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Based on observation, and interview, the facility failed to ensure that side rail spaces were in compliance with U.S. Department of Health and Human Services, Food and Drug Administration (FDA) guidance Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment for 2 of 2 beds observed in seclusion rooms of the locked psychiatric unit of the hospital . Findings include:

At 11:00 am on 8/9/2011, during a tour of the seclusion rooms on the locked unit, the bed rails on two beds were observed to have large gaps inside the bars that posed a risk for entrapment. Registered Nurse (RN)-A was interviewed on 8/9/2011, at 11:00 a.m. and stated that when patients were in seclusion and the beds, with or without the side rails were used, the patients were always in visual site of a 1:1 staff person. Additionally, RN-A stated the side rails were not assessed as a potential safety hazard to patients using the beds. The side rails spaces measured 7 and 1/4th inches to 9 and 1/2 inches vertically and the horizontal space was greater than 10 inches.

The 3/10/06, U.S. Health and Human Services, Food and Drug Administration publication, "Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment recommended a maximum opening of 4 and 3/4 inches for Zone 1 of the bed.

Based on observation, interview policy review, the hospital failed to ensure drugs/procedural supplies in 2 of 17 clinical areas observed were kept locked and secured. Findings include:

Medications and procedural supplies located in the neurology and pediatric orthopedic clinic were stored in unlocked cabinets with potential accessibility by patients.

On 8/10/2011, at 2 p.m. a cabinet in a hallway adjacent to the desk in the pediatric orthopedic clinic was found unlocked with the following medications and procedural supplies inside: 2 bottles of hydrogen peroxide, 2-4 ounce bottles of Betadine scrub, 2-4 ounce bottles of Betadine solution, 4.5-16 ounce bottles of isopropyl alcohol, 15-20 milliliter bottles of Lidocaine 1%, 1.5 vials of Celeston (a steroid medication, often injected into joints), 2 packages of Silver Nitrate swabs (rigid, wooden applicator stick tipped with 75% silver nitrate/25% potassium nitrate for precise placement. Often used to control bleeding and does require a prescription.), 1-10 ml vials of Maracaine 0.5% (local anesthetic) and 1 vial of Lidocaine 2% (local anesthetic).

Licensed practical nurse-A (LPN-A) was interviewed on 8/10/2011, at 2:10 p.m. and stated she was not clear as to who was responsible for keeping the cabinet locked.

On 8/10/2011, at 2:45 p.m. an unlocked cabinet in the neurology clinic had the following prescription medications: 3 vials of Toradol (a nonsteroidal anti-inflammatory drug used in the management of moderately severe acute pain given by intravenous injection or intra-muscular injection) and Sumavel subcutaneous medication (a prescription medicine given with a needle-free delivery system to treat adults who have been diagnosed with acute migraine or cluster headaches).

LPN-B was present when the cabinet was found unlocked and stated that the cabinet should have been locked.

On 8/11/2011, at 9:30 a.m. the director of pharmacy services was interviewed regarding the unlocked medications and procedural supplies found in the clinic settings. He stated that the medications were to be secured at all times.

The policy with the subject Medication Security dated 5/1995, with the last reviewed/revised date of 12/2009, indicated that all medication storage areas will be locked or secured. Examples of pharmaceutical items and storage requirements were listed in the policy. Items that will be locked or under constant surveillance were bottles of Betadine solution or scrub, isopropyl alcohol bottles, Silver Nitrate swabs and any product that is marked "Rx Only".

Based on observation, interview, and record review, the hospital was found to be out of compliance with the Condition of Participation related to the Physical Environment (42 CFR 482.41) related to lack of compliance with Life Safety Code requirements. Findings included:

The hospital was found out of compliance with the Condition of Participation related to the Physical Environment (42 CFR 482.41) as evidenced by deficiencies issued as a result of a Life Safety Code inspection. Findings include:

Please refer to Life Safety Code inspection tags: K011, K015, K020, K022, K025, K29, K033, K038, K052, K056, K062, K106, K141 and K211 for additional information.

