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Based on observation, interview, and document review, the facility failed to ensure the safe and appropriate storage of intravenous (IV) fluids within the fluid warmer. Specifically, the facility failed to store warmed IV fluids in a way to maintain therapeutic integrity.

This failure created the potential for IV fluids being unsafe to administer.

FINDINGS:

FACILITY POLICY

According to policy, Storage of Medications, revised 07/28/14, Medications shall be stored under the proper conditions of sanitation, temperature, light, moisture, ventilation, organization, segregation, safety, and security. Temperatures and ventilation in the work areas shall ensure the integrity of medications and the comfort of personnel.

When in conflict, the Director of Pharmacy shall ascertain whether the provisions of the United States Pharmacopeia National Formulary (USP/NF) or the specifications of the manufacturer take precedence.

REFERENCE

According to Hospira's manufacturer's directions, November 12, 2014, regarding intentional warming of intravenous solutions, solutions for injection and irrigation in PVC and CR3 plastic flexible containers, in their overwraps, may be warmed at a temperature not to exceed 40C (104F) and for a period no longer than two weeks.

1. The facility failed to ensure IV fluids were stored in accordance with manufacturer's directions.

a) On 02/02/15 at 2:15 p.m., a tour of the Emergency Department was conducted with the Trauma Nurse Coordinator (TNC). The IV fluid and blanket warmer was observed to have no temperature monitoring log or an alternative way to monitor the temperature. The TNC stated there used to be a log on the warmer, but was not sure why there wasn't one at that time.

b) On 02/04/15 at 11:00 a.m., a tour of the facility preoperative area was conducted with the Chief Clinical Officer (CCO). The IV fluid and blanket warmer was observed to have a temperature monitoring log and contained ten bags of Hospira Lactated Ringers solution. The IV fluid warmer log showed the temperature should be set to 110 and the actual temperature at the time of the tour was 107. The CCO stated s/he would provide a copy of the manufacturer's directions regarding warmed temperatures.

c) On 02/05/15 at 9:35 a.m., a followup tour of the facility was conducted with the Chief Clinical Officer and the Director of Support Operations. The fluid warmer located in the Emergency Department was observed to now have a temperature log with the documented temperature of 104F.

Further tour of the preoperative area was conducted. The IV fluid warmer was observed to have a temperature of 112F. Interview with RN #2 was conducted. S/he stated per facility policy the temperature should be set at 110F. The temperature of 112F was because the fluid warmer had not been opened and the heat had built up. If a staff member were to record an out of range temperature, s/he would call maintenance to look at it. RN #2 stated it would be important not to overwarm the IV fluids.

RN #2 provided a copy of the facility policy which confirmed the temperature of 110 was the setting per facility policy. RN #2 was shown the letter from Hospira regarding the recommended warmth of IV fluids. RN #2 stated s/he had not received this information.

d) On 02/05/15 at 12:00 p.m., an interview with the Director of Pharmacy (DOP) was conducted. The DOP stated the best practice would be to go by the manufacturer's letter, but did not feel the patients were harmed by the temperature of 110 based on research.

Review of facility document, Pharmacy Nutrition and Therapeutics, dated November 12, 2014, was conducted. The DOP confirmed the letter received from Hospira in November 2014, which was discussed in a facility meeting, should have been implemented.

The DOP provided an email s/he sent to the CCO and the Director of Support Operations, dated 02/02/15, which confirmed the requirement to store fluids in a warmer not more than 104F.

Based on observation, interviews, and document reviews the facility failed to ensure all mobile carts containing drugs or biological's remained locked in a secure area when not in use.

This failure created the potential for harm by allowing access by unauthorized persons.

FINDINGS:

FACILITY POLICY

According to policy, Storage of Medications, last revised 07/28/14, medications and biological's will be stored so that only authorized personnel have access. If the container is mobile or readily portable, when not in use, it must be stored in a locked room monitored location, or secured location that will ensure security of the drugs and biological.

