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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.

Findings Include:

Policy:

According to facility policy, Emergency Crash Cart Security and Accountability, crash cart inventories are checked monthly and after each emergency use.

According to facility policy, Equipment and Supply Guidelines, the equipment and supplies [used in life saving procedures] are checked daily by the Emergency Department nurse or delegated as appropriate. Any supplies that need replaced will be ordered by the ED nurse or designee.

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 10/8/18 at 11:41 a.m., a tour of the main campus emergency department (ED) was conducted with Registered Nurse (RN) #2. Inspection of the emergency airway cart in the ED revealed two laryngeal airway masks (LMAs), size 1.5, with an expiration date of 8/28/18 and three LMAs, size 1, with an expiration date of 9/28/18.

At the time of the tour, RN #2 confirmed the items were expired and stated they should have been discarded by staff.

b. On 10/8/18 at 2:50 p.m., a tour of the off-site campus ED was conducted. During the tour, an inspection of the adult crash cart revealed the following expired supplies: one CO2 detector (a device used to ensure proper placement of an endotracheal tube), with an expiration date of 8/21/18 and one CO2 detector with an expiration date of 10/4/18.

An inspection of the newborn emergency cart, also located in the ED, was conducted. During the inspection, the following expired items were identified: two Umbilical Vessel Catheter Insertion Trays, 3.5 French (a kit used to start intravenous catheters in newborns), with an expiration date of 3/18 and two Complete Vacuum Delivery Systems with Palm Pump (used to emergently deliver infants), with expiration dates of 8/15/18.

During the same tour, an inspection of the pediatric crash cart, also located in the ED, was conducted. The following expired items were observed: two yellow top lab tubes with an expiration date of 5/31/18, two purple top microtainer tubes with an expiration date of 9/30/18, two blue top lab tubes with expiration dates of 7/31/18, two blue top lab tubes with an expiration date of 5/31/18, five gray top lab tubes with expiration dates of 8/31/18 and four green top lab tubes with an expiration date of 7/31/18. Additionally, a Pediatric CO2 Detector (used to ensure correct placement of pediatric endotracheal tubes) with an expiration date of 10/2/18 and another Complete Vacuum Delivery System with Palm Pump with an expiration date of 8/15/18 were observed.

c. Chief Nursing Officer (CNO) #7 was interviewed on 10/10/18 at 12:43 p.m. She stated CO2 detectors were used to detect accuracy of endotracheal tube placement. CNO #7 stated CO2 detectors were often used in emergent intubations. She stated the risk of an expired CO2 detector would be possibly an inaccurate result.

d. During a tour of the main campus conducted on 10/8/18 at 10:31 a.m., multiple other expired supplies were observed throughout the facility as example by:

During an inspection of the ED expired items observed located in the patient care areas included:
- two packets of lubricant with expiration dates of 1/18
- two CO2 adapters (measure carbon dioxide levels in intubated patients), expired on 3/8/17
- two yellow top lab tubes with expiration dates of 6/30/18
- two blue top lab tubes with expiration dates of 5/31/18
- a nasal aspirator with an expiration date of 6/18
- a Polyurethane Umbilical Catheter Insertion Tray with an expiration date of 3/18
- a Pericardiocentesis kit (emergently aspirate fluid from around the heart) expired on 9/30/18
- a Culture Swab, with an expiration date of 9/17
- a Unisex swab kit, with an expiration date of 5/31/18

During an inspection of the central supply room expired items observed included:
- two 16 gauge IV catheters with an expiration date of 9/18 were observed.

e. Similarly, during a tour of the off-campus location conducted on 10/8/18 at 2:50 p.m., multiple expired supplies were identified throughout the facility in addition to the items found in the crash carts.

