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Based on policy review, staff interview and observation, the Critical Access Hospital (CAH) failed to ensure oversite by a registered pharmacist when staff nurses mixed intravenous (IV) medications or stocked the Pyxis (electronic medication dispensing system) machine. The CAH's failure to have a pharmacist's oversite had the potential to increase the risk of medication errors.

Findings Include:

- Review of Kansas State Board of Pharmacy regulations revealed the following:
68-7-11. Medical care facility pharmacy. The scope of pharmaceutical services within a medical care facility pharmacy shall conform to the following requirements:
(a) The pharmacist-in-charge shall be responsible for developing programs and supervising all personnel in the distribution and control of drugs and all pharmaceutical services in the medical care facility.
(b) The pharmacist-in-charge shall develop a policy and procedure manual governing the storage, control, and distribution of drugs within the medical care facility. The pharmacist-in-charge shall submit the policy and procedure manual for approval to the pharmacy and therapeutics committee or an equivalent committee governing the security, control, and distribution of drugs within the facility.
(d) The pharmacist-in-charge shall be responsible for developing procedures for the distribution and control of drugs within the medical care facility when a pharmacist is not on the premises. These procedures shall be consistent with the following requirements:
(1) Inpatient service. Drugs may be obtained upon a prescriber's medication order for administration to the inpatient by a designated registered professional nurse or nurses with approval and supervision of the pharmacist-in-charge. Adequate records of these withdrawals shall be maintained.
(3) The designated registered professional nurse or nurses may enter the medical care facility pharmacy and remove properly labeled pharmacy stock containers, commercially labeled packages, or properly labeled prepackaged units of drugs. The registered professional nurse shall not transfer a drug from one container to another for future use, but may transfer a single dose from a stock container for immediate administration to the ultimate user."


- Review of the Kansas State Board of Nursing Statutes revealed:
0-3-110. Unprofessional conduct. Any of the following shall constitute "unprofessional conduct"
(a) Performing acts beyond the authorized scope of the level of nursing for which the individual is licensed;
(b) assuming duties and responsibilities within the practice of nursing without making or obtaining adequate preparation or maintaining competency;


1) Observation and tour of the pharmacy on 8/16/16 at 7:45am revealed the pharmacy is staffed fulltime by the "pharmacy RN" (staff M). S/he was responsible for procuring and maintaining medications contained in the CAH formulary.

- Oversite of the pharmacy was performed by a part time registered pharmacist. The CAH had an agreement with a remote pharmacy to perform computerized online oversite and approval of medication orders.

- The CAH used the Pyxis system for CAH staff to obtain and administer approved ordered medications for inpatients, emergency department patients, and outpatients.

Interview with pharmacy RN staff M on 8/16/16 at 0745 revealed s/he "occasionally" has to restock the Pyxis system without the immediate and direct oversite of the registered pharmacist because "he is not available."

Interview with registered pharmacist staff HH on 8/17/16 at 1100 revealed s/he was responsible for Pyxis restocking, oversite of the restocking, and "does perform most of the stocking/restocking himself." S/he was unaware of the Kansas regulations regarding prohibition of medication dispensing by nursing personnel or any medical practitioner other than an MD, DO (Doctor of Osteopathy), or Registered Pharmacist.

- CAH policy titled "Pharmacy Organization and Scope of Practice" reveals ...Pharmaceutical services must be administered in accordance with accepted professional principles.

Accepted professional principles included compliance with applicable Federal and State laws, regulations, and guidelines governing pharmaceutical services...The policy also states...All pharmacy personnel must perform their duties within the scope of their license and education. There must be sufficient personnel to respond to the pharmaceutical needs of the patient population being served. The pharmaceutical service staff will be sufficient in types, numbers, and training to provide quality services. The pharmacist, pharmacy RNs, Director of Nursing or her designee will be available for emergency needs related to the pharmacy."

- CAH policy titled "Pyxis Profile 4000" reveals ...Routine Pyxis refills will be conducted daily-on days the pharmacy is "open." Refill privileges will also be granted to the Director of Nursing..."

2) According to the CAH policy titled "Pharmacy Organization and Scope of Practice" ...Pharmaceutical services must be administered in accordance with accepted professional principles. Accepted professional principles include compliance with applicable Federal and State laws, regulations, and guidelines governing pharmaceutical services ... The policy also states ...All pharmacy personnel must perform their duties within the scope of their license and education ...

