The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

KANAKANAK HOSPITAL P O BOX 130 DILLINGHAM, AK 99576 Sept. 27, 2018
VIOLATION: PROVISION OF SERVICES Tag No: C0270
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Based on observations, interviews, and record review the facility failed to develop and implement policies and procedures for the safe administration of medications to patients receiving services from the facility.

The facility failed to: develop and implement policies to ensure an effective system for safe pharmacy practices. Specifically, failed to ensure safe: dispensing; handling; storage; and administration of medications as evidenced C-278. These unsafe practices placed all patients receiving medications from the hospital at risk for significant adverse events and/or death from medication errors.

The facility was notified on 9/27/18 at 4:00 pm of an Immediate Jeopardy (IJ) to the health and safety of patients that received medications from the pharmacy. The IJ was not removed at the time of exit.

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VIOLATION: POLICIES - INFECTION CONTROL Tag No: C0278
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Based on record review, observation, and interview the facility failed to develop and implement policies to ensure an effective system for safe pharmacy practices. Specifically the facility failed to ensure safe: dispensing; handling; storage; and administration of medications as evidenced by this report. These unsafe practices placed all patients receiving medications from the hospital at risk for significant adverse events and/or death from medication errors. Findings:

The facility was notified on 9/27/18 at 4:00 pm of an Immediate Jeopardy (IJ) to the health and safety of patients that received medications from the pharmacy. The IJ was not removed at the time of exit.

Endoscopy observations

Review of the 9/25/18 endoscope schedule revealed, 6 patients were scheduled for endoscope procedures, with the first case to begin at 8:00 am.

Observations on 9/25/18 at 8:30 am, in the endoscope procedure room revealed the first patient had been moved from the endoscopy suite to the recovery area. On the counter in the endoscopy suite, lying on a blue pad were 5 syringes labeled Fentanyl [narcotic] and 4 syringes labeled Versed [sedative]. The labels had no date, time, expiration date, concentration, or initials on the syringe labels.

Further observation revealed an unsecured drawer below the counter that had multiple open and unopened vials of both Versed and Fentanyl. The Nurse stated she kept all the vials in the drawer so she could waste them with the Emergency Department (ED) Nurse at the end of the day.

During an interview on 9/25/18 at 8:30 am RN#1 stated the Fentanyl and Versed were pulled from the ED Pyxis (automated medication dispensing system) this morning under the fictitious name, "Endo [endoscope] 9/25." She stated because the ED Pyxis was so far away, it was easier to pull all the medications at one time under "Endo" and the date of surgery rather than under each patients name.

RN #1 further stated she always filled 4 or 5 syringes of each medication prior to the first patient, and then had more vials in the drawer to pre-draw more medications as needed throughout the day.

Observation on 9/25/18 at 12:25 pm, RN #1 was observed wasting the medications removed from the Pyxis for "Endo 9/25." The RN returned 3 vials of Versed 10mg/2ml and 1 vial of Fentanyl 100mcg/2ml to the Pyxis.

RN#1 then wasted, with a second RN, under "Endo 9/25": 275mcg Fentanyl 100mcg/2ml; 15 mg of Versed 100mg/2ml; and 2mg Versed 5mg/5ml.

Record review of the "All stations Events" Pyxis report revealed at 7:46 am RN #1 removed:
- 8 vials of Fentanyl 100mcg/2ml;
- 3 vials of Versed 5mg/5ml; and
- 5 vials of Versed 10mg/2ml.

The Versed vials at the bedside of the patients had different concentrations placing patients at risk for an adverse event from receiving the wrong dose.

During an interview on 9/25/18 at 12:45 pm Pharmacist #1 was asked if she had observed narcotic practices during endoscopy procedures and she stated she had not. When the Pharmacist was told nurses were batching scheduled medications under a non-patient identifier and had the same medication with different concentrations at the bedside, she stated that was not good practice.

When asked about the practice of drawing up the medications at the beginning of the day for several patients at a time, the Pharmacist stated she had no concerns with that if they were labeled, the vials were present, and the nurse was always present.

During random observations from 9/24-27/18, of the sharps containers in the endoscopy suite, inpatient unit, and the Emergency Department revealed, multiple syringes in the sharps containers that contained 0.5 - 3 mls of clear liquid.

During an interview on 9/25/19 at 1:00 pm RN #1 stated she did not waste medication down the sink.

