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Based on observation, policy review, document review, and staff interview the Critical Access Hospital (CAH) failed to ensure the emergency department (ED) had all the necessary medications and emergency medical supplies needed and ready to meet the needs of all inpatients and outpatients by failing to ensure expired medications and emergency medical supplies were removed from use. The CAH failed to ensure the Board of Trustees followed the approved bylaws, governing medical staff appointment/reappointment that included review and approval of the types and delineation (the action of describing or portraying something precisely) of privileges to be granted to each member of the Medical Staff providing Emergency Services.
The cumulative effects of the CAH's failure to ensure ED medications and emergency medical supplies are ready to meet the needs of all individuals and the lack of approved delineation of privileges for Medical Staff, has the potential to place all patient at risk for inadequate and ineffective symptom control, harm, injury or even death.


Findings Include:

Review of the CAH's policy titled, "Outdated Medications and Supplies," dated 02/26/20, showed ..."Monthly outdated medications will be performed by the Pharmacy Manager ...Nursing staff on duty will be responsible for checking specific, assigned areas for outdated medications and supplies ...the personnel assigned to perform the outdated medication and supply checks will also be responsible for replacing those medications and removing the outdated medications or supplies from the use area to the pharmacy outdate area ... ...the Director of Nursing will monitor on a monthly basis to see if the nurse are correctly performing their duties."

Review of the CAH's undated document titled, "Appendix B, Medical Staff Rules and Regulations," showed ... "Drugs used shall meet the standards of the United States Pharmacopoeia, National Formulary, New and Nonofficial Drugs ...the pharmacist or designee shall make periodic inspections of all drug storage and medication centers and maintain a log of all inspections. Medications that have expired or are near expiration must be returned to the pharmacy for replacement."

Observation on 06/24/20 at 1:05 PM and 06/25/20 at 12:00 PM showed numerous emergency medical supplies, including multiple Broselow Kit (pediatric emergency resuscitation kits) and endotracheal tubes (a tube placed in the throat to ensure an open airway and assist with breathing) expired.

During an interview on 06/25/20 at 11:05 AM, Staff K, RN, Pharmacy Manager, stated that her basic responsibilities are to order any hospital medications, pull outdates/expirations, and to check the pharmacy room and the nursing medication room. The ultimate responsibility for outdates is hers. Staff K explained the night nurses check the hospital crash cart and the day nurses check the ED crash cart monthly. She clarified that she has the ultimate responsibility for the hospital expirations and outdates to include medications in the ED triage room and treatment room. Staff K stated that the medical supplies are checked for outdates and expirations by central supply.
During an interview on 06/24/20 at 1:05 PM, Staff B, Registered Nurse (RN), Director of Nursing (DON) clarified she has oversight for Staff K, RN, Pharmacy Manager and all medications and supplies.
(Refer to C-0884 and C-0888)

Review of a document titled, Amended and Restated Bylaws of the Stanton County Hospital Board of Trustees, originally dated 03/25/15 showed the Board consists of five elected members and each member will serve a four-year term. Board responsibilities include determining CAH policies, supervise, control, direct, and manage the property, affairs and activities of the CAH along with additional responsibilities including the formation of the Professional Committee; Committee of the Whole. The duties of this Committee include: Receive and make determination on all applications for appointment and reappointment to the Hospital Medical Staff; determine after conference with the Chief of Staff, the types of privileges to be granted to each member of the Medical Staff ...
Review of Article VI (6), within this document showed, Medical Staff, ...Responsibility, Medical Staff membership and delineated Clinical Privileges are granted by the Board and are further subject to the full authority of the Board ... ... Membership of the Medical Staff shall be for a period of two years ...


Review of Staff I, Medical Doctor, (MD)'s credentialing file showed that it did not have a complete application packet for his original 90-day or two-year appointment applications for CAH privilege. The application lacked detailed delineation of requested and approved privileges.

Review of Staff J, MD's credentialing file showed there were no complete reappointment applications, between 2005 and 2020, that showed evidence of delineated privileges, approved by the Board of Trustees, every two years as required in the bylaws, found in Staff J's credentialing file for dates beyond 2005. Review of Staff J's current reappointment application dated 06/10/20 failed to include a full list of requested privileges and delineation of the privileges.

