HospitalInspections.org

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Based on observation, interview, and policy review the facility failed to ensure 1 patients right to privacy was maintained as per the facility's policy. This failed practice placed patients at risk for not having their medical information protected. Findings:


During an observation of the Emergency Department (ED) lobby on 6/20/16 at 8:52 am, RN #1 approached a Patient seated there with his family. The RN began to ask the Patient why he was there. A conversation then ensued with the Patient telling the RN he had recently had surgery on his right hip and was having increased pain with it. The RN then used a wheel chair to wheel the Patient out of the lobby and through the double doors of the ED. As RN #1 wheel the Patient through the doors the RN stated "My mother had her's [hip surgery] done too. There were 2 other patients seated in the lobby within earshot of the conversation.


Observation in the ED lobby, revealed a room labeled triage located to the right of the emergency room doors.


During an interview on 6/20/16 at 9:00 am, when asked what the process was for checking in patients, RN #2 stated the nurse greeted the patient, then non-urgent cases were brought to a regular exam room and the urgent cases were brought to the trauma room. When asked if the nurses used the triage room (located in the lobby) the RN replied "sometimes".


Review of the facility policy "Notice of Privacy Practices", revised 2/12/08, revealed "Our Duties to You Regarding Protected Health Information 'Protected health information' is individually identifiable health information...Make sure your PHI [Protected Health Information] is kept private. "

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Based on record review and interview the facility failed to ensure: 1) the infection prevention and control committee collected and reviewed all hospital acquired infections and investigations in real time so that opportunities to correct any deficiencies could be implemented, and 2) conducted sterilization surveillance given the scope of surgical services provided. The failure to collect, provide infection prevention data to the committee and develop action plans placed all patients at risk for infection transmission due to concerns not being addressed in a timely manner. Findings:

Record review of the "2015 Annual Infection Prevention Rates" on 6/22-23/16 revealed 3 surgical site infections had been identified: 1 in June 2015; 1 in July 2015; and 1 in August 2015.

Record review of the meeting minutes from 3/2015-1/2016 revealed no infections had been reported to the committee.

In addition, the meeting minutes on 3/18/15 identified low humidity in the operating room (OR) department but did not develop an action plan to correct it. Further review of the meeting minutes revealed, "Fixed [the] sterilization issue with scopes and ER [Emergency Room] and OR." There was no documentation the issue had been addressed nor were there further action plans.

Record review of the 9/2/15 meeting minutes revealed, the OR had one infection concern. No further information about the concern or action plan was identified. The OR humidity was discussed but did not identify how high the humidity was or if any action was to be taken should the humidity go out of range.

According to the AORN (Association of periOperative Registered Nurses) "Low humidity increases the risk of electrostatic charges, which pose a fire hazard in an oxygen rich environment or when flammable agents are used and increases the potential for dust. High humidity increased the risk of microbial growth in areas were sterile supplies are stored or procedures are performed."

Record review of the 1/6/16 meeting minutes revealed no documentation of the " infection concern" from the 9/2/15 meeting. In addition, no follow up on the OR humidity concerns or the infection concern was documented in the 9/2/15 minutes.

Record review of the 3/2/16 meeting minutes revealed "1 HAI [hospital acquired infection] was found at 84 days...Required six weeks of antibiotics." No report of any action plan taken by the Infection Preventionist or others. In addition, it was reported that the humidity in the OR was still a concern. No surveillance of the humidity was reported to the committee.

Record review of the "2015 Annual Infection Prevention Rates" revealed 2 surgical site infections had been identified: 1 in October 2015 and 1 in December 2015. Further review of the infection control meeting minutes for 1/6/16 to 3/2/16 did not reflect any infections or action plans.

Record review of the "Infection Prevention Plan" dated 9/24/14 revealed the purpose, "...to identify process improvement opportunities, plan intervention activities, implement the action plan, and evaluate for effectiveness..."

During an interview on 6/22/16 at 2:00 pm the Infection Preventionist stated there was no sterilization surveillance in the OR, She was not sure of what the humidity concerns were; and the infection investigations had not been reported to the committee.

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Based on observation, interview and record review the facility failed to make certain procedures were performed in a safe manner by failing to ensure: 1) staff processing of semi-critical and critical devices followed best practice standards; 2) semi-critical equipment was stored in a clean manner; 3) endoscopes were processed in a manner to prevent contamination; 4) best practice was used for immediate use steam sterilization (IUSS) and tracking of loads; and 5) ensure staff had necessary education for sterile processing. These failed practices placed patients at risk for infectious disease. Findings:

1) Sterile packaging

Observation on 6/20/16 at 10:20 am of the acute care unit code cart revealed 2 metal laryngoscope blades (device passed through the mouth used to examine and perform diagnosis and surgical procedures of the larynx) and 2- 3 ring forceps each in a separate single sterile pack with no internal indicator (a chemical strip that monitors critical sterilization parameters), sterilization label, or initials.

Observations on 6/20/16 at 10:40 am on the obstetric (OB) unit in the code cart revealed, 1- 3 ring forceps in a single sterile pack with no internal indicator, sterilization label, or initials.

Observation on 6/21/16 at 8:30 am revealed 1 metal laryngoscope blade in a sterile pack with no internal indicator on the endoscopy anesthesia cart and no sterilization label.

Observations on 6/21/16 at 9:05 am in the operating room (OR) on the sterile instrument storage shelves revealed an instrument in a sterile pack with red/orange spots on it (indicating rust), without an internal indicator. Also, one instrument pack had water marks.

