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The hospital failed to meet the regulatory requirements for the Condition of Participation: CFR 485.635 Provision of Services as evidenced by the following:

A. Based on observation, interview and record review, the hospital failed to ensure implementation of policy and procedures (P&P) for safe and effective systems for:

1. a) Pain Re-assessment for Patients 103, 106, 107, 205, 306, and 307.
b) Pain Assessment for Patients 103, 106, and 107.

2. Preventative maintenance on equipment.

3. Vital signs monitoring for Patient 205.

4. Telemetry monitoring (continuous tracking of a person's heartbeat) documentation for Patient 108.

5. Glucometer (device used to measure blood sugar) cleaning in the medical surgical department.

6. Removal of expired Epidural needles in the X-ray department.

These failures had the potential to result in patients not receiving quality care as per monitoring, assessment, reassessment, and use of expired equipment. (Reference C-1006).

B. The pharmacy or drug storage area must be administered in accordance with accepted professional principles.
Based on interview with hospital administrative staff and review of the hospital's P&P, the hospital failed to ensure the medication error data gathered had been used to effect changes in the hospital's processes for patient care. The hospital also failed to collect and use "near misses" (close call medication errors), to change and/or modify the way the hospital provides patient care.

This failure had the potential to jeopardize patient care for 23 of 23 sampled patients. (Reference C- 1016).

C. Based on observation, interview and record review, the facility failed to:
1. Ensure patient food was served within acceptable temperatures (Hot minimum 140 degrees Fahrenheit [F]).
2. Ensure kitchen refrigerator temperature was keep within acceptable temperature range (41 degrees F or less).
3. Ensure multiply food items had an expiration date, and/or food was not expired.

The facility's failures did not comply with acceptable nutritional standards, did not maintain the safety of food, and had the potential for food-borne illnesses. (Reference C-1020).

D. Based on observation, interview, and record review, the facility failed to ensure new lead (radiation protective garments used by personnel during fluoroscopy (medical procedure that makes a real-time video of the movements inside a part of the body by passing x-rays through the body over a period of time) was tested and assigned a number to identify the lead before putting into service.

The facility's failure placed staff at risk of using lead that has not been tested and could potentially not be tested annually since a number has not been assigned to the lead and placing staff at risk of being exposed to unnecessary radiation. (Reference C-1030).

E. Based on interview and record review the facility failed to:
1. Ensure medical surgical registered nurses (RNs) had end-of-life care training since they were providing end-of-life (palliative) care to patients.
2. Ensure medical and surgical RNs were competent (as evidence by the medical record findings) with the operation of patient-controlled analgesia (PCA-patient controlled analgesia for pain management that lets you decide when you will get a dose of pain medicine) pump, documented PCA pump elements and followed their P&P when providing pain management to five of five sampled patients (Patients 104, 202, 203, 204, and 205) with PCA pumps. (Reference C-1049).

The facility's failures placed patients at risk of not receiving quality and safe care resulting in harm to patients due to the lack of RNs training and competency. (Reference C-1046).

F. Based on interview and record review, the facility failed to follow their P&Ps and standards of practice for medication administration when:
1. Physician orders were not followed for PCA pump titration of opioid (narcotics to treat pain) medication administration for Patient 205.
2. Oxygen therapy was continued without a physician's order for Patient 205.
3. Physician orders were not followed for the medication administration of Morphine (narcotic medication to treat moderate to severe pain) IVP (intravenous push) for Patient 205.
4. PCA opioid medication administration was not documented per P&P for Patients 205, 203, 202, and 204.
5. Pain assessments were not done per PCA P&P for Patients 205, 204, and 203.
6. PCA opioid medication waste was not documented per P&P for Patient 203.
7. Medication error confirmed during PCA opioid medication administration for Patient 104.
8. MRI (magnetic resonance imaging scans images of the body using a large magnet and radio waves) contrast (liquid medication injected into the blood stream to make certain tissues and blood vessels show up more clearly and in greater detail) was opened and not discarded.
9. Patient 106 received Tylenol (medication to treat pain and fever) for fever and was not reassessed.
10. Patient 106 received Ativan (medication to treat anxiety) and was not reassessed.

These facility failures resulted in nurses not following physician orders, not following P&Ps for medication storage, medication administration and documentation, medication pain assessments and reassessments, and medication waste of opiates. These failures contributed to the medication error for Patient 104 and may have contributed to the death of Patient 104 from an overdose of PCA opiates. These failures may have adversely affected Patients 202, 203, 204, and 205 by potentially causing medication errors when they received PCA opioid medications. (Reference C-1049).

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure an effective system-wide provision of services resulting in the hospital's inability to ensure the safety and quality of care provided for patients in the hospital.

