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Based on interview and record review the facility failed to have a documented informed consent for a cystoscopy procedure on one of 53 sampled patients (Patient 19).

Findings:
In an electronic record review on 9/23/15 at 11:20 AM, Patient 19's medical record did not have a consent form for a Urethroplasty (plastic surgery of the tube that leads from the bladder and transports and discharges urine outside the body) performed on 3/5/15.

In an interview on 9/23/15, the Infection Control Practitioner 1 attempted to locate the consent in multiple sections of the electronic medical record but was unable to find it. Infection Control Director then attempted to locate the consent form and acknowledged the consent was not available in the medical record.

3) During an observation at Outpatient Services Clinic A on 9/22/15 at 9:40 AM, LVN 2 went to Room 528 with a container of a used and dirty rigid scope. LVN 2 put the container on counter near the sink, opened the container, flushed the scope and sprayed the rigid scope with an enzymatic spray (solution used for keeping soiled instruments like scopes moist and preventing bio-burden from adhering to the surface prior to decontamination and sterilization). The room was small (40.47 square feet verified by Regulatory Affairs Staff 1), and inside the room were two clean, ready for use flexible scopes hanging on the wall. The distance between the dirty sink and the wall where the clean scopes were hanging was approximately 2 feet. There was no clear dividing line between dirty and clean areas inside the room where possible splashes and cross-contamination (cross-contamination is the physical movement or transfer of harmful bacteria/virus from one person, object or place to another) could occur because of the close proximity of dirty and clean scopes.

During an interview on 9/22/15 at 9:45 AM, Nurse Manager (NM) 1 stated the room was small and the clinic was challenged with space so dirty and clean scopes were put together in one room. NM 1 stated the Infection Control team were aware that Room 528 was used for dirty and clean scopes.

Review of the facility's Ambulatory Services Procedure Manual Rooms with Clean and Soiled Areas Procedure 7.2, indicated, "III Policy - When separate rooms cannot be used, UCSF Medical Center policy requires that clinical practice locations standardize practice and maximize patient and staff safety. Practice Managers will consult with the Department of Epidemiology and Infection Control to ensure environment meets the requirement of the policy..., IV Procedure - B. Look for traffic flow. Locations must be set up to prevent cross-contamination. C. Obtain input on the proposed division from the staff who will work in the area. D. Arrange for clear, durable signage to identify CLEAN and SOILED areas. These signs must be durably affixed and clearly visible location. E. A clear dividing line between the clean and soiled areas will be identified, usually with durable tape of a bright color, customarily red...".

According to the AORN (Association of Perioperative Nurses, a professional organization that provides perioperative nursing education, standards,and clinical practice resources) Guidelines - Recommendation V: "Instruments should be cleaned and decontaminated in an area separate from locations where clean items are handled. Physical separation of decontamination areas from areas where clean items are handled minimizes the risk of cross-contamination. Cross-contamination can result when soiled items are placed in close proximity to clean items or are placed on surfaces upon which clean items are later placed. Droplets and aerosols created during cleaning of soiled instruments can cause cross-contamination of any nearby clean items or surfaces. V.a. The sterile processing area should have: separate clean and decontamination spaces, which may be rooms or areas; decontamination and clean spaces that are separated by one of three methods: 1. a wall with a door or pass-through, 2. a partial wall or partition that is at least 4 ft high and at least the width of the counter, 3. a distance of 4 ft between the instrument washing sink and the area where the instruments are prepared for sterilization; separate sinks for washing instruments and for hand hygiene; decontaminating equipment (e.g., automated washer, ultrasonic cleaner); and storage space for PPE and cleaning supplies in the decontamination area.".

4) During an observation at Outpatient Services Clinic A on 9/22/15 at 9:40 AM, Room 528 was small (40.47 square feet), and inside the room were three clean, ready for use flexible scopes hanging on the wall. The distance between the sink and the wall where the clean scopes were hanging was approximately 2 feet. There was no clear dividing line between dirty and clean areas inside the room where possible splashes and cross-contamination could occur because of the close proximity of soiled and clean scopes.

During an interview on 9/23/15 at 9:40 AM, the Director of Ambulatory Services (DAS) stated clean and ready for use scopes should be in a cabinet. DAS stated a cabinet will be purchased by the facility.

Review of the Manual and Automated Flexible Scope Reprocessing/TEE Probes (Transesophageal Echo) policy and procedure, reviewed 1/12, indicated, "I. 9. Storage - a. All flexible scopes that are sterilized will be stored in their corresponding sterilization container... c. Scopes stored in the Endoscopy Department will be stored in a vertical cabinetry.".

