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315 W MADISON AVE

CHESTER, MT 59522

MAINTENANCE

Tag No.: C0914

Based on observation, interview, and record review, the facility failed to establish written policies and procedures for establishing strategies to ensure the maintenance of all essential mechanical, electrical, and patient-care equipment utilized by the facility; failed to ensure all essential mechanical, electrical, and patient-care equipment were identified and included in an inventory list which included a record of maintenance activities; and failed to ensure all essential medical equipment was identified and maintained through a facility established maintenance strategy. The accumulative effect of this deficiency had the potential to affect all patients provided care services by the facility. Findings include:

1. Established Equipment Maintenance Policy and Procedures

A review of the facility's policy and procedure titled Medical Equipment Management Plan, with a revision date of 7/13/17, failed to include strategies to ensure the maintenance of all essential mechanical, electrical, and patient-care equipment utilized by the facility was established.

During an interview on 8/16/23 at 9:50 a.m., staff member GG stated the facility utilized the provided policy and procedure for ensuring the maintenance of patient-care equipment. She stated the facility used a contract company for their periodic equipment maintenance of all patient-care devices.

2. Periodic Maintenance of Patient-Care Equipment

During an observation on 8/15/23 at 10:15 a.m., the following equipment showed a blue equipment tag with an "Inspection Date of 7/2022" and "Next Inspection 7/2023":

- Located in the Emergency Department was a Sigma Spectrum IV pump with an equipment control number of 2310LCH.

- Located in the Emergency Department was a bed with an internal scale with an equipment control number of 324LCH.

- Located in a procedure room next to the Emergency Department was a baby warmer with an equipment control number of 10088060.

- Located in a procedure room next to the Emergency Department was a fetal heart monitor with an equipment control number of 401LCH.

- Located in an acute patient care room was a Mindray Remote Telemetry Monitor with an equipment control number 2312LCH.

During an observation on 8/15/23 at 10:15 a.m., the following equipment did not have a visible equipment maintenance tag:

- Located in the storage room across the hall from the Emergency Department was a Luccas II Chest Compression System.

- Two glucometers one Located in the Emergency Department and one located at the primary nursing station.

During an observation on 8/15/23 at 3:00 p.m., the following equipment located in the facility's procedure room did not have a visible equipment maintenance tag:

- Logio GE Ultrasound machine with a system identification number of 530361US8.
- Padnet electrocardiogram machine.
- Mindray vital sign system monitor.

During an interview on 8/15/23 at 3:00 p.m., staff member B stated all equipment utilized for patient-care should have an up-to-date maintenance sticker with a date of the last periodic maintenance, which was 7/11/23.

During an interview on 8/16/23 at 9:50 p.m., staff member FF stated all patient care equipment utilized by the facility should have an equipment maintenance tag which identifies it equipment number and date of most recent service maintenance. Staff member FF stated they utilize a contract agency which managed the periodic maintenance of all of their equipment. He stated the equipment should be reviewed at least yearly unless otherwise specified by the equipment manufacture. Staff member FF stated the contract agency had just been to the facility on 7/11/23 and provided biomedical safety and performance testing on the facility's patient-care equipment.

3. Patient-Care Equipment List

A review of the facility's policy and procedure titled Medical Equipment Management Plan, with a revision date of 7/13/17, showed:

"The purpose of the Medical Equipment Management Plan is to support safe patient care and treatment environment for health related occupancies operated by Liberty Medical Center by managing risks associated with the use of medical equipment. The plan includes processes for selection, maintenance and training that are designed to promote safe and effective use of medical equipment while minimizing risks to patients and staff..."

Inventory

A. The inventory of all medical equipment listed is maintained by the specific Department Manager/Business Office/Central Supply..."

A review of the facility's Active Equipment List, failed to identify and include the following patient-care equipment in their list of serviced items:

- Sigma Spectrum IV pump with an equipment control number of 2310LCH.

- Bed with an internal scale with an equipment control number of 324LCH.

- Electronic baby warmer with an equipment control number of 10088060.

- Fetal heart monitor with an equipment control number of 401LCH.

- Mindray Remote Telemetry Monitor with an equipment control number 2312LCH.

- Luccas II Chest Compression System.

- Two Glucometers.

- Logio GE Ultrasound machine with a system identification number of 530361US8.

- Padnet electrocardiogram machine.

- Mindray vital sign system monitor.

