathered to be able to implement preventive actions. This has the potential to effect all patients who receive Hospital services.

Findings include:

1. The Hospital's QAPI program was reviewed on 7/18/12. Documentation titled, "CFH Medication Events by Type 4th Quarter 2011" was reviewed. It indicated 17 medication errors were identified as being related to "Order Related Issue".

2. During an interview with the QAPI committee on 7/18/12 at 2:20 PM, they were asked what caused the medication errors related to ordering issues. It was verbalized the Committee had not analyzed the causes of these errors, or implemented any corrective actions.

A. Based on medical record review and staff interview, it was determined that in 1 of 1 (Pt #12) medical records reviewed in the CardioVascular Intensive Care Unit (CVICU), the Hospital failed to ensure the orders of the Registered Dietitian were followed.

Findings include:

1. The medical record of Pt #12 was reviewed on 7/17/12. It indicated Pt #12 was admitted to the Hospital with a diagnosis of Chronic Obstructive Pulmonary Disease with acute exacerbation. The Dietary Recommended Progression for Feedings indicated that Pt #12's feeding tube was to be flushed with 30cc of water every 4 hours. The "Intake" flowsheet indicated that on 7/15/12, the feeding tube was flushed with 50cc of water on 4 occasions.

2. During an interview with the Director of the CVICU, conducted on 7/17/12 at 2:15 PM, it was verbalized that staff should have been flushing the feeding tube with 30cc of water per the Registered Dietitian assessment.

B. Based on medical record review and staff interview, it was determined in 1 of 30 (Pt #26) medical records reviewed, the Hospital failed to ensure care was provided in accordance with physician orders.

Findings include:

1. The medical record of Pt #26 was reviewed on 7/18/12. It indicated Pt #26 was born on 7/13/12 and remains in the Level III nursery. On 7/13/12, there was a physician order for Noninvasive Mechanical Ventilations to be at "Rate- 40, PIP- 20" with subsequent changes. On 7/14/12 at 7:30 AM, nursing documentation indicated the "rate found at 35." There was no order to change the rate to 35 and no documentation to indicate the physician was notified that the rate was changed. On 7/14/12 at 8:00 AM, nursing documentation indicated the Peak Inspiratory Pressure (PIP) was decreased to 17. There was no physician order for the PIP change. On 7/14/12 at 8:15 AM, Respiratory Therapy documentation indicated the Rate was corrected back to 30 after discussion with the Midlevel provider; however, there was no order for this change.

2. During a staff interview, conducted on 7/18/12 at 3:00 PM with the Neonatal Resource Nurse, it was verbalized that all changes in care were expected to be placed into writing and any care assessed and found not to be following the physician order would be expected to be reported to the physician.

A. Based on a review of Hospital policy, medical record review, and staff interview, it was determined in 1 of 2 (Pt #25) medical records reviewed, in which the patient was a Neonate receiving Total Parenteral Nutrition (TPN) and Lipid Intravenous (IV) therapy, the Hospital failed to ensure TPN and Lipid IV tubing was changed every 24 hours, as per Hospital policy.

Findings include:

1. The Hospital policy titled "Peripheral IV Therapy (Neonate)" (reviewed 5/8/12) was reviewed. It indicated "B. Infection Control: 2. For TPN and Lipids, change the tubing every 24 hours."

2. The medical record of Pt #25 was reviewed on 7/18/12. Pt #25 was born 6/15/12 and continues to be in the Level II nursery. Nursing documentation indicated Pt #25 received TPN and Lipids from 6/16/12 thru 6/23/12. There was no documentation to indicate the tubing on either solution was changed on 6/17/12, 6/19/12, or 6/21/12, as per Hospital policy.

3. During a staff interview, conducted with the Neonatal Resource Nurse on 7/18/12 at 3:00 PM, it was verbalized that all TPN and Lipid tubing is required to be changed every 24 hours.

A. Based on a review of Hospital policy, medical record review, observation, and staff interview, it was determined in 1 of 30 (Pt #16) medical records reviewed, the Hospital failed to ensure that the medical records contain all practitioners' orders.