1. The facility failed to ensure the mobile emergency code cart was secured at all times while not in use.

a) On 2/2/15 in the afternoon on the Intensive Care Unit (ICU) observed the adult and Braslow (pediatric) code carts unlocked.

b) 0n 2/2/15 in the afternoon, review of the ICU Crash Cart Checklist, the adult code cart was left open 12/14/14 thru 12/22/14, 12/25/14 thru 12/27/14, and 12/30/14 thru 12/31/14 a total of 14 out 31 days. The pediatric code cart was open 12/1/14 thru 12/9/14, and 12/27/14 thru 12/31/14, a total 12 out of 31 days in December.

c) On 2/2/15 in the afternoon, further review of the January ICU Crash Cart Checklist, the adult code cart remained open 1/1/15 thru 1/12/14; 1/21/14 thru 1/25/14; and 1/29/14 thru 1/31/14,, a total of 17 out of 31 days. The pediatric code cart remained open 1/1/15 thru 1/5/15, a total of 5 out of 31 days.

d) An interview on 2/2/15 with RN#1 was conducted in ICU. S/he stated the crash carts are checked mostly every 24 hours if the unit is open and can remain unlocked until it is re-supplied by the pharmacy or if we are waiting for other supplies. There aren't any controlled medications in the cart, just medications for code situations and for intubation.

35461

Based on observation, interviews, and document reviews the facility failed to maintain a sanitary environment by not identifying and rectifying infection control issues hospital-wide.
Specifically, the facility failed to appropriately transport and store flexible endoscopes and failed to ensure food was clearly identifiable and appropriately dated.

The failures created the potential for preventable illnesses and the spread of nosocomial or infectious diseases throughout the facility.

FINDINGS:

A. The facility transported and stored flexible endoscopes in a manner that did not maintain infection control or reduce the risk of acquiring an infection.

FACILITY POLICY

According to policy, Cleaning and Processing of Flexible Endoscopes and Accessories, revised 08/30/12, Transport the contaminated flexible endoscope and accessories to the decontamination area using a closed container (eg, enclosed by a plastic bag, container with a lid) that is labeled to indicate biohazardous contents. If the decontamination area is adjacent to the procedure room, the contaminated items may be transported in an open container by personnel wearing appropriate personal protective equipment (PPE).

Store clean flexible endoscopes in a closed cabinet.

1. The facility transported and stored flexible endoscopes in a manner that did not maintain infection control or reduce the risk of acquiring an infection.

a) During observation of a procedure on 02/04/15 at approximately 11:30 a.m., the door to the procedure room was closed to the preprocedure area; however, the door was open to the decontamination room. At the completion of the procedure, the Surgical Technician (ST) was observed to transport the contaminated flexible endoscope with his/her gloved hands to the reprocessing area.

In the reprocessing room next to the scope storage area, two flexible endoscopes were observed to be hanging vertically from an IV pole. Two staff members were observed to open the door to the reprocessing area, walk next to the clean hanging scopes, and into the procedure room.

b) An interview was conducted with the ST assigned to the scope processing room. S/he stated this was the routine process for transportation of a contaminated flexible endoscope to the processing area. The ST stated the reason s/he regularly hung scopes from the IV pole was so they could finish air drying. When asked how would the ST ensure the scopes would not become contaminated, s/he said that neither the scope or the procedure was sterile, so that was a good question.

c) On 02/05/15 at 10:30 a.m. an interview with the Infection Preventionist (IP) was conducted. The IP shared what oversight s/he has over surgical services. The IP stated s/he would go through the surgical suite and inspect looking for breaks in infection control. The IP stated s/he has not done much yet with the procedure rooms. The IP stated s/he was not aware the scopes were being carried by hand instead of a container, or the scopes were being hung from an IV pole to dry.