(Refer to C-0962)

Based on observation, interview, document review and policy review the Critical Access Hospital (CAH) failed to ensure expired medications and medical supplies used in emergency cases were removed from use in the emergency department (ED) triage room and treatment room and failed to store products, that have the potential for harm if ingested, in an inaccessible, secured area in the ED triage and treatment room. Failure of the CAH to ensure expired medications and medical supplies used in emergency cases are removed from use in the ED and failure to secure products that have the potential for harm if ingested, places all patients who present to the ED at risk for inadequate and ineffective symptom control, harm, injury or even death.

Findings Include:

Review of the CAH's policy titled, "Outdated Medications and Supplies," dated 02/26/20, showed ...monthly outdated medications will be performed by the Pharmacy Manager ...Nursing staff on duty will be responsible for checking specific, assigned areas for outdated medications and supplies ...the personnel assigned to perform the outdated medication and supply checks will also be responsible for replacing those medications and removing the outdated medications or supplies from the use area to the pharmacy outdate area ...the Director of Nursing will monitor on a monthly basis to see if the nurses are correctly performing their duties.

Review of the CAH's undated document titled, "Appendix B, Medical Staff Rules and Regulations," showed ... "Drugs used shall meet the standards of the United States Pharmacopoeia, National Formulary, New and Nonofficial Drugs ...the pharmacist or designee shall make periodic inspections of all drug storage and medication centers and maintain a log of all inspections. Medications that have expired or are near expiration must be returned to the pharmacy for replacement."

Observation on 06/24/20 at 1:05 PM in the ED triage room showed the following medical supplies expired:
-Two Sure Prep No-Sting Barrier Wand (used to protect delicate skin from adhesive tapes) expired on 04/30/20
-Three 3M Scotchcast Plus Casting Tape 2-inch (in.) 5.0-centimeter (cm) roll (used to splint fractures) expired on 05/31/20
-One 3M Scotchcast Plus Casting Tape 2 in. 5.0 cm roll (used to splint fractures) expired on 04/30/20
-One unlabeled bottle with an undetermined type of liquid that may have the potential to cause harm if ingested, stored in an unlocked, unsecure cabinet under the sink in the triage room.


Observation on 06/24/20 at 1:05 PM in the ED treatment room showed the following medications expired:
-One Health Smart Aspirin 325 milligram 100-tab bottle (used as a blood thinner) expired 05/2020
-Two 50% D5 (an intravenous fluid containing dextrose, a sugar substitute), 25-gram (gm) syringes expired 04/01/20, that were stored in the malignant hyperthermia (a fast rise in body temperature and severe muscle contractions when someone gets general anesthesia) supply box.


Observation on 06/24/20 at 1:05 PM in the ED treatment room showed the following medical supplies expired:

-One bottle of Chemstrips (unknown type) containing 9 testing strips expired 04/30/20, that were stored in the malignant hyperthermia (a fast rise in body temperature and severe muscle contractions when someone gets general anesthesia) supply box.

-One Single use Anoscope with Integrated LED Light Source Speculum size 90 x 18 ml slotted (used in gynecological exams) expired 06/19/20
-11 blood draw kits each consisting of one purple top, blue top, red and gray top, green top, and grey top blood draw vial each outdated with varying expiration dates.

Observation on 06/24/20 at 1:05 PM of the ED treatment room showed the following supplies that have the potential to cause harm if ingested, stored under an unlocked, unsecured sink:
-One EZ-Cleans Plus Spill Clean-Up kit
-One Purell hand sanitizer 4-ounce bottle
-One Betco Quat-Stat 5 (used as a disinfects with a contact time of 5 minutes) 946 ml bottle
-One Pro Safe All-purpose sprayer 32 ounces (used as a disinfectant)

During an interview on 06/24/20 at 1:05 PM, Staff B, Registered Nurse (RN), Director of Nursing (DON) verified the expired medications and medical supplies in the ED triage and treatment rooms. Staff B clarified she has oversight for Staff K, RN, Pharmacy Manager and all medications and supplies.

