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Based on interview and record review, the facility failed to ensure that all capital expenditures (new items purchased), as part of the Institutional Plan and Budget, were reviewed by members of the Medical Staff. This failure is evidenced by 1) allowing the Chief Operating Officer (COO) to review and delete possible capital expenditures before they were reviewed by the Medical Staff and 2) allowing the construction committee to vote on important purchases without Medical Staff representation. This failure increased the risk of 1) limited physician involvement in planning hospital purchases and 2) a poor patient health outcome for all facility patients.

Findings:

During an interview with the COO and the Chief Medical Executive (CME), on May 15, 2014, at 10:10 AM, facility capital expenditures were discussed. The COO stated that, at that time, the facility did not have a Capital Review Committee to review capital expenditures. During a follow-up interview on May 15, 2014, at 3:00 PM, the COO clarified that all capital expenditure requests were pre-screened, and some items were deleted by the COO, before Medical Staff review. Thus, this pre-screening was performed before Medical Staff members had a chance to review the list and vote on the capital expenditures.

During a review of the CPMC Capital Program Informational Binder, dated May 14, 2014, a review of the form "CPMC 2014 Program and Budget Items Requested but NOT Approved" indicated on the second line, an OB Ultrasound (machine that creates a picture of the baby using sound, during pregnancy). This capital expenditure was not approved. According to the facility form, the equipment price was less than $300,000 dollars and so did not need a "Physician Reviewer." According to the last page of the form, 43 medical equipment requests were denied for that time period. Review of the Committee Member list for the "Construction Committee" indicated the absence of Medical Staff Members on the Committee. These findings were verified by the COO per interview on May 15, 2014, at 3:00 PM.

Based on interview and record review, the facility failed to ensure that the Governing Body evaluated the Laundry contracted service to make sure the Laundry services were provided in a safe and effective manner. This failure increased the risk of a poor health outcome, including infection, for all facility patients.

Findings:

During an interview with the Administrative Director of Logistics (ADL), on May 16, 2015, at 10:25 AM, he was asked to provide documented evidence that the Governing Body had evaluated the quality and safety of the laundry services provided under the contract with Specialized Laundry Service, Inc. He was unable to provide documented evidence of the Governing Board's evaluation of this contracted service.

During a review of the Supply Agreement (contract), dated April 4, 2011, indicated "During the Term of this Agreement, Supplier (the laundry company) agrees to sell the products listed on the attached Exhibit A, and (facility name) agrees to purchase products from supplier at the prices and in accordance with the terms and conditions set forth herein."

During a review of the "Amended and Restated Bylaws of Sutter West Bay Hospitals (Governing Body), effective May 1, 2013, indicated the requirements for the Quality and Safety Committee (a sub- committee of the Governing Body). "The Quality and Safety Committee shall ...conduct appropriate monitoring and oversight to ensure that the quality and safety functions of the hospitals and facilities are being consistently and effectively performed so as to enhance the quality of patient care and assure patient safety."

Based on interview and record review the facility did not ensure that the responsibility for the organization and conduct of the Medical Staff was assigned to only one physician. This failure increased the risk of 1) limited physician involvement in the facility Medical Staff Affairs and 2) poor quality healthcare.

Findings:

During an interview on May 13, 2014, at 9:40 AM, in the facility 1 conference room, the team was introduced to the Chief Medical Executive (CME) and the Department Chairman of Medicine (DCM). When it was mentioned that the CME and DCM may have job duties similar to the Chief of Staff (COS- Chief Officer of the Medical Staff), both the CME and DCM stated that their job duties were different, than the COS, because they had administrative job duties in addition to Medical Staff duties. The CME and the DCM added that they "work as a team" with the Chief of Staff (COS).

During an interview with the COS and CME on May 13, 2014, at 11:20 AM, in the facility 2 conference room, the COS was asked how adverse events (events with potential to cause harm to patients) and peer review events (physician actions that are reviewed) were handled, by himself, and the Medical Staff. The COS answered that the Administration had informed the Medical Staff about a Red Event (adverse event) that occurred recently. The CME added that Red Event notices are widely dispersed by the administration to everyone concerned.

During an interview with the DCM on May 14, 2014, at 9:30 AM, the DCM provided an email which described the Red Event mentioned earlier. He stated that the "Medical Staff was informed of the event."

During a review of the above mentioned email, regarding the Red Event, dated April 16, 2014, at 6:36 PM, the email included a description of the Red Event and informed the recipients of the "Action Plan" that had been created and followed. There was no documented evidence of COS or Medical Staff participation or action involving the described Red Event.

During a review of the CME's job description, revised May 29, 2013, indicated under "Primary Purpose ...The CME oversees medical department chairs (physicians in charge of each hospital department) and selected medical directors, and manages the relationships among physician activities at (facility name)." "The CME also represents the Medical Staff's interests to Administration."

During an interview with the CME on May 15, 2014, at 1:45 PM, he confirmed that all of the Department Chairmen of the facility reported directly to both the COS (Medical Staff Officer) and the CME (an administrative position).

