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Based on review of facility documents and staff interview (EMP), it was determined the facility failed to conform to all applicable State regulations.

Barnes Kasson County Hospital was not in compliance with the following state laws:

The Medical Care Availability and Reduction of Error Act, 40 P.S. § 1303.101 et seq. § 1303-310 Patient Safety Committee (a) Composition (1) A hospital's patient safety committee shall be composed of the medical facility's patient safety officer, and at least three health care workers of the medical facility and two residents of the community served by the medical facility who are not agents, employees, or contractors of the medical facility. No more than one member of the patient safety committee shall be a member of the medical facility's board of trustees. The committee shall include members of the medical facility's medical and nursing staff. The committee shall meet at least monthly.

The Infection Control Plan Act, 52 P.S. § 1303.403 (a) DEVELOPMENT AND COMPLIANCE, revealed "Within 120 days of the effective date of this section, a health care facility and an ambulatory surgical facility shall develop and implement an internal infection control plan that shall be established for the purpose of improving the health and safety of patients and health care workers and shall include: ...(ix) The community, except that these representatives may not be an agent, employee or contractor of the health care facility or ambulatory surgical facility."
This is not met as evidenced by:

1. Based on review of facility documents, state law, and staff interview (EMP), it was determined the facility failed to ensure two residents of the community were in attendance at the Patient Safety Committee meetings.

Findings include:

Review on April 15, 2024, of the facility's "Patient Safety Improvement and Management Program Plan," last reviewed July 20, 2023, revealed "... Patient Safety Improvement and Management Committee Composition The Patient Safety Improvement and Management Committee is an interdisciplinary committee comprised of individuals with organizational responsibility for quality, safety, and risk management, representatives from various clinical departments, and representatives from other hospital and medical staff committees wherein patient safety is of vital importance, (i.e. the pharmacy and therapeutics committee, infection control committee, corporate safety committee, performance improvement committee, transfusion committee, and others). Additionally, Barnes Kasson County Hospital Patient Safety Improvement and Management Committee will include the patient safety officer, hospital in-house legal counsel, an identified member from the hospital's board of directors, and two residents of the community served by Barnes Kasson County Hospital. All members of Barnes Kasson County Hospital will be required to sign a confidentiality attestation, which outlines their responsibilities relative to the sharing or discussion of information dealt with in the committee. The patient Safety Improvement and Management Committee will be comprised of the following individuals: Patient Safety Officer. Medical Staff physician. Actively practicing Registered Nurse within the facility. Executive Director. Risk Manager. 2 community residents currently not employee by Barnes Kasson County Hospital ... "

Review on April 15, 2024, of the facility's "Patient Safety Committee Meeting Minutes" dated April 20, 2023; May 18, 2023; June 29, 2023; July 20, 2023; August 17, 2023; September 21, 2023; October 19, 2023; January 23, 2024; February 15, 2024; and March 21, 2024, revealed EMP16 was listed as the community member in attendance at each of these meetings.

Interview with EMP1 on April 15, 2024, at approximately 1315 revealed EMP16 was an employee of the hospital. EMP1 confirmed there was no community member in attendance at the Patient Safety Committee Meetings on the dates listed above.

2. Based on review of facility documents, state law, and staff interview (EMP), it was determined the facility failed to include a community member on the infection control committee.

Findings include:

A request was made to the facility regarding a policy related to the Infection Control Committee required members. None was provided.
Review on April 15, 2024, of the facility, "Infection Control Committee Meeting Minutes," dated April 20, 2023; May 18, 2023; June 29, 2023; July 20, 2023; August 17, 2023; September 21, 2023; October 19, 2023; January 23, 2024; February 15, 2024; and March 21, 2024, revealed no community member attended the Infection Control meeting.
Interview on April 15, 2024, with EMP1, at approximately 1300, confirmed the above findings.

Based on review of facility documents and staff interview (EMP), it was determined the facility failed to ensure electrical equipment items that failed the preventative maintenance check were removed from use.

Findings include:

A request was made of EMP3 on April 18, 2024, for the facility policy / procedure / protocol or guideline staff use to ensue electrical equipment items that failed the preventative maintenance check were removed from use. None was provided.

Review on April 18, 2024, of the facility provided [Name of Preventative Maintenance company] report dated June 1, 2023, to June 30, 2023, revealed this company performed a Preventative Maintenance (PM) check on the following equipment:

A defibrillator located in the facility's Operating Room (OR); further review revealed documentation this device failed the test due to having very old batteries, the batteries needed replacement and this device is no longer supported by the manufacturer. There was no documentation provided by the facility indicating this defibrillator was removed from service.