Findings include:

1. The Hospital policy titled "Infection Prevention & Control/Patient Care Practice" revised May 2012 was reviewed on 7/18/12. Under In-Patient 2a, it indicates providers will be responsible to: order appropriate isolation precautions based on known or suspected infections, and history of infection.

2. The medical record of Pt #16 was reviewed on 7/18/12 at 12:00 pm. Pt #16 was admitted to the Hospital on 7/17/12 with uncontrolled diabetes, and end-stage renal disease. The medical record of Pt #16 indicates a past history of recurrent Clostridium Difficile Colitis (C-DIFF). The medical record of Pt #16 did not contain a written order for contact isolation due to Pt# 16 having a history of C-DIFF.

3. On 7/18/12 at 12:15 pm, it was observed that Pt #16 had an isolation cart placed outside of Pt #16's room. Pt #16 also had contact isolation signs posted on Pt #16's door.

4. During a staff interview with the Nurse Manger of R8 Medical Surgery Unit and the Registered Nurse for Pt #16, it was stated that Pt #16 was put on isolation by the Nurse because Pt# 16 had a history of C-DIFF. It was also stated that there was no isolation precaution order written by Pt #16's physician. The Registered Nurse for Pt #16 verbalized that the physician would be immediately notified that Pt #16 did not have isolation orders written.

B. Based on medical record review and staff interview, it was determined that in 1 of 1 (Pt #12) medical records reviewed in the CardioVascular Intensive Care Unit (CVICU), the Hospital failed to ensure there was a physician's order for intubating patients.

Findings include:

1. The medical record of Pt #12 was reviewed on 7/17/12. It indicated Pt #12 was admitted to the Hospital with a diagnosis of Chronic Obstructive Pulmonary Disease with acute exacerbation. A nurse's note, dated 7/13/12 indicated "Pt began shift on BiPAP" (Bilevel Positive Airway Pressure) "post extubation on day shift. Pt was very anxious, sitting up in bed intermittent desaturations in the mid 80's....ABG" (Arterial Blood Gas) "drawn per RT." (Respiratory Therapy) "Pt hypoxic, MD notified, re intubated per RT with no complications...." There was no physician's order in the medical record for Pt #12 to be intubated.

2. During an interview with the CVICU Manager, conducted on 7/17/12, it was verbalized that RT should have had a physician's order prior to intubating Pt #12.

A. Based on a review of Hospital policy, the "Hospital Medical Record Statistics Form," and staff interview, it was determined that the Hospital failed to ensure all medical records are completed within 30 days following discharge.

Findings include:

1. A review of Hospital policy, "Medical Staff Plan - Subject: Medical Record Review" revised 09/2011, was conducted on 07/18/12. The Hospital policy indicated "IV. Medical Record Review...B...define a medical record as delinquent when it is not completed within 30 days from the date of the patient's discharge.

2. The "Hospital Medical Record Statistics Form" was reviewed. Documentation on the form indicated 1172 medical records were past 30 days late following discharge as of 6/30/12.

3. During an interview with the Accreditation and Regulatory Coordinator on 07/18/12 at 2:00 PM, the above findings were confirmed.

A. Based on observation and staff interview, it was determined that the Hospital failed to ensure all medications were stored in accordance with pharmacy directions. This has the potential to effect all patients who receive pharmacy services.

Findings include:

1. During a tour of the CardioVascular Intensive Care Unit (CVICU), conducted on 7/17/12 at 2:45 PM, it was observed that a mixed piggyback Intravenous (IV) bag of Ancef was in the refrigerator. The piggyback bag had a green sticker on both sides of the bag that indicated, "DO NOT REFRIGERATE".

2. During an interview with the CVICU Manager, conducted on 7/17/12 at 2:30 PM, it was verbalized that the Ancef should not have been stored in the refrigerator.

A. Based on a review of Hospital policy, observation, and staff interview, it was determined the Hospital failed to ensure all expired medications, medical supplies, and biologicals were not available for patient use. This has the potential to effect all patients.

Findings include:

1. The Hospital policy "Medication Management/Preparing & Dispensing" revised 4/19/12, was reviewed on 7/19/12. Under Statement of Policy C. "Upon initial access, the vial will be labeled with the initials of the staff member and the beyond use date of twenty-eight days or as determined...."

