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A. Based on document review and interview, it was determined in 1 of 1 emergency crash cart observed, the CAH (Critical Access Hospital) failed to ensure the emergency crash cart was monitored per policy. This has the potential to affect all patients (average daily census of 8, 65-70 surgical patients per month) served by the the CAH.

Findings include:

1. The policy titled "Crash Cart" (reviewed 9/15) was reviewed on 6/2/16 at approximately 2:00 PM. The policy required a daily check of the emergency crash cart to ensure it was properly stocked and available with a functioning defibrillator.

2. During a tour of the ICU (Intensive Care Unit) on 6/2/16 at approximately 11:40 PM, the emergency crash cart checklist was reviewed. The crash cart check list lacked documentation the crash cart was checked on the following days: 8/26/15 (1 of 31 days); 9/12/15 (1 of 30 days); 11/2/15, 11/22/15, 11/23/15 (3 of 30 days); 12/14/15, 12/25/15 (2 of 31 days); 1/3/16 (1 of 31 days); 5/5/16, 5/6/16/ 5/13/16, 5/14/16, 5/15/16, 5/16/16, 5/20/16 (7 of 31 days).

3. During an interview on 6/2/16 at approximately 11:45 AM, E#11 (Director of Inpatient Services) verbally agreed the crash cart had not been checked on the days as noted above and should have been.


B. Based on document review, observation and interview, it was determined the CAH (Critical Access Hospital) failed to ensure medical equipment was inventoried and maintenance per policy. This has the potential to affect all patients (average daily census of 8, 65-70 surgical patients per month) served by the the CAH.

Findings include.

1. The policy titled "Equipment Management Program (Clinical, Non-Clinical, Non-Owned Equipment" (reviewed 3/15) was reviewed on 6/2/16. The policy required "Medical Equipment characteristics will be evaluated... the Medical Risk Assessment Evaluation Form. Equipment with a total rating of 12 or greater will be included in the program. Equipment with a rating below 12 will be included in the inventory for management purposes... Hospital will reduce the potential of equipment failure by periodically testing, performing scheduled maintenance... Bio-med to manage clinical equipment beyond the scope of the maintenance Department." The policy "Medical Equipment Management Plan" (revised 3/16) required all medical equipment to be in the medical equipment inventory and all equipment to be evaluated for equipment maintenance.

2. During an observational tour of the CAH, the following lacked a bar code to indicate the equipment was inventoried or Periodic Maintenance (PM) tag: OR#2 (operating room)- Wolfe light source #4510 and #4509, central supply area a Ethicon Endosurgery Harmonic scalpel; Rehabilitation room- hydrocollater and hydro therapy unit; Dietary- all equipment (mixers, refrigerators, steamers, ovens, etc.).

3. During an interview on 6/2/16 at approximately 2:30 PM, E#9 (Biomedical Maintenance Manager) stated "We are under new management and are trying to inventory all the equipment and bar code what needs maintenance. We just can't keep up." E#9 stated many items are "Run until it fails" but the equipment needs to be inventoried before decisions about what equipment needs PM' d or runs until it fails. E#9 stated although some equipment does not required PM by Bio-med, an annual visual inspection to ensure the condition of the equipment is intact, functional and electrical cords are intact should be conducted.

A. Based on observation, interview, and document review, it was determined the Critical Access Hospital (CAH) failed to ensure outdated drugs and biological's were not available for patient use. This has the potential to affect all inpatients (average daily census of 8 patients) and outpatients (average daily census of 143 patients) served by the CAH.

Findings include:

1. An observational tour of the CAH was conducted 5/31/16 between 12:30 PM and 4:00 PM. The following outdated drugs and/or biological's were observed available for patient use:
a. At approximately 12:45 PM in the Radiology department, two emergency boxes (one in the Computerized Tomography room and one in the Fluoroscopy room) were observed to contain one 20 ga (ga) BD Insyte Autoguard expired 12/2015, one 18 ga BD Insyte Autoguard expired 08/2015, one IV (intravenous) Administration Set expired 12/2014, three 1/2 ml (milliliter) syringe expired 12/2014, one 23 ga Vacutainer Blood Collection Set expired 08/2013, and one 25 ga Vacutainer Blood Collection Set expired 06/2013 in each box.

