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Based on interview and clinical record review, the hospital failed to ensure medication was administered in accordance to physician orders. This failure had the potential to cause significant harm to patients receiving an incorrect dose of medication.

Findings:

The clinical records of patients who received Propofol (medication for sedation) for the most recent 7 day period was provided by the Director of Pharmacy (DPH) on 8/7/12. Review of the clinical records with Registered Nurse (RN) 6 and RN 7 on 8/8/12 showed Patient 4 was admitted to the Intensive Care Unit (ICU) on 7/5/12 and was ordered Propofol intravenous (IV) drip (a continues flow of medication into a vein) for sedation with a targeted sedation management titrate to a Motor Activity Assessment Scale (MAAS) is scale of 3. A MAAS is an assessment scale used to assess a patients motor activity during sedation. The scale goes from 1 to 6 where 0 (patient is unresponsive) to 6 (patient is dangerously agitated).

Further review of clinical record revealed that the Propofol dose rate was initiated at 5 mcg/kg/min (micrograms/kilogram/minute) at 1:36 PM and was later decreased to 4 mcg/kg/min at 4:06 PM. At 4:16 PM, the dose rate was increased to 8 mcg/kg/min. Additionally, the sedation level of Patient 1 was maintained throughout at a MAAS scale of 0 or 1 rather than at the targeted MAAS scale of 3 as ordered by his physician.

Thus the administration and titration of Propofol was not performed in accordance to the specific parameter (initiation for sedation at 5 mcg/kg/min; titration 5 mcg/kg/min every 5 minutes to a maximum rate of 50 mcg/kg/min) and the targeted sedation level as outlined in the Propofol protocol/policy to maintain at a desired level of sedation.

Review of the hospital policy/protocol entitled "Propofol (Diprivan) Drug Protocols" on page 1 under Infusion, it read, "Initial therapy: Start at 5 mcg/kg/min and increase by 5 mcg/kg/min every 5 minutes to a maximum rate of 50 mcg/kg/min to maintain desired level of sedation."

During the interview with RN 6 and RN 7 on 8/8/12 at 10:29 AM, they both acknowledged the administration and titration of Propofol by nursing staff did not follow the hospital policy and procedure, and the physician order to maintain at a desired level of sedation for Patient 1 at the MAAS scale of 3.

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Based on observation, interview, and record review, the hospital failed to ensure outdated and contaminated medications were removed from one location in the hospital, which had the potential for adverse patient outcomes.

Findings:

During an inspection of the ED (Emergency Department) with DPH (Director of Pharmacy) and Registered Nurse (RN) 5 on 8/7/12 at 10:45 AM, a 100 milliliter (ml) reconstituted (mixed with water) bottle of Amoxicillin (medication used to treat infections caused by bacteria) 250 mg/5 ml (milligram per milliliter) suspension and an opened multiple dose vial of Novolin R (medication used for the treatment of elevated blood sugar) were found on a shelf inside the refrigeration across from the clean utility room. Both medications were undated and there was no information on them to indicate how long they had been left inside the refrigerator.

Review of the Amoxicillin packaging label on the bottle, it was noted that the oral suspension remains stable for 14 days at room temperature and for 14 days, if refrigerated, after it was reconstituted.

At this time, RN 5 acknowledged that both medications should have been properly labeled with new expiration dates once they were opened.

Review of the hospital policy and procedure entitled "Multi-Dose Vial Expirations" on page 1 under procedure, it read "All multi-dose medication containers shall be dated (with the expiration date, not the date first opened) and initialed when opened. Follow the expiration date on the container or the guidelines delineated below, whichever is sooner ...Insulin-28 days after opening ..."



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Based on interview and record review, the hospital failed to ensure the effective organization of the Food and Nutrition Services Department, as the Lead Clinical Dietitian, with responsibilities for oversight and guidance of the Food and Nutrition Department, reports directly to the Director of the Department. This reporting structure impedes the effective consultative role to the Food Service Department and does not empower the Lead Clinical Dietitian to report findings directly to administration. This failure had the potential to affect the quality of the dietary services.