Based on observation, interview, and record review, the hospital failed to ensure implementation of policy and procedures (P&P) for safe and effective systems for:

1. Pain Re-assessment for Patients 103, 106, 107, 205, 306, and 307.

2. Pain Assessment for Patients 103, 106, and 107.

3. Preventative maintenance on equipment.

4. Vital signs monitoring for Patient 205.

5. Telemetry monitoring (continuous tracking of a person's heartbeat) documentation for Patient 108.

6. Glucometer (device used to measure blood sugar) cleaning in the medical surgical department.

7. Removal of expired Epidural needles in the X-ray department.

These failures had the potential to result in patients not receiving quality care as per monitoring, assessment, reassessment, and use of expired equipment.

Findings:

1. During a review of the facility's P&P titled, "Pain Management," dated 9/2023, the P&P indicated in part "To provide safe, appropriate, and efficacious use of pain management (analgesia) infusions and Patient Controlled Analgesia (PCA) ... to provide guidelines for proper monitoring, documentation, and maintenance ... to ensure patient safety and a smooth transition of pain control therapy throughout the continuum of care ... C) Re-assessments of pain score is completed: i) within one hour after an intervention to assess improvement of pain/symptoms whenever the clinician needs to intervene to relieve pain ..."

During a concurrent interview and record review on 2/2/24 at 11:40 a.m. with the education manager (EM), Patient 103's e-MAR (electronic medication administration record) was reviewed and indicated Patient 103 was administered Tylenol 650 mg by mouth for pain level of 3/10 (pain scale 0-10 with 0 no pain and 10 is severe pain) on 12/9/23 at 8:41 a.m., and on 12/10/23 at 5:11 p.m. The pain assessment section of the flowsheet indicated there was no pain reassessment performed and/or documented one hour after intervention. The EM acknowledged and confirmed pain re-assessments were not documented on the flowsheet one hour after the pain medication was administered.

During a concurrent interview and record review on 2/7/24 at 12:30 p.m. with the medical surgical manager (MSM), Patient 106's e-MAR was reviewed and indicated Patient 106 was administered pain medication on 12/27/23 at 8:44 a.m., for pain level 5/10. The pain assessment section of the flowsheet indicated, there was no pain re-assessment performed and/or documented one hour after intervention. The MSM acknowledged and confirmed pain re-assessment was not documented on the flowsheet one hour after the pain medication was administered, this area on the flowsheet is blank.

During a concurrent interview and record review on 2/7/24 at 12:51 p.m. with the patient safety director (PSD), Patient 107's e-MAR was reviewed and indicated Patient 107 was administered Norco (narcotic medication to treat moderate to severe pain) 1 tablet by mouth for pain on 12/6/23 at 8:20 a.m., and on 12/6/23 at 1:36 p.m. The pain assessment section of the flowsheet indicated, there was no pain re-assessments performed one hour after the medication was administered. The PSD acknowledged and confirmed there were no pain re-assessments performed one hour after the medication was administered.

During a concurrent interview and record review on 2/7/24 at 5:31 p.m. with the PSD, Patient 306's "Pain Monitoring Flowsheet" and "Medication Administration Record (MAR)," dated 8/10/23 at 10:38 p.m., were reviewed and indicated, Patient 306 received 1 mg (milligram) of Dilaudid (narcotic medication to treat moderate to severe pain) IVP (intravenous push) and the patient's pain score was 7. Further review of Patient 306's "Pain Monitoring Flowsheet," indicated, there was no pain re-assessment documented at 11:38 p.m., an hour after receiving the Dilaudid (narcotic medication to treat moderate to severe pain) IVP. PSD acknowledged there was no pain re-assessment documented within an hour of Patient 306 receiving the Dilaudid, and further acknowledged there should be. PSD further confirmed staff did not follow facility P&P for pain management.

During a concurrent interview and record review on 2/8/24, at 9:50 a.m., with the education manager (EM), Patient 307's "Pain Monitoring Flowsheet," dated 9/30/23 at 3:36 a.m., was reviewed and indicated, Patient 307 received 15-325 mg of Norco orally and Patient 307's pain score was 7. Further review of Patient 307's "Pain Monitoring Flowsheet" indicated, there was no pain re-assessment documented at 4:36 a.m., an hour after receiving the Norco orally. EM acknowledged there was no pain re-assessment documented within an hour of Patient 307 receiving the Norco, and further acknowledged there should be. EM further confirmed staff did not follow facility P&P for pain management.

During a concurrent interview and record review on 2/8/24 at 10:13 a.m. with the EM, Patient 205's "Pain Monitoring Flowsheet," dated 12/4/23 at 12:24 a.m. and 12/4/23 at 7:38 p.m., was reviewed and indicated, Patient 205 received 4 mg of Morphine (narcotic for moderate to severe pain) IVP (Intravenous push) and Patient 205's pain score was unable to assess. Further review of Patient 205's "Pain Monitoring Flowsheet," indicated, there was no pain re-assessment documented at 1:24 a.m. and 8:38 p.m. an hour after receiving the Morphine IVP. EM acknowledged there was no pain re-assessment documented within an hour of Patient 205 receiving the Morphine, and further acknowledged there should be.

