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Based on observation, policy and procedure review, review of manufacturer's instructions, and staff interview, the Critical Access Hospital (CAH) failed to ensure the provision of services by failing to ensure the secure storage and safe administration of medications and failing to follow pharmacy policy regarding controlled substances (Refer to C276); failing to ensure staff followed manufacturer's instructions for the use and testing of chemicals used for cleaning and disinfecting equipment and supplies for the operating room and emergency department (Refer to C278); failing to ensure the dietary manager had the appropriate education/certification, dietary staff properly measured and tested sanitizing solutions per manufacturer's instructions, and dietary staff maintained a clean kitchen environment (Refer to C279); and failing to initiate an agreement with the consulting dietician (Refer to C289). Failure to ensure the provision of services placed patients at risk of receiving improper care and could result in the patients experiencing adverse consequences.

Based on observation, review of hospital policy, and staff interview, the Critical Access Hospital (CAH) failed to store medications in a manner that prevented unauthorized access, failed to follow hospital policy regarding controlled substances, and failed to dispense medications in accordance with hospital policy during 2 of 3 days of survey (July 9 and 10, 2018). Failure to store all medications securely may result in unauthorized access to medications. Failure to confirm patient identity may result in medication errors and adverse reactions.

Findings include:

MEDICATION ADMINISTRATION

Review of the CAH policy titled "Identification of Patients" occurred on 07/11/18. This policy, revised 06/28/16, stated, ". . . Presentation Medical Center (PMC) utilizes at least two patient identifiers to confirm identification of patients. Identification of inpatients is made using the patient's name and medical record number on the patient ID bracelet. . . . Each patient should be instructed that the bracelet is not to be removed. In the event that the bracelet has to be removed for treatment of the patient, it must be placed on the other wrist immediately. . . . In the event that it is not appropriate to place the ID bracelet on the patient's wrist, another extremity may be used. If there is not an appropriate or available extremity, the ID bracelet may be placed on the patient's bed. . . ."

Observation on 07/09/18 at 2:30 p.m. showed a staff nurse (#12) administer medications to Patient #1. The patient's arm band was located on the sharps container hanging on the patient's wall.

Observation on 07/09/18 at 2:40 p.m. showed a staff nurse (#13) administer medications to Patient #2. The patient's arm band was located on the sharps container hanging on the wall.

Observations on 07/10/18 at 8:16 a.m. showed a staff nurse (#14) administer medications to Patient #3. The patient's arm band was located on the sharps container hanging on the wall.

Observation on 07/10/18 at 8:30 a.m. showed a staff nurse (#14) administer a medication to Patient #1. The patient's arm band was located on the sharps container hanging on the wall.

CONTROLLED SUBSTANCE INVENTORY

Review of the CAH policy titled, "Controlled Substances" occurred on 07/11/18. This undated policy stated, "Pharmacy will also maintain a perpetual inventory of all controlled substances located in the pharmacy department. Pharmacy will inventory the controlled substance weekly and maintain a record of inventory. . . ."

- During observation of the Pharmacy Department on 07/10/18 at 10:00 a.m., a pharmacy staff member (#3) stated staff periodically complete inventory of controlled substances in the pharmacy department. The Narcotic Checks sheet identified staff completed the last narcotic inventory on 06/21/18.

DRUG STORAGE

Review of the policy, "Monthly Medication and Area Checks and Drug Storage Requirements" occurred on 07/11/18. This undated policy stated, "Drugs must be stored under proper . . .security . . ." This policy did not address who the hospital had authorized to access drug storage areas.

During observation of medication storage areas on 07/10/18 at 10:00 a.m., a pharmacy staff member (#3) identified a locked room on the first floor that contained intravenous (IV) solutions and additives. The IV solutions included normal saline and Dextrose of 50 milliliters (ml) to 1000 ml. IV additives included ampicillin, azythromycin, cefazolin, cefoxitin, ceftazidime, gentamicin, heparin, lidocaine, magnesium sulfate, piperacillin, tobramycin, vancomycin, dopamine, mannitol, potassium chloride, and ertapenem.

