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28991

Based on observation, interview, and medical record reviews, the hospital failed to provide an environment to avoid sources and transmission of infections and communicable disease as evidenced by failure to have:

A. An effective system in place to ensure its participating physicians were consistently screened for infectious diseases in accordance with nationally accepted infection control standards and State and Federal regulations (cross reference A 749, item 1).

B. A functional and sanitary environment for the provision of surgical services so that the types of surgery conducted can be performed in a manner that protects the lives and assures the physical safety of all individuals in the area cross reference (A 749, item 2a, 2b, 2c, 2d, 2e, 2f, 2g, 2h, and 2i).

C. System(s) to identify multiple-system break-down related to infection control (cross reference item 3).

The cumulative effects of these systemic problems resulted in the hospital's inability to provide infection control services and care in a safe and effective manner in accordance with the statutorily-mandated Condition for Coverage for Infection Control Services.

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28991

Based on observation, interview and record review, the hospital failed to:

1. Have an effective system in place to ensure its participating physicians were consistently screened for infectious diseases in accordance with nationally accepted infection control standards and Federal and State regulations. This failure had the potential to spread infectious disease.

2. Provide a functional and sanitary environment for the provision of surgical services. This failure had the potential to expose patients to unsafe surgical practices, which increased patient risk for post-surgical infection when the facility failed to ensure:

2. a. Hinged surgical instruments were sterilized in an open position and/or in a single layer in trays in accordance with nationally accepted infection control guidelines.

2.b. The interior of the sterilizer used for cardiovascular surgical supplies was maintained in a clean and sanitary condition.

2.c. Staff were trained to safely and effectively clean blood spill in the perioperative areas.

2d. An air vent in the operating room (OR) was maintained to prevent cross contamination of the operating room sterile fields.

2.e. Traffic patterns in the endoscopy procedure area included a semi-restricted area that limited traffic, which conformed to nationally accepted infection control standards.

2.f. Staff wore appropriate personal protective equipment in the endoscopy area.

2.g. Staff wore appropriate surgical attire in the perioperative area.

2.h. Potentially contaminated patient items were kept separate from clean and sterile patient supplies.

2.i. Material covering OR equipment, i.e. patient gurney, armboard, rolling chair, was maintained in a condition that would permit the equipment to be disinfected.

3. Identify multiple-system breakdowns related to infection control, which had the potential to prevent correction of infection control issues.

The cumulative effects of these systemic failures had the potential to place patients at risk for infectious and communicable diseases.

Findings:

1. During a review of the personnel health records on 11/1/11 for physicians practicing at the hospital, it indicated four of the five physicians reviewed were not provided the CDC (Center for Disease Control) recommended screenings for vaccine preventable diseases for healthcare workers. The personnel medical record for MD (Medical Doctor) 2, indicated there was no evidence for screening for measles, mumps, or rubella (MMR) (contagious diseases). Review of the personnel records for MD 5, showed no documented evidence of screening for MMR, varicella, hepatitis B, or for screening for tuberculosis in 2013. Review of the personnel records for MD 6 showed no documented evidence for screening for MMRV or hepatitis B. Review of personnel records for MD 3, showed no documented evidence for screening for MMRV, hepatitis B, and screening for tuberculosis was incomplete in the presence of positive answers on the TB risk assessment questionnaire.

During an interview with Manager (Mgr) 8 and 9, on 10/31/13 at 10:45 AM, they acknowledged the hospital did not include physicians in their employee screening program for vaccine preventable diseases (the program was based on the Centers Disease Control guidelines). Mgr 8 and 9 confirmed the physicians reviewed were all hospitalists, (physicians in charge of caring for hospitalized patients), and there was a possibility that the physicians could come into contact with patients' bodily secretions, including blood.

