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.

AVERA ST MARY'S HOSPITAL 801 E SIOUX PIERRE, SD 57501 April 24, 2014
VIOLATION: PHARMACEUTICAL SERVICES Tag No: A0490
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**






A. Based on interview and observation, the provider failed to ensure:
*Policies and procedures were in place related to the keyed access to one of one pharmacy.
*One of one pharmacy was monitored to ensure limited access to it.
Findings include:

1. Observation on 4/23/14 at 12:03 p.m. of the pharmacy entrance and interior revealed:
*The door to the pharmacy had a keyed lock.
*No cameras or other electronic monitoring devices were on the door or in the pharmacy.

Interview, observation, and policy review on 4/23/14 at 12:15 p.m. with the former pharmacy director Q who was now serving as a staff pharmacist revealed:
*The pharmacy director position was currently in transition as she was retiring. The new pharmacy director was not available for interview as he was not at the facility.
*She had been the pharmacy director for many years prior to her recent retirement.
*She would answer my questions related to pharmaceutical services for the current director.
*When asked how the pharmacy was accessed by staff she stated by key. When asked who had keys she stated the pharmacists, the pharmacy technicians, and nursing house supervisor.
*Pharmacists took their keys to the pharmacy home with them including the keys to the schedule II controlled substances.
*No log was kept of which keys to the pharmacy had been issued to which person. Furthermore keys had no identifying marking that she was aware of.
*No random audits of pharmacy keys issued were conducted.
*The keys possessed by the pharmacy technicians, two pharmacists, and nursing house supervisor on duty were all worn and in some cases the "Do Not Copy" mark was gone along with the key numbers.
*The three pharmacy technicians did not take the keys home with them. They kept those keys at night in a unlocked pharmacy staff locker on the coat hooks. No tracking or accounting for those keys were completed.
*The nursing house supervisor had unlimited access to the pharmacy excluding schedule II narcotics. No policy was in place to address the nursing house supervisors access to medications including schedule III-V medications stored with all of the non-narcotic medications.
*No policies were in place to address keyed access to the pharmacy to ensure pharmaceutical security and safety.
*A pharmacist had resigned on 4/21/14 and was still in possession of the keys to the pharmacy. She believed that was being worked on. She would not be able to identify if she had the proper keys back from the resigned pharmacist once they came back as she had not kept any logs.
*She was unable to tell this surveyor how access to the pharmacy had been monitored.
*They had thought about placing cameras in the pharmacy and at the door, but that had never been completed.
*She agreed access to the pharmacy had not been properly monitored, and she could not ensure unauthorized access to the pharmacy had not occurred.

Interview on 4/23/14 at 10:30 a.m. with the delegate for the vice president of pharmacy services revealed he:
*Was a pharmacist for the corporation and was representing the vice president of pharmacy as he was out of town.
*Confirmed policies and procedures were not in place to address the keyed access of the pharmacy.
*Agreed the current process related to the keyed entry into the pharmacy was flawed and needed to be corrected.

B. Based on observation, interview, record review, and policy review, the provider failed to ensure:
*Policies and procedures were in place to prevent and monitor for diversion (theft) of controlled substances from one of one pharmaceutical service.
*Scheduled II medications were properly monitored, accounted for, and disposed of in one of one pharmacy, one of one obstetric unit, one of one intensive care unit (ICU), one of one medical/surgical unit, and one of one outpatient surgery area.
*The control and accountability of physician ordered diazepam for alcohol withdrawal symptoms for one of one sampled patient (5).
Findings include:

