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Based on observation, interview and document review, the hospital failed to provide adequate training to ensure accurate and timely preparation and administration of pediatric emergency medications by staff in the treatment center of the hospital. Registered Nurse 9 (RN 9) was unable to timely determine the appropriate doses of emergency medications needed during a pediatric code exercise.

Findings:

During a tour of the treatment center of the hospital at approximately 2:35 p.m. on 4/13/15, Registered Nurse 12 (RN 12) stated that emergency services is provided in the treatment center for walk-in patients, physician referrals as well as patients arriving in ambulances. A pediatric emergency supply cart was observed in the treatment center. RN 12 stated that the hospital was equipped to handle pediatric emergencies.

A review of the 7-day treatment center record indicated that 3 pediatric patients aged 2 to 5 years old were treated in the treatment center between 4/5/15 to 4/8/15.
During a pediatric code blue exercise simulating a situation of a pediatric emergency conducted at the treatment center at approximately 9:50 a.m. on 4/14/15, Registered Nurse 9 (RN 9) was asked by the surveyor to calculate doses of emergency medications for the resuscitation of a pediatric patient. A pillow in the room was used to assume the size of the pediatric patient in the code exercise. RN 9 estimated that the patient 's weight was approximately 6-7 kilograms using the Broselow Tape (a color-coded tape measure for weight estimation and medication dosing guidelines in pediatric code situations). Referring to the Broselow tape, RN 9 stated that 130mg of Calcium Chloride (for management of cardiac arrest in the presence of electrolyte imbalance) was needed for the patient. RN 9 selected a box of 10-ml Calcium Chloride 10% syringe from the emergency cart. RN 9 first attempted to calculate the volume of the medication needed with paper and pen and later requested for a calculator to assist with calculation. After approximately 5 minutes, RN 9 stated that she was unable to calculate the volume of Calcium chloride needed. RN 9 was then asked to determine the dose of Sodium bicarbonate (for correction of metabolic acidosis during cardiac arrest) needed for the code exercise. Referring to the Broselow tape, RN 9 stated that a dose of 6.5mEq (milliequivalents, a weight unit for chemicals) of sodium bicarbonate was needed. RN 9 picked up a box of 10-ml (milliliters, volume unit) Epinephrine 0.1mg/ml (milligram per milliliter, concentration unit) from the emergency cart and attempted to calculate the proper dose. After approximately 1 minute, RN 9 stated she was unable to determine the dose of sodium bicarbonate needed for the patient in the code exercise. RN 9 was then prompted by the surveyor and acknowledged that she picked the wrong medication (epinephrine) from the emergency drug supply when attempting to determine the dose of sodium bicarbonate for the code exercise.

During an interview at approximately 10:05 a.m. on 4/14/15, RN 9 stated that the hospital began requiring nurses in the treatment center to be PALS (Pediatric Advanced Life Support) certified about one year ago but there had not been any in-hospital pediatric mock code conducted to ensure that staff are competent in the management of pediatric code situations.

Based on interview and record review, the physician (MD 1) failed to sign a verbal order within the 24 hours required by hospital policy. This had the potential for mis-interpretation of verbal orders.

Findings:

During record review on 4/15/15, it was noted that MD 1 had given a verbal order for Patient 28 for a "Restraint: Posey jacket." on 12/26/14 at 8:25 PM to Registered Nurse, RN 2. Further review of this order indicated that MD 1 did not authenticate and sign this verbal order until 1/3/15 at 5:38 PM.

During this record review on 4/15/15 at 10:45 AM, the Registered Nurse (RN 1) assisting with record review stated that this verbal order for the Posey jacket restraint, was not signed in a timely manner.

The facility's policy and procedure titled "Verbal Orders", dated 12/14, stated "Restraints - shall be signed, timed, and dated by the physician on his/her next visit but not more than 24 hours."

Based on observation, interview and document review, the hospital failed to ensure the pharmacy was administered in accordance with accepted professional principles. Rust was observed on the four sides of the outer metal screen of the laminar flow hood for compounded sterile preparation.