During an interview on 8/16/23 at 9:50 p.m., staff member FF stated all patient care equipment utilized in the facility should be identified on the active equipment list. If the equipment was no longer utilized, it would be added to the discontinued equipment list and removed from the patient care area.

During an interview on 8/16/23 at 9:50 a.m., staff member GG stated the contract company which the facility used to ensure the periodic maintenance of patient-care equipment utilized the active equipment list to identify and maintenance the facility's equipment. She stated if the equipment was not identified on the active equipment list the contract company would not know which equipment needed maintenance.

PROVISION OF SERVICES

Tag No.: C1004

Due to the manner and degree of the deficient practice, the facility failed to meet the Condition of Participation for the Provision of Services.

Based on observation, interview, and record review, the facility failed to:

- Establish an accurate accountability procedure to ensure control of the distribution, use, and disposition of all scheduled drugs; failed to ensure an accurate documentation system of scheduled medications in a readily retrievable manner to facilitate the reconciliation of the receipt and disposition of controlled medications which clearly tracks the movement of all scheduled drugs from point of receipt to distribution and/or destruction; and failed to establish a system to promptly identify and reconcile any scheduled medication discrepancies. The accumulative effect of these deficiencies had the potential to affect all patients and staff providing care. (See 1016).

PATIENT CARE POLICIES

Tag No.: C1016

Based on observation, record review, and interview, the facility failed to establish an accurate accountability procedure to ensure control of the distribution, use, and disposition of all scheduled drugs; failed to ensure an accurate documentation system of scheduled medications in a readily retrievable manner to facilitate the reconciliation of the receipt and disposition of controlled medications which clearly tracks the movement of all scheduled drugs from point of receipt to distribution and/or destruction; and failed to establish a system to promptly identify and reconcile any scheduled medication discrepancies. The accumulative effect of these deficiencies had the potential to affect all patients and staff providing care. Findings include:

A. Accountability Procedure

A review of the facility's policy and procedure titled, Controlled Drug Distribution, with a revision date of 6/2018, showed:

"...Discrepancy: All nurses with access to controlled substance will document any discrepancies they find before the end of their shift. All discrepancies must be documented and if it cannot be resolved, the DON [Director of Nursing] and pharmacist will be notified immediately and nurses will not be permitted to leave until discrepancy is resolved..."

During an interview on 8/16/23 at 1:00 p.m., staff member B stated controlled medications were stored in the medication cart, the acute care nurses' station and the emergency department. He stated it was the expectation that a count of all narcotics was completed by two nurses at the end/beginning of each shift for these areas. Any discrepancy noted during the narcotic count should be immediately reported. Staff member B stated there should always be two people accountable on the count and both should sign the narcotic log.

Review of the facility's Narcotic Count log sheets from February 2023 to current, showed the following missing reviews by a two-person accountability method at each shift change:

On the Acute Care Narcotic Count Log:
- 2/1/23
- 2/25/23
- 3/4/23
- 3/5/23
- 3/10/23
- 3/25/23
- 4/7/23
- 4/12/23
- 6/8/23
- 6/9/23
- 6/14/23
- 6/20/23
- 6/26/23
- 6/27/23
- 7/21/23
- 7/22/23
- 7/25/23

On the Emergency Department Narcotic Count Log:
- 2/4/23
- 2/25/23
- 3/2/23
- 3/3/23
- 3/8/23
- 3/10/23
- 3/25/23
- 4/7/23
- 4/12/23
- 4/30/23
- 6/3/23
- 6/24/23 through 6/30/23
- 7/19/23 through 7/31/23
- 8/1/23
- 8/11 through 8/15/23

Medication Cart Narcotic Drawer:
- 7/2/23
- 7/8/23
- 7/23/23
- 7/29/23 through 7/31/23

During an interview on 8/16/23 at 1:12 p.m., staff member O stated two nurses complete a narcotic count of the narcotics in the med cart, the acute care nurses' station, and the emergency department. These counts were to be completed by the off-going nurse with the on-coming nurse. The off-going nurse looks at the count and the on-coming nurse counts the medications in the cart. She stated there should always be a two-person count.

During an interview on 8/16/23 at 1:20 p.m., staff member P stated the Narcotic Count log was a verification system to ensure the narcotic medications in the med cart, acute care med room and emergency department were accurate. She stated the count occurs with the on-coming and off-going nurses. She stated there were rare times when the acute care nurse was busy with an emergency in the emergency department and could not count off with the on-coming nurse. In those instances there may only be one nurse signing the narcotic log.

