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Based on record review, personnel interview and facility policy review, the facility failed to collect, track, trend, and analyze quality improvement data from all departments of the facility. This resulted in the Condition of Participation for Periodic Evaluation and Quality Assurance Review.

The findings included:

A review of the record titled, "Medical Staff Committee Meeting" revealed there was no data collected from Physical Therapy, Outpatient Services, Medical Records, Dietary, Surgery, Emergency Room, and Nursing Services.

Interview with Personnel 1 on the afternoon of 08/20/20, when asked who reviews/audits the physician credential files for quality, Personnel 1 stated there was no quality review for physician appropriateness of care or credentialing.

Review of the policy titled, "Quality Assurance and Improvement Plan" stated in part, "Quality Coordinator: The QC will direct the monitoring and evaluation activities of each department/service, and assure that each is performed appropriately and effectively. The QC will provide support services necessary for quality improvement by:
*Reviewing Quarterly Quality Reports; tracking and trending data
*Offer support as needed to department managers
*Accumulate data, track and trend data, formulate reports to analyze data and report conclusions/concerns to Board of Directors, Quality Committee, Medical Staff, Physician's Quality Team and QA team..."

During an interview on the morning of 08/21/20, Personnel 8 reported, "I took over last August and had no background, so I was doing a QA residency program." When asked if all services were reviewed for quality, Personnel 8 reported, "The program said all contracted services must be reviewed, so that's what I've been working on." When asked who was responsible for conducting periodic evaluations, Personnel 8 reported, "I am responsible, but we are hiring a full-time quality person to take over." When asked how the evaluation process ensured sampled records are representative of services furnished, Personnel 8 reported, "I mainly review the records to make sure nurses are charting correctly." When asked who was responsible to evaluate CAH patient care services, Personnel 8 stated, "I would say [Personnel 2]."

There was no robust collection, tracking, trending, and analyzing of data provided by the departments of the facility.

Based on record review and personnel interview, the facility failed to ensure all staff of the CAH were licensed in accordance with State licensure laws for 2 (Personnel 11 and 26) of 2 paramedics working in the facility.

The findings included:

Review of Personnel 11's file revealed a job description/performance appraisal that was for a Licensed Practice Nurse (LPN). In areas where "LPN" was written, these were crossed out and "Paramedic" was handwritten. Personnel 11 was a licensed paramedic.

Review of the State of Nebraska 2019 "Statutes relating to Emergency Medical Services Practice Act" referred only to paramedic practice out-of-hospital emergency medical care. The statute does not address in-hospital practice.

Review of the Job Description/Performance Appraisal, dated 08/02/16, stated in part, "Job Summary: Provides care to OP/Acute/SNF patients utilizing the developed plan of care. The Paramedic will also provide emergency medical care to patients presenting that are acutely ill or injured. May act as Charge utilizing delegation skills to prioritize and oversee all patient care delivered during assigned shift. May act within their scope of practice under the supervision of the Medical Director."

In an interview with Personnel 1 and 2 on 08/21/20, they confirmed the facility was using paramedics as staffing personnel for acute, outpatient, skilled nursing, and emergency services.

Based on observation and personnel interview, the facility failed to ensure that expired medication was not available for patient use.

The findings included:

During a tour of the Central Supply area on the afternoon of 08/20/20 the following was observed:

* Two D 5 NS 1000 cc, expired on 07/2020
The solutions were observed on the central supply shelf available for patient use.

An interview with Personnel 24 on 08/20/20 confirmed the intravenous solutions had expired.

Based on observations and personnel interview, the facility failed to maintain readily available supplies commonly used in life-saving procedures.

The findings included:

During the facility tours on 08/20/20 and 08/21/20, the following expired supplies were observed:

*Operating Room:
-Four Telfa Pad, expired 10/2019
-Five cautery tip cleaners, expired 12/2018
-Six snare wire for biopsies, expired 12/07/19
-Ten endoscopic tattoo syringes, expired 02/22/20
-Package of electrodes, expired 07/31/20
-Endotracheal tube Size 8.0, expired 05/2020
-Endotracheal tube Size 7.0, expired 05/2020

*Emergency Room:
-Two Halo Vent, expired 06/26/20

-Blue Braslow Bag:
Stomach tube 14 French, expired 12/2019
Uncuffed tracheal tube size 5.5 X 2, expired 02/2020

-Yellow Braslow Bag:
Stomach tube 10 French, expired 10/2019
Uncuffed tracheal tube size 4.5 X 2, expired 02/2019

-Crash Cart:
Two 20 mL (milliliter) leurlock syringe, expired 06/2020
Two 18 Gauge needle, expired 08/2019
Two 18 G needle, expired 03/2020
Three 18 G IV catheter, expired 02/29/20
Three 24 G IV catheter, expired 02/29/20
Three 22 G IV catheter, expired 04/20/20

*Radiology:
-18 G IV cath, expired 08/2017
-18 G IV cath, expired 10/2018

An interview with Personnel 2 on 08/20/20 and 08/21/20 confirmed the above findings during the tours.