Findings:
During a tour of the hospital pharmacy at approximately 2:30 PM on 4/15/15, the laminar flow hood for the preparation of intravenous medications was observed to have rust on all the 4 sides of the outer metal screen of the HEPA (high efficiency particulate air) filter. In addition, on the front edge of compounding surface, there was a damage area in the size of approximately 1/2 inch by 1/2 inch exposing the wood underneath.

Intravenous medication is for direct administration into the vein of the patient. Intravenous medications should be free of contaminants to ensure patient safety.

During an interview at approximately 3:00 p. m on 4/15/15, the hospital infection control coordinator (ICC) stated that the rust on the metal screen might compromise the air quality of the hood due to accumulation of particulate or dirt on the rough surface of the rusty area. ICC also stated that the damage area on the compounding counter should be repaired to ensure effective cleaning and disinfecting of the surface.

Based on observation, interviews and record review, the hospital failed to ensure that pharmaceutical services was provided in accordance with applicable standards of practice and consistent with Federal and State law to ensure patient safety as evidenced by:

1. Medication was not labeled in accordance with hospital policy and procedure. Medication administered to a patient in the off-site infusion center was not labeled with patient ' s information to minimize the risk of administration error.

2. The malignant hyperthermia (MH) cart was not stocked in accordance with hospital policy and procedures. One 250-ml (milliliters, volume unit) and three 1-liter sodium chloride 0.9% solution were missing from the MH supply cart.

3. Emergency drug supplies were not sealed in such a manner that a seal must be broken to gain access to timely alert staff of need to replenish emergency supply.

Findings:
1. During a tour of the off-site infusion center at approximately 1:00 p.m. on 4/15/15, Patient 46 was observed receiving infusion treatment of Privigen (a 10% liquid intravenous immunoglobulin (antibody) therapy). An examination of the bottle of Privigen hanging on the pole that Patient 46 was receiving showed that there was no pharmacy label affixed to the bottle. Registered Nurse 11 (RN 11) also showed another bottle of unlabeled Privigen in the drawer compartment of the mobile computer unit. RN 11 stated that the 2 bottles of Privigen were delivered from the pharmacy.

A review of the hospital policy and procedure on medication dispensing and maintenance last revised 12/2014 indicated that all medications dispensed to patients should have at least 2 identifiers, such as name and date of birth of the patient.

2. During an inspection of the malignant hyperthermia cart with Registered Nurse 4 (RN 4) at approximately 1:30 p.m. on 4/14/15, 1 bag of 250-ml of 5% Dextrose was missing from drawer 3 and 3 bags of chilled 1-liter sodium chloride 0.9% were missing from the refrigerator. RN 4 reviewed the malignant hyperthermia cart content list and acknowledged that the abovementioned supplies were missing.

Malignant hyperthermia (MH) is a rare life-threatening medical emergency that is usually triggered by exposure to certain drugs used for general anesthesia. In susceptible individuals, these drugs can induce a drastic and uncontrolled increase in skeletal muscle oxidative metabolism, which overwhelms the body's capacity to supply oxygen, remove carbon dioxide, and regulate body temperature. Timely management to regulate the patient ' s temperature is crucial in preventing fatal outcome.

California Code of Regulations Title 22 Section 70263 (f) stipulates that supplies of drugs for use in medical emergencies shall be immediately available at service area as required.

3. During a tour of the off-site infusion center at approximately 1:00 p.m. on 4/15/15, the emergency reaction supply kit was inspected. RN 11 presented a plastic box containing medications to manage adverse reactions to drugs such as diphenhydramine (a medication to block allergic reactions) and Epinephrine injection (for the management of allergic reaction). A clear tape was observed over the temper proof adhesive seal compromising the temper-proof feature of the seal allowing the emergency kit to be opened repeatedly without the seal being broken.

