Initial Comments:
This report is the result of a full State Licensure survey conducted on May 12 - 13, 2021, at Barnes-Kasson County Hospital. It was determined that the facility was not in compliance with the requirements of the Pennsylvania Department of Health's Rules and Regulations for Hospitals, 28 Pa Code, Part IV, Subparts A and B, November 1987, as amended June 1998.
Plan of Correction:
101.64 LICENSURE
HOSPITAL RESPONSIBILITIES
Name - Component - 00
101.64 Hospital responsibilities
A hospital shall comply with all
applicable environmental, health,
sanitation, and life-safety standards
which are not under the direct
jurisdiction of the Department. This
shall include but not be limited to
radiologic health, sanitation, food
services, pharmacy, electric wiring,
and life-safety code compliance. When
the hospital has been inspected by
another regulatory agency, it shall
have on the record during the survey
by the Department written confirmation
of compliance as provided by the rules
and regulations of appropriate
agencies.
Observations:
Based on review of facility documents, observation, and staff interview (EMP), it was determined the facility failed to properly dispose of expired microbiologic testing medium in the laboratory; the facility failed to ensure the phone, light and cord in the third refrigerator was free of dust and the facility failed to ensure temperatures were recorded for food stored in the coolers.
Findings include:
1. A request was made of EMP7 on May 13, 2021, for a facility policy, procedure, guideline, or protocol laboratory staff follow regarding checking and discarding of expired microbiologic testing medium. None was provided.
Interview with EMP7 on May 13, 2021, at approximately 9:50 a.m. revealed the facility does not have a policy, procedure, guideline, or protocol laboratory staff follow regarding checking and discarding of expired microbiologic testing medium.
Observation on May 13, 2021, of the laboratory refrigerator revealed the following:
Microorganism QCK Quick Start E-coli expired June 30, 2020
A box containing 30 Micro Reagent QC expired March 31, 2020
Five Microorganism Plate Medium sets expired May 6, 2021
Interview with EMP7 on May 13, 2021, at approximately 10:00 a.m. confirmed the Microorganism QCK Quick Start E-coli expired June 30, 2020, the box containing 30 Micro Reagent QC expired March 31, 2020, and the five Microorganism Plate Medium sets expired May 6, 2021.
2. Review on May 12, 2021, of the facility's "Cleaning the Reach in Production Coolers" policy, last revised February 2020 revealed "Scope: This policy is applicable to all personnel in the food service department of Barnes Kasson County Hospital. Purpose: The purpose of this policy and procedure is to prevent cross contamination and to make sure cooler is properly cleaned. Policy: All coolers in the dietary department will be cleaned on a weekly basis ... 5. Clean inside ceiling, walls and floor of cooler...."
Observation on May 12, 2021, of the inside of the third refrigerator in the dietary department revealed an accumulation of dust on the following: the telephone measuring approximately a nickel in size when gathered together; the cage of the light measuring approximately a nickel in size when gathered together and the cord of the light measuring approximately a quarter when gathered together.
Interview with EMP5 on May 12, 2021, at the time of the observation confirmed the inside of the third refrigerator in the dietary department had an accumulation of dust on the telephone measuring approximately a nickel in size when gathered together; the cage of the light measuring approximately a nickel in size when gathered together and the cord of the light measuring approximately a quarter when gathered together.
3. Review on May 12, 2021, of the "Coldside Temperature Chart" no review date, revealed columns labeled Date Month Year; Cooler #1 Trayline Production Count Cooler (40 degrees F or less) AM PM 8:30 Temp and Initials and Cooler #2 Cold Side Double Cooler (40 degrees F or less) AM PM 8:30 Temp and Initials.
Review on May 12, 2021, of the Coldside Temperature Chart for March 2021, revealed no documentation of temperatures for the following dates:
Cooler #1 for March 1 through March 8, 2021
Cooler #1 for March 12, 16, 20, 21, 27 and 31, 2021
Cooler #2 for March 1 through March 8, 2021
Cooler #2 for March 12, 14, 16, 20, 21, 27, 29 and 31, 2021
Interview with EMP5 on May 12, 2021, at approximately 2:00 p.m. confirmed these missing temperatures for Cooler #1 and Cooler #2 in March 2021.
