HospitalInspections.org

Based on observation, interview, medical record review, job description review, and policy review, the provider failed to ensure the regional pharmacy department:
*Had documentation to support ongoing monitoring, security, and handling of medications by unauthorized staff was approved by the Advisory Board.
*Had ensured only authorized staff had access to:
-All meds in one of one medication room.
-The meds in two of two Omnicell medication dispensing machines located in the medication room and emergency department.
-The meds in three of three emergency crash carts.
*Was involved with the quality assurance performance improvement (QAPI) committee to ensure all matters pertaining to the use of medications and pharmacy operations was reviewed and evaluated on a routine basis.
*Had completed monthly reviews for swing bed patient's meds who had a 30 day or greater hospital stay.
*Was knowledgeable of and involved with the internal medication processes for three of three emergency crash carts.
*Provided education for the licensed professional staff on the proper process and policy for medication destruction.
Findings include:

1. Interview on 9/13/22 at 3:00 p.m. with regional pharmacist director K revealed:
*He was the regional pharmacist for the Monument Health system, which had included this facility.
*They had struggled to get pharmacy assistance for this facility and was working on the possibility of Telepharmacy for them.
-Monument Health Spearfish pharmacy was available and had pharmacy oversight of the facility from 7:00 a.m. through 7:00 p.m.
-Monument Health Rapid City pharmacy was available and had pharmacy oversight of the facility from 7:00 p.m. through 7:00 a.m.
*There was a pharmacy technician that came to the facility once a month to check and go through the facility's two Omnicell medication units.
*The facility assigned a nurse to have oversight of all medication related processes in the facility when there was no pharmacy technician available.
-He was unsure which nurse was assigned that responsibility or the extent of that nurse's oversight of the medication process. It was the facility's responsibility to determine that.
-He had not mentioned the duties and responsibilities that were assigned to nurse aide (NA) F or her involvement with refilling, monitoring outdates, and restocking the crash cart meds.
*There was no pharmacy staff working in the facility for him to have completed performance and competency evaluations on.
*He was not involved with the facilities process for use of medications outside of the Omnicells.
*There were three crash carts in the emergency department that contained medication for emergency use.
-The retail pharmacy delivered those meds in secured totes.
*He stated: "They have assigned a nurse to oversee and handle the meds here."
*They had a detailed process for monitoring drug activities in both Omnicells.
*Pharmacy was represented at the medical executive committee (MEC) meeting.
-Antibiotic stewardship and the pharmacy and therapeutics meetings would have been reviewed at that time.
-The QAPI meeting was scheduled at the same time as the MEC meeting.
-He offered no further comment on the level of involvement he had with the QAPI committee.

Observation and interview on 9/13/22 at 3:30 p.m. of the emergency crash carts, med room, and Omnicells with regional pharmacist director K revealed:
*All three crash carts:
-Were located within the emergency department.
-Contained medication trays that could be used in emergency situations.
-Those meds had the potential for creating a negative outcome if they were used inappropriately.
*Those meds included:
-Dopamine (used for blood pressure support).
-Epinephrine (treated serious allergic reactions and low blood pressure).
-Atropine (increased heart rate, reduced saliva production, and controlled effects from poisoning).
-Naloxone (reversed the effects of an opioid overdose).
-Amiodarone (treated life-threatening heart rhythms).
-Norepinephrine (raised blood pressure in patients with severe, acute hypotension).
*All three med trays had been covered with clear, plastic lids that were secured with a pull-away numbered tab.
*Underneath those lids was a form that listed the meds inside that tray and their expiration dates.
-There was a place at the bottom of that form for the pharmacy technician to sign to verify the contents of that tray and a nurse to sign to verify the accuracy of the technician's information.
-All three forms had been signed by a pharmacy technician with the initials of "TP" on them.
-One of those forms had not been co-signed by a nurse.
*The pharmacist was not knowledgeable on the process for restocking the trays once they had been opened.

