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Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.618, EMERGENCY SERVICES, was out of compliance.

C-0888. Equipment and supplies commonly used in life-saving procedures, including airways, endotracheal tubes, ambu bag/valve/mask, oxygen, tourniquets, immobilization devices, nasogastric tubes, splints, IV therapy supplies, suction machine, defibrillator, cardiac monitor, chest tubes, and indwelling urinary catheters. Based on observations, document review, and interviews, the facility failed to ensure equipment and supplies commonly used in life-saving procedures, were available for patient use and not expired. Specifically, the facility failed to ensure expired emergency medical supplies were removed from inventory and not available for patient use in two of two trauma bays, one of one pediatric emergency crash cart (a cart used to store medical supplies and medications used during an emergency) and one of two rapid sequence intubation (kit containing medications used to rapidly maintain an airway) (RSI) kits.

Based on observations, document reviews, and interviews, the facility failed to ensure equipment and supplies commonly used in life-saving procedures were available for patient use and not expired. Specifically, the facility failed to ensure expired emergency medical supplies were removed from inventory and not available for patient use in two of two trauma bays, one of one pediatric emergency crash cart (a cart used to store medical supplies and medications used during an emergency) and one of two rapid sequence intubation (kit containing medications used to rapidly maintain an airway) (RSI) kits.

Findings include:

Facility policies:

The Administration of Medication policy read, discontinued and outdated drugs are returned to pharmacy staff for pharmacy waste disposal.

1. The facility failed to ensure expired medical supplies and medications were removed from inventory and not available for patient use.

a. Observations

i. On 9/18/23 at 3:32 p.m., observations of the emergency department (ED) trauma bay RSI kits revealed one vial of Rocuronium (medication used to rapidly relax muscles for airway control) 100 milligram (mg) per 10 milliliter (ml) expired 3/31/23.

This was in contrast to the Administration of Medication policy which instructed to return outdated drugs to the pharmacy staff for pharmacy waste disposal.

ii. On 9/18/23 at 3:32 p.m., observations of the ED trauma bay pediatric emergency cart revealed one i-gel supraglottic airway (a device inserted into the pharynx (the throat) to help a person breathe) size 1 expired 6/30/23, three i-gel supraglottic airways size 1.5 expired 7/31/23, four i-gel supraglottic airways size 2 expired 6/30/23, two i-gel supraglottic airways size 2.5 expired 6/23, three intubation stylets 2.5mm thru 4.5mm expired 8/31/23, one CO2 detector expired 8/21/23, one 500 ml bag of normal saline expired 8/31/23, eight single-use packets of lubricating jelly expired 8/23, and three single-use packets of No Sting Barrier Field (swab used to prevent skin damage prior to applying a bandage) expired 1/21/23.

iii. On 9/18/23 at 3:32 p.m., observations of the ED trauma bay Glidescope (a medical device used to visualize the airway) cart revealed one disposable Glidescope blade (a single-use device inserted in the mouth to visualize the airway) expired 6/29/23 and one disposable Glidescope blade expired 9/9/23.

iv. On 9/18/23 at 3:32 p.m., observations of the ED trauma bays' supply cabinets revealed two piston irrigation (a syringe used for irrigation) trays expired 6/30/23, two female catheter (small tube placed in the bladder) kits expired 5/31/23, and one multi-lumen central venous catheter (a long flexible tube inserted into a large vein) kit expired 6/30/23.

b. Interviews

i. On 9/19/23 at 1:32 p.m., an interview with registered nurse (RN) #4 was conducted. RN #4 stated emergency medical services (EMS) personnel were responsible for checking the crash carts for expired supplies and medications; however, they had not checked the pediatric crash cart. She said there was a miscommunication between EMS and the nurses on who was responsible for checking the pediatric crash cart for expired supplies and medications. RN #4 said that it was important to remove outdated medical supplies because they could be faulty or lose their sterility. Further, she stated the risk to a pediatric patient, especially with an outdated airway, could be death, harm, or a poor outcome to the patient. Additionally, RN #4 stated the risk of expired medication used on a patient could be changes in the therapeutic level of the medication and the medication might not have the expected outcome.