California Code of Regulations Title 22 Section 70263 (f) (2) stipulates that emergency drug supply shall be sealed by a pharmacist in such a manner that a seal must be broken to gain access to the drugs. A broken seal serves as a timely alert to staff to inspect and restock of the supply within.

Based on observation, interview and document review, the hospital failed to ensure that outdated or otherwise unusable drugs were unavailable for patient use. Expired and opened single-use medications were found in the hospital intensive care unit, treatment center, peri-anesthesia care unit and radiology department.

Findings:
During a tour of the treatment center with the hospital Director of Pharmacy (DOP) at approximately 2:25 p.m. on 4/13/15, four 4-ml (milliliters, volume unit) syringes of Bicillin LA (Penicillin G, an antibiotic for the treatment of bacterial infection) with expiration date of 3/2015 were observed in the medication storage refrigerator. The DOP stated that the expired products were not suitable for patient use and should have been removed from the refrigerator.

During a tour of the radiology department at approximately 1:45 p.m. on 4/13/15, an open partial bottle of reconstituted barium sulfate suspension 96 % was found in one of the storage cabinet.
A review of the manufacturer ' s product labeling of the identified barium sulfate product indicated that the product should be administered immediately following reconstitution and must not be stored.

During a tour of the hospital intensive care unit (ICU) with Registered Nurse 10 (RN 10) at approximately 1:10 p.m. on 4/14/15, one opened single-use vial of Metoprolol ( a medication for management of heart and blood pressure conditions) 5mg/5ml ( milligrams per milliliters, concentration unit) with remaining volume of approximately 2ml was found in a medication storage cabinet. RN 10 stated that the medication should have been discarded after a single use.
According to the Centers for Disease Control and Prevention ' s (CDC) Single-dose/Single-use Vial Position and Messages dated May 2, 2012, a single-dose or single-use vial is a vial of liquid medication intended for parenteral administration (injection or infusion) that is meant for use in a single patient for a single case/procedure/injection. Single-dose or single-use vials are labeled as such by the manufacturer and typically lack an antimicrobial preservative. Even if a single-dose or single-use vial appears to contain multiple doses or contains more medication than is needed for a single patient, that vial should not be used for more than one patient nor stored for future use on the same patient.

During a tour of the hospital peri-anesthesia care unit (PACU) with Registered Nurse 4 at approximately 1:30 p.m. on 1/4/15, four 10-ml syringes of sodium chloride 0.9% (for intravenous line flushing) were found frozen in the medication storage refrigerator. RN 4 removed the syringes from the refrigerator and stated that the syringes should be discarded.

A review of the manufacturer ' s product labeling of the identified product showed that sodium chloride 0.9% syringes should be stored at room temperature.

Based on observation, interview and document review, the diet manual used by the hospital was not:
1. Approved by the dietitian, and
2. Medical and nursing staff did not have access to the enteral formulary (list of nutritionally complete liquid food supplements) used by the hospital.
This failure had the potential for the nutritional needs of patients to not be met, compromising their health status. Census of 26.
Findings:
1. On 4/14/15 at 1:15 p.m., during review of the hospital diet manual with Registered Dietitian 1 (RD 1), the approval page was signed by the patient care committee chairman and the chief operating officer on 3/10/15, but not by the dietitian.
During a concurrent interview, RD 1 stated the diet manual was not signed by the Department Manager (dietitian) because she was on on an extended leave and unavailable to sign it. RD 1 further stated she was the acting Department Manager, but she did not want to approve it.
2. On 4/14/15 at 1:15 p.m., during review of the hospital diet manual Enteral Nutrition Section 9.1, it indicated, "In-house available enteral feeding formulas, please refer to the attached Replacement Table for Enteral Products (Table)." However, the referenced attachment was not located in the diet manual. The diet manual also referenced Dietary Department Policy #8340-30.07 which included the "Table." However, nursing and medical staff did not have access to the Dietary Department Policy manual.
RD 1 stated the "Table" was available to nursing and medical staff on the 3rd floor of the hospital. However, a visit to the 3rd floor revealed it was removed and no longer available.
During a concurrent interview, Nursing Supervisor 1 (NS 1), stated the "Table" was removed when they were cleaning the 3rd floor. She stated physicians ordered enteral feeding formulas through their electronic computer ordering system. The ordering system used by the hospital included all enteral formulas available and not just the ones used by the hospital. She stated that the only way physicians and nurses would know what formulas were available, was to talk to the dietitian. She stated that if a physician ordered a formula that was not available, they had to call the dietary office causing a delay until an equivalent substitute was approved, or another formula was ordered.

