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Based on observation, document review, and interview, it was determined the Hospital failed to ensure its quality program had a Hospital wide periodic evaluation and quality assurance review, to track, trend, and evaluate the provision of care and services, and implement revisions as indicated by the findings. This has the potential to affect all inpatients and outpatients serviced by the Hospital. Therefore, the Condition of Participation, 42 CFR 485.641, Periodic Evaluation and Quality Assurance Review, is out of compliance, as evidenced by:

Findings include:

1. Refer to C-1200, Event ID ET6X11.

2. The Hospital failed to ensure the method of data collection for the environmental services performance improvement study accurately reflected the monitoring and data collection performed throughout the Hospital. See C-336A.

3. The Hospital failed to ensure an effective quality assurance program to evaluate the quality and appropriateness of immediate use sterilization (called flash). See C-336B.

4. The Hospital failed to ensure oversight of high level disinfection process to assure the capability of tracking compliance with disinfection and ability to identify patient use. See C-336C.

5. The hospital failed to ensure its quality assurance program was a organized hospital wide program to evaluate the cares/services provided. See C-337.

A. Based on document review and interview, it was determined the Hospital failed to ensure the method of data collection for the environmental services performance improvement study accurately reflected the monitoring and data collection performed throughout the Hospital. This has the potential to affect all inpatients and outpatients serviced by the Hospital.

Findings include:

1. The Hospital's quality improvement and patient safety plan and was reviewed on 2/4/2020 thru 2/6/2020. The plan indicated, "QI (Quality Improvement) Methodology... Data Collection Methodology: Describe the method you are using to collect your data."

2. The August 21, 2019 thru November 20, 2019 patient safety and infection prevention committee meeting minutes and the respective observation reports were reviewed 2/5/2020 at approximately 2:30 PM. The minutes and observation reports indicated the following:
On August 21, 2019, "Terminal Clean Report: Blacklight Study. We are going to do ten rooms a month. The hospital rooms, ER (emergency room), and ASD (ambulatory surgery department)..." (ten room in each of the mentioned departments). On September 18, 2019, "Six surveys were done in Surgery... thirteen rooms in the 400 hall and ASD were done as well." On October 16, 2019, "After the OR (operating room) has been used... They are trying to do 10 rooms per month...". On November 20, 2019, "Overall clean in surgery was at 73.3%... The 400 hall and ASD was at 75%..." However, each of the observation reports (August 21, 2019 thru November 20, 2019) indicated 12 (twelve) observations per month, with 3 three) in surgery and 9 (nine) combined for the 400 Hall and ASD, instead of 10 (ten) each and the 400 Hall and ASD numbers were not segregated to indicate how many rooms were done in the 400 hall and ASD. The Observation reports lacked any documentation that observations were performed in the ER. The August 21, 2019 thru November 20, 2019 patient safety and infection prevention committee meeting minutes and the respective observation reports lacked prevention, identification and data analysis; identification of corrective actions; implementation of corrective actions; and measures to improve quality on a continuous basis.

3. An interview was conducted with the Environmental Services Director (E#12) during the document review. E#12 stated, "I don't do the same number of each every month, like in November, it was surgery and 400 (hall). No, I haven't been doing the ER. I didn't think about how it (the number of observations monthly) wouldn't really show the right picture because it wasn't the same every month. I guess it (the results) wouldn't really tell much then."

B. Based on document review and interview, it was determined the hospital failed to ensure an effective quality assurance program to evaluate the quality and appropriateness of immediate use sterilization (called flash). This has the potential to affect all surgical patients serviced by the facility.

Findings include:

1. The policy titled "Immediate Use Sterilization" (approved by the hospital 11/5/2014) was reviewed on 2/6/2020. The policy noted "Immediate Use Sterilization should be avoided whenever possible, utilized only in the following instances: Emergent situations when no replacement instruments are available... Quality Control/Quality Assurance: Director of surgery should be responsible for ensuring compliance with this policy and procedure by periodic audit."