Review on May 12, 2021, of the Coldside Temperature Chart for April 2021, revealed no documentation of temperatures for the following dates:
Cooler #1 for April 1 through 5, 2021
Cooler #1 for April 17, 18, 25 and 27, 2021
Cooler #2 for April 1 through 6, 2021
Cooler #2 for April 9, 17, 18, 20 and 27, 2021
Interview with EMP5 on May 12, 2021, at approximately 2:15 p.m. confirmed these missing temperatures for Cooler #1 and Cooler #2 in April 2021.
Review on May 12, 2021, of the Coldside Temperature Chart for May 2021, revealed no documentation of temperatures for the following dates:
Cooler #1 for May 1, 2, 3, 5, and 6, 2021
Cooler #2 for May 1, 2, 3, 5, and 6, 2021
Interview with EMP5 on May 12, 2021, at approximately 2:25 p.m. confirmed these missing temperatures for Cooler #1 and Cooler #2 in May 2021.
Plan of Correction:A policy and procedure for laboratory staff to follow regarding checking and discarding of expired microbiologic testing medium will be written to ensure proper disposal of expired laboratory testing mediums. All Laboratory staff will have the procedure reviewed with them so they are aware of the guideline for disposal of expired mediums. The Quality Department, in conjunction with Laboratory staff, will perform routine spot checks of the laboratory, a minimum of 1 time per week, for 12 weeks to make sure that all expired laboratory mediums have been properly disposed. Data gathered from these compliance checks will be presented to the Quality Control Committee for review, follow up, and any corrective action necessary. The Laboratory manager will be responsible for continued compliance with this plan of correction.
The procedure for proper cleaning of the production coolers will be reviewed and revised, if necessary. All Dietary staff assigned to cleaning of the production coolers will have the procedure reviewed with them so they are aware of the proper method for cleaning the production coolers. The Quality Department will perform a routine spot check in the Dietary Department, a minimum of 2 times per week, for 12 weeks to make sure that the kitchen, including the production coolers, is properly cleaned and maintained. Data gathered from these compliance review checks will be presented to the Quality Control Committee for review, follow up, and any corrective action necessary. The Dietary Manager will be responsible for continued compliance with this plan of correction.
The Cooler and Freezer Temperatures policy will be reviewed and revised, if necessary. All Dietary staff will have the Cooler and Freezer Temperatures policy reviewed with them so they are trained in the proper way to take and record cooler/freezer temperatures. The Quality Department will perform a routine spot check in the Dietary Department, a minimum of 2 times per week, for 12 weeks to make sure that cooler and freezer temperatures are being taken and recorded correctly. Data gathered from these compliance review checks will be presented to the Quality Control Committee for review, follow up, and any corrective action necessary. The Dietary Manager will be responsible for continued compliance with this plan of correction.
113.28 LICENSURE
DISTRESSED DRUGS, DEVICES, COSMETICS
Name - Component - 00
113.28 Distressed drugs, devices, and
cosmetics.
Drugs, devices, and cosmetics
under the control of the pharmacist
which are outdated, visibly
deteriorated, unlabeled or
inadequately labeled, recalled,
discontinued, or obsolete shall be
indentified by the pharmacist and
shall be disposed of in compliance
with applicable State and Federal laws
and regulations.
Observations:
Based on a review of facility policy, observation, and interview with staff (EMP), it was determined the facility failed to properly dispose of outdated medications.
Findings include:
A review on May 14, 2021, of facility policy "Department of Pharmacy Policy and Procedures Section 42.00 Monthly Pharmacy Inspections," last reviewed February 6, 2013 revealed "... Procedure, I. Responsibility, A. Pharmacy, I Action, A. Once each month, perform audit of designated medication storage areas in hospital B. Designated areas include ...9. Central Pharmacy - Shelves, refrigerator, Storage room C. During audits, ensure proper storage of medications, as well as removal of all expired pharmaceuticals...."
Observation on May 12, 2021, of the central pharmacy revealed six boxes of oseltamivir (a medication used for the treatment of influenza) 75 milligrams (mg) on the pharmacy shelf with an expiration date of September 2020.