During an interview on 06/25/20 at 11:05 AM, Staff K, RN, Pharmacy Manager, stated that her basic responsibilities are to order any hospital medications, pull outdates/expirations, and to check the pharmacy room and the nursing medication room. The ultimate responsibility for outdates is hers. Staff K explained the night nurses check the hospital crash cart and the day nurses check the ED crash cart monthly. She clarified that she has the ultimate responsibility for the hospital expirations and outdates to include medications in the ED triage room and treatment room. Staff K stated that the medical supplies are checked for outdates and expirations by central supply.

Based on observation, policy review and staff interview the Critical Access Hospital (CAH) failed to ensure expired emergency medical supplies used in life-saving procedures were removed from use and replaced with in date supplies and failed to ensure the Director of Nursing (DON) monitored nursing staff on a monthly basis to determine they were correctly performing their duties per policy. Failure of the CAH to ensure expired emergency medical supplies used in life-saving procedures were removed from use and replaced with in date supplies, places all patients at risk for worsening of their condition, injury or even death.

Findings Include:

Review of the CAH's policy titled, "Outdated Medications and Supplies," dated 02/26/20, showed ...Nursing staff on duty will be responsible for checking specific, assigned areas for outdated medications and supplies. The personnel assigned to perform the outdated medication and supply checks will also be responsible for replacing those medications and removing outdated medications or supplies from the use area ... ...Supplies are to be replaced and disposed of properly ... ...the Director of Nursing will monitor on a monthly basis to see if the nurses are correctly performing their duties.

Observation on 06/24/20 at 1:05 PM of the ED triage room showed the following emergency medical supplies expired:

-Two 14 F (French-tube size) suction catheter kit with water (used to extract bodily secretions) expired on 05/31/20
- Endotracheal Tube 9.0 millimeter (mm) Cuffed without Stylet (a tube placed in the throat to ensure an open airway and assist with breathing) expired on 03/01/20.
- Endotracheal Tube 4.0 mm Cuffed without stylets expired on 04/01/20
- Endotracheal Tube 8.0 mm Cuffed without stylet expired on 05/04/20
- Endotracheal Tube5.5 mm Cuffed without stylets expired on 03/01/20
- One Nellcore Pediatric Colorimetric CO2 Detector 1 kg-15 kg (kilograms) (used to check carbon dioxide level in your blood after an airway is placed) expired on 04/22/20 and two Nellcore Pediatric Colorimetric CO2 Detector 1 kg-15 kg expired on 04/21/20
-One suction tip labeled as, sterile until open, that was opened and attached, hanging from the suction canister

Observation on 06/24/20 at 1:05 PM in the ED treatment room showed the following medical supplies expired:
- One Quick-Combo Radiotransparent (RTS), Pediatric Pacing/Defibrillator Electrocardiography (ECG- the electrical activity of the heart) Electrodes Radiotransparent System 0-15 kilograms (used in life saving cardiac measures) expired on 06/21/20.
- Seven Smith Medical Accuvance Plus IV Catheter Safety Jelco 22-gauge x 1inch needle (needle placed in vein to administer fluids and medication) expired on 10/10/17.
- One 16 French, (FR, tube size measurement), 5 milliliter (ml), indwelling urinary catheter expired 09/30/19, that were stored in the malignant hyperthermia (a fast rise in body temperature and severe muscle contractions when someone gets general anesthesia) supply box.

During an interview on 06/24/20 at 1:05 PM, Staff B, Registered Nurse (RN), Director of Nursing (DON) verified the expired medical supplies in the ED triage and treatment rooms. Staff B clarified she has oversight for Staff K, RN, Pharmacy Manager and all medications and supplies.