According to the CDC Morbidity and Mortality Report (MMWR) MMWR. 2011;60 (RR07):1-45 "Healthcare personnel (HCP) include physicians, nurses, emergency medical personnel, dental professionals and students, medical and nursing students, laboratory technicians, pharmacists, hospital volunteers, and administrative staff." The guidelines recommend "...any facility or organization that provides direct patient care to formulate a comprehensive vaccination policy for all HCP ... To ensure that all HCP are up to date with respect to recommended vaccines, facilities should review HCP vaccination and immunity status at the time of hire and on a regular basis (i.e., at least annually) with consideration of offering needed vaccines, if necessary, in conjunction with routine annual disease-prevention measures (e.g., influenza vaccination or tuberculin testing)... On the basis of documented nosocomial transmission, HCP are considered to be at substantial risk for acquiring or transmitting hepatitis B, influenza, measles, mumps, rubella, pertussis, and varicella." CDC provides detailed recommendations for these vaccinations in the MMWR document cited at the beginning of this paragraph.
The 2010 Cal/OSHA (California Occupational Safety and Hazard Administration - a regulatory agency concerned with the health and safety of personnel), Aerosol Transmissible Disease (ATD) Act, under CCR, Title 8, Section 5199 requires hospitals to make the recommended vaccinations available to all employees with occupational exposure within 10 days of assignment unless the employee has previously received the recommended vaccinations, medical reasons make vaccinations contraindicated, or ... Healthcare worker is defined in this regulation as: "A person who works in a healthcare facility, service, or operation or who has occupational exposure." The Aerosol Transmissible Disease Vaccination Recommendations for Susceptible Health Care Workers (Mandatory) are, in part,: Measles, mumps, rubella, and varicella.

The OSHA Bloodborne Pathogens (diseases carried in the blood) standard, 29 CFR 1910.1030, requires employers to make hepatitis B vaccine available free of charge to any non-immune workers who have reasonably anticipated contact with blood or other potential infectious material during performance of their job.

According to the 2005 Centers for Disease Control (CDC) guidelines for the prevention of transmission of tuberculosis in healthcare settings. "All healthcare workers (HCWs) are classified as medium risk and should receive baseline TB screening upon hire and annually.

2.a. During a concurrent observation and interview in the Central Supply area with Mgr 4 and Mgr 2, on 10/29/13, at 10 AM, three sterile surgical trays were opened. Two of the three trays were observed as follows:

In tray 2, four squeeze-handled (opens when squeezed) instruments and a few other instruments were observed stacked on top of one another. The tops of three of the four squeezed-handled instruments were in the closed position.

In tray 3, sixteen long handled hinged instruments were noted on a stringer in a tight group, also placed on top of a few other instruments. Although on a stringer, all of the long handled instruments were almost entirely closed and one instrument had it blades completely closed with tips touching.

Mgr 4 stated the reason some sterile trays have instruments stacked on top of each other is because they do not have enough large pans to accommodate all the instruments. Mgr 4 stated the hospital had just received a shipment of large pans, and they were in the process of being added to the hospital inventory. Mgr 4 was asked if there was a problem with the instruments being sterilized stacked on top of each other in layers. Mgr 4 replied, "No, the steam will penetrate through all the instruments."

Mgr 2 stated, "We need to continue to do education for staff. Not all the staff appreciates the importance of doing this [opening hinged instruments fully and not stacking instruments]. We need to broaden the scope of our education." When asked what standards the hospital followed for instrument sterilization, Mgr 2 stated the hospital followed AORN (Association of Operating Room Nurses) and AAMI (Association for the Advancement of Medical Instrumentation) as the standards for surgical instrument sterilization and deferred to the standard that was more stringent if there was a difference between the two entity's standards.

During a concurrent observation and interview in the Central Supply area with Mgr 4, on 10/31/13, four trays were opened. One of the four trays had over 10 instruments bundled tightly on top of each other in a blue cloth and positioned directly on top of the instruments. In a concurrent interview, Mgr 4 stated, "That many instruments (bundled) together should not be. We still have some trays that we haven't incorporated the changes. There is definitely some we need to change. This is a work in progress "

The hospital's policy entitled "Sterilization of Reusable Surgical Instrumentation", dated revised and approved 9/24/13, indicated, "Instruments must be in the open and unlocked position." "Wrap package in a manner that will allow adequate air removal, steam penetration ...".