An interview was conducted with the Director of Radiology (E#6) and the Radiology Technician (E#7) at approximately 1:15 PM. Both stated Pharmacy was responsible for checking for outdated supplies in the emergency boxes.

b. At approximately 3:50 PM, in the Respiratory department, the Stress laboratory medication cabinet was observed to contain one bottle of Nitrostat 0.4 mg (milligram) 25 tablets expired 03/2016 and two Aminophylline 250 mg/10 ml expired 05/01/2016.

An interview was conducted with the Director Respiratory Therapy (E#5) at approximately 4:00 PM. E#5 stated "Isn't Pharmacy suppose to be responsible for that (the outdated drugs) or are we (Respiratory Therapy)?"

2. The CAH policy titled "Emergency Medications" (last reviewed 07/2015) was reviewed on 6/1/16 at approximately 11:30 AM. The policy stated "Policy... Emergency medications are kept in patient treatment areas and are stored in sealed carts maintained and monitored by Pharmacy..."

3. An interview was conducted with the Chief Nursing Officer (E#2) on 6/1/16 at approximately 11:30 AM. E#2 stated "Pharmacy is responsible for maintaining the emergency boxes and we use the same policy for biological's (such as IV administration sets, syringes)."

B. Based on observation and interview, it was determined the Critical Access Hospital (CAH) failed to ensure Sleep Laboratory disinfection supplies were labeled. This has the potential to affect all patients (average weekly census of 3 to 5 patients) served by the CAH.

Findings include:

1. An observational tour of the Sleep Laboratory was conducted on 5/31/16 at approximately 4:00 PM with the Director Respiratory Therapy (E#5). A spray bottle with "Sanizide" written on it with black marker and a paper with hazard symbols taped on the bottle was observed in a cabinet. The bottle lacked any lot number, date it was prepared, and/or date of expiration.

2. An interview was conducted with E#5 during the tour. E#5 stated "We use it to clean the equipment (for Sleep studies). I don't know who put it in the bottle or when. You're right, it doesn't have any dates on it."

3. An interview was conducted with the Chief Nursing Officer (E#2) on 6/1/16 at approximately 10:00 AM. E#2 researched the product and returned at approximately 3:00 PM with Sanizide product information. E#2 stated "They (environmental services) have large bottles of this (Sanizide) and they put it into the bottle. It should have been labeled with the lot number, the date it was added to the bottle, and the expiration date. We have no idea how long that bottle has been there."

C. Based on document review and staff interview, it was determined the CAH failed to ensure medication discrepancies were resolved per policy. This has the potential to affect inpatients (average daily census of 8 patients) and surgery patients (65-70 patients per month).

Findings include:

1. The policy titled "Automated Dispensing System-PYXIS" (reviewed 5/16) was reviewed on 5/31/16. The policy noted "Whenever there is a discrepancy between a manual count and the system inventory... nursing staff shall investigate the discrepancy... and resolved during the shift on which they appear before staff members leave... The "Comments" field must be completed with an acceptable statement regarding the resolution

2. The "All Discrepancies" report dated 5/18/16 to 5/31/16 was reviewed on 5/31/16. The following examples of deficiencies were identified:
a) On 5/24/16 at 12:31 AM, a discrepancy for the Ativan count was created. The discrepancy was resolved as a "missed count"on 5/24/16 at 7:35 AM by the Pharmacy Technician (E#12).
b) On 5/19/16 at 7:17 AM, E#12 noted the Norco 5/325 (narcotic) tablet count as 0. At 2:42 PM E#13 (Pharmacist) created a discrepancy that 0 Norco tablets were found although 1 was expected to be in the bin and commented "dilaudid in bin not norco..." On 5/20/16 at 2:17 PM, E#13 created the discrepancy that 2 Norco tablets were found and only 1 was expected, then commented the nurse removed 2 instead of 1 tablet. Their was no investigation as to how there were 2 Norco tablets available when the last count was inventoried as 0.
c) On 5/20/16 at 6:43 AM, Alprazolam tablet count was noted as 11 (last prior access). On 5/23/16 at 6:05 PM, the Alprazolam tablet count was 9, therefore a discrepancy was created, resolved and commented as "miscounted twice". On 5/23/16 at 6:05 PM 1 Alprazolam tablet was removed and the final count was 8 tablets. On 5/23/16 at 9:36 PM, the Alprazolam count was 10 and only 8 were expected, therefore a discrepancy was created. The discrepancy was resolved on 5/25/16 at 12:02 PM by E#13 and commented as "Miss counted..."
d) On 5/29/16 at 8:59 PM, Ultram tablets were noted as 21 tablets. On 5/29/16 at 9:46 PM, the Ultram count was 23 tablets and only 21 tablets were expected, therefore a discrepancy was created and commented as "auto resolve". A Ultram tablet was removed and the final count was 22 tablets. On 5/30/16 at 6:24 AM, the Ultram was 20 and 22 were expected, therefore a discrepancy was created, resolved and commented as "auto resolve".