The items included:
- a silicone Penrose drain (inserted into surgical sites to aid in drainage) expired 5/27/18
- a Injection Site IV cap which had expired 7/18
- two 14 gauge IV cannulas which had expired 2/18
- two 14 gauge IV cannulas which had expired 1/18
- a pediatric blood culture set which expired on 8/31/18
- a Pericardiocentesis kit, which expired 9/30/18
- a nasopharyngeal airway, which expired 5/18.

f. On 10/11/18 at 9:16 a.m., an interview was conducted with the Lab Supervisor (Supervisor #1). Supervisor #1 stated using expired lab tubes could result in the blood samples being rejected by the laboratory, which could result in a delay in patient care. She also stated the additives in the different colored tubes could degrade, which could affect the accuracy of the results.

g. On 10/11/18 at 12:31 p.m., an interview was conducted with RN #6. RN #6 stated expired supplies may not work as effectively and further stated, they were an infection risk, because packaging could lose its viability and may become contaminated. RN #6 then stated if the supplies contained fluid, they may grow bacteria. She stated expired lab tubes may not be as effective.

h. An interview with CNO #7 was conducted on 10/10/18 at 10:36 a.m. CNO #7 stated her expectation was to have no expired supplies located in the facility. She stated she expected staff to identify and remove expired supplies from inventory during the monthly rounds.

Based on the onsite complaint investigation, completed November 1, 2018, the facility failed to comply with the regulations set forth for Life Safety and, therefore, deficiencies were cited under Life Safety Code tags K0211, K0222, K0291, K0300, K0321, K0324, K0325, K0331, K0345, K0347, K0353, K0521, K0918, K0919, and K0920. See survey event ID #FPOD21 for full details of the cited deficiencies.

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

C-0276- Patient Care Policies: Rules for the storage, handling, dispensation, and administration of drugs and biologicals. These rules must provide that there is a drug storage area that is administered in accordance with accepted professional principles, that current and accurate records are kept of the receipt and disposition of all scheduled drugs, and that outdated, mislabeled, or otherwise unusable drugs are not available for patient use. The facility failed to ensure outdated medications were removed from stock according to manufacturer's expiration date and failed to identify multi-dose vials with a beyond-use date.

C-0278 - Patient Care Policies: A system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel. The facility failed to provide a sanitary environment in the areas of equipment reprocessing, food storage and supplies usage.

Based on observations, record review and interviews, the facility failed to ensure outdated medications were removed from stock and not available for patient use. Further, the facility failed to identify opened medication with an opened on or use-by-date.

Findings Include:

Policy:

The policy, Medication Security and Storage read, all unusable medications and devices are removed from stock in the pharmacy. This included but was not limited to: expired/outdated medications. When a sterile multi-dose vial was used, if visible contamination occurs, the vial must be discarded immediately. All multi-dose vials are used as single dose vials and must be discarded after use.

The policy, Multi-dose Vials read, utilize single-use vials when available. This will prevent multiple accessing of multi-dose vials. Multi Dose Vials are to be used for one patient unless an exception has been made (i.e.: backordered medications). Only vials approved by the manufacturer as multi-dose may be used as such.

According to facility policy, Anesthesia: CRNA Duties and Responsibilities, the CRNA will check all resuscitative equipment prior to the beginning of the first surgery of the day.

References:

According to CDC (Centers for Disease Control), Frequently Asked Questions (FAQs) Regarding Safe Practices for Medical Injections, if a multidose vial has been opened or accessed the vial should be dated and discarded within 28 days unless the manufacturer's expiration date specifies a different date for the opened vial.

According to the package insert for Diprivan (propofol) injectable emulsion, USP, Diprivan was a single access parental product (single patient infusion vial) which contains 0.005% disodium edetate (EDTA) to inhibit the growth of microorganisms, for up to 12 hours.

1. The facility failed to ensure outdated medications were removed and not available for patient use across various units.

a. A tour of the main campus was conducted with Registered Nurse (RN) #2 on 10/8/18 at 11:45 a.m. During the tour of the central supply area, two bags of 100 ml Dextrose 5% solution with an expiration date of 9/18, six bags of 250 ml 10% Dextrose and 0.20% Sodium Chloride with expiration dates of 5/18 were observed.