Review of the scope manufacturer's instructions for use indicated, "Caution - Store the endoscope and accessories in an endoscope storage cabinet which also protects the equipment from physical damage... Warning - Proper storage procedures are important as proper reprocessing procedures in maintaining good infection practices...".

According to AORN Guidelines - Recommendation IX: "Flexible endoscopes should be stored in a manner that protects the device from damage and minimizes microbial contamination. IX.a. Flexible endoscopes should be stored: in a closed cabinet with: venting that allows air circulation around the flexible endoscopes,internal surfaces composed of cleanable materials, adequate height to allow flexible endoscopes to hang without touching the bottom of the cabinet, and sufficient space for storage of multiple endoscopes without touching; hanging in a secure vertical position; with all removable endoscope components (e.g., valve mechanisms, biopsy valve covers, irrigation tubes) detached; with all accessories removed; and with scope protectors applied if the protector does not interfere with the flexible endoscope hanging straight or restrict the air movement around channel openings. When flexible endoscopes are hung in the vertical position, coiling or kinking is prevented, allowing any remaining moisture to drain out of the endoscope and decreasing the potential development of an environment conducive to microbial growth in the endoscope. Proper storage facilitates drying and decreases potential for contamination. Opening all valves and removing all accessories facilitates drying. The scope protector may create an environment favorable for microbial growth if the flexible endoscope is not dry and cannot hang straight.".

5) During an observation and interview at Outpatient Services B on 9/22/15 at 1:15 PM, the Sterile Processing Room had a storage cabinet with flexible scopes hanging vertically. The GI Tech Supervisor stated the scopes were labeled when they were processed, however, there was no policy and procedure for management of storage inventory and rotation of scopes. The GI Tech Supervisor stated the maximum time the scopes were stored and not used was 14 days based on the volume of patients' cases they do in a month.

During an interview on 9/23/15 at 11:40 AM, Infection Control Director stated the facility did not have policy and procedure for management of storage inventory of scopes' shelf life (how long a device is stored). Infection Control Director stated there was no defined guidelines for shelf life or hang time for scopes, however, multiple facility staff verified they follow AORN Guidelines on processing and storage of scopes.

Review of the 2015 AAMI (Association for the Advancement of Medical Instrumentation, a professional organization that is the primary source of consensus standards for the medical devise industry) page 33 indicated, "10.4.2 Existing guidelines - A number of guidelines and recommended practices provide recommendations as to the maximum duration of storage time before the endoscope is processed for the next use..., a) AORN: AORN guidelines recommend that endoscopes be reprocessed before use, if not used for more than five days.".




27921

2) During an observation, on 9/22/15 at 9:40 AM, MD-1, removed a clean, ready to use, flexible scope and was carrying it from room 528 in Operative Services Clinic A and entering a procedure room. MD-1 was handling the clean scope with bare hands with no noticeable hand hygiene. MD-1 was not wearing proper PPE (personal protective equipment) a gown, gloves, and no mask and was not following "Standard Precautions" as defined by the facility's policy.

During an interview on 9/22/15 at 9:45 AM, Nurse Manager-1 stated, "He's not supposed to do that. There is no container for transporting the scope".

During an interview on 9/22/15 at 10:00 AM, DAS stated, " we don't have a policy that deals with the transportation of scopes."

Review of "Policy 1.1, STANDARD PRECAUTIONS, Last Approval: 9/12, indicated, "Standard Precautions are designed to reduce the risk of transmission of microorganisms from both recognized and unrecognized sources of infection in healthcare settings. Standard Precautions apply to...all situations...adhering to Standard Precautions...is essential to interrupting the transmissions of microorganisms...Staff,faculty and students will assess situations and implement Standard...Precautions as noted in the practices below. Standard Precautions are sufficient to interrupt the spread of most infectious agents...Standard Precautions are practices to reduce healthcare associated infections...".

Review of "Standard and Practice Guidelines" by "SGNA" (Society of Gastroenterology Nurses and Associates, a professional organization of nurses and associates dedicated to the safe and effective practice of gastroenterology and endoscopy nursing) indicated: "Multisociety guideline on reprocessing flexible gastrointestinal endoscopes: 2011, 1. All health care personnel in the endoscopy suite should be trained in and adhere to standard infection prevention and control recommendations (for example, standard precautions), including those to protect both patients and health care workers".



33399

Based on observation, interview and document review, the facility failed to develop a system for identifying, reporting, investigating and controlling infections and communicable diseases of patients and personnel when:

1) An employee LVN 1 (Licensed Vocational Nurse 1) did not follow the facility's policy and procedure for hand hygiene.

2) MD-1(medical doctor) did not follow the facility's policy and procedure on Standard Precautions.