1. Interview, observation, and record review on 4/23/14 from 12:20 p.m. through 1:15 p.m. in the pharmacy with the former director of pharmacy revealed:
*Pharmacists would give the keys to the schedule II controlled substances cabinets to the pharmacy technicians to remove medications unsupervised. The running counts for those medications were not countersigned with a pharmacist once removed by the pharmacy technician to ensure accuracy of the amount removed and to prevent diversion. The above finding was confirmed by reviewing the scheduled medications log book during the observation.
*A small clear tackle box with masking tape around it was on the pharmacy desk with no staff directly responsible for it. Multiple controlled substances including Fentanyl, and morphine were in it when it was opened. When asked what that was for she stated those went to the procedure room for use by the anesthesia providers. An additional box containing the same medications and wrapped with masking tape was found in the intravenous storage area in a rolling cart with other supplies. When asked why that box of controlled substances was sitting out unattended this surveyor was told the pharmacy technician must be getting ready to transport it. The pharmacy technician was not in the room at the time of this finding.
*No tagging/identification process was in place for the above mentioned anesthesia tackle boxes to ensure medication safety and prevent diversion.
*The provider had no pharmaceutical policies or procedures related to diversion.
*The provider had no policies or procedures related to pharmacy technician access to controlled substances (specifically to schedule II medications).
*The provider had not been running house-wide reports from its electronic dispensing system to help detect diversion until 4/22/14.

Surveyor:
2. Observation on 4/23/14 at 1:50 p.m. with registered nurse (RN) G during (intravenous [given through a vein]) IV administration of Dilaudid (an opiate analgesic medication [meds] used for severe pain) for patient 5 revealed:
*She removed a Dilaudid 2 milligram (mg)/1 milliliter (ml) vial.
*She then:
-Drew up 1 mg (0.5 ml) of the IV med Dilaudid in the syringe.
-Administered the med to the patient.
-Drew up the remaining med in the vial with a syringe.
-Disposed of the med filled syringe in the sharps container.
*The disposal of the controlled medication was not secure.

3. Observation, interview, and record review on 4/23/14 at 1:51 p.m. with the director of surgical services and the former director of pharmacy Q in the nurses station of the obstetrics unit revealed:
*An opened single-use bottle of the schedule II medication hydromorphone was found in a clear plastic drawer in a single locked cabinet. No documentation or patient information was attached to that bottle. When questioned as to why that bottle was in the cabinet unidentified nursing staff were unable to give an answer. Upon record review with the director of surgical services it was found the medication was brought up from surgery with a patient. It was then found the nurse from a prior shift had accepted it and stored it in the area found.
*They both agreed proper monitoring, storage, and disposal of a scheduled II medication had not occurred in the above noted instance.

4. Observation, interview, and record review on 4/23/14 at 2:40 p.m. with the director of surgical services and the former director of pharmacy Q in the nurses station of the intensive care unit revealed:
*The home prescription bottle of patient 24 was found behind a punch key lock. That medication was D-amphetamine salt a schedule II medication. No documentation as to the verification of the bottles contents by pharmacy was with that medication nor was any evidence of a count of that medication present. Furthermore the bottle had not been sealed in a tamper proof package to prevent diversion of the medication.
*The patient the above medication belonged to had been discharged on [DATE].
*The unidentified nurses on duty that day were not aware of the proper procedures for home medication disposition.
*They both agreed proper monitoring, storage, and disposal of a scheduled II medication had not occurred in the above instance.

Surveyor:
5. Observation on 4/23/14 at 2:15 p.m. with RN H during IV administration of Dilaudid for patient 2 revealed:
*She removed a Dilaudid 2 mg/1 ml vial.
*She then:
-Drew up 0.4 mg (0.2 ml) of the IV med Dilaudid in the syringe.
-Administered the med to the patient.
-Drew up the remaining med in the vial with a syringe and disposed the med filled syringe in the sharps container.

Interview following the above observation with RN A revealed:
*All unused controlled IV medications were disposed of in the sharps containers after verification of the left over amount of the med.
*The maintenance men would come to the floor daily and dispose of the sharps containers.

6. Observation and interview on 4/24/14 at 8:05 a.m. with RN A and RN B of patient 5's medication drawer revealed:
*There were three injectable syringes of diazepam (a medication used for sedation or withdrawal symptoms) 10 mg/2 ml placed in a plastic bag.
*The plastic bag had the patient's name and the amount of the diazepam in it.
*RN A was unsure how staff ensured the diazepam was accounted for, because it was not counted or taken out of the Omnicell.
*The medication had been brought to the medical surgical floor by the pharmacy.
*During the interview RN A had called the pharmacy. The pharmacy stated to her they would have been able to track the diazepam within twenty-four hours if the medication had gone missing.