During a review of the job description for the COS, undated, indicated "Chief of Staff shall ...represent the views, policies, needs and interests of the Medical Staff to the Board (Governing Body) and the CEO." Also, "Additional administrative services of Medical Staff Officers (ex. COS) ...providing support and counsel to the Hospital's Departmental Chairs."

During a review of the Medical Staff Bylaws, dated November 7, 2013, indicated "The term "Chief of Staff" means the chief officer of the Medical Staff elected by members of the Medical Staff ...The purposes of this organization are to strive to maintain and improve the quality of care rendered and provide oversight of care, treatment, and services provided by all practitioners authorized to practice in the Hospital ..."

During a review of the DCM job description provided, titled "Physician Duties and Services," undated, indicated "The chair (the DCM) shall report to the Vice President of Medical Affairs (VPMA- or-CME) ... To ensure that the quality of care provided by attending physicians and house staff physicians meets the department's standards." Also, "Meet with the VPMA (the CME) on an annual basis to establish goals and objectives for the department."

During a review of the Medical Staff Bylaws, dated November 7, 2013, indicated under the duties of the Administrative Staff "Assist administration and the Medical Staff in carrying out medical-administrative functions; submit documentation of eligibility for Medical Staff membership; when appropriate, attend department meetings, committee meetings and educational programs, but shall have no right to vote at such meetings, except to the extent the right to vote is specified at the time of appointment."

Based on observation, interviews, and medical record reviews the hospital failed to provide an environment to avoid sources and transmission of infections and communicable disease in accordance with nationally accepted infection control guidelines and hospital policy as evidenced by the hospital's failure to have effective systems in place to ensure:


A. Staff persons were knowledgeable and competent to effectively disinfect shared patient glucometer equipment between patient uses (Refer to 749, item 1).


B. Staff persons were knowledgeable and competent to effectively clean and disinfect hospital environments in accordance with nationally accepted infection control guidelines and manufacturer recommendations (Refer to 749, item 2.a.-2.c).


C. Staff wore appropriate surgical attire in the endoscopy suite and surgical perioperative areas in accordance with nationally acceptable policy and facility policy (Refer to 749, item 3a.-c).


D. Participating hospital providers were screened for vaccine presentable diseases in accordance with hospital policy and nationally accepted infection control guidelines (Refer to 749, item 4).


E. There was a system in place to ensure surgical instruments were sterilized in a position that ensures adequate steam contact with all surfaces. (Refer to 749, item 5).


F. A sterile item removed from it packaging was not available for patient use (Refer to 749, item 6).


G. Sterile supplies were stored under monitored environmental conditions for temperature and humidity in accordance with nationally accepted infection control guidelines (Refer to 749, item 7).


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.

Based on observations, staff interviews, and document reviews the infection control officer failed to develop effective systems for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel in accordance with facility policy and nationally recognized infection control guidelines as evidenced by the failure to ensure:

1. Staff persons were knowledgeable and competent to effectively disinfect shared patient glucometer equipment between patient uses

2. Environmental cleaning was performed in accordance with nationally accepted infection control guidelines and the manufacturer's guidelines when staff:

a. Did not allow adequate wet surface contact time with the disinfectant.

b. Cleaned using techniques that caused surfaces to become contaminated.

c. Attempted to disinfect operating room gurney mattress surface without first removing tape residue and attempted to disinfect an OR gurney surface that had pin-prick tears on the surface (the surface was porous).

3. Staff wore appropriate surgical attire in the endoscopy suite and surgical perioperative areas in accordance with nationally acceptable policy and facility policy when:

a. Surgical masks were worn around the neck

b. Facial hair was uncovered in the semirestricted areas

c. Non scrubbed staff had their arms uncovered in the restricted areas of the perioperative suite

4. Participating staff members were screened for vaccine presentable diseases in accordance with current hospital and in accordance with hospital policy and nationally accepted infection control guidelines.

5. There was a system in place to ensure surgical instruments were sterilized in a position that ensures adequate steam contact with all surfaces.

6. A compromised sterile supply item was not available for patient use.

7. Sterile supplies were stored under monitored environmental conditions for temperature and humidity in accordance with nationally accepted infection control guidelines.

Findings:

1. An interview was conducted with RN 3 on 5/15/14 at 2:30 p.m.in the ambulatory surgery unit located at Facility 2. When asked how she cleaned the glucometer (a devise that measures blood sugar levels) that was shared among patients needing this test, RN 3 stated she wiped the machine with a sani-cloth from the grey topped bottle(referring to the product sani-cloth AF3). When asked how long the machine needed to be visibly wet with the sani-cloth solution in order to kill the germs that may be on it, RN 3 stated, "About a minute." When asked when the glucometer should be cleaned, RN 3 indicated the glucometer was cleaned daily when the quality check was done and when it was visibly bloody.