2. During a review of the facility P&P titled, "Pain Management," dated 9/2023, the P&P indicated, "B. Assessment for pain will be done at least once each shift. This will be recorded in the patient's medical record. Factors to be assessed when performing a pain assessment include, but not limited to: i) Does the patient have pain?, ii) Intensity, iii) Sedation score (when receiving opiates/sedatives), iv) Pain quality, v) Location, vi) Description, vii) Patient's personal goal for pain relief (numerical, function/activity), viii) Interventions taken and effectiveness, ix) Side effects."

During a concurrent interview and record on 2/2/24 at 11:40 with the EM, Patient 103's e-MAR was reviewed and indicated, Patient 103 was administered Tylenol 650 mg by mouth for pain level of 3/10 on 12/9/23 at 8:41 a.m., and on 12/10/23 at 5:11 p.m. The pain assessment section of the flowsheet indicated the assessment only contained a number, the rest was blank. The EM acknowledged the assessment was incomplete.

During a concurrent interview and record review on 2/7/24 at 12:15 with the PSD, Patient 106's pain assessment section in the flowsheet was reviewed and indicated, on 12/15/23 at 4:37 p.m., 12/27/23 at 7:44 a.m., and 12/28/23 at 6:35 a.m., the pain assessment documentation only contained a number, and the rest of the pain assessment elements were missing. The PSD confirmed the pain assessments were incomplete because most of the assessment elements were missing. Furthermore, PSD acknowledged the pain assessment elements listed in the policy did not match the pain assessment elements listed in the assessment section in the flowsheet.

During a concurrent interview and record review on 12/7/23 at 1:16 a.m., with the PSD, Patient 107's e-MAR was reviewed and indicated, Patient 107 was administered Norco (narcotic for moderate to severe pain) 1 tablet by mouth for pain on 12/7/23 at 1:16 a.m. The pain assessment section in the flowsheet indicated the assessment documentation only contained a number, and the rest of the pain assessment elements were missing. The PSD confirmed the pain assessment was incomplete because most of the assessment elements were missing.

3. During a review of the facility's P&P titled, "Preventative Maintenance System," dated 1/24, the P&P indicated in part "To ensure the proper operation of patient care equipment and building/utility systems by providing regularly scheduled preventative maintenance ... All patient care equipment will be inspected when newly installed and at intervals of not more than 12 months there after ..."

3a. During a concurrent observation and interview on 1/31/24 at 4:01 p.m. with the surgical services manager (SSCM), in PACU (Post Anesthesia Care Unit), two patient monitors had preventative maintenance (PM) stickers that were observed and indicated the PM was due on 9/2023. The SSCM acknowledged the PM sticker indicated the PM was overdue.

During a concurrent interview and review of the facility's PM work order, on 2/1/24 at 3:25 p.m. with the facilities manager (FM), the PM stickers were reviewed. The FM stated the PM stickers are supposed to be replaced when the PM is done however our computer system can be checked to see when the equipment was PM'd. FM confirmed the two patient monitors in PACU were not done annually and the PMs were performed today.

3b.During a concurrent observation and interview on 1/31/24, at 4:30 p.m. with the radiology manager (RadM), x-ray room 2 was observed. The room had a mattress air pump machine which is used to inflate transfer mattresses when moving patients. The PM sticker was observed and indicated, the PM was due on 9/14/23. The RadM acknowledged the PM was overdue. RadM verbalized the PM sticker may not be accurate and would have to call the facilities manager for a copy of the PM work order for the mattress air pump.

During a concurrent interview and review of the facility's,"PM work order,"on 2/1/24 at 3:00 p.m. with the facilities manager (FM), the PM work order for the mattress air pump was reviewed and indicated, the Annual Preventative Maintenance was completed. Further review of the PM work order had missing documentation. There was no date or time documented when the PM was done. There was no signature or date from the labor technician, and there was no signature or date from the FM indicating the work was completed. FM acknowledged the date and time were missing from the PM work order and did not know the date when the PM was done.

4. During a review of the facility's P&P titled, "Standards of Care," dated 4/2023, the P&P indicated in part," ... A registered nurse directly provides ongoing patient assessment and documents the findings in the patient's medical record for each shift and upon receipt of the patient when transferred to another care area ..."

During a concurrent interview and record review on 2/7/24 at 12:10 p.m. with the EM, Patient 205's "Physician's Orders," dated 12/3/23, was reviewed and indicated, to take vitals routinely per unit policy. When asked what the unit policy was for vital signs, EM verbalized once a shift. During a review of Patient 205's "Vital Signs Flowsheet," dated 12/4/23 at 7:05 a.m., the flowsheet indicated, a shift assessment was done but there were no vital signs documented. On 12/4/23 at 7:23 p.m., 12/5/23 at 7:41 p.m., and 12/6/23 at 7:25 a.m., there were no vital signs documented. EM acknowledged the vitals signs should have been documented during the shift assessments and the physician orders and unit policy were not followed.

