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Based on observations and interviews, the facility failed to ensure supplies in the crash carts and emergency supplies were maintained in accordance with manufacturer's expiration dates to ensure efficacy. This failure was identified in 3 of 4 emergency carts and 2 or 2 identified glucometers.

Findings Include:

Policy:

According to facility policy, Crash Cart Medications and Restocking, it was the responsibility of the Nursing and Pharmacy staffs to maintain the crash cart system. The policy stated an exchange tray system will be used, Medication trays were exchanged with pharmacy and supplies trays were exchanged with Materials Management. Nursing and or clinic staff were responsible for checking non-medication stock items monthly.

According to facility policy, Assure Platinum Glucometer, for performance and procedure of use of the glucometer, the user should refer to the User Instruction Manual.

Reference:

According to the manufacturer's instruction manual for the Assure Platinum Glucometer, the control solution should be used within 90 days of first opening. It was recommended the user write the date of opening on the control solution bottle label as a reminder to dispose of the opened solution after 90 days.

1. The facility failed to ensure expired supplies were removed from the crash cart (supply cart for medical emergencies) and from other locations in which emergency supplies were kept.

a. On 5/13/19 at 2:28 p.m. a tour of the respiratory therapy and supply closet was conducted. In the supply closet there was a crash cart for use during sleep studies and or cardiac studies. On top of the crash cart a tackle box with medical supplies was identified. Pharmacist #8 identified this box for use during stress tests (a test to show how the heart works when the heart rate was elevated either by activity or medications). Pharmacist #8 stated the box was not currently in use, although present in a patient care area. In the box, there were two blunt end needles which expired 2/2016, one 18 gauge safety needle which expired 9/2016, and four 20 gauge safety needles which expired 11/2016, 7/2017 and 9/2017. After the observation, the pharmacist removed the expired supplies and disposed of them.

b. On 5/13/19 at 2:48 p.m., a tour of the emergency department (ED) was conducted. During the tour, an inspection of the adult crash cart revealed the following expired supplies: nasopharyngeal airway (a tube placed in the nose to maintain an open airway) which expired 2/2019, and an arterial puncture kit (a kit used for accessing a blood sample from an artery) which expired 5/8/2019.

An inspection of the supplies in the same emergency room, identified as the cardiac room by staff, revealed an endotracheal tube (a tube inserted into the mouth and the airway to assist a patient with breathing) which expired 4/2019.

During the same tour, an inspection of the IV cart (cart which contained supplies for starting IV's and obtaining blood samples), was conducted. In the cart was a bag of seven tall purple top lab tubes (identified by Director #5 as tubes used for testing blood specifically for transfusions) which expired 4/30/19. Additionally, there were five more tall purple top lab tubes with the same expiration date, and three green top lab tubes which also expired 4/30/19 in the IV cart.

c. On 5/13/19 at 4:12 p.m. a tour of the medication room within the ED was conducted. In the medication room a tackle box labeled RSI (rapid sequence intubation, which contained supplies for emergent intubation) was noted. Inside the box there were three packages of ChloraPrep (solution used for cleaning the skin) which expired 2/2019, two 20 and two 18 gauge IV radiopaque catheters (identified as used by anesthesia during intubation) which expired 2/2016 and 3/2016 respectively.

d. Similarly, during a tour of the pre-operative and recovery area and the post-anesthesia care unit (PACU) conducted on 5/14/19 at 2:30 p.m., multiple expired supplies were identified in the crash carts. Expired items observed located in the patient crash cart included:

A tracheal introducer (a shaft which was placed in the cannula of the tube during intubation) expired 10/2018
Two 20 gauge angiocatheters (used to insert IV's) expired 2/2018
A drawer in the crash cart which was sealed with an expiration sticker for 12/2018

e. An interview was conducted on 5/13/19 at 2:47 p.m. with ED Technician # 7 who stated the supplies in the cardiac room of the ED were checked on a daily basis on a checklist. He stated both registered nurses and ED technicians were allowed to complete the checklist and the purpose was to identify the presence of the supplies as well as the expiration dates on the supplies.

f. An interview was conducted with Director #5 on 5/13/19 at 2:50 p.m. Director #5 stated it was the responsibility of the ED nurses and technicians to check the equipment on a daily basis. Director #5 stated the expiration dates meant the shelf life of the product was good for that time frame.

