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Based on observations, policy review, and staff interview, the hospital failed to protect confidential clinical information of 2 randomly observed patients at QMC Punchbowl.

Findings include:

On 12/15/15 in the afternoon on QET 8 E wing, observed a folded page of handwritten notes with random patient names, room numbers, and health information resting on an unattended Computer on Wheels (COW) facing patient Room 842. The hand written note was legible and could be seen while standing in the hallway next to the COW. At 2:34 PM on the same day while walking in the hall near patient Room 830 on QET 8 E, observed on the COW an opened computer screen showing a random patient record. There was no licensed nurse standing near the opened computer screen. Resting on the top of the COW was a page of handwritten notes with random patient names, room numbers, and other health information. The hand written note was legible and could be read while standing next to the COW in the hallway. A staff member came out of Room 830 and acknowledged leaving the screen opened while attending to the patient in Room 830. The staff member was identified as a licensed nurse.

The System-Wide Policies and Procedures of the Queen's Health Systems states under Subject: Health Information Security and Privacy Sanctions. #2. Definitions. 2.1 Privacy Violation - "A privacy violation occurs when a member of the workforce accesses, reviews, uses, discusses and/or discloses a patient's protected health information (PHI) in violation of Queen's policies".

Based on observations, electronic medical record review, staff interviews, and policy review, the facility did not ensure patients were free of any manual, physical or mechanical device, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body for one (Patient #58) of 3 sampled patients with restraints.

Findings include:

On 12/18/15 at 9:22 A.M. an initial tour of the 4th floor of the QMC WO was done with the assistant administrator for patient care services (AAPCS), the 4th floor nurse manager (NM), and the charge nurse (CN). Accessed the electronic medical record (EMR) system with the assistance of the CN. The EMR for Patient #58 was reviewed, as the patient was identified as using restraints.

The EMR noted the patient was admitted to the hospital on 12/12/15 through the emergency department with diagnosis of hepatic encephalopathy and alcohol intoxication. The hospital initiated protocols for clinical indicators withdrawal of alcohol (CIWA), and the patient required vest and bilateral wrist restraints due to confusion and restlessness. Documentation on 12/16/15 at 11:30 A.M. noted that the vest and wrist restraints were discontinued, but the vest restraint order was renewed at 6:12 P.M. due to the patient's restlessness.

On 12/18/15 at 10:45 A.M., observation was made of the patient with vest restraint and bilateral bulky white mitts on. Asked the patient how long were the "gloves" placed on his/her hands and the patient replied, "yesterday". The patient then asked of the CN when "they" could be removed while lifting both gloved hands.
A review of the EMR documentation dated 12/17/15 noted that the patient "pulled out IV line at 2300 and bilateral mittens applied." Inquired of the AAPCS and Director, Quality & Regulatory Affairs (DQRA), about the use of the bilateral mittens, as they were present during the observation. The DQRA stated that mittens are not considered restraints if not tied to the side of the bed, and therefore the Restraint and Seclusion (674-13-763-B) policy did not apply in this situation. Inquired about a care plan (CP) for the use of the bilateral mittens, and according to the DQRA, the use of the mittens would fall under the Alcohol Withdrawal CP for Patient Safety, Patient will be free of self harm. The Alcohol Withdrawal CP for Patient Safety did not include the use of bilateral mittens for the patient. Inquired of the hospital's policies and procedures and/or protocols for indication of use for bilateral mittens, if not considered a restraint, and the DQRA stated that there was none.

From 12/17/15 at 11:00 P.M. through 12/18/15 at 10:45 A.M., the patient had the bilateral mittens on and there was no physician order for the restraints, no documentation that the restraints were released at least every 2 hours to allow the staff to assess the patient's circulation to his/her hands and allow the patient to move his/her fingers, wrists and hands.

During this discussion of the use of the bilateral mittens as restraints, the NM stated that the hospitalist just discontinued the bilateral mittens for the patient after assessing him/her at approximately 11:00 A.M. on 12/18/15.

