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Based on document review, interview, and observation, it was determined that the Governing Body failed to demonstrate it is effective in carrying out the responsibilities for the operation and management of the hospital. The Governing Body failed to provide necessary oversight and leadership as evidenced by the lack of compliance with the following Conditions of Participation:

CFR 482.25 Pharmaceutical Services

CFR 482.42 Infection Control

Based on document review and staff interview, it was determined that the facility's performance improvement activities failed to aggregate and evaluate the collected data from the preventive actions implemented for all adverse events.

Findings include:

1. On 12/4/14, three Root Cause Analysis' (RCAs) were reviewed for Performance Improvement (PI) in the presence of Staff #1 and Staff #22. The PI data being collected for these three RCAs was not aggregated, therefore, it could not be determined if the interventions implemented were effective, needed to be adjusted, or new interventions created.

2. There was no evidence to reflect the PI activities for these specific events was reported into the PI/Quality Assurance Committee.

3. Staff #1 and Staff #22 confirmed the above.

Based on observation, staff interview and document review, it was determined that the facility failed to ensure the development and implementation of policies and procedures to ensure that outdated or otherwise unusable drugs are not available for patient use.

Findings include:

The facility failed to have policies and procedures addressing the use of predrawn medication syringes. Refer to Tag A-0505.

Based on observation, review of facility policies and procedures, and staff interviews, it was determined that the facility failed to ensure that all drugs and biologicals are secured and locked.

Findings include:

Reference #1: Facility policy titled "Resuscitation Cart - Broselow Pediatric" states, "WHO MAY PERFORM: RN ...PROCEDURE: ... 3. Maintenance of the Broselow Cart: a. The cart will be locked at all times. b. The cart will be checked daily to confirm lock is intact."

Reference #2: Facility policy titled "Pharmacy Policy Manual... Emergency Kits and Crash Carts" states, "...Inspections All crash carts and medications boxes are checked for dating and security during scheduled monthly unit inspections...."

1. On 12/2/14 at 11:40 AM, the Emergency Department (ED) was toured in the presence of Staff #10, Staff #11, Staff #12, and Staff #13.

a. The ED Broselow/Pediatric Resuscitation Cart #4, located outside of Trauma Room #2 lacked a secure lock and was easily opened.

b. The facility was unable to provide a logbook for the Broselow/Pediatric Resuscitation Cart that indicated daily checks of the lock were being performed by the RN, as indicated in Reference #1.

2. An orange pharmacy sticker, dated 11/14, was present on the front of the Broselow/Pediatric Resuscitation Cart indicating the cart was checked for dating and security by pharmacy during the monthly inspection.

3. This was confirmed by Staff #10, Staff #11, Staff #12, and Staff #13.

A. Based on observation and staff interview, it was determined that the facility failed to ensure development and implementation of policies and procedures to ensure that outdated or otherwise unusable drugs are not available for patient use.

Findings include:

Reference: United States Pharmacopoeia Chapter 797 (USP 797) states, "Opened or needle-punctured single-dose containers, such as bags, bottles, syringes, and vials of sterile products and CSPs [compounded sterile products] shall be used within 1 hour if opened in worse than ISO [International Organization for Standardization] Class 5 air quality and any remaining contents must be discarded."

1. On 12/2/14, at approximately 11:50 AM, Staff #17 was observed removing three (3) prefilled syringes from the anesthesia cart. One 10 ml (milliliter) syringe was labeled with the date (12/2/14) and a time (16:30). The other two (2) syringes were 3 ml syringes that contained a clear liquid. Each syringe was labeled with the date (12/2/14). Staff #17 was observed administering the medications to Patient #37 at approximately 12:00 Noon.

a. Upon interview at approximately 11:50 AM, Staff #17 stated that he/she had prepared the syringes towards the end of the previous case.

2. During interview with Staff #17 on 12/2/14 at approximately 3:00 PM, when asked what the beyond use date for predrawn syringes was, Staff #17 stated the following:

a. That single patient use vials of Propofol (the white liquid in the 10 ml syringe) can be drawn into a syringe up to 6 hours prior to administration.

b. That single dose vials of other medications, such as Fentanyl and Midazolam (what was in the other syringes) can be drawn into a syringe up to 24 hours prior to administration.

c. This is not in compliance with USP 797 referenced above.