An interview was conducted with RN 4 on 5/15/14 at 2:35 p.m. in the ambulatory surgery unit located at Facility 2. When asked how she cleaned the shared patient glucometer, RN 4 stated she cleaned it was cleaned with a sani-cloth contained in the grey/clear topped bottle (referring to the product sani-cloth AF3). When asked how long the glucometer needed to be visibly wet with the sani-cloth solution in order to kill the germs that may be on it, RN 4 stated. "I'm not sure, I would have to look it up." When asked when the glucometer should be cleaned, RN 4 indicated the glucometer was cleaned once on day shift and when it was visibly dirty or bloody. RN 4 stated she received training on when and how to clean the glucometer from the point of care people in the lab, and was tested for competency annually.

Review of the hospital's policy titled "Glucose Test Procedure", dated 8/23/13, was reviewed. The policy stipulated, "The FDA, CDC, and CMS have published updated requirements for disinfection of point of care devises. Glucose meters must be cleaned and disinfected after each patient using Hospital approved wipes ... Ensure the meter surface remains wet for 3 minute."

Review of product information for sani-cloth AF3, EPA registration number 9480-9, indicated it had a kill time (the time the surface needs to remain visibly wet to kill the harmful organisms/germs) of three minutes.

Failure to disinfect the glucometer effectively and after each patient use placed patients at risk for transmission and potential infection from bloodborne pathogens such as hepatitis B, C, and HIV.

2.a. An interview was conducted with RN 1 on 5/14/14 at 10:40 a.m. in the neonatal intensive care unit at Facility 2. RN 1 explained she was responsible throughout her work shift for keeping the counters in the patient areas she worked cleaned and disinfected. When asked what product she used, she indicated she used the sani-cloths contained in the bottle with the grey/clear tops (referring to sani-cloth AF3). When asked how long the surfaces needed to remain visibly wet with the sani-cloth soultion to kill the microorganisms, RN 1 stated "Probably a few seconds." RN 1 stated she had worked at the hospital for 25 years.

An interview was conducted with RN 2 on 5/14/14 at 10:45 a.m. in the neonatal intensive care unit located at facility 2. During the interview RN 2 acknowledged she was responsible throughout her work shift for keeping the counters in the patient areas she worked cleaned and disinfected. When asked how long the surfaces needed to remain visibly wet with the sani-cloth solution to kill the microorganisms (germs), RN 2 stated "I don't know how long it needs to stay wet."

Review of product information for sani-cloth AF3, EPA registration number 9480-9, indicated it had a dwell time (the time the surface needs to remain visibly wet to kill harmful organisms/germs) of three minutes.

In a meeting on 5/14/14 at 1:20 p.m. at facility 2, EVS Lead explained the product SaniMaster 4 was used to clean and disinfect all surfaces in the perioperative area. EVS Lead indicated SaniMaster 4 had a dwell time listed on the label of either 5 or 10 minutes (depending on the organisms selected for elimination). EVS Lead stated that if 24 cloths were soaked in ? gallon of SaniMaster 4 when applied to surfaces the surface would remain visibly wet for 10 minutes.


On 5/14/14 at 3:10 p.m.in operating room (OR) 6 located at facility 2, EVS 4 was observed soaking 24 cloths in 1/gallon of SaniMaster 4 solution. EVS 4 was then observed performing terminal cleaning the OR with SaniMaster 4 solution. EVS 4 wet the patient gurney in OR 6 with SaniMaster 4 solution and it was observed to begin to dry in one minute. The gurney was observed to be completely dry three minutes after the initial application. At no time did EVS 4 re-wet the surface as the gurney dried. In a concurrent interview, OR Mgr acknowledged the gurney dried in three minutes and the product being used to clean the operating rooms (ORs),SaniMaster 4, required the surfaces to be visibly wet for either 5 or 10 minutes. When shown the organisms that would not be eliminated if the 5 minute kill time was chosen, OR Mgr stated, "I want to kill all the organisms, we need the 10 minute kill time."


A review of the manufacturer's instructions for use for SaniMaster 4 surface disinfectant, decontaminant cleaner" (EPA Registration No.3377-58-1677) was conducted. Product information revealed it was bactericidal for many organisms including pseudomonas aeruginosa and staphylococcus aureus with a 10 minute dwell time.


