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Based on observation and interviews, the facility failed to ensure supplies in the facility's crash cart were maintained and used in accordance with manufacturer's guidelines and in a manner to ensure efficacy.

Findings Include:

Policy:

According to the policy, Materials Management, each unit/department that stores and utilizes supplies that outdate must establish and adhere to a system of monitoring expiration dates of all supplies on a monthly basis and more frequently if needed for a specific supply. Expired supplies must be promptly removed from the inventory and sequestered as to not allow the product to re-enter the usable inventory.

According to the policy, Crash Carts, once a month all facility crash carts should be opened and checked for outdated supplies.

1. The facility failed to ensure expired supplies were removed from the facility's crash cart (supply cart for medical emergencies).

a. On 9/4/18 at 8:30 a.m., a tour of the facility was conducted with the director of the emergency department (Director # 7). During this tour, a Covidien Adult Colorimetric CO2 (carbon dioxide) detector (a device used on patients after intubation to help determine whether the tube is in the correct location) with an expiration date of 7/18 was observed in the crash cart near the main nursing station. Additionally, a blue top blood tube (tube used for collecting patient blood for lab tests) with an expiration date of 8/31/18 was also observed in the same crash cart.

During the tour, the tube and the CO2 detector were shown to Director #7 who confirmed the items were expired and should not be in patient care areas.

b. On 9/5/18 at 12:41 p.m., an interview with registered nurse (RN) #10 was conducted. During this interview, RN #10 stated the code cart was checked daily for expired supplies. She stated expired supplies were more likely to malfunction. She stated the CO2 detector is used to make sure intubated patients are getting the right amount of oxygen. She stated an expired CO2 detector could possibly malfunction and give a false reading. She stated blue top tubes contain sodium citrate (a medication used to prevent clotting). She stated an expired blue top tube could prevent an accurate blood test, due to the medication it contains losing efficacy. The tube also could lose its vacuum, resulting in the patient needing to be stuck with a needle again.

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 and interviews, 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.

Findings Include:

Policy:
According to the policy, Use of Multidose Vials, the beyond-use date for an opened or entered (i.e.) needle punctured multiple dose container with antimicrobial preservatives shall be 28 days, unless otherwise specified by the manufacturer.

The healthcare provider shall write the expiration date on the vial when it is opened.

For multiple dose vials, the expiration date will occur 28 days after the vial has been opened/punctured, providing there is no obvious contamination, aseptic technique was followed when withdrawing the medication, and the vial has been stored according to the manufacturer's instructions.

Reference:

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 that opened vial.

1. The facility failed to ensure outdated medications were removed and not available for patient use. Further, the facility failed to identify opened medication with an opened on or beyond use date.

a. A tour of the facility's wound care clinic was conducted 9/5/18 at 10:15 a.m.. During this tour, a 50 ml vial of 0.5% marcaine (a medication used as a local anesthetic) was observed in the supply cabinet of exam room #2. The vial was opened, however no opened on or beyond use date was written on the vial. An opened 20 gram tube of Silvadene cream (a medication used in wound care) and an opened one ounce tube of 1% hydrocortisone cream USP (a steroid cream) were also observed in a supply drawer in exam room #2. Neither medication tube was marked with an opened on date or a beyond use date. Further, the manufacturer's expiration date on the Silvadene cream was written as 4/18 on the crimp of the tube.

b. An interview with Medical Assistant (MA) #9 was conducted on 9/5/18 at 10:25 a.m.. She confirmed the medications in exam room #2 were not marked with any dates or information that would allow her to determine when they were opened. She stated she was unable to determine when the medications were opened or when they should be disposed. She also confirmed the Silvadene cream was expired, and stated it should not be in the patient care area.

c. An interview was conducted with the director of pharmacy (Director #8) on 9/5/18 at 11:34 a.m.. She stated the facility would not keep an expired product and it should be discarded. She stated the facility attempted to minimize multidose medications, but when they are used, staff are expected to place a sticker on the medication with the opened-on date. She stated any medications without this sticker or opened on should be discarded immediately. She stated she did inspections of patient care units within the facility for these dates, however, had not expanded her inspections to include the wound clinic.

d. On 9/6/18 at 8:33 a.m., an interview was conducted with the director of the emergency department (Director #7). She stated medications that are expired or past their beyond use date should be discarded. She stated the risk of continuing to use expired or beyond use medication is they might not be as effective, or become more effective, therefore could be unreliable.