5. During a review of the facility's P&P titled, "Adult Cardiac and Oxygen Saturation Monitoring," dated 4/2023, the P&P indicated, "PROCEDURE 1. Upon a physician's order for telemetry ... the patient's Nursing Unit will communicate with SBCH Telemetry Unit to initiate monitoring. 2. The monitoring equipment will be placed on the patient by attaching electrodes ... 3. The qualified staff at SBCH telemetry unit will: A) Continuously watch all patients being monitored. B) Interpret monitored patient strips every six hours at 0400, 1000, 1600, and 2200. C) Interpreted strips will be uploaded into the patient's electronic medical record (EMR). Prior to the upload, these strips will be verified by a qualified RN on the SBCH telemetry unit ..."

During a concurrent interview and record on 2/7/24 at 5:16 p.m. with the MSM and vice president (VP), Patient 108's telementry monitor (observation tool that allows continuous ECG, RR, SpO2 monitoring while the patient remains active without the restriction of being attached to a bedside cardiac monitor) patient strips for the times, 0400, 1000, 1600, and 2200 were reviewed and indicated, there were no telemetry strips on 12/14/23 at 1600, and 12/15/23 at 1000. The MSM explained perhaps the patient was working with physical therapy at the time and that's the reason why the strips were not documented. Communicated to MSM and VP that if the patient is not available at the time the strip is supposed to be documented (i.e., 0400, 1000, 1600, 2200) then they can document a monitor strip as close to that time and/or as soon the patient becomes available. The MSM and VP acknowledged and confirmed two telemetry monitor strips were missing on this patient's record therefore the policy was not fully implemented.

6. A review of the facility's P&P titled, "Whole Blood Glucose by [manufacture's name]," dated 1/2023, the P&P indicated, "C. (b) i. Using a new, fresh germicidal wipe, thoroughly wipe the surface of the meter (top, bottom, left, and right sides) a minimum of three times horizontally, followed by three times vertically avoiding the barcode scanner and electrical connector. ii. Gently wipe the surface area of the strip port making sure that no fluid enters the port."

During an observation on 2/2/24 at 10:27 a.m. of registered nurse (RN 1), RN 1 was observed cleaning and disinfecting the glucometer using a germicidal wipe in the presence of the MSM. RN 1 was observed wiping the barcode scanner and electrical connector three times using the germicidal wipe.

During a concurrent interview and document review on 2/2/24 at 10:48 a.m. with MSM, the facility's P&P titled, "Whole Blood Glucose by [manufacture's name]," dated 1/2023 was reviewed. The MSM acknowledged the observation and confirmed RN 1 should not have wiped the barcode scanner and electrical connector of the glucometer with the germicidal wipes therefore the policy was not followed.

7. During a review of the facility's P&P titled, "Supply Outdate Check," dated 12/2017, the P&P indicated, "To provide clarity on the frequency and procedure for evaluating outdates for supplies and medications Imaging will evaluate outdates the first week of every month ... and interventional will evaluate each area. Expired supplies will be brought to the manager's office. Supplies will be utilized on the first in, first out principle (FIFO)."

During a concurrent observation and interview on 1/31/24 at 4:10 p.m. with the imaging technician (IT) and imaging manager (IM), Radiology Room 8 was observed. Inside a cart containing multiple procedure supplies, eight epidural (a hollow hypodermic needle, very slightly curved at the end, suitable for inserting epidural catheters) needles were observed to have an expiration date of 11/14/2023. The IT and IM acknowledged and agreed those expired needles should not be inside the cart, available to be used.

The pharmacy or drug storage area must be administered in accordance with accepted professional principles.
Based on interview with hospital administrative staff and review of the hospital's policy and procedures the hospital failed to ensure that the medication error data which had been gathered had been used to affect changes in the hospital's processes for patient care. The hospital also failed to collect and use "near misses" (close call medication errors), to change and/or modify the way that the hospital provides patient care. This failure had the potential to jeopardize patient care for 23 out of 23 sampled patients.