On May 13, 2014, at 1:30 pm, during observation and interview, EVS 1 cleaned the "Taylor" Operating Room between surgeries. EVS 1 stated "SaniMaster 4 is the facility's disinfectant and it immediately kills on contact, like 3 minutes." EVS 2 applied SaniMaster 4 to the procedure table. Before 3 minutes passed, the head of the procedure table was dry and the remainder was approximately ? dry, verified by ICP. When asked the disinfecting dwell time of "SaniMaster 4, ICP 1 stated "3 minutes." The following manufacturer's directions for SaniMaster 4 were reviewed with ICP 1: "DISINFECTION: To disinfect inanimate, hard non-porous surfaces ...Apply solution ...so as to wet all surfaces thoroughly. Allow to remain wet for 10 minutes "
On May 14, 2014, at 9:45 am, during interview, ICP 1 stated "SaniMaster 4 requires a 10 minute dwell time."
According to Sutter Health CPMC, Policy and Procedure, Policy Number 600.5911, Surgical Services, Cleaning of the Surgical Practice Area, Reviewed Date 4/14: "Cleaning procedures are performed ...to reduce the amount of dust, organic debris, and microbial load in the surgical environment. Operating rooms are cleaned before and after each surgical procedure ...Environmental Protection Agency (EPA)-registered hospital approved disinfectant is used for cleaning. Manufacturer ' s directions for use ...of the disinfectant are followed when using and preparing solution."
According to Ecolab (distributor of SaniMaster 4 quaternary ammonium disinfectant), Contact Time and Disinfectants, 2013: " Using EPA-registered disinfectants is critical to achieving improved environmental outcomes, and it's just as important to ensure that the disinfectants stay wet on surfaces for the required contact time. As stated in the CDC [Centers for Disease Control and Prevention] Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2008, federal law requires all applicable label instructions on EPA [United States Environmental Protection Agency]-registered products to be followed. Contact time (or dwell time) is the length of time a disinfectant ' s label states that it must remain wet on a surface in order to achieve efficacy. This time is determined through laboratory testing, the results of which are reviewed and approved by the Antimicrobials Division of the United States Environmental Protection Agency. As it is usually unknown which specific microorganisms are on surfaces, it is generally recommended that users follow the longest contact time listed on the product label.Most dilutable, quaternary-based disinfectants (quats) currently available in the market are very effective at killing a broad range of microorganisms, and have a ten minute contact time. However, a single application of quat usually does not leave surfaces wet for ten minutes. Non-compliance with contact times may mean that surfaces are not being properly disinfected and that pathogens could survive even after application. In order to meet a contact time of ten minutes, additional applications of product are usually needed ... "
On May 13, 2014, at 1:00 pm, during interview, ICP 1 stated the facility follows AORN (Association of periOperative Registered Nurses) nationally recognized infection control guidelines.
According to the Association of periOperative Registered Nurses, Perioperative Standards and Recommended Practices, Recommended Practices for Environmental Cleaning in the Perioperative Setting, 2013: "The patient should be provided a clean, safe environment. Health care-associated infections have been linked to external sources, which can include environmental surfaces. Environmental surfaces can serve as a means of secondary transmission by providing a reservoir for infectious organisms ...showing the importance of environmental cleaning and disinfection as part of an infection prevention process in reducing microbial bio-burden in the environment, thereby interrupting microorganism transmission."
Notably, according to the Centers for Disease Control and Prevention / Healthcare Infection Control Practices Advisory Committee, Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008: "Antimicrobials are regulated by the EPA [United States Environmental Protection Agency] and FDA [United States Food and Drug Administration] ...Any substance or mixture of substances intended to prevent, destroy, repel, or mitigate any pest (including microorganisms) must be registered and users must explicitly follow the labeling directions on each product, i.e., It is a violation of federal law to use this product in a manner inconsistent with its labeling." Thus, health-care workers must follow the safety precautions and use directions on the labeling of each registered product. Failure to follow the specified use-dilution, contact time, method of application, or any other condition of use is considered a misuse of the product and potentially subject to enforcement action.
Failure to effectively disinfect the hospital operating room environment placed surgical patients at risk for transmission and potential infection from harmful organisms.

2. b. On 5/14/14 at 3:20 p.m.in operating room (OR) 6 located at Facility 2, EVS 4 was observed cleaning. EVS 4 was observed cleaning the feet of a metal table, the cloth touching the floor, and then using the same cloth to clean the legs and the top of the table (which he had previously cleaned). EVS 4 was observed cleaning the wheels of a stool, the cloth touching the floor, and then using the same cloth to clean the seat of the stool. In a concurrent interview OR Mgr acknowledged staff persons were supposed to clean from top to bottom, and OR Mgr was cleaning from bottom to top and contaminating surfaces with a dirty cloth.

In a meeting on 5/14/14 at 1:20 p.m. at facility 2, EVS Lead stated it was the hospital's policy that staff persons should clean from clean to dirty, from high (referring to height of surfaces) to low, and from left to right.

The Association for Professionals in Infection Control and Epidemiology (APIC) 3rd edition text chapter 100 titled "Environmental Services" was reviewed. The text stipulated, "Cleaning schedules and procedures should progress from the least soiled areas to the most soiled and from high surfaces to low ones. Routine cleaning is necessary to maintain a standard of cleanliness. Procedures must be effective, consistent, and thorough."
Failure to effectively clean and disinfect the hospital operating room environment placed surgical patients at risk for transmission and potential infection from harmful organisms.

2.c. On 5/13/14 at 12:30 p.m. in a hospital operating room, after EVS 5 was observed cleaning the patient gurney mattress in Operating Room 8 located at Facility 2, the material covering the patient gurney mattress was observed to have small pin point holes and white sticky paper substance stuck to several surfaces. Later, after staff removed the tape the pinpoint tears were still observed visible on the mattress surface. In a concurrent interview with ICP 2, she acknowledged the tape would need to be removed before the disinfectant would be able to work.