Review of patient 5's medical record revealed the diazepam had been ordered for possible withdrawal symptoms from alcohol abuse.

Interview on 4/24/14 at 8:10 a.m. with the supervisor of facility services C regarding the disposal of controlled substances revealed:
*The maintenance men would go the floors of the hospital and remove the filled sharps containers daily.
*They would take the sharps containers to the locked maintenance area and place the sharps containers in unsecured large drums.
*The drums would be picked up every two weeks for destruction.
*There were thirteen keys to the locked area for all the employed maintenance men.
*He had taken his keys home a few times.
*He agreed the security of the unused controlled substances in those sharps containers could not be guaranteed.

Interview on 4/24/14 at 8:25 a.m. with RN A and B regarding the unused portions of controlled substances revealed they both agreed the unused portion of those controlled substances were not secured.

Interview on 4/24/14 at 11:20 a.m. with the vice president of patient care regarding the security of unused controlled substances revealed:
*There should have been a procedure in place to secure and prevent the diversion of the unused portions of the controlled substances.
*She agreed those sharps containers that contained unused controlled substances were not secure from diversion.

7. Interview and policy review on 4/24/12 at 11:30 a.m. with the delegate for the vice president of pharmacy services regarding findings 1 through 4 revealed:
*Pharmacy diversion policies and procedures were not in place.
*He agreed the findings demonstrated lack of proper monitoring, accounting for, and disposing of schedule II medications.

8. Observation, interview, and record review on 4/24/14 at 1:51 p.m. with the director of surgical services in the detached outpatient surgical areas revealed:
*Scheduled medications for those areas were not ordered by the pharmacy at the hospital. Those medications were ordered by the clinic pharmacist who was currently out on vacation.
-Review of his processes for scheduled medications were not available to this surveyor at the time of survey.
*The anesthesia work room had a large double-locked cabinet where they stored large supplies of schedule II medications. Anesthesia staff would dispense those medications to themselves for the day and fill out log sheets. According to an unidentified nurse anesthetist audits of the use of those medications by the provider were not completed.
*She was not aware of scheduled medication use audits being performed for the anesthesia providers at the detached outpatient surgical area.

9. Interview on 4/24/14 at 3:45 p.m. with the chief of anesthesia regarding the anesthesia tackle boxes and storage/use of narcotics at the detached outpatient surgical area revealed:
*She was not fully familiar with the detached outpatient surgical areas scheduled medication storage, ordering, and use.
*She was not aware of any current pharmacy processes in place to audit the anesthesia department use of schedule II medications.
*She agreed the anesthesia department was a high risk area for diversion of scheduled medications.

Review of the provider's revised May 2010 Controlled Substance policy revealed:
*"All controlled drugs used throughout the healthcare center are under the direct control of the Pharmacy Department."
*Schedule II medications were to be stored in the "Omnicell" on the nursing units.

C. Based on observation, interview, job description review, and policy review, the provider failed to ensure:
*The on-the-job training of three for three unidentified pharmacy technicians mixing chemotherapy had been documented.
*Competencies were created to ensure the proper training of three of three unidentified pharmacy technicians mixing chemotherapy.
*Policies and procedures were developed for the roles and responsibilities of the pharmacy technicians preparing chemotherapy.
Findings include:

1. Observation and interview on 4/23/14 at 12:45 p.m. in the chemotherapy mixing area with the former director of pharmacy Q revealed:
*A unidentified pharmacy technician was mixing chemotherapy.
*All the pharmacy technicians had received on-the-job training for the mixing of chemotherapy. When asked if that training had been documented she stated she was uncertain.
*She agreed mixing chemotherapy was not a base skill for pharmacy technicians.
*She agreed annual competencies for chemotherapy mixing should have been in place to ensure the technicians knowledge.