During interview on 07/11/18 at 10:13 a.m., a facility pharmacist (#3) stated staff having access to the IV storage room included pharmacy staff, nursing staff, housekeeping, and maintenance staff. The facility pharmacist (#3) also stated she does not have an inventory list of the products stored in the IV room, therefore she would be unaware of any product missing.

- Observation of the Physical Therapy department, on 07/10/18 at 8:00 a.m., showed an unlocked cupboard with topical medications used for physical therapy treatments. A supervisory staff member (#5) stated staff lock the door to the room when it is not occupied, but the maintenance department has a master key to the room.

- Observation of the Respiratory Therapy department, on 07/10/18 at 9:45 a.m., showed an unlocked cupboard with medications used for patient nebulizer treatments. A supervisory staff member (#7) stated staff lock the door to the room when it is not occupied, but the maintenance department has a master key to the room.

Based on observation, review of hospital policy, review of manufacturer's instructions, and staff interview, the Critical Access Hospital (CAH) failed to ensure staff followed manufacturer's instructions for the use and testing of chemicals used for cleaning and disinfecting equipment and supplies for 1 of 1 operating room and 1 of 1 emergency department. Failure to follow appropriate infection control practices and manufacturer's instructions may result in transmission of organisms and pathogens from equipment to patients.

Findings include:

- Observation of the operating room on 07/10/18 at 1:15 p.m. with a surgical nurse (#9) showed an Olympus OER Pro machine used for disinfecting endoscopes. The manufacturer's instructions for this machine, reviewed 07/10/18, stated, ". . . Prior to reprocessing, check the concentration of the disinfectant solution using a test strip to verify that the concentration of disinfectant solution meets the minimum recommended concentration. Replace the disinfectant solution when it fails to meet the minimum recommended concentration or beyond the specified use life. The use life of the disinfectant solution may vary depending on many factors . . . Routinely check the concentration of the disinfectant solution with the test strip before performing endoscope disinfections. If this check is not performed, the disinfection process may be ineffective. Replace the disinfectant solution when it fails to meet the minimum recommended concentration . . . "

During interview on 07/11/18 at 10:15 a.m., a surgical registered nurse (#10) stated staff do not test the concentration of the disinfectant of the Olympus machine when disinfecting endoscopes.

- Review of the policy "Decontamination of Reusable Equipment and Instruments" occurred on 07/11/18. This policy, dated December 2012, stated, ". . . Emergency and Outpatient Departments: Instruments and equipment used in the Emergency Department are returned to Central Supply for decontamination . . . Recyclable instruments from disposable suture trays are returned to Central Supply, decontaminated, air dryed [sic] and placed in provided buckets. . . . Operating Room: Instruments used in OR [operating room] are returned to OR [operating room] clean up room via trays or carts. They are cleaned and taken to the Central Supply central room for packaging and sterilization. Procedure for decontamination of instruments [sic] and equipment. Contaminated instruments are placed in the sink with warm water and cleaning product . . ."

The Ecolab instrument presoak solution manufacturer's instructions, reviewed 07/11/18, stated, "use 1/8 ounce of solution to one fluid ounce of water."

During interview on 07/11/18 at 11:00 a.m., a licensed practical nurse (LPN) (#11) working in Central Supply stated she uses one squirt of the enzymatic presoak solution to unmeasured water in the sink. The LPN (#11) confirmed she does not follow manufacturer's instructions for mixing the enzymatic presoak solution.

Based on observation, review of the Licensing Rules for Hospitals in North Dakota, review of the 2017 Food and Drug Administration (FDA) Food Code, review of manufacturer's instructions for use, review of hospital policy, and staff interview, the Critical Access Hospital (CAH) failed to ensure 1 of 1 designated employee (Staff member #4) responsible for the food service of the facility was qualified based on education or specialized training; and failed to follow recognized dietary practices regarding food service sanitation in 1 of 1 kitchen. Failure to ensure completion of a food service course allowed the designated employee to manage the operation of food service without the appropriate education/credentials as required. Failure to ensure the correct concentration of chemical sanitizer for dishware and food preparation surfaces and failure to ensure cleanliness of fans has the potential to result in a food borne illness or food contamination.