Inpatient unit

Observation on the inpatient unit on 9/26/18 at 12:20 pm revealed pharmacy bottle of medication sitting on the medication counter. The bottle had a yellow sticky note label "[patient's last name]" and "Lisinopril [blood pressure medication]" affixed to the bottle.

During multiple interviews on 9/26-27/18 nursing staff stated sticky note medication labeling frequently comes to the nursing unit from the Pharmacy. They have been told to take pictures of the bottles and complete an incident report. During the interviews multiple staff expressed concerns of retaliation for reporting safety concerns to administration.

During an interview on 9/26/18 at 12:45 pm, a Pharmacist was shown the bottle of medication with the sticky note label for "Lisinopril" She stated it was a onetime order and expressed no concerns with labeling the single dose medication with that label.

Pyxis refilling and return medications

During an observation and interview on 9/25/18 between 1:30 pm and 2:15 pm Pharmacy Technician (PT) #1 was observed checking the Pyxis return medication box in the outpatient clinic. The Pyxis screen report revealed multiple medications had been returned. The medications listed on the Pyxis report were:

Albuterol [used to open airway in lungs] inhaler: expected 1
Haloperidol [anti-psychotic] 5mg/1ml: expected 2
5 refrigerated vaccines: expected 1 of each

The only medication found in the Pyxis return bin was a vial of Kenalog (steroid medication), which was not on the list of medications returned. The PT was not sure why the reported medications were not in the bin. When asked if this concern was reported anyone, the PT stated "no".

During an observation and interview on 9/25/18 between 1:30 pm and 2:15 pm, PT #1 was asked to check the Pyxis return medication box on the Acute Care - Inpatient unit. The Pyxis report revealed multiple medications had been returned in the Pyxis. The multiple medications listed on the Pyxis report did not correlate with the medications found in the return bin.

The PT returned the medications from the return box to the Pyxis bins. The PT did not verify or correct the expiration date listed, used to help staff quickly identify if the medications were expired, in the Pyxis system. When asked if she verified or entered medication expiration dates into the Pyxis, the PT stated she had not been.

During an interview on 9/27/18 at 4:00 pm the facility was asked to provide policy and/or procedures for Pyxis stocking, bar scanning, reports, and medication reconciliation. No documents were provided by the time of exit.

During random interviews on 9/24-27/18, multiple nursing Staff and physicians had expressed concerns with the bar-scanning capabilities of the Pyxis not being up to date with the medications in stock. The facility staff expressed concerns about the additional layer of safe medication administration and monitoring of the scanning compliance rates, not being utilized.

During random observations in the Pharmacy on 9/25-27/18 revealed:

- Cups of staff liquid drinks on the counters where medication were dispensed;
- Multiple bottles of stock medication to include:
" Methotrexate [chemotherapy agent];
" Zofran [anti-nausea];
" Digoxin [heart medication];
" Mirtazapine [antidepressant];
" Verapamil [heart medication];
" Fluconazole [antifungal];
" Nitrofurantoin [antibiotic];
" Aspirin; and
" Atrovasin [lowers cholesterol];
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Stacked on the counter where the Pharmacy Technicians fill prescriptions.

Compounding

Observations in the Pharmacy from 9/25-27/18, revealed a compounding aseptic containment isolator (CACI), used to mix medications under sterile conditions.

During random Pharmacist interviews on 9/25-27/18, revealed no Pharmacist had completed compounding competencies. In addition, one Pharmacist, when asked was not able to state the compounding risk level other than the Pharmacists did not mix chemo (anticancer medications) or TPN (total parenteral nutrition) medications, but they did provide "banana bags" (a term used for an IV-intravenous fluid bag with 3 or more medications).

During an interview on 9/27/18 at 4:00 pm, the Director of Clinical Services was asked to provide compounding policies, environmental reports, and staff competencies for compounding. No documents were provided by the time of exit.

Medication incident reports

During an interview on 9/25/18 at 12:45 pm, Pharmacist #1 was asked if she had reviewed the medication event or Risk Management Event (RME) reports and stated she had not been asked to review the incident reports for medication errors.

Record review of the RME (incident) report from 7/1 - 25/18, revealed 45 medication event reports had been reported to leadership and none of the events had been investigated.