Findings:

Review of the written standards for ASHP's (American Society of Hospital Pharmacists), (an organization who sets hospital standards), which had been published with a copyright of 2018, entitled: "Guidelines on Preventing Medication Errors in Hospitals", which is a standard of practice for hospitals reads: " ...A system for reporting and reviewing errors is an essential component of a medication safety system; the goal is to enhance patient safety and prevent patient harm. Errors and close calls should be reported and analyzed e.g., (for example) root cause analysis [RCA] to identify the causes and develop measures to prevent similar occurrences ... the organization must evaluate and adopt technologies that will help reduce the risk of medication errors and help prevent patient harm ... Regardless of how medication errors are discovered, the information should be used to prevent future errors. A multidisciplinary group should evaluate error information where feasible to develop risk reduction strategies. While it is important to focus on errors that have caused harm to the patient, close calls (or near misses) should also be reviewed ... thus, medication errors (including close calls) must not be taken lightly, and risk-reduction strategies and systems should be established to prevent or mitigate patient harm from medication errors ... The organization must have a comprehensive program that includes a medication safety leader, key elements in place to provide the structure for safe medication practices, and a successful strategic plan ...supporting elements include a culture of safety built on principles of just culture that is supported at all levels of the organization (from the C-suite to the frontline), an event-reporting system, an interdisciplinary medication safety team, a continuous improvement philosophy regarding evaluation of errors and harm, and strong designs that assess and reduce the risk of errors ...Risk-reduction strategies should be implemented that will (1) prevent errors, (2) make errors visible, and (3) mitigate the harm if an error occurs. Strategies will be successful if they effectively address the underlying cause of error and impact as many steps of the medication-use process as possible; a single risk-reduction strategy should not be depended on in most cases... A system-based approach should be
undertaken at institutions to prevent future errors; this approach strives to change worker conditions and build defenses, barriers, and safeguards to prevent errors from occurring or mitigate the harm if errors do occur."

Review of the hospital's policies and procedure and interview with the hospital's DOP revealed that the hospital had a "shell" of a policy regarding medication errors, as the policy and procedure was incomplete (e.g., there was no policy that outlined how the hospital staff were to handle medication errors and near misses). This policy and procedure which had been last approved by P&T in 12/2014 (more than 10 years ago), was very generic and was only composed of two paragraphs.

The policy read: "A medication error is any incorrect or wrongful administration of a medication, such as a mistake in dosage or route of administration, failure to prescribe or administer the correct drug or formulation for a particular disease or condition, use of outdated drugs, failure to observe the correct time for administration of the drug, or lack of awareness of adverse effects of certain drug combinations ...A medication error is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use." This policy stated nothing else about how hospital staff: will report these errors, if these medication errors need to be put into an event reporting system, nothing about how to capture "near misses" (potential medication errors), where or how to report "near misses", what will be done with the "near miss" data that will be collected or how medication error data will be used to modify the systems that the hospital has in place to improve patient care. This medication error policy was incomplete, as it did not address a system for medication error data collection and how this data collection information would be used to make patient care improvements. During an interview with the DOP on 2/7/2024 at 9:35 am, the DOP was unable to provide documentation/evidence of how the hospital had used it's collected medication error data to make patient care improvements.

During an interview with hospital administrative staff, which included the hospital's DOP (Director of Pharmacy), on 2/6/2024 at 4:45 pm, the surveyor asked the hospital administrative staff, if the hospital had a medication error policy and procedure and what has been the hospital's highest medication error category? The DOP stated that the hospital had a policy and procedure on adverse events, but the hospital did not have a specific policy and procedure on medication errors that was complete.

The DOP was interviewed on 2/2/2024 at 11:45 am by a surveyor who had requested the hospital's medication error data. When the DOP was asked again on 2/6/2024 at 4:45 pm, if he could provide all of the hospital's medication error data, he indicated that he was unsure as no one else other than the off-duty pharmacist had access to all of the medication error data for this campus (SY). The DOP was not able to verify that he had obtained all of the medication error data for this campus because the sole keeper of this data (a pharmacist who was off), was not available to provide the needed medication error data. The surveyor asked if it was the hospital's policy to have only one person who was the sole keeper of the medication error data for the hospital. The DOP was not able to confirm that he had been able to provide me with all of the hospital's medication error data until 2/7/2024 at 10:30 am, after the off -duty Pharmacist had been called into the hospital at the request of the hospital's Vice President. The off-duty pharmacist was able to verify upon her arrival, that the medication error reports that the DOP had been able to locate was all of the medication error data that the hospital had. The hospital had failed to develop a system to ensure that medication error data for the hospital was available and accessible by hospital staff, no matter who the pharmacist was that was on or off duty, upon a surveyor's request.

Review of the hospital's medication error data indicated that the hospital's highest medication error category had been "incorrect dose", followed by a category entitled "other", (which was an ambiguous category). The surveyor then asked the hospital how they had used this error data entitled, "incorrect dose" to change or improve the hospital's "medication administration errors"? Hospital administrative staff replied: "we have not used these categories to make changes to our patient care processes, but this data is only being gathered for "informational" purposes.
Review of the hospital's 1-4th quarterly "Medication Error Summaries" on 2/7/2024 at 9:35 am and again on 2/8/2024 at 1:50 pm revealed that the hospital's pharmacist had reported the following non-medication errors (as medication errors), to the hospital's Pharmacy and Therapeutics Committee (P&T Committee):