2. The immediate use sterilization logs for December 2019 to January 2020 were reviewed on 2/4/2020. The logs lacked documentation as to why the immediate use sterilization was being utilized and lacked documentation of oversight as to whether or not the immediate use sterilization was appropriately used.

3. The Hospitals Quality Assurance documents were review throughout the survey. The hospital lacked a effective quality assurance program for immediate use sterilization that included: ongoing monitoring, evaluation, and data collection.

4. An interview was conducted with the Infection Control Preventionist (E#3) on 2/11/2020 at approximately 11:50 AM. E#3 stated, "I made rounds (in surgery) sometime in October, just before the last manager left (the previous manager left towards the end of October). I identified that the staff were not filling out the logs (steam sterilization and high level disinfection) completely and told (the previous manager) that. I went back around November 20th (2019) and it was still not being done. I then reported this to the COO (Chief Operating Officer- E#2) as (E#2 - a non-clinical person) was providing oversight for surgery at that time. Later (uncertain of exact time), I got in contact with the tech (surgery technician) who (E#2) had instructed to do the policies (related to steam sterilization and high level disinfection competency and documentation) to see if there was anything I could help with. No, I haven't done any official rounds since then."


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C. Based on observation, document review, and interview, it was determined the Hospital failed to ensure oversight of high level disinfection process to assure the capability of tracking compliance with disinfection and ability to identify patient use. This has the potential to affect all patient's who receive endoscopic services, approximately 42 patient's per month.

Findings include:

1. During a tour of the dirty instrument room in the surgery department on 2/4/2020 at approximately 11:30 AM, the surgical aide (E#4) was asked how patient identifiers for each reprocessed scope was documented, E#4 stated the patient's sticker was scanned and the scope number was entered into the automatic high level disinfection machine. When asked how scopes that were manually cleaned were tracked, E#4 "I don't write that down anywhere. How would I?"

2. The high level disinfection log dated 11/5/2019 to 2/5/2020 was reviewed on 2/7/2020. The log noted 156 endoscopes were reprocessed, although 47 entries lacked a patient identifier.

3. During an interview on 2/4/2020 at approximately at 12:30 PM, the Certified Surgical Technician (E#6) stated "The Administrator can run a report (from the high-level disinfection machine) and see what scopes were used on which patient." When asked for the report, E#6 stated "No one has access since the Director left (October 2019). I will call the company and see if I can get access to the report."

4. During an interview on 2/6/2020 at approximately 11:30 AM, the Medical Director of Surgical Services (MD#1) stated the Surgery Department had not had a Director of Surgical Services since 10/2019. MD#1 stated there had not been oversight of compliance or periodic audits conducted since 10/2019 and should have been. MD#1, the Director of Nursing (E#1) and the Chief Operating Officer (E#2) verbally agreed a reprocessing quality indicator had not been monitored for compliance and should have been.


5. An interview was conducted with the Infection Control Preventionist (E#3) on 2/11/2020 at approximately 11:50 AM. E#3 stated, "I made rounds (in surgery) sometime in October, just before the last manager left (the previous manager left towards the end of October). I identified that the staff were not filling out the logs (steam sterilization and high level disinfection) completely and told (the previous manager) that. I went back around November 20th (2019) and it was still not being done. I then reported this to the COO (Chief Operating Officer- E#2) as (E#2 - a non-clinical person) was providing oversight for surgery at that time. Later (uncertain of exact time), I got in contact with the tech (surgery technician) who (E#2) had instructed to do the policies (related to steam sterilization and high level disinfection competency and documentation) to see if there was anything I could help with. No, I haven't done any official rounds since then."

Based on document review and interview, it was determined the hospital failed to ensure its quality assurance program was a organized hospital wide program to evaluate the cares/services provided. This has the potential to affect all inpatients and outpatients serviced by the Hospital.

Findings include:

1. The Hospital's Performance Improvement and Patient Safety program was reviewed 2/4/2020 thru 2/6/2020. There was no documentation of the quality assurance program including all care/services provided by the Hospital.

