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Based on medical record review, interview, and policy review, the critical access hospital (CAH) failed to ensure medical staff are on site within 30 minutes of notification of emergency patient arrival in one (1) of 10 ED (emergency department) medical records reviewed (Patient #30).

Findings Include:

Patient #30's medical record review on 11/29/2017 at 2:15 pm revealed the patient arrived in the ED on 10/31/2017 at 7:07 am with complaints of physical assault. The initial MSE (medical screening exam) was performed at 7:12 am and PA Staff JJ was notified at 7:13 am of a patient in the ED. PA Staff JJ arrived in the ED to assess the patient at 7:54 am, 41 minutes later.

Chief Executive Officer (CEO) Staff A interviewed 11/29/2017 at 4:00 pm stated "the Medical Staff Policy requires Medical Staff to be on site within 30 minutes of notification of an ED patient if the patient condition warrants their presence."

Medical Staff Rules and Regulations, effective date 3/28/2016, reviewed 11/29/2017 at 3:00 pm directed, Emergency services shall be available 24 hours a day, and medical staff coverage shall be adequate so that the patient will be seen within a reasonable period of time relative to the severity of the patient's illness or injury. Qualified personnel will be on call and immediately available by telephone or radio contact within 30 minutes on a 24 hour basis.

Based on observation, interview, and record review the critical access hospital (CAH) failed to maintain and document maintenance of medical equipment in three of three observations (linen room, emergency department, and Dexa scan (used for bone density scans) room). Failure to perform regular patient care equipment maintenance can lead to inaccurate results and patient safety issues for improperly maintained equipment.

Findings include:

- Observation of ED room 2 revealed a thermometer labeled "inspected 3/16 next inspection due 3/17". No further inspection documented on device or in PM (periodic maintenance) list.

-Observation of ED room 2 revealed upright patient scales with no label PM's were performed. Scales were not listed on the PM document list.

-Observation in the Dexa scan room revealed floor scales with no label PM's were performed. Scales were not listed on the PM document list.

-Observation in the ED Trauma room revealed a thermometer labeled "inspected 3/15 next inspection due 3/16". No further inspection document on device or in PM list.

- Observation in the clean linen room on 11/27/2017 at 3:23 pm revealed the warmer for disposable bath cleansing washcloths with a sticker revealing the last preventative maintenance (PM) was performed 5/17 (6 months ago).


Interview in the clean linen room on 11/30/2017 at 9:55 am, Staff S verified the last PM was performed on 5/17 to the warmer for disposable bath cleansing washcloths.


- Policy titled "Biomedical Equipment" directed, hospital will contract for biomed services to perform routine preventative maintenance and safety inspections on all clinical equipment in the hospital...each piece of equipment is to be evaluated on a routine basis.

Based on record review and staff interview the critical access hospital's (CAH's) Governing Body failed to ensure completion of medical staff credentialing files for five (5) of 13 files reviewed (Physician Staff HH, Advanced Practice Registered Nurse (APRN) Staff H, APRN Staff CC, Physician Assistant (PA) Staff JJ, and Physician Staff NN). This deficient practice places the facility at risk for having unqualified providers or providers performing procedures or care beyond their capabilities.

Findings include:

- Record review on 11/28/2017 at 4:00 pm revealed Physician Staff HH, APRN Staff H, APRN Staff CC, PA Staff JJ, and Physician Staff NN had a facility application for re-appointment in each of their credential files. Applications were reviewed by the Medical Staff with incomplete documentation of recommendations for re-instatement. Further review of the applications revealed missing dates, missing signatures, missing re-appointment recommendations and/or re-appointment approvals by the reviewing medical staff and governing body.

Chief Executive Officer (CEO) Staff A interviewed on 11/28/2017 at 4:30 pm confirmed the missing information.

- Document titled "Medical Staff Bylaws 2017" reviewed on 11/28/2017 at 4:45 pm directed, Duration of Appointment and Reappointment will be for two years.

Based on staff interview, document, policy and procedure review the critical access hospital (CAH) failed to ensure all policies and procedures were reviewed at least annually. Failure of the facility to ensure all policies and procedures are reviewed annually puts all patients at risk for receiving care that lacks current recommendations and changes needed to provide safe patient care according to State and Federal guidelines and regulations, and fails to ensure staff are appropriately educated to give safe patient care.

Findings include:

- Policy and Procedure book located in the Pharmacy reviewed on 11/27/2017 at 4:19 pm revealed the pharmacy policy and procedures were last reviewed in 2014.

- Minutes of the Pharmacy and Therapeutic meeting held on 10/16/2017 reviewed on 11/27/2017 directed, pharmacy policy and procedure manual needs face sheet signed for 2017...signature list needs to be current for 2017.