1) In the hospital's 1st Quarter 2023 Medication Error Summary report to the P&T Committee, the pharmacy reported the following three items as medication errors: 0.5 mg lorazepam tablet was removed from the Omnicell (a vending machine type of device that requires some type of security verification for drugs), by RN (Registered Nurse) and not returned to the Omnicell until the next day ...the dose was placed inside the locked beside WOW (workstation on wheels) instead of returning it to the Omnicell." The second items, read: "Hydromorphone (a controlled drug) 1mg dose ordered for ED (Emergency Department) patient. RN removed from Omnicell, and then dose was changed to 0.5mg. RN used 1 mg injection to administer (a) partial dose. The remaining 0.5 mg dose was unaccounted for ...". Amiodarone (a heart rhythm medication) bolus and infusion ordered for ED patient. Kit was removed from Omnicell under null transaction (a transaction does not get recorded onto the Automated Drug Device's log as a transaction), so it was not removed from the inventory count ...". During an interview with the DOP on 2/8/2024 at 1:50 pm, the DOP confirmed that neither of these incidents were actual medication errors and that they did not meet the hospital's definition for a medication error and thus neither of these events should have been reported to the hospital's P&T Committee as medication errors and these were the only three items reported as medication errors for the entire 1st Quarter.

2) In the hospital's 3rd Quarter 2023 Medication Error Summary report to the P&T Committee, the pharmacy reported the following item as a medication error: "Pt (patient) to CT (Computed tomography, which is a noninvasive medical examination or procedure that uses specialized X-ray equipment), for chest/abdomen/pelvis with contrast (used in imaging techniques to enhance the differences between body tissues on images). No history of allergy to contrast reported. After completion of exam, patient was assisted to a seated position. Patient then became unresponsive, and a code blue (cardiac emergency) was called. Patient was transferred to the ED (Emergency Department) and subsequently to MICU (Medical Intensive Care Unit). "Vocera", (a communications technology company most known for its badge, which is a wearable, voice-activated device used by employees to speak with one another), not available in the CT trailer and overhead paging extension was not allowed on landline (wired phone) in trailer. During an interview with the DOP on 2/7/2024 at 9:35 am, the DOP confirmed that this incident was not an actual medication error and that this did not meet the hospital's definition for a medication error and thus this event should not have been reported to the hospital's P&T Committee as a medication error. Review of the hospital's P&T minutes 2023, revealed that any medication error data which had been reported to the P&T Committee had been done so under the meetings as "Standing Business", and no action or follow up had been documented in the minutes. On the meeting minutes the medication error data review had been documented as "Informational" only, which added confirmation that the hospital had not been using their medication error data to make improvements to overall patient care. The P&T Committee minutes did not contain any evidence of any discussions which were had around the medication errors which had been reported to the Committee nor did the P&T Committee minutes indicate that the Committee questioned any of the validity of any of the medication errors which had been reported to them.

3) Further review of these quarterly Medication Error Summaries for 2023, (which had been reported to P&T), revealed a description code at the end of each summary. The codes read as follows: "A" unsafe condition, "B1" Near miss - no harm, didn't reach patient; caught by chance, "B2" Near miss - no harm didn't reach patient due to active recovery by caregivers. Review of all four quarters of the "Medication Error Summary", revealed that the hospital had not one single "near miss" for the entire 12 months reviewed.

Review of the hospital's "Medication Error Reduction Plan 2023 update (SB 1875), states: " ...Our hospital uses a multidisciplinary approach to medication safety. We have a nonpunitive notification process to collect medication errors, near misses and ...". Again, a review of the last 4 quarters of the hospital's "Medication Error Summaries for 2023", revealed that the hospital's data collection process to collect medication "near-misses" had failed. As outlined in the ASHP standards referenced above: " ...while it is important to focus on errors that have caused harm to the patient, close calls (or near misses) should also be reviewed ... Thus, medication errors (including close calls) must not be taken lightly, and risk-reduction strategies and systems should be established to prevent or mitigate patient harm from medication errors.".

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

1. Ensure patient food was served within acceptable temperatures, hot food minimum 140 degrees Fahrenheit (F).
2. Ensure kitchen refrigerator temperature was keep within acceptable temperature, 41 degrees Fahrenheit or less.
3. Ensure multiply food items had an expiration date and/or food was not expired.

The facility's failures did not comply with acceptable nutritional standards, did not maintain the safety of food, and had the potential for food-borne illnesses.

Findings:

1. During a food serving observation on 2/1/24 at 12 p.m., food was observed brought into the kitchen, served, and distributed out of the kitchen to units. Review of "The Hot/Cold Food Temperature Logs," dated:
a. 2/1/24, indicated, veggie # 1 temperature was measured at 133 degrees F and veggie # 2 was measured 132 degrees F.
b. 1/14/24, indicated, veggie # 1 temperature was 138 degrees F and veggie # 2 was 136 degrees F.
c. 1/19/24, indicated, starch # 2 temperature was 138 degrees F.
d. 1/22/24, indicated, starch # 1 temperature was 138 degrees F.
e. 1/23/24, indicated main entrée # 2 temperature was 138 degrees F.
f. 1/31/24, indicated veggie # 1 temperature was 137 degrees F.