Interview, record review, job description review, and policy review on 4/24/14 at 10:30 a.m. with the delegate for the vice president of pharmacy services revealed:
*No annual competencies for mixing chemotherapy were in place.
*They had no records of the on-the-job training for the three unidentified pharmacy technicians related to chemotherapy mixing.
*The job description of the pharmacy technician had not covered the mixing of chemotherapy.
*The provider's policies related to the mixing of chemotherapy did not include the use of the pharmacy technician in that process.
*He agreed mixing chemotherapy was not a base skill for pharmacy technicians.

D. Based on observation, interview, and policy review, the provider failed to:
*Monitor and document the temperature of one of one pharmacy.
*Ensure medications in three of four patient care units (medical/surgical, obstetrics, and outpatient surgery) were properly labeled with an expiration date, stored according to manufacturers' recommendations, and disposed of according to manufacturers' recommendations.
Findings include:

1. Observation and interview on 4/23/14 at 1:35 p.m. in the pharmacy with the former director of pharmacy Q revealed:
*Multiple temperature sensitive medications (according to the manufacturers' labels) were on the shelves of the pharmacy. When asked if she monitored the temperature of the pharmacy she stated she never had.
*The provider had no policy for the monitoring and documenting of the pharmacy's temperature.

2. Observation and interview on 4/23/14 at 1:51 p.m. with of the director of surgical services and the former director of pharmacy in the nurses' station of the obstetrics unit revealed:
*The freezer contained Cervidil vaginal inserts. Those inserts were to be stored at minus 4 degrees Fahrenheit (F) to 14 degrees F. No monitoring of the temperature of that freezer had ever been done.
*A opened multi-dose vial of Labetalol that had been opened on 2/8/14 was still available for patient use.
*A opened single-use vial of Terbutaline was available for patient use.
*They both confirmed the Terbutaline and the Labetalol noted above should have been disposed of.
*They both confirmed the freezer temperature should had been monitored and documented as a temperature sensitive medication was being stored in it.

3. Observation and interview on 4/23/14 at 2:55 p.m. with the director of surgical services and the former director of pharmacy on the medical/surgical unit revealed:
*The medication storage bins for rooms 4528 and 4522 contained Levemir and Novolog insulin pens.
*None of the above pens were labeled with an expiration date.
*They both confirmed the pens should had been labeled with an expiration date.

Surveyor:
4. Observation on 4/24/14 at 8:00 a.m. in the medical/surgical floor patient medication drawers revealed:
*Patient 3 had a Novolog insulin pen and a Levemir insulin pen with no expiration date noted on the pens.
*Patient 25 had a Levemir insulin pen with no expiration date noted on the pen.
*Patient 4 had an Advair diskus 250/50 mg inhaler that had no expiration date noted on the disk.

Interview during the above observations with RN A and RN B revealed those medications should have had an expiration date to follow manufacturer's recommendations.

5. Observation on 4/24/14 at 9:30 a.m. with the director of surgical services in operating room 1 of the detached outpatient surgical area revealed the anesthesia cart contained the following:
*A pre-drawn syringe of succinylcholine. That syringe did not have the date it was drawn-up, who drew it up, or the concentration of the medication.
*A partially used multi-dose bottle of glycopyrrolate without an expiration date.

6. Interview and policy review on 4/24/14 at 11:15 a.m. with the delegate for the vice president of pharmacy services regarding findings 1-5 revealed:
*The providers revised April 2014 Intravenous Admixtures/Solutions policy had not been followed regarding proper use/labeling of single and multi-dose vials of intravenous medications.
*Medications were not properly labeled with expiration dates.
*Medications had not been disposed of properly and made not available for patient use.
*Temperatures had not been properly monitored in the pharmacy or the obstetric freezer.

Surveyor:
Review of the provider's July 2013 Administration of Medications policy revealed the expiration dates should have been verified.