Findings:

On 8/6/12 at 1:30 PM, the organization of the Food and Nutrition Department was reviewed. The Director of Food and Nutrition stated the Lead Clinical Dietitian (a Registered Dietitian) provided guidance and oversight of operational management of the Dietary Department. The Director of Food and Nutrition who was a dietary service supervisor stated the Lead Clinical Registered Dietitian reported directly to her. The Director of Food and Nutrition stated she was responsible for writing the Lead Clinical Dietitian's performance reviews.

During an interview with the Lead Clinical Dietitian on 8/6/12 at 1:30 PM, she stated she had been assigned to use 30 percent of her time for meeting with the Director of the Department to plan the food service operations, safe food handling, sanitation audits, policy review, and staff training planning.

Review of the Lead Clinical Dietitian Job description revised 4/12, indicated the Lead Clinical Dietitian reported to the Food Service Manager. The job description did not specify the oversight or guidance function to the Director of the Department. Job duties were for clinical patient care and did not outline the specific responsibilities of oversight and guidance to the department.

The placement of the Lead Clinical Dietitian in a reporting role to the Director of the Department does not give the lead Clinical Dietitian the ability to report directly to administration and impedes her ability to effectively impact the operational guidance to the department.



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Based on interview and record review, the hospital failed to ensure the nutritional needs of the patients were met in accordance with recognized dietary practices. Menus were not analyzed to ensure they met Dietary Reference Intakes (DRIs) of the Food and Nutrition board of the National research council. Lack of nutrient analysis of patient menus could potentially place patients at risk of not receiving required nutrients and compromising medical care and nutritional status.

Findings:

During an interview with the Lead Clinical Dietitian on 8/7/12 at 10:30 AM, she stated the menu nutrient analysis was still in the process of being completed. The nutrition program they were using did not contain all of the nutrients (Biotin, Chloride, Chromium, and Iodine- nutrients required in minute quantities to maintain proper physical functioning) specified in the DRIs. She stated they were working on the analyses of the missing nutrients. She also acknowledged the menus were not meeting 100 percent of the nutrients and they were working on improving the menu to ensure all of the nutrients met the requirements.



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Based on interview and record review, the hospital failed to ensure the customized diet manual was available on line. This failure had the potential of compromising patient care when physician and staff do not have therapeutic diet and medical nutrition therapy information available.

Findings:

During an interview with the Lead Clinical Dietitian on 8/7/12 at 10:30 AM, she stated the on-line diet manual was still in the process of being completed. She stated they had purchased a new diet manual and customized the diet but the application was not implemented on line at this date.



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

A functional, safe, and sanitary environment for the provision of healthcare in a manner that protects the lives and assures the physical safety of all individuals in the area when:

a. Shared equipment, potentially exposed to bloodborne pathogens (microorganisms that are transmitted via human blood and cause disease in humans), was not effectively cleaned and disinfected between each patient use.

b. Sterile and clean patient supplies were not stored in sanitary conditions.

c. Laboratory specimens were not transported and stored in a manner to prevent cross-contamination.

d. Food products were stored in close proximity to chemicals disinfectants and patient supplies.

Findings:

On 8/8/12 at 11:40 AM, a metal instrument was observed in the x-ray room (located on a building across from the hospital). During a concurrent interview, Technician (Tech) 5 stated the instrument was called a Bard Magnum Reusable Core Biopsy and was used to obtain patient tissue/cells. Tech 5 stated the manufacturer indicated the instrument could not be sterilized but should be disinfected with Cidex (a high level disinfectant solution that kills germs) after use. Tech 5 indicated the instrument was wiped down between patient use with Cidex and then allowed to air dry. When questioned, Tech 5 stated the Cidex manufacturer's instructions indicated the devise should be totally immersed in the Cidex solution for 12 minutes in order to disinfect (kill the germs). Tech 5 stated the biopsy devise could not be immersed in solution and that was why she wiped it down instead. When questioned, Tech 5 acknowledged she was unsure if the biopsy instrument was effectively disinfected when the Cidex manufacturer's directions for use were not followed.