3. Upon request on 12/2/14 and 12/3/14, Staff #59 was unable to provide facility policies and procedures addressing predrawing syringes, including the proper labeling of syringes and the beyond use date.

4. Upon interview on 12/2/14, Staff #19 stated that all of the anesthesiologists (this is a contracted service) had completed mandatory training in medication preparation. He/she stated that proper labeling of predrawn syringes and the 1 hour beyond use date for predrawn syringes were covered in the training.

These findings resulted in an Immediate Jeopardy which immediately curtailed this practice. The Immediate Jeopardy was removed on 12/3/14, day of survey, upon receipt of an acceptable plan of correction.


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B. Based on observation, review of facility policies and procedures, and staff interviews, it was determined that the facility failed to ensure that outdated drugs and biologics are not available for patient use.

Findings include:

Reference #1: Facility policy titled "Resuscitation Cart - Broselow Pediatric" states, "WHO MAY PERFORM: RN ...PROCEDURE: ... 3. Maintenance of the Broselow Cart: ... c. The cart supplies will be checked for expirations monthly... e. The medication drawer will have an expiration date noted. Pharmacy will review and replace medications monthly."

Reference #2: Facility policy titled "Pharmacy Policy Manual... Emergency Kits and Crash Carts" states, "...Inspections All crash carts and medications boxes are checked for dating and security during scheduled monthly unit inspections...."

1. The Emergency Department (ED) Broselow/Pediatric Resuscitation cart located outside of Trauma Room #2, contained an orange pharmacy sticker on the outside of the medication drawer with the documentation, "Drugs Outdate 11/14." The inside medication tray contained an orange pharmacy sticker on the top of the tray with the documentation, "Drugs Outdate 11/14." On 12/2/14, the day of survey, the following expired medications were found inside the medication tray:

a. Two (2) Pediatric 8.4% Sodium Bicarbonate 10 MEQ (milliequivalents) Injections, expired December 1, 2014.

b. Infant Sodium Bicarbonate 5 MEQ injection, expired November 1, 2014.

c. Furosemide 40 mg (milligram)/4 ml (milliliter) injection, expired December 1, 2014.

d. 2.5 Dextrose 25% injection, expired December 1, 2014.

e. Two (2) Epinephrine 1 milligram injections, expired December 1, 2014.

2. These findings were confirmed by Staff #10, Staff #11, Staff #12, and Staff #13.

Based on observation and staff interview on 12/2/14, it was determined that the facility failed to ensure that a safe and sanitary environment is maintained for patients, staff and the general public.

Findings include:

1. At approximately 1:30 PM, in the presence of Staff #64, stained ceiling tiles were observed in the Soiled Utility Room located on unit 2 Hussey.

2. At approximately 2:00 PM, in the presence of Staff #64, wall damage, which would preclude proper cleaning, was found at the Documentation Work Area located on unit 2 West.

3. At approximately 2:05 PM, in the presence of Staff #64, the light fixture in the bathroom adjacent to the Documentation Work Area on unit 2 West was found to be in need of bulb replacement.

4. The above findings were confirmed by Staff #64.

Based on observation and staff interview, it was determined that the facility failed to be maintained at an acceptable level of quality.

Findings include:

1. During a tour of the Operating Room (OR) Suite on 12/2/14 between 11:00 AM-11:30 AM, the following was observed:

a. The upper cabinet door hinges in OR #5 were broken.

(i) The OR table contained black residue at the base.

b. The Clean Supply Room had three (3) stained ceiling tiles near the smoke detector and the outer edge of the ceiling vent had rust stains on its surface.

2. During a tour of the PACU (Post Anesthesia Care Unit) on 12/2/14 at 11:15 AM, the following was observed:
a. The walls in Bay #6 and Bay #7 were chipped.
b. The base of the cabinet under the sink, next to Room #8 had dirt/stain accumulation.
(i) The cabinet was without a handle.
(ii) The wall had the corner bead exposed.
c. The base of the cabinet under the sink across from Bay #1 had dirt accumulation.
3. The above findings were confirmed by Staff #7.

Based on observation, staff interview, and a review of documentation, it was determined that the facility failed to maintain an ongoing program designed to prevent, control, and investigate infections and communicable diseases.

Findings include:

The facility failed to maintain a sanitary environment to avoid sources and transmission of infections and communicable diseases. Refer to Tag A-0749.

A. Based on observation, document review and staff interview, it was determined that the facility failed to ensure that hand washing was performed in accordance with facility policy.