During a concurrent interview and document review on 2/1/24 at 12:29 p.m. with the registered dietitian (RD), the food temperature logs were reviewed. The RD confirmed the food served was not within acceptable temperature range on all these dates.

During a review of the facility's policy and procedure (P&P) titled, "Meal Preparation and Service," dated 11/17/23, the P&P indicated, "There will be a daily evaluation for safety and sanitation for the ... kitchen to ensure safety and sanitation standards are met. Foods should be prepared and delivered to ensure safety and quality of foods being served. 3) Foods that fall outside the acceptable standards for service will be disposed of."

2. During a concurrent observation and interview on 2/1/24 at 11 a.m. with the RD, the kitchen's walk-in refrigerator was observed with a thermometer inside the refrigerator measuring the internal temperature or the refrigerator. According to the RD, the internal temperature is the most reliable method to measure if the refrigerator temperature is within acceptable range.

During an interview on 2/1/24 at 11:15 a.m. with facilities manager (FM), the FM reported anytime the refrigerator's temperature is out of range, a technician gets a call, responds to the call, adjusts the refrigerator temperature etc. ... but none of this gets documented in the log or anywhere in the facilities department.

During a concurrent interview and document review on 2/1/24 at 11:30 a.m. with the RD, the refrigerator temperature logs were reviewed. The temperature logs indicated, on the following dates the refrigerator temperatures were not within range, 2/1/24 at 11:30 a.m., 8/17/23, 10/13/23, 10/18/23, 10/26/23, 10/30/23, 10/31/23, 11/1/23, 11/16/23, 11/17/23, 11/20/23, and 12/11/23. The top of the log indicated, "Temperature in the refrigerator will be kept at 41 degrees Fahrenheit or less ..." The RD confirmed that on these dates the refrigerator temperature was higher than 41° Fahrenheit, temperatures need to be recorded twice daily at 7:30 a.m. and 5:30 p.m. The corrective action plan on the temperature logs for refrigeration units' area was left blank. There was no documentation as to how long and what was done to correct the refrigerator temperature and/or how the food in the refrigerator was affected and the intervention taken.

During a review of the facility's P&P titled, "Monitoring of Refrigerator and Freezer Temperatures," dated 11/21/23, the P&P indicated, "1. The recording of temperatures is the responsibility of the executive chef. The daily monitoring and recording of refrigerator and freezers temperatures is incorporated into the workflow of the nutrition storekeeper. 2. The internal temperature in all refrigerators will be kept at 41°F or below at all times. 5. If nutrition staff is unable to adjust or maintain appropriate temperature range, it will be reported to the immediate supervisor, who will then contact facilities management department ... Corrective Action, In the event of a refrigerator downtime, food will be discarded after four hours of reaching greater than 41°F."

3. During a review of the facility's P&P titled, "Meal Preparation and Service," dated 11/17/23, the P&P indicated, "There will be a daily evaluation for safety and sanitation for the ... kitchen to ensure safety and sanitation standards are met. Foods should be prepared and delivered to ensure safety and quality of foods being served. 3) Foods that fall outside the acceptable standards for service will be disposed of."

a) During a concurrent observation and interview on 2/1/24 at 11:45 a.m. with the RD in the kitchen, 55 ready to use, individual cereal packages were observed without an expiration date. The RD stated, "Yes, there is no expiration date on all these cereals, they should be discarded."

b) During a concurrent observation and interview on 2/1/24 at 11:55 a.m. with the RD in the kitchen, a box of waffle mixture was observed, opened, inside a plastic bag and ready for use with an expiration date of 4/24/23. The RD stated, "Yes, this waffle mix is expired, it should have been discarded."

c) During a concurrent observation and interview on 2/1/24 at 12:15 p.m. with the RD in the kitchen, a box of pancake mixture was observed, opened and ready for use without an expiration date. The RD inspected the pancake mixture box in attempt to locate the expiration date, without success. The RD stated, "Yes, I agree there is no expiration date on this pancake box."

d) During a concurrent observation and interview on 2/2/24 at 10:12 a.m. with the medical surgical manager (MSM), emergency department manager (EDM), and ED nurse coordinator (EDNC) in the medical surgical unit kitchen, 19 individual tea bags and ten seasoning packets were observed without an expiration date. The MSM, EDM, and EDNC acknowledged the observation and confirmed the items had no expiration dates.

Based on observation, interview, and record review, the facility failed to ensure new lead (radiation protective garments used by personnel during fluoroscopy (medical procedure that makes a real-time video of the movements inside a part of the body by passing x-rays through the body over a period of time) was tested and assigned a number to identify the lead before putting into service.