An exercise bicycle in the facility's Cardiac Rehab; further review revealed documentation this device failed the test for the second year in a row with multiple defects noted, the device was not able to be repaired due to age and needed to be removed from service. There was no documentation provided by the facility indicating this exercise bicycle was removed from service.

An aspirator in the facility's ambulance; further review revealed documentation a search for this device was complete but was not located and the recommendation was to remove this item from service until a PM check can be performed. There was no documentation provided by the facility indicating this aspirator was removed from service.

An AED (Automated External Defibrillator) in the facility's ambulance; further review revealed documentation this device failed PM due to having damage to the outer case, making it unsafe and an infection control issue. There was no documentation provided by the facility indicating this AED Defibrillator was removed from service.

A heat therapy pump located in the facility's Central Supply area was unable to be found; further review revealed documentation if this device is found it is to be removed from active inventory. There was no documentation provided by the facility indicating this heat therapy pump was removed from service.

An automatic tourniquet located in the facility's OR; further review revealed documentation this device had a major defect; it had a dead battery and was throwing an error code and the tech was unable to receive support from the manufacturer. There was no documentation provided by the facility indicating this automatic tourniquet was removed from service.

Interview with EMP3 on April 18, 2024, confirmed the above findings at the time of review.

Based on review of facility documents, observation, and staff interview (EMP), it was determined the facility failed to ensure a sanitary environment in the Dietary Department; the facility failed to ensure a clean environment on the Medical Surgical unit, in the Laboratory Department and in the Emergency Department and the facility failed to ensure facility property was maintained in good repair.

Findings include:

1. Review on April 16, 2024, of the facility's "Refrigerators and Freezers" policy, last revised March 17, 2020, revealed "Policy Statement This facility will ensure safe refrigerator and freezer maintenance, temperatures, and sanitation, and will observe food expiration guidelines. Policy Interpretation and Implementation ...9. Refrigerators and freezers will be kept clean, free of debris, and mopped with sanitizing solution on a scheduled basis and more often as necessary."

Observation tour of the facility's Dietary Department on April 16, 2024, revealed the following:
Dust and dried food debris behind the soup and water kettle.
The convection oven had dried food debris on the inside bottom surface.
There were two ovens which had dried food debris on the inside bottom surface of both ovens.
There was dust and dried food debris on the table around the slicer.
The milk, meat and vegetable / fruit refrigerators had dried food debris and paper debris under each of the shelving units in these refrigerators.
The Dietary storage room had two silver standing shelf units use to store items for food service. These shelving units did not have a solid bottom rack to prevent splashing of dirty water when mopping the floor.

Interview with EMP3 and EMP10 on April 16, 2024, confirmed these findings at the time of the observations.

2. Review on April 15, 2024, of the facility's "Basic Cleaning Concepts" policy, last reviewed/revised March 12, 2024, revealed "Policy Statement: To follow best practices for environmental cleaning procedures for all patient care areas. Cleaning Concepts: General Sanitizing: To make a surface or area clean by removing dirt, germs, or unwanted substances ..."

Review on April 18, 2024, of the facility's "COVID-19 High Touch Cleaning Checklist" policy, last reviewed/revised February 10, 2021, revealed "Overview: Everyone must share the responsibility of providing a clean and safe work environment ... "

a. Observation tour of the facility's Medical Surgical unit on April 15, 2024, revealed the following observations:
Patient room 206 - Black colored fleck particle debris and brown colored fleck particle debris on the top sheet and brown colored debris on the window ledge. There was dust on the overbed table measuring approximately a dime when gathered.
Patient room 204 - Black colored fleck particle debris and brown colored fleck particle debris on the top sheet. There was dust on the overbed table measuring approximately a dime when gathered.
Intensive Care (ICU) bed A - Black colored fleck particle debris on the top sheet.
ICU bed B - An accumulation of white/gray dust on the TV extension from the wall measuring approximately a dime when gathered.

Interview with EMP2 on April 15, 2024, confirmed the above findings at the time of the observations.

b. Observation tour of the facility's Laboratory Department on April 16, 2024, revealed the following observations:
An accumulation of white dust on the three shelves of the Blood Bank refrigerator, measuring approximately three quarters in size when gathered.
An accumulation of dirt and debris in the Chemistry Reagent refrigerator, measuring approximately two quarters in size when gathered.
An accumulation of ice in the Quality Control refrigerator / freezer and in the Reagent refrigerator / freezer measuring approximately 2 inches thick x 4 inches wide and 5 inches long.