Based on observation, interview, and document review, the hospital failed to clean and sanitize the ice machine located on the 3rd floor at a frequency necessary to prevent soil and mold accumulation. This failure had the potential to cause food-borne illness in patients who ingested it. (cross reference A 749)

Findings:

On 4/13/15 at 2:40 p.m., during observation of the 3rd floor ice machine located in the nourishment room with Engineer 1 and Administrator 1, the internal components of the chute where the ice drops from the storage compartment into a cup or other container was coated with a crusty white colored substance with multiple black spots. Engineer 1 and Administrator 1 validated the observation and stated the ice machine needed to be cleaned, however, the ice from this machine was not ingested by hospital patients. There was no sign posted indicating the ice was not to be used for human consumption. Engineer 1 further stated he followed the manufacturer's guidelines by cleaning it every six months.

On 4/14/15 at 11:15 a.m., during review of the hospital document entitled, Trayline Report, it indicated the diet order for Patient 21 was "NPO except Ice Chips" (nothing by mouth except ice chips).

During a subsequent interview at 11:40 a.m., Licensed Nurse 1 stated if any patient had an order for ice chips, including Patient 21, she would obtain the ice chips from the 3rd floor ice machine located in the nourishment room by placing a cup under the chute. She further stated that she always got ice from the nourishment room ice machine located on the 3rd floor if she needed ice for any patient.

According to the Federal Food Code 2013, ice machines shall be cleaned at a frequency to preclude accumulation of soil or mold.

Based on interview and record review, the facility failed to have a scheduled preventative maintenance for patient's lift to ensure it was efficient and safe for use. The deficient practice had the potential to cause injury when safety and maintenance were not done.

Findings:

During an interview on 4/15/15 at 1:10 PM, RN 3 stated the patient lift was last used a week ago to transfer a patient from bed to chair.

During an interview on 4/15/15 at 1:20 PM, the Director of Facilities stated the patient lift had no instruction manual available in the facility, so there was no guidance on the frequency of maintenance needed for the patient lift. The Director of Facilities stated there was no preventative maintenance record on file.

Based on observation, interview and record review, the Hospital did not have proper ventilation in an area where a hazardous substance was being handled. This was evidenced by Formalin (a solution containing Formaldehyde used for the preservation and long term storage of tissue) being poured in the Central Processing Department decontamination area, without a ventilation hood. This had the potential for toxic fumes to be inhaled on a repetitive basis.

Findings:

In an interview during initial tour of the Central Processing Department (CPD) on 4/14/15 at 9:40 AM, the CPD Technician (Tech) confirmed specimen containers to be used in the operating rooms were being prepared and filled with Formalin in the decontamination area (area where dirty instruments from surgical cases are washed and sterilized). When asked about a ventilation hood for the Formalin, the Tech stated there wasn't a hood. When asked about the toxic fumes from Formalin, the Tech stated staff wear masks and open the doors in the decontamination room.

During an observation on 4/14/15 at 10:57 AM, an opened container with a spigot, labeled Formaldehyde 10% buffered, pH 7.0 (Formalin), was located on a counter in the far right corner (in relation to the doorway) in the CPD decontamination room. The room did not have a ventilation hood.

In an interview on 4/15/15 at 10:35 AM, the CPD Manager (MG 2) acknowledged staff preparing specimen containers with Formalin did not use a ventilation hood for the toxic fumes.

