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29618

Based on observation, interview and record review, the hospital failed to follow policy and procedure on medication labeling. This failure had the potential to create a patient medication error.

Findings:

During an observation on 12/10/12, at 10:35 AM, in Operating Room (OR) 3, Registered Nurse (RN) 2 was setting up for a surgical procedure, and there was no patient present. RN 2 had three vials of 0.25% Bupivacane with epinephrine (indicated for local anesthesia including infiltration). It is commonly injected to surgical wound sites to reduce pain for up to 20 hours after the surgery. Sometimes it is co-administered with epinephrine to prolong the duration of its action.)1:200,000; one (1) vial of Kenalog 40 mg (synthetic glucocorticoid corticosteroid with anti-inflammatory action).; and one (1) vial of Clonidine HCL 100 mcg (used to treat high blood pressure, anxiety/panic disorder, and certain pain conditions). RN 2 drew all the medications up into one unlabeled 60 milliliter (ml) syringe, placed it on the counter and walked out of OR 3.

During an interview with RN 1, on 12/10/12, at 10:40 AM, she stated, "She (RN 2) should have labeled the syringe when the medication was drawn up."

The hospital policy and procedure titled "MEDICATION AND SOLUTION LABELING ON AND OFF STERILE FIELD" dated 9/26/12, indicated at Policy- B. "Labeling must occur when any medication or solution is transferred from the original packaging to another container." D. "Label will include: 1. name of the medication/solution, 2. strength of the medication/solution..."

The Association of periOperative Registered Nurses (AORN), Standards and Recommended Practices, 2012, Recommendation VIII, indicated at VIII.f. "Unless the medication is to be administered immediately, all medications removed from the original package and transferred to a secondary container should be clearly marked and easily identifiable. At a minimum, the secondary container should be labeled with the medication and dose in accordance with the health care organization's policy. Medications that are removed from the original package and not labeled cannot be verified before administration, increasing the risk for administering the wrong medication."

Based on observation, interview and record review, the hospital failed to provide an environment to avoid sources and transmission of infections and communicable disease as evidenced by the hospital's failure to have effective systems in place to ensure:

1. Ensure positive air pressure (air flow out of room instead of in to keep any airborne organisms away) in two of the catheterization laboratory rooms were maintained while sterile procedures were in progress. (A 747 No: 1)

2. The hospital infection control nurses were not aware positive air pressure in the catheterization laboratory rooms shall be maintained constantly while procedures were in progress. (A749 No: 1)

3. Follow its policies and procedures to maintain required temperature and humidity ranges in multiple areas where procedures were being performed. (A 749 No: 2)

4. Ensure its policies and procedures were followed to maintain required temperature and humidity ranges in multiple areas where procedures were being performed. (A 749 No: 2)

5. Ensure single use contaminated surgical attire was disposed of before leaving the procedural room. (A 749 No: 3)

The cumulative effects of these systemic failures resulted in the hospital's inability to ensure a sanitary environment placing patients at risk of being exposed to infectious and communicable diseases.

Based on observation, interview, and record review, the hospital failed to ensure positive air pressure in two of the catheterization laboratory rooms (Cath Lab 1 and 2, catheterization laboratory is a room equipped with diagnostic imaging equipment used to support catheterization procedures) were maintained while sterile procedures were in progress. The hospital also failed to have a policy in place to maintain minimum of 15 air exchange rates per hour as recommended by AORN (Association of periOperative Registered Nurses, a national association provides education and practice support to nurses in achieving optimal outcome in the operating room) in its Cath Lab 1 and 2. These failures had placed patients at risk of contracting airborne infectious contaminants.

AORN recommended: "Doors to the operating or procedure rooms should be closed except during movement of patients, personnel, supplies, and equipment. The air pressure within each operating or procedure room should be greater than in the semi-restricted area (an area where only authorized staff and patients are allowed)... Leaving the door open can disrupt pressurization and cause turbulent airflow that could increase airborne contamination. Traffic in and out of the Operating Room should be minimized by preplanning so that turbulence from this activity is minimized during the procedure or when sterile supplies are open."

AORN ' s Recommendation V read: " The minimum rate of total air exchanges per hour should be maintained at a constant level as ...Cardiac Catheterization rooms: 15 air exchanges per hour ... " and " Air exchange per hour should be monitored per the organization ' s policy. "

Findings:

1. On 12/12/12, at 10:38 AM, the hospital's Cath Lab area was toured with the Director of Cath Lab (Dir Cath). The Cath Lab had three rooms, Cath Lab 1, 2, and 3. All three rooms had procedures in progress. It was observed there was an open area in the rear of the Cath Lab 1. This opening provided direct access to the control center in the hallway adjacent to Cath Lab 1. The opening did not have a door to block the air flow between the procedure room and the control center. At this time, a staff in surgical attires walked out of Cath Lab 1 and back to the control center. The main entrance door to Cath Lab 1 was wide open. Down the hallway was Cath Lab 2 and 3. With procedures in progress, Cath Lab 2 also had its door open.

