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Based on observation, staff interview, and manufacturer's guidelines, the facility failed to ensure pharmaceuticals were stored safely when:

1. Expired Scheduled (drugs classified by the Drug Enforcement Agency as having a high potential for addiction and abuse) medications were stored in the same cabinet as nonexpired medications making the expired medications potentially available for use.
2. The temperature in the medication storage area was not monitored to ensure compliance with manufacturer's directions for medications stored in this area.

These failures resulted in the increased risk of patients receiving potentially expired medications and/or medications not stored safely.

Findings:

1. On 4/17/12 at 11:15 a.m., during an observation in the medication room, expired scheduled medications were observed on the bottom shelf of the scheduled medication cabinet. Nonexpired mediations were observed on the other shelves of this cabinet.

On 4/17/12 at 11:15 a.m., during an interview, RN (registered nurse) 4 confirmed expired scheduled medications were placed on the bottom shelf of the scheduled medication cabinet. RN 4 acknowledged that expired and unexpired medications were stored in the same cabinet.

The facility was not able to provide a policy and procedure on the storage and/or discarding of expired scheduled medications.

2. On 4/17/12 at 8:10 a.m., during an observation, the medication storage room was located between the medical-surgical in-patient area and the emergency department. The dimensions of the medication storage room were approximately 14 feet by 6 feet and the ambient room temperature was cool relative to the hallway directly outside of the room. There was no temperature gauge in the room to measure the room temperature. The hospital did not have a pharmacy.

On 4/17/12 at 8:10 a.m., during an interview in the medication storage area, RN 3 confirmed there was no thermometer in the medication room. RN 3 could not state the temperature in the room. No temperature logs were provided for review. RN 3 confirmed no room temperatures were taken of the medication room. RN 3 confirmed medications stored in this area required storage within specific temperature range.

Manufacturer's recommendations for storage temperature were indicated on 3 of 3 medications observed. The recommendations indicated, "Phenytoin (used to control seizures), store at 68?F to 77?F (Fahrenheit); Megestrol (hormone used to treat cancers) Acetate store at 59?F to 77?F; Albuterol (used to treat bronchospasm and asthma) Syrup, Store at 36?F to 86?F."

Based on observation, staff interview, administrative document and product manufacturer's recommendations, the facility failed to implement a system to prevent the spread of infection when:

1. Biological Indicators (BI or Attests, small vials of bacteria designed to monitor the effectiveness of the steam sterilization process) were not being used as required by the facility's policy and procedure (P&P) to determine the effectiveness of sterilizing equipment with the steam sterilizer.

2. Cidex test strips (paper indicator used to measure effectiveness of disinfectant solution or Cidex solution) were used only before the first use of the day, and not before each use of the endoscope as required by the facility's P&P. An endoscope is a specialized instrument able to visualize inside the body. Cidex solution is a high level disinfectant used to clean endoscopes. The soak pan and rinse basins used to disinfect the scopes were not sterile at the initial mixing of the Cidex solution, as specified in the facility P&P.

3. The centrifuge located in the blood bank was not being cleaned as required by manufacturer's guidelines and was observed with brownish spots and fuzz-like substance built up within the bowl and inner side of the lid. (A centrifuge is a motorized lab equipment able to spin at high speeds to separate a substance into to its heavier and lighter components. The substance is placed in a test tube in the inner compartment of the centrifuge. The inner compartment is protected by a lid. For example, centrifuging blood separates it into the solid components [red blood cells and white blood cells] and the liquid component or serum.)

These failures resulted in the potential of not preventing the spread of infections.

Findings:

1. On 4/17/12 at 2:30 p.m., during a tour of Central Supply, a box of BI and an unplugged incubator was observed sitting on the counter. CNA (Certified Nurse Assistant) 1 confirmed the attest incubator was unplugged and not in use. CNA 1 provided documentation of the last recorded use of Attest biological monitoring as 5/23/10.

On 4/18/12 at 10:15 a.m., Operating Room Scrub Tech (ORST) 1 stated she was the person who was in charge of running the steam sterilizer. ORST 1 acknowledged the effectiveness of the sterilization process was measured by using the Attests. ORST 1 stated the Attests and the incubator sitting on the counter in Central Supply were "old" and were not being used. She stated, "I'm not there every third day to read them. I decided not to use them." ORST 1 confirmed the BI last recorded use date was 5/23/10.