During the tour of the main campus emergency department (ED) an inspection of the ED's pediatric crash cart revealed one vial of dexamethasone (a steroid) 4 mg/1 ml vial which had expired 9/18.

b. A tour of the off-site ED was conducted with the Director of Nursing (Director) #3 on 10/8/18 at 3:28 p.m. During the tour an inspection of the crash carts was conducted. One bag of 500 ml lactated ringers with an expiration date of 9/18 was observed. One bag of 250 ml dextrose 5% with an expiration date of 7/18 was observed in the pediatric emergency crash cart. One bag of 100 ml dextrose 5% which had expired 6/18 was observed in the obstetric newborn cart. Two vials of etomidate (used for the induction of general anesthesia) with an expiration date of 10/1/18 and a vial of atropine sulfate (medication in surgical patients to reduce secretions in the airway) which had expired 9/18 were observed in the RSI (rapid sequence intubation) kit.

c. An interview was conducted with RN #6 on 10/11/18 at 12:31 p.m. RN #6 stated the expectation was for staff to check the items in the crash carts, remove expired items and replace them with new medications and supplies. RN #6 stated it was the emergency department nurse's responsibility on the 25th day of the month to check all medications in the crash cart.

d. Review of the ED's pediatric and adult crash cart audit logs in both of the facility's locations confirmed the carts were marked as checked monthly for expired medications by staff. However, expired medications were located by the survey team in both of the crash carts.

e. A tour of the facility's off site pre-operative (pre-op) area was conducted with the Director of Surgery (Director) #4 on 10/8/18 at 2:51 p.m. During the tour, racepinepherine 2.25% with an expiration date of 7/18 was observed in the crash cart. Additionally, lidocaine 2% 100 mg (20 mg/ml) which had expired 1/10/18 along with a vial of Norepinephrine 4 mg/4 ml which had an expiration date of 9/18 was observed in the Rapid Sequence Intubation (RSI) airway cart.

During the tour, an interview was conducted with Director #4. Director #4 stated racepinepherine was used in emergencies as a bronchodilator. He also stated Lidocaine 2% was used for arrhythmias, and norepinephrine was a vasoactive medication (a medication that affects blood vessels). Director #4 also stated the risk of using expired medication was the medication could lose its effectiveness.

f. An interview was conducted with the Director of Risk Management (Director) #5 on 10/11/18 at 1:34 p.m. Director #5 stated expired medications had the potential to cause harm to a patient. She stated the risk of giving expired medication was the medication may not be as effective. Director #5 stated her expectation was for expired medications to be removed from use and the facility does not allow the use of expired medications. She stated every month, medications were monitored by staff and leadership for expiration dates and documented on a tracking log.

g. An interview was conducted with Lead Pharmacy Technician (LPT) #8 on 10/11/18 at 10:17 a.m. LPT #8 stated the risk of using expired medications was they may not be as potent and may not work to the manufacture's fully intended effect. LPT #8 also stated every medication was tested for shelf life and for half-life, and these were the basis for the expiration dates.

2. The facility failed to identify opened medication with an opened on or use-by-date.

a. On 10/8/18 at 3:30 p.m., a tour was conducted of the off-site perioperative area. During the tour, inspection of an anesthesia cart revealed an opened and accessed 20 ml vial of Diprivan (a medication used in anesthesia). There was no indication of when the vial had been opened on or use-by-date/time.

This was in contrast to manufacturer instructions which noted, Diprivan was a single access parental product (single patient infusion vial) which contains 0.005% disodium edetate (EDTA) to inhibit the growth of microorganisms, for up to 12 hours.

b. On 10/11/18 at 10:17 a.m., an interview was conducted with LPT #8, who stated all opened vials were to be dated when they were opened. LPT #8 also stated the facility did not use multi-dose vials because they posed a cross contamination risk.

c. On 10/11/18 at 1:34 p.m., an interview was conducted with Director #4, who also serves as the facility infection preventionist. Director #4 stated her expectation was for staff to dispose of unused Diprivan after surgical cases. She stated the facility tried to minimize use of multi-dose vials because vials could become contaminated. She stated if the vial was not marked with an opened on or dispose by date and time, you would not know when it was opened and if it was expired.marked with an opened on or dispose by date and time, you would not know when it was opened and if it was expired.

Based on observations, interviews, and document review, the facility failed to provide a sanitary environment in the areas of equipment reprocessing, food storage, patient care supplies storage and supplies usage.

Findings Include:

Policy:

The policy, Surgical Services: Care and Cleaning of Surgical Instruments and Power Equipment read, manufacturer's recommendations will be followed in the care of surgical instruments and powered equipment. Powered equipment will be packaged and sterilized according to manufacturer's instructions before use. Batteries will be flashed in a pre-vac cycle for a total of three minutes at 270 degrees Fahrenheit. There will be no drying time for the cycle to prevent damage to the battery.