2. The Hospital policy "Proper Handling, Storage, Use, and Disposition of Supplies" revised 4/12, was reviewed on 7/18/12. The policy indicates department staff will be responsible to check monthly for outdated or damaged supplies and discard them when necessary.

3. During a tour of the Surgical Intensive Care Unit on 7/17/12 at 1:00 PM the following multi dose vials were observed to be opened with no date of opening or beyond use date: 2 Tuberculin 5ml vials.
During a tour of the T7 Surgical Unit on 7/18/12 at 3:30 PM the following multi dose vial was observed to be opened with no date of opening or beyond use date: 1 Tuberculin 5ml vial.
During a tour of the Emergency Department on 7/17/12 at 11:00 AM, One Opticath catheter was observed in the ED supply pyxis with an expiration date of 1/1/11.
During a tour of the Nuclear Medicine Department on 7/17/12 at 1:00 PM, One 50 ml bottle of Ethyl Acetate Anhydrous expired in 2011 was observed.
During a tour of the Neonatal Intensive Care Unit on 07/17/12 at 1:00 PM, the following were observed: on the procedure cart one #18 gauge Angiocath expired 3/12, and on the Hemorrhage Cart 2 light purple top Vacutainer tubes expired 6/12.

4. During an interview conducted on 7/17/12 at 11:15 AM with the ED Manager, it was stated that the pharmacy was responsible for ensuring out dated supplies were removed from the supply pyxis and it should have been removed from the patient care area.

5. During an interview conducted on 7/17/12 at 1:30 PM with the Radiology Manager, it was stated that expired biologicals should have been removed from the Nuclear Medicine Department.

6. During an interview conducted on 7/17/12 at 2:30 PM with the Director of Nursing, it was reported that any opened multi dose vial requires date of opening and a use by date.

A. Based on a review of Hospital policy, observation, and staff interview, it was determined the Hospital failed to ensure First In/First Out (FIFO) for the rotation of stock was implemented. This has the potential to effect all patients who receive dietary services.

Findings include:

1. The Hospital policy titled, "Storage of Food, Non-food Products, and Cleaning Supplies" with a revision date of July 2010, was reviewed. It indicated under "Procedure 1. Food a. Dry Foods /Storage... Food stocks are rotated as stock is received in first in/first out (FIFO) and top down procedures....b. Perishable Foods Storage... All perishable foods are rotated in the FIFO and top down approved procedures."

2. During a tour of the dietary department, conducted on 7/17/12 at 10:45 AM, it was observed in the dry stock room that none of the shelved items were dated or otherwise marked so as to ensure that FIFO was being employed. Also, in the walk in cooler where cheese was stored, there were approximately 18 unopened packages of sliced white cheese. There were no dates or other markings to assist in the rotation of stock to ensure FIFO was being utilized.

3. During an interview with the Dietary Manager, conducted on 7/17/12 at 11:00 AM, it was verbalized that the FIFO system is used by the dietary department but that items are not dated because everything in stock is used up in 2 to 5 days.

B. Based on a review of Hospital policy, observation, and staff interview, it was determined the Hospital failed to ensure temperature logs were maintained for all refrigerators. This has the potential to effect all patients who receive dietary services.

Findings include:

1. The Hospital policy titled, "Storage of Food, Non-Food Products, and Cleaning Supplies" with a revision date of Jul 2010, was reviewed. It indicated under "Procedure 1. Food b. Perishable Foods Storage. Temperature records are maintained for refrigeration and freezer units to ensure the units are properly functioning and recommended temperature ranges are maintained..."

2. During a tour of the Dietary Department, conducted on 7/17/23 at 10:00 AM, it was observed that the serving line dessert cooler was filled with plates of desserts including pies and cakes. There was no temperature log to indicate if appropriate temperatures were maintained.

3. During an interview with the Dietary Manager, conducted on 7/17/12 at 10:20 AM, it was verbalized that there is an internal thermometer in the dessert cooler but no log is kept to ensure the proper temperatures are maintained.

C. Based on a review of the disinfectant test strip instructions and staff interview, it was determined that the Hospital failed to ensure test strips were used according to manufacturer's instructions to ensure proper dilution of disinfectant in the 3 compartment pan sink. This has the potential to effect all patients who receive dietary services.