Observation on 06/25/20 at 12:00 PM, in the ED treatment room showed the following emergency medical supplies expired from the Broselow kit (pediatric resuscitation kit) expired:
- One Broselow/Hinkle Pediatric Emergency System blue color zone (for 6-year old's, height between 18"-20", and estimated weight 6.6 pounds) oxygen delivery module kit (contains an airway and a non-rebreathing oxygen mask used to provide an airway) expired 09/2019.
- Two Broselow/Hinkle Pediatric Emergency System blue zone Intravenous (IV) delivery module (contains an IV prep kit, IV catheter (needle) and IV extension tubing used to start an IV) expired 03/31/19
- One Broselow/Hinkle Pediatric Emergency System blue zone Intraosseous module (module containing a sternal/iliac (breast bone/hip bone) aspiration (action of drawing fluid out) needle and extension tubing used to provide medication into the bone) expired on 01/2019.
- One Broselow/Hinkle Pediatric Emergency System orange zone (for 8-year old's, height between 47"-51", and estimated weight 52-63 pounds) Intraosseous module (used to provide medication into the bone) expired on 02/2019.
- Two Broselow/Hinkle Pediatric Emergency System orange zone IV delivery module (used to provide medication in the vein) expired on 03/2019.
- One Broselow/Hinkle Pediatric Emergency System orange zone oxygen delivery system (used to maintain an airway) expired on 05/2019.
- Two Broselow/Hinkle Pediatric Emergency System green zone (for 10-year old's, height between 51"-56", and estimated weight 66-79 pounds) IV delivery module (used to provide medication in the vein) expired on 01/2019.
- One Broselow/Hinkle Pediatric Emergency System green zone intubation module (contains a laryngoscope (an instrument used to insert a breathing tube) endotracheal tube (breathing tube inserted in the airway), stylet (used to stiffen the breathing tube), suction catheter, nasogastric tube (a tube put through the nose into the stomach), lubricant jelly, gauze pad, tape and 10 cubic centimeter (cc) syringe used to maintain an airway) expired on 09/2017.
- One Broselow/Hinkle Pediatric Emergency System green zone intraosseous module (used to provide medication in the bone) expired on 02/2019.
- One Broselow/Hinkle Pediatric Emergency System green zone oxygen delivery system (used to maintain an airway) expired on 09/2019.
- Two Broselow/Hinkle Pediatric Emergency System pink/red zone (for 4-8-month old's, height between 23"-29", and estimated weight 13-19 pounds) IV delivery module (used to provide medication in the vein) expired on 07/2018.
- One Broselow/Hinkle Pediatric Emergency System pink/red zone oxygen delivery module (used to maintain an airway) expired on 09/2019.
- One Broselow/Hinkle Pediatric Emergency System pink/red zone intraosseous module (used to provide medication in the bone) expired on 01/2019.
- Two Broselow/Hinkle Pediatric Emergency System purple zone (for 1-year old's, height between 29"-33", and estimated weight 22-24 pounds) IV delivery module (used to provide medication to vein) expired on 01/2018, both kits were open.
- One Broselow/Hinkle Pediatric Emergency System purple zone oxygen delivery module (used to maintain an airway) expired on 09/2019.
- One Broselow/Hinkle Pediatric Emergency System purple zone intubation module (contains a laryngoscope (an instrument used to insert a breathing tube) endotracheal tube (breathing tube inserted in the airway), stylet (used to stiffen the breathing tube), suction catheter, nasogastric tube (a tube put through the nose into the stomach), lubricant jelly, gauze pad, and tape used to maintain an airway) expired on 11/2017.
- One Broselow/Hinkle Pediatric Emergency System white zone (for 4-year old's, height between 37"-42", and estimated weight 33-39 pounds) intraosseous module (used to provide medication in the bone) expired on 02/2019.
- Two Broselow/Hinkle Pediatric Emergency System yellow zone (for 2-year old's, height between 33"-37", and estimated weight 26-30 pounds) intubation module ((contains a laryngoscope (an instrument used to insert a breathing tube) endotracheal tube (breathing tube inserted in the airway), stylet (used to stiffen the breathing tube), suction catheter, nasogastric tube (a tube put through the nose into the stomach), lubricant jelly, gauze pad, and tape used to maintain an airway) expired on 03/31/20.
- Two Broselow/Hinkle Pediatric Emergency System yellow zone IV delivery module (used to provide medication in the vein) expired on 02/2019.
- One Broselow/Hinkle Pediatric Emergency System yellow zone intraosseous module (used to provide medication in the bone) expired on 02/2019.