Upon request for a patient insulin and inhaler expiration dating policy from the vice president of patient care and RN A there were no policies provided.

Surveyor:
7. Observation on 4/23/14 at 12:15 p.m. revealed one of two Omni-Cell medication storage units on the medical/surgical floor contained expired medications. Those medications included:
*One of four tablets of metoclopramide 10 mg had expired on [DATE].
*Five of eight tables of olanzapine 5 mg had expired on [DATE].
*Six of six tables of pramipexole 0.125 had been repackaged on 12/3/12 and had the expiration date of 5/31/14 on the package.

Interview at the above time with pharmacist N revealed:
*The OmniCells were spot checked on a daily basis by the pharmacy technicians when they refilled medications.
*A full inventory was done every two months to check for outdated medications.
*When a medication was placed in the OmniCell the last expiration date was entered in, not the first expiration date of a medication.
*The last full inventory of the OmniCells had been completed the end of February 2014.





E. Based on record review and interview, the provider failed to ensure there was adequate availability of proper authentication of physician medication administration documentation for two of two patients (12 and 14) who received intravenous (IV) Ketamine (general anesthetic). Findings include:

1. Review of patient 12's 4/4/14 emergency department (ED) notes and the electronic medication administration record (MAR) revealed:
*He had received Ketamine 500 milligrams (mg) on 4/4/14.
*There was no documentation on the electronic MAR that indicated who had given that medication.
*The electronic MAR only indicated in red print "Confirm Administered Dose."
*The ED note by registered nurse (RN) L indicated "Pt. (patient) given Ketamine 20 mg IV."

Interview on 4/24/14 at 2:30 p.m. with RN A revealed:
*The physicians did not have access to document on the electronic MAR.
*She agreed the electronic MAR had not been signed.
*She agreed the physician had not signed the order.

2. Review of patient 14's electronic MAR revealed he had received Ketamine 125 mg intramuscularly on 3/27/14 at 10:36 p.m. The electronic MAR had been signed by RN M at that time.

Interview on 4/24/14 at 3:00 p.m. with the vice president of patient care/chief nursing officer revealed:
*The nurses who had taken the order and had retrieved the medication signed the electronic MAR.
*The physicians did not have access within the electronic medical record to document medications they had given.
*She agreed it appeared the RNs had administered a general anesthetic medication.

F. Based on record review and interview, the provider failed to ensure one of one certified registered nurse anesthetist (CRNA) student (O) had received the correct electronic medical record credentials. Findings include:

1. Review of patient 5's electronic medical record revealed RN P had retrieved Ketamine for use during a surgical procedure.

Interview on 4/24/14 at 11:30 a.m. with the director of operative services revealed:
*CRNA student O had been given electronic medical record and electronic medication administration access on 4/13/14 by a former hospital pharmacist.
*He had given her the same access as RN P, as they both had the same first initial and the same last name.
*RN P was an RN at another hospital within the corporations ownership.
*RN P was no longer employed at that other hospital.
*She agreed the proper paperwork had not been completed for CRNA student O's medical record access.
VIOLATION: INFECTION CONTROL Tag No: A0747
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, record review, and policy review, the provider failed to ensure:
*One of one sampled patient (2) with a possible multi-drug resistant organism on admission had been placed on isolation precautions pending laboratory (lab) results.
*One of one sampled patient (6) on contact isolation for a contagious infection had the appropriate linen and garbage removal to prevent further transmission of the infection.
Findings include:

1. Observation and record review on 4/24/14 at 8:00 a.m. of patient 2 with registered nurse (RN) A and RN B revealed:
*The patient had been admitted on [DATE].
*A nasal (nose) swab had been done on 4/22/14 to rule out methicillin resistance staphylococcus aureus (MRSA [a contagious infection]).
*There were no contact or respiratory isolation precautions noted on the patient's door to alert staff or visitors of the possible contagious infection.
*There was no isolation cart outside the patient's room.

