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Based on observations and interviews, the facility failed to ensure supplies used in treating emergency cases were readily available and not beyond their expiration date.

This failure created the potential for supplies and equipment to lose both sterility and effectiveness leading to avoidable infection or the inability to emergently treat patients timely and efficiently.

FINDINGS

POLICY

According to Crash Cart Check Policy, all Central Supply (CS) items are to be checked and replaced 1 month prior to expiration, after use of each crash cart and at least on a monthly basis.

1. The facility failed to ensure supplies readily available for use in emergency situations were safe and effective for patient use.

a) On 03/15/16 at 9:15 a.m. a tour of the Medical Surgical Unit was conducted with the Chief Nursing Officer (CNO #2). Review of the inner contents of crash cart #2 revealed several emergency supplies which were past the expiration date. As example:

2 LoPro ETT with expiration dates of 02/1996 and 07/1996
1 Adult Introducer Bougie expired on 08/1996
1 Satin Slip Intubating stylet expired on 08/1996
1 sterile laryngeal blade expired on 04/14/13
8 blood vacutainer tubes expired on 10/15 and 11/15.

b) CNO #2 stated it was the expectation of nursing staff to monitor the contents of the crash cart at least on a monthly basis for expired supplies and replace as needed.

c) On 03/15/16 at 9:35 a.m., Pharmacist #17 (RPH) confirmed the expectation was for nursing to monitor all of the contents of the crash cart except the medications. Pharmacist #17 monitored the medication contents of the cart.

Based on observations, interviews, and document review, the facility failed to ensure patient care equipment was maintained through a preventive maintenance program.

This failure created the potential for patient harm due to the facility's inability to ensure patient care equipment was maintained and safe for patient use.

FINDINGS

REFERENCE

According to the BioMedical (BioMed)Manager Position Description, the individual in this position is responsible for the repairs, calibration and maintenance of medical equipment, instrumentation, and support systems of moderate complexity used in healthcare delivery at the facility. The BioMedical Manager is additionally responsible to perform inspections and preventive maintenance (PM) of the facility medical equipment.

1. The facility had patient care equipment, readily available for use by staff with overdue preventive maintenance stickers used to indicate when preventative maintenance was due to be performed.

a) On 03/15/16 at 9:11 a.m., a tour of the facility revealed the following pieces of patient care equipment with overdue preventative maintenance stickers:

In the emergency department, 4 Datex-Ohmeda Suction Aspirators, 2 Welch Allyn Otoscope/Ophthalmoscopes, 1 Detecto Electronic Infant Scale, and 1 Enthermics EC230 Warmer had a preventive maintenance sticker that stated inspection was due 09/2015, which was 6 months overdue at the time of the observation.

In the inpatient nourishment room, 2 Hospira/Abbott Plum XL Intravenous Infusion Pumps and 1 Genesis Hoyer Lift had preventive maintenance stickers that stated inspections were due 09/14. 09/15 and 03/14, which was 6 months to 2 years overdue at the time of the observation.

b) On 03/16/16 at 12:05 p.m., an interview was conducted with the Maintenance Supervisor (Supervisor #5). Supervisor #5 stated the last individual who held the position of BioMedical Manager had assured Supervisor #5 all required maintenance and inspections of patient care equipment were up to date. Supervisor #5 stated s/he would be assuming the responsibility of the preventive maintenance program but had not started work on the program. Supervisor #5 was not sure policies existed for the preventive maintenance of medical equipment and stated preventive maintenance depended upon the manufacturer's recommendation "but most everything is yearly".

Supervisor #5 verified the preventive maintenance of patient care devices had not been completed as required to ensure all equipment was calibrated and safe for patient use.

c) An interview was conducted on 03/16/16 at 4:58 p.m. with the Clinical Practice Manager (Manager #6). Manager #6 stated the biomed department had become part of the maintenance department under his/her supervision and s/he was recently made aware the preventive maintenance of patient care equipment was overdue. Manager #6 stated s/he was confident the preventive maintenance program would be maintained in the future.

d) On 03/17/16 at 10:15 a.m., an interview was conducted with the Chief Executive Officer (CEO #4). CEO #4 stated s/he had been made aware of the overdue preventive maintenance of equipment during the completion of this inspection. CEO #4 stated s/he did not perform walk around inspections of the facility.

Based on interviews and record review the Board of Directors (Board) failed to ensure the facility's operating policies had been reviewed and/or updated to fully reflect the responsibilities of the facility for the provision of safe, quality care.

This failure created the potential for facility staff to deliver sub-optimal patient care to the community.

