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Based on record review and interview the hospital failed to:
1. Recognize the patient's right to seek review by the Quality Improvement Organization (QIO), Kepro.
2. Recognize a grievance
3. Recognize the difference between a complaint and a grievance

Findings:

A hospital policy titled, "Patient Grievance" did not contain any contact information for patients to lodge a grievance with the QIO, Kepro. The policy documented patients are informed of the complaint procedure through the patient rights and responsibilities brochures and notices posted throughout the hospital. The policy interchanges complaint and grievance and does not follow a resolution process.

A document titled "ERS Event Listing Report" lists the complaints and grievances of the facility; there was no distinction between a grievance and a complaint. There was no documentation of resolutions listed in the "Event Description". There was no documentation of letters sent to patients explaining the investigation process and resolution.

On 1/8/18 at 2:45 pm, Staff M stated he/she did not understand the difference between a complaint and grievance. He/She was referred to Appendix A for additional information.

Based on record review, interview and observation, the hospital failed to maintain surgical instruments that was recently sterilized and cooling in the proper environments of limited traffic exposure, and validated temperature and humidity ranges.

This failed practice potentially resulted in the surgical instrument oberved on 2 of 2 wire racks in the surgical corridor being exposed to an environment which was not conducive for minimizing infection control.

Findings:

A review of policy titled, "Temperature and Humidity Monitoring (dated 07/12)" documented the scope of the policy to include OR [Operating Room] Rooms, Pain Management Rooms, PACU [Post Anesthesia Care Unit] , Sterile Supplies and "SPD" [Sterile Processing Department] and defined the temperature for SPD, but failed to specifically define the humidity and temperature for sterile supplies.

A review of State Regulation 667 for the temperature and humidity requirements for a clean work room are "humidity 30-60% and temperature maximum of 75°F", and for Sterile Storage "humidity maximum of 70%" and no temperature requirements.

A review of AORN 2018 documented sterilized materials should be stored in a manner to ensure sterility, materials should be limited to exposure to moisture, dust, excessive light or handling, and temperature and humidity extremes decreases potential contamination of sterilized items, and access to sterile supply areas should be limited to personnel who are trained in handling sterile supplies.

On 01/04/18 at 12:14 pm, surgical instruments in blue packaged in non-woven wrap were observed on two covered wire racks in the surgical corridor.

On 01/04/18 at a 2:14 pm, Staff M stated due to lack of space recently sterilized instruments were put on covered wire racks in the surgical corridor to cool before putting them into the Sterile Storage Room, and could remain in the hallways for hours, if necessary, to cool.

On 01/04/18 at 12:30 pm, the Staff L stated the surgical corridor was not monitored for temperature and humidity.

Based on record review and interview, the hospital failed to maintain acceptable humidity levels in the operating rooms.

Findings:

See Life Safety Code survey Tag K-0323

Based on record review and interview, the hospital failed to designate the responsibility of the infection control program to a qualified (through ongoing education, training, experience or certification) individual to oversee the infection control program.

This failed practice of an untrained Infection Control Preventionist (ICP) had the potential to cause harm to all patients by causing an increased risk of developing infections and communicable diseases due to the ICP's lack of knowledge regarding the infection control program. (Refer to A-0749)

Findings:

The previous ICP (who had been in the position for 20 years) retired in August, 2017, the qualified interim ICP resigned September 2017, and currently the responsibilities have been delegated to 4 different nurses with Staff G primarily over the program.

A review of Staff G's employee file showed no training in the infection control field.

On 01/05/18 at 9:20 am, Staff G stated she had no education, training or experience in infection control or quality; she had stepped up because of the need after the previous ICP retired and she did have other responsibilities.

Based on record review, interview, and observation, infection control preventionist failed to implement and maintain an infection control action plan that:
I. minimized the occurrence of hand hygiene issues such as the five issues identified during 69 minutes of observation in the pre-operative area,
II. minimized the occurrence of improper personal protective equipment use for the surgical staff such as the 3 issues identified during 69 minutes of observation in the pre-operative area,
III. ensured adherence of manufacturer's instructions for use for the sterilization as evidenced by Flarehawk instrument being improperly processed by immediate use steam sterilization (IUSS),
IV. adherence to proper storage of sterile instruments as evidence by observing cooling sterile instruments being improperly stored in surgical corridor which had higher traffic and no evaluation of air handling,
V. ensured adherence of the disinfection of supplies and equipment after each patient use as evidenced by observing Neptune waste system, X-ray apron lead, bronchoscope, and paper medical record notebook and clip boards being used on multiple patients without disinfection between patients.
VI. ensured proper storage of textiles to minimize as evidenced by observing linens, towel, and surgical scrubs not properly covered and protected from traffic and dust/lint, and
VII. ensured proper environmental cleaning as evidenced by observing wall partitions in the pre-operative area were not a cleanable surface, "ready for use" patient bathroom toilet contained stool on an in-patient unit, and the joint stripping coming off surgical corridor wall was not cleanable .