ii. On 9/19/23 at 1:32 p.m., an interview with pharmacy manager (Manager) #5 was conducted. Manager #5 stated there had been a lot of turnover in leadership with nursing and EMS and accountability was not taken for the supplies in the trauma bays. Additionally, she explained the RSI kits were checked by the pharmacy tech monthly by looking for the next expired medication date. However, she said the expired vial of Rocuronium in the RSI kit was missed by the pharmacy tech.

iii. On 9/20/23 at 9:08 a.m., an interview with the director of quality and infection control (Director) #6 was conducted. Director #6 stated she did monthly environment of care (EOC) rounds to check for outdated supplies. She said each department was responsible for checking for outdated supplies in their area. Director #6 stated it was important not to use outdated supplies because they could have been contaminated or the materials may have been damaged which could have harmed a patient. Upon request, Director #6 stated the facility did not have a policy for outdated medical supplies.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.623 Physical Plant and Environment, was out of compliance.

C-0922. Drugs and biologicals are appropriately stored; Based on observations, document reviews, and interviews, the facility failed to ensure safe and appropriate temperature control of warmed intravenous (IV) fluids for patient administration. Specifically, IV fluids for patient use were warmed with no temperature monitoring in one of two medical warming devices.

Based on observations, document reviews, and interviews, the facility failed to ensure safe and appropriate temperature control of warmed intravenous (IV) fluids for patient administration. Specifically, IV fluids for patient use were warmed with no temperature monitoring in one of two medical warming devices.

Findings include:

References:

The instruction manual for the Olympic Warmette read, warm only external-use-only solutions.

The Baxter IV fluid instructions for use (IFU) read, IV fluids should be stored at room temperature; brief exposure to 40 C/104 F degrees does not adversely affect the product. The Food and Drug Administration (FDA) has not approved the following information: if you choose to warm injection solutions, the use of controlled temperature warming cabinets is recommended. The IFU warming parameters state that IV fluids be warmed for a period of no longer than 14 days.

The Braun IV fluid IFU read, IV fluids should be stored at room temperature; however, brief exposure at 40 C degrees does not adversely affect the uncompromised product.

1. The facility failed to ensure that warm IV fluids for patient use were stored in a temperature-controlled manner in accordance with IFU for safe patient administration.

a. Observations

i. On 9/18/23 at 3:32 p.m., observations of the emergency department (ED) clean storage room revealed two medical warming devices. One of the devices contained multiple one-liter bags of IV fluids. The warmer had no temperature monitoring device or temperature logs to ensure IV fluids were stored in accordance with IFU which instructed that fluids be warmed in a controlled temperature warming cabinet. Further observations revealed that not all IV fluid bags were labeled with the date the fluids should be removed in accordance with the IV fluid IFU.

The storage of IV fluid bags in the medical warming device was in contrast to the IFU for the device which read, warm only external-use-only solutions.

b. Interviews

i. On 9/19/23 at 1:32 p.m., an interview with pharmacy manager (Manager) #5 was conducted. She said the facility kept warm IV fluids for traumas, hypothermic (a significant drop in body temperature) patients, and elderly patients. Manager #5 stated it was important to keep IVF in the correct temperature range to keep the stability of the IV fluids in the bag. Further, she said the correct temperature was important for patient safety to avoid the risk of burning patients.

ii. On 9/20/23 at 9:20 a.m., an interview with the director of quality and infection control (Director) #6 was conducted. She stated it was important to monitor IV fluid temperatures because if the IV fluids were stored too hot, too cold, or too long, the IV fluids might be contaminated. She said there could be a risk to patients of bloodstream infections or harm if the patient received IV fluids that had been stored incorrectly.

Based on observations, interviews, and document review, the facility failed to ensure staff stored food in the kitchen per facility policy in one of one observation of the kitchen.

Findings include:

Facility policies:

The Dry Food Storage policy read, dry food storage will be maintained on a rotating basis for safe periods of time and under sanitary conditions to assure safe food of good quality. Sugar must be marked and dated when open. Flour can be kept in a seamless container with a tight-fitting lid for up to 6 months. Mark and date the container when the flour is opened. Mark and date the containers of flour when flours or grains are open. All spices are to be dated when purchased and dated on top with the open date. All items are to be dated upon delivery. Stock is rotated. First in - first out.

References:

The ServSafe Food Handler Guide 6th edition read, when storing foods that need time and temperature control for safety, time and temperature control is critical. Carefully monitor storage temperatures and times. You must be able to tell when food was stored and by what date it must be used. This means correctly labeling food as it is stored. Store food away from walls and at least six inches off the floor.