According to the 2008 CDC Guideline for Cleaning and Disinfection in Healthcare Settings, Cleaning is the removal of visible soil (e.g., organic and inorganic material) from objects and surfaces and normally is accomplished manually or mechanically using water with detergents or enzymatic products. Thorough cleaning is essential before high-level disinfection and sterilization because inorganic and organic materials that remain on the surfaces of instruments interfere with the effectiveness of these processes.

A review of the manufacturer's instructions for use for SaniMaster 4 surface disinfectant, decontaminant cleaner" (EPA Registration No.3377-58-1677) was conducted and revealed surfaces must be cleaned before application of the disinfectant and the product was for use on hard non porous inanimate surfaces.

On May 13, 2014, at 1:20 pm, during observation and interview in the "Taylor" Operating Room, EVS 1 and EVS 2 used SaniMaster4 (disinfectant) on a procedure table that had areas of adhesive residue and an equipment cart that had areas with corrosion and without paint. ICP 1 verified the observations and stated the residue should be removed and the corrosion and missing paint make disinfection difficult.

According to Ecolab (distributor) SaniMaster 4 (disinfectant) directions: "To disinfect inanimate, hard non-porous surfaces ...For heavily soiled areas, a pre-cleaning step is required."
Notably, according to the Centers for Disease Control and Prevention / Healthcare Infection Control Practices Advisory Committee, Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008: "Environmental surfaces can become contaminated with infectious agents and contribute to the spread of health-care-associated infections ...Surface type ...affects cleaning effectiveness because the surface irregularities can shield microorganisms from disinfection products."

According to the Centers for Disease Control and Prevention, New and Updated Questions and Answers About Cleaning, Sanitizing, and Disinfectants, 2008: "In general, cleaners don't disinfect, and disinfectants don't clean ...before you use the detergent/disinfectant product to disinfect a surface, the surface should be cleaned. Soil, dirt, dust, and organic matter all can often interfere with the active ingredients of disinfectants. Removing dirt from a surface by cleaning the surface before using a disinfectant will make sure it is most effective. Most products will use the words 'precleaned surface' to point out that a surface should be cleaned before using the disinfectant. "

3.a. On 5/13/14 at 11:55 a.m., OR Mgr was observed in operating room 1 at Facility 2 with a surgical mask hanging around her neck. In a concurrent interview, OR Mgr acknowledged the mask around her neck, stating, "I forgot, it 's not common practice (referring to wearing the mask around her neck). "

On 5/13/14 at 12:25 p.m. MD 1 was observed in a hallway of the perioperative suite at facility 2 with a surgical mask hanging around his neck. In a concurrent interview, OR Mgr acknowledged MD 1 had a surgical mask hanging around his neck.

During an interview in the perioperative suite of facility 2 on 5/13/14 at 12:50 p.m., OR Mgr stated the hospital followed AORN and hospital policy for surgical attire requirements.

Review of the hospital's policy titled "Attire for Surgical Services and Procedural Areas", revised 3/14, was conducted. The policy stipulated under V.a. and V.b. Semi-restricted area/restricted area, "Masks should be changed by all personnel between each case. Masks may not be saved by hanging them around the neck or in a pocket for future use."

The 2014 AORN Perioperative Standards and Recommended Practices, under Surgical Attire, stipulates, under Recommendation VI.b.1., "Masks should not be worn hanging down from the neck. The filter portion of a surgical mask harbors bacteria collected from the nasopharyngeal airway. The contaminated mask may cross-contaminate the surgical attire top."

3.b. On 5/13/14 at 12:50 p.m. OR3 was observed with his mustache uncovered in the hallway outside the operating rooms at Facility 2. In a concurrent interview, OR Mgr indicated OR3 wore a full mask over his face when scrubbed but did not need to cover his mustache when in the semirestricted area of the perioperative suite. OR Mgr stated the hospital followed AORN and hospital policy for surgical attire requirements.

Review of the hospital's policy titled "Attire for Surgical Services and Procedural Areas ", revised 3/14, was conducted. The policy stipulated under V.a. Semi-restricted area, "Surgical head covers/hoods shall confine all head and facial hair, including sideburns and the nape of neck." The policy referenced AORN standards, Recommended Practices and Guidelines, 2012 edition.

3.c. On 5/15/14 at 10:45 a.m. in operating room (OR) 2 located at Facility 2, a circulating registered nurse was observed wearing sterile gloves, and a short sleeved scrub top preparing a sterile field in OR 2 (a restricted area located within the perioperative suite). In a concurrent interview, OR Mgr indicated the circulating registered nurse did not need to wear long sleeves because the procedure was an airway procedure.

During an interview in the perioperative suite of facility 2 on 5/13/14 at 12:50 p.m., OR Mgr stated the hospital followed AORN and hospital policy for surgical attire requirements.