The facility failed to ensure kitchen environment and equipment was maintained to an acceptable level of safety and quality. Findings included:

During kitchen observation on 8/9/11 at 10:00 a.m. and 8/10/11 at 10:11 a.m. the deep fat fryer was observed to be leaking grease onto the floor. Blankets were observed under the deep fat fryer and were saturated with oil/grease. Freezer four's floor, under the shelving units, was soiled with debris (cookies, ice cream containers, pureed items and pie pieces). Fridge one had dust on the screens of the condenser fans and fridge two had dust on the ceiling above food items. A storage area by the soda dispenser had cans, cardboard and food on floor under the shelving unit. These observations were confirmed by the Food Service Manager (FSM) and Operations Manager.

Interview on 8/10/10 at 10:22 a.m. with Food Service Worker (FSW)-A verified the deep fat fryer was leaking and blankets were being used absorb the leak. FSW-A stated the fryer had been broken for several months. FSW-A reported the issue had been relayed to the maintenance department.

During interview on 8/10/11 at 3:13 p.m. the Maintenance Director (MD) stated the deep fat fryer has been repaired several times in the past. He stated the last work order was placed on 7/28/11. MD was unsure exactly what for, however he did state he was aware the fryer has been having leaking problems for the past several months. MD stated the liner needed to be replaced. MD verified the facility had the liners but the task had not been completed.

During interview on 8/10/10 at 10:42 a.m. the FSM stated the person responsible for cleaning the freezer floor and storage area floor was "new." FSM stated there may need to be closer monitoring and training for newer staff. In addition, FSM stated it was the responsibility of all staff to ensure the cleanliness of the fridge and dust build up. However, maintenance was responsible for cleaning the condenser fans as part of their preventative maintenance plan.

Based on observation, interview and record review, the hospital failed provide a sanitary environment to avoid potential sources and transmission of infections and communicable diseases to prevent food borne illness. The lack of appropriate sanitation had the potential to affect most patients in the hospital. Findings included:

The hospital failed to ensure the ice machine, three compartment sink sanitization solution and steam jacketed kettle cleaning brush were effectively sanitized and stored to prevent possible transmission of infectious diseases.

During the kitchen observation on 8/9/11 at approximately 10:00 a.m. an ice machine was observed near the entrance of the kitchen. The ice machine was being utilized by Food Service Worker (FSW) - B. FSW-B was scooping ice into a bucket with a clean scoop to line the salad bar before serving. Operations Manager (OM) stated maintenance was in charge of sanitizing the ice machines internal components.

The preventative maintenance log indicated ice-o-matic ice machine needed to be sanitized by; " Prepare 1 ½ to 2 gallons of approved (EPA/FDA) sodium hypochloride food equipment sanitizer to form a solution with 100 to 200 maximum parts per million (ppm) free chloride yield. Add enough sanitizing solution to fill the water trough to overflowing and place the ice/off/wash switch to the "wash" position and allow circulation to occur for 10 minutes ... Depress the purge switch and hold until sanitizer has been flushed down the drain. Turn on the ice machine water supply and continue to purge to diluted sanitizing solution for another 1 to 2 minutes."

During interview on 8/9/11 at 2:30 p.m. Maintenance Worker (MW)- A stated he was responsible for the cleaning/sanitizing of all ice machines in the facility. MW- A provided the Nu-Calgon nickel safe ice machine cleaner he used to clean the machine. MW-A verified he did not use sanitizing solution to sanitize any of the ice machines. MW-A confirmed the preventative maintenance plan indicated the ice machines should be sanitized semi-yearly.

Kitchen observation 8/10/10 at 10:38 a.m. indicated that the Ecolab sanitation dispenser for the three compartment sink was flashing "battery low." The Food Service Worker (FSW) - C demonstrated his process for checking proper quaternary levels in the third sink (sanitation sink). The quaternary was low so FSW-C manually dispensed more from the machine by pushing a button.