Interview with EMP4 and EMP5 on April 15, 2024, confirmed the above findings at the time of the observations.

c. A request was made of EMP9 on April 16, 2024, for a facility policy / procedure / guideline / protocol for storage, use and cleaning of physician owned procedural instruments. None was provided.

Observation tour on April 16, 2024, of the facility's Emergency Department (ED) revealed a locked cabinet identified by EMP9 as a cabinet for the ED physician. This locked cabinet contained three storage boxes.
The first box had green foam pad lining on the top and the bottom. This silver box contained the following:
3 - Ear instruments used for cleaning ear wax. These instruments were individually wrapped in plastic and had particles of white/gray dust on the inside and the outside of each plastic wrapped instrument.
5 - Eye stylet instruments. Each stylet instrument had particle of white/gray dust.
1 - Mini curved forceps. This instrument had black fleck particle debris on the outside surface.
2 - Mini scissors. These instruments were individually wrapped in plastic and had particles of white/gray dust on the inside and the outside of each plastic wrapped instrument.
1 - Disposable scalpel and replacement blade.
2 - Suture removal scissors. These scissors had white/gray dust on the outside handles.
2 - Tweezers. These tweezers had solid white material on the outside handles.
2 - Tweezers with plastic coverings. These tweezers had white/gray dust on the inside and the outside of the plastic coverings.
1 - 2 milliliter (ml) of 1 percent Cyclogyl Ophthalmic solution which was open and partially used. There was no open date, and the expiration date was worn off.
1 - Mini forceps. This instrument had black fleck particle debris on the outside surface.

The second box contained the following:
A Corneal Rust Ring Removal instrument which was battery operated and had a needle tip.

The third box contained the following:
A head light.
1 - open and partially used 15 ml bottle of Tetracaine Hydrochloride Ophthalmic Solution 0.5 % with an expiration date of February 2014.
1 - open and partially used 2 ml bottle of Tetracaine Hydrochloride Ophthalmic Solution 0.5 % with an expiration date of October 2013.
2 - open and partially used 2 ml bottle of Tetracaine Hydrochloride Ophthalmic Solution 0.5 % with an expiration date of September 1996.

Interview with EMP9 on April 16, 2024, confirmed the above finding at the time of the observation. EMP9 confirmed these instruments were not considered sterilized and not ready for patient use.

3. Review on April 17, 2024, of the facility's "Designation of Responsibility Policy," last revised June 13, 2000, revealed "The ultimate responsibility for seeing that the needed maintenance and repair is accomplished in the Facility or on the equipment in an area occupied by a department rests [sic] with the head of each department. Repair Requisitions are available to each department. These forms are used for day to day [sic] work orders which are forwarded to the Maintenance Chief for completion. The Maintenance Chief is responsible to the Executive Director to ensure that these repair requisitions are completed as soon as possible. Department Heads are responsible for all facilities, areas, and equipment used and occupied by their particular department. Once work orders have been written, the Maintenance Chief is responsible for seeing that they are completed. IF for any reason it is not practical to perform the work, or if the performance of the work will be delayed, the Maintenance Chief is responsible for communication with the Department Head inform the individual of the condition existing and the reason. Emergency work orders are phoned in to the Maintenance Chief who, in turn, assigns a member of the Maintenance Staff to complete the order ..."

Observation of the Medical Surgical unit on April 15, 2024, revealed in patient room 206 there was a silver metal TV control plate on the wall between Bed A and Bed B with loose bottom screws and there was a 1 inch x 3 inch hole through the wall at the base of the plate; there was a one-inch hole in the wall next to the wall mounted clock; in patient room 204 there were wall patches between Bed A and Bed B that needed repair and in the Intensive Care Unit (ICU) Bed C the plastic protective piece was missing from the top of the wall mounted air conditioning unit.

Interview with EMP2 and EMP3 on April 15, 2024, confirmed these findings at the time of the observations.

Observation of the Laboratory Department on April 16, 2024, revealed a window installed air conditioner that had a rolled-up towel tucked on the top and there was damaged and missing wall plaster on the wall next to the air conditioner measuring approximately 24 inches wide and 30 inches long.

Interview with EMP4 and EMP5 on April 16, 2024, confirmed the above findings at the time of the observation. EMP5 revealed staff placed the rolled-up towel to prevent the draft from coming through.

Observation of the Dietary Department on April 16, 2024, revealed an area behind a storage rack in the storage room with wall plaster separating from the wall and the plastic base board separating from the wall.

Interview with EMP3 and EMP10 on April 16, 2024, confirmed the above finding at the time of the observation.