The policy, Food Storage and Labeling read, all items must be labeled to include contents and use by date and all food is rotated first in first out (FIFO).

The policy, Linen Handling, Processing and Transport read, all linen was handled, stored, transported, and processed in a manner that will prevent contamination and maintain a clean environment for patients, health care workers, and visitors. Occupational Safety and Health Administration (OSHA), Center of Disease Control (CDC) and manufacturer's guidelines will be followed.

The policy, Environment of Care Program read, medical waste was placed in labeled biohazard containers and stored in soiled utility closets. The waste is segregated at the nurse unit, clinic and laboratory by color of bag and treated accordingly.

According to the policy, Equipment and Supplies Guidelines, the quality and quantity of supplies are maintained as determined by state and local law and in accordance with acceptable standards of practice.

References:

According to The Association of Perioperative Registered Nurses (AORN), Guidelines for Perioperative Practice, 2017:

Recommendation III (Page 666), items to be sterilized should be cleaned, decontaminated, inspected, packaged, sterilized and stored in a controlled environment and in accordance with the AORN Guideline for Cleaning and Care of Surgical Instruments and the device manufacturer's validated and written instructions for use.

The Cautery instructions for use read, do not use the device if the pouch was damaged or opened. Additionally manufacturer's instructions for use state the medical device cannot be effectively cleaned and/or sterilized by the user and therefore cannot be safely reused. It was intended for single use only. Any attempt by the user to clean and re-sterilize the device may result in bio incompatibility, infection, or other risks of device failure to the patient.

1. The facility failed to ensure the sterilization process was followed according to manufacturer instructions for use and acceptable standards of practice for surgical equipment, specifically battery packs.

a. Review of the steam sterilization record keeping log for sterilizer number two revealed four entries were documented as "flash batteries" for June 2018. In July 2018, ten entries were documented as "flash batteries." In August 2018, six entries were documented as "flash batteries." In September 2018, five entries were documented as "flash batteries." In all of the entries, the steam sterilizer settings documented were a temperature of 275 degrees Fahrenheit with a three minute exposure time and one minute dry time.

b. According to the Stryker System 6 battery packs cleaning and sterilization recommendations, to obtain optimal performance and prevent damage perform one of the following sterilization procedures either "Flash" Autoclave or Hi Vac. Listed instructions for a "Flash" autoclave cycle were a temperature of 270-272 degrees Fahrenheit with the instruments unwrapped. Further, a exposure time of three minutes with no dry time was listed. Alternatively, Hi Vac cycle instructions listed a temperature of 270-272 degrees Fahrenheit with either wrapped or unwrapped instruments and a four minute exposure time.

c. An interview was conducted on 10/11/18 at 9:43 a.m. with Director of Surgical Services (Director) #4. Director #4 stated the facility sterilized all the Stryker System 6 batteries on the same cycle, with three minutes exposure time and one minute dry time at 275 degrees Fahrenheit. He stated the facility used this cycle because the batteries would not hold a charge if they were off the charger longer than 48 hours.

Director #4 stated surgical equipment and batteries should be processed according to manufacturer's guidelines because otherwise, the manufacturer could not guarantee the equipment and it could pose a risk to patient safety. He stated batteries not processed according to manufacturer's guidelines could "blow up, break, or lose [their] charge," and the facility could be liable if they malfunctioned. He stated the batteries could possibly lose their charge during a procedure, which would require surgical staff to have to get a new battery.

2. The facility failed to ensure all food was labeled and dated with a use-by-date. Further, the facility failed to ensure food was discarded after the expiration date or use-by-date.

a. On 10/8/18 at 11:57 a.m., a tour of the kitchen was conducted with Dietary Manager (Manager) #10. Inspection of the freezer revealed the following items with no expiration or use by date: a package of sliced roast beef, two packages of ground turkey, a package of turkey franks, three packages of turkey sausage, four packages of hot dogs, two bags of bagels and two bags of hot dog buns.

Inspection of the refrigerator revealed the following items with no expiration or use by date: three bags of bagels, a bag of english muffins and half a head of lettuce.

Other items found in the food preparation area with no use-by or expiration date included: an opened container of sour cream, a loaf of light rye bread, a bag of tortilla chips, three bread rolls, a box of cereal, a 25 lb. bag of granulated sugar and a bag of brown sugar.