During an interview on 6/21/16 at 1:45 pm the OR Manager confirmed sterilized items required an internal indicator, and the sterile package should have a sterilizer label and the initials of staff. In addition, she confirmed the rusted instruments should not have been sterilized and put out for use.

2) Storage of Contaminated Items

Observations on 6/20/16 at 9:45 am revealed multiple metal laryngoscope blades and a handle in a zip lock bag on the EKG cart. In addition, a single metal laryngoscope blade covered with dried secretions was located in a separate bag on the EKG cart.

During an interview on 6/20/16 at 10:00 am the Respiratory Therapist (RT) was asked about the laryngoscope blades. The RT stated he was not sure why the laryngoscope blades were stored on the EKG cart and confirmed they appeared soiled.

3) Endoscope sterilization and storage

Observation on 6/21/16 at 10:30 am revealed multiple endoscopes (instrument used to examine the inside of the body inserted through a natural opening such as the mouth) hanging in a glass enclosed cupboard in the OR. The shelving in the cupboard was soiled with debris.

Further observations revealed the scopes each had a sterilization strip taped to the scope. The latest date of sterilization on 2 of the scopes was 5/27/16.

During an interview on 6/22/16 at 8:30 am Certified Surgical Technologist (CST) #1 stated he was not sure if scopes should be re-processed after a specific hang time. The CST confirmed the shelving in the storage cupboard was dirty.

Observation on 6/22/16 at 8:17 am revealed CST #1 cleaning an endoscope in the sink. The CST was not wearing a protective face shield to prevent the splash of potentially contaminated fluids into his face and eyes.

Review of the endoscope processing documentation revealed:

· No sterilization verification on the processor printout;

· Incomplete documentation of the diagnostic and chemical indicators used for further investigation;

· No traceability of each cycle ran in the processor;

· No traceability of the each scope to a sterilization cycle;

· No documentation of the scope used during a procedure in the medical record.

During an interview on 6/21/16 at 8:30 am CST#1 stated the facility had not been documenting the scope number used during a procedure in the medical record. CST# 1 also confirmed he had not been initialing each load to verify processing parameters had been met.

Review of the facility policy "Endoscopy Cleaning, Processing and Maintenance" dated 9/28/12, did not address the PPE (personal protective equipment-protective clothing, goggles, hats, gloves) to be worn during decontamination of endoscopes or documentation of sterilization practices.

4) Class 4 indicator use for IUSS

Record review of the IUSS log revealed the facility was using a class 4 indicator for all immediate use loads. Further review and interview revealed a class 5 indicator was used for all other sterilization loads.

According to the Association of periOperative Registered Nurses (AORN), a class 4 reacts to two or more critical parameters of the sterilization process and indicate exposure to the sterilization cycle at the stated values of the chosen parameters. A class 5 indicator is an integrator designed to react to all critical parameters over a specified range of the sterilization cycles.

During an interview on 6/21/16 at 11:40 am CST #2 stated she was not sure why class 4 indicators were being used because all other loads were run with a class 5 indicator. In addition, the CST stated the facility had frequently used IUSS for their cataract trays because the facility only had 2 trays available on the days they scheduled 3-4 cataract surgeries.

According to AORN, immediate use sterilization should be the exception and should not be used to replace a lack of instruments.

An interview with the Infection Preventionist revealed the facility did not know what their IUSS rates were.

5) Central Sterile Processing

Record review of the IUSS logs, load cards, packaging labels, and sterilization strips on 6/20-23/16 revealed:

· No IUSS logs were maintained prior to 2015;

· A less sensitive, class 4 indicator was used for IUSS;

· IUSS and load documentation cards were incomplete;

· On 5/17/16 the sterilizer strip for IUSS and the IUSS load card did not match;

· On 5/17/16 the load label stated the load was run in sterilizer #3, the facility did not have a sterilizer #3.

· No chronological accounting of each cycle count for the 2 sterilizers;

· Sterilization was not verified by documentation on the sterilizer strips.

Review of the facility policies provided for sterilization, included the policy: "Cleaning and Disinfecting Equipment." The policy did not reference best practice standards and did not include multiple critical steps in the sterilization processes or record keeping.

Further interviews with CST #s 1,2 and the OR Manager revealed the facility had no certified sterile technician or ongoing staff education in sterile processing. During multiple interviews all three staff stated the facility followed the AORN best practice standards for sterilization practices. Both CST#s 1 and 2 had not received any formal education in sterile processing and had learned through on the job training.

The AORN provides standards, recommended practices, guidelines, and guidance statements to guide the delivery of safe perioperative care.

According to SurgicalTechTraining.org, accessed 7/6/16 at www.surgicaltechtraining.org "Most of the duties of a surgical technologist are in the operation room helping the surgical team directly by aiding and performing tasks during the procedure. The sterile processing technician on the other hand, is outside the OR and mainly deals with the cleaning and sterilization of equipment and medical instruments."

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Based on observation and interview the facility failed to ensure EMTALA (Emergency Medical Treatment and Labor Act) signage was posted at all entrances and in patient treatment areas. This failed practice placed patients at risk for not being notified of their right to a medical screening exam. Findings:


Observations in the Emergency Department (ED) on 6/20/16 at 9:00 am revealed no EMTALA signage in the ambulance bay or in any of the patient treatment rooms.


During an interview on 6/20/16 at 9:35 am, the ED Manager confirmed patients entering though the ambulance bay would not see any signage posted.


During a second interview on 6/22/16 at 8:45 am, the ED Manager stated he had ordered new signage for the ambulance bay entrance and the patient care areas.

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