Review of the facility's Restraint and Seclusion policy noted "restraint is any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely".

The use of the bilateral bulky hand mittens meets the definition of restraints and require a physician order, assessment, care plan, monitoring, and documentation. The facility did not ensure this patient was free of the use of restraints.

Based on observation, interview, and hospital policy, the hospital failed to keep an accurate record of the receipt and distribution of a control substance II for one medication storage room at QMC Punchbowl.

Findings include:

On 12/16/15 at 9:00 A.M. found in a locked drawer in the Medication Storage room on QET 9 DH were 2 small intravenous (IV) bags labeled as Dilaudid. When asked for a log to account for the Dilaudid, a partially filled form titled "PCA Requisition" was shown with the words printed on the top left corner, "Controlled Substance Disposition and 24 Hours Nursing Audit Record ". A concurrent review of the form with the Charge Nurse found no entry entered for one Dilaudid IV bag with control number #025474. The entry for control #025474 was written in by the Charge Nurse during the observation. On the PCA Requisition there were no written entries under "Oncoming, Outgoing and Totals per shift. There were 19 written entries on the PCA document with only two control numbers written on 12/15 at 1515 and 1630; the other entry dates from 12/1 at 0620 to 12/15 at 0345 had no control numbers.

A telephone call to the pharmacy on 12/21/15 confirmed that Dilaudid is a Control II medication similar to morphine. The QMC Policy titled: Medications - Controlled Substance Floor Stock states under General Information. #3 "Federal and State regulations require complete and accurate records on distribution of each controlled substance received issued/dispensed, administered and disposed."

Based on observations, staff interviews, and policy review, the hospital did not ensure security of drugs and biologicals during transport from the pharmacy to the patient floors.

Findings include:

On 12/18/15 at 3:00 P.M. met with the QMC WO Pharmacy Manager (PM) who provided a tour of the hospital pharmacy and how medications and biologicals are stored, dispensed, and delivered to the floors. The PM pointed out how medications and biologicals were separated by floor and automated dispensing machine (ADM) being placed into a separated plastic bin and delivered to the floors on an open plastic push cart that had 3 shelves.

On 12/21/15 at 10:05 A.M. observations were made of the pharmacy's dispensing, delivering and filling of medications and biologicals to the patient floor and each ADM. The pharmacy technician had already pulled the controlled substances (e.g. Oxycodone ER 10 mg tab; Qty. 20), and the PM stated that a pharmacist already checked the orders. The PM separated the controlled substances by floor and ADM (e.g. 3 A, 3 B, 3 C), and placed them into the corresponding plastic bin. The pharmacy technician (PT) continued filling the medication orders and placed them in the same plastic bins as the controlled substances. After pulling all of the prescription orders and placing them in the plastic bins, a bin was placed on the 1st and 2nd shelf of the open push cart. The PT pushed the cart towards the main lobby of the hospital where the elevator was accessible to the general public and went up to the 4th floor.

On the 4th floor the PT filled and checked expiration dates of medications and biologicals for 3 ADMs of which only one (4 A) was located in a secured room. The ADM (4 B) was located to the back of the nursing station, and the open push cart was blocking the entry way of the nursing station while the PT filled the ADM. Several nursing staff had to maneuver past the push cart that held the plastic bins filled with medications and biologicals that included controlled substances. The prescriptions of controlled substances for ADM 4 B included: Clonazepam 0.5 mg tab; Fentanyl 50 mcg/1 ml, 2 ml inj Qty 30; and, Guaifen/Codeine 10 mg/5 ml Qty. 8.

The hospital's policy: Guidelines For The Selection and Procurement, Storage, Ordering Preparing and Dispensing, Administration and Monitoring of Medications (674-15-713-B), under 3. Storage, 3.2.3 "Medications delivered to patient care areas (hand delivered or via the pneumatic tube system) shall be kept under constant surveillance or stored in a secure location". Under 3.3 Controlled Substances (CSAs), "CSAs in Schedule I and II must be stored in a securely locked, substantially constructed cabinet or automated dispensing machine (ADM). CSAs III, IV, and V must be stored in a securely locked, substantially constructed cabinet ... or distributed through-out the inventory of non-controlled drugs in a manner which will obstruct theft or diversion of the CSAs".

