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A. Based on observation and interview, the provider failed to maintain the air handling systems in three randomly observed locations (dietary, main wellness center, and small wellness center). Findings include:

1. Observation on 3/8/16 at 11:20 a.m. in the dietary department revealed:
*Each air duct register had a moderate amount of blackish, grey residue on the surface.
*The ceiling tiles in the path of airflow surrounding the air duct register also had a moderate amount of blackish, grey residue on them.

Interview on 3/8/16 at 2:30 p.m. with the manager of support services who oversees dietary, laundry, and housekeeping revealed:
*She agreed the ducts and ceiling tiles should have been cleaned.
*Maintenance was responsible for cleaning the air duct registers and ceiling tiles.

2. Observation and interview on 3/8/16 at 4:45 p.m. with the manager of support services in the main wellness center revealed:
*One air duct register had an excessive amount (approximately fifty percent covered) of a blackish, grey residue on it. Within the residue were solid black spots with circular patterns that had a mold like appearance.
*The ceiling tiles in the path of airflow surrounding the air duct register also had an excessive amount of blackish, grey residue on them. Approximately six inches of tile on the north side of the duct was completely covered with residue.
*The rest of the air duct registers had a moderate amount of blackish, grey residue on the surface.
*The ceiling tiles in the path of airflow surrounding those air duct registers also had a moderate amount of blackish, grey residue on them.
*The manager of support services agreed the air duct registers and ceiling tiles should have been cleaned.
*She also agree the circular black spots had a mold like appearance.

3. Observation on 3/9/16 at 9:45 a.m. in the front wellness center revealed:
*The air duct registers were covered with a moderate amount of a blackish, grey residue.
*The residue left a dry black powder on this surveyors finger when it was wiped.

4. Interview on 3/9/16 at 11:15 a.m. with the head of maintenance revealed:
*The maintenance department was responsible for cleaning the air duct registers and ceiling tiles.
*The registers and ceilings were on a quarterly cleaning schedule. They were not cleaned last quarter but had been cleaned six months ago.
*His department had been operating short of staff and had not cleaned the registers last quarter.
*The air ducts from the air handlers to the registers had not been cleaned in the sixteen years that he had worked at the facility.
*The filters for all of the air handling systems were to be changed every four months.
*The person who was responsible for changing the air handler filters no longer worked at the facility.
*He had replaced all of the filters for the patient rooms and realized the previous employee might not have changed the filters as often as they should have been.
*He checked on the previous employee work by asking him verbally if he had changed the filters. He had not gone and physically checked to verify the filters had been changed.

Interview on 3/9/16 at 2:15 p.m. with the head of maintenance revealed he had checked and replaced the filter for the wellness center as it was very dirty.



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B. Based on observation and interview, the provider failed to ensure outdated obstetrics (OB) supplies had been removed from one of one storage area located next to the chapel/waiting room. Findings include:

1. Observation on 3/7/16 at 3:45 p.m. in the storage room located next to the chapel/waiting room revealed a dresser with supplies in it. There were ten Qwik Connect Plus Spiral Electrode packages (used for patient monitoring) that had expired on 5/31/09.

Interview on 3/8/19 from 7:50 a.m. through 9:15 a.m. with the director of nursing revealed the above listed supplies had expired and should not have been available for use. The staff should have followed policy and procedures for checking expiration dates.

Based on observation, interview, and policy review the provider failed to ensure:
*Medications were secured and not accessible to unauthorized individuals for two of two crash carts (emergency room (ER) and critical care unit (CCU)) and one of one medication kit (desk outside of examination (exam) room 1).
*Medications were not expired in two of two areas where medications were stored (desk outside of exam room 1 and in the medication room).
*Wastage of Versed (anesthesia medication) was documented for one of two sampled surgical patients (37).
*Accountability of a controlled schedule IV (minimal abuse potential) medication brought from home for one of one sampled patient (32).
*Multiple (multi)-dose medication vials located in the desk outside of exam room 1 were labeled with an opened date.
*Multi-dose medication vials were labeled with an opened or a used-by date in one of three outpatient clinics (Avera Dell Rapids).
*Food and drink items were not stored in three of three medications refrigerators in one of three outpatient clinics (Avera Dell Rapids pod A/B nurse station refrigerator, pod A/B medication room refrigerator, and pod C).
*Accountability and appropriate destruction occurred in a timely manner for two of two boxes of expired sampled medications located in one of three outpatient clinics (Avera Dell Rapids).
Findings include:

1a. Observation on 3/7/16 at 3:00 p.m. in the ER revealed:
*The door to the ER had a keypad on it used to gain access into the ER.
*The door was also opened by using the handicap door button that could have given anyone access to the ER.
*There was one crash cart with a break-away tie securing the bottom drawer of the cart.
*The break-away tie was used to keep the crash cart secured.
*There was no identifying number on the break-away tie to track when the cart had been opened.
*There were unused break-away ties on the top of the crash cart.
*Anyone walking into the ER could have broken the break-away tie and gained access to the medications in the cart.
*There had been no accountability for the break-away ties.

Observation on 3/9/16 at 4:20 p.m. in the CCU revealed:
*There was a crash cart in the hallway.
*It had a break-away tie used to keep it secured.
*There was no identifier on the break-away tie to track when the cart had been opened.
*There were unused break-away ties on the top of the crash cart.
*Anyone walking in the CCU could have broken the break-away tie and gained access to the medications in the cart.
*There had been no accountability for the break-away ties.

b. Observation on 3/7/16 at 3:30 p.m. in the hallway by exam room 1 revealed there was a desk against the wall. In the right bottom drawer there was a small tote. The tote had not been labeled, and there were seven vials of medications in the tote. The desk had been unlocked.

Interview on 3/8/16 at 8:05 a.m. with the director of nursing (DON) revealed she was unaware the tote had been in the desk. She thought the tote belonged to a nurse of one of the visiting doctors. She agreed the medications in the tote should have been secured.

c. Review of the provider's 7/20/15 Medication Administration policy revealed "Medications in patient care areas are properly and safely stored in automated dispensing machines, in a room under constant surveillance or in a locked storage area in the patient room."

2. Observation on 3/7/16 of the small tote mentioned above revealed the following medications had been expired:
*Lidocaine with an expiration date of 11/1/15.
*Two vials of sodium chloride with expiration dates of 10/1/14.
*Iodoform packing strip with an expiration date of September 2011.
*Mesalt sodium chloride dressing (used for wounds) with an expiration date of March 2015.

Interview on 3/8/16 at 8:05 a.m. with the DON revealed the above mentioned medications were expired and should have been removed from the tote. She thought the tote belonged to a nurse of one of the visiting doctors.

Interview on 3/9/16 at 8:15 a.m. in the medication room with pharmacist B revealed seven bags of sodium chloride had expired on 3/1/16. He agreed they had expired and should have been removed from the medication room.

Review of the provider's May 2011 Drug Recall & Outdated Medications policy revealed if a medication had not been used prior to its expiration date it should have been removed from the inventory.

3. Review of patient 37's procedure nursing notes revealed he had been given 5 milligram (mg) of Versed.

Review of patient 37's physician's order revealed three 2 mg vials of Versed had been dispensed totaling 6 mg.

Interview on 3/9/16 at 10:40 a.m. with pharmacist B revealed 1 mg of Versed should have been documented as being wasted because 6 mg had been drawn-up and only 5 mg had been given. There was no documentation regarding the 1 mg having been wasted.

Interview on 3/9/16 at 1:40 p.m. with registered nurse (RN) A revealed they had no policy regarding wasting medication.

4. Interview on 3/9/16 at 8:00 a.m. with an unidentified RN revealed:
*They stored medication patients brought from home in an unlocked medication cart in the medication room.
*In one drawer was a small bottle of Nitroglycerin tablets.
*In the bottom drawer was a bag of four medications for patient 32.
*That patient had been admitted to the hospital on 3/8/16.
*They did not have an accountability system for those above medications.

Interview on 3/9/16 at 8:15 a.m. in the medication room with pharmacist B revealed:
*In the unlocked bottom drawer of the old medication cart was a bag with four medication bottles that had been brought from home by patient 32.
*The four bottles had medications in them.
*One of the bottles was Tramadol (pain medication) a controlled scheduled IV medication.
*Controlled medications should have been accounted for.
*All nurses had access to the medication room.
*Any medications brought from home should have been sent back with the family.
*He had not been aware those medications were in the cart.
*They had no system in place to account for those medications.

Review of the provider's August 2011 Patient's Own Medication policy revealed patients' own medications should have been returned to the family members if possible.

Review of the provider's August 2014 Controlled Medications policy revealed the pharmacist should have maintained an inventory of all controlled schedule II through V drugs.