2. An interview was conducted with the Infection Control Preventionist (E#3) on 2/7/2020 at approximately 2:15 PM. E#3 stated having requested information from all departments as to what they have been gathering data on. It was discovered that all the departments had been gathering some data; however, there was not a venue for them to report it anywhere. Therefore, the information was not provided to the medical staff and governing body for analysis and evaluation.

Based on observation during the survey walk-through, staff interview, and document review during the Life Safety portion of a Critical Access Hospital Recertification Survey conducted on February 10-11, 2020, the surveyor finds that the facility failed to provide and maintain a safe environment for patients and staff.

This is evidenced by the number, severity, and variety of Life Safety Code deficiencies that were found. Also see C930.

Based on document review, observation, and staff interview, it was determined the Hospital failed to ensure essential mechanical, electrical, and patient-care equipment was maintained in safe operating condition, including inspections and routine preventive maintenance, in accordance with its policy. This has the potential to affect all patients receiving services at the Hospital.

Findings include:

1. The manufacturer guidelines for the GI-825 Portable Top Work Station, was reviewed on 2/11/2020 at approximately 2:35 PM. On page 11, the guidelines indicated, "Replacement of Main Carbon or HEPA Filters and Prefilters... The frequency of replacement is dictated by the results of regular filter monitoring (see Operational Safety Log Book)..." On page 17, the guidelines indicated, "It is important that the filters in this unit are replace on a consistent basis. It is recommended that all Carbon Filters be changed every 10 to 12 months. The pre-filters should be changed every 2 months."

2. A tour of the substerile room (a room that clean equipment is taken prior to going into the sterilizer) was conducted on 2/4/2020 at approximately 11:25 AM, with certified surgical technician (E#6). The safety log for the portable benchtop work station was reviewed during the tour. The safety log indicated, "change filter every 6 months". The log indicated the last date of installation or replacement of filter was 5/16/2018. During an interview with E#6 during the tour, E#6 stated "we don't use it is as much as we used to, so I haven't changed it." E#6 verbally agreed the manufacturer's instructions were to change the filter every 6 months. "I haven't changed the carbon filter because we haven't been using it. No, I haven't been changing the pre-filter every 2 months, again, because we haven't been using it."

3. The policy titled "Maintenance and Inspection: Scheduled Equipment (Preventative) (effective date by the Hospital: July 26, 2011)" was reviewed on 2/6/2020 at approximately 12:00 PM. The policy noted, "Scheduled (Preventative) Maintenance- Includes... preventative and corrective maintenance...Equipment File Listing by Location- List is updated as needed at least quarterly..."


4. A tour of the Ultrasound room in the Radiology department was conducted on 2/4/2020 at approximately 2:45 PM, with the Manager of Ultrasound (E#7). The doppler machine maintenance sticker indicated the last date of inspection was 3/2016. During an interview with the Director of Nursing (E#1) on 2/5/2020 at approximately 1:00 PM, E#1 verbally confirmed the doppler machine's last preventative maintenance was 3/2016 and it had not been added to the schedule of routine preventative maintenance.

5. The policy titled "Daily Rounds Check of Equipment Temperatures/ Ice Machines/ Water Meter Readings (Effective Date by the Hospital, April 26, 2011)" was reviewed on 2/6/2020 at 1:30 PM. The policy noted "...check and record the temperature of the upper and lower compartment of the blanket warmer in the Recovery Room on the Temperature Log for surgery...Notify Director of Plant Operations if temperatures are out of range..."

6. The January 2020 temperature logs for the recovery room blanket warmer and fluid warmer for OR (operating room) were reviewed on 2/6/2020 at approximately 1:00 PM, for the month of . The logs lacked temperature monitoring on 1/10/2020 and 1/21/2020. The recovery room blanket warmer top and bottom and OR #1/2 and OR #4 fluid warmer lacked temperatures for 1/23/20. The OR #1/2 fluid warmer and OR fluid warmer #4 lacked temperatures for 1/13/20. The recovery room blanket warmer top and bottom lacked temperatures for 1/15/2020 and 1/29/2020.