A second interview was conducted with Director #5 on 5/13/19 at 3:15 p.m. with regards to the IV supply cart. She stated she was not aware if supplies within the cart were checked for expiration and it was the responsibility of the ED technicians to be sure the cart was stocked with supplies.

g. An interview was conducted with Chief Nursing Officer (CNO) #4 and Infection Control Nurse (ICRN) #16 on 5/16/19 at 2:02 p.m. CNO #4 stated she was not aware of who was checking the dates of supplies within the nursing areas. Both CNO #4 and ICRN #16 stated expired supplies were to be removed from stock as the quality of the items could not be ensured.

2. The facility failed to identify expiration of supplies as recommended by the manufacturer to ensure accuracy of the instrument used both emergently and routinely.

a. On 5/13/19 at 4:18 p.m. a tour of the ED was conducted. During the tour the glucometer identified for emergency use was observed. The solutions used to calibrate the glucometer were identified as opened and used for quality control testing. The bottles read, use within 90 days of first opening, and had a manufacturer's expiration date of 12/2019. Registered Nurse (RN) #6 was able to determine based on the logs, the solutions were opened in December 2018. RN #6 verified the solutions were beyond the recommended date of use per the manufacturer.

A second observation was conducted on the medical-surgical inpatient unit on 5/13/19 at 4:46 p.m. The control solutions identified with the glucometer had no open date identified on the bottles.

b. An interview was conducted with RN #6 on 5/13/19 at 4:30 p.m. She stated the risk of using the glucometer with expired control solutions was the possibility for inaccurate patient testing results due to possible inaccurate calibration.

c. An interview was conducted with CNO #4 on 5/16/19 at 2:05 p.m. She explained the importance of using the control solution within the recommended date was to prevent a false high or low blood glucose. CNO #4 stated the staff were trained by preceptors upon hire, and orientation to the facility which could be inconsistent.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.635 Provision of Services, was out of compliance.

C-0278 [The policies include the following:] A system for identifying, reporting, investigating and controlling infections and communicable diseases of patients and personnel. Based on observation, interviews, and document review the facility failed to ensure compliance with infection control standards. Specifically, the facility failed to ensure staff completed hand hygiene and aseptic technique during medication administration. The failure was identified in 1 of 2 medication administration observations conducted. The facility also failed to establish a process which prevented multi-dose vial (MDV) medications from entering a direct patient care area. The failure was identified in 2 of 2 patient care units observed (inpatient unit and emergency department). Additionally, the facility failed to ensure a consistent process in which food throughout the kitchen was identified, labeled, and dated with expiration or use by dates.

Based on observation, interviews, and document review the facility failed to ensure compliance with infection control standards. Specifically, the facility failed to ensure staff completed hand hygiene and aseptic technique during medication administration. The failure was identified in 1 of 2 medication administration observations conducted. The facility also failed to establish a process which prevented multi-dose vial (MDV) medications from entering a direct patient care area. The failure was identified in 2 of 2 patient care units observed (inpatient unit and emergency department). Additionally, the facility failed to ensure a consistent process in which food throughout the kitchen was identified, labeled, and dated with expiration or use by dates.

Findings include:

Facility policies:

The policy, Safe Injection Practices, read MDV medications used for more than one patient are stored appropriately and do not enter the immediate patient treatment area (i.e., patient room, operating room, anesthesia carts).

The policy, Safe Injection Practices, read aseptic technique was utilized to avoid contamination of sterile injection equipment. Disinfect the rubber septum on all vials prior to each entry, even after initially removing the cap of a new, unused vial.

The policy, Hand Hygiene, read hand must be washed with soap and water or with antisepsis alcohol hand rubs before and after all patient contact, before and after donning personal protective equipment (e.g. gloves, masks).

References:

The Colorado Retail Food Establishment Rules and Regulations read, package food, once opened shall be kept covered. Food date source marking is critical for food safety.