Interview on 9/14/22 at 12:50 p.m. with registered nurse (RN) H regarding the interview and observations with regional pharmacist director K revealed:
*She stated:
-"Can we get [name of NA F] in with us as she is our pharmacy tech [pharmacy technician]?"
-"She takes care of those trays after they are opened and with any outdates."
-"We don't have a pharmacist here on a regular basis."

Interview on 9/14/22 at 1:00 p.m. with RN H and NA F revealed:
*NA F had been trained by a pharmacy technician at the Rapid City hospital location on the process for:
-Checking for expired meds and restocking the Omnicells with meds that came in from the retail pharmacy.
-Checking for expired meds and restocking the emergency med trays with meds.
-Duties of a pharmacy technician.
*A charge nurse was to check behind her after restocking the emergency med trays.
*She:
-Had not been aware no one had checked behind her on one of those trays.
-Would have opened the crash carts and checked the trays for outdates every seven days.
*Her official job title was nursing assistant.
*They had been informed that with her training at the Rapid City hospital location, she had been considered the pharmacy technician for this facility.
*RN H stated:
-"We really don't have any pharmacy oversight here and I agree we should."
-"The pharmacists are our gate keepers."

2. Observation on 9/14/22 at 9:12 a.m. with licensed practical nurse (LPN) G with patient 6 revealed:
*Patient 6 had been on contact isolation for a highly infectious disease in her urine.
*Staff and visitors had been required to wear a gown and gloves when assisting and visiting.
*Anything taken out of the room should have been disinfected or disposed of in the garbage.
*The nurse had prepared to administer the patient her meds for the morning.
-One of those meds had required splitting in half to ensure the proper dose was administered.
*She:
-Was not sure what to do with the other half of the med.
-Had thought of putting it in the Sharps container but was not sure if she could.
-Did not know the provider's policy and process for med destruction.
-Agreed she should have known.

Interview on 9/14/22 at 10:15 a.m. with RN D regarding the process and policy for med destruction revealed she was not sure what that policy was. She stated: "I usually destroy all of mine before I go into the room." "We have a special container for meds." "But I don't know for sure what the policy is." She agreed she should have known.

Interview on 9/14/22 at 1:20 p.m. with RN H regarding the above observation and interviews with LPN G and RN D revealed she:
*Had not been aware the licensed staff did not know the process and policy on med destruction.
*Agreed they should have been educated on that process upon hire.
*Stated: "[RN D's name] told me what happened, and we found the policy for all of them to read."

Interview on 9/15/22 at 2:00 p.m. with director of nursing (DON) I and President Custer Market J regarding the above observations and interviews revealed:
*They had been aware that NA F was considered the pharmacy technician for the facility.
-They confirmed her official job title was NA and not pharmaceutical technician.
*She had been assigned this task after they were having issues with the timeliness of meds being put away after delivery.
-The meds would sit for days before anyone would take care of them. That had included controlled substances.
*She had gone through training with a pharmacy tech at the regional hospital and everyone thought that had been sufficient.
*They confirmed:
-A pharmacy technician had to go to school for approximately three years to earn that title.
-A NA was not considered an authorized staff to handle and manage the medication processes for the facility.
-A charge nurse was expected to quality check NA F's work when she handled the emergency med trays.
*They:
-Were not aware the licensed staff did not know the proper process for med destruction and should have.
-Confirmed the pharmacy availability and process with Monument Health Spearfish and Monument Health Rapid City.
-Agreed outside of electronically reviewing the Omnicells by the pharmacists at the regional hospital, there was no oversight and direction offered by a pharmacist that was specific to their facility.

3. Review of patient 6's medical record revealed:
*She had been admitted on 7/22/22 to acute care for a stroke.
-On 7/28/22 she was transitioned out of acute care and admitted to swing bed services.
*On 9/14/22 she was still an inpatient in the facility and receiving swing bed services.
-That had been 49 days since her admission on 7/28/22.
*There was no documentation to support a pharmacist had completed a monthly review of her medications per CMS guidance and their policy.