- Observation and interview of the outpatient infusion (IV Therapy) room on 8/17/16 at 0930 revealed the infusion room is staffed part time by the "Infusion RN" staff Y. S/he was responsible for mixing and administering medications in the outpatient setting of the CAH. Orders for the medications administered are written by local medical providers and outlying medical providers. The outpatient infusion RN is responsible for obtaining and storing all ordered medications prior to administration. There is a pharmacy mixing "hood" located in the outpatient infusion room. The hood is used to mix intravenous medications by the infusion room staff RN Y immediately prior to patient administration. The medication mixing frequently occurs without direct oversite by a registered pharmacist present in the administration room.

- Prior to the medication administration there is no pharmacist oversite of the correct medication mixed or observation of the appropriate mixing practice. Interview with the Infusion RN staff Y revealed that she had received education through the Oncology Nurse Society and had spent time at an outlying oncology office for specific training for admixture mixing.

Interview with registered pharmacist staff HH on 8/17/16 at 1100 revealed s/he was responsible for all pharmacy oversite to include inpatient and outpatient medication dispensing. S/he was unaware of the Kansas regulations regarding prohibition of medication dispensing by nursing personnel or any medical practitioner other than an MD, DO, or Registered Pharmacist.



Based on observation and interview the hospital failed to ensure the Kansas State food code regulations were implemented for preventing the potential contamination of food when an airgap was not installed on the kitchen preperation sink to prevent the backflow of sewage, gas or other contaminates. This failed practice potentially placed all patients and visitors at risk for food contamination.

Findings include:

Reference: According to the Kansas State Food Code 2012 regulation 107 5-203.14 Backflow Prevention Device, states, "A PLUMBING SYSTEM shall be installed to preclude backflow of a solid, liquid, or gas contaminant into the water supply system at each point of use at the FOOD ESTABLISHMENT (includes, but is not limited to: ...cafeterias, public or nonprofit organizations routinely serving food...")

At 8/18/2016 at approximately 10:40 AM the preparation sink (used to prepare fresh vegetables and food items) in the dietary department (kitchen) was observed and revealed there was no airgap under the prep sink to prevent a backflow of sewage, gas or other contaminates into the prep sink.

At 8/18/2016 at 10:45AM Staff MM C interviewed and stated, "We don't have an airgap and haven't since I have been here."
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Based on observation and interview the Critical Access Hospital (CAH) failed to ensure a process was implemented that remove expired medical supplies from stock in the labor and delivery room area. Failure to ensure inventory was inspected and not out of date placed all patients at risk for potentially receiving medications/treatments that were no longer effective.

Findings included:

1) On 8/18/2016 at 9:10 AM the labor and delivery room supplies and the nursery cabinets were inspected. Ten units of 3M Red Dot Neonatal electrodes (a conductor through which electricity used to monitor heart rates) with an expiration date of 7/2016 were found.

2) On 8/18/2016 at approximately 9:25 AM delivery room medical supply cabinet was observed and 2-10 ml (milliliter) vials of Xylocaine 1% (treatment of irregular heartbeats and relieve pain and numb skin) were found with an expiration date of 7/20/2016.

3) On 8/18/2016 at approximately 9:25 AM a delivery room medical supply cabinet contained a 2 ounce bottle of Benzoin Compound tincture USP (solution of benzoin resin in alcohol) with an expiration date of 4/2016.

4) On 8/18/2016 at 9:40 AM the Labor and delivery Crash Cart (a cart with supplies for a medical emergency) contained 2 arterial blood sample syringes (3 mls) had an expiration date of 6/2016.

5) On 8/18/2016 at 9:40 AM a Sterile Umbilical Cut down Tray was found with an expiration date 10/28/2015.

Based on observation and policy review, the radiology supervisor and surgical supervisor failed to ensure staff compliance with appropriate attire and the Critical Access Hospital (CAH) failed to provide appropriate protective equipment to reduce the exposure of the staff to harmful radiation exposure. This deficient practice had the potential to increase staff exposure to harmful radiation and accompanying complications.

Findings Include:

- During observation of surgery in surgical suite east on 8/16/16, a torn radiology protective apron was observed hanging in the surgical suite. Interview with surgical supervisor staff N revealed the apron was a personal radiology apron of physician staff I and acknowledged the apron was torn which potentially could increase exposure risk.