The AORN Standards and Recommended Practices, 2013 edition, Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment was reviewed. Under Recommendation XII, the following information was provided:

"Cleaned surgical instruments should be organized for packaging in a manner to allow the sterilant (a sterilizing agent) to contact all exposed surfaces. The proper organization of instruments on a surgical tray will facilitate sterilant contact on all surfaces and adequate drying.

II.a. Instruments should be placed in a container tray or basket that is large enough to evenly distribute the metal mass in a single layer. Instruments should be contained within the tray or basket in a manner that protects the instruments from damage and prevents puncturing of the sterilization wraps. Overloading trays can cause wet packs because an increase in metal mass in the tray results in more condensate, which requires additional drying at the end of the cycle.

XII.b. Broad-surfaced instruments and those with concave surfaces...should be placed on edge (on their sides). Instruments placed on edge facilitate drying because in this position, steam condensate will drain off the instrument rather than pool on it.

XII.c. Instruments with hinges should be opened and those with removable parts should be disassembled when placed in trays designed for sterilization, unless the manufacturer has provided validated instructions to the contrary. Sterilization occurs only on surfaces that have direct contact with the sterilant. Disassembly of multiple-part instruments and those with sliding parts (e.g., retractors) enables the sterilant to contact all surfaces.

XII.c.1. Instruments should be kept in the open and unlocked position using instrument stringers, racks, or instrument pegs designed to contain instruments."

2.b. During an observation of the Central Supply Area, on 10/29/13, at 1:40 PM, a reddish brown substance was visible throughout the interior surfaces and shelving of the cardiovascular sterilizer (sterilizes instruments used in cardiac procedures). Further inspection with a moistened tissue placed on the interior surfaces revealed pink, red, and brown substances pulled out on the tissue. In a concurrent interview, Mgr 2 confirmed the findings and stated, "The sterilizer is old and does at least 3 sterilization cycles per day." Mgr 2 stated the sterilizer was used to sterilize all cardiovascular surgical instruments and it was serviced for preventative maintenance 4-6 weeks previously. Mgr 2 acknowledged she did not know how long the sterilizer had the colored substances present within its interior. She stated "I will tell them not to use it for now."

During an interview with the Mgr 10, on 10/29/13, at 1:55 PM, he stated, "I don't know what is in the sterilizer, but we need to find out."

During an interview with Mgr 2, on 10/31/13, she stated, "We will not use the autoclave if we continue to see residue in it. We don't want this (referring to the residue) in our operating rooms."

Review of the Hospital's policy entitled "Sterilization of Reusable Surgical Instruments", dated approved 9/24/13, indicated, "Regular preventative maintenance and cleaning is required to assure the effectiveness of the machine (sterilizer)." No record was available indicating when the sterilizer was last cleaned.

2.c. During an observation in Operating Room 6 on 10/29/13 at 2:20 PM, Tech (Surgical Technician) 3 and Tech 2 were noted cleaning the room after a cardiac surgery. There were several U.S. fifty cent to dime size drops of blood scattered throughout the floor and visible blood pooled on the floor in various areas around the patient gurney. Tech 3 was wearing nylon material athletic-type (tennis) shoes without covers. The hems of his pants were under the heels of his shoes and they became bloodied, as he walked about, cleaning the room's operating table, gurney, and other equipment. Tech 3 walked through the blood repeatedly and exited and re-entered the operating room.

Other staff, including Tech 2, came into the room, walked through the blood on the floor, and walked back out of room, without shoe protectors. Tech 3 used the same cloth used to wipe the operating table and equipment to wipe off his shoes, and left the room without waiting the one minute required for the Cavicide-1 (disinfectant) to be effective. Tech 3 did not change his bloodied scrub pants and re-entered the room with more blue cloths and continued cleaning.

Tech 3 was observed wiping down the following areas with one 14 X 18 inch blue cloth soaked with what he stated was "Cavicide-1" liquid (all measurements approximate):

1. Operating Room mattress areas, consisting of six areas of about 20-24 square feet total, often stepping into the blood drops on the floor as he did so,
2. 3-4 inch coiled tubing, several feet long, suspended from above,
3. Four more surfaces, about 12 - 16 square feet total,
4. Threw the cloth to a Tech 2, who cleaned up what he stated was "blood" from the bottom area of a cart first, then moved up towards the top of the cart, then threw the cloth in the air back to Tech 3.