Observation of the Radiology Department on April 17, 2024, revealed a window screen in the (computerized tomography) room taped to the window opening with silver tape.

Interview with EMP13 on April 17, 2024, confirmed the above findings at the time of the observation.

Based on review of facility documents and staff interview (EMP), it was determined the facility failed to periodically review / revise personnel policies / procedures at a minimum of every two years.

Findings include:

Review of the facility's "Administrative Policy - Policy Guidelines - Review of Policy Manuals" policy, last reviewed August 24, 2023, revealed "Purpose: To provide guidelines for initiating, preparing, and updating policies and procedures and to outline the mechanism for approval, authorization and distribution. To ensure that policies are developed in collaboration with associated departments. Policy: ...6. All hospital policies will be reviewed at least every three years and/or as needed 7. Department specific policies and procedures shall be reviewed and revised at least every three years and as needed, top ensure compliance with institutional practices ..."

Review on April 16, 2024, of the facility's Dietary Policy and Procedure manual revealed these policies and procedures were last reviewed /revised March 17, 2020.

Review on April 16, 2024, of the facility's Housekeeping Policy and Procedure manual revealed these policies and procedures were last reviewed /revised April 2018.

Interview with EMP3 on April 16, 2024, at the time of review, confirmed the above findings.

Based on review of facility documents, observation, and staff interview (EMP), it was determined the facility failed to ensure the microscopes used in the Laboratory department had the required preventative maintenance performed every six months as indicated in the facility's policy.

Findings include:

Review on April 15, 2024, of the facility's "Microscope Preventative Maintenance" policy, last reviewed January 15, 2024, revealed "Principle: to ensure microscopes are kept adjusted and clean. Procedure: [Name of biomedical company] cleans and services all hospital microscopes every 6 months. If special adjusting is need [sic] a microscope company will be called for service. Certification reports are kept on file in the maintenance department."

Observation tour of the facility's Laboratory department on April 15, 2024, revealed a microscope in the chemistry area with a Preventative Maintenance sticker indicating the last preventative maintenance was performed June 2023. There was no documentation indication this microscope was checked six months from June 2023.

Observation tour of the facility's Laboratory department on April 15, 2024, revealed a microscope in the Urinalysis area with a Preventative Maintenance sticker indicating the last preventative maintenance was due January 2024. There was no documentation indicating this microscope had preventative maintenance completed in January 2024.

Interview with EMP4 and EMP5 on April 15, 2024, confirmed the above findings at the time of the observations.

Based on review of facility documents and staff interview (EMP), it was determined the facility failed to ensure all radiation protective devices worn by patients, staff and visitors were checked for holes, leaks, or cracks annually, as required by facility policy in the Radiology Department and in the Dental Clinic.

Findings include:

Review on April 17, 2024, of the facility's "Physicist Checks" policy, last reviewed February 2, 2024, revealed "Policy: It is the policy of Barnes Kasson Hospital to have an annual inspection of all ionizing radiation producing equipment checked by a licensed physicist to ensure all equipment is within normal range. Procedure: ... Protective equipment (lead shields, thyroid shields, lead glasses, lead gloves) for the Radiology department is also inspected on a yearly basis. If an item does not pass it must be taken out of use ..."

1. Review of the facility provided Annual Protective Apparel Evaluation report for January 17, 2022, revealed Thyroid Shields OR T-4 and OR T-5 could not be located.

Review of the facility provided Annual Protective Apparel Evaluation report for July 7, 2022, revealed Thyroid Shields OR T-4 and OR T-5 were not on the report.

Interview with EMP13 on April 17, 2024, at approximately 1245 revealed Thyroid Shields OR T-4 and OR T-5 were still in use in the operating room.

Interview with EMP13 on April 17, 2024, at approximately 1245 confirmed the above findings.

Review of the facility provided Annual Protective Apparel Evaluation report for January 17, 2022, revealed Apron #11 in CT (computerized tomography) could not be located.

Review of the facility provided Annual Protective Apparel Evaluation report for July 7, 2022, revealed Apron #11 in CT was not on the report.

There was no evidence Apron #11 in CT was still in use in CT or if the facility removed it from use.

Interview with EMP13 on April 17, 2024, confirmed the above findings at the time of review.

2. Observation tour of the Dental Clinic on April 17, 2024, revealed this department has an x-ray machine used for dental x-rays and there were three protective radiology aprons.

A request was made of EMP13 and EMP15 for the Annual Protective Apparel Evaluation on these three protective radiology aprons. None was provided.

Interview with EMP13 on April 17, 2024, at approximately 1300 revealed these three protective radiology aprons used in the Dental Clinic were never tested by the physicist.