Policy titled "Radiation Exposure in the OR for patient and staff " revealed, "...it is the policy protect our patient and staff as much as possible from radiation exposure with time, distance, and shielding to keep radiation exposure within safe levels ...to protect our patient and staff as much as possible from radiation exposure with time, distance, and shielding to keep radiation exposure within safe levels ..."

Based on observation, staff interview and policy review, the physical therapy, occupational therapy and radiology departments failed to assure they had a clean, orderly and safe departments. This deficient practice has the potential to expose all patients to an unsafe environment.


Findings Include:

1) Occupational Therapy (OT) Department was a single room in the Physical Therapy Department used specifically for all OT patients. Observation of the OT room on 8/17/2016 at 9:55AM revealed staff failed to secure disinfectant (potentially harmful to patients or visitors), located in an unsecured cabinet under a sink. The hospital also failed to ensure the ultrasonic gel bottle (used for patient therapy), cleansing solution spray bottle, and cleaning cloths under the sink were secured in a locked cabinet to prevent potential access by patients or visitors.

2) At 8:57 AM observation of a small oxygen tank sitting on top shelf of shelving unit not in a holding rack or secured in any manner.

At 3:10 PM a return visit to the physical therapy department revealed the small oxygen tank in same place, staff removed the oxygen tank and placed it in on the floor in a holding tank for a larger oxygen tank. The staff member was unaware that oxygen tanks needed to be secured from falling over to prevent injury.

3) At 8:55AM observation in Physical Therapy storage closet revealed supplies stacked too less than 8 inches from the ceiling tile.

4) On 8/17/2016 at 11:00 AM in the CT (computerized tomography) room of Radiology Department, an Omniscan (gadolinium-based contrast agent) was in a cabinet that was unlocked at the time of observation and accessible to patients.

Interview with Radiology staff LL regarding the unlocked cabinet for the Omniscan, it was disclosed that it was to be in a locked cabinet but an Omniscan was done earlier that morning and it did not get locked back up.

Based on interview and record review the hospital failed to ensure temperature control for food items and that staff disposed of expired food items. This failure placed all patient at potential risk of food-borne illnesses.

Findings include:

On 8/16/2016 at 6:55 AM, review of log sheets of temperatures of all the kitchen freezers and refrigerators for food revealed they were not completed daily. July logs had missing temperatures on 7/12/2016, 7/13/2016, 7/18/2016, 7/19/2016 and all evening temperatures were missing. Temperatures for 7/27/2016, 8/9/2016 and 8/14/2016 were not documented.

On 8/16/2016 at 8:17 AM in dietary/kitchen found Half & Half creamer expired on 8/2/2016.

Based on policy review, staff interview and observation revealed the Critical Access Hospital (CAH) failed to ensure security of all pharmaceutical storage. This deficient practice of unsecured pharmaceuticals had the potential to increase the risk of unauthorized access to medications stored in the pharmacy and outpatient infusion area.

Findings Include:

During interview and observation with pharmaceutical staff RN M: the pharmacy keys are in the possession of pharmacist staff HH, pharmaceutical staff RN M, director of nursing staff A who carry the keys in the CAH as well as take them to their homes when leaving the CAH. Additionally, two nurses who are in charge on evenings and nights also carry the pharmaceutical keys when on duty.

During interview and observation with outpatient infusion staff RN Y: the pharmacy keys for the outpatient infusion room are in her possession while in the CAH and s/he also takes them to her/his home when leaving the CAH.
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Based on observation, interview and record review the hospital failed to ensure a system was implemented for identifying practices inconsistent with professional standards for infection control, controlling infections and communicable diseases of patients and personnel. This failure placed all patients at risk for infections.

Findings include:

1) On 8/16/2016 at 9:49 AM Operating Room, East, Staff H (Certified Registered Nurse Anesthetist) was observed when he failed to clean the IV port (a rubber septum located on IV tubing) of a needleless system before injecting medication into it. Staff H failed to don gloves before patient contact during a surgical procedure, after administering drugs into an IV port and manipulating IV lines.

2) Physical Therapy; At 9:00 AM on 8/16/2016 observation of the area and interview with staff KK indicated that cleaning of items used by patient in the physical therapy department was completed twice a month or as needed but not after each patient use.