B. Documentation of Receipt, Reconciliation, and Disposition

A review of the facility's policy and procedure titled, Controlled Drug Distribution, with a revision date of 6/2018, showed:

"...Purchase/Receipt: All invoices for controlled drugs in schedule II, III, IV and V will be maintained in a readily retrievable file according to federal guidelines. The purchaser copy of DEA-222 forms will be kept in a separate file for all CII purchases. CII invoices will be kept with the DEA form.

Records/Distribution: A transaction record for all controlled substances in schedules II, III, and IV will be maintained by the hospital. All controlled drug records will be maintained for the period required by law and be readily available.
- A perpetual inventory record of all CII drugs stored in the pharmacy will be maintained.
- When controlled drugs are transferred outside the pharmacy, a record will be made in the controlled substance inventory logbook.
- Each drug administration will be recorded on the drug administration record log. There will be a count sheet that will be used for documentation for hospital inpatients. The dose administered will also be recorded by the nurse in the EMAR [Electronic Health Administration Record]...

Destruction: Destruction of any controlled substance must be done in the presence of two licensed individuals who are authorized to handle these dn1gs. This waste will be documented in the waste log of the EMAR. The destruction/waste of overstock/outdated controlled drugs will be performed in accordance with the federal law and by the pharmacist...

An order for a controlled drug for use by a hospital patient shall be entered in the EHR [Electronic Health Record] by the provider. If the pharmacist or pharmacy technician if not available to fill this medication the nurse signs out the ordered dosage utilizing the medication sign out log and faxes it to the pharmacy for verification. In the event the patient does not consume the medication the narcotic waste is documented in the waste log in the E H R by two licensed staff."

During an observation and interview on 8/15/23 at 11:28 a.m., there were two different forms used for the documentation of receipt, reconciliation and disposition of controlled medications. One form contained a carbon copy and the other was a sheet of paper with Narcotic Record written at the top of the sheet. Staff member P stated they utilized both the carbon copy form and the non-carbon copy form interchangeably. She stated each form was used to track the receipt, administration, and destruction of the controlled medications. Staff member P stated each controlled medication in stock had a corresponding sheet which was used to document the date, time, amount on hand, the amount given, amount remaining, the patient which the medication was given and the nurse who gave the medication. She stated these sheets were then reviewed at the end of each shift to ensure the amount of narcotic left in stock corresponded with the number entered on the form. She stated any discrepancies would be immediately reported.

During an interview on 8/16/23 at 4:37 p.m., staff member HH stated each controlled medication in stock should have a corresponding narcotic record sheet which identified the name of the medication, the strength, beginning and ending quantity of medications, name of the receiving individual with the date the medication was entered into stock, and the NDC (National Drug Code). Each sheet should also be utilized as a disposition record which would identify the name of the patient receiving the medication, the date and time the medication was removed from stock, the name of the individual removing or receiving the medication, the amount on hand, the amount given, and the amount remaining.

A review of the controlled medication and their corresponding narcotic administration record of the acute care medication room showed the following discrepancies:

1. On a carbon copy form titled, Receipt Drug Administration Record for Fentanyl Patch 25 mcg/hr.: a patient name was crossed off and written over the space was a notation stating, "injectable - not patch". There was no signature identifying the individual who made the correction. There was then a new ticket which was taped onto the sheet with the ticket number crossed off and a new number written into the space.

During an interview on 8/15/23 at 11:00 a.m., staff member B stated the original copy must have been wasted when the wrong patient was written into the log. He stated someone must have then taped a new copy into the space and crossed off the last number and entered the remaining amount on the ticket. He stated that was not the correct way to manage the reconciliation of the logbook.

2. On a carbon copy form titled, Receipt Drug Administration Record for Percocet 5/325 mg tablet with a page control number of 704170:

- The form did not include a date the medication was received into stock.

- On 3/27/23 four tablets were recorded as given. The record then had three blank spaces below the entry without documentation of administration.