During interview on 8/10/11 at 10:38 a.m. FSW-C confirmed that sanitization sink was "often" over 400 parts per million (PPM). FSW-C stated "oh yeah it goes over 500 ppm," but would not think being too concentrated would "hurt anything." The Registered Dietitian (RD)-A, interviewed at that time, stated staff are trained on the three compartment sink "on the job by each other." RD-A stated there was no in-service on how to use the three compartment sanitizing sink. RD-A confirmed that the parts per million (PPM) were to be between 150-400 PPM to properly sanitize dishes. RD-A verified that they currently had no system in place to ensure that staff knew the correct PPM and that the sanitizing sink concentration was between 150-400 every day. RD-A confirmed staff could and do manually add sanitizing solution to this sink after it was already reformulated if the dispenser system was not working or was suspected to not be working.

The safety infection prevention manual dated 10/10 indicated that food service items should be disinfected (sanitize) with an approved sanitizing solution (i.e. bleach/water, quaternary products). The policy did not include the process for monitoring staff ability to ensure proper procedure was completed when using the three compartment sink.

Ecolab Oasis 146 Multi-Quat Sanitizer Procedure (undated) indicated to withdraw and tear off approximately 2 inches of paper from dispenser. Dip paper for 10 seconds and compare colors immediately with colors on test strip package to determine parts per million. "Always compare against package scale. Testing solution should be between 150-400 ppm." It indicated 150-400 ppm was the efficacy range for sanitization.

During kitchen observation on 8/9/11 at 10:00 a.m. the brush to clean the steam jacketed kettle drain was being stored on top of a fridge in the kitchen. The OM confirmed this finding.

Based on interview, record review and policy review, the hospital was found not to be in compliance with the Conditions of Participation for Surgical Services (CFR 482.51) due to failure to ensure proper sterilization of eye surgical instruments for surgeries from 01/01/2011 through 07/31/2011. This practice had the potential to affect approximately 243 patients provided eye surgery in the hospital since 1/1/2011. Findings include:

The hospital did not follow their policy/procedures or manufacturer's guidelines to ensure eye surgical instruments were correctly sterilized to prevent the risk of surgical infections.

During the tour of the surgical department on 8/10/2011, at 9:45 a.m., the nurse manager of Surgical Services (NM) was interviewed regarding the use of flash sterilization. The NM stated that there were four instrument trays available for microsurgical eye procedures. Due to the volume of eye surgeries, the instruments are washed between cases, placed unwrapped in a tray and are then placed in the autoclave cycle for ten minutes.

The NM confirmed on 8/10/2011, at 9:50 a.m. that nine eye cases were scheduled that day and five eye instrument trays would be sterilized by using the flash sterilization method.

The policy and manufacturer's recommendations for use of flash sterilization on surgical instruments were requested. Seven months of the logs with recorded use of the flash sterilization was also reviewed.

Based on hospital data, the total flash percentage rates for the entire surgical services area (to include all surgical cases) from 01/2011, through 7/2011, ranged from 6.44 percent to 12.91 percent.

The flash sterilization counts for 2011 were reviewed on 8/11/2011, at 9:00 a.m. with the NM. It indicated that flash sterilizing was used for ophthalmology surgical cases as follows; 25 times during 7/2011, 71 times during 6/2011, 29 times during 5/2011, 36 times during 4/2011, 37 times during 2/2011 and 45 times during 1/2011.

The facility policy with the subject of "Sterilization, Flash" dated 4/20/1978, with a review/revise date of 01/2008, indicated that flash sterilization of instrument trays and individual instruments was to be restricted to unplanned or emergency situations when there was insufficient time to process by the preferred wrap or container method.

Review of the manufacturer's instructions for the "Eagle Century Series Gravity and Pre-vacuum Sterilizers" indicated that "it is designed to permit flash sterilization using a single wrapper on the instrument tray. Rationale: The single wrapper serves to confine and contain the sterilized items from environmental contaminants that may be encountered enroute from the sterilizer to the point of use." The NM confirmed on 8/11/2011, at 9:00 a.m. that "gravity sterilization" is used to "flash sterilize" instruments for ten minutes at 270 degrees and that the instruments were not wrapped. The NM also stated that there was an awareness of the recommendation to minimizing flash sterilization of surgical instruments.

"Guideline for Disinfection and Sterilization in Healthcare Facilities" published by the Center for Disease Control (CDC) 2008, indicated that flash sterilization maybe associated with increased risk of infection and should not be used for reasons of convenience, as an alternative to purchasing additional instrument sets, or to save time.