Interview in the pharmacy on 11/27/2017 at 4:19 pm, Staff E, Pharmacy RN explained the pharmacy failed to ensure some of the policies and procedures have been updated since 2014.

- Document titled "Medical Staff ByLaws 2017" directed, the Pharmacy Department Director will be a licensed pharmacist designated by administration in accordance with State regulations...The Department Director, along with the Medical Director, will maintain and annually review the department policies and procedures for approval by Medical Staff. Policies and procedures shall be consistent with State law and regulatory agencies.

- Observation of various departments in the CAH on 11/27/2017 - 11/29/2017 revealed policies that failed to be updated within this last year.

Interview in the team conference room on 11/29/2017 at 5:30 pm, Staff A, Administration explained the CAH has been in the process of updating the policies and procedures in each department. The CAH failed to have all the policies updated annually for the year 2017.

- Document titled "Periodic Evaluation Report" directed, department policies and procedures are reviewed and approved by the hospital-wide policy and procedure review committee, Medical Staff, and the Board of Trustees on a rotating basis.

- Review of Medical Staff and Governing Body meeting minutes from the past year failed to show documentation of policies and procedures reviewed.

Based on observation, staff interview, and policy review the critical access hospital (CAH) failed to ensure expired medications were removed from all patient care areas in three of three patient care areas (nursing station medication room, emergency department (ED), and central supply); failed to correctly label multi-dose medications for outdates in five of five vials observed (nursing station medication room and emergency department); failed to ensure nursing staff limit number of medication doses from pharmacy to immediate use in one of one observations (Registered Nurse (RN) Staff J); failed to secure medications at all times in one of one observation (RN Staff J); failed to dispose of one of one open multi-dose vial after 28 days from open date (operating room (OR); and failed to remove and store all outdated medications from patient care areas (central supply). Failure to ensure safe medication practice puts the facility at risk of loss of medications and places all patients at risk of ineffective and unsafe medication administration.



Findings include:


Nursing Unit Crash Cart observed on 11/27/2017 at 1:25 pm revealed the following outdated medications:

-3 vials Atropine Sulfate (smooth muscle relaxant), 1mg (milligram)/ml (milliliter), outdated 9/2017.

Staff RN I on 11/27/2017 at 2:00 pm acknowledged and removed the outdated medications.


ED crash cart observed on 11/27/2017 at 2:10 pm revealed the following outdated medications:

-1, 30ml vial Epinephrine 1:1000 (1mg/ml) (used to treat life threatening allergic reactions), outdated 9/2017.

Staff RN J acknowledged the outdated medications on 11/27/17 at 2:20 pm.


Nursing station medication room refrigerator observed on 11/27/2017 at 5:10 pm revealed the following open, undated multi-dose vials:

-1 vial Lantus insulin, 100u (units)/ml, 10ml vial with handwritten date on box of 11/3/17. There was no evidence of a date written on the vial, no evidence of initials of staff opening the vial, and no evidence of expiration date after opening vial.

-1 vial Humalin R insulin 100u/ml, 3ml vial with handwritten date on box of 11/8/17. There was no evidence of a date written on the vial, no evidence of initials of staff opening the vial, and no evidence of expiration date after opening vial.

-1 vial Humalin 10/30 insulin 100u/ml, 10ml vial with handwritten date on box of 11/18/17. There was no evidence of a date written on the vial, no evidence of initials of staff opening the vial, and no evidence of expiration date after opening the vial.

-1 vial Humalog insulin 100u/ml, 3ml vial with handwritten date on vial of 11/26/17. There was no evidence of initials of staff opening the vial and no evidence of expiration date after opening the vial.

-1 vial Enoxaparin Sodium (anticoagulant), 300mg/3ml with handwritten date on vial of 11/27/17. There was no evidence of initials of staff opening the vial and no evidence of expiration date after opening the vial.

DON Staff B confirmed the mislabeled medications on 11/27/2017 at 5:30 pm and stated all multi-dose vials are to be labeled on the vial with the open date and expiration date with a label attached to the vial.


ED procedure room observed 11/28/2017 at 9:00 am revealed the following undated open medications:

- 1 - 500ml 0.9% Normal Saline pour bottle used for wound care with no written documentation of date of opening, date of expiration, or employee initials.

RN Staff K on 11/28/2017 at 9:00 am confirmed there was no dating on the bottle and was not sure when the bottle was opened.


- Observation in OR 2 on 11/28/2017 at 9:15 am revealed one multi-dose vial of Viscous Lidocaine 2% (a topical medication used to numb an area) with a date "opened 5/6/17". The facility failed to discard the outdated medication after 28 days per policy.

OR Staff RN U interviewed on 11/28/2017 at 9:38 am in the surgical area verified the opened multi-dose vial of Viscous Lidocaine 2% failed to be discarded 28 days after being opened.