3) There was no clear separation of dirty and clean area inside the room where scopes were handled in Operative Services Clinic A and the proximity of dirty and clean area were approximately 2 feet which had the potential for cross-contamination.

4) The flexible scopes at Operative Services Clinic A were not stored appropriately to protect the device from damage and minimize microbial contamination which could cause an infection.

5) There was no policy and procedure for management of storage inventory and rotation of scopes in Operative Services Clinic A.

Findings:

1) On September 21, 2015, at 1430 hours, during the observation of the pre-cleaning of cystoscopy equipment, LVN 1 was observed to remove contaminated gloves and apply clean gloves without performing hand hygiene. This observation was validated with ICP 2 (Infection Control Practitioner 2).
On September 22, 2015 at 1630 hours, the Hand Hygiene Policy, dated May 2015, was reviewed. Section V Procedures numbered A 3 g. states that: hand hygiene indications include after removing other personal protective equipment including gloves.
On September 21, 2015, at 1245 hours, during an interview with Infection Control Director, she stated that the facility's hand hygiene program was based on the World Health Organization (WHO) standards. According to the WHO Guidelines on Hand Hygiene in Health Care, 2009, "...hands are not sufficiently protected by gloves, and hand hygiene is strongly recommended after glove removal".

On 9/23/15, record review of personnel files indicated that three other employees, staff 14, 23, and 24, did not have evidence of Color Blindness Testing in their health records. This was verified with the Manager of Employee Health. These three employees also had duties which required them to differentiate variations in color for point of care testing on Cidex/OPA.

2) Record review of MD 1's credential file did not include documentation that he had attended Infection Control Training at the time of his appointment to the medical staff of the hospital. The hospital was unable to provide documentation from any other sources that indicated MD 1 had received this training at the time of his appointment to the medical staff.

This had the potential for MD 1 to contaminate the equipment he used on patients.









31794

Based on interview and record review the facility failed to:

1) Ensure staff were qualified to perform their duties when five staff did not have the necessary Color Blind Test (CBT- a device use to determine if a person has a color vision deficiency). This failure had the potential to have an inaccurate result.

2) Ensure that all providers received Infection Control training during their initial orientation when one physician, MD 1, had not received this training.

Finding:

1) Review of the document titled: Sterile Processing Department, Cidex OPA HLD, Policy/Performance Criteria (PPC), dated 8/14/15 for Hospital Assistants (HA) 5, and on 8/17/15 for HA 9, indicated both staff should be able to: "1. Demonstrate knowledge of guidelines for High Level disinfection using Cidex OPA (ready to use high-level disinfectant that provides a broad spectrum of kill) for heat sensitive, semi-critical devices (devices coming in contact with intact mucous membranes or non-sterile areas of the body such as the mouth, nose, ...)". Further review of the PPC document indicated staff should be able to perform quality control using Test Strips dipped in a mixture of the Cidex solution and water and be able to compare the color to the chart on the bottle, to be repeated two more times. If the color was completely or partially blue, lavender or spotty an all three strips, the negative control has passed. If the color is completely purple on all three test strips, the positive control has passed. The PPC document indicated HA's 5 and 9 met the criteria and had a "Pass" result. The PPC document was signed by HA 5 on 8/14/15, HA 9 on 8/17/15, and their Observers/Proctors.

In an interview with the Director of Ambulatory Services (DAS) on 9/23/15 at 11:14 a.m., DAS stated both HA's 5 and 9 performed Point of Care Testing (POC - defined as medical testing at or near the site of patient care) that included the Test Strips using Cidex Solution. DAS stated HA's 5 and 9 should had a Color Blind Test (CBT) done. When asked what would be the potential risk if CBT was not done, DAS stated the result may "not be read correctly."

Review of the document titled: "Competency: CIDEX/OPA", dated 5/5/15, for both HA's 5 and 9, indicated: "... 5. b. Understands how to conduct a test strip "control" test. ... d. Understands what a Pass and a Fall test strips readings look like. ..." Both HA's 5 and 9 met the competency criteria with the initials of the Proctor and signed by both staff on 5/5/15.

In a concurrent review of the Surveillance Profile forms for HA's 5 and 9, and interview with the Administrative Director of Occupational Health (ADOH) on 9/23/115 at 11:35 a.m., ADOH stated HA's 5 and 9 performed PCT and Color Blind Test (CBT) was required. ADOH acknowledged there was no CBT done for HA's 5 and 9, it must had been an "oversight, it needs to be done." When asked what was the importance of having a CBT done for staff, ADOH stated, the staff could be "misinterpreting the result."

The facility did not have Policy and Procedure on performing Color Blind Test (CBT) for employees.