Interview on 9/14/22 at 3:30 p.m. with RN O and RN P regarding pharmacy med reviews revealed:
*They were unaware of any med reviews completed by the pharmacists.
*They had never seen a note from the pharmacists on new admissions or with long-term stays.
*The Monument Spearfish pharmacy was who they would consult with.
-That pharmacy was their contact and resource from 7:00 a.m. through 7:00 p.m.
-They were more knowledgeable on their policies and processes for pharmacy concerns.

Interview on 9/14/22 at 3:40 p.m. with pharmacist N regarding patient 6's medical record review revealed he:
*Confirmed he was the pharmacist at the Monument Health Spearfish facility and had oversight of the facility during daytime hours.
*Was not aware that swing bed patient's meds required a monthly review from a pharmacist with a 30 day stay or greater.
*Stated:
-"I've been doing this for 10 years and have never completed a chart review every month on a 30 day stay or longer."
-"I do not do a review on the patient's meds; the nurse's are responsible for doing that."
-"We have never gotten a med review notification ever."
-"We do orders, confirm meds with nurses, but Rapid City has oversight of them, we do not."
-"Do you know how much work that would be for all the facilities I'm involved with?"
-"We have been trying to get a pharmacist there or at least a technician for some time now."
*Agreed the nurses have knowledge on meds, but do not have the pharmacy education to complete med reviews like they do.

Interview on 9/15/22 at 2:20 p.m. with the DON I and President Custer Market J regarding monthly med reviews by the pharmacists revealed they were aware of the process and requirements for stays longer than 30 days. They were not aware the process had not been completed by a pharmacist. They agreed it should have been completed.

4. Review of the QAPI meeting minutes from 2/24/22 through 8/25/22 revealed no documentation to support the pharmacy department had attended the meetings and presented on any identified concerns, pharmacy and therapuetics meetings, antibiotic stewardship program, med errors, and near misses.

Interview on 9/15/22 at 2:35 p.m. with Custer Market President J and director of quality L revealed:
*The oversight pharmacist was in another facility.
*Staff were expected to contact other affiliated facilities in nearby communities with their pharmacy needs.
-The Monument Health Spearfish hospital pharmacist was available to staff from 7:00 a.m. through 7:00 p.m.
-The Monument Health Rapid City hospital pharmacist was available to staff from 7:00 p.m. through 7:00 a.m.
*They confirmed the pharmacy department had not:
-Been active members of the meetings and committee and should have been.
-Represented and did not participate in the QAPI meetings per CMS regulations and provider policy.
-Reviewed been reviewed to ensure compliance was maintained.
*To their knowledge no interventions, processes, or goals had been put in place for the pharmacy department to work on and achieve.
*The regional pharmacist had attended medical executive committee meetings, but not QAPI.
-The information and concerns addressed at those meetings were not brought forward for review at the quality meetings and should have been.
*Medication error information was provided at the Safety and Risk Connect meeting.
-Only the number of medication errors that had occurred was discussed.
-No specific information regarding med errors were discussed such as:
--What occurred, how it was investigated, and the root cause analysis from those investigations.
--Any adverse patient events that required tracking, analysis, or any preventative measures that had been implemented.
--"Near miss" med errors and Omnicell med errors had not been discussed.
*Antimicrobial stewardship was discussed in MEC but not reviewed in QAPI and should have been.
*The pharmacy and therapeutics committee meetings had not been reviewed in QAPI and should have been.

Review of the advisory board meeting minutes from 6/17/21 through 7/13/22 revealed no documentation to support ongoing monitoring, security, and handling of medications by an unauthorized staff [NA F] was approved by their committee.

Review of the Director of Pharmacy's 1/6/22 Job Description revealed:
*"The Director of Pharmacy is responsible and accountable to ensure that the Department Goals and Objectives are aligned with the corporate objectives and strategic plan."
*"The Department manager is responsible and accountable to ensure that action plans are set in place to reach goals the organization should successfully attain for its strategy to succeed."
*No documentation to support his role and responsibility with:
-Other provider's within their region.
-Oversight responsibilities to ensure all meds have a policy and process in place for the monitoring, security, and safe handling of all meds for each provider within their region.
-Ensuring only authorized staff had access and control of meds within their facility.
-Education and training for pharmacy processes and policies for each provider within their region.
-His role and participation requirements with and for the QAPI committee.