These failed practices had the potential to increase the infectious risk for the approximately 12 surgical patients per day (300 patients per month) by failure to maintain an environment that minimized infection control risks in the pre-operative, operative, central processing, post-operative areas, and in-patient areas.

Findings:
A review of policy titled, "Infection Prevention Surveillance Plan (dated 07/17) ranked hand hygiene as #1 high risk activity in the 2017 Infection Control Risk Assessment. The plan included IUSS as part of the surveillance program, but failed to address use of personal protective equipment (PPE), general sterilization techniques, sterile storage monitoring, disinfection of supplies and equipment, management of textiles, and environmental monitoring.

A review of multiple policies to include, but not limited to Dress Code, Aseptic technique, Practices for Environmental Cleaning listed AORN (Association of peri-Operative registered Nurses) as the resource for the documents.

I. Hand Hygiene

A review of policy titled, "Infection Prevention Surveillance Plan (dated 07/17) documented a goal of ten observations per team member to be conducted per month with a goal of 90% compliance.

A review of document titled, "Hand Hygiene Assessment Form" defined the indications for alcohol-based hand sanitizer to include: before having direct contact with a patient, after direct contact with a patient's skin, after touching equipment or objects in the patient zone, after removing gloves, and before putting on sterile gloves....

A review of policy titled, "Hand Hygiene (dated 07/17)" referenced CDC guidelines, but failed to address the hand hygiene requirements before donning or after glove removal as an indication for hand hygiene.

A review of document titled, "Performance Improvement Quality Management Oversight Committee Report 01/17-09/17" documented the hand hygiene audit results for four of nine monthly observations. The results ranged from 84% to 100 % compliance, and no other hand hygiene observational data was provided after 09/17, which coincided with the resignation of an credentialed infection control preventionist which was replaced by four uncredentialed leadership nursing staff.

On 01/05/18 at 9:20 am, surveyor observed patient care activities and the following hand hygiene deficiencies were noted in the pre-operative area:
* Staff X lifted the medical record (notebook) of Patient #10, exited the bay without performing hand hygiene taking the record to the copier to make copies and then went into the unit's drug room.
* After touching Patient #10, Staff X used contaminated hands to pull the curtain shut, then exited the bay without performing hand hygiene to type at the computer.
*Staff X left bay after touch Patient #10 to retrieve a stethoscope at the nursing station, gloved hands and used stethoscope, then exited the bay cleaned the stethoscope with contaminated gloved hands at the nursing station, removed gloves and did not perform hand hygiene.

On 01/15/18 at 10:29 am, retrieved the medical record notebook and stethoscope from the nursing station, Staff Z entered Patient # 10's bay to examine the patient and review the consent, and exited without performing hand hygiene.

II. Personal Protective Equipment
A. PPE in Restricted Areas
A review of policy titled, "Dress Code (dated 11/99) documented uniformed personnel would wear paper scrubs/cover-ups provided by the hospital over their clothes and also must wear shoe covers.

On 01/05/18 at 10:21 am, Staff D entered the pre-operative from the public hallway and walked into the surgical corridor with no shoe covers and his/her personal long sleeve shirt exposed on his/her arms.

B. Masks
A review of policy titled, "Department of Anesthesia Infection Prevention and Control (dated 05/16) documented masks will cover the mouth and nose completely, changed after each surgery and were not to be worn hanging around the neck of personnel.

A review of AORN 2018 documented a fresh surgical mask should be donned before the health care worker performs or assists with each new procedure. The mask should be replaced and discarded whenever it becomes wet or soiled or has been taken down. Surgical masks should not be worn hanging around the neck.

A review of AORN 2018 documented masks with ear loops may not have been designed and intended for use as surgical masks and may not provide a secure facial fit that prevented venting at the sides of the mask. A mask that conforms to the perioperative team member ' s face decreases the risk that the health care worker will transmit nasopharyngeal and respiratory microorganisms to the patient or the sterile field.

On 01/05/17 at 10:18 am, Staff Y entered the pre-operative area from the surgical corridor with a mask hanging from his//her neck, and upon entry into the surgical corridor, surgical masks with ear loops were available as a selection for surgical attire.

C. Scull caps
A review of policy titled, "Department of Anesthesia Infection Prevention and Control (dated 05/16) documented all possible head and facial hair including sideburns, beard, and neckline were to be covered when in the restricted area of the surgical suite.