- On line item #5, with a date of 6/4/23, showed two tablets were removed from stock. The following line item #4 was dated 6/3/23 without a time and showed "2 of 2" as doses given. The next entry for line item #3, had a date of 6/4/23, without a documented time and showed "2 of 2" doses given. The next line item#2 was dated 6/5/23, without a documented time and showed two tablets were given. The following line item #1 was blank with downward pointing arrows written on the line. The final line item #0 was dated 6/4/23. The record was not maintained in a chronological order, and failed to ensure an accurate documentation system of the scheduled medications to allow for the medications administered from this stock to be readily retrievable in order to facilitate the reconciliation of the receipt and disposition of the controlled medications which clearly tracks the movement of all scheduled drugs from point of receipt to distribution and/or destruction.

During an interview on 8/16/23 at 3:00 p.m., staff member B stated he was not sure why the logbook with control number 704170, was written out of chronological order, unless the individual who took the medications out of stock did not complete the entry correctly and had to write the reconciliation of the medications into the log at a later date. Staff member B stated that was not the correct method to reconcile the narcotic log. He also stated the reconciliation did not include a two-person authentication of the correction.

3. On a sheet of paper titled, Narcotic Record, showed "Percocet 5/325 mg" was written on the top. There was no additional identifying information as to the medication inventory.

- On 6/4/23, the first entry on the page showed, "received from pharmacy" with number 17 received and remaining. The record did not show who received the medication.

- On 6/4/23 at 12:30 p.m., showed an entry for "#10 sent home/#1 given PO [by mouth] now". The remaining amount showed 6. Then entered on the following line was a notation, "see next page" with an arrow pointing to the right of the page. There was no further documentation of disposition for this medication on this sheet.

- This form did not indicate a name or responsible individual who removed or administered the medications for all entries on this log.

During an interview on 8/16/23 at 3:00 p.m., staff member B stated the facility only had dose packs of #10 tablets of Tramadol and Norco to send home with patient. He stated sometimes the provider will want to send the patient home with something stronger, such as Percocet. So the provider will write an order for the nurse to dispense. Staff member stated it was not within the role and scope of the nurse to dispense narcotics.

4. On a sheet of paper titled, Narcotic Record, showed "Oxycodone 5 mg" was written on the top of the sheet. There was no additional information to identify the medication in inventory.

- The first entry dated, 6/30/22 at 3:00 p.m., showed, "received from pharmacy", with 25 tablets remaining. The entry did not indicate the receiving individual.

- An entry, dated 12/17/22, showed two tablets were removed from inventory. The entry was then crossed out and entered on the side of the form was a notation which showed, "wrong patient". The notation did not identify the individual who made the correction or show a two-person authentication of the correction.

-The following entry, dated 3/12/23, showed amount given of six tablets. A notation was written next to the entry which showed, "sent [with] pt. [patient]". This entry did not include identification of the individual removing the medication from the stock.

- This form did not indicate a name or responsible individual who removed or administered the medications for all entries on this log.

5. On a carbon copy form titled, Receipt Drug Administration Record, with a page control number of 704172 showed, Norco 5/325 mg tablets:

- On entry line #11, dated 7/7/23, showed a patient was provided with one tablet and zero tablets wasted. The section to document the name of the ordering provider was blank. The following two lines for entry #10 and #9 were blank. The following line with entry #8 was dated for 8/4/23. There was no record of administration or disposition for the blank items noted on the record.

- Line item entry #6 was blank. The document and the count in stock showed there were five tablets remaining. Line item #6 indicated one tablet of oxycodone was unaccounted for in the logbook.

6. On a carbon copy form titled, Receipt Drug Administration Record, with a page control number of 704163, showed: Norco 5/325 mg tablet:

- An entry dated 3/9/23, showed a patient was provided two tablets. The following line was left blank.

- The next entry was dated 3/10/23, which showed two tablets were given to a patient. The following line was blank.

- Another entry dated 3/29/23, showed two tablets were given to a patient. The following line was blank.

During an interview on 8/16/23 at 3:00 p.m., staff member B stated there should not be any blank lines on the narcotic log sheets.

7. On a sheet of paper titled, Narcotic Record, showed "Tramadol 50 mg tab" was written top of the sheet. There was no additional information to identify the medication in inventory.

- An entry dated 4/14/22 showed, "received from pharmacy #20". The record did not indicate the receiving individual.

-An entry on 6/2/23, showed, "received from pharmacy #20". The record did not indicate the receiving individual.

-An entry on 8/5/23, showed, "received from pharmacy" #20". The record did not indicate the receiving individual.