Review of the Cidex manufacturer's instructions for manual use read, "CIDEX OPA Solution is a high level disinfectant when used or reused, according to the Directions for Use, at or above its Minimum Effective Concentration (MEC) as determined by CIDEX OPA Solution Test Strips, with an immersion time of at least 12 minutes for a reuse period not to exceed 14 days."

Failure to effectively disinfect the biopsy instrument placed the hospital's patients at potential risk for exposure to and infection from infectious agents, including blood borne pathogens.

On 8/6/12 at 2:20 PM, in the labor and delivery clean utility room, located behind the nurse's station the following was observed: supply bins with heavy deposits of black and grey particles adhering to patient supplies. The patient supplies included: baby bottle nipples, perineum (The diamond-shaped region of the body between the pubic arch and the anus) pads, 15 wrapped tooth brushes, 3 unwrapped hair combs, and gauze dressing packages. Brown cardboard boxes were also stored next to the supply bins.

On 8/7/12 at 9 AM, in a mammogram examination room, patient drapes, and gauze sponge pads were observed located in a bin that contained thick grey and black particles. Additionally, a yellowed opened package that contained ECG (electrocardiogram) wires (ECG wires are attached to pads which were placed on a patient to evaluate heart rhythms) was observed on a shelf.

On 8/7/12 at 9:20 AM, a torn discolored plastic Ambu bag (a hand-held device used to provide air to someone who is either not breathing or breathing inadequately) was observed in the radiology operating room available for use. Large black and brown particles were observed inside the bag.

During an interview on 8/7/12 at 10 AM in the radiology area (located across from the hospital), the DIP ( Director of Infection Prevention) stated, "I can't argue, it should be clean." The DIP acknowledged the Ambu bag should be made unavailable for patient use.

During an interview on 8/7/12 at 10:05 AM, EVSM (Environmental Service Manager)indicated it was currently the responsibility of the unit/area staff persons to clean the inside of the supply bins. EVSM indicated the contents of the Ambu bag would be tested for pests.

Review of the hospital's Materials Management Staff Meeting minutes revealed the following statements: "All cardboard boxes need to be kept away from patient care areas. Supplies are to be kept in bins. All bins and shelves need to be wiped down clean on a routine basis in all areas. Any bins that need to be replaced, please do so."

The undated hospital policy titled "Environmental Facility Cleanliness" and presented as currently stipulated, read "Separate clean items from soiled items at all times and ensure a process for cleaning and disinfection of all equipment/supplies that are used in patient care ...Only clean supplies and equipment shall be kept in the clean utility room. No clean supplies shall be kept in the soiled utility room."

On 8/6/12 at 2 PM, an unlabeled metal tray containing pink fluid was observed located on a counter in the dirty utility room in the hospital's obstetrics area.

During an interview on 8/6/12 at 2:05 PM, Tech 4 stated the pink drainage in the metal tray was blood. Tech 4 stated placenta specimens were brought from the labor and Delivery area in the tray(s) and were then collected by pathology staff persons. Tech 4 stated, "The problem is that pathology staff take the specimens and do not clean the tray." Tech 4 stated nurses and housekeepers accessed the utility room and she acknowledged the potential for staff members to have exposure to the blood in the tray.

According to 1910.1030(d)(4)(ii)(C) of the Occupational Safety and Health Standards (OSHA) bloodborne pathogen section, "All bins, pails, cans, and similar receptacles intended for reuse which have a reasonable likelihood for becoming contaminated with blood or other potentially infectious materials shall be inspected and decontaminated on a regularly scheduled basis and cleaned and decontaminated immediately or as soon as feasible upon visible contamination."