Inspection of the pantry area of the kitchen revealed the following expired food items: a container of dried oregano with an expiration date of 5/16/16, a container of dried basil with an expiration date of 6/16/14, a container of garlic powder with an expiration date of 6/5/17, a container of dried ginger with an expiration date of 5/15 and a container of white pepper, with no expiration date marked.

b. On 10/8/18 at 3:30 p.m., a tour of the off-site perioperative area was conducted. Inspection of the post-operative area revealed two containers of beef barley soup with an expiration date of 10/5/18.

c. During the tour of the kitchen, an interview with the Manager #10 was conducted. She stated all food should be marked when it went into storage. She stated this was necessary to ensure the food was kept safely. Manager #10 stated without the dates being marked, staff may not know how long the food was good for and when it should be discarded. She stated expired food could grow bacteria, and many of the patients have compromised immune systems so were more likely to become sick.

3. The facility failed to maintain a separate area for clean and dirty supplies.

a. On 10/8/18 at 12:58 p.m., a tour of the main campus emergency department (ED) was conducted with Registered Nurse (RN) #2. Inspection of a utility room located at the back of the ED revealed clean supplies being stored in the same room next to soiled supplies. Soiled patient care items observed in the utility room included: a hopper (waste disposal toilet for biohazard waste), a bin marked for "biohazard" waste, a bin marked for "biohazard" laundry, a bin marked for "regular trash," a bin for dirty instruments requiring transport to sterile processing at the facility's off site location, and a bedside commode with a partially used roll of toilet paper on top of the lid.

On a shelf directly above the biohazard waste receptacle, the following clean patient care items were observed: Xeroform Occlusive Gauze Strip Overwrap (wound care supply), Broselow/Hinkle pediatric emergency system orange intravenous delivery module, drug screen urine testing cups, HCG lab test (pregnancy test kits), RSV and flu swabs, pertussis tests, anaerobic culture swabs, aerobic culture swabs, and body fluid collection kits.

Observed on a shelf to the left of the sink used for cleaning soiled instruments were patient lab testing materials to include; blood culture vials, Hemoccult (a test used to look for hidden blood in a stool sample), and Gastroccult (test designed for detecting the presence of blood and the pH of gastric contents). Also observed was an infant papoose board (used to immobilize infants for procedures) hanging over a trash receptacle. Intravenous pressure bags, finger traps used for traction and a gait belt were hung over and touching the trash receptacle.

b. On 10/11/18 at 1:34 p.m., an interview was conducted with Director of Risk, Quality and Infection Control (Director) #5. Director #5 identified the room as the "soiled utility room." Director #5 stated patient care supplies should not be stored in the soiled utility room. Director #5 further stated the risk of storing clean supplies alongside dirty supplies was a risk for contamination. She stated such contamination could lead to patient harm.

An interview with Chief Nursing Officer (CNO) #7 was conducted on 10/10/18 at 10:36 a.m. CNO #7 stated each department director was responsible for EEOC rounding. However, when requested, the facility was unable to provide evidence of EOCC rounding completed in the emergency department.

4. The facility failed to ensure supplies were stored and maintained in a manner which would ensure the supplies were hygienic and safe for use on patients.

a. On 10/8/18 at 12:12 p.m., a tour of the main emergency department was conducted with RN #2. During the tour, an inspection of an emergency cart, revealed a single-use cautery stick (a device used to impede blood flow from a vessel) which was opened and not located in the manufacturer's original wrapping.

An interview was conducted with RN #2 at the time of the tour. RN #2 stated she would not use the cautery stick due to the package being opened and not in the original package. RN #2 stated she was unsure if the stick had been used on anyone else.

b. On 10/11/18 at 1:34 p.m., an interview was conducted with Director #5. Director #5 stated she had previously explained to staff that they could cause harm to patients if patient care supplies were opened prior to use.

c. An interview with Chief Nursing Officer (CNO) #7 was conducted on 10/10/18 at 10:36 a.m. CNO #7 stated each department director was responsible for EEOC rounding. Review of the facility's Environment of Care (EOCC) Program document, specifically, the EOCC Tours Checklist included staff check: supplies sterile items stored to maintain integrity of package in clean dry area. However, when requested, the facility was unable to provide evidence of EOCC rounding completed in the emergency department.