Record review of the Hospital's Material Safety Data Sheet (MSDS- a document that contains information and instructions on hazardous materials present in the workplace) for Formaldehyde, Buffered, 10% in Phosphate Buffer, pH 7.0, revision date 5/4/07, indicated "...Section 3. Emergency Overview: Contains Formaldehyde, a suspected carcinogen. Irritating to the eyes, respiratory system and skin. May cause sensitization by inhalation...Inhalation: Inhalation of concentrated vapors may cause serious damage to the lining of the nose, throat and lungs...Section 15: Regulatory Information...OSHA (Occupational Safety and Health Administration- federal agency that enforces safety and health legislation) Status: These items meet the OSHA Hazard Communication Standard definition of a hazardous material..."

Based on observation, interviews, and record reviews, the hospital failed to develop, implement, and maintain an active hospital-wide program for the prevention, control, and investigation of infections and communicable diseases and failed to provide a sanitary environment to avoid sources and transmission of infections as evidenced by:

1. One of four staff members did not wear a cover jacket in the Operating Room suite during surgery.

2. The mop sink in the housekeeping closet adjacent to the surgical suites had an accumulation of black debris.

3. Instruments/supplies were transported, cleaned and stored in areas that allowed cross-contamination.

4. Cleaning of the surgical suite occurred prior to removal of contaminated instruments.

5. Preparation of specimen containers (with a chemical fixative) for use in the operating room was done in a non-vented area of Central Processing Department where instruments were cleaned.

6. Radiology staff did not change the bottom sheet of a gurney after patient use and did follow manufacturer's recommendations for wiping down the gurney with Sani-Wipes.

7. Failure to follow through past noncompliance with the Infection Control Coordinator not becoming CBIC (Certification Board of Infection Control) certified as indicated by the end of 2012. (cross reference to A-748)

8. The hospital failed to clean and sanitize the ice machine located on the 3rd floor at a frequency necessary to prevent soil and mold accumulation. This failure had the potential to cause food-borne illness in patients who ingested it. (cross reference A 701)

9. The infection control officer placed non-food grade approved hand sanitizer gel dispensers at various locations in the hospital kitchen, and did not include inspection of the hospital's ice machines as part of the infection control surveillance system. These failures had the potential to cause cross-contamination and food-borne illness in patients, compromising their health status. (cross reference A 749).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.



29956

Findings:

1. In an observation on 4/13/15 at 10:55 AM, accompanied by Registered Nurse 4 (RN4), Registered Nurse 13 was observed in Room 1 without a cover jacket. RN 4 said, "RN 13 is aware of the policy but she says she gets too hot with a cover jacket".

Review of facility's Policy and Procedure - Policy for Surgical Attire (2.c) indicates: "Perioperative team members should wear scrub attire that covers the arms while performing patient skin antisepsis and opening sterile items".

The Association of periOperative Registered Nurses (AORN- a nationally recognized organization for guideline in perioperative practice) Recommendation I (c) indicates "When in restricted areas all non-scrubbed personnel should completely cover their arms with a long-sleeved scrub top or jacket".

2. In an observation on 4/14/15 at 10:15 AM,accompanied by RN 4, the janitor's closet adjacent to the Operating Room 2, (an area where the housekeeping staff prepare and store cleaning mops, buckets and cleaning supplies) mop sink was noted to have an accumulation of built-up black debris on the four sides and the bottom of the sink.

AORN Recommended Practices - Recommendation 5 indicated "All areas and equipment that are not terminally cleaned should be cleaned according to an established schedule" which included "environmental services closet". RN 4 said the housekeeping staff cleans mop sink daily but was unable to explain the built up black debris in the sink area or provide a checklist of cleaning janitor's closet.



32774

3. During observation in the Surgical Suite on 4/13/15 at 11:05 AM, an area delineated with red tape housed sterile instruments, supplies, and sterilizing equipment. After walking past the red line into the "clean area", a doorway to the right led to a room with a sink and bottles containing solution.