Findings include:

1. The instructions for the disinfectant test strips used to ensure proper dilution of the disinfectant, in the dietary department at the 3 compartment sink, were reviewed. It indicated under, "NOTE: Sample must be at room temperature (above 75F)." There was no documentation to indicate the disinfectant solution was tested at room temperature to ensure accurate test results.

2. During an interview with the Dietary Manager, conducted on 7/17/12 at 10:10 AM, it was verbalized that they do not check the temperature of the water prior to using the test strips to ensure the ratio of disinfectant to the amount of water in the 3 compartment tub sink.

D. Based on a review of Hospital policy, observation, and staff interview, it was determined that the Hospital failed to ensure all opened/prepared food items were properly wrapped and labeled. This has the potential to effect all patients who receive dietary services.


Findings include:

1. The Hospital policy and procedure titled, "Storage of Food, Non-Food Products, and Cleaning Supplies" was reviewed on 7/17/12. It indicated under "Procedure... b. Perishable Foods Storage... Leftover foods are labeled with the product name, dated, timed, and covered with an approved lid....All opened perishable foods are labeled and dated...."

2. During a tour of the Dietary Department, conducted on 7/17/12, it was observed that in 3 of the dietary coolers, perishable foods, including but not limited to diced celery, diced onion, french fries, and prepared salad dishes either were not covered completely with plastic wrap and/or dated.

3. During an interview with the Dietary Manager, conducted on 7/17/12 at 10:20 AM, it was verbalized the foods in the coolers should have been completely covered with the plastic wrap and dated.

A. Based on observation, review of manufacturer's insert for cleansing agents, and staff interview, it was determined that the Facility failed to ensure appropriate disinfection of patient equipment to prevent the spread of infection. This has the potential to effect 100% of all patients who receive Hospital services.

Findings include:

1. During a tour of the orthopedic unit, conducted on 07/18/12 at 2:00 pm, an isolation cart was noted outside Pt. # 21's room. Pt. #21 was hospitalized with a diagnosis of colitis and C. difficile infection.

2. During an interview on 7/18/12 at 3:00 PM, the Nurse Manager of Orthopedics verbalized that the Oxivir-TB wipes were used to cleanse the isolation cart for the C-difficile patient.

3. The manufacturer's insert for Oxivir-TB wipes indicated the germicide was useful in destroying the tuberculin virus, but not effective in killing C-difficile.

A. Based on a review of Hospital policy, medical record review, and staff interview, it was determined in 1 of 1 (Pt #11) medical record reviewed for fire risk assessment (FRA) that a FRA was not documented as per Hospital policy, and that 6 of 6 surgical services staff interviewed on 7/18/12 were unfamiliar or could not identify how to perform a FRA prior to the surgical procedure as per Hospital policy. This has the potential to effect an average of 2420 surgical patients per month.

Findings include:

1. The Hospital policy titled, "Fire Safety" with an approval date of Jul 2011, was reviewed on 7/18/12. It indicated under "Policy It is the policy of Carle Foundation Hospital that: 1. All perioperative team members are responsible for preventing fires. 2. All perioperative team members are responsible for participating in department fire safety training ANNUALLY....6. A risk assessment will be performed before each surgical or other invasive procedure in which all three (3) of the parts of the fire triangle (ie, fuel, ignition source, oxidizer) come together...Procedure Interventions...Performing a fire risk assessment: 1. The RN circulator will report fire risk assessment as a, b, c, d, or e or any combination of the letters before the procedure begins. The designation a, b, c, d, e is determined by the code assigned to each of the critical questions in bold below having an affirmative response. The procedure may be any one letter or any combination of the letters...." Under "Documentation 1. Fire risk assessment score. 2. Time fire risk assessment was performed." The policy indicated under "Competency All personnel will receive education, training, and competency validation on fire prevention, including but not limited to the following:...2. Performing and documenting the perioperative fire risk assessment..."

2. The medical record of Pt #11 was reviewed on 7/18/12. It indicated Pt #11 was admitted on 7/18/12 with the diagnosis of Cervical Spondylosis with myelopathy, and had a surgical procedure done above the xiphoid process. There was no documentation in the medical record to indicate a FRA was performed, which is to include what the FRA score was and what time the FRA was performed as per Hospital policy.

