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Based upon observation, interview and record review, the Critical Access Hospital (CAH) failed to ensure that two pharmacy refrigerators, one pharmacy freezer, and a refrigerator in the Birthing Center (BC) was appropriately labeled and maintained in safe operating condition; and a soiled utility closet containing housekeeping chemicals was secured in the Emergency Department (ED). Findings include:

Per observation on 8/20/18 at approximately 12:30 PM of the BC soiled utility room, a refrigerator that was used to hold medical waste (placentas-the afterbirth from labor) did not contain a biohazard label; and the temperature of the refrigerator was not being monitored. Per interview with the BC Nurse Manager at that time, s/he stated that the Environmental Services staff monitored the refrigerator temperature. Per interview on 8/21/18 at 8:58 AM with the Vice President of Support Services, s/he confirmed that there was no biohazzard label on the refrigerator; and that no one in the facility was monitoring the refrigerator temperature.

During a tour of the ED on 8/21/18 at 9:08 AM, the soiled utility room was observed to be unsecured. This room was located in the main hallway of the ED and was easily accessible to unauthorized individuals. The room contained a 1 quart bottle of Clorox bleach, 2, 10 ounce bottles of Neutra-Air aerosol, an 18.9 liter bottle of Sparkle glass cleaner, and a bucket of recyclable instruments. Per interview with the ED Nurse Manager at that time, s/he stated that the door had never been locked; and s/he was unsure if the door should be locked. Per interview on 8/22/18 at 2:30 PM with the Director of Quality Management, s/he confirmed that the door to the soiled utility room in the ED was not locked and should be.

Per observation of the Pharmacy and staff interview, the VP of Ancillary Services and Pharmacy Manager confirmed on 8/20/18 at 11:30 AM that two pharmacy refrigerators and one pharmacy freezer, that contain patient chemotherapy and patient medication, have audible alarms that sound in the event of an equipment failure however are not monitored when the pharmacy is closed. These alarms are only monitored by pharmacy staff during working hours from 7:30 AM - 5:30 PM Monday thru Friday and 7:30 AM - 4:00 PM Saturday and Sunday. Refrigerator and freezer alarms are not monitored by maintenance when the pharmacy is closed. The alarms would continue to sound until staff return the next day. Per ASHP (American Society of Health-System Pharmacists) Practice Setting Guideline: Copyright 2013, page 551: " Medication Storage and Preparation Areas: there shall be suitable facilities to enable the receipt, storage, and preparation of medications under proper conditions of sanitation, temperature ...to ensure medication integrity ..."

Refer to C-0276.

Based upon observation, record and policy review, and staff interview, the CAH failed to ensure health care services were furnished in accordance with appropriate written policies; the storage of Nitrogen Gas is in compliance with applicable State law; and failed to develop policies/procedures applicable to the reprocessing of cystoscopes.
Findings include:

1. Per observation of the Medical Gas Storage area and confirmed with the VP of Ancillary Services on 8/20/18 at 11:37 AM, a cylinder of Nitrogen Gas was free standing in the storage room and was not secured to the wall to prevent falling or being knocked over. Per record review of the "Safety Data Sheet", Nitrogen Gas is considered hazardous by the Occupational Safety and Health (OSHA) Hazard Communication Standard (29 CFR 1910.1200). Conditions for safe storage include: Cylinders should be stored upright with valve protection cap in place and firmly secured to prevent falling or being knocked over. Per policy review and confirmed with the Quality Manager on 8/22/18 at 11:45 AM, there is no CAH policy concerning the handling and storage of medical gases.