The facility P&P titled, "Biological Monitoring," dated 7/29/09, indicated, "Policy: An Attest biological indicator shall be run in the first load of every month. Purpose: To monitor the effectiveness of sterilization... The appearance of a yellow color in the processed indicator demonstrates bacteria growth and sterilization failure... Act on any positive test as soon as it is noted: a. Fill out an Unusual Occurrence Form; b. Recall all items that have been autoclaved since the last biological testing; c. Retest the autoclave [sterilizer] and do not use it until the biological indicator test negative."

On 4/19/12 at 11:30 a.m., the Infection Control Nurse (ICN) stated P&Ps had not been reviewed annually. The ICN presented printed Attest product guidelines that indicated the following: "Attest biological indicators should be... used to monitor every load. This presents an appropriate challenge and improves the performance to the sterilization process... Incubate at least one unprocessed Attest biological indicator (positive control) each day a processed indicator is incubated... Incubate processed and control biological indicators for 24 hours... Early detection 12 hours... The appearance of a yellow color in the processed indicator demonstrates bacterial growth and a possible sterilization process failure. No color change (media remains purple) indicates that sterilization conditions have been met. A final readout of a negative result is made after 24 hours of incubation. The positive control indicator should show a yellow color change for the processed indicator results to be valid."

2. On 4/18/12 at 10 a.m., during an interview, ORST 1 explained the process of disinfecting the endoscopes. ORST 1 confirmed that the endoscopes were disinfected by using Cidex solution and not by steam sterilization. ORST 1 stated one soak basin and one rinse basin was used for all endoscopes. The soak basin contained Cidex solution and was used to soak all endoscopes. ORST 1 stated a test strip was used to test the Cidex solution at the start of the shift, before the first use, not before each use. (No procedures were scheduled during the time of the survey in order to observe the process). As an example to explain the process, ORST 1 reviewed the processing log for 3/21/12. ORST 1 stated on 3/21/12, four different scopes had been soaked in the same Cidex solution; two of them had been used once; one had been used three times; and one had been used four times. ORST 1 stated a Cidex test strip would have been used to check the effectiveness of the solution only before soaking the first scope of the day. ORST 1 stated they had been using the same soak pan and rinse basins over and over without sterilizing them. ORST 1 stated, "We never put the blue Cidex container through the sterilizer."

The facility P&P titled, "Chemical Disinfection and Sterilization," dated 7/29/09, indicated, "Equipment... Sterile soak pan... Sterile basin with sterile water for rinsing... The Cidex solution will be tested with the Cidex solution test strip prior to each use..."

The facility P&P titled, "Cidex Solution Test Strips," dated 7/29/09, indicated, "If excess dilution causes the concentration of Glutaraldehyde [chemical disinfectant] to fall below 1.5%, the solution may not be effective against all organisms, especially Mycobacterium Tuberculosis [bacteria causing TB]. Cidex solution is to be tested prior to use, or when excessive dilution or contamination with organic soil is suspected."

3. On 4/17/12 at 9:10 a.m., during an observation, the centrifuge in the blood bank contained brownish spots on the inside and outside of the lid. On the inner bowl, there was a dust like substance and brownish sediment and spots.

On 4/17/12 at 9:50 a.m., during an interview, Clinical Lab Scientist (CLS) 1 stated substance within the bowl looked like dirt. He stated a lump of lint like material found on the outer rim of the centrifuge bowl was fuzz.

On 4/17/12 at 9:55 a.m., during an interview, CLS 2 stated the centrifuge had last been used on 4/13/12. CLS 2 stated he observed dust and possibly blood and reagent on the lid and within the bowl of the centrifuge. CLS 2 stated the centrifuge was cleaned as needed and was not aware of any polices regarding the cleaning of the centrifuge.

The Manufacturer's "Operator's Manual" titled "SERO-FUGE 2000 Series Centrifuges" dated 1995, indicated "...Keep the centrifuge clean and dust-free in accordance with the Maintenance and Service instructions found in this manual. ...Cleaning and Decontamination of Spills, It is recommended that all interior surfaces of the centrifuge be clean periodically with a clean cloth dampened with a 10% bleach solution..."