B. The facility failed to to ensure food was clearly identifiable and appropriately dated.

POLICY:

According the policies, HACCP(Hazard Analysis & Critical Control Points/FDA) and Food Storage, Food Storage, and Use of Leftovers, certain foods are considered potentially hazardous because of the protein content, moisture content and food source. These foods, described as time/temperature controlled for safety include, but are not limited to milk and milk products (yogurt, cottage cheese, etc.) and meat (beef, poultry, chicken). Additionally, when maintaining food safety staff must be sure foods are not past expiration dates to prevent bacteria growth. The Facility must ensure staff follow HACCP principles by identifying all steps of food preparation that need to be monitored including time and temperature, be sure standards are measurable and can be monitored at any time and include systems to assure foods are properly covered, labeled and dated. Leftover shall be stored in covered containers, or wrapped safely and securely, tabled and dated before being refrigerated to ensure it is used within 3 days or discarded.

Additionally, the Facilities policy, Food Product Shelf-Life Guidelines, revised 1/30/12 indicates spices may be stored open for 6 months; salad dressings (opened) may be kept for 10-14 days; deli-style meats (turkey, roast beef, pastrami, etc.) (opened) may be stored 3-5 days. The policy further states, to refer to the manufacturer's expiration or use by date before using the policy chart.

1) On 2/3/15 at 8:40 a.m. toured the Facility kitchen with the Kitchen Supervisor. Observed in refrigerator #1 (dairy items) an open yogurt without date. Kitchen Supervisor verified opened items should dated when opened and kept for 3 days then discarded.

2) Joined by Director of Food Production at 9:00 a.m. on 2/3/14. Director of Food Production stated food in refrigerator #3 (produce cooler) should be dated when it is to be thrown out. Observed a cucumber wrapped loosely in plastic dated 2/2/15 and raspberry vinaigrette undated. The Director of Food Production states s/he is unfamiliar with a policy for opened salad dressings.

3) In refrigerator #4 (rapid use refrigerator) noted a container of cooked brown rice prepared 1/31/15 with use by date 2/5/15; open sliced deli turkey with prepare date 1/31/15 and use by date 2/7/15; a small block of Swiss cheese wrapped in plastic without dates; a package of shredded parmesan wrapped in plastic without dates; and a package of white cheese wrapped in plastic wrap with a future date of 2/7/15. Director of Food Production then stated "the Health Department provided us a 7 day rule". The Kitchen Supervisor confirms if an item is purchased it is good for 7 days, and if made it is good for 3 days. Additionally observed a metal container covered with plastic wrap holding flank steak in marinade dated 2/2/14 with the use by date blank and initialed by Cook #11. An interview was conducted with Cook #11 at this time. Cook #11 stated "I didn't label the flank steak because the assumption is that we were going to use it today on the menu, but generally items are good for 3 days in this refrigerator". The Director of Food Production stated there were no signs posted which identify how long different food items are to be kept refrigerated or frozen. S/he stated "but we try to instill in the staff the time frames I told you".

4) Observation at 9:05 a.m. on 2/3/15 showed spice containers on the spice rack without expiration dates. The Director of Food Production stated spices have no expiration date, "we keep them for about a year. If they become contaminated with water then we throw them right out".

5) An interview with the Director of Food Production conducted in his/her office on 2/3/15 at 9:15 a.m. revealed there is one dietician on staff who sets the menus and monitors the trays. Training of kitchen staff is done at orientation and ongoing education is completed at monthly meetings with the dietician. Review of the monthly department meetings for the year 2014 lacked any record of the facility dietician in attendance.

6) An interview was conducted on 2/3/15 with the Facility Registered Dietician (RD). The RD states s/he tries to conduct monthly kitchen walk throughs to ensure proper housekeeping and accurate dating of foods, and food temperatures as part of the environment of care rounds. S/he further stated anything not in its original package must be accurately dated when it was prepared and it is generally accepted in "ServSafe" that 7 days is an appropriate time frame to store opened foods. Additionally, the RD stated "I am unaware of policies regarding food labeling because I deal with the clinical side primarily". When questioned if he/she attends the monthly kitchen staff meetings the RD stated "I attend when when they ask me to. It's pretty rare I even know when they are".