Findings include:

Reference: Facility policy titled "Hand Hygiene" states, "Policy: ... Procedure: Indications for Hand Hygiene for all healthcare workers (HCW): ... Decontaminate hands after removing gloves ... Techniques: A. Hand washing: ... 3. Rub hands together vigorously for a least 15 seconds covering all surfaces of hands and fingers ... 5. Turn off faucet with paper towel and discard."

1. On 12/2/14 at 11:30 AM, in the PACU (Post Anesthesia Care Unit), Staff #54 was observed washing his/her hands for approximately 10 seconds and then turning off the faucet handle without the use of a paper towel.

2. On 12/2/14 at 11:35 AM, in the PACU, Staff #17 was observed washing his/her hands and then turning off the faucet handle without the use of a paper towel.

3. The above was confirmed by Staff #7.

4. On 12/4/14, at approximately 11:40 AM, during a tour of unit 1 Hussey, Staff #4, Staff #55 and Staff #56 were observed washing their hands then turning off the faucet handle without the use of a paper towel.

5. On 12/2/14, during a procedure on Patient #37, Staff #17 and Staff #55 were observed removing their gloves and continuing with tasks/or placing clean gloves on without decontaminating their hands. Staff #44 was observed placing his/her hands on the floor while assisting with placement of the pedal of the cautery unit and once completed the task, did not decontaminate his/her hands.

Reference: Guideline for Hand Hygiene in Health Care Settings: Recommendation of the Healthcare Infection Control Practices Advisory Committee and the ICA/SHEA/APIC/IDSA Hand Hygiene Task Force, published in the Morbidity and Mortality Weekly Report at MMWR 2002; 51 (No. RR-16).
Recommendations:
1. Indications for Handwashing and Hand antisepsis...
C. Decontaminate hands before having direct contact with patients.
E. Decontaminate hands before inserting...peripheral vascular catheters, or other invasive devices...
F. Decontaminate hands after contact with a patient's intact skin...
G. Decontaminate hands after contact with ... a patient's nonintact skin...
I. Decontaminate hands after contact with inanimate objects...in the immediate vicinity of the patient.
J. Decontaminate hands after removing gloves.

1. On 12/3/14 between 10:55 AM and 11:05 AM in the Endoscopy Suite's Soiled Utility Room, Staff #23 was observed making multiple glove changes without performing hand hygiene in between glove changes.

2. On 12/3/14 at 11:10 AM in the Scope Cleaning Room, Staff #23 was observed making two glove changes without performing hand hygiene.

3. This was confirmed by Staff #7.


B. Based on observation, document review and staff interview, it was determined that the facility failed to ensure that aseptic technique is used for the preparation of medication.

Findings include:

Reference: Center for Disease Control website titled " FAQs Regarding Safe Practices for Medical Injections " states, " ....1. How should I draw up medications?...Parenteral medications should be accessed in an aseptic manner. This includes using a new sterile syringe and sterile needle to draw up medications while preventing contact between the injection materials and the non-sterile environment. Proper hand hygiene should be performed before handling medications and the rubber septum should be disinfected with alcohol prior to piercing it. "

1. On 12/2/14 during a procedure on Patient #37, Staff #54 was observed drawing up medications from two new vials into syringes without first wiping the rubber septum with alcohol.

2. The above was confirmed by Staff #7.

C. Based on observation, document review, and staff interview, it was determined that the facility failed to ensure that medications are prepared in a clean area.

Findings include:

Reference #1: Facility policy titled "Medication Administration" states, "...Medication Preparation: Medication will be prepared in a clean, uncluttered, and functionally separate area in order to avoid contamination of medications."

1. On 12/2/14, at approximately 11:50 AM, Staff #17 was observed removing three (3) prefilled syringes from the anesthesia cart and administering them to Patient #37. One 10 ml (milliliter) syringe contained a white liquid; labeled with the date (12/2/14) and a time (16:30). The other two 3 ml syringes contained a clear liquid; labled with the date (12/2/14).

a. Upon interview at approximately 11:50 AM, Staff #17 stated that he/she had prepared the syringes towards the end of the previous case.

2. During interview with Staff #17 on 12/2/14 at approximately 3:00 PM, Staff #17 confirmed that he/she had prepared the medication syringes that he/she administered to Patient #37 while there had been a different patient in the operating room.