Review of the hospital's policy titled "Attire for Surgical Services and Procedural Areas " , revised 3/14, was conducted. The policy stipulated under V.a. and V.b. Semi-restricted area/restricted area, "All non-scrubbed personnel should wear a freshly laundered or single-use long warm-up jacket snap closed with the cuffs down to the wrist to cover bare arms and /or exposed undergarments."

4. On 5/15/14 at 10;45 a.m. during an interview with CME in a conference room at Facility 2 , he explained the hospital's current immunization screening program for participating providers was limited to offering participating providers annual influenza immunization and screening them annually for tuberculosis. The CME explained the hospital was in the process of developing and implementing a immunization program for participating providers that will be the same as the immunization program implemented for its employees. The CME acknowledged the hospital's employee immunization program was based on the Centers for Disease Control and Prevention (CDC) healthcare worker immunization guidelines.

During an interview with the CME on 5/15/14 at 2:50 p.m., he acknowledged the hospital's current immunization screening program for participating providers, which was limited to offering participating providers annual influenza immunization and screening them annually for tuberculosis, was not based on any nationally accepted infection control standard(s).

Immunization records were reviewed for 20 participating providers (P1-P20). Three providers did not have any patient contact and these records (P13, P18, and P20) were removed from consideration reducing the sample size to 17. The review revealed that there was documentation of the tuberculosis status for only three of the 17 participating providers reviewed (P11, P12, and P17). Documentation of Flu vaccine provided or declination present in chart was present in 10 of the 17 providers reviewed (P1, P3, P4, P5, P6, P10, P11, P12, P17, and P19). Three of the 17 participating providers had evidence of hepatitis B screening (P12, P17, and P19). Only two of the 17 providers had evidence of screening for measles, mumps, rubella, and varicella (MMRV) (P12 and P19) and P17 had evidence of screening for measles, rubella, and varicella but not for mumps.

The Centers for Disease Control and Prevention (CDC)/ACIP is nationally recognized and accepted for immunization guidelines for the public and healthcare workers. According to the CDC Morbidity and Mortality Report (MMWR) MMWR. 2011;60 (RR07):1-45 "Healthcare workers (HCP) include physicians, dental professionals administrative staff, and ... 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." The CDC provides detailed recommendations for these vaccinations in the MMWR document cited at the beginning of this paragraph.
The 2010 Cal/OSHA 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: Measles, mumps, rubella, varicella, tetanus, diphtheria, acellular pertussis and seasonal influenza.

The OSHA Bloodborne Pathogens standard, 29 CFR 1910.1030, accessed online, 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.

Not having an immunization program for participating providers that screens and offers vaccine preventable immunizations based on nationally accepted infection control guidelines places hospital patients at increased risk of transmission and infection from vaccine preventable diseases such as hepatitis B. influenza, measles, mumps, rubella, pertussis, and varicella. Deficient practice with implementing the screening program in place for screening participating providers for tuberculosis and offering influenza also places at patients at increased risk of communicable disease transmission and infection.

5. On 5/13/2014 at 11:40 p.m. three bins of surgical instruments were observed in a operating room sterile supply storage area at Facility 2. 13 Kelly Forceps (handheld, hinged instrument used for grasping and holding objects).Two (2) Mayo Scissors ( a type of surgical scissor), and one Jake Clamp (A hinged instrument used for fine dissection around delicate vascular and nerve structures and also for ligation of small blood vessels).. All the instruments were enclosed in a double peel pack (Peel-apart pouches with a see-through front and paper backing that are sealed and used to contain single instruments or small loads for sterilization and subsequent storage. Double peel pack indicates instrument(s) are enclosed in a pouch within a pouch.). All instruments had tips touching and blades closed. The hinged instruments, the Kelly and Jake clamp had their ratchets in the unlocked position. During a concurrent interview with OR Dir when asked if the instruments needed to be positioned in the open position when sterilized, OR Dir stated, " The size of packet (referring to the inner pouch of the peel package where the instrument was enclosed) does not permit the instrument to be open. " OR Dir indicated the instrument did not need to be open to be sterilized and stated, "That's why we use the indicators" (referring to the use of indicators placed inside and outside the peel pouch to indicate if sterilization parameters are reached). OR Dir stated the hospital followed AAMI (Association for the Advancement of Medical Instrumentation) for sterilization guidelines.

On 5/13/14 at 2:30 PM during an interview with SPD3 in the operating room sterile supply storage area while looking at the packages of sterilized instruments described above at facility 2, he stated, "Everything should be open"(referring to the need for the instruments to be open during sterilization). We might need to go to next size (referring to enlarging the inner pouch that the mayo scissors/clamps were stored within the peel pouch so the instruments could be opened for sterilization). It's very important to have the instruments open so the steam can penetrate. Old hires may not be getting the message." When asked if SPD3 felt confident the instruments described above in OR had been sterilized in the open position, he stated, "No they (referring to the instruments) need to be reprocessed."

