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Based on observation, review of professional literature, review of policy and procedure, and staff interview, the Critical Access Hospital (CAH) failed to ensure staff followed professional standards of care related to infection control practices on 2 of 3 days of survey (November 17 and 18, 2014). Failure to follow established infection control practices may allow transmission of organisms and pathogens to patients.

Findings include:

- Observation of the operating room (OR) on 11/17/14 at 1:15 p.m. with an OR staff member (#8), showed an anesthesia machine set up for patient use with an attached breathing circuit and anesthesia/face mask, and attached oxygen and gas measurement tubing. The top shelf of the anesthesia machine showed supplies set up for patient use under a towel including two laryngoscope blades attached to handles, three oral airways, and a tracheal tube contained in an open package. Observation showed a 10 milliliter (ml) syringe with the plunger drawn back to the 9 ml mark, attached to the cuff of the tracheal tube. The package of the tracheal tube stated, "Sterile until damaged or open." Further observation of the OR showed a cupboard which contained open packages of patient supplies including a yankauer and breathing circuit.

The staff member (#8) stated the CAH used the OR for podiatry and endoscopy procedures with administration of anesthesia. She stated staff last used the anesthesia machine and supplies on 10/16/14 and confirmed the next surgical procedure day as 11/20/14.

Staff failed to store medical supply items in a manner to prevent contamination and maintain sterility. Attaching, opening, and placing medical supply items prior to immediate use on a patient increased the risk for contamination.

Observation of the emergency room (ER) occurred on 11/18/14 at 9:45 a.m. with an administrative nurse (#4) and showed a crash cart. The crash cart included several uncovered/unpackaged laryngoscope blades and oral airways throughout the drawers of the cart. Staff failed to contain the blades and airways in a manner to prevent contamination.

During an interview on 11/19/14 at 9:30 a.m., an administrative nurse (#6) stated the above practices were unacceptable. The nurse (#6) stated staff should not prepare and open patient care supplies prior to immediate use on a patient and should store patient supplies to prevent contamination.

- Review of the Centers for Disease Control and Prevention's "Frequently Asked Questions (FAQS) Regarding Safe Practices for Medical Injections," page 6, "Questions About Multi-dose Vials," updated 02/09/11, stated, ". . . 4. When should multi-dose vials be discarded? . . . the United States Pharmacopeia . . . General Chapter 797 . . . recommends the following for multi-dose vials of sterile pharmaceuticals: If a multi-dose has been opened or accessed (e.g., needle punctured) the vial should be dated and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial. . . ."

Review of the policy "Medication Expirations" occurred on 11/18/14. This policy, reviewed/revised October 2014, stated, ". . . 5. Opened multi-dose vials will be dated when opened and are expired 6 months after date of opening. . . ."

Observation of medications stored behind the nurses station occurred on 11/18/14 at 11:35 a.m. with a staff nurse (#10). A locked cupboard contained the OR medication box. Observation of the contents in the OR box showed three different multi-dose medication vials (one Marcaine vial and two Lidocaine vials). Labels on the vials identified staff opened/punctured the vials in May, July, and October 2014.

During an interview on 11/18/14 at 11:45 a.m., an administrative nurse (#4) stated, according to CAH policy, multi-dose medications expired six months from the time of opening/puncturing. The nurse (#4) stated she did not know the manufacturer's specifications for expiration of the above opened/punctured multi-dose medications and confirmed the CAH failed to follow nationally recognized guidelines for multi-dose medications.

Based on observation, review of dietary standards, policy review, and staff interview, the Critical Access Hospital (CAH) failed to ensure dietary services provided in accordance with recognized dietary practices regarding sanitation in 1 of 1 kitchen. Failure to follow recognized dietary practices regarding warewashing and sanitization of surfaces placed patients and staff consuming food prepared in the kitchen at risk of contracting a food borne illness.

Findings include:

The North Dakota Requirements For Food and Beverage Establishments, North Dakota Administrative Code, Chapter 33-33-04, adopted 04/01/12, stated, "33-33-04-53.5 Warewashing equipment - Determining chemical sanitizer concentration. Concentration of the sanitizing solution shall be accurately determined by using a test kit or other device."