Medication events -Incident reports

Record review on 9/24-27/18 of the "Risk Management Event" (RME) medication incident reports from 7/1 - 8/26/18, revealed 45 medication events had been reported to Administration. The report included multiple reports of mislabeled medications, medications unable to scan, co-mingled medications, expired medications, delay in delivery of medications, and repeated medication errors. In addition, the medication events had not been investigated, therefore unresolved, leaving patients at risk for more medication errors and possible significant adverse reaction.

Inpatient RME


Report #171 dated 9/14/18, revealed "incorrectly labeled medications, medication identification on lexicomp [a web based drug information application found on a cell phone] to verify med."

Further review of the documents attached to report #171 revealed pictures of 3 bottles of medications, inappropriately labeled with a sticky note attached to 2 of the bottles. One bottle had an attached sticky note "Pacrealipase [improves digestion] 24,000 units. Second bottle has an attached sticky note "Magnesium chloride 64," and a third bottle with a label but due to a sticker on the bottle this surveyor could not identify the labeling.

Report #173 dated 9/16/18, revealed a duplicate error from 9/14/18. Nursing was unable to scan the medication Pancrelipase 24,000 units. "Bottle not labeled clearly. It appears that all three tabs (caps) together equal 24,000 units (see picture of bottle) [picture was not provided] so patient got all 3 tablets. I'd noticed I'd given too many when looking again at the MAR [medication administration record] after I gave and saw it said 1 tab not 3 tabs + 24,000 units." As a result the Patient was given 3 times the dose to be given. The report contained no supervisory findings or follow up recommendations.

Report #160 dated 8/28/18, revealed 3 Omeprazole DR (used for gastric acid reflux0 in the Pyxis with an expiration date of 7/2018. The report contained no supervisory findings or follow up recommendations. Contributing factors from staff reporting the event were "need procedure to outdate medications."

The policy was requested, and was not provided by time of exit.

Report #156 dated 9/16/18, revealed "loose pills placed inside a bio-hazard bag and placed in the Metformin [lowers blood sugar] Pyxis drawer. Medication not labeled with name or dose. Pills had to be verified online with marked number before giving."

Attached to the incident was a picture of 15 pills in a clear bag with a sticky note "10/2019 - ." In addition, the report had a cell phone picture of a medication pill. The report contained no supervisory findings or follow up recommendations.

Report #154 dated 8/23/18, revealed the wrong dose of insulin pen was stocked in the Pyxis and insulin pens do not scan into the Pyxis system. In addition, the report states multiple medications do no scan into the bar code medication system. The report contained no supervisory findings or follow up recommendations.

Report #153 dated 8/13/18, revealed an incident where the patient was given only 150mg of Clindamycin [antibiotic] instead of 450 mg due to Pyxis not scanning. The report contained no supervisory findings or follow up recommendations.

Report #142 dated 8/1/18, with a report date of 8/11/18 revealed the label on a Fentanyl drip prepared by a Pharmacist had an label that was smeared and obscured the dosing, initials, and beyond use date.

A printed picture of the IV label and the narrative on the picture revealed the label stated there was 100mcg of Fentanyl in the 250ml bag of normal saline. Hand written on the label was 1mcg/1ml. Further review of the RME documentation revealed a request to teach Pharmacist how to print labels. RME report form incomplete: no supervisory findings or follow up recommendations.

Report #141 dated 8/10/18, revealed the medication Ketorolac (anti-inflammatory) 30mg was co-mingled in the same Pyxis bin as Ketorolac 60mg. The report contained no supervisory findings or follow up recommendations.

Report #130 dated 8/9/18, revealed D5NS (dextrose normal saline) with 20KCL (potassium) was stocked in the Pyxis under NS with 20KCL. RME report form incomplete: no supervisory findings or follow up recommendations.

Report #129 dated 8/8/18, revealed "Antibiotics for possible Sepsis was supposed to be Grant Air Shipped yesterday, requested around 11am yesterday. Spoke to pharmacy today, 2 flights arrived with no meds."

Further review of an attached email note from the MD to the Compliance Department revealed, "Dr. [name] spoke with Pharmacist who stated the medication would be out on 8/7/18 at 3:00 pm. Due to the patients worsening condition he was sent via air to ANMC for further care on 8/8/18." The report contained no supervisory findings or follow up recommendations.