Findings include:

STAFF QUALIFICATIONS

- Review of the "Licensing Rules for Hospitals in North Dakota" revised on July 1, 2017, stated, ". . . Dietary Services. . . . The hospital shall designate an employee, to be responsible for the total food service of the facility. If this employee is not a licensed registered dietitian, the employee must have at least completed a food service course approved by the academy of nutrition and dietetics or its predecessor or successor organization . . ."

During interview on 07/10/18 at 10:30 a.m., a dietary staff member (#4) identified herself as the dietary manager in charge of the dietary department. The staff member (#4) confirmed she was not a licensed registered dietitian and had not completed a food service course approved by the academy of nutrition and dietetics.

DISINFECTION AND CLEANING

- The 2017 FDA Food Code, Annex 3 - Public Health Reasons/Administrative Guidelines, page 507, states ". . . The effectiveness of chemical sanitizers can be directly affected by the . . . concentration of the sanitizer solution used. . . . Therefore, it is critical to sanitization that the sanitizers are used consistently with the . . . label. . . ."

Review of the policy "Sanitizing Solution," occurred on 07/11/18. This policy, dated 1998, stated, "Policy and Purpose: To assure safe and sanitary conditions in all food preparation/service areas. Procedures: Sanitizing solution will be mixed according to label directions in the quantity of 1 gallon per shift. . . ."

- The 2017 FDA Food Code, Annex 3 - Public Health Reasons/Administrative Guidelines, page 430, states, ". . . Food Storage. Pathogens can contaminate and/or grow in food . . . Drips of condensate and drafts of unfiltered air can be sources of microbial contamination for stored food. . . ."

Review of the policy "Proper cleaning and sanitizing of equipment" occurred on 07/11/18. This policy, dated 1998, stated, "Policy and Purpose: To assure all equipment used is cleaned and sanitized properly. . . . H. Kitchen counters: The kitchen counters are to be cleaned upon completion of a task and as needed. Special care and attention should be used when changing from raw to cooked food items or from dirty to clean dishes, equipment, and surfaces. . . Counters are cleaned first . . . then wiped with sanitizer. . . . W. Fans: Cleaned monthly. . . ."

Observation of the kitchen occurred on 07/10/18 at 10:40 a.m. with the dietary manager (#4) showed the following:
- Large accumulation of black dust/debris on the condenser fans and wiring in two walk-in coolers (walk-in cooler #1 and #2).
- Three compartment sink, used to wash pots, pans, and items that do not fit in the automatic dishwashing machine: the dietary manager tested the concentration of the quaternary sanitizing solution in the third sink, with a result of 100 parts per million (ppm). Review of the manufacturer's instructions on the bottle of "22 Multi-Quat Sanitizer" which is automatically dispensed into the third compartment of the sink and into sanitizing buckets stated, "To sanitize food contact surfaces, . . . : Use 22 Multi-Quat Sanitizer to sanitize pre-cleaned hard non-porous surfaces of . . . food utensils, dishes, silverware, glasses, sink tops, countertops . . . Apply a use-solution of 1.04 oz. [ounces] to 2.72 oz of 22 Multi-Quat Sanitizer per 4 gallons of 400 ppm [parts per million] hard water (150-400 ppm active quat) or 1.36 oz. to 2.72 oz. of 22 Multi-Quat Sanitizer per 4 gallons of 500 ppm hard water (200-400 ppm active quat). . . ."
- Bucket of quaternary sanitizer in the kitchen: the dietary manager tested the concentration of the solution with a result of 100 ppm.
- Review of the May and June sanitizing logs for the three compartment sink, the diet-aide bucket, the cook's bucket, and the dish-room bucket, showed dietary staff recorded concentrations of 100 ppm for the quaternary solution.

During interview with the dietary manager (#4), at 11:30 a.m. on 07/10/18, the dietary manager confirmed staff should clean the fans and wiring and stated she didn't think they were included on the cleaning schedule, and confirmed staff should follow the manufacturer's instructions on the label for the sanitizer concentration.