Review of the CAH policy and procedure "maintenance of Automatic Dishwasher" occurred on 11/18/14. The policy, dated November 2013, stated, "PURPOSE: effective care and use of dish machine POLICY: maintenance of dish machine with rinse agent . . . PROCEDURE: . . . wash, rinse and sanitizer will work automatically when turned on. . . . Check temperature indicated on dish machine to ensure safe temperature. . . ." The policy failed to address checking and recording the chemical concentration of the rinse cycle.

Observation of the dietary department occurred on 11/17/14 at 1:00 p.m. with a dietary staff member (#1). Observation identified the dishmachine as a chemical sanitizer and indicated the appropriate temperature for both the wash and rinse cycles should be 120 degrees Fahrenheit (F). Observations of dishmachine cycles showed the wash cycle reached 165 degrees F and the rinse cycle reached 149 degrees F. The staff member (#1) stated the CAH had no system in place for monitoring temperatures or chemical concentration in the dishmachine.

Observation also showed a bucket which the staff member (#1) stated contained a chlorine solution used for cleaning surfaces. The staff member (#1) stated staff do not check the concentration of the chlorine in the bucket.

Additional observations in the dietary department occurred on 11/18/14 at 1:15 p.m. with the dietary staff member (#1) and a representative (#2) of the company that services the dishmachine. The dietary staff member (#1) stated she and a maintenance staff member (#7) had determined the dishmachine was not dispensing chemical and called the representative to fix the machine. The representative (#2) stated, for the dishmachine to properly sanitize, the temperature should be at least 120 degrees F but no greater than 150 degrees F to avoid "burning off" the chlorine.

An interview with the dietary staff member (#1) and a consulting dietician (#3) occurred on 11/19/14 at 10:15 a.m. The staff members agreed the facility currently had no system in place for monitoring chemical concentration of the sanitizing bucket or the dishmachine and no system for monitoring the temperatures in the dishmachine.

Based on review of policy and procedure, record review, and staff interview, the Critical Access Hospital (CAH) failed to ensure staff administered treatment and medications in accordance with physician orders and accepted standards of practice for 2 of 4 closed surgical patient (Patient #14 and #17) records reviewed. These failures have the potential to place patients at risk of improper care.

Findings include:

Review of the policy "Physician's Orders" occurred on 11/19/14. This policy, reviewed/revised November 2014, stated,
". . . A. All orders for . . . therapeutics shall be done by the physician . . . C. Method. 1. Obtain orders. . . . 2. Note orders . . . and complete . . ."

During an interview on 11/19/14 at 10:00 a.m., a staff nurse (#11) stated nursing staff placed an intravenous (IV) line on all patients upon admission to the CAH for a surgical procedure and attached a bag of Lactated Ringers (a solution to replenish fluids and electrolytes) for infusion as a routine practice.

- Review of Patient #14's medical record occurred on 11/17/14 and identified the CAH admitted the patient on 06/13/14 for a podiatry procedure. A pre-operative (pre-op) nurses note, dated 06/13/14 at 7:00 a.m., stated, ". . . IV started." and a pre-operative checklist showed, ". . . Pre-op Medications. Type: Ancef [an antibiotic] . . ." A pre-op physician order listed, ". . . 1 gram Ancef IV . . ." and a post-op physician order listed, ". . . Ketorolac [used to decrease swelling and treat pain] 30 mg [milligrams] IM [intramuscular] [times] 1 immediately post-op . . ."

Review of Patient #14's record failed to include evidence staff administered the Ancef and Ketorolac as ordered by the physician. The record failed to include a physician order for the IV, including an order for the type of IV fluid infusion.

- Review of Patient #17's medical record occurred on 11/18/14 and identified the CAH admitted the patient on 08/22/14 for a podiatry procedure. A pre-op nurses note, dated 08/22/14 at 8:15 a.m., stated, "20 [gauge] [saline lock] in [patient's] [left] wrist . . ."

The record failed to include a physician order for the IV, including an order for the type of IV fluid infusion.