Based on observation and personnel interview, the facility failed to ensure that the AED (Automated External Defibrillator) was in working condition in the dietary department.

The findings included:

During a tour of the Dietary and Emergency departments on the afternoon of 08/20/20, the following issues were observed:

Dietary area:
-The AED pad had expired 07/18/20.
-When the AED was turned on the machine announced, "replace battery." There was an indicator light showing a large red X, which indicated the battery needed to be replaced.

Emergency room:
-Portable E-cylinder oxygen tank was laying on the floor.
OSHA [Occupational Safety and Health Administration] Gas Cylinder Safety Regulations and Guidelines stated in part, "Compressed gas cylinders shall be secured in an upright position at all times, if necessary, for short periods of time while cylinders are actually being hoisted or carried."

An interview with Personnel 2 and 19 on 08/20/20 confirmed the above findings.

Based on personnel interview, the facility failed to ensure that the quality and appropriateness of the diagnosis and treatment furnished by doctors of medicine or osteopathy at the CAH were evaluated by another network hospital or QIO.

The findings included:

During an interview with Personnel 1 on the afternoon of 08/20/20, when asked who reviews/audits the physician files for quality, Personnel 1 stated there was no quality review for physician appropriateness of care or credentialing.

Based on record review and personnel interview, the governing body failed to ensure the policy and procedures for the Physical Therapy Department were read and approved.

The findings included:

A review of the Physical Therapy policies and procedures revealed the policies had not been approved by the Medical Staff or Governing Body.

A review of the Medical Staff meeting from October 2019 to present revealed the Medical Staff or the Governing Body had not approved the Physical Therapy policies. The Medical Staff meetings for October 2019 and November 2019 approved policies for most of the departments of the Critical Access Hospital, but not Physical Therapy.

An interview with the Personnel 20 (Physical Therapist) on 08/21/20 confirmed the Physical Therapy department policies had not been approved.

Based on record review and personnel interview, the facility's medical record department failed to ensure that there was a current list of authenticated signatures that have been authorized by the Governing Body and were protected by adequate safeguards.

The findings included:

In an interview with Personnel 22 on 08/21/20 at 9:50 AM, an authenticated signatures list was requested. There was no document provided by the facility.

In an interview with Personnel 23 (HIM Director) on 08/21/20, Personnel 23 confirmed they had no current list of authenticated signatures.

Based on record review, personnel interview and review of facility policy, the facility failed to ensure the informed consent was dated and timed for surgical procedures that require written patient consent for 5 (Patients 1, 10, 11, 12 and 13) of 5 surgical records reviewed; the surgeon failed to perform an update to the history and physical for a surgical patient for 1 (Patient 12) of 5 surgical patients; and the facility failed to follow their own policies.

The findings included:

A review of the medical record for Patient 1 revealed the anesthesia consent form was not timed. There was no way to know if the consent was signed by the patient prior to having the surgical procedure.

A review of the medical record for Patient 10 revealed the surgical consent form was left blank except for signatures. The surgeon was not listed, and the type of procedure was not listed on the informed consent for the surgical procedure.

A review of the medical record for Patient 11 revealed the anesthesia consent form was not timed. There was no way to know if the consent was signed by the patient prior to having the surgical procedure.

A review of the medical record for Patient 12 revealed the anesthesia consent form was not dated or timed. There was no way to know if the consent was signed by the patient prior to having the surgical procedure. Also, the update to the History and Physical for Patient 12 was not performed by surgeon prior to the procedure.

A review of the medical record for Patient 13 revealed the anesthesia consent form was not timed. There was no way to know if the consent was signed by the patient prior to having the surgical procedure.

A review of the facility policy titled, "Informed Consent" revealed the following:
"Policy:
Have a pre-anesthesia assessment performed by anesthesia provider to determine that the patient was an appropriate candidate to undergo the planned anesthesia..."