During an interview on 06/25/20 at 12:00 PM, Staff B, RN/DON verified items in the Broselow Pediatric Resuscitation Kit in the ED treatment room were expired and they were removed. Staff B stated, "I was afraid of that."

Based on document review, medical staff file review, and interview, the above-named Critical Access Hospital (CAH) failed to ensure the Board of Trustees (Governing Body) fulfilled their responsibility by failing to follow the approved bylaws, governing medical staff appointments/reappointment including review, determination and approval of the types and delineation (the action of describing or portraying something precisely) of privileges to be granted to each member of the Medical Staff.

The cumulative effect of the CAH's failure to ensure the Board of Trustees follow the approved bylaws, governing medical staff appointment/reappointment including determination and approval of the types and delineation of privileges has the potential to place all patients receiving care from the medical staff at risk of poor quality outcomes.


Findings Include:


Review of a document titled, Amended and Restated Bylaws of the Stanton County Hospital Board of Trustees, originally dated 03/25/15 showed the Board consists of five elected members and each member will serve a four-year term. Board responsibilities include determining CAH policies, supervise, control, direct, and manage the property, affairs and activities of the CAH along with additional responsibilities including the formation of the Professional Committee; Committee of the Whole. The duties of this Committee include: Receive and make determination on all applications for appointment and reappointment to the Hospital Medical Staff; determine after conference with the Chief of Staff, the types of privileges to be granted to each member of the Medical Staff ...
Review of Article VI (6), within this document showed, Medical Staff, ...Responsibility, Medical Staff membership and delineated Clinical Privileges are granted by the Board and are further subject to the full authority of the Board ... ... Membership of the Medical Staff shall be for a period of two years ...


Review of Staff I, Medical Doctor, (MD)'s credentialing file showed that it did not have a complete application packet for his original 90-day or two-year appointment applications for CAH privilege. The application lacked detailed delineation of requested and approved privileges.


Review of Staff J, MD's credentialing file showed there were no complete reappointment applications, between 2005 and 2020, that showed evidence of delineated privileges, approved by the Board of Trustees, every two years as required in the bylaws, found in Staff J's credentialing file for dates beyond 2005. Review of Staff J's current reappointment application dated 06/10/20 failed to include a full list of requested privileges and delineation of the privileges.


During an interview on 07/01/20 at 11:00 AM, Staff A, Chief Executive Officer (CEO) confirmed Staff I, MD did not have a complete application packet for his original 90-day or two-year appointment applications for CAH privilege. Both applications lacked detailed delineation of requested and approved privileges.
Staff A further confirmed Staff J, MD did not have a complete application packet since 2005. All reapplication packets from 2015 to 2020 lacked the detailed delineation of privileges requested, signed, and approved by the CAH Board of Trustees. Staff J is currently in the process of reapplying for staff privileges and review of the packet completed by Staff J failed to include a full list of requested privileges. The application for privileges reviewed and granted by the Board on 12/16/05 was the most recent of privilege request granted that contained a list of requested privileges.


During an interview on 07/01/20 at 12:15 PM, Staff H, Board of Trustees President confirmed the requested list of appointment privileges was not completed when the Board approved the initial application for Staff I and had not been updated for the last several reapplications submitted for approval for Staff J.

(Refer to C-0962)

Based on document review, medical staff file review, and interview, the above-named Critical Access Hospital (CAH) failed to ensure the Board of Trustees followed the approved bylaws, governing medical staff appointment/reappointment that included review and approval of the types and delineation (the action of describing or portraying something precisely) of privileges to be granted to each member of the Medical Staff. Failure of the CAH to ensure the Board of Trustees followed the bylaws during the appointment/reappointment of Medical Staff places all patients seeking care at the CAH at risk of unsafe care provided by unqualified medical staff.