Storing Food for Safety and Quality read, approximate refrigerator storage time for food include: cooked meat and poultry 3-4 days, spinach 3-7 days, mushrooms 2-3 days, tomatoes 5-6 days, broccoli 3-5 days. Approximate cupboard storage as follows: pasta 1-2 years, egg noodles 6 months, rice 1-2 years, flour 6-12 months in an airtight container

1. The facility failed to ensure staff completed hand hygiene and utilized aseptic technique during medication administration.

a. On 5/13/18 at 4:25 p.m. observations were conducted of a patient in the emergency department receiving two intravenous (IV) medications. The observation revealed breaches in hand hygiene and aseptic technique by the administering registered nurse (RN #3).

RN #3 entered the patient's room prior to medication administration without completing hand hygiene.

At 4:33 p.m. RN #3 began to prepare two IV medications, Toradol (medication to provide short-term treatment of moderate to severe pain) and Metoclopramide (medication to alleviate symptoms of nausea, vomiting, or heartburn). RN #3 had not completed hand hygiene prior to preparing the medications.

The observation also identified RN #3 had not disinfected the top rubber septum of the Toradol prior to accessing it with a syringe.

At 4:44 p.m., RN #3 completed the medication administration and exited the patient's room. The nurse had not completed hand hygiene following medication administration or when exiting the patient's room.

b. On 5/16 19 at 11:38 a.m., an interview was conducted with RN #17. RN #17 stated hand hygiene was performed to prevent the spread of infections. RN #17 stated hand hygiene was required before and after entering a patient room, when hands were visibly soiled and before and after touching or assessing a patient. RN #17 stated hand hygiene was also performed prior to and after donning gloves.

RN #17 stated the process to administer an IV medication was to perform hand hygiene, don gloves, clean the medication bottle with alcohol prior to withdrawing the medication into a syringe, clean the patient's IV port with alcohol for 15 seconds, administer the medication, remove the gloves and perform hand hygiene. RN #17 stated aseptic technique meant clean.

c. On 5/16/19 at 11:38 a.m., the infection control nurse (ICRN) #16 was interviewed. ICRN #16 stated hand hygiene prevented the spread of infection and diseases and was performed either by washing hands with soap and water or by using an alcohol based foam or scrub. ICRN #16 stated staff were expected to follow the hand hygiene policy regarding when to perform hand hygiene and were required to complete a training module yearly regarding hand hygiene. IC RN #16 stated nurses should perform hand hygiene before and after administering an IV medication. IC RN #16 stated if no hand hygiene was performed prior to giving an IV medication the patient was at a greater risk for getting an infection directly to their venous system. She stated aseptic technique was cleaning an area to kill the bacteria with an item such as an alcohol wipe.

2. The facility failed to establish a process which prevented multi-dose vial (MDV) medications used for multiple patients from entering a direct patient care area.

a. Document review was conducted of the facility's Safe Injection Practices policy, which read MDV medications used for more than one patient are stored appropriately and do not enter the immediate patient treatment area.

However, RN interviews conducted during observation of the emergency department revealed a lack of established processes in place to prevent staff from bringing MDV medications into direct patient treatment area.

b. On 5/14/ 19 at 8:17 a.m. an interview was conducted with the emergency department registered nurse (RN #3). RN #3 stated the facility transitioned to an electronic health record (EHR) system as of April which required medications and the patient's identification armband to be scanned at the bedside prior to administration.

RN #3 stated the new process required the nurse to bring multi-dose medication vials used for multiple patients, such as insulin, into the patient's room prior to administration in order to be scanned. RN #3 stated the medication would be scanned and prepared in the patient's room, and then returned to the medication storage area where it could then be administered to a different patient. RN #3 stated the facility had not provided guidance after the new EHR system was implemented on a process to avoid bringing MDV into multiple patient rooms.

RN #3 stated they were unsure how to avoid bringing MDVs into each patient's room since staff were now required to scan medications at the bedside.

c. On 5/14/19 at 11:14 a.m., an interview was conducted with the chief nursing officer (CNO #4). CNO #4 stated after implementing the new EHR system as of 4/1/19, staff were now scanning medications at the patient's bedside. However, CNO #4 stated the facility had not educated staff or created a process to prevent MDV medications from entering a patient treatment area.

CNO #4 stated medications were scanned at the bedside, along with the patient's ID wristband, prior administration in order to ensure the correct medication and correct patient. However, CNO #4 stated the facility had not identified a process to prevent staff from bringing MDV medications into multiple patient's rooms after the bedside scanning process was implemented.