2. During a tour of the Specialty Clinic on 8/21/18 at approximately 12:30 PM, one of the two exam rooms, which were used primarily for Urology services (study of the functions and disorders of the urinary system), contained two cystoscopes (instruments used to examine the bladder) hanging separately in solutions, in vacuum sealed compartments. Per interview with the Specialty Clinic Manager at that time, s/he stated that the clinic staff reprocesses the cystoscopes in the clinic after each cystoscopy procedure. S/he further stated that the reference used for the cystoscope reprocessing was a "Joint AUA/SUNA (American Urological Association/Society of Urologic Nurses and Associates) White Paper on Reprocessing of Flexible Cystoscopes; published in 2009, updated in 2013". S/he stated that the staff was trained to reprocess the cystoscopes in the clinic; and that the expectation was that each staff member would perform a return demonstration of the procedure prior to performing the procedure independently. Per review of the clinic policies and procedures, there was no evidence of a policy for reprocessing of cystoscopes. Per interview on 8/22/18 at 10:35 AM with the Director of Quality, Vice President of Operations, Nurse Manager and Interim Nurse Manager of the Operating Room, Specialty Clinic Manager, Infection Control Nurse and VP of Support Services; they all confirmed that a policy had not been developed for the reprocessing of cystoscopes in the Speciality Clinic.

3. Per observations of the hospital's kitchen and food storage areas during the initial tour of the Nutrition and Food Service areas on 8/20/18 at 10:10 AM, the following perishable foods were not stored in accordance with the Food Services policies/procedures for safe food handling practices. The walk-in refrigerator had 2 containers of prepared muffin batter (lemon poppy and apple cinnamon flavored) that had been opened and staff failed to write the date opened for use on each container. In a reach in refrigerator near the food service line area, 4 containers identified as holding various broths (2 chicken, 1 beef and 1 vegetable) were dated 7/17/18. When questioned about the dates, the Director of Hospitality and Food Services confirmed that the broths had been pulled from the freezer for use; however they were not labeled with the date the broths were removed from the freezer, and no new expiration date was recorded on each container.

The hospital policy # NFS-310, titled "Infection Prevention for Nutrition and Food Services", under "II. Food Service, C. Food Handling, 1. Refrigerate or freeze foods in appropriate containers, cover and date with expiratory dates for Potentially Hazardous foods", and under 6. " "Date foods stored in unit refrigerators." During interview at the time of the observation, the Director confirmed that dietary staff should have dated the muffin batter when opened for use and relabeled the foods pulled from the freezer with the date pulled and a new expiration date.

Based on staff interview and record review, the CAH failed to ensure that all policies were reviewed at least annually by members of professional and clinical personnel as required. Per review of the CAH policies, multiple departments had not reviewed policies in the past twelve months in the following areas:

1. Per review of the Emergency Department polices, "Domestic Abuse and Violence" approved 5/11/17, "Child Abuse and Neglect Reporting" approved 5/11/17, and "Emergency Department Staffing Plan" approved 5/11/17, there was no indication that these policies had been reviewed on an annual basis. Per interview on 8/22/18 at 3:00 PM with a Quality Management Specialist, s/he confirmed that these policies had not been updated annually and should have been.

2. Per review of the Birthing Center policies, "Assignment for Patient Care-Birthing Center" approved 10/20/15, "Guidelines for Consultation, and Notification of Pediatricians" approved 8/12/16, and "Adoption" approved 10/21/15, there was no indication that these policies had been reviewed on an annual basis. Per interview on 8/22/18 at 3:00 PM with a Quality Management Specialist, s/he confirmed that these policies had not been updated annually and should have been.

3. Per policy review and staff interview, the Lab Manager confirmed on 9/21/18 at 9:12 AM, the Lab Policy titled "Communication and Documentation of Critical Laboratory Values, LAB - 202", with effective date of 3/13/13 was last approved on 8/5/16. In addition, the Lab Manager acknowledged this policy was on a 3 year cycle for review as opposed to a 1 year review per organizational policy.

4. Per review of policy "Cleaning and Disinfecting" with effective date of 01/13/2016 has not been reviewed since the effective date. Per interview on 8/22/18 at 10:05 AM the Director of Quality Management confirmed although it is the CAH policy to review all organizational policies on a one year cycle, s/he is aware not every policy has been reviewed as per policy and as required. In addition, the Director acknowledged Administrative policies are presently on a 3 year cycle for review as opposed to the 1 year review.

5. The CAH policy, "Advanced Directives and Vermont Advanced Directives Registry" with an effective date of 10/18/2011, was last approved on July 7, 2016. The Director of Quality confirmed this policy had not been reviewed in the last 12 months at 9:00 AM on 8/22/2018.