Findings Include:


Review of a document titled, Amended and Restated Bylaws of the Stanton County Hospital Board of Trustees, originally dated 03/25/15 showed the Board consists of five elected members and each member will serve a four-year term. Board responsibilities include determining CAH policies, supervise, control, direct, and manage the property, affairs and activities of the CAH along with additional responsibilities including the formation of the Professional Committee; Committee of the Whole. The duties of this Committee include: Receive and make determination on all applications for appointment and reappointment to the Hospital Medical Staff; determine after conference with the Chief of Staff, the types of privileges to be granted to each member of the Medical Staff ...
Review of Article VI (6), within this document showed, Medical Staff, ...Responsibility, Medical Staff membership and delineated Clinical Privileges are granted by the Board and are further subject to the full authority of the Board ... ... Membership of the Medical Staff shall be for a period of two years ...



Review of Staff I, MD's credentialing file showed that it did not have a complete application packet for his original 90-day or two-year appointment applications for CAH privilege. The application showed the requested privileges were medical, surgical (sutures) and pediatrics. A six-page document titled "Delineation of Medical Privileges Desired" was blank and lacked detailed delineation of privileges desired. The application showed the Medical Staff recommended the applicant's appointment/reappointment and was signed by Staff J, MD on 11/15/18. The Medical Executive Committee (MEC) Recommendation had no recommendations marked, but was signed by Staff H, Governing Body President on 11/28/18. The next section showed, Hospital Board Action was crossed through and MEC was handwritten above Hospital Board. The Board Action taken showed, appointment/reappointment of all requested privileges, this section was signed and dated 01/18/19.


Review of Staff J, MD's credentialing file showed an application for Reappointment to the Professional Staff of the CAH for the dates of 01/2006 to 01/2008. The application was received on 11/16/05 and privileges were reviewed and granted by the Board of Trustees on 12/16/05. There were no other complete reappointment applications, between 2005 and 2020 that showed evidence of delineated privileges, approved by the Board of Trustees, every two years as required in the bylaws, found in Staff J's credentialing file for dates beyond 2005. Review of Staff J's current reappointment application dated 06/10/20 failed to include a full list of requested privileges and delineation of the privileges.



During an interview on 07/01/20 at 12:15 PM, Staff H, Board of Trustees President stated that she has been a Board member for approximately 25 years and has been President for the last ten years. Staff H stated that the CAH provider credentialing review is initiated by a CAH staff member who oversees the process for completeness. The provider applying or reapplying for membership to the medical staff then has the application reviewed by Staff I, Medical Director and Staff J, MD, then the Board of Trustees, and finally the Joint Medical Staff made up of providers with appointments at three surrounding CAH's. She further stated the CAH Board of Trustees follows the Medical Staff recommendations for appointment/reappointment and generally only review the first two pages of the credential application for signatures of approval by the medical staff. She clarified the full packet is provided for review however the Board only reviews the entire packet if the application request is for initial privileges, not a reapplication.

Staff H confirmed the requested list of appointment privileges was not completed when the Board approved the initial application for Staff I and had not been updated for the last several reapplications submitted for approval for Staff J.

Staff H further stated that the CAH Board of Trustees reviews the Bylaws annually and she does not know when the most recent addendum was made to the Bylaws. She acknowledged the Board of Trustees are responsible for determining CAH provider staff appointments for privileges and the types of privileges granted to each provider. She further confirmed she was not fluent in the Federal or State regulations governing a CAH.


During an interview on 07/01/20 at 11:00 AM, Staff A, Chief Executive Officer (CEO) stated that approval of the CAH Board of Trustees Bylaws was completed at the 02/26/20 Board Meeting without changes or addendums. He confirmed the CAH Board, utilizing the Bylaws, provide over site of all CAH activities including the review and confirmation of provider applications and reapplications for privileges.

Following review of the CAH Bylaws, the provider application packet and application/reapplication form, Staff A, CEO confirmed Staff I, MD did not have a complete application packet for his original 90-day or two-year appointment applications for CAH privilege. Both applications lacked detailed delineation of requested and approved privileges.

Staff A further confirmed Staff J, MD did not have a complete application packet since 2005. All reapplication packets from 2005 to 2020 lacked the detailed delineation of privileges requested, signed, and approved by the CAH Board of Trustees. Staff J is currently in the process of reapplying for staff privileges and review of the packet completed by Staff J failed to include a full list of requested privileges. The application for privileges reviewed and granted by the Board on 12/16/05 was the most recent of privilege request granted that contained a list of requested privileges.