5. Observation on 3/7/16 of the small tote mentioned above in finding 1 revealed the following medications had not been labeled as to when they were opened:
*Lidocaine (numbing medication).
*Two vials of sodium chloride (solution used to flush intravenous (IV) lines.
*Xylocaine (numbing medication).
*Marcaine (numbing medication).

Interview on 3/8/16 at 8:05 a.m. with the DON revealed those medications should have been dated when they were opened.

Interview on 3/9/16 from 8:05 a.m. through 9:30 a.m. with pharmacist B revealed vials of medication were good for twenty-eight days from the date they were opened. Vials of medication should have been labeled with a date at the time they were opened.

Review of the provider's May 2011 Drug Recall & Outdated Medications policy revealed "All multi-use medication vials will have a handwritten date documented on the vial the date it was opened. The opened multi-use vial will expire and [be] discarded 28 days from the handwritten date documented on the vial unless package insert verifies stability beyond 28 days."



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6. Observations on 3/7/16 from 2:45 p.m. through 4:15 p.m. with the clinical director and licensed practical nurse (LPN) D in the Avera Dell Rapids Outpatient Clinic revealed:
*In pod A/B there was:
-One 50 milliliter (ml) multi-use vial 0.5% Marcaine (numbing medicine) that had no opened or used by date written on the vial.
-One Epi-Jr pen (epinephrine) (medication used for an emergent severe allergic reaction in children) that had expired February 2016.

*In pod D/E there was:
-One opened influenza vaccination vial that had no opened on or used by date.
-One Epi-Jr pen that had expired February 2016.
-One 50 ml vial lidocaine with epinephrine (numbing medication) that had no opened on or used by date.
-One 50 ml vial of lidocaine without epinephrine that had no opened on or used by date.
-One 30 ml vial of sensorcaine (numbing medication) that had no opened on or used by date.

*In the sampled medication room:
-There were two large boxes of expired medications stored on the floor under the shelving.
-There was no record of the medications once they had expired and were placed into the box by nursing staff waiting for destruction.
-The last time medications had been destroyed was over one year ago.
-Those medications were from all three outpatient clinics.

Interviews with the clinical director and LPN D during the above observations revealed they agreed:
*The above medications were not labeled appropriately for expiration.
*Medications needed to be accounted for and destroyed when expired in a timely manner.

Review of the provider's May 2011 Drug Recall and Outdated Medications policy revealed:
*Medications that were outdated would be sent to the returns vendor on a quarterly basis.
*Multi-dose vials were to have had a handwritten opened date documented on the vial and discarded twenty-eight days after that handwritten date.

7. Observations on 3/7/16 from 2:45 p.m. through 4:15 p.m. with the clinical director and licensed practical nurse (LPN) D in the Avera Dell Rapids Outpatient Clinic revealed:
*In pod A/B:
-One large container of opened V 8 juice had been stored in the medication refrigerator located in the nurses station and was reported to belong to a staff member.
-One freeze pop food item, one ice cream push-up food item, two 1 liter Rubbermaid containers filled with brown cloudy tap water, and four opened various department store labeled waters were stored in the medication room refrigerator for pods A/B in their procedure room.
*In pod C - There was one bottled drinking water that was opened and stored in the refrigerator used for medication.

Interviews with the clinical director and LPN D during the above observations revealed they agreed staff were not to store food and drink in refrigerators where medications were stored.

Review of the provider's August 2011 General Safety Requirements policy revealed food and beverage may not be stored in refrigerators and freezers where patient items were kept.

Based on observation, interview, and policy review, the provider failed to maintain infection control practices during medication administration for one of two patients (35) and for sterilized items in the emergency department. Findings include:

1. Observation on 3/7/16 at 2:20 p.m. of registered nurse (RN) A revealed she was preparing medication for patient 35. During the observation she had taken an alcohol pad and wiped off the top of the vial of medication. She drew the medication out with a syringe. Using that same alcohol pad she wiped the top of the second vial of medication.

Interview on 3/9/16 at 11:25 a.m. with RN C revealed RN A should not have used the same alcohol pad on the second vial of medication, as that would have contaminated the top of the vial.

2. Observation and interview on 3/8/16 at 9:00 a.m. with the director or nursing revealed suction tubing had been attached to the suction container. The suction tubing should not have been attached to the container as it would have been contaminated.