- Policy titled "Multi-Dose Vials" dated 9/9/12, reviewed 11/28/2017 at 11:00 am directed, multi-dose vials shall be discarded 28 days after opening; the "Date Opened" shall be filled in on the label...MULTI-DOSE VIAL, DISCARD ___days after opening or reconstituting. Date Opened:.


Nursing station medication room observed on 11/27/2017 at 5:10 pm revealed 2 vials of Tazobactam powder (antibiotic) and 2 vials of Vancomycin powder (antibiotic) on the counter. There were no labels with patient specific information on the vials.

Director of Nursing (DON) Staff B confirmed the medications and returned them to pharmacy. S/he stated "the pharmacy probably forgot these were in here."

Pharmacist Staff D interviewed 11/28/2017 at 9:30 am stated s/he did not know why the medications were in the nursing station medication room.


- RN Staff J observed on 11/28/2017 at 7:30 am at the medication cart in the nursing station revealed s/he had entered the pharmacy to obtain missing medications for two separate inpatients.

RN Staff J interviewed on 11/28/2017 at 7:35 am stated the pharmacist was in the facility 2 hours a day during the week. Orders for new medications or medication changes written after the pharmacist leaves are not reviewed until the pharmacist returns. RN Staff J confirmed the nursing staff have access to the pharmacy in the absence of the pharmacist and frequently have to obtain medications. S/he stated "I get what I need for my shift. This morning I picked up my patients' medications and another nurses medications because the pharmacist was not here."

Pharmacist Staff D interviewed 11/28/2017 at 9:30 am stated the nursing staff do have access to the pharmacy when s/he is unavailable to obtain medications. S/he further stated there is no mechanism currently used by the pharmacy to review all medication orders prior to administration, but s/he does review all orders each day when s/he is in the facility. S/he also fills all of the patient ordered medication drawers daily and on weekends and holidays s/he refills enough medications to meet the patients' needs until s/he returns. The Pharmacy RN does not fill the medication drawers. Pharmacist Staff D stated s/he had looked at a more secure computerized medication system but felt it was too expensive of an investment at this time. Pharmacist Staff D stated the nursing staff are to only get the dose needed at the time of administration but are not to get additional doses. S/he further stated that the nursing staff can get medications for more than one patient at a time. There are no cameras in the pharmacy but staff are required to log all medications removed from the pharmacy and the log is reconciled against the drug count. Narcotics in the pharmacy are only accessible to the nursing supervisor and surgery supervisor.

Policy titled "Obtaining Drugs form Drug Room" revised 7/02 directed, a registered nurse on duty shall be the only persons authorized in the pharmacy when the pharmacist is not on duty...in cases of emergency, unit doses of medication may be removed from stock bottles in main drug room by the registered nurse on duty, with proper notations made...all medication taken from the main drug room shall be written in the pharmacy log book and initialed by the registered nurses. The policy does not limit the number of doses to be obtained.


- Respiratory Care Staff N observed on 11/28/2017 at 8:30 am in room 104 had respiratory medication on the top counter of the computer on wheels. Staff N left the patient room and the cart unattended.

- RN Staff J observed at the medication cart at the nursing station on 11/28/2017 at 7:30 am removed the medication drawer labeled 104 and set it on top of the COW (computer on wheels) located in the hallway next to the nursing station. S/he left the medications unattended and re-entered the nursing station medication room out of sight of the medications. No nursing staff were present in the nursing station at the time. RN Staff J returned to the COW and moved it to the hallway outside room 104. S/he parked it outside of room 104, left it unattended, and entered room 106. S/he returned to the cart, documented the medications for administration, and pushed the cart into room 104.

- RN Staff J observed in room 104 on 11/28/2017 at 7:35 am filled a syringe with medication, left the COW with the medication drawer on the top unattended and left the room with a vial of medication and the syringe. S/he returned to room 104 and reviewed the medications and verified them with the computer.

RN Staff J interviewed on 11/28/2017 at 7:40 am confirmed s/he had left the medications unattended both at the nursing station, outside the patient's room, and in the patient's room.


- Observation in the Central Supply Room on 11/27/2017 at 3:37 pm revealed a large plastic tub marked discontinued medications containing:

10 - 100 ml bags of Intralipid 20%, (IV calories and essential fats), outdated 9/17
8 - 250ml bags of 400mg Dopamine HCI (a medication that causes constriction of the blood vessels), outdated 9/1/17.

Staff TT interviewed on 11/27/2017 at 3:37 pm in in the central supply room acknowledged the tub with the outdated medications belonged to pharmacy and s/he was unsure why it was stored in central supply.

Pharmacy RN Staff E interviewed on 11/27/2017 at 4:19 pm in the pharmacy explained the tub of outdated medications was stored in central supply because of adequate storage space the pharmacy. Pharmacy RN Staff E removed the outdated medications from central supply and relocated them in pharmacy with other outdated medications.