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

Findings Include:

Policy:

According to the policy, Care of Surgical Instrumentation, Power Equipment and Scopes, instruments should be unhinged and opened, sprayed with enzymatic cleaner and taken to CS on case cart.

Immediate use steam sterilization should only be used when there is insufficient time to process by the preferred wrapped or container method intended for terminal sterilization. Immediate use steam sterilization should not be used as a substitute for insufficient instrument inventory.

According to the policy, Steam Sterilization of Surgical Instrumentation, Supplies and Equipment, flash (steam) sterilization should only be used in emergency situations or when there is insufficient time to sterilize using the preferred wrapped method.

According to the policy, Food Receiving and Storage, the Dietary Services Department will receive and store in proper methods to prevent bacterial, viral, or chemical contamination. All food products shall be marked with the date the item was received by Dietary Services. Expiration dates and use-by dates will be checked to assure the dates are within acceptable parameters.

Ready-to-eat foods shall be marked with a discard date at the time of opening or preparation: The discard date shall be determined by the dietary services standard of practice chart. Food that is repackaged will be placed in a leak-proof, non-absorbent, sanitary container with a tight fitting lid. The container will be labeled with the name of the contents and dated with the date it was transferred to the new container.

Reference:

According to American for the Advancement of Medical Instrumentation (AAMI) Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities (2017):

Recommendation 10.2.3 (Page 63), Immediate-use steam sterilization (IUSS) should not be used for purposes of convenience or as a substitute for sufficient instrumentation. Instrument inventories should be sufficient to meet anticipated surgical volume and to ensure that there is enough time to complete all critical elements of reprocessing. Immediate use steam sterilization should be kept to a minimum and should only be used in urgent clinical situations.

Recommendation 8.2 (Page 50), Ratcheted instruments should be unlatched. Tacks, pins, stringers, and other specifically designed devices can be used to hold the instruments in the unlatched positions.

According to The Association of Perioperative Registered Nurses (AORN), Guidelines for Perioperative Practice, 2015:

Recommendation VII (Page 671), Immediate use steam sterilization (IUSS) should be kept to a minimum and should only be used in selected clinical situations and in a controlled manner. Immediate use steam sterilization may be associated with increased risk of infection to patients.

Recommendation IX (Page 871), In preparation for manual cleaning, instruments should be disassembled and ports, valves, stop cocks, ratchets, and joints should be opened. Opening and disassembling instruments facilitates contact of the cleaning solution with all surfaces of the instruments.

According to Association of Professionals in Infection Control and Epidemiology (APIC) Basic Principles of Infection Prevention Practice Cleaning and Disinfection (www.apic.org, 2016), hinged instruments should be fully opened to fully allow adequate contact with the detergent solution.

According to gSource manufacturer's instructions for use instrument care checklist, instruments are to be cleaned, autoclaved and sterilized in an open position.

According to Medihoney Dressing with Active Leptospermum Honey instructions for use, dressing tubes are for single use only.

1. The facility failed to ensure surgical instrumentation was sufficient to minimize routine use of immediate use steam sterilization (IUSS).

a. Review of the facility's IUSS log (a log maintained to track usage of IUSS within the sterile processing department) revealed from 2/5/18 to 7/31/18, IUSS was used to process 74 loads of instruments.