3. Observation and interview on 3/8/16 at 9:25 a.m. with surgical technician E revealed:
*They kept sterile items in the emergency room.
*There were twelve sterile packages observed.
*Six of the twelve sterile packages had the chemical indicator (device used to monitor the sterilization process) stuck in the seal.
*One of the twelve did not have a chemical indicator in the package.
*One of the twelve packages had rust on the instrument in the package.
*She agreed the packaging would be compromised with the chemical indicator stuck in the seal, without the indicator it was unclear if the items were sterilized properly, and items with rust should not be used.

Review of the provider's August 2014 Sterilization Quality Assurance Monitoring policy revealed internal indicator strips should have been placed in the center of each package. The policy had not addressed rusted items or proper sealing of packages.

Based on observation, record review, interview, and policy review, the provider failed to ensure physician's orders had been followed for one of one sampled outpatient (35). Findings include:

1. Observation and interview on 3/7/16 at 2:25 p.m. with registered nurse (RN) A regarding a medication administration for patient 35 revealed she:
*Had a physician's order for Venofer (medication used to treat iron deficiency) 300 milligram (mg) in 150 milliliter (ml) normal saline times three doses.
*Used a 250 ml bag of the normal saline, because they did not have the 150 ml saline bags.
*Drew the medication and ejected it into the saline bag.
*Looked patient 35's medication administration record up on the computer and found:
-The order on the computer said to use a 100 ml saline bag.
*Then called the pharmacist to change the order in the computer to read 250 ml saline bag.
*Administered the medication to patient 35.

Interview on 3/9/16 at 1:45 p.m. with RN C revealed RN A should have checked with the physician before placing the medication into the 250 ml saline bag for administration.

Review of the provider's 8/19/11 Pharmacist Order Verification policy revealed if there were questions about an order the physician should have been contacted.

Based on observation, interview, and policy review, the provider failed to:
*Secure medical records from unauthorized personnel in one of three outpatient clinics (Avera Medical Group Garretson).
*Store medical records in a manner that would prevent potential damage by storing them directly on the floor in one of three medical records storage areas (attached garage).
Findings include:

1. Observation and interview on 3/9/16 from 8:17 a.m. to 9:00 a.m. with the outpatient clinical administrator at the Avera Medical Group Garretson outpatient clinic revealed three areas of filing cabinets:
*In the rear of the building were:
-Four filing cabinets in the back storage room.
-Those filing cabinets were not locked or secured.
-Those filing cabinets contained complete medical records of deceased patients.
-The door to the storage room was not locked and was not able to have been locked.

*In the middle-front of the building were:
-Two additional filing cabinets in the hallway between the front desk and the laboratory.
-Those filing cabinets contained complete medical records of deceased patients.
-Those filing cabinets were unlocked.

*In the front reception desk area were:
-Medical records that were stored on two large shelving units.
-There was no way to secure those medical records.

During the above observation and interview it was discovered:
*The local ambulance service shared the same building and were not separated from the clinic.
*It was also discovered contracted cleaning staff would clean the above clinic on Tuesdays each week.
*Contracted staff and ambulance staff would have access to patient medical records.
*The clinical administrator agreed security of the paper medical records could not be guaranteed from unauthorized access.



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2. Observation and interview on 3/9/16 at 11:30 a.m. with the medical records director of the garage/storage area attached to the hospital revealed:
*A locked room in the garage contained boxes of patient medical records.
*Several boxes were placed directly on the floor.
*She confirmed the boxes should not have been directly on the floor.
-They should have been on pallets to prevent any potential for damage from water leaking in the building.
*One box of old credentialing files was on the floor, and one of the files in the box was damp.

Review of the provider's September 2015 Storage, Security, and retention of Medical Records policy revealed:
*Areas housing medical records shall be restricted to authorized personnel.
*Records of deceased and inactive patients were stored in a storage warehouse.
*There was no mention in the policy of the storage of medical records from potential damage from natural causes like water or fire.

Based on interview and policy review, the provider failed to have the pharmacy department attend the quality assurance meetings. Findings include:

1. Interview on 3/9/16 at 9:45 a.m. with pharmacist B and registered nurse C revealed the pharmacy department had not attended the quality assurance meetings. Pharmacist B stated he provided pharmacy information to the medical staff but had not provided it to the quality assurance committee.

Review of the provider's 7/27/15 Quality Monitoring Program policy revealed all departments were required to have a minimum of one quality monitoring project in process at all times.