Policy titled "Outdated Medications" directed, a list is made ...of medications that will outdate in the following six months. The medication and date of expiration are listed by month of expiration and reviewed at the beginning of each month. At this time, these medications are pulled from the shelf ...these outdated medications are then returned to the main drug room. The pharmacy RN or an outside service will log all outdated medications and either return outdated medications to the wholesaler or manufacturer for credit ..."

Based on observation, staff interview, and policy review the critical access hospital (CAH) failed to ensure expired supplies were removed from surgery (OR) and the emergency department (ED), failed to remove outdated food from the kitchen, failed to ensure proper head covering in the OR for two of five staff (Staff KK, Staff NN), failed to store patient care supplies safely away from exposure to moisture (ED room 2, ED trauma room, ED dirty utility room), failed to monitor and ensure proper hand hygiene was performed in four of five staff observed (Staff KK, Staff J, Staff V, Staff L), failed to ensure disinfectant used to clean one of one cystoscope (a scope used to look into the urinary bladder) was measured correctly, failed to safely transport one of one cystoscope from the OR to the dirty utility room (Staff X), filled medication syringes in the patient care room using a multi dose vial of medication (Staff J), failed to clean multi use patient care equipment between each use in six of six observations (CNA Staff L, RT Staff N); failed to adjust air change rates in the perioperative services (Maintenance Staff O); and failed to perform environmental testing of admixture pharmacy hood. These deficient practices have the potential to expose patients, staff and guests to bacteria, viruses and other pathogens that could result in harm, severe illness, poor health outcomes, or death.

Findings include:

- Surgery area observed on 11/27/2017 at 2:39 pm of the malignant hyperthermia (MH) kit (a life threatening temperature elevation that can occur in the presence of certain anesthesia medications) revealed:
1-Irrigation Tray (a tray and syringe used to irrigate or aspirate solutions into the bladder) outdated 10/17.

Registered Nurse (RN) Staff U interviewed on 11/27/2017 at 2:39 pm in the surgery area confirmed the expired irrigation tray and removed it.

- Pre-surgery scrub room observed on 11/28/2017 at 9:12 AM revealed:
1- bottle of hydrogen peroxide (a disinfectant) 16 ounces outdated 7/17.

RN Staff X interview on 11/28/2017 at 9:12 AM in the pre-surgery scrub room confirmed the expired bottle of hydrogen peroxide and discarded it.

- Observation in the ED (emergency department) room #2 on 11/27/2017 at 12:10 pm revealed the following outdated medical supplies:
2-16 g. Jelco IV needles, outdated 8/17

- Observation in the ED dirty utility room on 11/27/2017 at 12:15 pm revealed the following outdated medical supplies:
1-tube diaper rash paste, outdated 6/16
3-sexual assault kits, outdated 1/15

- Observation in the Dexa Scan (bone mineral density measurement) on 11/27/2017 at 12:25 pm revealed the following outdated medical supplies:
1-container peroxide disinfectant wipes, outdated 8/4/17

Director of Nursing (DON) Staff B confirmed the outdated supplies on 11/27/2017 at 1:05 pm.

Policy titled "Out Dated Products" directed, any items that outdate from other departments in the hospital should be brought to Central Supply ...the director will print an adjustment report that lists all outdated items for that month ...items that cannot be donated will be disposed of. Items that can be donated to missionary designations, will be boxed and stored until notified of acceptance. It shall be noted on the "Out Dated Supplies" form whether each item was donated or destroyed.

- Observation of the kitchen on 11/28/2017 at 10:15 am revealed the following outdated food:
12-32 ounce frozen containers of egg whites, outdated 3/3/16
2-50 ounce cans of cream of chicken soup, outdated 3/16

Dietary Manager Staff G on 11/28/2017 at 10:30 confirmed the outdated food and removed them from the shelves.

Dietary Manager Staff G interviewed on 11/28/17 at 10:35 stated "I thought if we froze the egg whites they could be used even after the expiration date."

The facility failed to provide a policy regarding for outdated food.


- Physician Staff KK observed in OR 1 on 11/28/2017 at 8:16 AM revealed wearing a disposable skull cap that was untied, and failed to cover the sideburns and hair on the back of the neck.

RN Staff U interviewed on 11/28/2017 at 9:47 AM in the surgery area acknowledged Physician Staff KK failed to fully cover all hair while performing an OR procedure.
- Physician Staff NN observed on 11/29/2017 at 9:30 am performing surgery in surgery suite #1 revealed facial hair not covered by surgical mask.

Surgery Director Staff RN U interviewed on 11/29/2017 at 11:30 am acknowledged the exposed facial hair and stated "covering the facial hair is an ongoing problem that has been discussed frequently in the facility."