In February 2018, instruments from 24 cases were reprocessed using IUSS, with the rationale documented on the log as "back to back" procedures for 11 of those procedures. During March 2018, instruments from 14 cases were reprocessed using IUSS, with instruments from seven of those cases documented as "back to back" and one case documented as "not enough time to reprocess." During April 2018, instruments from 16 cases were preprocessed using IUSS, with 11 cases identifying "back to back" as the rationale. During May 2018, instruments from 23 cases were reprocessed using IUSS, with 17 cases identifying "back to back" as the rationale. During June 2018, instruments from 12 cases were reprocessed using IUSS, with seven identifying the rationale as "back to back." During July 2018, instruments from 14 cases were reprocessed using IUSS, with 11 identifying "back to back" as the rationale. During August 2018, instruments from 10 cases were reprocessed using IUSS, with all ten cases identifying "back to back" as the reason.

During an interview on 9/4/18 at 4:10 p.m., the surgical services director (Director #6) stated the facility averaged 70 surgical cases per month.

b. On 9/5/18 at 7:35 a.m., an interview was conducted with sterile processing technician (SPT) #5. During this interview, SPT #5 stated IUSS should only be used during emergency situations, such as instruments being dropped during procedures. SPT #5 was asked to review the IUSS log during this interview. She stated most instruments required two and a half hours to reprocess completely and according to manufacturer's instructions for use. She stated when certain procedures were scheduled back to back, the instruments had to be reprocessed using IUSS in order to be prepared in time for the next case. She stated she was aware the facility lacked adequate instrumentation which contributed to regular use of IUSS. She also stated the facility had been in the process of obtaining more instrumentation.

c. An interview was conducted with Director #6 on 9/5/18 at 8:10 a.m. During this interview, Director #6 stated the facility often performed "quick cases", which meant the facility did not always have time to do a complete reprocessing cycle in between cases. He stated the facility had a shortage of instruments for hand, foot and shoulder surgeries, which sometimes resulted in instruments for cases later in the day requiring IUSS to have the instruments ready in time.

d. On 9/6/18 at 7:58 a.m., an interview with the infection preventionist (IP) #4 was conducted. During this interview, she stated IUSS should be limited because it does not provide a complete cleaning cycle. She stated use of IUSS could result in steps in reprocessing being skipped to save time. She states lack of instrumentation was not a good reason to perform IUSS at regular intervals.

e. On 9/6/18 at 8:32 a.m., an interview was conducted with the chief nursing officer (CNO) #11. She stated the facility should minimize use of IUSS and only use it in emergency situations because it "doesn't do as good of a job as a longer sterilization cycle." She also stated IUSS is a potential infection risk.

2. The facility failed to ensure hinged instruments were open during pre-cleaning and during reprocessing of surgical instruments.

a. On 9/4/18 at 1:59 p.m., observations were conducted in the facility's sterile processing department following a surgical procedure. During this observation, SPT #5 was observed spraying enzymatic cleaner on multiple closed hinged instruments in a red bin used for transport of soiled instruments in between the operating room and sterile processing department.

b. On 9/4/18 at 4:10 p.m., an interview with SPT #5 was conducted. During this interview, she identified the instruments left closed during pre-cleaning as three towel clamps, one Allis clamp, one pair Crile forceps, one pair of bandage scissors and one pair of suture scissors. She stated hinged instruments should be left open during pre-cleaning because dried blood can cause the instruments to stick together and they are easier to clean when opened.

c. On 9/5/18 at 11:56 a.m., an interview with Director #6 was conducted. He stated the facility follow AAMI and AORN recommendations and guidelines for pre-cleaning and reprocessing of sterile instruments.

d. On 9/6/18 at 7:58 a.m., an interview with IP #4 was conducted. She stated all hinged instruments should be opened prior to precleaning and sterilization. She stated this step was necessary to clean all surfaces of the instrument and to remove all "crud" from the instrument.