On 5/14/14 an interview was conducted with SPD3 at 9 a.m.at the sterile processing department located at Facility 2. SPD3 explained the hospital's system was to position instruments to remain open during the sterilization process by placing them on a card with the tips in the open position under a tight piece of plastic and a piece of rubber in the middle portion of the instrument to keep the blades apart. SPD3 stated he had trained all his new hires to follow this system starting a few years ago and he had talked to the other SPD employee in huddles about using this card system. SPD3 stated he had concerns that two or three of his staff were not following the procedure. When asked if the standard of work (the Hospital's step-by-step procedure) indicated if instruments needed to be open for sterilization, SPD3 stated it was not currently on the standard of work but it could be added.

Review of the hospital's policy, titled "Packaging Procedures for Preparing Items for Sterilization " , revised 2/13 and reviewed 2/14, was conducted. No documentation was found related to positioning of surgical instruments to ensure steam contact with all surfaces during sterilization.

On 5/16/14 the standard of work (the Hospital's step-by-step procedure) for sterilization processes was requested, The RM stated the hospital did not have a standard of work for sterilization processes and only had a standard of work for high level disinfection processes.

Review of 2013 AAMI guidelines (ST 79:2010; A1:2010; A2:2011; A3: 2012; A4:2013-consolidated text) was conducted. The guidelines stipulate under Preparation and Assembly of Surgical instrumentation, page 75, "Instruments should be sterilized in ...or containment devises ... with all instruments held open and unlocked ... " " Individual instruments may be packaged in an acceptable packaging material with the instruments held open, unlocked, or disassembled and sterilized in a position that ensures adequate steam contact with all surfaces."

6. On 5/13/14 at 11:50 a.m. unpackaged suction tubing was observed resting on top of two sterile packages containing suction tubing in an anesthesia cart located in an OR at Facility 2.

During an interview with OR3, he indicated the suction tubing was sterile and should always be packaged. He indicated the unpackaged tubing should be thrown away.

7. On 5/14/14 at 9:30 a.m., during a tour of the pediatric emergency department located at Facility 2, sterile supplies were observed stored in the Pixis machine (a machine that is password protected and dispenses medications and supplies similar to a vending machine) in room five. There was no evidence that the temperature and humidity was being monitored in the room the supplies were stored. In a concurrent interview ICP 2 confirmed sterile supplies were stored in the Pixis and acknowledged temperature and humidity should be monitored in an area where sterile supplies are stored.

During an interview on 5/13/2014 at 11:40 p.m. with the OR Dir in the perioperative suite located at Facility 2, she stated the hospital followed AAMI (Association for the Advancement of Medical Instrumentation) for sterilization guidelines.

Review of 2013 AAMI guidelines (ST 79:2010; A1:2010; A2:2011; A3: 2012; A4:2013-consolidated text) was conducted. The guidelines under the section titled "Storage Facilities", stipulated, "Sterile items should be stored in a manner that reduces the potential for contamination, In general the temperature in storage areas should be approximately 75 degrees Fahrenheit. There should be at least four air exchanges per hour, and relative humidity should be controlled so that it does not exceed 70% (AIA 2006)."

Based on observation, interview and record review, the facility failed to ensure surgical care services policies and procedures were implemented for appropriate cleaning between surgical cases, appropriate terminal cleaning, hand hygiene and acceptable operating room attire. These deficient practices had the potential for cross-contamination and to expose all patients undergoing surgery to microorganisms-causing infection.

Findings:

1. During an observation on 5/13/14 at 2:35 PM, at the California West Campus, in Operating Room 8, the inbetween case cleaning was monitored. EVS 3 was wiping the OR gurney with pre-soaked cloths with Sani-Master 4( cleaning solution). EVS 3 was missing spots needed to be cleaned on the mattress. The cleaning solution was allowed to dry within a minute. EVS 3 continued to clean tubes lying on the floor, then wiped the foot of the gurney, then used the same cloth to wipe the mattress again.

Review of manufactures guidelines for "SaniMaster 4" dated 2010, indicated, "...so as to wet all surfaces thoroughly. Allow to remain wet for 10 minutes, then remove excess liquid."

During an interview on 5/13/14 at 2:45 PM, OR Manager and OR Director both stated, " we were not aware of the 10 minute contact time for Sani-Master 4."

During an observation on 5/14/14 at 10:40 AM, at the California West Campus, in Operating Room 2, the inbetween case cleaning was monitored. EVS 3 cleaned the IV Pole from top to bottom and used the same cloth to wipe the table. EVS 3 removed tape from the gurney but didn't reclean the gurney after removing tape.

During an interview on 5/14/14 at 10:50 AM, OR manager stated, "the gurney should have been rewashed after the tape was removed."

During an interview on 5/14/14 at 1:15 PM, EVS Lead Manager for all campus's stated, "Cleaning is supposed to be from clean to dirty, top to bottom, high to low, and left to right."
It was observed that the EVS staff did not follow this instruction. "After training, EVS staff will return demonstration after training." There were no audits done for cleaning the OR.