FINDINGS

1. The board of directors failed to ensure the facility's policies for operation were reviewed and updated.

a) On 03/16/16 at 4:28 p.m. an interview was conducted with the Compliance/Risk Manager (Manager #1). Manager #1 stated all facility operating policies were reviewed by the Policy Review committee on an annual basis in September of each year. Manager #1 further stated a board of directors (Board) member was also a member of the policy review committee and was expected to present all reviewed policies to the board of directors for review and approval.

Manager #1 stated once policies were approved by the board of directors there was documentation in the board of director meeting minutes to show the facility's operating policies had been reviewed and approved for the next year.

b) Review of the Board of Director (Board) meeting minutes on 03/17/16 revealed no documentation to show the Board had reviewed the facility operating policies in the months of October or December, 2015.

c) A second interview was conducted with Manager #1 on 03/17/16 at 9:25 a.m. Manager #1 stated s/he had reviewed the Board meeting minutes for 2015 and verified there was no documentation to show the facility's current operating policies had been reviewed and approved. Manager #1 further stated s/he should have placed the review of policies on the Board meeting agenda but had not done so. Manager #1 stated the facility had a policy on policy review but did not provide the policy when requested.

d) An interview was conducted with the Chief Executive Officer (CEO #4) on 03/17/16 at 10:15 a.m. CEO #4 stated the facility was governed by its policies and s/he was responsible for the overall operations of the facility and was under the direct supervision of the Board. CEO #4 stated the Board reviewed all operating policies at the end of each year and s/he expected the compliance department to ensure all policies had been reviewed by the policy review committee and then presented to the Board for review and approval. CEO #4 further stated s/he expected the Board meeting minutes to reflect all policies had been reviewed.

Based on observations, and document review, the facility failed to ensure medications were not outdated and were safe for patient use.

This failure resulted in the potential for patients to receive compromised or expired medications.

FINDINGS

POLICY

According to Use of Multiple Dose Vials Policy, each multi dose vial will be labeled at the time opened with date, time and initial of the person opening the vial. Multi dose vials should be discarded at the time of patient discharge, manufacturer's expiration date, or if there is obvious or suspected contamination of the diaphragm, whichever occurs first.

1. The facility failed to ensure expired or possibly contaminated medications were prevented from use in patient care.

a) An inspection of the locked controlled medication cabinet was completed on 03/15/16 at 11:30 a.m. with Certified Registered Nurse Anesthetists #13 (CRNA). A review of the medications revealed several open vials which did not have the opened date and staff initials as required by facility policy. Additionally, there were medication vials which had expired and should have been discarded according to the previously referenced policy. As example:

-2 vials of 5 mg/5 ml Morphine Sulfate had expired on 10/2014.
-1 opened vial of Morphine Sulfate was not dated and initialed as to when it was opened and by whom.
-2 opened vials of 5 mg Versed were not dated and initialed
-1 opened vial of Ketamine was not dated and initialed.
-2 vials of 50 mg/ml Ephedrine expired 08/2015.

CRNA #13 stated multi dose vials of medications were not typically seen in the medication box and s/he was unable to verify when the medication vials had been opened and whether they were compromised.

Based on observations, interviews, and document review the facility failed to maintain infection control processes in the areas of hand hygiene, intravenous medication administration, disinfection of surgical instruments, and laboratory specimen storage.

This failure created the potential for patients to experience illness due to the transmission of infection among patients and employees during the provision of care procedures.

FINDINGS:

POLICY

According to Infection Control Policy, hand washing should be done:
-when coming on duty
-when hands are soiled
-between handling of individual patients
-on leaving an area where universal precautions are in effect
-before and after medication administration to patients


REFERENCE

According to the CDC Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (2007), Part II.D., (pg. 49), Hand Hygiene, improved hand hygiene practices have been linked to a sustained lowering of the incidence of infection. Use of alcohol-based products, which do not require the use of water, have been approved for hand disinfection and are preferred for use in light of their superior microbial activity and convenience when hands are not visibly soiled.

Settings include but not limited to: when hands are visibly dirty, before direct contact with patients, before donning and after doffing gloves, when moving from a contaminated body site to a clean body site during patient care, after contact with inanimate objects in the immediate vicinity of the patient and upon exiting the patient's room.

Furthermore, Part II.E.1., (pgs. 50-51), Gloves can protect patients from exposure to infectious material that may be carried on hands. Gloves should be changed if the patient interaction also involves touching portable computer keyboards or other mobile equipment used in the care of multiple patients. Hand hygiene following glove removal prevents the transmission of potentially infectious material that may have penetrated unrecognized tears or contaminate the hands during glove removal.