-An entry on 4/3/23 at "2100 [9:00 p.m.]" showed the amount on hand was 13, and a patient was provided half of a tablet. The record did not indicate the remaining half tablet was destroyed or witnessed of destruction. The remaining amount was left blank. The next entry on the line below was left blank for date and patient and amount on hand. There was a time entered on the line which showed, "2230 [10:30 p.m.]". The administration showed another half tablet was given and a remaining amount was entered as "12".

- An entry on 4/4/23, showed a date entry as "0650 [6:50 a.m.]/1430 [2:30 p.m.]. The amount given showed, "0.5 tablet x 2". There was no indication of disposal of the remaining half tablet or a witnessed waste.

- This form did not indicate a name or responsible individual who removed or administered the medications for all entries on this log.

During an interview on 8/16/23 at 3:00 p.m., staff member B stated the half of the tablet which was not administered should have been destroyed by a two-person authentication. He stated the tablet should not have been saved and administered at a later time. Staff member B stated the "received from pharmacy" entries were by the pharmacist when new medication was entered into stock. He stated they would write the amount entered and add it to the remaining stock.

8. During a record review and interview on 8/16/23 at 4:00 p.m. A document titled, Narcotic Record, showed, "Norco 5/325" was written on the top of the sheet. There was no further identifying information for the "Norco 5/325" that was currently in stock. During an interview, staff member B stated the form was used to track and record dose packs of Norco 5/325 mg tablet packs of ten tablets each. He stated each pack of 10 was entered into the record as one pack of 10. The record did not indicate the dose packs of 10 tablets.

- The first entry showed, "carried over" and then written on the first line was an entry showing, "received from pharmacy" dated 12/7/22, amount on hand #1, amount received #2, and amount remaining #3. The record did not indicate the receiving individual, or how much medication was actually available in the narcotic cabinet.

-The following dates showed entries stating "received from pharmacy" which did not include the receiving individual: 12/8/22, 1/25/23, 7/4/23, and 7/25/23. There was not a new sheet created for new receipts of the Norco 5/325 mg tablets dose pack count of 10 tablets on those dates. During an interview on 8/16/23 at 4:37 p.m., staff member HH stated they utilized a "rolling" entry to log any new Norco dose packs.

- An entry dated 7/24/23 at 1:20 a.m., showed #1 was given. The record did not show an order or an administration for this entry, or identification of the individual who removed this item from stock. During an interview on 8/16/23, staff member B stated there was no provider order or administration noted in the record for the removal of this medication from stock. He stated he believed the nurse who provided the medication was a travel nurse.

- This form did not indicate a name or responsible individual(s) who removed or administered the medications for all entries on this log.

C. Identification and Reconcile Medication Discrepancies

A review of the facility's policy and procedure titled, Controlled Drug Distribution, with a revision date of 6/2018, showed:

"...Discrepancy: All nurses with access to controlled substance will document any discrepancies they find before the end of their shift. All discrepancies must be documented and if it cannot be resolved, the DON [Director of Nursing] and pharmacist will be notified immediately and nurses will not be permitted to leave until discrepancy is resolved. Any employee who may have had the ability to divert any controlled substance and who was on site when the discrepancy occurred, whether on shift or not, may be subject to blood and or urine drug testing at the discretion of the DON or other supervising head."

During an interview and record review on 8/16/23 at 2:00 p.m., staff member B stated for all above identified (item #s 1-8) which outlined controlled drug discrepancies identified during survey, there were no investigations or reconciliations completed prior to the survey. Staff member B stated any deficiencies found on the controlled medication logs or counts should be documented when identified and reconciled of findings should be completed immediately. No further documentation was provided during the survey to show the discrepancies were identified and reconciled prior to the end of survey.

During an interview on 8/16/23 at 4:37 p.m., staff member HH stated there should be a written record which clearly identifies any controlled medication discrepancies with the reconciliation of the findings. He stated he was not currently aware of any concerns.

During an interview and record review on 8/16/23 at 2:00 p.m., staff member A stated the facility was on track to receive an ADC (automatic dispensing cabinet). He stated they hoped the installation of the new ADC would help with the tracking and accountability of controlled medications at their facility. Staff member A stated he did not have a confirmed date when they were going to get the ADC. He stated although they planned on transitioning to the new ADC system, they had not changed their current narcotic tracking system or provided education to the staff. A review of a corresponding email dated 8/16/23, did not indicate a date when the ADC would be in service at the facility.