The Early Shift Checklist read, check dates and monitor ingredient freshness.

1. The facility failed to ensure staff stored food in the kitchen per facility policy.

A. Observations

i. Observations conducted on 9/18/23 at 12:50 p.m. in the pantry area of the kitchen revealed multiple examples of improper food storage.

a. In the pantry, multiple packages of previously opened food did not have an open date written on the packaging. These items included two bags of brown sugar, one bag of raisins, one bag of hot cocoa mix, one bottle of instant coffee crystals, one bag of nonfat dry milk powder, one bag of gravy mix, one 10-pound bag of white flour, one bag of corn chips, one bag of pinto beans, one container of croutons, one bottle of butterscotch syrup, one bottle of pancake syrup, and assorted bottles of spices.

This was in contrast to the Dry Food Storage policy which read, dry food storage was maintained on a rotating basis for safe periods of time and under sanitary conditions to assure safe food of good quality. Flour was marked and dated when opened. All spices were dated when purchased and labeled on top with the open date. All items were dated upon delivery. This was also in contrast to the Early Shift Checklist which read, the staff checked dates on food and monitored ingredient freshness.

b. This observation also revealed a container of homemade cookies labeled with a handwritten date of 8/6/23.

This was in contrast to the Dry Food Storage policy which read, dry food storage was maintained on a rotating basis for safe periods of time and under sanitary conditions to assure safe food of good quality. This was also in contrast to the Early Shift Checklist which read, the staff checked dates on food and monitored ingredient freshness.

c. This observation additionally revealed one box of oranges and one box of apples sitting directly on the floor.

This was in contrast to the ServSafe Food Handler Guide 6th edition which read, food was stored at least six inches off the floor.

B. Interviews

i. On 9/18/23 at 12:50 p.m., an interview was conducted with dietary cook (Cook) #1. Cook #1 stated all kitchen staff were responsible for checking stock. She stated the open date should have been written on a food package once it was opened. Cook #1 stated she was going to throw away the boxes of fruit on the floor of the pantry but had not yet been able to do so. She stated the container of cookies marked with the date 8/6/23 had been put in the freezer on 8/6/23 and were removed on 9/14/23.

ii. On 9/18/23 at 1:09 p.m., an interview was conducted with dietary cook (Cook) #2. Cook #2 stated the boxes of fruit on the floor were not going to be used in food preparation and there was no risk to the patients or staff as they were meant to be thrown out. She stated the packages of foods in the refrigerator and freezer which were opened but not labeled, did not need opened dates and this did not pose a risk to patient or staff health. Cook #2 then stated expired foods, if used in food preparation, could make people sick.

Cook #2's interview was in contrast with the ServSafe Food Handler Guide 6th edition, which read, when storing foods that needed time and temperature control for safety, time and temperature control was critical. The Guide instructed to carefully monitor storage temperatures and times.

iii. On 9/18/23 at 2:05 p.m., an interview was conducted with chief compliance officer (Director) #3. Director #3 stated all the kitchen staff, including himself as the interim manager, were ServSafe certified. He stated the staff were expected to write the date packages were opened on the outside of the package with a marker or sticker and food was not to be stored on the floor. Director #3 stated following policies and ServSafe guidelines were expectations for ensuring food safety. He stated there was a risk of food-borne illnesses if food safety policies were not followed.

Based on document review and interviews, the facility failed to maintain an emergency preparedness plan which was reviewed and updated every two years.

Findings include:

Facility policy:

According to the Emergency Preparedness Plan policy, the Emergency Preparedness Plan will be evaluated annually in terms of its objectives, scope, performance and effectiveness.

1. The facility failed to ensure its emergency preparedness plan was reviewed and updated every two years.

a. On 09/18/2023 12:01 p.m., a request was made for the facility's emergency preparedness plan. On review of the document provided, it was dated May 2021, two years and eight months prior to the survey and four months past the required update.

b. On 09/20/2023 at 10:30 p.m., the chief compliance officer (Director) #3 was interviewed. Director #3 stated the facility had not updated the emergency preparedness (EP) plan since 2021; however, they were in the process of rewriting the EP. Director #3 stated an updated emergency plan was important to ensure staff and patients were safe during an emergency situation.