In a concurrent interview, Registered Nurse 4 (RN 4) stated the area housing the sterile instruments, supplies and sterilizing equipment was designated as a "clean area" (an area regulated to minimize transmission of infectious material, and requiring appropriate surgical attire for entry). RN 4 was asked what happened to the instruments after a case was finished. RN 4 stated if instruments are bloody or if the case finishes after the Central Processing Department (CPD- the department that processes the instruments for sterilization) is closed, instruments are washed or soaked in the "dirty utility" room (decontamination room used to rinse or perform preliminary cleaning before disinfection and sterilization). RN 4 indicated the "dirty utility" as the room with a sink, and bottle containing solution located beyond the "clean area". When asked where dirty instruments are left after a case, RN 4 pointed to an area inside the designated "clean area".

In an interview on 4/14/15 at 10:10 AM, Operating Room Nurse Manager (MG 1) was asked what happened to the instruments after a case was finished. MG 1 stated staff bring the enzymatic cleaner (cleaner that uses proteins to break down blood, debris, soils) in to the operating room to soak the instruments. When asked what happens after CPD closes, MG 1 stated the enzymatic cleaner is placed with the instruments in a white bin, covered, and set in the "clean area" to be picked up. MG 1 stated manual cleaning to wash away blood was done in the decontamination/ "dirty area".

During observation on 4/14/15 at 10:40 AM, Registered Nurse 5 (RN 5) put dirty instruments from a case that just ended into a white bin, and placed the white bin and dirty instruments into the "clean area".

In an interview on 4/14/15 at 1:05 PM, Infection Control Coordinator (ICC) stated the Surgical Suite followed the Association of periOperative Registered Nurses (AORN) Standards for infection control.

In an interview on 4/15/15 at 10:05 AM, Registered Nurse 6 (RN 6) was asked what happened to the instruments after a case was finished. RN 6 stated dirty instruments are sprayed inside the operating room with enzymatic cleaner or are sometimes brought into the "dirty room" for cleaning.

In an interview on 4/15/15 at 10:15 AM, MG 1 acknowledged that dirty instruments were passing through a "clean area" to get to the "dirty area", and then stored in the "clean area" to be picked up for disinfection and sterilization.

Record review of the Hospital's Policy on Traffic Patterns in the Surgical Suite, revision/review date 11/2014, indicated "...Procedure: 7. Clean, sterile supplies and equipment should be separated from contaminated supplies and equipment at all times.

The Association of periOperative Registered Nurses' (AORN- a nationally recognized organization for guideline in perioperative practice) Guideline for Cleaning and Care of Surgical Instruments, online publish date 3/9/12, indicated "...Recommendation IV.b.3. Contaminated instruments and other items should be separated from clean and sterile supplies before transport to the processing area. Separation of soiled instruments from clean supplies minimizes the risk of cross-contamination..."

During observation in the Surgical Suite on 4/13/15 at 11:15 AM, a shelving unit housing sterile instrument sets was located in the main hallway. The main point of entry into the Surgical Suite entered into the hallway. The path from the operating rooms to the recovery rooms had to pass through the hallway.

In an interview on 4/13/15 at 1115, Registered Nurse 4 (RN 4) stated the hallway was sometimes used as a patient holding area, and a place for anesthesia to interview the patient before surgery.

In an observation and interview on 4/13/15 at 11:25 AM, Operating Room Nurse Manager (MG 1) confirmed that surgical sets for orthopedic, general surgery, emergency, urology cases were housed on the shelving unit. MG 1 acknowledged that sterile instrument sets were housed in an area that did not require use of surgical attire and considered non-sterile.

In an interview on 4/14/15 at 1:05 PM, Infection Control Coordinator (ICC) stated the Surgical Suite followed the Association of periOperative Registered Nurses (AORN) Standards for infection control.

In an interview on 4/15/15 at 10:15 AM, MG 1 acknowledged the sterile instruments were housed in a high traffic area.