Review of the provider's 7/19/22 Certified Pharmacy Technician job description revealed:
*They must be:
-Registered with the South Dakota Board of Pharmacy.
-Certified as a Pharmacy technician.
*Required experience:
-One plus years of healthcare experience.
-One plus years of Pharmaceutical experience.
-One plus years of Retail experience.

Review of the provider's September 2021 Drug Security and Storage policy for Monument Health System - Wide revealed:
*"The Pharmacy Department is in charge of drug security and storage at Monument Health and monitors in accordance with Federal, State, and Institutional guidelines to prevent theft and/or unauthorized personnel from access to drug storage areas."
*"Only authorized personnel will have access to drug storage areas, machines, cabinets or carts.
-Authorized personnel includes staff members providing care and services to patients including, but not limited to, medical staff, anesthesia, surgical staff, nursing, pharmacy, respiratory therapy, paramedics and ancillary support personnel as necessary to perform their assigned duties."
*"All medications will be stored securely to prevent unauthorized access."

Review of the provider's May 2022 Pharmaceutical Waste policy for Monument Health System - Wide revealed:
*C. "Regular Pharmaceutical Waste:
-Any Pharmaceutical waste that is not specified as "Chemotherapy" and cannot be disposed of as "Regular waste" is placed in a Black pharmaceutical waste container.
-Prior to pick-up the hazardous waste hauler this waste is placed in the pharmaceutical waste storage room.
-Exampled of regular pharmaceutical waste include partial vials, tablets, partial IV [intravenous] solutions, and syringes.
-For loose tables or capsules, place in BLACK pharmaceutical waste container."

Review of the provider's August 2017 Swing Bed: Monthly Drug Therapy Review policy for Monument Health System - Wide revealed:
*"Perform a drug regimen review for swing bed patients on a monthly basis."
*"The pharmacist will review all medication orders upon admission and all those thereafter and all orders at least monthly."

Based on observation, interview, and policy review, the provider failed to ensure one of two sampled patients (6) was provided privacy during personal care by one of one nurse aide (NA) (B) and one of one registered nurse (RN) (D). Findings include:

1. Observation on 9/13/22 at 11:25 a.m. of NA B and RN D with patient 6 in her room revealed:
*The patient had to use the bathroom and requested to use the bedside commode (BSC).
*RN D moved the BSC in front of the window.
-The blinds on that window were open and visible to the visitor parking lot, main entrance into the facility, and the healing garden.
-Outside the window an unidentified staff member was observed seated at a table eating her lunch in the healing garden.
*RN D and NA B assisted the patient to stand-up, pull down her pants and incontinent brief, and sit down on the BSC.
-The patient was facing the window during the entire process.
*Staff left the room so the patient could use the BSC in private.
*Upon staffs return, the door was opened, and the patient was seen sitting on the BSC by anyone passing by her room.
*NA B and RN D had not closed:
-The window blinds for privacy from the staff and visitors.
-The privacy curtain in front of the room door to ensure no staff and visitors could see her when it was opened.
*When staff assisted the patient up from the BSC to provide personal care they had not:
-Shut the window blinds to ensure privacy away from staff and visitors who had been in the visitor parking lot, entering the facility, or in the healing garden.

Interview on 9/13/22 at 12:00 noon with NA B regarding the observation above revealed:
*She stated:
-"I thought you couldn't see in the window from the outside."
-"But yes, we should've shut the blinds and closed the privacy curtain."

Interview on 9/14/22 at 1:30 p.m. with RN/Nurse Manager H revealed:
*Anyone from the outdoors looking into resident 6's room would have seen her using the BSC.
*The window blinds and privacy curtain should have been closed to ensure privacy had occurred.