Tech 3 then used another 14X18 inch cloth to clean some other items, including the lights and light assemblies. The operating room floor was wet mopped with the blood spill cleaned last.

An interview was conducted with Techs 2 and 3, on 10/30/13, at 3:40 PM, with Mgr 1 and Mgr 2 in attendance. During the interview Tech 3 explained he had begun employment at the hospital with duties that included cleaning the operating rooms after cases were completed and at the end of day doing the very thorough cleaning known as terminal cleaning in February 2012. Tech 2 indicated he began employment with the hospital in 2009. Tech 2 indicated they (referring to Tech 3 and himself) had only been taught how to do the 2-step method of cleaning (referring to cleaning off any visible debris first and then applying the germ killing solution) just a few days ago after the State came and the surveyors had observed them cleaning the operating room. At this recent training Tech 2 said they were taught to get rid of the blood first then use another solution to sanitize. Tech 2 stated he had not been told previously about needing to wear shoe protectors-booties but he was told at this training. Tech 2 confirmed he and Tech 3 cleaned after surgical cases and performed the end of day terminal cleaning as well. When asked if anyone performed competency checks on their abilities to clean the operating rooms, Tech 3 indicated the manager of the central processing department had come around about a month ago and identified areas that he needed to work with staff on. Mgr 2 interjected to say that the central processing department manager oversees the surgical orderlies and central processing staff and he had planned to do more staff education but had been busy with following up on previous survey findings related to instrument sterilization.

Review of the Department-Specific Orientation and Skills List for Techs 2 and 3 was conducted and documentation indicated both employees had been evaluated and shown to be proficient on 9/11/13 in ensuring contaminated spills/debris in the procedural rooms are confined or placed in leak-proof containers. None of the other documented skills appeared to relate to cleaning and disinfection, preventing cross-contamination, or use of personal protective equipment when cleaning up blood or other infectious material.

During an interview with Mgr 1, on 10/29/13, at 2:50 PM, in OR 6, she indicated that according to the hospital's policy the floor should have been first cleaned and then disinfected.

"In the case of contamination with blood/other body fluids or when gross visible debris is present, a thorough cleaning of surfaces and objects must occur prior to disinfection. In order for disinfection to occur properly, the disinfectant must be able to come in direct contact with the intended surface." ...Regarding use of CaviCide1 (Trademark), from the manufacturer, at www.metrex.com/cavicide1.

The hospital's policy titled "Spill Containment" dated revised 3/11, indicated: "The purpose of the policy is to provide a safe procedure in response to a blood or body fluid spill. Supplies needed: spill containment kit." Under Eight-Step procedure the policy indicated the following actions: 1) Put on disposable gloves 2) Completely cover the spill with Vital ITM absorbent beads (this compound instantly deodorizes and binds blood and other body substances 3) When a semi-solid forms, use the pickup shovel to place the congealed fluid back into the white bag 4) Seal the white bag tightly 5) Apply the ready to use Enviro-Safe germicidal, (a product to destroy germs), to the contaminated area and wipe with absorbent cloth provided (referring to the cloth provided in the kit) 6) Discard white bag in medical waste container 7) Remove gloves and wash hands ...8) Sanitize the area with hospital approved disinfectant."

According to the Association for Professionals in Infection Control and Epidemiology (APIC - a multi-disciplinary, voluntary, international organization promoting wellness and prevention of infection) third edition text, "Training of all personnel involved in the generation, handling, transporting, treatment, or disposal of infectious waste is imperative for the infectious waste management plan to be effective. Training should include the definition of infectious waste, handling procedures, appropriate personal protective equipment, hand hygiene, labeling or coding that designates an item as infectious waste, and post exposure management. Records associated with worker training must be maintained by the employer."

These practices potentially placed patients and staff members at risk for transmission of serious infectious diseases caused by blood borne pathogens.