3. The following OR personnel were interviewed with the Director of Nursing and the Vice President of Hospital Operations present:

Certified Respiratory Nurse Anethetist (CRNA) #1 was interviewed on 7/18/12 at 12:45 PM. During the interview it was stated that CRNA #1 has been working in the Hospital's surgery department for 11 years. CRNA #1 stated that she had not received any training related to preventing fires in the Operating Room (OR) for more than 1 year. CRNA #1 verbalized that she did not know of any Hospital policy and procedure or guidelines that would prevent or reduce the risk of an OR fire. When asked if CRNA #1 knew what a fire risk of a, b, c, d, or e meant, CRNA #1 stated she did not know. When asked if a Fire Risk Assessment (FRA) was announced during the surgical time out, CRNA #1 verbalized that she did not know of any FRA being announced in any surgical time outs when she was present.

CRNA #2 was interviewed on 7/18/12 at 1:00 PM. During the interview it was stated that CRNA #2 has been working in the Hospital's surgery department for 33 years. CRNA #2 stated that he had not received any training related to preventing fires in the OR for more than 1 year. CRNA #2 verbalized that he did not know of any Hospital policy and procedure or guidelines that would prevent or reduce the risk of an OR fire. When asked if CRNA #2 knew what a fire risk of a, b, c, d, or e meant, CRNA #2 stated he did not know. When asked if a FRA was announced during the surgical time out, CRNA #2 verbalized that he did not know of any FRA being announced in any surgical time outs when he was present.

Registered Nurse (RN) #1, a surgical circulator was interviewed on 7/18/12 at 1:05 PM. During the interview it was stated that RN #1 has been working in the Hospital's surgery department for 11 years. RN #1 stated that he had not received any training related to preventing fires in the OR for more than 1 year. RN #1 verbalized that he did not know of any Hospital policy and procedure or guidelines that would prevent or reduce the risk of an OR fire. When asked if RN #1 knew what a fire risk of a, b, c, d, or e meant, RN #1stated he did not know. When asked if a FRA was announced during the surgical time out, RN #1 verbalized that he did not know of any FRA being announced in any surgical time outs when he was present.

RN #2, a surgical circulator, was interviewed on 7/18/12 at 1:15 PM. During the interview it was stated that RN #2 has been working in the Hospital's surgery department for "30 plus years". RN #2 stated that she had not received any training related to preventing fires in the OR for more than 1 year. RN #2 verbalized that she did not know of any Hospital policy and procedure or guidelines that would prevent or reduce the risk of an OR fire. When asked if RN #2 knew what a fire risk of a, b, c, d, or e meant, RN #2 stated she did not know. When asked if a FRA was announced during the surgical time out, RN #2 verbalized that she did not know of any FRA being announced in any surgical time outs when she was present.

Surgical Tech #1 was interviewed on 7/18/12 at 1:25 PM. During the interview it was stated that Surgical Tech #1 has been working in the Hospital's surgery department for 2 years. Surgical Tech #1 stated that she had not received any training related to preventing fires in the OR for more than 1 year. Surgical Tech #1 verbalized that she did not know of any Hospital policy and procedure or guidelines that would prevent or reduce the risk of an OR fire. When asked if Surgical Tech #1 knew what a fire risk of a, b, c, d, or e meant, Surgical Tech #1 stated she did not know. When asked if a FRA was announced during the surgical time out, Surgical Tech #1 verbalized that she did not know of any FRA being announced in any surgical time outs when she was present.

Surgical Tech #2 was interviewed on 7/18/12 at 1:30 PM. During the interview it was stated that Surgical Tech #2 has been working in the Hospital's surgery department for 9 years. Surgical Tech #2 stated that she had not received any training related to preventing fires in the OR for more than 1 year. Surgical Tech #2 verbalized that she did not know of any Hospital policy and procedure or guidelines that would prevent or reduce the risk of an OR fire. When asked if Surgical Tech #2 knew what a fire risk of a, b, c, d, or e meant, Surgical Tech #2 stated she did not know. When asked if a FRA was announced during the surgical time out, Surgical Tech #2 verbalized that she did not know of any FRA being announced in any surgical time outs when she was present.