The provider had no policy for patient privacy while receiving care and assistance from staff.

Based on observation, interview, and policy review, the provider failed to ensure infection control practices were maintained for:
*Hand hygiene and glove use by two of three nurse aides (NA) (A and C) and one of one registered nurse (RN) (D) while assisting three of three sampled patients (3, 4, and 6) with personal care.
*Appropriate mask use by two of two RNs (E and M) while assisting one of one sampled patient (4) with personal care.
*Proper handling and transporting of contaminated trash and linens in the swing bed and acute care unit by two of two NAs (B and C).
*A safe and hygienic process for transporting contaminated trash and linens to the emergency room (ER) soiled utility room.
*Safe and hygienic disposal by of clinical and bodily wastes by all staff using two of two hoppers (flushing rimmed sinks for cleaning and disposal of biohazardous wastes) in two of two soiled utility rooms (ER and swing bed/acute care).
Findings include:

1. a. Observation on 9/13/22 at 10:40 a.m. with NAs A and B with patient 3 revealed:
*They had prepared to assist the patient with personal care and repositioning.
*The patient was:
-On end of life care, unresponsive, and unable to make bodily movements on her own.
-Dependent upon the staff to complete all activities of daily living for her.
-Laying in her bed sleeping.
-Using a Foley catheter to assist her bladder with draining of urine.
*They sanitized their hands upon entering the room and prior to putting on clean gloves.
*With those clean gloves on NA A:
-Moved the trash can closer to the bedside.
-Gathered the necessary supplies to cleanse her peritoneal area and change her incontinent brief.
-Those supplies had been a package of wet wipes, bottle of peritoneal wash, and an incontinent brief.
-Opened drawers and cupboard doors to get the above necessary supplies.
-Touched the bed remote and raised the bed to better assist her.
-Pulled down her covers and assisted NA B with removing her soiled incontinent brief.
-Removed a wet wipe from the package and sprayed peritoneal wash on it.
*With those same soiled gloves NA A:
-Cleansed the patient's front peritoneal area with the wet wipes.
-Took another wet wipe and cleansed the Foley catheter tubing with it.
-Continued to wear those soiled gloves and assisted NA B with rolling the patient onto her left side.
*The patient had been incontinent of bowel movement (BM).
*NA A continued to wear the same soiled gloves, used a wet wipe, and removed the BM from her bottom.
*Without changing her gloves and sanitizing her hands she had assisted NA B with:
-Putting an incontinent brief on the patient and repositioned her onto her right side.
-Placing pillows behind her back and legs for support.
*Prior to leaving the room, they removed their gloves and sanitized their hands.
*NA A was not observed changing her gloves and sanitizing her hands during the entire process above.

b. Observation on 9/13/22 at 11:25 a.m. of NA B and RN D with patient 6 revealed:
*They:
-Prepared to assist the patient with personal care and a transfer from the bedside commode (BSC) to her chair.
-Sanitized their hands upon entering the room and prior to putting on clean gloves.
*With those clean gloves RN D opened drawers and cupboard doors to get a package of wet wipes, bottle of peritoneal wash, and an incontinent brief.
*With those soiled gloves RN D:
-Assisted NA B to stand the patient up with a gait belt (transferring device), removed a wet wipe for the package, sprayed peritoneal wash on the wipe, and cleaned her peritoneal area.
-Pulled up her pants and transferred her to the chair while using the gait belt.
-Put a blanket on the patient's lap and pushed the bedside table closer to her.
*Prior to leaving the room, they removed their gloves and sanitized their hands.
*RN D was not observed changing her gloves and sanitizing her hands during the entire process above.

Interview on 9/14/22 at 10:05 a.m. with NA B and RN D regarding the observations with patients 3 and 6 revealed they agreed:
*There had been missed opportunities for hand hygiene with breaches in infection control practices.
*The patients had the potential for a facility acquired infection from the processes used to assist them with personal care by the staff.