The hospital's policy for handling and transporting laboratory specimens, titled "Specimen Collection Labeling and Handling" dated 7/20/12, was reviewed. The policy stipulated "All specimens transported to Premier Pathology Laboratories, Inc. from an outside facility (in this case the hospital shall be transported in a safe manner so as not to endanger the specimen, employee or general public. The laboratory employee shall ensure that all specimen containers are securely closed prior to transportation. The specimens shall be placed in the bio-hazardous specimen transportation carrier. The biohazardous transportation carrier shall be closed prior to transportation in order to contain a spill should one occur ... If a spill should occur during transport it shall be handled as hazardous material and full personal protective measures must be initiated prior to clean up." Under the section titled Transport of Specimens, it stipulated, "Specimen containers will be placed within biohazard zip lock plastic bags, which are then sealed."

Failure to transport and store bloody specimens in a safe manner potentially exposed patients and hospital staff to exposure and infection from blood borne pathogens.

On 8/7/12 at 8:30 AM, an unwrapped piece of peach pie and sandwich were observed in a refrigerator that also contained patient ice packs. In a concurrent interview, Registered Nurse (RN) 8 stated the ice packs and the food were both for patient use.

On 8/7/12 at 9:15 AM, a brightly blue water bottle was observed located on a counter in a mammogram examination room. The bottle was approximately 1/3 full with a clear liquid. The bottle was unlabelled. When questioned, Tech 2 stated the bottle contained a 5% bleach solution which she used to clean with. In a concurrent interview, Tech 2 acknowledged that all chemical disinfectants should be labeled and having an unlabeled water bottle containing in a patient area was a safety concern.

On 8/7/12 at 9:15 AM, a container of Cidex Plus, a high level disinfectant (a solution that kills germs) was observed stored next to two cases of water in the central supply room located in the mammography area. In a concurrent interview, Tech 2 confirmed the water was for patient use.

On 8/8/12 at 11:30 AM, Pedialyte (a nutritional drink for infants and young children), three containers of jam, three wrapped baby bottle nipples, an unwrapped gauze dressing, and a wrapped band-aide were observed located together on a shelf in a hospital ultrasound examination room.

On 8/7/12 at 9:25 AM, 4 bottles of Pedialyte were observed located on a shelf next to a bottle of Aquasonic ultrasonic gel (a gel used during an ultrasound examination) in the radiology operating room (located across from the main hospital). In a concurrent interview, RadM acknowledged the Pedialyte should not be stored with patient supplies.

During an interview with Tech 5 on 8/8/12 at 11:30 AM, she stated she was not aware food items were being stored with patient supplies and chemical disinfectants. Tech 5 acknowledged it was not appropriate to have food stored with nonfood items or chemical disinfectants.

The hospital policy titled "Nourish Room Floor Stock", dated reviewed 1/10 and presented as current stipulated, read "Adequate quantities of nourishments will be delivered to the patient nourishment rooms... All items placed in the refrigerator will have an expiration date, labeled, and appropriately sealed ... Any items found to be open or not clearly labeled and dated will be discarded."

The medical record for Patient 5 was reviewed on 8/7/12 at 12:20 AM. Patient 5 was admitted to the hospital on 7/5/12 and had a central venous line (a catheter placed in a large vein in the chest, neck, or groin for purpose of medication administration) placed on 7/10/12. The line was in place at the time of the record review. The record showed no evidence of physician documentation related to the necessity for the central venous line from 7/11/12 through 8/6/12.

The medical record for Patient 6 was reviewed on 8/7/12 at 11:45 AM. Patient 6 was admitted to the hospital on 7/28/12 and had a central line inserted on 8/2/12, which was in place at the time of the record review. The record showed no evidence of physician documentation related to the necessity for the central venous line from 8/3/12 through 8/6/12.

At this time, RN 6 stated the hospital did not have a system to ensure daily documentation of central line necessity.

Review of the hospital policy titled "Central Venous Catheters, Care and Maintenance Of" dated reviewed 1/10 and presented as current was reviewed. The policy did not contain requirements for physician daily documentation of central venous line necessity.

The California Department of Public Health (CDPH) all facilities letter (AFL) dated April 22,
2008 was reviewed. The regulatory requirements for compliance with Senate Bill 737,
"All hospitals are required to develop and implement a process to ensure daily assessment central line necessity for all patients with central lines on units under surveillance and to be able to present results of that process to CDPH surveyors."



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