Policy titled "Surgical Attire" directed, all perioperative personnel will cover head, ears and facial hair including sideburns and the nape of the neck.

The Board of Regents of the American College of Surgeons (ACS) approved this statement in July 2016, During invasive procedures, the mouth, nose, and hair (skull and face) should be covered to avoid potential wound contamination. Large sideburns and ponytails should be covered or contained. There is no evidence that leaving ears, a limited amount of hair on the nape of the neck or a modest sideburn uncovered contributes to wound infections.

Recommendations by the Association of periOperative Nurses (AORN) for proper surgical attire directed, hair coverings should cover facial hair, sideburns, and the nape of the neck. Perioperative nurses can help minimize the risk of surgical site infections by covering head and facial hair, which prevents skin squamous and hair shed from the scalp from falling onto the surgical field.


- ED Room 2 observed on 11/27/2017 at 12:10pm revealed the following items stored under the handwashing sink:
3-graduated specimen containers
3-urinals
1-bag underpad
1-sharps container
- ED dirty utility room observed on 11/27/2017 at 12:20 am revealed the following items stored under the handwashing sink:
1-umbrella
1-graduated specimen container
3-hazmat decontamination kits
-biohazard bags
- ED trauma room observed on 11/27/2017 at 12:40 am revealed the following items stored under the handwashing sink:
3-bedpans
4-graduated specimen containers
3-urinals
4-bath pans
4-packages disposable wash cloths
-adult diapers
-powder
-Kleenex

RN Staff J and RN Staff M acknowledged the stored items on 11/28/2017 at 12:50 pm.

The facility failed to provide a policy regarding under sink storage.


-Physician Staff KK observed in OR 1 on 11/28/17 at 8:21 AM revealed s/he removed surgical gloves and left the OR. Physician Staff KK failed to perform hand hygiene.

RN Staff U interviewed on 11/28/2017 at 9:47 am in the surgery area acknowledged Staff KK failed to perform hand hygiene.

- RN Staff V observed on 11/27/2017 at 5:24 PM in patient room # 106 revealed s/he entered the patient room, fixed the computer cords/machine, administered medications and left the patient room without performing hand hygiene.

RN Staff V interviewed on 11/27/2017 at 5:35 in the patient hallway acknowledged s/he forgot to perform hand hygiene during the administration of his/her medications.

- RN Staff J observed on 11/28/2017 at 8:00 am in patient room #104 with a multi dose vial of insulin and syringe. RN Staff J pulled insulin into the syringe, left the room with the vial and syringe, returned to room 104, confirmed the patient #2 identity, and administered the medication. No hand hygiene was performed when RN Staff J entered or exited the room and the injection was administered without performing donning gloves. RN Staff J performed hand hygiene when exiting the room with the computer on wheels (COW).

RN Staff J interviewed on 11/28/2017 at 8:20 am stated "I performed hand hygiene several times while in the room. I had to leave the room with the insulin to confirm the dose with another nurse before administering it. I just forgot to put the gloves on when I gave the injection."

- Certified Nursing Aide (CNA) staff UU observed 11/28/2017 at 8:05 am in patient room #104 obtaining vital signs on patient #2. CNA Staff UU entered and exited the room without hand hygiene.

Policy titled "Hand Hygiene" reviewed 11/28/2017 at 4:00 pm directed, hand hygiene is the single most important means of preventing the health care worker from transmitting infection to patients and themselves ...indications for use - World Health Organization (WHO) Guidelines...before patient contact, before aseptic task, after body fluid exposure risk, after patient contact and after contact with patient surroundings.


- RN Staff X observed on 11/28/2017 at 8:23 am in OR 1 revealed s/he carried the cystoscope (used on the patient observed in OR 1) with gloved hands across the room, through the hallway, and into the dirty room. RN Staff X donned proper protective equipment and cleaned the cystoscope, failing to accurately measure the water (a random amount was filled in the sink) and cleaning/disinfectant solution (a few squirts from the bottle were attempted and as it was close to the bottom of the bottle s/he took off the cap and poured a random amount in the water in the sink.)
RN Staff X interviewed on 11/28/2017 at 8:27 am in the dirty cleaning room acknowledged s/he failed to place the dirty cystoscope in a designated container used to carry the cystoscope after patient use and that s/he failed to ensure the accurate amount of water and disinfectant were used during the cleaning of the cystoscope.

RN Staff X re-measured the water and cleaning solution which verified the amount was incorrect.

The manufacturer's label for the cleaning/disinfectant solution MetriZyme directs one ounce of disinfectant to one gallon of water.

Policy titled "Endoscope Reprocessing using the Medivator" directed, manufacturer's instructions for cleaning, high-level disinfection ...will be used ...prior to removing the scope from the procedure room bedside cleaning will need to be completed; wipe scope down using an enzymatic soaked sponge, suction enzymatic detergent through scope, transport the scope, endo transport bag, to the decontamination area ...add the appropriate amount of enzymatic detergent to the water.