7. During an interview with the Registered Nurse (E#5) on 2/6/2020 at 1:30 PM, E#5 reviewed the January 2020 temperature logs and verbally confirmed the lack of the temperature monitoring of the warmers.

8. The refrigerator/ freezer log for January 2020 was reviewed on 2/5/2020 at approximately 1:00 PM. The log indicated the refrigerator temperatures were to be between 36 to 39 degrees. The log included the following temperatures were out of the normal range and lacked documentation the Director Plant Operations was notified for repair or maintenance to the machines: East refrigerator: 29 out of 31 days; Dietary cooler: 7 out of 31 days; 400 wing breakroom: 5 out of 31 days; and Ambulatory Surgery: 31 out of 31 days

9. During an interview with the Director of Nursing (E#1) on 2/7/2020 at approximately 8:30 AM, E#1 reviewed the refrigerator/ freezer log for January 2020 and verbally confirmed there was no documentation for repair of the abnormal temperatures.

Based on observation during the survey walk-through, staff interview, and document review during the Life Safety portion of a Critical Access Hospital Federal Recertification Survey conducted on February 10-11, 2020, the surveyor finds that the facility does not comply with the applicable provisions of the 2012 Edition of the NFPA 101 Life Safety Code.

See the Life Safety Code deficiencies identified with K-Tags on the CMS Form 2567, dated February 11, 2020.

Based on observation document review and interview, it was determined the Hospital failed to ensure drugs and biologicals were managed, labeled, handled and stored in a manner that is safe and appropriate. This has the potential to affect all patients who receive surgical services, with a average monthly census of approximately 100 patients.

Findings include:

1. During a tour of the Post Anesthesia Care Unit (PACU) in the surgery department on 2/4/2020 approximately 10:15 AM, the malignant hyperthermia cart was unlocked and accessible to unauthorized persons. The cart was contained: Dantrium Intravenous (IV) 20 mg (milligrams) x 24 vials; Nitroglycerin 5% 50 mg/250 ml (milliliters) x 1; Sodium Bicarbonate 8.4% 50 ml x 2 bottles; Manitol 20% 500 ml x 2 bottles; Lidocaine HCL injection USP 2% 100 mg/5/ml x 6 bottles; Calcium Gluconate injection 1000 mg/10 ml x 2 bottles; Heparin 10,000 units/ml x 1; and multiple syringes and needles. During an interview on 2/4/2020 at approximately 10:30 AM, the registered nurses (E#3, E#5) noted the the malignant hyperthermia cart and verbally agreed the cart was unlocked and the drugs and biologicals were accessible to unauthorized individuals and should not have been.

2. An undated form titled, "Info (information) from AORN", was reviewed on 2/5/2020 at approximately 9:00 AM. The Director of Nursing (E#1) stated the form was used for a surgery staff meeting, "but the date of the meeting was uncertain). The form indicated, "16. Syringes not allowed to be pre-labeled".

3. The Hospital policy titled, "Medication syringe labeling" (date created by Hospital 4/15/2013) was reviewed on 2/5/2020 at approximately 9:00 AM. The policy noted, "The anesthesia department has decided that there should be 10 syringes labeled and available for use for every anesthesia case, including induction, reversal, emergency and sedation medications... This task is assigned to one of the RN's in the department and should be checked daily prior to cases... 1. There is a bin in the anesthesia medication room that has a drawer for each medication that should be filled with labeled syringes... 4. Open the appropriate size syringe from the surgery stock. 5. Take a medication label of choice from the drawer labeled "Medication labels". 6. Place the label on the syringe... 7. Make sure each drawer is filled with 6 syringes." This policy contradicts the AORN standards of practice.