Interview on 9/14/22 at 1:45 p.m. with RN/Nurse Manager H regarding the above observations revealed:
*She agreed the staff had missed hand hygiene opportunities.
*She would have expected the staff to remove their gloves and sanitize or wash their hands:
-Between different tasks.
-When their gloves had become soiled or dirty.

c. Observation on 9/14/22 at 9:00 a.m. of NA C preparing to enter resident 4's room to assist him with care revealed she:
*Performed hand hygiene then put on eye protection, gown, and gloves.
*Used her gloved hands to remove and discard the unclean surgical mask she was wearing.
-Without changing her unclean gloves, she removed an N95 mask from a boxed dispenser, placed it over her mouth and nose, and entered the resident's room to perform cares.

Interview on 9/14/22 at 9:30 a.m. with NA C after exiting resident 4's room revealed:
*Resident 4 had COVID-19.
*NA C understood the cleanliness of her gloves had been compromised when she used them to remove her surgical mask.
-Should have discarded those gloves, performed hand hygiene then put on a clean pair of gloves before putting on the N95 mask.

2. Observation on 9/13/22 at 11:15 a.m. of RNs E and M entering resident 4's room revealed they:
*Wore personal protective equipment (PPE) that included a gown, eye protection, gloves, and masks prior to entering that room.
-Both RNs placed a surgical mask over their N95 mask prior to entering that room.

Interview on 9/13/22 at 11:40 a.m. with RNs E and M regarding the observation above revealed:
*Resident 4 had COVID-19.
*RN E stated: "that's a good question" when she was asked why she had "double masked" prior to entering that resident's room.
-"Facility policy would probably state we shouldn't double mask."
*RN M stated double masking was "a habit" she developed at the onset of COVID-19 over two years ago when PPE was scarce.
*Both RNs agreed the facility currently had an ample supply of surgical and N95 masks.
-Double masking was contra-indicated and could have compromised the fit of the N95 mask.

Interview on 9/15/22 at 2:00 p.m. with director of nursing (DON) I and RN/President Custer Market J regarding the use of PPE referred to above revealed:
*They agreed there had been missed opportunities for hand hygiene and proper glove use
*"Double masking" was not an acceptable infection control practice.
*They agreed the processes above:
-Were completed in an unsanitary manner or a manner that was not currently an acceptable standard of practice.
-Created the potential for cross contamination of bacteria which could create a hospital acquired infection for those patients.
*RN/President Custer Market J stated: "There's opportunity for improvement."

3. a. Observation and interview on 9/13/22 between 11:45 a.m. and 11:50 a.m. with NA B revealed she:
*Exited resident 6's room holding a clear garbage bag in her ungloved hands.
-Part of a blue PPE gown hung partially outside the top of that bag.
*Stated resident 6 was on contact precautions related to a history of vancomycin-resistant enterococci (VRE) in her urine.
*Knew she was expected to contain the contents of that garbage bag prior to transport and wear gloves when handling potentially hazardous garbage but had not done that.
*Transported that bag to a housekeeping storage room at the end of the hall near the nurses' station, exited that room after depositing the bag, and had not performed hand hygiene.
-Knew she needed to perform hand hygiene after handling that garbage, but there was not a handwashing station or alcohol based hand sanitizer available inside or immediately outside of that room.
*Should have used the designated soiled utility room and not the housekeeping storage room for disposal of trash and soiled linen.
b. Observation on 9/14/22 at 8:40 a.m. of NA C revealed:
*She:
-Was at the far end of the hallway and leaving room 9.
-Was coming down the hallway wearing gloves, carrying a bag of garbage, and pushing a soiled linen cart.
-Went past several patient rooms and the nurse's station.
-Continued down a short hallway to the soiled utility room.
*Inside of the room there:
-Were bins to dispose of the garbage and linens.
-Was a sink to wash your hands.
*She:
-Went inside of the soiled utility room to dispose of the garbage and soiled linens.
-Removed her soiled gloves and left the room with the soiled linen cart without washing her hands.
-Went back to room 9 and without sanitizing her hands entered the patient's room.