The discrepancy report noted 18 of 23 resolved discrepancies were not witnessed. The discrepancy report noted 10 of 23 resolved discrepancies were commented as "auto resolve" and lacked documentation of an investigation.

2. During an interview on 5/31/16 at approximately 2:10 PM, E#13 (Pharmacist #1) stated each day a discern report is generated and reviewed. E#13 stated the discrepancies are not tracked or trended usually the nurses just don't correctly count or enter the wrong amount of what's being withdrawn from inventory. E#13 stated E#12 (Pharmacist Technician) usually resolves the discrepancies and verbally agreed the Pharmacist do not review the resolutions to ensure accuracy of E#12.

3. During an interview on 6/1/16 at approximately 1:30 PM, E#11 (Director of Inpatient Services) stated "I don't see any discrepancy reports or know if there are problems. Pharmacy manages them (discrepancies). I assume if there was a problem they would tell me."

D. Based on document review and interview, it was determined the CAH failed to ensure an accurate narcotic inventory. This has the potential to affect approximately 65-70 surgical patients per month.

Findings include:

1. The policy titled "Controlled Drug Records" (reviewed 5/16) was reviewed on 5/31/16. The policy noted "Administration: "Record of Narcotics Administered" sheet... is used to record each dose administered and any drug that is wasted... An area is included to document any drug wasted in which case each entry includes a date, amount wasted, an explanation and two signatures. When the entire quantity of drug dispensed is depleted, the administration record should account for the usage of the drug. The completed sheet is returned to Pharmacy...A daily printout of all discrepancies, narcotics transactions and inventories are printed, reviewed, signed and filed....

2. During an observation tour of the surgical suite on 5/31/16 at approximately 12:05 PM, E#14 (Certified Registered Nurse Anesthetist) demonstrated the narcotic retrieval, storage and documentation process. The Record of Narcotics Administration labeled Versed noted 10 vials of Versed (Midazolan) were issued by Pharmacy to E#14 on 5/17/16. The first entry by E#14 was 5/24/16, 1 week after obtaining the vials. The record noted on 5/27/16 at 10:42 AM, Versed 1 mg was administered to Pt #4 although lacked documentation a nurse witnessed the waste of the remaining dose. E#14 verbally agreed the waste was not documented as witnessed and should have been. E#14 stated "We make sure the waste documentation is completed before we take the sheets back to Pharmacy."

3. During a tour of the Pharmacy 5/31/16 at approximately 2:10 PM, the Narcotic Sign-Out sheets were reviewed with E#12 (Pharmacy Technician), E#13 (Pharmacist #1), E#15 (Regional Pharmacy Director), E#16 (Pharmacy Manager), E#17 (Administrative Regional Director) and E#18 (Pharmacist #2). The Narcotic sheet for Fentanyl 2 ml vial noted 10 vials of Fentanyl were given to E#14 on 4/11/16, 4/14/16, 4/21/16, 4/25/15, 4/29/16, 5/17/16, 5/20/16 x 2, 5/26/16. The 10 vials of Fentanyl were unaccounted for any where from 3-17 days. E#16 verbally agreed there are multiple days in which the narcotics were not accounted for and should have been. E#16 reviewed E#14's Record of Narcotics Administration for Versed and verbally agreed Pt #4's waste was not witnessed and should have been.

Based on document review, observation and interview, it was determined the CAH (Critical Access Hospital) failed to ensure perishable food items were disposed of per policy. This has the potential to affect all patients, staff and visitors who receive food services from the CAH.

Findings include:

1. During an observational tour of the dietary department on 6/2/16 at approximately 10:30 AM with E#10 (Food Services Director), perishable food items in the walk in refrigerator were observed to be labeled with a received date. The following food items were observed to be expired: 1 large bag of shredded carrots expired 5/26/16, 2 large bags of chopped green peppers expired 5/25/16, 4 large bags of iceberg lettuce expired 5/31/16, and 1 large bag of ready to eat spinach with a received date of 5/18/16, greater than 1 week and without an identifiable expiration date was wilted and browning.

2. During an interview on 6/2/16 at approximately 10:30 AM, E#10 was unable to verbalize how expiration dates were identified or when perishable food items were discarded.