4 The "2019 Guidelines for Perioperative Practices 2019 Edition Association of periOperative Registered Nurses (AORN)" was reviewed on 2/6/2020 at approximately 3:30 PM. The guidelines noted under Medication Safety section on page 465 " A sterile needle and a sterile syringe should be used each time a medication is withdrawn from a single-dose/single-use vial.... multidose vial."


5. During a tour of the medication room in the surgical department on 2/4/2020 at approximately 11:00 AM, a storage box with 15 drawers was noted. Each drawer was labeled with a medication name and stocked with unpackaged syringes was labeled with the corresponding medication name. The syringes lacked a patient name or date or name of the person, whom opened the syringes. During an interview on 2/4/2020 throughout the tour of the surgical department, the registered nurse (E#3) and the registered nurse (E#5) stated the medication syringes were labeled so when the medication was drawn up, just the date and initials of the patient needed to be added to the label. E#3 and E#5 verbally agreed it was unable to be determined if sterility of the syringe and needle was maintained.

6. During an observation of Pt #13's surgery on 2/4/2020 approximately 11:15 AM, the Registered Nurse (E#13 ) poured 500 ml (milliliters) of irrigation solution mixed with 80 mg (milligrams) of Gentamicin medication into an unmarked container and the Surgical Technician (E#14) placed the container with the irrigation solution onto the sterile surgical field without labeling the solution/medication. During an interview on 2/4/2020 at approximately 11:30 AM, the registered nurse (E#5) who was present during the observation verbally agreed the irrigation solution/medication had not been labeled and it should have been.

Based on document review and interview, it was determined in 1 of 1 (Pt #10) medical record reviewed of a patient with a Broviac catheter (a type of central venous catheter used for long term intravenous therapy), the Hospital failed to ensure the nursing staff provided care to meet the patient needs as per policy. This has the potential to affect all patients with a Broviac catheter receiving care at the Hospital.

Findings include:

1. The policy titled "Central Venous Catheter Care (date created by the Hospital, 10/06/2017)" was reviewed on 2/7/2020 at approximately 2:05 PM. The policy noted, "...Broviac...9...cleanse connection with Betadine...10. cleanse injection port with Betadine...20...saline flush catheter as identified per physician orders..."

2. Pt. #10 Diagnosis: Active Endocarditis
The clinical record was reviewed on 2/6/2020 at approximately 1:55 PM. Pt. #10 was an outpatient receiving Rocephin IV (intravenous) daily. The clinical record included an order, dated 1/6/2020, to change the Broviac catheter site dressing daily, to cleanse the Broviac site with Betadine, and to flush the Broviac catheter with saline. The nursing service note, dated 1/31/2020, lacked documentation the Broviac catheter site was cleansed with Betadine. The nursing service note, dated 2/4/2020, lacked documentation the Broviac catheter was cleansed with Betadine and flushed with normal saline.

3. During an interview with the Director of Nursing (E#1) on 2/7/2020 at approximately 8:30 AM, E#3 reviewed Pt #10's record and verbally confirmed the lack of the Broviac catheter site care with the Betadine and the lack of the saline flush as ordered per physician.

Based on document review, observation, and interview, it was determined the Hospital failed to ensure all patient health information was securely protected. Therefore, the Condition of Participation, 42 CFR 485.638, Clinical Records, is out of compliance. This has the potential to affect all inpatients and outpatients serviced by the Hospital.

Findings include:

1. The Hospital failed to ensure medical records were secured and patients identities were protected. See C-1120.

Based on observation, document review and interview, it was determined the Hospital failed to ensure patient care equipment high level disinfection and respective patient use were documented and accessible for review. This has the potential to affect all patients who receive endoscopic services, approximately 42 patients per month.

Findings include:

1. During a tour of the dirty instrument room in the surgery department on 2/4/2020 at approximately 11:30 AM, the surgical aide (E#4) was asked how patient identifiers for each reprocessed scope were documented. E#4 stated the patient's sticker was scanned and the scope number was entered into the automatic high level disinfection machine. When asked how scopes that were manually high level disinfected were documented and tracked, E#4 stated, "I don't write that down anywhere. How would I?"