On 12/12/12, at 4:30 PM, during an interview, the Director of Construction stated the catheterization laboratory required to use positive pressure. Asked how the pressure could be maintained when there was an opening in the rear of Cath Lab 1 and with the door open during a procedure, the Director of Construction answered, "It (positive pressure) would not be maintained when the door was open."

2. During a review of the air exchange log on 12/12/12, it was identified only one of the three cardiac catheterization rooms (Cath Lab 3) was tested for level of air exchange. There was no record of air exchange rate tested for Cath Lab 1 and 2.

On 12/12/12, at 3:20 PM, during an interview with Vice President of Support Services and Plant Operations (Plt Op) in regards to the last air exchange testing, both stated there had been problems with the air circulation in the Cath Lab area and some physical changes would have to be made. At 4:30 PM, the Director of Construction (Dir Cons) was interviewed. He stated Cath Lab 1 and 2 did not meet the requirements of minimum air exchange per hour and the construction should have been completed in 2/2012. He stated it would take some time to reconstruct the air circulation. When asked to review the hospital ' s policy on air exchange testing, both Dir Cons and Plt Op stated they could not recall having such policy. At 4:30 PM, the Regulatory Compliance confirmed the hospital did not have a policy on air exchange testing.



28467

Based on observation, interview, and record review, the hospital's infection control officer failed to develop effective systems for identifying, reporting, and investigating sources and transmission of infections and communicable diseases in accordance with hospital policy and nationally recognized guidelines as evidenced by:

1. The hospital's infection control officers failed to recognize the importance of maintaining a positive air pressure in two of the three rooms in the catheterization laboratory (Cath Lab 1 and 2, catheterization laboratory is a room equipped with diagnostic imaging equipment used to support catheterization procedures) as recommended by national guidelines.

2. Ensure its policies and procedures were followed to maintain required temperature and humidity ranges in multiple areas (Interventional Radiology, Decontamination rooms, and Cardiac Catheter room) where procedures were being performed.

3. Ensure single use contaminated surgical attire was disposed of before leaving the procedural room.

These failures placed patients at risk of coming into contact with disease causing organisms.

Findings:

1. On 12/12/12, at 10:38 AM, during a tour of the Cath Lab, it was observed two of the three rooms in the laboratory (Cath Lab 1 and 2) had doors open while procedures were in progress. It was also observed in the rear of Cath Lab 1 there was an opening in the rear that connected to the control room.

Again, during a concurrent observation and interview with the Director of the Cardiac Cath Lab (Dir Cath), on 12/13/12, at 8:50 AM, Cath Lab Room 2 was observed with the doors open. A table was set up with sterile supplies fully visible from the hallway. The Dir Cath stated, "They are prepping the room, the door doesn't auto close, so they leave the room open while prepping." Registered Nurse (RN) 3 stated, "I'll get rid of that pack (sterile supplies on the table) and get a new one, I've closed the door."

AORN (Association of periOperative Registered Nurses, a national association provides education and practice support to nurses in achieving optimal outcome in the operating room) recommended: "Doors to the operating or procedure rooms should be closed except during movement of patients, personnel, supplies, and equipment. The air pressure within each operating or procedure room should be greater than in the semi-restricted area (an area where only authorized staff and patients are allowed)... Leaving the door open can disrupt pressurization and cause turbulent airflow that could increase airborne contamination."

On 12/13/12, at 10:20 AM, the Interim Infection Control Director (IC 1) and the Infection Preventionist (IC 2) were both interviewed. IC 1 stated she had been making rounds to the catheterization laboratory but was not aware that positive air pressure should be maintained in the catheterization laboratory rooms while procedures were in progress.



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2 a. During an interview and record review with the IC 1, on 12/13/12, at 12:20 PM, the "Interventional Radiology Patient Case log" for 11/12/12, Room 2 was reviewed. There were three cases done in Room 2 on 11/12/12. The temperatures for Room 2 that day were: 67.1, 68.4, and 68.9 degrees F (below the range of 70-75 degrees F per facility policy), and there was no documentation for action taken. IC 1 said she was not aware of this, and stated "Maybe the cases were an emergency... I have to look into it."

During an interview with IC 1 on 12/13/12 at 2:20 PM, she stated "Plant Operations (Plt Ops) said there's no paperwork to show the work (action taken)... the guys aren't good with keeping up with the paperwork. The three cases done were all emergencies."

During a review of the electronic medical record for Patient 14 (one of the patients on 11/12/12), the "Doctor's Order" dated 11/8/12 at 9:10 AM indicated, "Schedule patient for fistulogram (an X-ray taken of a fistula [abnormal connection between two body organs] after a contrast medium has been injected)." The "Diagnostic Imaging Services" sheet for interventional procedures "fistulogram" indicated "Reschedule 11/12 at 1:00", and the "Authorization for Consent to Surgery or Special Procedure" dated 11/12/12 was for "Right arm fistulogram with possible angioplasty (mechanically widening narrowed or obstructed arteries)".