An interview with EMP6 conducted on May 12, 2021 at 10:30AM, confirmed the central pharmacy had six boxes of oseltamivir 75 mg on the pharmacy shelf with an expiration date of September 2020.
Plan of Correction:The Pharmacy department policy and procedure for monthly pharmacy inspections will be reviewed and revised, if necessary.
The Director of Pharmacy will implement an education program for all pharmacy staff regarding the procedure for conducting monthly pharmacy inspections, including the procedure for checking medications for outdates and proper disposal of outdated medications.
The Quality Department, in conjunction with the Director of Pharmacy, will perform routine compliance review checks of the pharmacy medication stock, a minimum of 1 time per month, for 3 months to make sure that the procedure for monthly pharmacy inspections, including disposal of expired medications, is being followed appropriately.
Data gathered from these compliance review checks will be presented to the Quality Control Committee for review, follow up, and any corrective action necessary.
The Director of Pharmacy will be responsible for ensuring continued compliance with this plan of correction.
115.22 LICENSURE
STORAGE OF MEDICAL RECORDS
Name - Component - 00
115.22 Storage of medical records
Medical records shall be stored in
such a manner as to provide protection
from loss, damage, and unauthorized
access.
Observations:
Based on review of facility documents, observation, and staff interview (EMP), it was determined the facility failed to ensure medical record information was secured from unauthorized access in the facility's dental clinic.
Findings include:
Review on May 14, 2021, of the facility's "Security of Dental Records/Charts" policy, effective February 25, 2025, revealed "All dental records are place [sic] in filing cabinets at the front desk. The Dental office door is to be locked to secure all records when no one is present at the front desk or in the office."
Observation on May 14, 2021, at approximately 11:30 a.m. revealed a sign indicating Dental above a door.
Interview with EMP2 on May 14, 2021, at the time of the observation revealed this was the dental clinic and this dental clinic was under the facility's license.
Observation on May 14, 2021, revealed the door to the dental clinic was open. There was no dental staff at the front desk area or in the office. There were ceiling tiles missing from the ceiling. A ladder was in front of the filing cabinets and construction power tools were plugged into an outlet and charging on top of the first filing cabinet.
Interview with EMP2 on May 14, 2021, at the time of the observation confirmed the door to the dental clinic was open. There was no dental staff at the front desk area or in the office. There were ceiling tiles missing from the ceiling. A ladder was in front of the filing cabinets and construction power tools were charging on top of the first filing cabinet. EMP2 revealed the construction crew required entry into the dental clinic to install new pipes in the ceiling.
Observation on May 14, 2021, of the dental clinic revealed four 4-drawer filing cabinets. These filing cabinets did not contain locks. Further observation revealed the files stored in these file cabinets revealed completed patient forms containing patient name, date of birth, social security number, employer information financial responsibility information, emergency contact information, dental insurance and a completed medical history form.
Interview with EMP2 and EMP4 on May 14, 2021, at the time of the observation confirmed the four 4-drawer filing cabinets. These filing cabinets did not contain locks. The files stored in the four 4-drawer filing cabinets contained completed patient forms containing patient name, date of birth, social security number, employer information financial responsibility information, emergency contact information, dental insurance and a completed medical history form. EMP4 revealed the files were of adult and pediatric patients.
Plan of Correction:The policy for Security of Dental Records/Charts will be reviewed and revised as necessary. Locked file storage will be added to the dental unit to ensure security of the dental files.
The Dental Office Manger will conduct an education for all dental staff on the policy for security of dental records/charts, including that when dental staff is not present in the Dental Clinic the dental records must be secured so that unauthorized access can not occur.
The Quality Department will perform a routine spot check in the Dental Clinic, a minimum of 2 times per week, for 4 weeks to make sure that the dental clinic records are properly secured. Data gathered from these compliance review checks will be presented to the Quality Control Committee for review, follow up, and any corrective action necessary.
The Dental Office Manager will be responsible for continued compliance with this plan of correction.
147.82 LICENSURE
STERILIZATION CONTROL
Name - Component - 00
147.82 Sterilization control
There shall be written policies
establishing a method of control to
assure sterilization of supplies and
water, and requiring a sterile
supplies to be reprocessed at
specified intervals.