Report #125 dated 7/14/18, reported on 8/6/18 revealed a STEMI [a kit filled with the cardiac medication to treat a heart attack] kit was not restocked for 2 days after an email was sent to pharmacy. The report contained no supervisory findings or follow up recommendations. Not having the medications readily available place all patients who presented to the ED at risk for increase cardiac injury and/or death.

Report #124 dated 8/1/18 wrong medication prochlorperazine (used for nausea/vomiting) was stocked in the Pyxis under acetaminophen (Tylenol). The report contained no supervisory findings or follow up recommendations.

Report # 121 dated 8/1/18 revealed a STAT (immediately) request for a Levophed (potent blood pressure medication given via an intravenous infusion) drip was called to the pharmacist at 1:00 pm and it was not received on the unit until 2:20 pm. "When the medication was received a handwritten label was smeared and illegible. This cause further delay in the patient's emergent care." The report contained no supervisory findings or follow up recommendations.

Report #121 dated 8/1/18 revealed an order for IV Clindamycin [antibiotic] was called to the Pharmacy at 10:09 am and not ready for the patient infusion until 11:30 am. In addition, the reporter states one Pharmacist was attempting to hand write a label while another Pharmacist prepared the IV medication, because neither Pharmacist was able to print a label. The report contained no supervisory findings or follow up recommendations.

Report #118 dated 7/31/18 revealed nursing staff was instructed by Pharmacy to administer Morphine (narcotic) elixir using patient's medications from home, even though there were 3 bottles of elixir available in pharmacy. The label on the bottle of the home medication did not scan and the Rx on the bottle stated give 2.5ml every 2 hours, which the patient was given. The MD admission orders were to give 0.5 ml morphine every 2 hours as needed. The report, dated 7/31/18 revealed someone, signature illegible, wrote the follow up actions were that all staff were instructed to send patients meds to pharmacy upon admit.

Report #100 dated 7/16/18, revealed a patient brought back an expired pre-packaged prescription for Metronidazole (antibiotic) dispensed from the ED. The report contained no supervisory findings or follow up recommendations.

Report #165 dated 8/29/18, revealed the medication Levofloxacin (antibiotic) was not given at 10 pm as ordered. The report contained no supervisory findings. A box was marked for education in a staff meeting and individual follow-up.

Out-Patient RME

Record reviews revealed:

Report #170 dated 9/7/18 revealed "Patient medication was delivered to the wrong clinic instead of going to Naknek clinic it was delivered to the South Nakenk clinic"

Review of an email sent to the Director of Clinical Services on 9/10/18 revealed the medication Omeprazole [for gastric acid reflux] was delivered to the South Naknek did not get to the Naknek Clinic until 9/7/18, 1 month later, delivered by the an Itinerant CHP (community health aide practitioner). The report contained no supervisory findings or follow up recommendations.

Report #169 dated 9/7/18 revealed "Patient medication was delivered to the wrong clinic instead of going to Naknek clinic it was delivered to the South Nakenk clinic. Medication is no longer required."

Review of an email sent to the Director of Clinical Services on 9/10/18 revealed the medication Fluocinonide (steroidal cream) cream and Cefdinhir (antibiotic) was delivered to the South Naknek did not get to the Naknek Clinic until 9/7/18, 1 month later, delivered by the CHP. The report contained no supervisory findings or follow up recommendations.

Report #168 dated 9/7/18 revealed "Patient medication was delivered to the wrong clinic instead of going to Naknek clinic it was delivered to the South Nakenk clinic. Medication is no longer required."

Review of an email sent to the Director of Clinical Services on 9/10/18 revealed the medication "Enbrel [for arthritis] Sureclick was delivered to the South Naknek did not get to the Naknek Clinic until 9/7/18, 1 month later, delivered by the an Itinerant CHP. The medication was to be refrigerated but was not and is no longer able to be used." The report contained no supervisory findings or follow up recommendations.

Report #168 [duplicated number] dated 9/7/18 revealed "meds ordered 8/16/18 and 8/19, says filled on these dates in the HER. Tracking # shows shipped on 8/23/18. Pt. out of heart meds, including Apixaban an anticoagulant."

Further review of attachments to the REM revealed an email was sent to the Compliance Department on 8/24/18. The email states "Patient ordered medications on 8/16 ...Tracking shows the medications were shipped on 8/23/18 with a delivery date of 8/27/18 ... patient states out of 3 heart medications including her Apixaban [Eliquis, an anti-thrombolytic]."