The hospital policy and procedure titled, "Humidity and Temperature Monitoring Policy", dated 11/26/12, indicated at F. 1. a. "The temperature of the Interventional Radiology Rooms shall be kept between 70-75 degrees Fahrenheit (21-24 degrees celsius)."

2 b. During a concurrent observation and interview of the Surgical Decontamination Room (room for items that are considered potentially contaminated with harmful germs) and reviewing the Temperature and Humidity logs with RN 1 on 12/10/12 at 10:53 AM, the temperature in the decontamination room was 68.4 degrees Fahrenheit(F) (acceptable temperature range is 60-65 degrees F per hospital policy). RN 1 stated, "It's been running high on the temperature side, so Plant Operations was notified." When the logs were reviewed from 10/19/12 through 12/10/12 there were 15 days (10/19/12 69.1 degrees, 10/20/12 68 degrees, 10/21/12 69 degrees, 11/29/12 67.4 degrees, 11/30/12 68.2 degrees, 12/1/12 68 degrees, 12/2/12 66.3 degrees, 12/3/12 67.8 degrees, 12/4/12 67.6 degrees, 12/5/12 67.3 degrees, 12/6/12 67.3 degrees, 12/7/12 67.8 degrees, 12/8/12 67.2 degrees, 12/9/ 67.2 degrees, 12/10/12 67.6 degrees), when the temperature was out of range. The temperatures ranged from 66.3 to 69.1 degrees F.

During an interview with the Plt Ops on 12/10/12 at 4:50 PM, the Temperature and Humidity logs and Plant Operations work orders were reviewed. On 11/29/12 at 6:30 AM, the log indicated the temperature was 67.4 F, and staff left a message with plant operations at 6:40 AM. Plant operations took action on 11/30/12 per the work order. Plt Ops had no comment regarding the late response, but stated, "We are having the TRANE system (system to monitor heating, cooling, ventilation, circulation, and air filtering) installed, and it will auto alert the department when out of range." The following dates 10/20/12, 10/21/12, 12/1/12, 12/2/12, 12/8/12, and 12/9/12 all had temperature greater than 65 degrees F, and no action was taken. Plt Ops stated, "Those were all weekends. Staff would have to call On-call engineer to have it corrected."



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2 c. During a concurrent observation and interview of the Endoscopy area and reviewing the Temperature and Humidity logs with Nurse Manager of the Endoscopy (NME) on 12/13/12 at 10 AM, the Temperature and Humidity logs for the Gastrointestinal (GI) Decontamination room for November 2012 indicated the room temperature was out of range every day in November 2012. The temperatures ranged from 67.7 Fahrenheit (F) to 70.5 F. The NME stated, "Plant Operations was notified", but was unable to find documentation of follow-up for the out of range temperatures.

During a review of the Cath Lab temperature and humidity logs for Rooms 1 and 2 on 11/13/12, four cases were done when the temperature and humidity was out of range. Room 1 had one case where the temperature was 68.4 and humidity 25 percent. Room 2 had three cases temperature was 64.4, 65, and 65.3; humidity was 26 percent, 26 percent, and 26 percent. The Cath Lab log indicated "Normal range: Temp 70-75 degrees, Humidity 30-60%."

The hospital policy and procedure titled, "Humidity and Temperature Monitoring Policy," dated 11/26/12, indicated: "A. Surgical Services...2. a. The temperature of the Decontamination Rooms shall be kept between 60-65 degrees Fahrenheit...D. Endoscopy 1. a., The temperature of the Decontamination Rooms shall be kept between 60-65 degrees Fahrenheit. E. Cardiac Catheterization Lab 1.a. The temperature of the Cardiac Catheterization Room shall be kept between 70-75 degrees Fahrenheit. 1.b. The humidity... kept between 30-60%." Further, this policy and procedure read, under K, "Additional Information 2. a. "If using manual logs...Plant Operations will be notified if values are out of range and corrective action will be documented by Plant Operations."

The 2012 Perioperative Standards and Recommended Practices, published by the AORN read "Safe environment of care, Recommendation V, V.c. Temperature should be monitored and recorded daily.... V.c.2 The decontamination area temperature should be maintained between 60 degrees F to 65 degrees F."

3. During a concurrent observation and interview with the NME on 12/13/12, at 10 AM, MD (Medical Doctor) 1 was observed walking out of the Endoscopy procedure room, that had just been used, dressed in single use surgical attire (scrub gown, surgical hat and shoe covers). The room was in the process of being cleaned as he left. MD 1 did not discard his single use surgical attire before leaving the room. MD 1 then walked across the Endoscopy unit in the surgical attire and spoke to a patient in the holding area. NME stated, "He's just showing you he wears his gown."

The hospital policy and procedure titled "Appropriate Surgical Attire", dated 7/2011, indicated, "Reusable or single use contaminated attire should be placed in appropriately designated containers after use."



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