4. Observation and interview on 9/13/22 at 12:05 p.m. with RN E regarding the emergency room (ER) soiled utility room revealed:
*Staff walked through procedure room C to access the ER soiled utility room.
-That procedure room was used to treat overflow patients from the emergency room and for outpatient procedures.
*There was one direct point of entry into that soiled utility room.
*Inside the ER soiled utility room were two red plastic totes each containing one biohazard bag.
*RN E agreed any number of staff entered procedure room C when it was unoccupied to dispose of biohazard waste and other unclean items in the ER soiled utility room.
-That practice compromised the cleanliness of procedure room C and the patients who used that room for treatment.

5. Continued observation on 9/14/22 at 2:00 p.m. in the ER soiled utility room and swingbed and acute care soiled utility rooms revealed:
*There were hoppers in both utility rooms that were used to rinse soiled patient linens or unclean patient equipment.
*The ER soiled utility room had a box of gloves but no gown or eye protection for staff to use to protect their clothes or shield their eyes during processes that required use of that hopper.
*The swingbed and acute care utility room had a box of gloves and eye protection, but no disinfectant wipes to clean the eye protection between staff use or gowns to protect their clothes during processes that required use of that hopper.

Interview on 9/15/22 at 2:00 p.m. with RN/President Custer Market J and DON I revealed:
*They agreed the soiled utility rooms were not located in ideal areas for transport of soiled linens and garbage.
-There was potential for cross contamination to have occurred.
*Staff were expected to remove soiled gloves prior to exiting the room then sanitize their hands prior to transporting soiled linen.
*PPE should have been securely contained inside a garbage sack prior to removing it from a resident's room.
*They confirmed PPE and hand sanitizers should have been available for use by staff in both the soiled utility room and the ER soiled utility rooms.
-Had not realized there was not full PPE or hand sanitizers available for staff use in those rooms.
*RN/President Custer Market J: "There's plenty of opportunity for improvement."

Review of the revised January 2022 Hand Hygiene policy revealed:
*A. Indications for handwashing and alcohol-based hand rub use:
-"2. If your hands are not visibly soiled, use an alcohol-based hand rub for routine cleaning of hands.
-3. Clean hands before having direct contact with patients/residents."
-"6. Clean hands after contact with a patient's or resident's intact skin."
-"9. Clean hands after contact with inanimate objects in the immediate vicinity of the patient or resident."
*I. Other Aspects of Hand Hygiene:
"1. Gloves do not replace hand hygiene.
-2. Wear gloves when contact with blood or other potentially infectious materials, mucous membranes and non-intact skin could occur."
-"4. Change gloves during patient/resident care if moving from a contaminated body site to a clean body site."
Q. To remove PPE:
-"1. Remove gloves being careful not to touch the outside "contaminated" portion of the glove with an ungloved hand."
-"4. Remove mask or respirator by touching only headband or loops. Drop into waste receptacle. Wash hands."

Review of the revised October 2019 Hazardous Materials/Wastes: Receipt, Handling, Storage and Disposal of policy revealed:
*"A. Hazardous materials are broadly defined as any item, substance or mixture of substances having properties capable of producing adverse effects on the health or safety of a human being or the environment. These items include, but are not limited to, materials that are corrosive, ignitable, reactive, toxic, radioactive, sharps and infectious materials."
*"D. The above items will be treated as infectious wastes, placed in infectious waste containers (red bags) and placed in the designated area for collection."
-The policy had not addressed how those hazardous wastes were expected to be transported to mitigate breaches in infection control such as not carrying that waste through cleaned patient treatment areas.

Review of the revised March 2021 Standard Precautions policy revealed:
*N.2.b. Eye Protection:
-"1. Safety glasses, safety goggles and face shields are available for use as needed. They will be stored in areas where the need is anticipated.
-2. Eye protection is indicated if splash or spray of body fluid in the eyes is anticipated or likely to occur."
*"N.3. Gowns or aprons will be worn during procedures that are likely to generate splashes of blood or other body fluids.
-a. Gowns will be disposable long-sleeve garments or easily laundered. They are available in areas where a need is anticipated. Disposable gowns are worn once and discarded."