A review of AORN 2018 documented a clean surgical head cover or hood that confines all hair and completely covers the ears, scalp skin, sideburns, and nape of the neck should be worn.

A review of a position statement titled, "CMS Response to the American College of Surgeons (dated 09/16) documented "Net caps, caps or skullcaps that do not offer complete hair cover should not be worn in the surgical suite."

On 01/05/17 at 10:18 am, Staff Y entered the pre-operative area from the surgical corridor wearing a skull cap.

On 01/08/18 at 2:30 pm, Staff M he/ she was unaware that skull caps were deemed unacceptable surgical attire.

III. Immediate Use Steam Sterilization (IUSS)
A. One Tray
A review of manufacturer's instruction for use for "One Tray" documented that instrument drying time was not a requirement for product.

A review of the document titled, "Immediate Use Sterilization-Prevacuum for 11/10/17" showed the contents load of "Flarehawk Instrument" was processed in the rigid container called "One Tray" by immediate use steam sterilization (IUSS) method at 270 °F for 5 minutes and a 1 minute drying time.

A review of the manufacturer's (DePuy) instructions for use for Flarehawk instrument documented a warning that due to the complexity of orthopedic joint construction cases, the manufacturer did not recommend IUSS. The Flarehawk instructions for use documented the steam sterilization requirements were 270 ° for 4 minutes and a 30 minute drying time.

A review of policy titled, "Immediate Use Steam Sterilization (dated 11/99) documented the device manufacturer's instructions for reprocessing an item must be followed.

A review of AORN 2018 documented, "Health care personnel are responsible for ensuring that rigid sterilization container systems are suitable for proposed sterilization uses and are compatible with existing sterilizers."

On 01/05/18 at 1:30 pm and 2:30 pm, Staff M and Staff R stated they did not know if using One tray was the correct sterilization practice for Flarehawk instrument.

IV. Management and Storage of Sterile Instruments

A. Sterile Instruments Drying in Surgical Corridor

A review of policy titled, "Temperature and Humidity Monitoring (dated 07/12)" documented the scope of the policy to include OR [Operating Room] Rooms, Pain Management Rooms, PACU [Post Anesthesia care Unit] , Sterile Supplies and "SPD" [Sterile Processing Department] and defined the temperature for SPD, but failed to specifically define the humidity and temperature for sterile supplies.

A review of State Regulation 667 for the temperature and humidity requirements for a clean work room are "humidity 30-60% and temperature maximum of 75°F", and for Sterile Storage "humidity maximum of 70%" and no temperature requirements.

A review of AORN 2018 documented sterilized materials should be stored in a manner to ensure sterility, materials should be limited to exposure to moisture, dust, excessive light or handling, and temperature and humidity extremes decreases potential contamination of sterilized items, and access to sterile supply areas should be limited to personnel who are trained in handling sterile supplies.

On 01/04/18 at 12:14 pm, surgical instruments in blue packaged in non-woven wrap were observed on two covered wire racks in the surgical corridor.

On 01/04/18 at a 2:14 pm, Staff M stated due to lack of space recently sterilized instruments were put on covered wire racks in the surgical corridor to cool before putting them into the Sterile Storage Room, and could remain in the hallways for hours, if necessary, to cool.

On 01/04/18 at 12:30 pm, the Staff L stated the surgical corridor was not monitored for temperature and humidity.

V. Disinfection of Supplies and Equipment

A. X-ray Lead Aprons

On 01/04/18 at 12:15 pm, in response to being asked how lead aprons was disinfected after each patient use, Staff R stated the OR was "working on the process".

On 01/05/18 at 9:07 am, Staff M stated lead aprons in the OR were worn all day without protective gowns. Staff M stated the organization had newly created a policy requiring the lead aprons to be disinfected after each use and it was begun in radiology, but was not communicated to OR.

On 01/08/18 at 1:47 pm, Staff H stated sometimes the anesthesiologist would were a lead apron without a gown, but did not know if the apron was disinfected between each patient.

On 01/18/18 at 1:50 pm, Staff AA stated he/she had never seen protective gowns worn over lead aprons, and during pain management, lead aprons were worn by the physician, x-ray staff, and staff responsible for sedation and 'the tray". Staff AA stated lead aprons were disinfected by purple-lid wipes daily.

On 01/04/18 at 12:15 pm, radiology lead aprons were observed hanging on a wall in the OR suite.

B. Neptune Waste Management System
A review of policy titled, "Environmental Cleaning in the Perioperative Setting (dated 11/08)" documented all equipment from outside the restricted area of the OR should be cleaned before being brought into the OR.