A second email, sent to Compliance Department on 8/27/18 revealed the patient received Lisinopril [for blood pressure], Apixaban [anti-coagulant] and Metoprolol [for blood sugar] on 8/24/18. However the patient not supposed to receive Lisinopril, instead was to receive Pravastatin [lower cholesterol], which she is out of. RME report form incomplete: no supervisory findings or follow up recommendations.

Report #149 dated 8/17/18 revealed 2 medication re-fills were mailed to the wrong patients. This left one patient without medications for COPD (congestive obstructive pulmonary disease-narrowing of airways and difficulty breathing) and a second patient without a diuretic (medication that removes fluid).

Attached to REM #149 is an undated and unsigned investigation form that states a conversation occurred with Pharmacy and a (female name) will ensure the patients get their medications this day.

Report #148 dated 8/9/18 with a reporting dated of 8/15/18 revealed "meds ordered 8/9, wasn't filled until 8/11/18, still not received. Spoke with [person name] in pharmacy, given a tracking #, looked in USPO tracking and says 'label made, not yet in system.'"

Further review of the REM attachments revealed multiple emails sent to a Pharmacist and the Compliance Department dated 8/15/18 and 8/16/18 from a CHP communicating what she had learned by doing her own investigation and stated "The problem with medication orders in pharmacy is very dangerous to patients." The report contained no supervisory findings or follow up recommendations.

Report #147,146, 145, 144 dated 8/8/18, with a reporting date of 8/14/18 revealed 4 separate patient reports from a CHP was emailed to the Compliance department of patients having ordered medications on 8/8/18 and still not received them as of 8/14/18. In addition, the Health Aide stated "Possible pharmacy hot line issues." The report contained no supervisory findings or follow up recommendations.

Report #137 dated 7/20/18 with a report date of 8/13/18 revealed "Medication not received still. Ordered 7/20/18, never arrived." The report contained no supervisory findings or follow up recommendations.

Report #134 dated 8/13/18 revealed a patient was dispensed the insulin Lantus with a reported anaphylactic (severe allergic reaction) shock allergy that required in-patient admission for 2 days. The prescription to be filled was for Victoza, another brand of long acting insulin.

Further review of and email dated 8/13/18 sent from the Chief Compliance Officer to Risk Management revealed the Patient's family spoke with a Pharmacist on 8/13/18 who the family member states the Pharmacist stated it was OK to take the Lantus insulin even though it was stated as an allergy. The report contained no supervisory findings or follow up recommendations.

Report #174 dated 9/20/18, revealed the pharmacy had been notified on 8/28/18 via email to increase the quantity of Fentanyl and Versed medication order for the week of September 17-21. The incident further stated that as of "9/20/18 at 1:15 pm we will not have Fentanyl for our scopes on Friday." In addition, the report stated "Next, we ran out of Fentanyl Wednesday end of day. We only had enough that day due to nursing not wasting amounts already drawn up them previous day because we were told we had no more. Not standard practice." Inferring the medication prepared for use the prior day were saved to use for the next day.

Schedule lJ discrepancy report

During an interview on 9/25/18 at 12:45 pm Pharmacist #1 was asked if she had any concerns with diversion and stated no. When asked if Pyxis reports were ran to monitor usage for schedule II medications, the Pharmacist stated, she had never ran a report to review practice concerns or discrepancies.

Record review on 9/27/18 of the printed "Open Discrepancy" Pyxis report from 8/28/18 - 9/27/18 revealed:

8/28/18 Phenobarbital (barbiturate often used to treat seizures) 130mg/1ml vial with an expected inventory of 10 and found 0 on 9/12/18 at 2:52 pm. Resolution: Currently unresolved

9/12/18 Lorazepam (anti-anxiety) 1mg tablets with an expected inventory of 19 tablets and 20 found. Resolution: Currently unresolved;

9/17/18 Midazolam (intravenous sedative) 5mg/5ml vial with an expected inventory of 3 vials and found 1 vial. Resolution: Currently unresolved;

9/19/18 Midazolam 10mg/2ml vial with an expected inventory of 9 vials and found 10 vials. Resolution: Currently unresolved;

8/29/18 Quetiapine (antipsychotic) 25mg tab with an expected inventory of 10 tabs and found 4 tabs. Resolution: Currently unresolved;