Record review of the Hospital's Policy on Traffic Patterns in the Surgical Suite, revision/review date 11/2014, indicated "...Procedure: 2. b. The semi-restricted area includes the most peripheral support areas of the surgical suite and has storage areas for clean and sterile supplies, work areas for storage...Traffic is limited to authorized personnel and patients. Personnel are required to wear surgical attire and hats."

The Association of periOperative Registered Nurses' (AORN- a nationally recognized organization for guideline in perioperative practice) Guideline for Sterilization, online publish date 3/9/12, indicated "...Recommendation XV. Sterilized materials should be labeled and stored in a manner to ensure sterility...XV.b. Sterile packages should be store under environmentally controlled conditions...XV.b.3. Access to sterile supply areas should be limited to personnel who are trained in handling sterile supplies..." The Guideline for Safe Environment of Care, Part 2, online publish date 3/9/12, indicated "...Recommendation II. Semi-restricted area:...The area may include storage areas for equipment and clean and sterile supplies...Personnel in the semi-restricted area should wear surgical attire and cover all head and facial hair..."

4. During an observation on 4/15/15 at 10:10 AM, housekeeping staff was cleaning Operating Room 1 while dirty instruments were still in the room.

In a concurrent interview, Registered Nurse 6 (RN 6) stated the dirty instruments from a previous case were in the room waiting to be picked up by Central Processing Department (CPD- the department for disinfection and sterilization of instruments). Operating Room Nurse Manager (MG 1) and RN 6 acknowledged that housekeeping was cleaning while dirty instruments from the previous case were still in the operating room.

Record review of the policy for Surgical Suite Procedure for Preparation and Cleaning, revision/ review date 11/2014, indicated "...Procedure: 3. At the completion of the procedure, OR (operating room) staff will discard all materials from the surgical suite to the appropriate areas. This includes removing...dirty instruments...5. The operating room environment services personal (personnel) will sanitize any patient equipment used during the procedure according to the hospital cleaning protocols and clean the room in preparation for the next case..."

5. In an interview during initial tour of the Central Processing Department (CPD) on 4/14/15 at 9:40 AM, the CPD Technician (Tech) confirmed specimen containers to be used in the operating rooms were being prepared and filled with Formalin (a solution containing Formaldehyde used for the preservation and long term storage of tissue) in the decontamination area (area where dirty instruments from surgical cases are washed and sterilized). When asked if specimen containers being prepared in the decontamination area and then sent to the operating room would still be considered "clean", the Tech did not answer.

During an observation on 4/14/15 at 10:57 AM, an opened container with a spigot, labeled Formaldehyde 10% buffered, pH 7.0 (Formalin), was located on a counter in the far right corner (in relation to the doorway) in the CPD decontamination room. Various sized specimen cups (small, medium, and large) were horizontally stacked in a cabinet underneath the Formalin.

In an interview on 4/14/15 at 1:05 PM, Infection Control Coordinator (ICC) stated the Surgical Suite followed the Association of periOperative Registered Nurses (AORN) Standards for infection control.

Record review of the Hospital's Policy on Traffic Patterns in the Surgical Suite, revision/review date 11/2014, indicated "...Procedure: 7. Clean, sterile supplies and equipment should be separated from contaminated supplies and equipment at all times.

The Association of periOperative Registered Nurses' (AORN- a nationally recognized organization for guideline in perioperative practice) Guideline for Cleaning and Care of Surgical Instruments, online publish date 3/9/12, indicated "...Recommendation IV.b.3. Contaminated instruments and other items should be separated from clean and sterile supplies...Separation of soiled instruments from clean supplies minimizes the risk of cross-contamination..."



20340

6. During a tour of the Radiology Department on 4/15/15 at 11 am, Radiology Technician 1 was observed preparing the x-ray room between patient exams. A top sheet was removed from the patient gurney, leaving a second bottom sheet in place, then a fresh sheet was placed over the existing bottom sheet. Next, the equipment which was exposed to patient contact, including gurney railings and standing chest x-ray image receptor, was wiped down with an EPA registered disinfectant disposable wipe. The manufacturer ' s recommended wet-to-dry time is 3 minutes; the observed wet-to-dry time was less than a minute. The failure to prevent potential cross-contamination of the top and bottom sheets plus the failure to follow the disinfectant manufacturer ' s recommendations present an infection control risk to patients in the Radiology Department.