3. The operating room is an immediate patient care area. Preparing the medication during a surgical procedure on a different patient does not meet the requirement to prepare medication in a clean and functionally separate area in order to avoid contamination of medications.

These findings resulted in an Immediate Jeopardy which immediately curtailed this practice. The Immediate Jeopardy was removed on 12/2/14, the day of survey, upon receipt of an acceptable plan of correction.









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D. Based on observation, staff interview, and a review of documents, it was determined that the facility failed to maintain an ongoing program designed to prevent and control infections and communicable diseases in a manner consistent with hospital policy.

Findings include:

Reference: Facility policy Title: "Care of Hospital Patients with Infections Policy" states "...Contact precautions and Patient Placement...4. (1) Disposable gloves must be worn by all personnel upon entering the room, (2) gowns must be worn by all personnel upon entering the room, (3) remove gloves and gown before exiting the room, 5. Practice strict hand washing after removal of gloves and after removing all other personal protective equipment...."

1. On 12/2/14 at 11:00 AM, the ICU was toured in the presence of Staff #10. Patient Room #5E contained a Contact Isolation Sign outside the door, indicating that staff and visitors are to gown and glove prior to entering the room. The following observations were made:

a. Staff #16 entered Room #5E wearing gloves but lacked a gown.

b. Staff #16 removed a full garbage bag from the patient's room and placed it in a large garbage receptacle outside of Room #5E.

c. Staff #16 then proceeded to enter the PPE cart located outside of Room #5E, to refill the PPE with clean equipment, while wearing contaminated gloves.

d. Staff #16 then pushed the large garbage receptacle down the hall wearing contaminated gloves.

e. Staff #10 confirmed that Staff #16 did not wear a gown upon entering the patient's room nor did he/she change gloves or wash his/her hands after leaving the patient's room.

2. Without staff using the proper PPE (gowns and gloves) upon entering an isolation room, removing gloves that were exposed to patient's on contact isolation, and performing strict handwashing, the facility could not ensure the prevention of direct and indirect transmission of diseases, as per policy.

E. Based on observation and staff interview, it was determined that the facility failed to provide and maintain aseptic technique during the preparation of medications.

Findings include:

Reference: Center for Disease Control, "The One and Only Campaign" states, "...1. Follow proper infection control practices and maintain aseptic technique during the preparation and administration of injected medications. For example, perform hand hygiene and prepare injections in a clean medication preparation area away from patient treatment areas and other potential sources of contamination such as sinks...."

1. On 12/2/14 at 10:40 AM, the Emergency Department was toured in the presence of Staff #10, Staff #11, Staff #12, and Staff #13.

2. Staff #13 stated that medications area prepared in the medication room in an area next to the sink.

3. The medication preparation area was in close proximity alongside a hand wash sink.

Based on medical record review, review of facility policies and procedures, and staff interviews, it was determined that the facility failed to ensure that ventilator checks are completed in accordance with facility policy and procedure.

Findings include:

Reference: Facility policy titled, "Respiratory Therapy Department, Subject: Patient Ventilator Check, Policy: It is the policy of (facility name) to check patients on mechanical ventilation and equipment at every two hours but least every three hours. Procedure: Filing [sic] out the ventilator flow sheet in EMAR (electronic charting system) or on paper. The ventilator flow sheet must be properly filled out. This shall include: . . .3. All ventilator checks. . . ."

1. In 2 out of 2 medical records reviewed of patient's on mechanical ventilation, the ventilator flow sheet was not completed as follows:

a. Medical Record #1 was reviewed on the Intensive Care Unit (ICU) at 12:10 PM, in the presence of Staff #6.

(i) The medical record revealed that a ventilator check was performed on 12/2/14 at 07:34 AM.

(ii) The next ventilator check was performed on 12/2/14 at 12:55 PM.

(iii) The time frame reveals the ventilator check was performed 2 hours and 24 minutes late.

2. This was confirmed by Staff #6.

a. Staff #6 stated that the respiratory therapist did complete the ventilation check within the 2 to 3 hour time frame, but failed to document at the time of the reassessment check.

3. Review of Medical Record #2 revealed that a ventilator check was performed on 12/2/14 at 02:11 AM.

a. The next ventilator check was performed on 12/2/14 at 06:03 AM.

b. The time frame reveals the ventilator check was performed 52 minutes late.

c. This was confirmed by Staff #6.