9/05/18 Quetiapine 25mg tab with an expected inventory of 8 tabs and found 6 tabs. Resolution: Currently unresolved;

8/27/18 Dronabinol [man made cannabis like drug for nausea] 2.5 mg capsule with an expected inventory of 11 and found 1 capsule. Resolution: Currently unresolved;

9/12/18 Phenobarbital 130mg/1ml with an expected inventory of 10 and found 0 vials. Resolution: Currently unresolved;

9/22/18 Lorazepam 1mg tablets with an expected inventory of 19 tablets and 20 found. Resolution: Currently unresolved;

9/21/18 Lorazepam 1mg tablets with an expected inventory of 19 tablets and 20 found. Resolution: Currently unresolved;

8/29/18 Levofloxacin (antibiotic) 500 mg/100ml with an expected inventory of 10 and found 0 vials. Resolution: Currently unresolved;

8/29/18 KCL 20mEq/D5W/NACL with an expected inventory of 4 and found 0 bags. Resolution: Currently unresolved;

8/30/18 Dronabiol 2.5 mg capsule with an expected inventory of 26 and found 25 capsule. Resolution: Currently unresolved;

9/23/18 Lorazepam 0.5mg tablets with an expected inventory of 10 tablets and 20 found. Resolution: Currently unresolved - count verified with 2 nurses;

9/16/18 Norco (narcotic pain medication) tablet with an expected inventory of 34 tablets and found 36 tablets. Resolution: Resolved with (Name) RN and (name); and

9/17/18 Norco tablet with an expected inventory of 35 tablets and found 33 tablets. Resolution: Resolved (name).

Review of the Scheduled Drug "All Station Event" report dated 9/17 - 21/18 revealed:

9/15/18 11:09 pm a Lorazepam 2mg vial was removed from Pyxis for Patient #1,
9/16/18 7:30 am 1 mg of lorazepam was wasted for Patient #1;

9/15/18 11:49 am and again at 12:56 am Morphine 2mg's was removed for Patient #2,
9/16/18 5:33 am Morphine 1 mg was wasted for Patient #2;

8/29/18 12:28 pm Lorazepam 2mg/1ml syringe/vial was removed for Patient #3,
8/29/18 7:49 pm Lorazepam 1mg was wasted for Patient #3;

9/4/18 7:17 pm Lorazepam 1 mg tab was removed from the Pyxis for Patient #4,
9/5/18 7:20 am Lorazepam 0.5mg was wasted for Patient #4;

9/14/18 At 7:30 pm Lorazepam 2mg/1ml syringe was removed from the Pyxis for Patient #5,
9/15/18 At 7:23 pm Lorazepam 1 mg was wasted for Patient #5;

9/18/18 At 3:14 pm Lorazepam 2mg/1ml syringe was removed from the Pyxis for Patient #6,
9/18/18 At 7:36 pm Lorazepam 1 mg was wasted for Patient #6;

9/15/18 At 4:00 pm Lorazepam 2mg/1ml syringe was removed for an unidentified ED patient;

9/16/18 At 8:26 pm Fentanyl 250mcg/5ml vial and Midazolam 5mg/5ml vial was removed for an unidentified ED patient;

9/18/18 At 3:54 pm Lorazepam 1mg tablet was removed for an unidentified ED Patient;

9/17/18 At 7:38 am 8 vials of fentanyl 250 mcg/5ml was removed for "Patient: endo 9/17";

9/17/18 At 4:31 pm 4 vials of fentanyl 250 mcg/5ml was returned for "Patient: endo 9/17";

9/17/18 At 4:32 pm 475mg of fentanyl was wasted for "Patient: endo 9/17";

9/17/18 At 7:39 am 12 vials of Midazolam 5mg/5ml vials was removed for "Patient: endo 917";

9/17/18 At 4:30 pm 8 vials of Midazolam 5mg/5ml vials was returned for "Patient: endo 917";

9/17/18 At 4:35 pm 13mg Midazolam was returned for "Patient: endo 917";

9/17/18 At 10:26 am 12 vials of Midazolam 5mg/5ml vial removed for "Patient: Endo 9/17";

9/25/18 At 7:46 am 8 vials of Fentanyl 100mcg/2ml was removed for "Patient: endo 9/25/18"; and

9/25/18 At 8:52 am 5 vials of Midazolam 10mg/2ml was removed for "Patient: endo 9/25/18.