2.d. During an observation on 10/30/13, at 3:10 PM, in the heart catheterization laboratory Room 3, a ceiling vent was noted to be missing paint and/or discolored. This vent was a few feet above the procedure patient gurney table. During a concurrent interview, Mgr 1 stated the vent appeared old, and may need to be replaced.

On 10/31/13 at 1:25 PM, Mgr 1 stated, "It was paint that was peeling off the vent in cath lab 3 (referring to heart catheterization lab number 3)."

According to the 2013 Association of perioperative Registered Nurses (AORN) Perioperative Standards and Recommended Practices under Recommended Practices for a Safe Environment of Care V.g., it states in part, "Preventive Maintenance should be performed on heating, ventilation, and air conditioning (HVAC - a system that helps reduce the amount of air-borne bacteria in the operating room) systems ... A properly functioning HVAC system minimizes the risk of contamination in the sterile field and is an essential component to infection prevention. Failure of the system poses an unnecessary risk for the elective surgical patient."

2.e. On 10/30/13, at 12:30 PM, individuals in street clothes were observed in the corridor hallway that had doors that opened directly into the endoscopy surgical procedure rooms. In a concurrent interview, Mgr 1 indicated this area (referring to the endoscopy perioperative area) does not have a semi-restricted zone. Mgr 1 indicated she had thought of implementing a semi-restricted zone but the physicians came up the stairwell (in their street clothes) and accessed the corridor in the endoscopy area that leads directly into the endoscopy rooms in order to get to a room they used to review their charts.

On 10/31/13, at 11:10 AM, a concurrent review and interview about the 2013 AORN, Recommended Practices for Traffic Pattern in the Perioperative Practice Setting was conducted with Mgr 3. During the concurrent interview, Mgr 3 indicted she followed AORN and APIC for the standards in the endoscopy area. Mgr 3 agreed the endoscopy area was considered a perioperative environment under the Centers for Medicare and Medicaid Services (CMS) definition of surgery. After reading the section in the AORN related to surgical traffic patterns, Mgr 3 acknowledged the endoscopy areas corridor hallway with doors that opened directly into the endoscopy procedure rooms should be designated as a semi-restricted area and currently was not.

Review of the 2013 AORN, Recommended Practices for Traffic Pattern in the Perioperative Practice Setting provided in part the following information: "Traffic patterns should be designed to facilitate movement of patients and personnel into, through, and out of defined areas within the surgical suite. Signs should clearly indicate the appropriate environmental controls and surgical attire required. The semi-restricted area includes the peripheral support areas of the surgical suite. It has....corridors leading to the restricted areas of the surgical suite. Traffic in this area is limited to authorized personnel and patients. Personnel are required to wear surgical attire and cover all head and facial hair."

2.f. During an observation on 10/30/13, at 11 AM, of a Esophagogastroduodenoscopy (EGD - A procedure to examine the lining of the tube that connects the throat to the stomach and the stomach to the first part of the small intestine-bowel) procedure with biopsy (removing a small piece of tissue, the surgeon inserted rubber tubes with increasing widths down the patient's throat to enlarge the patient's esophagus (the tube that connects the throat to the stomach). Throughout the procedure Registered Nurse (RN) 1 was talking to the patient, face-to-face. RN 1 was not wearing a mask or any personal protective equipment on the face. When asked why not, she answered "I'm very careful."

The hospital's policy titled "Bloodborne Pathogen Plan", indicated during endotracheal tube insertion personal protective equipment (PPE), including gloves, gown, mask, and eye protection should be worn. The policy also defined category 1 tasks as tasks that involve an inherent potential for membrane or skin contact with blood, body fluids, or tissues, or a potential for spills or splashes of them. The policy stipulated use of appropriate PPE should be required for every employee involved in category 1 tasks.

2.g. On 10/29/13, at 11:55 AM, Tech 1 was observed in OR 9 wearing a cap on his head that exposed his side-burns and hair at the nape of his neck. In a concurrent interview, Tech 1 stated he knew all his hair should be covered, and explained he had just come back from lunch.