- RN Staff J observed on 11/28/17 at 8:00 am in patient room #104 with a multi dose vial of insulin and syringe. RN Staff J pulled insulin into the syringe, left the room with the vial and syringe, returned to room 104, confirmed the patient #2 identity, and administered the medication.
Infection Control RN Staff CC interviewed 11/28/17 at 1:30 pm confirmed medications that are not patient specific are not to be taken into patient rooms. Medications that are to be drawn out of a multi dose vial used for multiple patients are to be drawn up into the syringe in the medication room and only the syringe is to be taken into the patient's room.

The facility failed to provide a policy regarding multi-use vials in direct patient care area.


- CNA Staff L observed on 11/28/2017 at 11:00 AM obtained patient finger stick blood glucose for 3 different patients prior to the noon meal. CNA Staff L used the same glucometer equipment in patient room 105, room 109, and room104. CNA Staff L did not clean the equipment between patient uses.

- CNA Staff L interviewed on 11/28/017 at 11:15 AM stated "I should have wiped it down with sanitation wipes".
Policy titled "Blood Glucose Testing" directed, A hydrogen peroxide wipe should be used after each patient.

- Respiratory Therapy (RT) Staff N observed on 11/228/2017 at 8:30 AM used a pulse oximetry device (a device to measure oxygen levels in the blood) to check three patients oxygen saturation before and after their breathing treatments. RT Staff N did not clean the equipment between each observed patient use.

RT Staff N interviewed on 11/28/2017 at 8:50 AM stated "I should have cleaned it".

Policy titled "Infection control Patient Care: Cleaning of Equipment" indicated, non-invasive equipment should be wiped with the appropriate disinfectant to clean.


- Record review on 11/28/2017 at 1:00 pm of document "Room Air Flow Test" results dated 11/18/16 revealed air exchanges of 12 for surgical suite #2.

- Record review on 11/28/2017 at 1:00 pm of document "Room Air Flow Test" results dated 11/18/16 revealed air exchanges of 9 for the sterilization room.

Maintenance Staff O interviewed on 11/28/2017 at 4:30 PM stated s/he did not have documentation of more updated air exchanges and the facility is researching an upgrade of the HVAC control system. Maintenance Staff O further stated that adjustments could be made to redirect air flow in other areas of the facility to accommodate the surgical area.

Guidelines for Environmental Infection Control in Health-Care Facilities reviewed 11/28/17 at 2:30 pm recommends air changes in an operating room should be 15 and the sterilization room 10.


- Observation on 11/28/17 at 7:30 am revealed the pharmacy hood located in the nursing station medication room was on with an unattended medication located in the hood.

RN Staff K on 11/28/2017 at 7:30 am confirmed the medication was being mixed for an outpatient medication administration. S/he stated "the medication takes a very long time to mix so we start the process early for it to go into suspension." RN Staff K stated the inside of the hood is to be cleaned before use and the nursing staff are trained annually on the correct use of the equipment. S/he stated the nursing staff do not culture the inside of the hood and s/he verbalized uncertainty if culturing is ever done.

Infection Preventionist APRN Staff CC interviewed on 11/28/2017 at 1:30 pm stated that s/he was unaware of any culture monitoring of the pharmacy hood are performed.

Pharmacist Staff D interviewed on 11/28/2017 at 9:30 am does not perform surface cultures of the pharmacy hood and is not sure if infection control does.

The facility failed to provide a policy regarding bacterial surface testing of the pharmacy hood.

The USP (United States Pharmacopeia) Chapter <795> directs, Specifications for environmental quality and control, including but not limited to; Specifications and related personnel training, including competency assessment and evaluation of skill in aseptically preparing CSPs using visual observation as well as bacterial sampling of glove fingertips and "media-fill testing" at specified intervals; Evaluation and monitoring/testing of the environment in which compounding takes place and, if applicable, the adjacent "ante-" and "buffer" areas, including facility layout, design, environmental controls, restricted access, air quality standards and testing, surface characteristics, furnishings, cleaning and disinfection, procedures, and standards for personnel health, attire/cosmetics, cleansing/garbing/gloving, aseptic work practices, etc.

Based on staff interview, record, policy and procedure review the critical access hospital (CAH) failed to ensure physician orders were authenticated (the process or action of proving or showing something to be true, genuine or valid) for verbal orders in 2 of 2 Outpatient records reviewed (Patients # 34 and 35), for verbal orders in 3 of 30 records reviewed (Patients # 3, 15, and 17), and the History and Physical signed within the 48 hour timeframe for 1 of 30 records reviewed (Patient # 17). Failure of the facility to accurately and timely authenticate physician orders puts all staff at risk for receiving medications, treatments and care that is unsafe with the potential of causing harm.