INFECTION PREVENT & CONTROL & ABT STEWAR PROG

Tag No.: C1200

Due to the manner and degree of the deficient practice, the facility failed to meet the Condition of Participation for Infection Prevention and Control.

Based on observation, interview, and record review, the facility failed to:

- Establish and follow facility policies and procedures to ensure timely and routine cleaning, disinfection, and biological spore testing of the autoclave sterilizer used to sterilize patient care instruments. The accumulative effects of these deficient practices had the potential to affect all patients receiving care within the facility. (See C1208).

- Ensure specific tracking and trending of infections were established for the Infection Prevention and Control Program. (See C1208).

- Ensure the facility had a facility wide Antibiotic Stewardship program in place with coordination among the ICP program, QAPI, medical staff, nursing, and pharmacy staff. (See C1218).

INFECTION PREVENT SURVEIL & CONTROL OF HAIs

Tag No.: C1208

Based on interview, and record review, the facility failed to establish and follow facility policies and procedures to ensure timely and routine cleaning, disinfection, and biological spore testing of the autoclave sterilizer used to sterilize patient care instruments: and failed to document the facility had an active Infection Control Program for tracking and trending infections, and monitoring for the spread of infections. The accumulative effects of these deficient practices had the potential to affect all patients receiving care within the facility. Findings include:

1. Autoclave Sterilizer Cleaning and Disinfection:

A Review of the facility's policy and procedure titled, Sterilization of Instruments, with a revision date of 10/2013, showed:

"Procedure for Cleaning the Autoclave

1. Autoclave is cleaned on a monthly basis with water and a lint free soft cloth.
2. Instructions for cleaning are kept in the procedure room with the autoclave."

A review of the facility's Operation and Maintenance Manual for the Tuttnauer Electronic Table-Top Autoclave showed:

"Program 5: Chamber Brite Cleaning

This is a maintenance cycle used with Tuttnauer's Chamber Brite TM cleaner for cleaning the chamber and piping of the autoclave. We recommend using Chamber Brite TM and cleaning the autoclave every 20 cycles or once per week whichever is longer. (see sec. 12.1.2 for detailed instruction on cleaning the chamber)...

12.1. Preventive and Scheduled Maintenance

The maintenance operations described in this chapter need to be followed as indicated to keep the device in good working condition. This maintenance schedule is the responsibility of the equipment owner and not covered under the warranty. The majority of instructions that follow can easily be carried out by the operating personnel and do not require a service technician...

12.1.2. Weekly by the operator
Once per week or after 20 cycles, clean and descale the chamber, copper tubes and the reservoir using Chamber Brite..."

Review of the facility's Autoclave Maintenance Log for 2023, showed the following items were to be completed every two months: "Cleaning, Chamber Brite, Tray Holders, Outside Cleaning." The facility's established maintenance procedures did not follow manufacture's time guidelines for cleaning and disinfection of the autoclave sterilizer.

Review of the facility's Autoclave Maintenance Log from February 2023 to Current showed maintenance of the autoclave was completed on 2/9/23 and 7/15/23. The facility failed to ensure timely cleaning and disinfection occurred every two weeks or 20 cycles for the autoclave sterilizer.

During an interview on 8/15/23 at 3:00 p.m., staff member DD stated it was the facility's expectation to complete the cleaning and disinfection of the autoclave either every 20 cycles or every two months, whichever occurred first. Staff member DD stated the individual who was to complete the autoclave maintenance had left and the cleaning and disinfection of the autoclave had been missed for several months.

2. Biological Spore Testing

A Review of the facility's policy and procedure titled, Sterilization of Instruments, with a revision date of 10/2013, showed:

"Procedure for Autoclave Sterility Test:

1. On outside of the Attest ampule, write the date and load number.
2. Sterility shall be tested weekly with the test pack.
3. A test pack shall be made up of material forming a solid pack with the attest amp placed in the center.
4. After being ran through the autoclave cycle, the amp is taken to the lab where it shall be incubated for 24-48hrs and results kept in a logbook which is kept in the lab area.
5. A positive report shall be promptly given to the Clinic Manager. All items autoclaved that day and after that date will be pulled from inventory and re-processed.
6. Another sterility test shall be run at this time to indicate that autoclave is sterilizing properly..."

Review of the facility's Weekly Attest (Spore Testing) Log from February 2023 to current showed the following dates of spore testing were completed on:

- 2/20/23
- 3/5/23
- 5/1/23
- 6/14/23
- 7/12/23
- 7/23/23
- 8/4/23

The facility failed to follow established policies and procedures for the weekly spore testing of equipment processed and used to ensure sterile patient care instruments.