Interview with RN A and RN B immediately following the above record review and observation of patient 2 revealed there should have been isolation precautions. Those precautions should have been implemented until the laboratory results were completed.

2. Observation on 4/24/14 at 8:30 a.m. with RNs A, B, and D during a morning medication pass for patient 6 revealed:
*There was a contact isolation sign on the door to the patient's room.
*There was a contact isolation cart outside the door.
*There were no red isolation bags noted in patient 6's room for the disposal of soiled linen or the contaminated garbage.
*There were disposable undergarments (pull-ups) that were visibly soiled with stool in the patient's garbage in the bathroom. Those pull-ups had been disposed of in a regular black garbage bag.

Interview immediately following the above observation with RN A and RN B revealed there should have been isolation containers in patient 6's room for the appropriate disposal of contaminated linen and garbage.

Review of patient 6's medical record revealed:
*She had been admitted on [DATE] with watery diarrhea stools.
*The physician had ordered clostridium difficile ([DIAGNOSES REDACTED]) testing done on her stools, and the test was positive on 4/22/14.

Interview on 4/24/14 at 8:45 a.m. with housekeeper E regarding patient 6 revealed:
*The soiled garbage was in a black garbage liner.
*She would collect the garbage and place it in the regular garbage bin in the soiled utility room.
*She had not been instructed on any special disposal of the contaminated garbage.

Interview on 4/24/14 at 9:05 a.m. with director of linen services F regarding patient 6's infectious linen revealed:
*A red bag would indicate the laundry was contaminated and would require a special procedure.
*She was not aware of any isolation procedures for patient 6.
*There had been no red bags delivered to the laundry area.

Interview on 4/24/14 at 9:15 a.m. with RN D regarding patient 6's infectious linen and garbage revealed:
*She transported the soiled laundry in a regular black garbage liner to the soiled utility room. The bag was placed in the linen bin.
*The soiled garbage was in a regular black garbage liner.
*She agreed the linen and garbage for patient 6 should have been placed in special isolation bags.

3. Interview on 4/24/14 at 11:20 a.m. with the vice president of patient care regarding the above observations, record reviews, and interviews revealed:
*The current infection control nurse had not come to work today, and she was uncertain regarding her return.
*Patient 2 should have been placed on isolation until the results of the MRSA lab test results were completed.
*The staff should have been aware of the [DIAGNOSES REDACTED] policy and procedures for patient 6.
*The linen and garbage should have been placed in specialized containers that would have alerted staff to use special care of the infectious linen and contaminated garbage for patient 6.
*There should have been communication between all the departments in the hospital regarding the appropriate procedures to have been followed for disposal of infectious linens and garbage.

Review of the provider's March 2014 MRSA Screening policy revealed the purpose of the policy was to "Establish guidelines to prevent disease transmission by timely identification of MRSA, ensure appropriate patient placement, and timely initiation/discontinuation of transmission based precautions. Screening patients on admission for the presence of MRSA allow early placement in isolation and demonstration that the patient was admitted with the organism."

Review of the provider's March 2014 [DIAGNOSES REDACTED] policy and procedure revealed:
*The purpose of the policy was to have clarified responsibility for specimen results and precautions related to [DIAGNOSES REDACTED].
*When a stool sample for [DIAGNOSES REDACTED] was ordered it was the nurses' responsibility to note the results of the specimen and institute contact precautions. The results were available about an hour after it was taken to the lab.
*Environmental services should have been notified when a patient was diagnosed with [DIAGNOSES REDACTED]
*Precautions should have been maintained for the duration of the illness.

Review of the provider's November 2013 Linen Services Department Infection Control policy revealed:
*Isolation linens were washed separately.
*Isolation linens were placed directly into the washer to avoid handling by laundry personnel.

Review of the provider's May 2011 Isolation Procedure policy revealed trash was bagged, tied, and removed to the appropriate disposal area by nursing personnel. Trash from known or suspected cases that presented an obvious infection hazard would be bagged by nursing personnel using a red plastic liner on the outside. Those bags would then be removed by plant operations staff.