Based on observation, interview, policy review, job description review, and Quality Assessment and Performance Improvement (QAPI) plan review, the provider failed failed to ensure:
*The pharmacy department had:
-Monthly medication reviews were conducted for applicable swing bed patients.
-Attended QAPI meetings, identified, tracked, and reported the results of pharmacy related improvement projects.
*Facility grievances had been reviewed by the QAPI committee to ensure appropriate action and follow-up had occurred.
Findings include:

1. Nurse aide (NA) F had not received proper training, certification, or professional oversight by a pharmacist and a pharmacy technician for:
-Monitoring, handling, and restocking outdated meds in two Omnicells and three emergency room crash cart med trays.
*A monthly review by pharmacy of medications for swing bed patient's meds with a length of stay of 30 days or greater had not occurred.
*Licensed staff had not known the proper process and policy for medication destruction.

Refer to C1004.

2. Review of the 2/24/22 through 8/25/22 QAPI meeting minutes revealed:
*No documentation to support:
-The pharmacy department had attended those meetings, reported to that committee on any identified pharmacy concerns or action plans that had been put in place for any concerns.
*Grievances for the facility had not been reviewed or were discussed during those meetings.

Interview on 9/15/22 at 2:35 p.m. with President Custer Market J and director of quality L revealed:
*Staff had been expected to contact that or another affiliated facility with their pharmacy needs.
-The Monument Health Spearfish hospital pharmacist was available to staff from 7:00 a.m. through 7:00 p.m.
-The Monument Health Rapid City hospital pharmacist was available to staff from 7:00 p.m. through 7:00 a.m.
*They confirmed the pharmacy department had not:
-Been active members of meetings or participated in QAPI meetings per the Center for Medicare and Medicaid Services (CMS) regulations and provider policy.
-Reviewed to ensure compliance was maintained on any issues or concerns.
*To their knowledge no interventions, processes, or goals had been put in place by the pharmacy department to work on and achieve.
*The regional pharmacist had attended medical executive committee meetings, but not QAPI.
-Information and concerns addressed at those meetings were not brought forward for review at the quality meetings and should have been.
*Medication error information was provided at the Safety and Risk Connect meeting.
-Only the number of medication errors that had occurred during a specific timeframe was discussed.
-No specific information regarding med errors were discussed such as:
--What occurred, how it was investigated, and the root cause analysis from those investigations.
--Any adverse patient events that required tracking, analysis, or any preventative measures that had been implemented.
--"Near miss" med errors and Omnicell med errors had not been discussed.
*Antimicrobial stewardship was discussed in MEC but not reviewed in QAPI and should have been.
*The pharmacy and therapeutics committee meetings had not been reviewed in QAPI and should have been.
*There was no formal process for reviewing and addressing grievances.
*Director of quality L received facility grievance information from her supervisor who was based out of a separate sister facility.
-She was expected to follow-up on those grievances herself or forward them to an appropriate manager, but she was not sure what happened to those grievances after she processed them.

Review of the provider's October 2019 Quality Assessment and Performance Improvement policy for the Monument Health System-wide [for all facilities] revealed:
*Guidelines:
-"A. Scope: Monument Health's quality assessment and performance improvement activities include those involving both clinical and non-clinical processes and all departments and services."
-"B. Goal: The goal of quality assessment and performance improvement activities is to increase the value of our services, by enhancing patient safety and quality."

Review of Monument Health Custer's 4/28/22 Quality Assurance & Performance Improvement policy revealed:
*Guiding Principles: "2. In our organization, QAPI includes all employees, all departments, and all services provided."
*Team members (Leaders or designee from each dept [department/service): A leader and/or designee from the pharmacy department was not listed as a member of that team.
*Standing Agenda and Annual Review: The pharmacy department was not included as part of the bi-monthly agenda or annual review.