During an interview on 11/19/14 at 10:00 a.m., an administrative nurse (#4) confirmed the above patient records failed to include orders for an IV and IV fluids and failed to show whether staff administered medications as ordered by the physician.

Based on record review, policy review, and staff interview, the Critical Access Hospital (CAH) failed to ensure staff kept current care plans for each patient for 3 of 5 closed acute patient records (Patient #8, #9, and #10) reviewed. Failure to develop care plans based on the patients' current needs limited staffs' ability to ensure continuity of care for the patients.

Findings include:

Review of the CAH policy and procedure "Care Plans and the Nursing Process" occurred on 11/19/14. The policy, dated April 2013, stated, "POLICY: The nursing process, including assessment, planning, intervention, and evaluation will be documented for each hospitalized patient from admission through discharge. PURPOSE: To provide a means by which to plan for and communicate appropriate patient care while providing a framework for establishing the standard of care in a given situation. . . . B. The Nursing Care Plan will be completed for patients admitted . . . inpatient . . . 4. The plan will include nursing measures that will restore, maintain, or promote the patient's well being. . . ."

- Patient #8's medical record, reviewed on 11/18/14, identified the CAH admitted the patient on 05/13/14 with abdominal pain and intractable (not responding to treatment) nausea and vomiting. The patient's care plan, initiated on 05/13/14, lacked individualized interventions to address the patient's abdominal pain, nausea, or vomiting.

- Patient #9's medical record, reviewed on 11/18/14, identified the CAH admitted the patient on 06/04/14 with a urinary tract infection (UTI), recent right tibial fracture immobilized with non-weight bearing status, and dehydration. The patient's care plan, initiated on 09/27/12 and modified on 12/04/12, lacked individualized interventions to address the UTI, tibial fracture, or dehydration.

- Patient #10 medical record, reviewed on 11/18/14, identified the CAH admitted the patient on 06/22/14 with septicemia (infection in the blood stream), insulin dependent diabetes mellitus, hypertension (high blood pressure), and chronic obstructive pulmonary disease (COPD). The record also indicated Patient #10 had a Foley catheter. The patient's care plan, initiated on 06/22/14 and modified on 06/25/14, lacked individualized interventions to address the Foley catheter, septicemia, diabetes, hypertension, or the COPD.

During an interview on 11/18/14 at 3:35 p.m., an administrative nurse (#4) agreed the care plans for Patient #8, #9, and #10 lacked individualized interventions. The nurse (#4) stated the CAH's electronic medical record generated the patient care plans, but staff have the ability to individualize interventions.

TRANSFER DOCUMENTS
1. Based on record review, policy review, and staff interview, the Critical Access Hospital (CAH) failed to ensure a complete medical record for 1 of 1 closed medical record of an emergency department (ED) patient (Patient #2) transferred to another hospital for treatment. Failure to ensure a complete medical record limited the CAH's ability to ensure the patient received appropriate care related to the patient's medical condition.

Findings include:

Review of the CAH policy and procedure "Transfer of Patients" occurred on 11/18/14. The policy, dated August 2013, stated, "PURPOSE: To provide efficient, safe transfer of patients to other facilities. . . . ESSENTIAL STEPS: . . .
2. . . . The physician informs the patient or responsible party of the reasons for and the risks/benefits of the transfer.
3. The patient's written consent will be obtained.
a. The transferring physician will contact the receiving physician to discuss the patient's clinical information and obtain the receiving physician's consent to accept the patient. The receiving physician's name will be documented on the 'Patient Transfer Sheet'. No patient will be transferred until a receiving physician has consented to accept the patient.
b. The nurse will contact the receiving facility to obtain the receiving facilities [sic] consent to provide a bed for patient. . . .
5. The physician will determine the mode of transportation to be used for transfer (private vehicle . . .) . . . This information shall be documented on the 'Patient Transfer Sheet.' . . .
8. . . . information necessary for continuity of patient care is copied and sent with the patient or faxed to the receiving facility . . ."

- Review of Patient #2's closed ED record occurred on 11/17/14 and identified the patient presented to the ED on 09/27/14 with severe abdominal cramping, bleeding, and passing clots. The record showed the patient was 11.5 weeks pregnant.