Based on observation and staff interview, the facility failed to ensure an acceptable level of safety and quality of cleaning agents for the initial cleaning of soiled tubings used for endoscopy procedures in the endoscopy department at QMC, Punchbowl.

Findings include:

On 12/16/15 at 9:51 A.M. during a tour of the endoscopy department, the endoscopy tech was asked to explain the cleaning process for soiled endoscopy tubings. The tech explained that to begin the cleaning process a liquid solution called Pro Ez is mixed with another clear solution for immediate cleaning. The tech pointed to a table with a medication cup containing a light blue solution that he identified as Pro Ez that he was going to mix with a basin containing a clear solution to begin the cleaning process. When asked to see the container the Pro Ez came from the tech pointed to a small plastic bottle with a pump 3/4 filled with the same blue liquid seen in the medicine cup. The tech was asked to turn the bottle so the label could be read. The tech turned the bottle, revealing a hand written label stating, "Pro Ez exp. 11/27/15. The tech read the label and confirmed the handwritten expiration date was 11/27/15.

Based on observations, interviews, and policy review, the facility failed to identify practices to control infections and communicable diseases of patients and personnel in 4 observations at QMC, Punchbowl.

Findings include:

1) On 12/17/15 at 10:25 A.M. an observation was made of a routine respiratory tubing exchange by a respiratory tech (RT) for Patient #13. The patient has a trachesotomy collar connected to a tubing used for the delivery of mist and oxygen to the patient's trach. The RT removed the patient's current tubing and exchanged it for a clean tubing set. After the tubing exchange the RT took scissors from her pocket; cut the tubing; and reconnected both cut ends to a short two-way tubing with a bag to collect condensation from the tubing. After the observation, the RT was interviewed and confirmed the scissors came from her pocket and was not cleaned prior to making the cut. The RT acknowledged the scissors was her own and she never thought of cleaning them before patient use "for germs".

The Respiratory Operation Manager was interviewed in the afternoon on the same day and confirmed personal scissors used to cut the patient tubing should be cleaned prior to making the cut.




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2) An observation of patient care on the morning of 12/15/15 at approximately 11:25 A.M. found a Licensed Nurse (LN), inserting an Intravenous (IV) line for Patient #21. The LN started by palpating the patient's veins to determine the best location for an IV line. The LN found a vein on the patient's left forearm. The LN sanitized her hands using an alcohol based hand gel, donned clean gloves, picked up her pen to write the date on the bandage, then placed clean laboratory blood collection vials directly onto the computer tabletop without a barrier. She proceeded with cleaning the patient's skin to prepare for the needlestick. Without sanitizing her hands and changing her gloves, the LN proceeded to insert the IV line.

An interview of the Infection Control Coordinator (ICC), on the morning of 12/17/15 revealed the LN did not follow infection control steps. After touching her pen and writing on the bandage, the LN should have removed her gloves, sanitized her hands and donned clean gloves before the insertion of the IV line.

A review of the facility's policy for Hand Hygiene with latest revision date of 12/27/13 found the "Indications for Hand Hygiene, 3.2 If hands are not visibly soiled, use an alcohol-based hand rub for routinely decontaminating hands in all other clinical situations described below. 3.2.3 Before inserting indwelling urinary catheters, peripheral vascular catheters, or other invasive devices that do not require a surgical procedure."



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3) A wound care observation was conducted on 12/16/15 at 11:45 A.M. The staff did not provide any barrier between the patient's bedside table and the patient's wound care supplies. Patient #22 has two abdominal surgical wound sites.

LN performed wet-to-dry wound care to both surgical sites. The staff removed the old packing from the wound one at a time. LN cleansed the outside of the two wound sites but did not clean the inside of the wounds. Then he measured the two wound sites using a Q-tip applicator.