CNO #4 stated it was important to have processes to prevent MDV medications from entering a patient treatment area in order to avoid contamination of the vial prior to use for another patient.




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3. The facility failed to ensure a consistent process in which food throughout the kitchen was identified, labeled, and dated with expiration or use by dates.

a. On 5/13/19 at 3:37 p.m., a tour of the kitchen was conducted with Supervisor of Nutritional Services (Supervisor) #10. Supervisor #10 stated once food was opened it was good for about five days. He stated food should be labeled with an open date and expiration date at the time food was opened for use. Supervisor #10 stated labeling was the responsibility of everyone who worked in the kitchen.

Inspection of the dry storage area revealed the following food items with no opened or use by date written on them: red quinoa, white quinoa, red beans. The following had opened dates with no clear year and no use by date: elbow macaroni 5/13, egg noodles 4/8, spaghetti noodles 5/13, masa corn tortilla mix 9/17. Rice noodles were labeled opened 3/13 use by 3/18. In addition, the following items had an open date, but no expiration date on the label: Croutons opened 4/26/19, cashews 4/30/19, ziti noodles 3/26/19, basmati rice 11/14/18. Two boxes of medium barley had the expiration date of 2/9/19 printed from the manufacturer which was three months prior to the survey.

Supervisor #10 stated the croutons and cashews were probably just opened and someone just forgot to change the label. Supervisor #10 stated they went through the food so fast, it did not really have time to expire. When shown the boxes of barley, Supervisor #10 read the expiration date as 9/19 instead of 2/9/19.

b. On 5/13/19 at 4:15 p.m., an observation of the refrigerator was conducted with Nutritional Services Worker (NSW) #11. The following issues were found in the refrigerator:

One bottle of prepared horseradish opened with 10/4/18 written on the lid.
One jar of capers opened with no date.
One opened jar of strawberry fruit puree with an opened date of 2/12/19.
Two opened containers of Kraft extra virgin olive oil balsamic vinaigrette with no expiration or use by date.
Cauliflower chopped and wrapped in plastic wrap with no date prepared or expiration date.
Burritos labeled made 5/24. No indication what year or when they were placed in the refrigerator
Bag of chicken tenders dated 3/17.
Key west lime juice expired 3/25/19.
Vegetables not labeled or dated and loosely wrapped with clear wrap: spinach, broccoli, onions, mushrooms, tomatoes.
Burgers with a date prepared label 5/11. No use by date identified.
Two containers of Yoplait yogurt expired 5/12/19, which was the day prior to the inspection.

NSW #11 stated the chicken tenders were probably frozen and taken from the freezer a day or two prior. NSW #11 could not confirm the exact date since it was not labeled, but stated she just knew they used them within a couple of days of defrosting. NSW #11 stated the balsamic vinaigrette was good to use for one month after opening, but was unable to verify the date opened. NSW #11 stated she did not know how long the fruit puree was good for once opened. NSW #11 stated she labeled items once they were opened with an open date. When shown the cauliflower, NSW #11 stated she knew it was good to use, because they went through it before it could expire.

c. On 5/14/19 at 8:34 a.m., an observation was made of pita bread wrapped in clear wrap with no opened or expiration date and two packages of english muffins with an expiration date of 4/23/19.

During this observation, Nutritional Services Manager (Manager) #12 was interviewed. Manager #12 stated staff were expected to label and date products once they were opened for use. Manager #12 stated once opened, dry products were good to use for 90 days, as well as dressings and condiments. Manager #12 stated produce and refrigerated items were good to use for six days. Manager #12 stated the kitchen staff followed the Colorado Food Code for reference of expiration dates and food was delivered on Mondays and Thursdays. Manager #12 stated staff were instructed to remove expired food when they stocked the new deliveries each week and each staff was assigned an area to be responsible for checking the expiration dates.

Manager #12 stated bread and dairy expiration dates were monitored by the vendors. Manager #12 stated no one from the kitchen had oversight of the vendors, nor did they monitor the expiration dates since the vendors did.