3. The facility failed to ensure food was identified, labeled and dated with expiration or use by dates. Further, facility failed to develop and use a consistent process for staff to ensure food was labeled and safe to serve to patients.

a. On 9/4/18 at 9:48 a.m., a tour of the kitchen was conducted with the kitchen supervisor (Supervisor #1). Inspection of the walk-in refrigerator revealed the following expired food items: Seven packages of flour tortillas all with the expiration date of 8/10/18, one package of bread with expiration date of 8/30/18 and one package of bagels with an expiration date 8/27/18. Further inspection of the walk-in refrigerator revealed a package of white cheese with no expiration or use by date written on it.

Supervisor #1 stated staff knew when food was no longer safe for consumption because they had been working in the kitchen for a long time. Supervisor #1 stated American cheese was safe to eat for two weeks after the package was opened. She stated labeling food was everyone's responsibility. She stated she used research from the internet for food storage guidelines; however, she was unable to provide evidence of resources kitchen staff were expected to use for guidelines of food expiration. Supervisor #1 further stated staff was verbally educated on food storage and handling.

During the same tour, an interview was conducted with a member of the kitchen staff (Employee #2), who stated sliced processed cheese was safe to eat for "probably 3 months." Employee #2 stated he did not know of any resources to use for guidelines regarding food expiration or storage other than asking his co-workers.

Inspection of the walk-in freezer revealed the following food items with no expiration or use by date written on them: One open package of chicken, two packages of frozen popsicles, and approximately 20 packages of beef.

Inspection of the stand alone freezer, located inside the dish cleaning room, revealed the following unopened food items with no expiration or use by date: Three packages of multiple frozen chicken fillets, one package of chicken nuggets, and one package of black bean burger patties.

Inspection of the stand alone reach in freezer, located in the food preparation area, revealed the following food items were not dated or labeled with an expiration date or use by date: Five pre-baked biscuits in plastic zipper bags, 15 ham cutlets individually wrapped in clear plastic wrap and eight individually wrapped pork cube packages.

b. On 9/6/18 at 7:09 a.m., an interview was conducted with the director of dietary services (Director #3). Director #3 stated her expectation for staff to label all food products per the Food Receiving and Storage policy guidelines, as well as the Food and Drug (FDA) guidelines. Director #3 stated staff were expected to date when food was opened or received as well as an expiration or use by date when food should be discarded. Director #3 stated the staff not following these guidelines could result in the distribution of hazardous foods. Director #3 stated once staff removed food products from shipment boxes, they were expected to label and date products before placing food in storage.

c. On 9/6/18 at 7:58 a.m., an interview was conducted with IP #4. IP #4 stated not labeling meat was potentially unsafe. She stated if the expiration date of food was questionable, it should not be served to patients. IP #4 stated unlabelled meat created the potential for expired meat being served, which could result in spreading food borne illnesses. ICP #4 stated frozen food should be labeled to create a timeline to ensure food safety.

4. The facility failed to follow manufacturer's recommendations for usage for wound care products.

a. On 9/5/18 at 10:15 a.m., a tour was conducted of the facility's outpatient wound care clinic. During this tour, two opened 1.5 ounce tubes of Medihoney wound dressing, an opened one ounce tube of Hydrocortisone 1% USP cream and one opened 20 gram tube of Silvadene wound dressing were observed in a supply drawer in exam room two. Inspection of the Medihoney tubes revealed manufacturer's printed instructions stating the tube was for single use only. It further stated the dressing sterility could not be ensured once the tube was opened.

b. On 9/5/18 at 10:25 a.m., an interview with the wound care clinic's medical assistant (MA) #9 was conducted. She stated the clinic kept the tubes of medications and wound care dressings for use on multiple patients seen in the clinic. She stated the Medihoney dressing was often used on diabetic foot wounds.

c. On 9/5/18 at 11:34 a.m., and interview was conducted with the director of pharmacy (Director #8). During this interview, she stated the facility tried to minimize multiple dose medications and wound care balms, including Medihoney. She stated using these items for multiple patients compromised the sterility of the products.

d. An interview with IP #4 was conducted 9/6/18 at 7:58 a.m.. During this interview, she stated using wound care supplies intended for single patient use on multiple patients could result in spreading infection from patient to patient and other types of cross contamination.