Based on interview and record review, the facility failed to follow through with past noncompliance with the Infection Control Coordinator (ICC) not becoming CBIC (Certification Board of Infection Control) certified. Part of the facility's plan of correction (POC) on the 5/31/11 Revisit Validation Survey indicated that the ICC would complete his CBIC by the end of 2012.

Findings:

During record review of personnel files on 4/15/15 at 10:30 AM, the ICC's file did not contain evidence of ongoing education, training or certification as an ICC.

During an interview on 4/15/15 at 1:00 PM, the ICC submitted documentation of his meetings with the San Francisco Infection Control Working Group on 01/23/14 and with APIC (Association for Professionals in Infection Control and Epidemiology)on 4/14/14. When the ICC was asked if he received further training or certification since the last validation survey, he stated that he was unable to complete his CBIC because he needed to attend to personal family affairs.

Based on observation, interview, and document review the infection control officer:
1. Placed non-food grade approved hand sanitizer gel dispensers at various locations in the hospital kitchen, and
2. Did not include inspection of the hospital's ice machines as part of the infection control surveillance system. (cross reference A 701)

These failures had the potential to cause cross-contamination and food-borne illness in patients, compromising their health status.

Findings:

1. On 4/13/15 at 11 a.m., during kitchen observations with Registered Dietitian 1 (RD 1), several hand sanitizer gel dispensers were located throughout the kitchen area (including outside the diet office, outside the food storage room, and inside the dish washing room).

During a subsequent interview with RD 1 on 4/14/15 at 10 a.m., RD 1 stated she did not know why they were in the kitchen area, and they were put there by the infection Control Coordinator (ICC). She stated dietary staff were instructed to wash their hands and not use the hand sanitizer gel.

On 4/15/15 at 9 a.m., during an interview with the ICC and Chief Operating Officer 1 (COO 1), ICC stated he was not aware hand sanitizer gel was not allowed in food service preparation areas unless approved for use in food service operations.

A review of the hospital's dietary department inservice and meeting minutes dated 2/3/2015 indicated under item number 8, "...If you are delivering meals to (an) offsite facility, use the hand sanitizer and put on the gloves again before you serve. ICC will supply us with the portable hand sanitizer."

According to the Federal Food Code 2013, hand sanitizers used in food service applications must meet Food and Drug Administration standards for food safety.

2. On 4/13/15 at 2:40 p.m., during observation of the 3rd floor ice machine located in the nourishment room with Engineer 1 and Administrator 1, the internal components of the chute where the ice drops from the storage compartment into a cup or other container was coated with a crusty white colored substance with multiple black spots. Engineer 1 and Administrator 1 validated the observation and stated the ice machine needed to be cleaned, however, the ice from this machine was not ingested by hospital patients. There was no sign posted indicating the ice was not to be used for human consumption. Engineer 1 further stated he followed the manufacturer's guidelines by cleaning it every six months.

On 4/14/15 at 11:15 a.m., during review of the hospital document entitled, Trayline Report, it indicated the diet order for Patient 21 was "NPO except Ice Chips" (nothing by mouth except ice chips).

During a subsequent interview at 11:40 a.m., Licensed Nurse 1 stated if any patient had an order for ice chips, including Patient 21, she would obtain the ice chips from the 3rd floor ice machine located in the nourishment room by placing a cup under the chute. She further stated that she always got ice from the nourishment room ice machine located on the 3rd floor if she needed ice for any patient.

On 4/15/15 at 9 a.m., ICC stated he did not include review of cleaning schedules and observation of the hospital's ice machines as part of the hospital infection control surveillance program.

According to the Federal Food Code 2013, ice machines shall be cleaned at a frequency to preclude accumulation of soil or mold.