Findings include:

Record review in the Outpatient Surgery area on 11/27/2017 at 12:57 pm revealed:

- 1 verbal order from 11/6/2017 for Patient # 35 failed to be authenticated by Staff VV (21 days late)
- 1 verbal order from 8/25/2017 for Patient #34 failed to be authenticated by the physician covering for Staff H, Advanced Practice Registered Nurse (APRN) (94 days late).
- 4 verbal orders for Patient #34 failed to be authenticated by Staff QQ, 8/29/2017 (90 days late), 8/31/2017 (88 days late), 9/20/2017 (68 days late), and 9/21/2017 (67 days late).

Interview in the Outpatient Surgery area on 11/27/2017 at 12:57 pm, Staff S, Registered Nurse (RN) verified the verbal orders for Patients #34 and 35 that failed to be authenticated by Staff VV and Staff QQ within the 24 hours per facility policy.


Record review in the Medical Records room on 11/29/2017 revealed:

- 1 verbal order for Patient #3 failed to be authenticated by Staff FF from 11/27/2017 (2 days late).
- 2 verbal orders for Patient #15 failed to be authenticated by Staff HH from 9/22/2017 (6 days late) and 9/25/2017 (3 days late).
- 2 verbal orders for Patient #17 failed to authenticated by Staff HH from 7/25/2017 (16 days late) and 7/26/2017 (15 days late).


Record review on 11/29/2017 revealed:

- The History and Physical (H&P) dated 7/24/2017 for Patient #17 failed to be authenticated by Staff HH until 8/18/2017 (25 days late).

Interview in the Medical Records room on 11/29/2017, Staff OO, Medical Records Staff verified the verbal orders for Patients #3, 15 and 17 failed to be authenticated by Staff FF and Staff HH within the facility's time frame of 24 hours. Staff OO also verified the H&P for Patient #17 failed to be authenticated by Staff HH within the facilities timeframe of 48 hours.

Document titled "Medical Staff ByLaws 2017" directed, verbal orders may be received by a nurse or other qualified personnel and subsequently signed by the physician or mid-level who originated the order...the ordering professional shall authenticate/sign, date and time the order within 24 hours.

Document titled "Medical Staff ByLaws 2017" directed, medical records will be considered delinquent if...medical history and physical examination are not dictated or documented, signed and on the patient's medical record within 48 hours of admission or no more than 30 days before admission.

The critical access hospital (CAH) reported performing an average of one procedure per day. Based on observation, document review, and staff interview, it was determined that the CAH failed to ensure surgical procedures were performed in a safe manner by failing to have enough Dantrolene or Revonto (specific medications used to treat Malignant Hyperthermia (MH - a rare life-threatening condition causing a severe high body temperature and inability to supply oxygen and remove carbon dioxide) usually triggered by exposure to general anesthesia drugs and/or succinylcholine (an neuromuscular blocking agent). The facility's failure to ensure a minimum amount of Dantrolene (36 -20 milligram (mg) vials) is available when anesthesia or succinylcholine are administered has the potential for delayed response to a medical emergency that could cause worsening of a patient's condition or death.

Findings Include:

- Observation in the surgery area on 11/27/2017 at 2:39 pm revealed the surgical malignant hyperthermia box contained 18 - 20mg vials of Dantrolene (specific medication used to treat malignant hyperthermia) with an expiration of 3/2019 and 6 - 20mg vials of Revonto (specific medication used to treat Malignant Hyperthermia) with an expiration date of 8/2017.

Operating Room (OR) Supervisor Registered Nurse (RN) Staff U interviewed in the surgery area on 11/27/2017 at 2:39 PM verified the 6 vials of Revonto were expired and shared they had been back ordered. Staff U was unaware a total of 36 vials of Dantrolene/Revonto were required.

Chief Executive Officer (CEO) Staff A interviewed in an empty patient room on 11/27/2017 at 3:00 pm was made aware the facility had only a total of 18 vials of Dantrolene available for patient use at this time and the required amount is 36 vials. Staff A was also made aware that until the facility obtained the full 36 vials required all surgeries have to be canceled and that the Centers for Medicare and Medicaid Services determined that the facility was in an Immediate Jeopardy (IJ - a situation which may cause potential or actual patient harm). Staff A verified with Pharmacy Director Staff D that no other Dantrolene was available in the pharmacy.

Certified Registered Nurse Anesthetist (CRNA) Staff F interviewed 11/27/2017 at 3:10 pm confirmed only 18 vials of Dantrolene were available and Succinylcholine (skeletal muscle relaxant used in surgery and emergency intubations) could be replaced by Rocuronium (a neuromuscular blocking agent used to relax skeletal muscle) which is not associated with the potential occurrence of malignant hyperthermia.