A review of policy titled, "Neptune Waste Management (date10/14)" failed to address the disinfection requirements for the equipment after each use. The Neptune's outer surface not disinfected after each case (A review of the manufacturer's instruction for use documented the external surfaces of the Neptune Waste Management System should be wiped with a soft cloth dampened with a non-abrasive hospital disinfectant.

On 01/04/18 at 12:15 pm, Neptune waste system was observed in the OR room, and Staff R stated after a surgery the Neptune system would be brought to the soiled utility room to be docked and emptied and would return to the OR for use. Staff R stated the outer surface was disinfected daily, and not disinfected between each patient use.

C. Bronchoscope
On 01/04/18 at 2:30 pm, surveyor requested the disinfection and storage information for an Olympus bronchoscope, and none was provided.

A review of Olympus Website 2018 titled, "Bronchoscope Disinfection Guide" documented to facilitate drying, bronchoscope should be stored by hanging vertically with all valves and caps removed.

A review of AORN guidelines advised flexible endoscope AORN should be reprocessed before patient use if unused for more than 5 days.

On 01/04/18 at 12:06 pm, Staff R stated the bronchoscope was reprocessed monthly if hung without use.

On 01/04/18 at 12:06 pm, a bronchoscope was observed hanging in a clear case with the sterilization protective cap in place.

E. PO/post notebook and clip boards

On 01/05/18 at 9:20 am, surveyor observed patient care activities in the pre-operative and OR areas. It was observed the patients' medical record was contained in a 3-ring binder and on a clip board, and followed the patients throughout the surgical/procedural visit. The binder and clipboard was observed to go in and out of pre-operative bays, placed on the patients' bed, on chairs, and on counters. The binders was transported to the OR suite and used in a writing area.

On 01/05/18 at 10:29 am, Staff X stated that seven patients touched chart, and that it made him/her want to wash his/her hands each time after it was touched.

On 01/08/18 at 1:55 pm, Staff AA stated the notebook and clipboard was not cleaned after each patient use.

VI. Management of Textiles
A. Pre-op and Post-op Staff Scrubs

A review of policy titled, "Dress Code (dated 11/99) documented the accepted infection control guidelines for proper attire in the sterile and substerile areas, but failed to address the hygienic requirements of staff attire in the pro-operative and post-operative areas.

A review the CDC publication titled, "Guidelines for Environmental Infection Control in Health-Care Facilities", documented that fabrics, textiles, and clothing used in health-care settings are disinfected during laundering and generally rendered free of vegetative pathogens (i.e., hygienically clean), but they are not sterile. The article defined proper laundering conditions.

On 01/08/18 at 1:55 pm, Staff AA the hospital did not provide commercial laundry services for cleaning personal scrub attire worn in the pre-operative and post-operative areas, and the staff was not trained on CDC guidelines for home laundering of clothing used in a healthcare setting. Staff AA stated his/her scrubs were washed with homemade soap.

B. Uncovered Clean Linen
A review of CDC guidelines titled, "Guidelines for Environmental Infection Control in Health-Care Facilities (2003)" documented linen storage methods should ensure their cleanliness until use.

On 01/04/18 at 11:33 pm, surveyors observed a storage closet with multiple shelves of uncover linen.

C. Scrubs Uncovered
A review of AORN 2018 documented laundered surgical attire should be stored in clean enclosed carts or cabinets that helps prevent contamination, and storing clean attire in a facility locker with personal items from outside of the facility may contaminate the clean scrub attire.

On 01/04/18 at 11:33 pm, surveyors observed surgical scrubs on uncovered shelves in a high traffic zone of the women's dressing room, and cover-up jacket uncovered on hangers by hanging personal clothing, and Staff M stated he/she did not realize they should be covered.

VII. Environment Cleaning

A. PO Cubicle Partition
On 01/05/18 at 10:15 am, cloth covered wall partitions were observed as the separation between each pre-operative bay. The wall covering was not washable. Patient #10's stretcher was pushed against the cloth partition. Patient's used disposable BP cuffs was clipped to wall after use.

On 01/05/18 at 1:30 pm , Staff M stated the company interior designer had selected the material for the wall partitions, and wash ability had not been discussed.

B. Toilet Not Clean in Room Ready
On 01/04/19 at 9:55 am, during a tour of PCU East Unit in room 125, stool was observed in the bowl of the commode.

On 01/04/19 at 9:55 am, Staff M stated the unit was temporarily closed due to low census, but was supposed to be clean and ready for use.

C. Wall of Sterile Corridor
On 01/04/18 at 12:00 pm, the wall board seam strip was observed loose on the wall of the sterile corridor.

On 01/04/18 at 12:00 pm, Staff R stated the wall was not cleanable and needed repair.