3) Interview, observation, and policy review of the CAH on 8/16/2016 at 11:00AM revealed physician staff I in the preoperative area assisting the nursing staff with adjusting the placement of a patient. Physician staff I had a surgical mask hanging under the chin. Surgical supervisor RN staff N was present during the observation. Once movement of the patient was complete, Physician staff I tied the surgical mask around the nose and mouth. S/he then scrubbed for surgery.

Following the observed surgery, anesthesia staff H (RN) pulled the mask off of the face and turned it so it hung over the shoulders on her/his back while assisting with patient movement. The mask remained hanging over the shoulders and back while post -surgical assessment was performed in the recovery room.

Surgical supervisor Staff N (RN) interviewed on 8/16/2016 at 3:2:00PM revealed, "The masks should not hang from the necks of surgical staff. "

4) Observation of surgery in surgical room east on 8/16/2017 at 11:00AM revealed physician staff I in the surgical suite revealed hair exposed over the forehead and around both sides of the face not fully covered by the bouffant.

Policy titled, "Attire in Restricted and Semi-restricted Surgical Areas" directed, "All persons entering restricted areas of the surgical suite shall wear a mask, when there are open sterile items and equipment present ....Masks are carefully removed and discarded after use, by handling only the ties. They are not to be saved by hanging around the neck or tucking into pocket for future use..."


Policy titled, "Attire in Restricted and Semi-restricted Surgical Areas" directed staff ...Head and facial hair shall be covered, when in the semi-restricted and restricted areas of the surgical suite. The first item of apparel shall be a clean, low-lint surgical hat or hood that confines the hair..."



5) Interview and observation on 8/16/2016 at 9:30AM with laboratory supervisor staff X revealed PPE (Personal Protective Equipment) is available for staff to wear when processing laboratory specimens. PPE equipment available for staff included disposable gloves, face mask, and protective jacket.

During the laboratory tour, a laboratory staff was observed transferring specimens using a transfer device from one container to another. Laboratory staff was observed not wearing face protection or a gown. No protective shield was in place. Laboratory supervisor staff X was present during the observation.

Policy titled "OSHA (Occupational Safety and Health Administration) Regulations on Bloodborne Pathogens in the Laboratory" reveals ...gloves are to be worn when the possibility of exposure of infectious material is present ...mask face shield and eye shield is to be worn when danger of spillage or splatter is possible ...lab coats are worn in lab area and to draw patients on floor."

Based on observation the Critical Access Hospital (CAH) failed to ensure intravenous medication was administered in accordance with accepted standards of practice. This failed practice placed all patients at risk for medication errors.


Findings included:


Observation at 10:18 AM of staff H, CRNA (Certified Registered Nurse Anesthetist) revealed no medication label was placed on an IV bag of Sodium Chloride 0.9% hanging with added medication in it. Staff H failed to label, date, time and initial a medication label with the correct information and place it on the patient's IV.

Based on interview and record review the Critical Access Hospital (CAH) failed to ensure that all medical records were processed in a timely manner. Failure to ensure the processing of all patient records in a timely manner according to applicable policies and procedures resulted in potential delay of medical record retrieval and medical information.


Findings included:

- According to the facility policy and procedure for Medical Records Service, reviewed 2/5/2016, section (f) states, "Records of patients discharged shall be completed within 30 days following discharge."

Interview with the Medical Records Director (Staff K) on 8/16/2016 at 11:15 a.m. revealed the CAH had approximately 61 delinquent (greater than 60 days of being completed) medical records.

Staff K stated that the physicians are notified weekly of delinquent records. When there is no response, the administrator is notified. There had been no response from the physicians regarding completing the delinquent medical records.

Based on interview and record review the Critical Access Hospital (CAH) failed to ensure a policy and procedure was in place to ensure patients received a 30 day notice of transfer or discharge, or as soon as practicable, from a swing bed for 4 of 4 sampled discharged swing bed residents (#s 18, 19, 20, & 21). Failure to provide timely notification of transfer or discharge placed all swingbed patients at risk for potential discharge plan complications.


Findings include:


- Review of the records for patients #18, 19, 20 and 21 revealed no documentation indicating a 30 day notice was completed for discharged or transferred patients.


- Review of the CAH of swing bed policies and procedures indicated that there was no policy and procedure to ensure patients received a 30 day notice for transfer or discharge when applicable.


Staff were unable to locate a policy and procedure that addressed the 30 day notice for transfer or discharge.