On 5/16/19 at 8:30 a.m., Manager #12 was interviewed a second time. Manager #12 provided the Colorado Retail Food Establishment Rules and Regulations (Food Code) and Storing Food for Safety and Quality as references for food storage and expiration dates. Manager #12 stated the Food Code stated perishables were good for seven days, but stated she did not have a good reference for dry goods. She stated the facility utilized a three month timeframe. Manager #12 stated staff were trained for food storage and labeling specific competencies during their orientation. Manager #12 stated expiration dates were important because bacteria could start to grow within seven days after a product was opened. Manager #12 stated quality was more the concern for dry goods once they had been opened for more than 90 days. Manager #12 stated she focused most of the training repetition dates on the refrigerated food since it was more hazardous than dry goods. She stated the infection control nurse provided yearly training to the kitchen staff related to hand hygiene and what to do if they were sick.

d. On 5/16/19 at 8:43 a.m., Nutritional Services Director (Director) #13 was interviewed. Director #13 stated her role was to support Manager #12. Director #13 stated she referred to Manager #12 to maintain processes in the kitchen such as labeling and discarding expired food. Director #13 stated expiration dates were more about food quality rather than food safety. Director #13 stated the infection control nurse had a role in the kitchen with hand hygiene, but did not have a role related to the expiration dates of food.

Director #13 stated she felt all the kitchen staff were aware the expiration date for ready to eat foods was five days. Director #13 was shown the expiration date of the rice noodle container and stated it was confusing to her as well. Dry goods had an expiration of 90 days, so she was unsure why it was labeled to only have five days once opened, but then was on the shelf for two months past that date. Director #13 stated food being defrosted in the refrigerator needed to be labeled when it was taken out of the freezer. Director #13 stated food should be used or discarded prior to expiration dates.

Based on document review and interviews the facility failed to follow their established process for reviewing and investigating reported incidents. The failure was identified in 3 of 3 incidents reviewed requiring further investigation.

Findings include:

Facility policy:

Occurrence Reports policy read, supervisors of the person completing an occurrence report should review for an immediate interventions necessary to prevent reoccurrence, document an additional information and follow-up, document any actions taken to mitigate the occurrence and prevent further incidents. The department manager instituting action/follow-up/tracking will communicate the response and follow-up action to the initiating personnel/department.

1. The facility failed to follow the established process for reviewing and investigating reported incidents.

a. Document review was conducted of an incident, dated 2/1/19, related to patient care on the medical/surgical unit. According to the incident, staff were having difficulty contacting the on-call hospitalist regarding a change in a patient's condition.

Review of the report provided by the facility showed no documentation of the investigative activities, findings of the investigation, risks identified for review, or the actions taken to address problems or risks identified.

The findings were not compliant with the Occurrence Report policy which read reported incidents included documented actions taken by the Department Director/Manager to mitigate the occurrence and prevent further events and to identify if any immediate action was necessary to ensure the safety of the patient.

b. Document review was conducted of another reported incident that occurred on 7/16/18, involving a patient discharged from the emergency department. According to the document, the patient "expressed concerned that she was not well cared for" and that her peripheral intravenous (IV) catheters were not removed prior to discharge home. The incident further read the patient had to call emergency medical service (EMS) providers to remove the IV catheters at home.

Further review found the facility was unable to provide documentation of the investigative activities conducted to mitigate the incident and prevent further events.

c. Document review was conducted of a reported incident which occurred on 6/6/18. The incident pertained to the surgeon's use of an expired surgical item during a patient's surgical procedure.

According to the report, the department director discussed the expired item with staff and the surgeon, and put a process in place to remove expired supplies. However, the facility was unable to provide documented evidence of the discussions with staff, the remediation processes put in place, or the follow-up/tracking activities per the Occurrence Policy.

d. On 5/16/19 at 12:19 p.m., an interview was conducted with the chief experience officer (Officer #1). Officer #1 reviewed the incident reports discussed and confirmed the facility was unable to identify any additional investigative activities, including: documented discussions, documented review for any follow-up/action plans needed, or when the facility closed the incidents.

Officer #1 stated all incident reports should be reviewed to ensure the facility conducted a comprehensive investigation of an event. Officer #1 stated department supervisors/managers were to investigate, review, and document follow-up with any incidents related to their area. Results would then be reported to the facility's quality team for review.

Officer #1 stated the facility previously identified opportunities for improvement with coordinating/documenting follow-ups to incident reports and was attempting to initiate improvement processes moving forward. Officer #1 stated revised policies and checklists for reviewing incident reports were still in a draft phase, and were not completed by the time of the survey.