He measured the depth of the wound with the cotton tip portion of the Q-tip, broke it off and placed the cotton tip portion directly on the patient's bedside table without any barrier. The patient's water pitcher and cup were next to the used cotton tip. Then he measured the width of the wound with the wooden part of the Q-tip and placed the used Q-tip portion on top the patient's bedside table next to the cotton tip.

He then applied clean moist gauze to each wound site. When he was done with the procedure, he gathered the rest of his supplies and tossed it inside the garbage receptacle, however, when he grabbed the left-over 4 x 4 gauze saturated with normal saline, the saline spilled all over the bedside table.

An interview was conducted with the staff at 11:55 A.M., and said he did not clean the inside of each wound because wet-to-dry wound care is used as debridement for wounds. He told surveyor that he cleaned the bedside table prior to the procedure, so barrier is not necessary.

An interview was conducted with the Nurse Manager on 12/16/15 at 12:00 P.M. She said her expectation is for staff to put a barrier even if the bedside table was sanitized. The "Clinical Skills: Dry and Moist-to-dry Dressing" quicksheet was provided and reviewed by the surveyor on 12/17/15 at 10:25 A.M. The quicksheet indicated on #21 "Cleanse the wound" and on #24 b. "Apply dressing. Moist-to-dry dressing."

An interview was conducted with the Wound Care Director on 12/17/15 at 1:45 P.M. She said the wound should be cleansed before applying a clean/new dressing; and a barrier should have been provided.



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4) On 12/15/15 at 11:20 A.M. observed a chemo IV drug procedure for Patient #29. The Licensed Nurse (LN) was wearing the appropriate personal protective equipment (PPE), including double gloves. Upon entering the patient's room the LN was at the computer on wheels (COW) accessing the patient's EMR. The nurse then went to the sink counter where the chemo drug bucket was located and read the drug label to the Charge Nurse (CN) who was now at the COW. The LN then went to the patient's bedside to scan the patient's name wrist band, and then scanned the drug label, while the CN remained at the COW verifying the scanned information. The LN then got the chemo drug that was in a piggyback IV solution bag, hung it onto the IV pole and connected the IV ports. After completing this task the LN removed her 1st layer of gloves and with the 2nd pair of gloves underneath inputted the proper infusion flow rate at the infusion pump with the CN to do double check. After this task the LN placed the chemo drug cellophane outer wrapper into the chemo drug bucket, removed the gloves and placed them into the empty cellophane wrapper and then washed her hands.

Outside of patient's room reiterated observations, and asked the CN and Operations Manager (OM) about the use of double gloves and should the LN have removed both pairs of gloves. According to the CN, the LN did not access the central venous catheter (CVC) port and only connected the piggyback chemo drug solution to the other IV solution. Asked the staff if the LN followed the facility's hand hygiene protocol. The CN and OM stated that they would check.

On 12/15/15 the hospital staff provided the Hand-Hygiene Policy For The Queen's Medical Center, ( 610-13-254-B); 3. Indications for Hand Hygiene;... 3.2 "If hands are not visibly soiled, use an alcohol - based hand rub for routinely decontaminating hands in all other clinical situations described below. Antimicrobial soap and water can also be used...; 3.2.7 After contact with inanimate objects (including medical equipment) in the immediate vicinity of the patient. 3.2.8 After removing gloves."


The hospital staff also provided, Clinical Skills, Medication Administration: Intermittent Infusion Methods, Quicksheet; "1. Perform hand hygiene before patient contact.; 2. Verify the correct patient using two identifiers; ...13. Visually inspect the medication for particulates, discoloration, or other loss of integrity...; 14. Perform hand hygiene; ...16. Ensure the six rights of medication safety: right medication, right dose...; 18. Perform hand hygiene and don gloves.; 19. Connect infusion tubing to the medication bag".


In the above observation and according to facility policy, the staff should have removed both pairs of gloves and then appropriately hand sanitize hands according to the facility's policy on hand hygiene.