Further review of the report revealed the practice of removing drugs under a fictitious name (Endo date), occurred on 9/18/18; 9/19/18; 9/20/18; 9/25/18 and 9/26/18.

During an interview on 9/26/18 when asked about signing the medications out under a fictitious name, Pharmacist #1 stated she was not aware of that practice.

/when asked how compliance of medication administration was monitored, Pharmacist #1 stated she was unfamiliar with the inpatient bar scanning system much about the bar scanning system and had not been monitoring compliance. When asked if she audited any reports from the Pyxis, she stated she had not and was not familiar with the reporting capabilities.

The Pharmacist was also asked if she or any Pharmacist was active on the Antimicrobial Stewardship committee, and she stated no.

During an interview on 9/27/18 at 9:30 am the Director of Clinical Services stated the Antibiotic Stewardship Committee had not met for several months because of the turnover with the Pharmacist, but that he would provide meeting minutes. No meeting minutes for the Antibiotic Stewardship were provided by the time of exit.

During random interviews from 9/25 - 27/18, Physicians #2-5 stated they had expressed on multiple occasions to Administration of their having concerns that the Pharmacy had little inpatient experience. In addition, had expressed concerns with the rise of significant medication events, the Pharmacists lack of training with the Resource and Patient Management System (RPMS). The knowledge deficit and maintenance of the RPMC system has resulted in patient safety and quality of care concerns. Further concerns had been expressed that the Physicians input in hiring Pharmacist had been dismissed.

Pharmacist in Charge (PIC)

During an interview on 9/26/18 the Director of Clinical Services stated Pharmacist #2 was the PIC and that it was posted in the Pharmacy.

During an interview on 9/25/18 Pharmacist #1 stated she was the PIC.

During an interview on 9/26/17 Pharmacist #2 stated she was the PIC, and that it was her name posted in the Pharmacy.

During random interviews on 9/26-27/18 with multiple Physicians, the stated Pharmacist #3 was the PIC.

Record review of the State of Alaska "Change in Pharmacy Manger" application revealed on 8/16/18 Pharmacist #1 had been appointed the PIC for Bristol Bay Area Health Corporation.

Record review on 9/26/18 of the 5 Pharmacist's job descriptions revealed all 5 Pharmacists had signed a job description for a Staff Pharmacist.

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VIOLATION: QA - QUALITY OF PATIENT CARE Tag No: C0336
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Based on record review and interview the facility failed to ensure an effective quality assurance program was maintained to monitor pharmacy services. This failed practice placed all patients at risk for harm and or death related to unsafe pharmacy practices. Findings:

Record review on 9/24-27/18 of the BBAHC Patient Safety Adverse Event data graphs, presented on August 13-17, 2018 revealed 22 medication errors had been reported in the Risk Medication Event system, 14 of the errors were identified by the facility as "Significant Medication Errors."

Record review of the Executive Committee Meeting Minutes dated August 13-17, 2018 revealed, the Chief Operations Officer reported, "Staff turnover in the pharmacy department causes issues which prompted ANTHC's assistance." The minutes did not reflect the significance of the medication events and the lack of investigations, or action plans to be implemented.

Further review of the Executive Committee Meeting Minutes dated August 13-17, 2018 the Quality Management report revealed, "Patient Safety-BBAHC patient safety adverse events for 2018 were reviewed. It was reported there was one adverse event in July. There were 29 medication errors from January to July 2018 compared to six during this same time frame in 2017. The minutes did not reflect the significance of the medication events and the lack of investigations, or action plans to be implemented.

During random interviews with multiple Leadership staff on 9/24-27/18, when asked to provide any action plans taken after the August report of increased medication events taken by the Pharmacy, Quality or Compliance revealed no actions had been taken on the medication event increase.

Record review of the most current Pharmacy and Therapeutics Committee meeting minutes revealed the last documented minutes had been dated 12/21/17.

Record review on 9/24-27/18, of the "Quality Improvement Policy" dated 4/20/18, revealed "The ...Quality Improvement efforts to improve the efficiency and effectiveness of services ... enhance and strengthen patient safety processes and address patient safety events. BBAHC will utilize a systems approach ... including prospective risk assessment and retrospective risk analyses as part of a comprehensive approach to reduce adverse events and risk to patient safety ..."




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