During an interview on 5/14/14 at 3:00 PM, OR manager stated, "I thought that it was 5 minute contact time but when I looked at the bottle it was 10 minutes. I was not trained about Sani-Master 4 when I became manager."

During an observation on 5/14/14 at 3:15 PM, at the California West Campus, in Operating Room 6, terminal cleaning was monitored. EVS 4 was wiping IV pole wheels then wiped the table in the OR with the same cloth. Sani-Master 4 cloth appeared 100% dry after 3 minutes when the gurney mattress was washed. EVS 4 did not follow the guidelines as stated by the EVS Lead Manager.




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2. During an observation on 5/15/14 at 10:35 AM, staff were preparing for a laryngoscopy (a rigid viewing tube [laryngoscope] is passed directly from the mouth, through the throat, into the larynx [voice box] to detect tumors, foreign bodies, nerve or structural injury, or other abnormalities) procedure in OR (Operating Room) 2. The staff inside the OR were circulating nurse (licensed nurse who monitors and coordinates during surgery), scrub nurse (licensed nurse assisting the surgeon during the operation), surgeon and anesthesiologist who were all wearing short sleeves scrub suit.

On continued observation at 11:15 AM, the circulating nurse was preparing the sterile table wearing sterile gloves and short sleeves scrub suit. The circulating nurse continued to wear the same attire throughout the surgical procedure while assisting the surgeon who was sterile gown and gloves. At 11:35 AM, the laser technician went into the room with short sleeves scrub suit and a head cover. The laser technician picked a small piece of paper from the floor, threw the paper in the garbage and without disinfecting or washing his hands, put on a pair of gloves and touched the laser machine.

During an observation and interview on 5/15/14 at 11:15 AM, the OR Manager stated scrub nurse could wear scrub suit with short sleeves but should wear sterile gloves when assisting the surgeon during an airway surgical procedure, because the scrub nurse will not touch the sterile field. On continued observation and interview, the OR Manager was informed the laser technician picked a small piece of paper on the floor and did not do hand hygiene before putting on a pair gloves, ICP 2 stated that the laser technician should have disinfected his hands before putting on a pair gloves and touching the laser equipment.




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3. In an observation on 5/13/14 at 2:00PM, OR Staff 1 (OR1) was "scrubbed in" which is thoroughly disinfecting hands and arms and putting on sterile clothing. Under the direction of the surgeon, they handle instruments, assist
with procedures and monitor the patient throughout the operation. OR1 had a disposable tie-back hat positioned in such a way that hair was exposed at the top, sides and nape of neck. OR1 had earrings hanging that were 1 1/2 - 2 inches long. At 2:10 PM ancillary staff member (OR2) entered surgical suite. OR2 had a surgical cap which covered his curly hair to the middle of the back of his head. OR Supervisor (ORS) acknowledged OR1's unacceptable attire and said, "this is not according to our polices and procedures".

Review of facility's Policy and Procedure - Attire for Surgical Services and Procedural Areas 27.2.1.12 (V)(B)(4)indicated, "Surgical head covers/hoods shall confine all head and facial hiar, including sideburns and the nape of the neck" and 27.2.1.12 (VI)(G) indicated, "Skull caps and/or cloth caps that do not entirely cover all head hair may not be worn, unless covered by a bouffant hat".

According to the Association of periOperative Nurses (AORN), Perioperative Standards and Recommended Practices, Recommendation II.b.indicated "Jewelry including earrings, necklaces, watches, and bracelets that cannot be contained or confined within the surgical attire should not be worn. Jewelry that cannot be confined within the surgical attire should be removed before entry into the semirestricted and restricted areas" and Recommendation IV which indicated "All personnel should cover head and facial hair, including sideburns and the nape of the neck, when in the semirestricted and restricted areas".

In addition, four of four non-scrubbed personnel in the surgical suite, did not wear long sleeved warm up jackets during the operative procedure.

According to AORN Recommendation III.b.indicated "When in the semirestricted or restricted areas, all nonscrubbed personnel should wear a freshly laundered or single-use long-sleeved warm-up jacket snapped closed with the cuffs down to the wrists.
Wearing the warm-up jacket snapped closed prevents the edges of the front of the jacket from contaminating a skin prep area or the sterile surgical field. Long-sleeved attire helps contain skin squames shed from bare arms

Further review of Policy and Procedure 27.2.1.12(V)(B)(2) indicated, "All non-scrubbed personnel should wear a freshly laundered or single-use long sleeved warm up jacket snapped close with the cuffs down to the wrist to cover bare arms and/or to cover exposed undergarments". In an interview on 5/16/14 at 10:30 AM, Vice President Surgical Services (VPSX) said that the facility has warm up jackets available for personnel and said she would have to review the policy for specifics. VPSX was shown policy by surveyors which addressed use of warm up jackets and VPSX acknowledged she was unaware of this section of the policy on attire which reyuqired the use of a warm up jacket to cover bare arms.