A review of the facility policy titled, "History and Physical" revealed the following:
"Policy:
The patient will be assessed by the surgeon (one hour) before surgery to ensure stable condition for procedure..."

An interview with Personnel 8 on 08/21/20 confirmed the above findings with the record review of anesthesia consents and the history and physical not being updated prior to the procedure.

Based on review of facility based policies, review of medical records and personnel interview, the facility failed to ensure a discharge summary was documented for 1 (Patient 8) of 5 patients reviewed for swing bed.

The findings included:

Review of the facility based policy titled, "Physician Services," stated in part, "All patients who are permanently discharged from the facility will have a discharge summary signed by the attending physician in the medical record, which includes condition on discharge and final diagnosis."

Review of the medical record for Patient 8 revealed the patient was admitted on 07/05/20 and discharged 07/16/20. There was no discharge summary documented.

The above was confirmed in an interview with Personnel 2 on the afternoon of 08/21/20.

Based on observation, record review, and personnel interview:

A. The facility failed to ensure that all surgical personnel are adequately trained and oriented, aware of surgical policies and procedures, supervised, and that their clinical activities are evaluated.

B. The facility failed to ensure the MH (malignant hyperthermia) cart was maintained with current supplies and that the surgical personnel had conducted a MH drill.

C. The facility failed to ensure the operating room (OR) had a register.

D. The facility failed to ensure the informed consent was dated and timed for surgical procedures that require written patient consent for 5 (Patients 1, 10, 11, 12 and 13) of 5 surgical records reviewed; the surgeon failed to perform an update to the history and physical for a surgical patient for 1 (Patient 12) of 5 surgical patients; and the facility failed to follow their own policies.
Cross refer to C1110.This resulted in the Condition of Participation for Surgical Services.

The findings included:

A. A review of Personnel 3's file revealed no documentation that Personnel 3 had been trained and competencies checked for the decontamination and cleaning of the colonoscope. Personnel 3 was observed cleaning the scope on 08/20/20.

B. In an interview with Personnel 25 on 08/20/20, it was confirmed MH medication was available in the operating room supply cart, which included Dantrolene and sterile water for injection.

The facility failed to ensure the MH cart contained the following contents according to MHAUS (Malignant Hyperthermia Association of the United States), the following should be included in the contents of a MH cart:
Sodium Bicarbonate
Dextrose 50%
Calcium Chloride
Regular Insulin
Lidocaine for injection
Refrigerated cold saline solution
Charcoal Filters
Syringes
IV Catheters
Pressure bag
Disposable Cold Packs

During the tour of the operating area on 08/21/20, it was observed that the facility had MH set-up. Personnel 2 was asked when had the facility had a "MH drill." Personnel 2 verified they had not performed a MH drill. There was no way to know if surgical personnel would perform competently in an emergency situation.

An interview with Personnel 2 on 08/21/20 confirmed the above findings.

C. During the entrance conference on 08/20/20, an OR register was requested. The facility provided a list containing the patient's name, date of birth, date of procedure, and the surgeon. It did not include the other required items.D. Cross refer to C1110.

Based on record review, personnel interview and review of facility policy, the facility failed to time the pre-anesthesia form prior to any procedures or surgical procedures for 3 (Patients 11, 12, and 13) of 5 surgical records reviewed. Also, the facility failed to follow their own policy.

The findings included:

A review of the medical record for Patient 11 revealed the pre-anesthesia form was not timed by the anesthesia provider. There was no way to know if the pre-anesthesia assessment was performed by an anesthesia provider prior to having planned anesthesia.

A review of the medical record for Patient 12 revealed the pre-anesthesia form was not timed by the anesthesia provider. There was no way to know if the pre-anesthesia assessment was performed by an anesthesia provider prior to having planned anesthesia.

A review of the medical record for Patient 13 revealed the pre-anesthesia form was not timed by the anesthesia provider. There was no way to know if the pre-anesthesia assessment was performed by an anesthesia provider prior to having planned anesthesia.

A review of the facility's policy titled, "Informed Consent" revealed the following:

"Policy:
Have a pre-anesthesia assessment performed by anesthesia provider to determine that the patient was an appropriate candidate to undergo the planned anesthesia..."

An interview with Personnel 8 on 08/21/20 confirmed the above findings with the record review of pre-anesthesia forms.

Based on observation, record review, and personnel interview:

A. The facility failed to prevent and control the transmission of infections related to Legionella.

Cross Refer 1206.