The Centers for Disease Control and Prevention Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 (pgs. 36-37), stated thorough cleaning of instruments is required before sterilization to remove inorganic and organic materials which would interfere with the effectiveness of the sterilization process. Additionally, enzyme solutions should be used according to the manufacturer's instructions for proper dilution of the enzymatic detergent and contact with the equipment for the specified amount of time.

1. The surgical staff failed to perform hand hygiene when performing patient care.

a) On 03/15/16 at 10:14 a.m., observation in room #1 of the Preoperative Unit revealed Certified Registered Nurse Anesthetist (CRNA #13), Registered Nurse (RN) #11 and RN #12 entered, provided patient care and exited the patient occupied room without performing hand hygiene on 4 separate occasions. As example,

CRNA #13 entered room #1, performed an assessment and obtained written consent for anesthesia from the patient, then exited without performing hand hygiene.

Physician #16 entered room #1, performed an assessment, obtained consent for surgery from the patient and then exited without performing hand hygiene at any time.

b) On 03/15/16 at 10:44 a.m., an observation in the operating room (OR) revealed CRNA #13 had repositioned the patient, administered intravenous (IV) medications, redressed a leaking IV site twice, adjusted the tubing connection to the patient's IV and touched his/her clothing without wearing gloves or performing hand hygiene.

CRNA #13 was observed retrieving cardiac monitoring cables off the floor, placing them on the patient and administering IV medications without first cleaning the medication port on the IV tubing.

RN #11 was observed wearing gloves entering and exiting the OR on 3 separate occasions, while retrieving blankets and supplies from the preoperative area without performing hand hygiene or glove changes.

c) An interview was conducted on 03/17/16 at 7:50 a.m. with CRNA #19. CRNA #19 stated the expectations were for hand hygiene to be completed when s/he entered or exited the OR or patient's room, and when gloves were removed. CRNA #19 stated gloves were to be worn when exposed to bodily fluids, upon entering or exiting the OR and to retrieve supplies.

d) On 03/15/16 at 10:25 a.m., observations of patient rooms in the preoperative unit (rooms #1, #2 and #3) were made. Physician #16 and Medical Student #15, exited and entered rooms #1 and #3 twice without performing hand hygiene. RN #12 entered and exited rooms #1 and #3, then returned to room #1 and failed to perform hand hygiene on each occasion.

During the same observation, RN #14 failed to perform hand hygiene upon entering and exiting room #1, prior to placing an intravenous (IV) catheter into the patient's arm and when administering IV fluids with a syringe into the patient's IV access site. RN #14 stated hand hygiene was to be done upon entering and exiting patient rooms.

e) On 03/15/16 at 11:27 a.m. CRNA #13 was observed exiting room #3, walking to the nurse's station and returning to the patient's room with a stapler without performing hand hygiene.

f) During two interviews with OR Manager #10, on 03/15/16 and 03/16/16, s/he stated hand hygiene was to be performed prior to entering and exiting the OR, patient rooms, donning or doffing gloves and when there was a potential of exposure to bodily fluids.

g) On 03/16/16 at 12:43 p.m. an interview with the Chief Nursing Officer/Infection Control RN (CNO #2) was conducted. CNO #2 stated, s/he expected staff to perform hand hygiene when hands were visibly soiled, prior to donning and doffing gloves, when a patient's room was entered or exited and in between glove changes.

CNO #2 stated each hospital staff member had received infection prevention education upon hire and yearly during the hospital's safety week. CNO #2 verified all staff were required to follow the infection prevention policy.





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2. The facility failed to ensure the laboratory maintained a separation of clean supplies from contaminated items.

a) During a tour of the laboratory on 03/15/16, patient urine and blood specimens were observed in refrigerators #1, #3 and #4 which also contained clean testing supplies. There was a poster on the front of refrigerators #3 and #4 which stated no patient specimens were to be kept in the refrigerators. Upon questioning the interim Laboratory Manager (Manager #18) began to tear the posters from the front of the refrigerators and stated the posters should not be there. Manager #18 was unable to verify if patient specimens could be stored with clean testing supplies.

b) During an interview conducted on 03/16/16 at 12:43 p.m. with the Infection Control Nurse (CNO #2), s/he stated the clean supplies in the laboratory should not be stored with contaminated specimens and s/he would include the lab in future infection control surveillance.

c) An interview was conducted with the Quality/Safety/Risk manager (Manager #1) on 03/16/16 at 4:28 p.m. Manager #1 stated infection control should be involved with the laboratory to ensure correct infection control processes are adhered to.