On 10/29/13, at 2:20 PM, MD 1 was observed with a paper cap on his head with the cap knotted on the top of his head and side-burns and hair at the nape of his neck exposed. During a concurrent interview with Mgr 2 and MD 1, Mgr 2 requested MD 1 cover all of his hair with the head cap and he did not comply.

On 10/29/13, at 2 PM, RN 2 was observed entering and then exiting OR 2 with her mask dangling around her neck.

The 2013, Perioperative Standards and Recommended Practices, published by AORN was reviewed. Under Recommendation II, direction was given that, "Personnel should cover head and facial hair, including sideburns and necklines, when in the semi-restricted and restricted areas of the surgical suite. A clean, low-lint surgical head cover or hood that confines all hair should be worn.... Shedding from hair has been shown to affect surgical wound infection; therefore, complete coverage is necessary."

Under Recommendation V1 b.1. direction was given that "Masks should not be worn hanging down from the neck." Under Recommendation VI .c. further direction was given that "Surgical masks should be discarded after each procedure."

2.h. On 10/29/13, at 11:40 AM, a pair of unwrapped scissors were observed available for use in the first drawer of the anesthesia cart located in OR 9, along with wrapped patient supplies. The scissors were observed to have reddish brown colored spots on the blade surfaces. During a concurrent interview, Mgr 1 indicated the scissors needed to be removed and re-sterilized.

On 10/30/13, at 9:30 AM, in the endoscopy area, a drawer was observed to contain various patient supplies, such as opened packages of nasogastric strips (adhesive strip to hold a tube in place), closed packages of sterile catheters and office supplies, such as paperclips, note paper, post-it notes. In a concurrent interview, Mgr 3 indicated patient supplies should not be stored with office supplies.

Review of the hospital's policy titled "Storage of Patient Care Supplies", dated approved 9/17/13, indicated "In order to maintain sterility, processed sterile items will not be stored with non-sterile items."

2.i. On 10/29/13, at 11:50 AM, in OR 9, the material covering the patient gurney mattress and patient arm rest were observed to have small holes and white sticky paper substance stuck to several surfaces. In a concurrent interview, Mgr 2 stated, "I did not know about this (referring to the holes in the patient gurney mattress and arm rest)." Mgr 2 stated the staff knew they are supposed to clean tape off the gurney before they used the CavaCide (referring to the disinfectant CavaCide 1 being used to kill germs on operating room surfaces).

On 10/29/13, at 2:05 PM, in OR 2, the material surfaces covering a rolling stool and arm board were observed to have small holes and a white sticky paper substance were observed stuck on the arm board. In a concurrent interview, Mgr 2 indicated new arm boards had been ordered and she acknowledged furniture with torn materials should not be in the operating rooms.

A review of the manufacturer's instruction titled "CaviCide 1: Surface disinfectant, decontaminant cleaner" (EPA Registration No. 46781-12) was conducted and indicated the product was for use on hard non-porous inanimate surfaces.

3. During an interview with Mgr 1, on 10/31/13, at 3:45 PM, when asked why many infection control deficiencies had been identified during the survey, described under section 749 of the survey findings report, had been either previously identified and not been resolved, Mgr 1 stated "It's hard to say". Mgr 1 stated the hospital was more proactive in implementing corrective actions and had implemented regular environmental rounding and formal processes meeting twice a week. Mgr 1 indicated all unit directors, infection control preventionists, and the chief nursing officer participated in the meetings. Mgr 1 indicated the quality manager, risk manager, chief operating officer, and chief medical officer participated in the weekly meetings as their schedules permitted.

During an interview with Mgr 2 on 10/31/13, at 3:00 PM, when asked about staff training in the perioperative areas, she stated the training was behind. Mgr 2 stated the individual who did competency checks had been pulled away to work with problems identified in the central processing department. Mgr 2 stated there had been lots of changes in requirements and implementation of new processes starting 18 months ago. During an interview on 10/29/13, at 10 AM, in response to continued problems with sterilization of surgical instruments, Mgr 2 stated "We need to continue to do education for staff. Not all the staff appreciates the importance of doing this [opening hinged instruments fully and not stacking instruments]. We need to broaden the scope of our education."