- Observation in the pharmacy on 11/27/2017 at 3:31 pm revealed the pharmacist removed the 20 vials of Succinylcholine from the anesthesia cart and placed them in the secured pharmacy refrigerator.

- Observation in the pharmacy on 11/27/2017 at 4:43 pm revealed the CAH had received 6 vials of Dantrolene and 12 vials of Revonto and placed them in the Malignant Hyperthermia box to total 36 usable vials of the rescue drug.

The CAH removed the IJ on 11/27/2017 at 4:43 pm by holding surgeries until a plan was in place, by removing succinylcholine from the anesthesia cart temporarily while the minimum amount of Dantrolene was not available, by using rocuronium in place of succinylcholine in their protocols, and finally, by obtaining the minimum amount of Dantrolene/Revonto (36 vials) recommended.

- The CAH's policy titled "Malignant Hyperthermia" directed, when a Malignant Hyperthermia (MH) crisis happens the Malignant Hyperthermia Association of the United States (MHAUS) recommendations for treatment...will be followed, under the direction of the CRNA and the surgeon...if more medications or supplies are needed in the event of a crisis, local hospitals, including, but not limited to; Marysville, Sabetha, and Hiawatha, will be contacted at that time.

- According to the Malignant Hyperthermia Association of the United States (MHAUS), Malignant Hyperthermia is a potentially fatal disease passed down through families. The signs of MH include muscle rigidity, rapid heart rate, high body temperature, muscle breakdown and increased acid content. Immediate treatment with the drug Dantrolene usually reverses the signs of Malignant Hyperthermia. It is recommended that 36, 20mg vials of Dantrolene or Revonto or Ryanodex 3, 250mg vials be available for use within 10 minutes of the decision to treat a patient for Malignant Hyperthermia.

Based on staff interview, document, policy and procedure review the critical access hospital (CAH) failed to ensure all policies were reviewed at least annually. Failure of the CAH to ensure all policies and procedures are reviewed annually puts all patients at risk for receiving care that lacks current recommendations and changes needed to provide safe patient care according to State and Federal guidelines and regulations, and fails to ensure staff are appropriately educated to give safe patient care.

Findings include:

- Observation on 11/27/2017 - 11/29/2017 of various departments in the facility revealed policies that failed to be updated within this last year.

Interview in the team conference room on 11/29/2017 at 5:30 pm, Chief Executive Officer (CEO) Staff A explained the facility has been in the process of updating the policies and procedures in each department. The facility failed to update all policies for the year 2017.

- Document titled "Periodic Evaluation Report" reviewed 11/30/2017 at 11:00 am directed, department policies and procedures are reviewed and approved by the hospital-wide policy and procedure review committee, Medical Staff, and the Board of Trustees on a rotating basis.

- Review of Medical Staff and Governing Body meeting minutes from the past year failed to show documentation of policy and procedure review.

Based on interview and document review the critical access hospital (CAH) failed to ensure the quality and appropriateness of the diagnosis and treatment furnished by the CAH physicians was evaluated by an outside entity. Failure of the CAH to ensure an evaluation of medical staff was performed by an outside entity puts all patients at risk for unsafe, poor quality care that does not meet industry standards according to State and Federal regulations.

Findings include:

Chief Executive Officer (CEO) Staff A interviewed on 11/29/2017 at 4:15 pm stated at present only an internal review of the medical staff occurs because "we are not part of a network".

Document titled "Medical Staff Bylaws 2017" reviewed 11/29/2017 at 5:00 pm directed, Peer Review Committees Authorized By Statute...In recognition of the responsibility of the Medical Staff to evaluate and improve the quality of care provided by its Members within the hospital and to perform or assist in the performance of the peer review functions...the Medical Staff as a whole is hereby designated as a peer review committee. Central verification services utilized by the Medical Staff and Hospital shall be considered a peer review committee of the Medical Staff.

Based on interview and document review the critical access hospital (CAH) failed to ensure the quality and appropriateness of the diagnosis and treatment furnished by the CAH physicians was evaluated by an outside entity. Failure of the CAH to ensure an evaluation of medical staff was performed by an outside entity puts all patients at risk for unsafe, poor quality care that does not meet industry standards according to State and Federal regulations.

Findings include:

Cief Executive Officer (CEO) Staff A interviewed on 11/29/2017 at 4:15 pm stated at present only an internal review of the medical staff occurs because "we are not part of a network".

Medical Staff Bylaws, 2017, reviewed 11/29/2017 at 5:00 pm directed, Peer Review Committees Authorized By Statute...In recognition of the responsibility of the Medical Staff to evaluate and improve the quality of care provided by its Members within the hospital and to perform or assist in the performance of the peer review functions...the Medical Staff as a whole is hereby designated as a peer review committee. Central verification services utilized by the Medical Staff and Hospital shall be considered a peer review committee of the Medical Staff.