6. Per review on 8/12/18, the pharmacy policy entitled " Drug Dispensing and Procurement in Event of all other Emergencies not including Evacuation" was last reviewed/revised on 8/12/16. During interview on the afternoon of 8/12/18, the Director of Quality confirmed that the policy had not been reviewed annually as required for CAH Conditions for Participation.

Based upon observation, interview and record review, the CAH failed to ensure the safe storage and disposal of unusable drugs in two refrigerators and one freezer located in the pharmacy that contain patient chemotherapy and patient medication. Finding includes:

Per observation of the Pharmacy and staff interview, the VP of Ancillary Services and Pharmacy Manager confirmed on 8/20/18 at 11:30 AM that two pharmacy refrigerators and one pharmacy freezer, that contain patient chemotherapy and patient medication, have audible alarms that sound in the event of an equipment failure and are not monitored when the pharmacy is closed. These alarms are only monitored by pharmacy staff during working hours from 7:30 AM - 5:30 PM Monday thru Friday and 7:30 AM - 4:00 PM Saturday and Sunday. Refrigerator and freezer alarms are not monitored by maintenance when the pharmacy is closed. The alarms would continue to sound until staff return the next day. Per ASHP (American Society of Health-System Pharmacists) Practice Setting Guideline: Copyright 2013, page 551: Medication Storage and Preparation Areas: "there shall be suitable facilities to enable the receipt, storage, and preparation of medications under proper conditions of sanitation, temperature, ...to ensure medication integrity ..."

Per staff interview on 8/20/18 at 3:40 PM, the Pharmacy Manager confirmed that the pharmacy policy titled "Storage of Medication PH-136" effective date 11/13/2017 does not address what actions staff should take in the event of an equipment failure of the two pharmacy refrigerators and pharmacy freezer which store patient chemotherapy and patient medications that require specific refrigeration/freezer temperatures for maintaining stability. In addition, the policy does not address what actions staff should take if the patient chemotherapy or patient medications were determined to be unusable for patient administration following an equipment failure and replacements were not immediately available if needed.

Also refer to C- 0222.

Based on observation, staff interview, and record review the CAH failed to maintain evidence of staff training and competency for reprocessing of cystoscopes for the Urology service of the Specialty Clinic. Findings include:

During a tour of the Specialty Clinic on 8/21/18 at approximately 12:30 PM, one of the two exam rooms, which were used primarily for Urology services, had two cystoscopes hanging separately in solutions, in vacuum sealed compartments. Per interview with the Clinic Manager at that time, s/he stated that the clinic staff reprocesses the cystoscopes in the clinic after each cystoscopy procedure. S/he stated that the reference used for the cystoscope reprocessing was a "Joint AUA/SUNA (American Urological Association/Society of Urologic Nurses and Associates) White Paper on Reprocessing of Flexible Cystoscopes; published in 2009, updated in 2013". S/he stated that the staff was trained to reprocess the cystoscopes in the clinic; and that the expectation was that each staff member would perform a return demonstration of the procedure prior to performing the procedure independently. Per review on 8/22/18 at approximately 9:00 AM of the Specialty Clinic Manager's personnel file, there was no evidence of training and/or documented competency for cystoscope reprocessing. Per interview on 8/22/18 at approximately 11:00 AM with the Director of Quality and Vice President of Operations, they each confirmed that there was no evidence of training and/or documented competency for the Specialty Clinic Manager and the other staff who reprocess cystoscopes for the Urology service of the Specialty Clinic.