Observations:
Based on review of facility documents, observations, and staff interview (EMP), it was determined the facility failed to maintain a clean autoclave in the sub-sterile room for one of one autoclave observed and failed to maintain the sub-sterile room ceiling integrity.
Findings:
Review on May 12, 2021, of the facility document, "Infection Control Policy," last reviewed January 2021, revealed "...Infection Control Policy Surgical Suite ... X. Sterilizer. Steam - conventional. i. 250 degrees F. for 30 minutes, small loads. ii. 250 degrees F. for 45 minutes, larger heavy loads. 1. Weekly attest for Biological Control when it [sic] use. 2. Cleaning and maintenance. a. Wiped out daily prior to use. b. Exhausted [sic] ports cleaned weekly with solution of Tri sodium phosphate - 2T. to 1 quart warm water. iii. Routine checking autoclave service contract every three (3) months. ... "
Review on May 13, 2021, of the facility policy, "Cleaning of Gravity - Prevac Sterilizer," last reviewed January 2021, revealed "... Scope: This policy is applicable to all CS workers. Purpose: The purpose of this policy and procedure is to assure that CS workers clean the sterilizer properly to assure the bestpossible [sic] processing function. If the sterilizer chamber is not cleaned properly mineral deposits can build up and stain objects in the load. Policy: It is the policy of Barnes Kasson County Hospital Central Supply Department to follow the procedure below while cleaning the sterilizer. Procedure: 1.The inside of the sterilizer chamber is washed using a solution of "non esidual [sic] cleaning agent" Never use a strong abrasive such as steel wool, etc. Asoft [sic] cloth/sponge may be used. 2.Rinse by wiping down with a clean damp cloth. 3.Stacking rack and bottom rack are also cleaned and rinsed the same as the sterilizer chamber noted in steps #1 & 2 abve [sic].4.Steps #1 & 2 are also used to clean loading car and/or carriage as applicable. 5.The screen plug must be removed from the bottom of the chamber, and it's [sic] openings must be freed of lint, sediment,etc. [sic]"
An observation tour of the Operating Room Suite was completed on May 12, 2021, at approximately 11:00 AM. It was observed there was limescale buildup on the interior side walls of the autoclave in the sub-sterile room.
Interview on May 12, 2021, with EMP3, at approximately 11:30 AM, confirmed there was limescale buildup on the interior side walls of the autoclave located in the sub-sterile room of the Operating Room Suite.
Continued observation tour revealed there was peeling paint on the ceiling of the sub-sterile room in a circular shape with a diameter of approximately 2.5 inches.
Interview on May 12, 2021, with EMP3, at approximately 11:35 AM, confirmed there was peeling paint on the ceiling of the sub-sterile room in a circular shape with a diameter of approximately 2.5 inches.
Plan of Correction:The Infection Control policy for Cleaning of Gravity – Prevac Sterilizer will be reviewed and revised, if necessary. Maintenance of the autoclave will occur to remove all limescale buildup on the interior walls of the unit.
The Chief Nursing Officer, in conjunction with the OR supervisor, will implement an education program for all operating room staff responsible for the regular cleaning and maintenance of the autoclave in the sub-sterile room, including daily and weekly cleanings to eliminate any mineral deposit build up.
The Quality Department, in conjunction with the OR supervisor, will perform a routine spot check in the sub-sterile room a minimum of 1 time per week, for 8 weeks to make sure that the guideline for maintenance of the autoclave is being followed. Data gathered from these compliance review checks will be presented to the Quality Control Committee for review, follow up, and any corrective action necessary.
The OR supervisor will be responsible for continued compliance with this plan of correction.
The peeling paint on the ceiling of the sub-sterile room will be repaired.
The OR supervisor will be educated to perform routine environmental inspections of the sub-sterile room, including ceiling integrity, and report any findings to facility management for correction.
The Quality Department, in conjunction with the OR supervisor, will perform a routine spot check in the sub-sterile room a minimum of 1 time per month, for 3 months to make sure that the sub-sterile room is free of environmental issues. Data gathered from these compliance review checks will be presented to the Quality Control Committee for review, follow up, and any corrective action necessary.
The OR supervisor will be responsible for continued compliance with this plan of correction.
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