2. The high level disinfection log, dated 11/5/2019 to 2/5/2020, was reviewed on 2/7/2020 at approximately 12:55 PM. The log noted 156 endoscopes were reprocessed. 47 entries lacked a patient identifier. Examples include:

a. . Pt #23 Date of Service (DOS): 2/5/2020
Procedure: Colonoscopy. The record was reviewed on 2/5/2020 at approximately 1:00 PM. The record lacked documentation of the scope used during the procedure.

b. . Pt #24 DOS: 2/4/2020
Procedure: Esophagogastroduodenoscopy and Colonoscopy. The record was reviewed on 2/5/2020 at approximately 1:05 PM. The record lacked documentation of the scope used during the procedure.

c. Pt #25 DOS: 2/4/2020
Procedure: Esophagogastroduodenoscopy. The record was reviewed on 2/5/2020 at approximately 1:10 PM. The record lacked documentation of the scope used during the procedure.

6. During an interview on 2/4/2020 at approximately at 12:30 PM, the Certified Surgical Technician (E#6) stated "The Administrator can run a report (from the high-level disinfection machine) and see what scopes were used on which patient." When asked for the report, E#6 stated "No one has access since the Director left (October 2019). I will call the company and see if I can get access to the report."

7. During an interview on 2/6/2020 at approximately 11:30 AM, the Medical Director of Surgical Services (MD#1) verbally agreed the endoscope number used should be documented in the patient's clinical record, an accurate log ( of both automated and manual high level disinfection) of the endoscopes utilized should include patient identifiers, and staff members should have had access to the reports.

Based on document review and interview, it was determined for 4 of 20 (Pt #1, Pt #5, Pt #10, Pt#20) patients records reviewed, the Hospital failed to ensure medical record entries were accurately timed and dated as per policy. This has the potential to affect all patients receiving services at the Hospital.

Findings include:

1. The policy titled "Medical Records Department Purpose and Objectives (date approved by the Hospital, 11/19/2019)", was reviewed on 2/4/2020 at approximately 2:15 PM. The policy noted, "... All entries in the record are to be dated, timed and authenticated..."

2. The policy titled "Telephone Orders, Verbal Orders, Written Orders (date approved by the Hospital, 09/25/2017)", was reviewed on 2/6/2020 at approximately 11:45 AM. The policy noted, "... Procedure: 3. Telephone and Verbal orders must be countersigned by the physician within 72 hours of time received. Written orders should be signed at the time the provider writes the order..."

3. Pt. #1 Diagnosis: Fall
Pt. #1 was admitted on 2/2/2020. The clinical record was reviewed on 2/6/2020 at approximately 8:45 AM. The record included an initial admission orders signed by the Physician. The order lacked the complete date and time the order was signed.

4. Pt. #5 Diagnosis: Osteoarthritis of Right Knee
Pt. #5 was admitted on 1/31/2020. The clinical record was reviewed on 2/6/2020 at approximately 11:00 AM. The record included a preoperative standing order signed by the physician. The order lacked a date and time of signature.
The record included a telephone orders, dated 1/31/2020 and 2/1/2020. The telephone orders lacked a signature by the physician.

5. Pt. #10 Diagnosis: Active Endocarditis
Pt. #10 was an outpatient, receiving intravenous antibiotics. The clinical record was reviewed on 2/6/2020 at approximately 1:55 PM. The record included a verbal order dated 1/6/2020. The physician signature lacked a date and time the order was signed. The record included verbal/ telephone orders dated 1/6/2020, 1/13/2020 and 1/17/2020, which lacked a signature by the physician.

6. Pt. #20 Diagnosis: Shortness of Breath
Pt. #20 was admitted on 1/24/2020. The clinical record was reviewed on 2/5/2020 at approximately 9:30 AM. The record included 3 telephone orders dated 1/25/2020. The telephone orders lacked a signature by the physician.