During an interview on 8/15/23 at 3:00 p.m., staff member DD stated they were to ensure the biological testing ampule was completed weekly. She stated the previous responsible individual for the weekly spore testing had left and the spore testing was not being completed. She stated she recently started completing the spore testing.

During an interview on 8/15/23 at 3:00 p.m., staff member B stated it was the expectation that the spore testing of the sterilized patient care instruments be completed as established in the facility's policy and procedures.


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3. During a review of the facility Infection Control Program, no documentation was provided by the end of survey.

During an interview on 8/16/23 at 2:20 p.m., staff member C stated the IP staff member had recently quit. The staff member had a large bin of paperwork, but it did not include an infection control log, tracking and trending of patient infections, monitoring and re-evaluation of the program or having a documented risk assessment. Staff member C stated the IP staff member was rarely in the facility before she quit.

Review of the facility Infection Control Committee Meeting notes, dated 7/20/23, showed the following topics were discussed:
1. Review minutes
2. Review of Any Employee Exposures
3. Review of Any New Clinical Equipment
4. EOC IP Findings and Concerns
5. Pet Policy
6. Infection Control Policies
7. Mock Survey
8. Water Quality
9. Action Items for next meeting

Review of the Committee Meeting notes, dated 6/20/23, also showed that staff member L was working with their corporation to consolidate 15 infection control policies.

Review of the prior five months Committee Meeting notes included the same topics as above, with no actions documented.

During an interview on 8/16/23 at 1:00 p.m., staff member L stated she had completed one staff education on who and what to report for infectious diseases or exposures. She stated she did not document the education, and was learning her new role as IP.

FACILITY-WIDE ABT STEWARDSHIP PROGRAM

Tag No.: C1218

Based on interview and record review, the facility failed to maintain an Antibiotic Stewardship Program, which could adversely affect the overuse of antibiotics for patients in the facility. Findings include:

During a review of the facility Antibiotic Stewardship Program, no documentation was provided.

During an interview on 8/16/23 at 2:20 p.m., staff member C stated the IP staff member had recently quit. The staff member had a large bin of paperwork, but it did not include an infection control log, tracking and trending of patient infections, or have a documented risk assessment. Staff member C stated the IP staff member was rarely in the facility before she quit. Staff member C did not know where any Infection Control or Antibiotic Stewardship documentation might be found.

Review of a facility handout titled "Antibiotic Stewardship" showed the facility should measure and evaluate the processes and outcomes of antibiotic use for their patients. The program should provide regular updates on antibiotic use, resistance, and infectious disease management.

Review of the facility's Quality/Safety meeting notes, dated 5/17/23, showed the facility would join the regional Antibiotic Stewardship program to help with their processes.

Review of the facility Quality/Safety meeting notes, dated 6/15/23, showed staff member L would be attending these meetings. No documentation was provided by the facility.

QAPI

Tag No.: C1306

Based on interview and record review, the facility failed to incorporate an Infection Control Program and Antibiotic Stewardship Program, and report to the monthly QAPI meeting. This deficient practice had the potential to affect all patients receiving care services by the facility. Findings include:

Review of the facility QAPI meeting notes, dated 2/15/23, showed there was no Infection Control report.

Review of the facility QAPI meeting notes, dated 3/15/23, showed no Infection control report was brought to the meeting,

Review of the facility QAPI meeting notes, dated 4/19/23, showed staff member C was not receiving information regarding infections.

Review of the facility QAPI meeting notes, dated 5/17/23, showed the Infection Control committee is finding it difficult to get members to attend the meetings. No Infection Control report was documented.

Review of the facility QAPI meeting notes, dated 6/21/23, showed the facility had a Mock Survey on 5/30/23, and had many findings regarding the lack of Infection Control.

Review of the facility QAPI plan, dated 2023, showed the committee will receive, review and approve reports from individuals or teams that reflect the status and success of quality improvement efforts that include Infection Prevention and Antibiotic Stewardship.

During an interview on 8/16/23 at 3:20 p.m., staff member C stated it would be the responsibility of the CEO or the DON to ensure the Infection Control Program was functioning. Staff member C stated she was aware that infection control was an area of concern for the facility. The former IP had recently quit, and no documentation of the program was found by the facility.