The facility did not provide for review a policy on the cleaning of the centrifuge.

Based on observation, staff interviews and administrative document review, the hospital failed to ensure the nutritional needs of inpatients were met in accordance with recognized dietary practices when:

1. Food service personnel (Cook 1) did not follow food cool down procedures.

2. Food service equipment was not sanitary and safe.

These failures could result in growth of microorganisms and the potential for food borne illness in patients.

Findings:

1. On 4/17/12 at 9:25 a.m., during an interview, Cook C discussed the cooling of potentially hazardous foods. Cook C stated at times they have leftovers that they will save and cool down. When asked, Cook C stated the method to cool down potentially hazardous foods were the following: the food was placed in a container on ice or the food was placed in the freezer and within four hours the food should be cooled to 70 degrees Fahrenheit (F); the food was then placed in the walk-in cooler. Cook C stated the food service staff would check the food every 30 minutes and would log the temperature of the food. Cook C stated after the food reached 70 degrees F then it should reach 40 degrees F in the next two hours.

At this time, Cook C showed the surveyor the cool down log that was hung on the refrigerator and freezer. Review of the Cooling and Storage Log dated April 2012, indicated there were four items that did not meet the proper cool down temperatures. The log indicated on 4/1/12 there was lasagna sauce that was cooled at 9:30 a.m. and was 180 F, then at 11:00 a.m. was 80F and at 1:00 p.m was 40F; potato salad was cooled at 1:30 p.m. and was 190F and at 2:15 p.m. was 90F there was no other times or temperatures recorded; ham on 4/3/12 was being cooled at 12:15 p.m. and was 168 F, at 2:00 p.m. was 90F, 3:00 p.m was 60F and at 4:00 p.m. it was 38F; and eggs were cooled down on 4/10/12 at 7:30 a.m. they were 160F, 10:00 a.m. they were 80F, 10:30 a.m. 60 F and at 11:15 a.m. they were 40F.

Review of the hospital ' s policy and procedure titled Food Preparation and Service, revised December 2008, indicated potentially hazardous foods should be cooled rapidly. This is defined as cooling from 135 degrees F to 70 degrees F within two hours and then to a temperature of 40 degrees F or below within the next four hours. The total cooling time between 135 degrees F and 40 degrees F is not to exceed six hours.

On 4/17/12 at 2:00 p.m. an interview was conducted with the consultant Registered Dietitian (RD A). The RD A stated he conducted quarterly kitchen reviews. When the log was shown to RD A, he stated he was unsure how to follow the times and temperatures. The surveyor informed him how Cook C told her how to read it. The RD A could not recall the cool down procedures. After review of the policy he stated that was correct and what the staff should be following. When asked, RD A stated he had not done any in-services with the staff on cool down procedures however he would need to now. RD A also stated that maybe the log needed the proper cool down procedures printed on the form to remind the staff on what to do.

Review of Cook C ' s job description and criteria based performance appraisal with an evaluation due date of 5/10/10, indicated the cook always storeed leftovers in a safe and sanitary manner with a score of a 5. A score of a 5 indicated the cook consistently excels and was a role model. The comments indicated foods are cooled if needed and stored according to policy. There was no documentation for the year 2011. No other documentation for competencies for Cook C were received prior to survey exit.

Review of the 2011-2012 in-services did not show any in-services on cool down. Review of the in-services dated 4/28/11 indicated everyone must read the dietary policies and procedure manual. The sign in sheet did not show the signature of Cook C.

The Centers for Disease Control and Prevention (CDC) Report for 1993-1997, " Surveillance for Food-borne Disease Outbreaks - United States, " identified the most significant factors to food borne illness. Improper cooking and improper holding temperatures as two of several categories identified as contributing factors directly relate to food safety concerns.

The US Food and Drug Administration (FDA) refers to improper cooling and holding temperature activities that directly relate to food safety concerns as foodborne illness risk factors.

To effectively reduce the occurrence of food-borne risk factors, food service operators develop and implement food safety management systems to prevent, eliminate or reduce the occurrence of food-borne illness risk factors. The FDA Food Code identifies a preventative rather than a reactive approach to food safety through a continuous system of monitoring and verification. Control measures essential to food safety, such as proper cooking, cooling, and refrigeration, includes time/temperature control for foods. For example, within two hours of cooking, the internal food temperature shall reach 70 degrees Fahrenheit (F) or less and 41 degrees F or less after an additional four hours.