7. During an interview with the Director of Nursing (E#1) on 2/7/2020 at approximately 8:30 AM, E#1 reviewed the above records and verbally confirmed the lack of the physician signatures, dates and times.

Based on document review, observations, and interview, it was determined the Hospital failed to ensure medical records were secured and patients identities were protected. This has the potential to affect all patients who receive surgical services, with a average monthly census of approximately 100 patients.

Findings include:

1. The policy titled "Medical Records Policy" (reviewed by Hospital 9/20/2018) was reviewed on 2/5/2020. The policy noted, "Each patient protected health record will be filed and stored in an area that is restricted from public access... the confidentiality of medical record information and provides safeguards..."

2. During a tour on the Post Anesthesia Care Unit (PACU) on 2/4/2020 at approximately 10:15 AM, the medical records of Pt #15, Pt #21, and Pt #22 were on a bedside table in the holding area where Pt #13 was waiting for surgery.

3. During a tour of the surgical hallway on 2/4/2020 at approximately 12:20 PM, the anesthesia record of Pt #14 was on a bedside table, unattended in the surgical hallway.

4. During tours of the PACU and the surgical hallway, registered nurse (E#3) noted the unsecured medical records in the PACU and the surgical hallway and stated that the medical records should not have been accessible and/or visible to other patients. E #3 stated that, the PACU was used as a holding area for patients prior to surgery and as a recovery room, which was accessible to patients and visitors.

A. Based on document review, observation, and interview, it was determined the Hospital failed to ensure that all opened containers of food in the dietary department included a open date to ensure that food was safe for consumption. This has the potential to affect all patients, visitors, and staff who consume food from the Dietary Department.

Findings include:

1. The policy titled "Food Waste and Expired Food Items (date approved by Hospital, 4/27/2015)" was reviewed on 2/5/2020 at approximately 1:30 PM, the policy noted, "... In the event of an expired item (s), it must be disposed of properly to follow food safety guidelines..."

2. An tour was conducted on 2/4/2020 at approximately 2:00 PM with the Manager of Dietary (E#9). Located in the kitchen area was an open container of cocoa with an expiration date of 5/2018 and 1 open container of ginger spice and 1 open container of pumpkin pie spice, both with no date as to when they were opened or an expiration date and/or date to discard.

3. During an interview with E#9 on 2/4/2020 during the tour. E#9 confirmed the lack of any dates on the opened food containers and stated that all opened containers of food should have the dates of when they were opened and/or expiration/discard dates.


B. Based on document review, observation, and interview, it was determined the Hospital failed to ensure sterile patient care items were in the unopened packages to prevent the potential for cross contamination, in accordance with its policy. This has the potential to affect all patients using items in sterile packages.

Findings include:

1. The policy titled "Event Related Sterilization" (revision date by the Hospital 12/2011)." The policy noted, "... To assure sterility of patient care items... Any item that has a torn wrapper...should not be used."

2. A tour of the Emergency Department was conducted on 2/4/2020 at approximately 11:45 AM, with the Assistant Manager of the Emergency Department (E#8). In the cabinet in room 601, 1 opened sterile package with a flexible yankauer tube was available for patient use.

3. During an interview with E #8 on 2/4/2020 during the tour, E #8 verbally stated the opened sterile package should have been thrown away once opened.

Based on document review and interview, it was determined the Hospital failed to ensure its Emergency Plan (EP) included a system for tracking the location of on-duty staff and sheltered patients both during an emergency and, if relocated, the specific name and location of the receiving facility or location. This has the potential to affect all inpatients, outpatients, and staff of the Hospital.

Findings include:

1. The EP was reviewed on 2/7/2020 at approximately 10:00 AM. The EP lacked a system for tracking on-duty staff and sheltered patients during an emergency and if relocated.

2. An interview was conducted with the Safety Director (E#11) on 2/7/2020 at approximately 12:15 PM. E#11 reviewed the EP and stated, "I'm certain that's not in here and it should be, so we'll need to add."