A physician's note, dated 09/27/14 stated, ". . . ASSESSMENT: 1) Miscarriage. PLAN: I did talk to one of the OB-GYN (obstetrics gynecology) doctors at [hospital name] and we plan to send her to emergency room to get an ultrasound . . . she will be going by private vehicle. . . ." The note failed to identify the name of the receiving physician.

The record lacked evidence the patient signed a consent for the transfer, a physician at the receiving facility agreed to accept the patient, the nurse contacted the receiving facility, or that staff sent all information necessary for continuity of care with the patient or faxed it to the receiving facility.

During an interview on 11/18/14 at 3:35 p.m. an administrative nurse (#4) agreed staff did not complete the required documentation prior to transferring Patient #2 to another hospital.


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TREATMENT PLAN
2. Based on record review and staff interview, the Critical Access Hospital (CAH) failed to ensure a complete medical record including development of a treatment plan for 1 of 1 cardiac rehabilitation patient (Patient #18) record reviewed. Failure to develop a treatment plan for cardiac rehabilitation limited the CAH's ability to establish an individualized course of treatment and evaluate the patient's progress.

Findings include:

Review of Patient #18's closed medical record occurred on 11/17/14 and identified the patient began cardiac rehabilitation on 07/14/14 after right coronary artery stent placement. The record lacked a treatment plan relating to Patient #18's rehabilitation program including specific focus areas, measurable goals, interventions, and outcomes.

During an interview on 11/17/14 at 3:50 p.m., a cardiac rehabilitation staff member (#8) confirmed Patient #18's record lacked a treatment plan related to cardiac rehabilitation.

Based on bylaws review, policy review, record review, meeting minutes review, and staff interview, the Critical Access Hospital (CAH) failed to ensure the quality assurance (QA) program evaluated all patient care services and other services affecting patient health and safety for 12 of 12 months reviewed (October 2013-September 2014). Failure to ensure departments report to the QA Committee as scheduled limits the CAH's ability to identify risk factors affecting patient care and implement corrective action if necessary.

Findings include:

Review of the "Medical Staff Bylaws Wishek Hospital-Clinic Association" occurred on 11/17/14. These bylaws, approved 02/21/12, stated, ". . . Article VII . . . Section 2. . . . 4. Quality Assurance Committee: The Wishek Hospital quality improvement plan shall be facility wide; to include all departments whose activities directly influence patient care. . . ."

Review of the CAH's "Quality Assessment and Performance Improvement Plan" occurred on 11/18/14. This plan, revised 06/13, stated,
". . . Purpose: The purpose and intent is to provide a comprehensive Quality Assessment and Performance Improvement Program for the WHCA [Wishek Hospital Clinic Association] through the detection and correction of factors hindering the provision of quality and appropriateness of health care. . . .
Procedure: All services and departments within the WHCA shall participate in the Quality Assessment and Performance Improvement Program. Each supervising Department Manager shall be responsible for implementation of quality improvement activities to . . . effectively identify and resolve high priority patient care problems.
. . ."

Review of the "Wishek Hospital Clinic Association Quality Assessment and Performance Improvement Reporting Schedule," occurred on 11/18/14. This document, updated 09/13, indicated Pharmacy should report quarterly in January, April, July, and October.

Reviewed on 11/18/14, the January, April, July, and October 2014 QA meeting minutes and department monitors for fourth quarter 2013, first quarter 2014, second quarter 2014, and third quarter 2014 lacked evidence pharmacy submitted a QA report. Upon request the CAH did not provide evidence the pharmacy department reported for the timeframe October 2013 - September 2014 (fourth quarter 2013, first quarter 2014, second quarter 2014, and third quarter 2014).

During interview on 11/18/14 at 8:45 a.m., a pharmacy staff member (#12) stated she had not submitted a QA report regarding pharmacy services to the QA Committee in the past year.

During interview on 11/18/14 at approximately 3:15 p.m., an administrative nursing staff member (#6) responsible for QA confirmed the pharmacy department had not submitted a QA report in the past year.