Based on observation and interview the Condition of Participation for Surgical Services was not met as evidenced by the failure of the CAH to ensure a designated space was delineated in the Decontamination room for individuals who enter this restricted area without proper protective attire; failure to ensure proper storage of endoscopes; failure to ensure ventilation hoods in Central Sterile remained free of dust/debris; and staff failure to recognize outdated test strips were being used during reprocessing of endoscopes. Findings include:

During a tour on 8/20/18 at 11:30 AM and from 1:00 - 3:00 PM of the perioperative locations with the interim nurse manager for Surgical Services the following observations were made:

1. An outdated and opened test strip container was observed sitting on top of the Steris/Reliance endoscope processing machine. The "Verify - Process Indicator for Reliance EPS Endoscope Processing System" test strips had an expiration date of 1/4/18. The test strips are to be used by staff when reprocessing endoscopes (an instrument that can be introduced into the body to give a view of its internal parts/digestive system which physicians use to diagnose and treat). The test strips validate that an effective dose of Paracetic Acid (a high level disinfectant) was utilized when reprocessing endoscopes, ensuring disinfection was effective prior to reuse and eliminating possibility of microbial contamination within the endoscope. The interim nurse manager confirmed staff failed to follow endoscope cleaning process by using outdated test strips.

2. Within Central Sterile Processing (where surgical instruments are prepared, packed and sterilized for patient use) dust was observed on 2 exhaust hoods located above the 2 autoclaves (large pressure chambers used for sterilization of surgical instruments). A third exhaust hood located above the instrument washer also had dust adhering to the hood. Each of the three hoods are connected to individual duct systems. Dust was also noted to be adhering to the round duct ventilation system extending approximately 3-4 feet above the room ceiling. On 8/22/18 at 8:20 AM the Facility Manager confirmed housekeeping would be responsible for the daily cleaning of the hoods and Facility/Maintenance staff would be responsible for the cleaning of the duct system, however s/he was unsure when the ducts were last cleaned and what the time frame would be for periodic scheduling to ensure Central Sterile Processing remained free of dust exposure.

3. Within the Decontamination room (a receiving area for cleaning soiled, contaminated instruments/equipment) and where blood borne pathogen precautions must be maintained there was a failure to provide a line of demarcation to alert staff who enter without required PPE (Personal Protective Equipment) not to travel beyond a certain point within the semi-restricted area. Central Sterile Processing staff confirmed on the morning of 8/20/18 staff occasionally will enter the Decontamination room to drop off soiled instruments from physician offices/clinics without donning protective covering as required.

Per 2016 AORN (Association of periOperative Registered Nurses): Patient and Workers Safety Environment of Care Part 2, page 267 states: "The designated areas should be separated by signage indicating the attire required for entering the area and who may access... the doors separating the restricted area from the semi-restricted area;" and "Doors, signage or a line of demarcation to identify the separation between the unrestricted and semi-restricted areas. Signs provide a visual cue that alerts persons to the restrictions required for entry into each area."

4. On 3 separate occasions between 8/20/18 -8/22/18 and confirmed with the interim nurse manager for Surgical Services, the door to the endoscope storage cabinet was observed to be left opened. The cabinet is located within the reprocessing room and after endoscopes are reprocessed they are placed in the scope cabinet. Keeping the rolltop cabinet door closed promotes drying, protects the endoscopes from damage and prevents recontamination. However, repeatedly the door was left open which lessened the benefits of the air drying system within the cabinet and limited the protection of the endoscopes when the door remained open for extended periods. Per Disinfection, Sterilization and Antisepsis Principles, Practices, Current Issues, and New Research edited by William A. Rutala, PhD., MPH states: "5. Store the endoscopes in a way that prevents recontamination and promotes drying".

5. When requested evidence of competency of staff identified responsible for the cleaning of endoscopes, the only evidence of competency was provided for 1 individual who works both in the operating room and endoscopy. A second individual, classified as a contracted traveler, was identified on the morning of 8/22/18 by the interim nurse manager for surgical services as a second person responsible for endoscope reprocessing. However, there was no evidence of this individuals competency in accordance with CAH policies and procedures for the cleaning of endoscopes, although s/he has been performing this process for several months since accepting assignment at the CAH. Per CDC (Centers for Disease Control) and HICPAC (Healthcare Infection Control Practice Advisory Committee) stated in January 25, 2017 within the published Essential Elements of a Reprocessing Program for Flexible Endoscopes - Recommendations of the Healthcare Infection Control Advisory Committee: " Management should ensure that: F. All personnel involved in the reprocessing of endoscopes, including supervisors and managers of reprocessing, receive ongoing education, training and assessment of competency...".