2. On 4/17/12 at 9:10 a.m. an interview was conducted with Food Service Worker (FSW) B regarding the cleaning of the ice machine in the kitchen. FSW B stated they clean the ice machine every month and it takes approximately two hours to clean it. FSW B stated they use bleach and water and cycle that through the ice machine system then they wipe down the bin with the bleach and water mixture. When asked, FSW B stated no other cleaner or sanitizer is used to clean the ice machine.

On 4/17/12 at 9:15 a.m. a dark yellow substance was observed on the ice machine evaporator and a black substance was observed on the legs of the cube deflector. An interview was conducted at this time, FSW B stated she wasn ' t sure if she had wiped down the evaporator the last time she cleaned the ice machine.

Review of the manufacturer ' s guidelines for the Scotsman ice machine located in the kitchen dated 12/95, indicated it was the user ' s responsibility to keep the ice machine and ice storage bin in a sanitary condition. It indicated that the ice machine would first be cleaned by pouring the proper amount of the Scotsman Ice Machine Cleaner (12 ounces) into the reservoir water (below the cube deflector). Then next steps after the cleaner have been cycled through the machine, then to mix two gallons of sanitizer solution. It also indicates to sanitize the ice machine bin.

Review of the Ice Machine Cleaning schedule indicated the ice machine had been cleaned monthly however the procedure was not following the manufacturer ' s guidelines.

On 4/16/12 at 2:00 p.m. the can opener was observed to have metal shavings on the blade.

On 4/16/12 at 2:20 p.m. an interview was conducted with Cook C. Cook C stated they would have to notify maintenance when the blade needed to be replaced. When asked, Cook C stated she was unsure how often to notify maintenance to replace the blade or when it was done last.

Review of the hospital ' s policy titled Sanitization revised December 2008 indicated all utensils and equipment shall be kept clean and maintained in good repair. There was no documentation of a specific policy regarding the changing of the can opener blade.

Based on staff interview and administrative record reviews, the facility failed to review patient care policies and procedures (P&P's) on an annual basis. The failures occurred when six P&P's dated back to 10/02/98 and had not been reviewed. These failures had the potential to not maintain current professional standards of practice and patient care.

Findings:

On 4/18/12 at 2:15 p.m., during an interview, the Medical Staff Manager (MSM) indicated the process of Policy and Procedure (P&P) review was not known, and some of the reviews had not been done for many years.

On 4/18/12 during review of an Administrative P&P titled, "Post Mortum / Dying Patient Care" was last reviewed 10/02/98.

On 4/18/12 during review of an Administrative P&P titled, "In-Service / Continuing Education," was last reviewed 5/21/04.

On 4/18/12 during review of an Administrative P&P titled, "Organ Donation," date last reviewed 12/17/02.

On 4/18/12 during review of an Administrative P&P Manual titled, "Sterile Processing," date last reviewed 7/29/09.

On 4/18/12 during review of an Administrative P&P Manual titled, "Infection Prevention," date last reviewed 4/30/09.

On 4/18/12 during review of an Administrative P&P Manual titled, "Laboratory," date last reviewed 11/15/2009.

Based on observation, staff interview, and administrative document review, the facility failed to maintain safety controls in Radiology when two of two Radiology staff were observed not wearing their radiation monitoring badges while in the Radiology Department as required by facility policy and procedure. This failure had the potential for increased levels of radiation exposure in the Department to go unnoticed.

Findings:

On 4/17/12 at 2:10 p.m., during a tour of the Radiology Department, two of two radiology staff (Rad 1 and RadS) were observed not wearing radiation monitoring badges.

On 4/17/12 at 4:10 p.m., during a concurrent observation and interview, the Radiology Supervisor (RadS) was observed not wearing her radiation monitoring badge. The RadS stated Radiology personnel only wear their badges when performing procedures. When asked if this was the Hospital's policy, she stated she was unsure.

The hospital policy and procedure titled "Radiology, Safety Controls" dated 11/17/92, indicated "Radiation monitoring badges will be worn at all times during duty hours by Radiologist, technologist, and all x-ray personnel."