B. The facility failed to maintain a clean and sanitary environment.

Cross Refer 1208. This resulted in the Condition of Participation for Infection Prevention & Control & Antibiotic Stewardship Program.

Based on record review and personnel interview, the facility failed to prevent and control the transmission of infections related to Legionella.

The findings included:

Review of the Legionella plan revealed a water temperature log that had been checked weekly until 01/18/18. There was no documentation since 01/18/18.

In an interview with Personnel 19 on the morning of 08/21/20, when asked about the Legionella plan, Personnel 19 reported, "We flush the water every week ... We have not been checking water temperatures." When asked about quality controls, Personnel 19 reported they do not check water quality.

Based on observations, personnel interview and facility policy review, the facility failed to maintain a clean and sanitary environment.

The findings included:

During the facility tours on 08/20/20 and 08/21/20, the following issues were observed:

*Laundry Area:
-There were multiple stained ceiling tiles and black substance around the air conditioner vent.
-Layer of dust on multiple high-horizontal surfaces, such as both dryers and washers
-Mop sitting in a dirty bucket

*Laboratory Area:
-Multiple stained ceiling tiles

During an interview on 08/20/20, the Lab Director stated, "All the stained tiles are from the condensation of the air conditioner leaking."

*Central Supply Area:
-This area stored open clean and sterile supplies for the facility including sterile surgical supplies.
-Corrugated cardboard boxes were stored over open sterile supplies.
-The shelves in the supply area were covered in dust and dirt particles.The nationally accepted standards set forth by the Association for the Advancement of Medical Instrumentation (AAMI) state, "External shipping containers have been exposed to unknown and potentially high microbial contamination. Also, shipping cartons, especially those made of corrugated material; serve as generators of and reservoirs for dust." (AAMI 5T46-Section 5.2 Receiving Items).

*Surgery Department:
-In the decontamination room, dead bugs in the light fixtures.
-Operating Room 1 had brownish-orange streaks of a substance running down the wall.
-There was an outlet for oxygen coming out the operating room wall, but there was no plate covering for the outlet and it was not labeled. The green hose was connected to the anesthesia machine.
-There was a cabinet where the colonoscope hung. In the bottom of that cabinet was a white soiled towel where the colonoscope had drained. There were black, brown, and yellowish stains on the white towel.

*In the radiology area:
-Several corrugated shipping boxes on the ground
-Sharps container that was completely fullReview of facility policy titled, "Contaminated Sharps" stated in part, "Container must be replaced when it is ¾ full."

*Throughout the facility, there were missing and water-stained ceiling tiles.

An interview with Personnel 2 and 15 confirmed above findings during the tours.

Based on review of facility-based policies, review of medical records, and personnel interview, the facility failed to conduct a comprehensive assessment of resident's needs and implement a comprehensive person-centered care plan for each resident for 1 (Patient 20) of 5 swing bed patients reviewed.

The findings included:

The facility-based policy, titled, "Comprehensive Care Plans (Swing Bed)," stated in part, "It is the policy ... to develop and maintain a written plan of care that includes measurable objectives and timetables to meet a resident's medical, nursing and psychosocial needs that are identified in the comprehensive assessment.
Procedure: The Comprehensive Care Plan must be developed within 7 days after the completion of the comprehensive assessment."

Review of the medical record for Patient 20 revealed they were admitted in swing bed status from 05/21/20 through 07/02/20, 42 days. There was no comprehensive assessment or comprehensive care plan charted for their stay.

In an interview with Personnel 2 on the afternoon of 08/21/20, Personnel 2 reported there should be a comprehensive care plan completed at least once a month. Personnel 2 verified there was no documented comprehensive assessment or care plan for Patient 20.

Based on review of facility documents and personnel interview, the facility failed to develop and maintain a comprehensive emergency preparedness program, utilizing an all hazards approach. This resulted in the Condition of Participation for Establishment of the Emergency Program.

The findings included:

Facility-based documents, titled, "Emergency Preparedness Guidelines," had several policies, titled, "Facility Disaster Plan," "Water Supply," and "Emergency Supplies, Equipment, Utilities." These policies were not marked as approved or effective.

In an interview with Personnel 19 on the morning of 08/21/20, when asked about the plan and the revised federal regulations regarding emergency preparedness, Personnel 19 reported, "I took this over. I don't know if [the person in the position prior] knew about the new regulations." When asked if any drills had been completed, Personnel 19 verified there had been no drills completed.