Based on policy/procedure review and staff interview, the Critical Access Hospital (CAH) failed to have an agreement, contract, or arrangement with 1 of 1 consulting dietitian (#8). Failure to have an agreement with the consulting dietitian does not allow the CAH to evaluate and ensure the services are being provided to meet the dietary needs of the patients.

Findings include:

Review of the policy, "Acute Care Nutrition Assessment" occurred on 07/11/18. This policy, dated February 2008, stated, "Policy and Procedure: Nutrition assessments will be done as requested by the patient's physician or as necessary by nursing. . . Procedure: 1. The patient will be visited by the Food Service Director. At this time the following may be discussed. A. Like/Dislikes B. Problems eating . . . C. Weight/weight history . . . D. Current medications if relevant. . . . 3. The information gathered will be forwarded to the Consulting Dietician for review and assessment. 4. Any pertinent information gathered or recommendations mad (sic) will be shared with other staff members through dietary progress notes. . . ."

Review of the policy, "Swing Bed Nutrition Care" occurred on 07/11/18. This policy, dated February 2008, stated, "Policy: Initial nutritional assessments will be completed within 5 days of admittance to swing bed status by the Food Service Director and will than (sic) be forwarded on the Consulting Dietician who will review, assess, and return them back within 2 weeks. .. . Procedure: . . . 2. The Food Service Director will complete a Nutrition Risk Assessment Form, . . . It will then be forwarded to the Consulting Dietician for review and recommendations to be returned within 2 weeks. . . ."

During interview on 07/10/18 at 10:30 a.m., a dietary staff member (#4) identified herself as the dietary manager in charge of the dietary department. The staff member (#4) confirmed she was not a licensed registered dietitian and had not completed a food service course approved by the academy of nutrition and dietetics. The staff member stated she is in contact with a consulting dietitian through e-mail, telephone, and text when there are any concerns or questions regarding patients. The staff member stated the consulting dietitian e-mails or mails her assessments to the CAH.

During an interview the afternoon of 07/10/18, an administrative staff member (#1) stated the CAH does not have a contract agreement with the consulting dietitian.

Based on observation and staff interview, the Critical Access Hospital (CAH) failed to maintain a roster identifying each practitioner's specific surgical privileges for 1 of 1 surgical suite and the area/location where staff complete scheduling of surgical procedures. Failure to maintain a current practitioner privileges roster in the surgical area, has the potential to place all surgical patients at risk for procedures performed by practitioners without privileges or qualifications.

Findings include:

Observation of the surgical unit on 07/10/18 at 1:15 p.m. with the surgical supervisor nurse (#9) identified no roster available in the surgical unit that identified the surgical practitioner's privileges.

During interview on 07/10/18 at 1:15 p.m., the surgical supervisor nurse (#9) stated the CAH keeps the practitioner's surgical privileges listing in the human resource department and is not available in the surgical unit.

Based on policy review, record review, and staff interview, the Critical Access Hospital (CAH) failed to have a network hospital or a quality improvement organization (QIO) or equivalent evaluate the quality and appropriateness of the diagnosis and treatment furnished for 1 of 3 active medical staff physician's (Provider #1) peer review records reviewed from 2017. Failure to have a network hospital or a QIO or equivalent evaluate the quality and appropriateness of the diagnosis and treatment provided by a physician limited the CAH's ability to ensure the physician furnished quality and appropriate care to the CAH's patients.

Findings include:

Review of the policy "Medical Services Function: Peer Review" occurred on 07/11/18. This policy, dated 3/2017, failed to require evaluation of the quality and appropriateness of the diagnosis and treatment furnished by doctors of medicine or osteopathy at the CAH by a network hospital or QIO or equivalent for all physicians.

Reviewed on 07/11/18, the 2017 medical staff peer review records failed to include evidence a network hospital or a QIO or equivalent evaluated the quality and appropriateness of the diagnosis and treatment furnished by Provider #1 in 2017.

During interview on 07/11/18 at approximately 9:55 a.m., an administrative staff member (#5) confirmed Provider #1 provided services to the CAH's patients and the CAH did not have a network hospital or QIO or equivalent evaluate the quality and appropriateness of the diagnosis and treatment furnished by this physician in 2017.