The facility's failure placed staff at risk of using lead that has not been tested and could potentially not be tested annually since a number had not been assigned to the lead and placing staff at risk of being exposed to unnecessary radiation.

Finding:

During a concurrent observation and interview on 1/31/24 at 4:23 p.m. with imaging technician (IT), a new Dalmatians print lead vest and apron were observed in Radiology Room 8 without an identification number marked on the vest and apron. The IT confirmed the vest and apron did not have an identification number marked on them.

During a concurrent observation and interview on 1/31/24 at 4:44 p.m. with the imaging manager (IM), a new Dalmatians print lead vest and apron were observed in Radiology Room 8 without an identification number marked on the vest and apron. The IM confirmed the Dalmatians vest and apron were new and stated they have not been tested and assigned a number to identify them.

During a review of the facility's P&P titled, "Lead Apron Testing," dated 5/2023, the P&P indicated, "New lead aprons, gloves, and gonad shields shall be taken to that Radiology Department to be numbered and tested."

Based on interview and record review the facility failed to:
1. Ensure medical surgical registered nurses (RNs) had end-of-life training before providing end-of-life (palliative) care to patients.
2. Ensure medical and surgical RNs were competent (as evidenced by the medical record findings) with the operation of patient-controlled analgesia (PCA) pumps, documented PCA pump elements and followed their policy and procedure when providing pain management to five of five sampled patients (Patients 104, 202, 203, 204, and 205) with PCA pumps. The patient-controlled analgesia (PCA) pump is a computerized machine that administers medicine for pain when you press a button, but a continuous rate (basal rate) may be added by the doctor if needed.) (Reference C-1049)

The facility's failures placed patients at risk of not receiving quality and safe care resulting in harm to patients due to the lack of RNs training and competency.

Findings:

1. According to the American Association of Colleges of Nursing (AACN), the End-of-Life Nursing Education Consortium (ELNEC) is a national education initiative to improve palliative care. Since 2000, ELNEC has collaborated with AACN to provide staff development and other nurses with training in palliative care, this essential information to nursing ... The healthcare system in the U.S ... requires nurses to be educated in meeting the palliative care needs of older adults. Unique features of the education content elaborate on physiologic changes in older adults, medications, and chronic conditions using a person-centered approach ... Despite their undisputed technical and interpersonal skills, professional nurses ... may not be completely comfortable with the specialized knowledge and skills needed to provide quality palliative care to patients. The end-of-life nursing education gives nurses ... the knowledge and skills required to provide this specialized care and to positively impact the lives of patients and families facing serious illness and/or the end-of-life.

During a review of the facility's policy and procedure (P&P) titled, "Palliative Care Consultation Service," dated 6/2023, the P&P indicated, "The Palliative Care Consultation Team offers an integrated and interdisciplinary service to meet physical, psycho-social, and the spiritual needs of patients and their families. Palliative care nurse works in collaboration with the palliative care physician and attending physicians to develop and implement the plan of care. Delivers palliative care and health care services to patients with special attention to pain and symptom control and the clarification of goals of care. Medical director-acts as advisor to the palliative care team, participates in reviewing/approving the ongoing development of the palliative care consultation service, and assists palliative care education of the staff."

During a concurrent interview and record review on 2/7/24 at 10:35 a.m. with the medical surgical unit manager (MSM), Patients 104, 202, 203, 204, and 205's medical records were reviewed. The MSM confirmed RNs were providing palliative/comfort care to patients on the medical surgical unit.

During a concurrent interview and document review on 2/7/24 at 8:51 a.m. with the education manager (EM), the facility's 2023 RN's annual competency summaries were reviewed. The EM confirmed the medical surgical RNs providing palliative care to the patients did not have end-of- life nursing training. In addition, the EM stated the facility does not require RNs to have end-of-life training, that it is optional.

During an interview on 2/7/24 at 4:20 p.m. with the palliative care medical director (PCMD), the PCMD reported the palliative care consultation team has not provided any training for the facility staff.

2. a) During a concurrent interview and record on 2/6/24 at 3:40 p.m. with the medical surgical manager (MSM) and patient safety director (PSD), Patient 104's clinical record was reviewed. Patient 104's clinical record indicated, Patient 104 was ordered a continuous infusion of Morphine Sulfate (narcotic medication to treat moderate to severe pain) 0.5 mg per hour utilizing a PCA pump. The RNs had programmed the incorrect dose of medication in the PCA pump. The total medication infused from the initiation of the PCA pump should have been 5 mg (milligram) or 5 mls (milliliters). Patient 104 received a total of 27.15 mgs of Morphine in 10 hours instead of 5 mgs. (Reference C-1049).

b) During a concurrent interview and record review on 2/7/24 at 10:12 a.m. with the EM, Patient 202's "PCA Flowsheet for Morphine," dated 4/4/23 at 12:33 a.m., was reviewed and the flowsheet indicated, a new PCA bag of Morphine IV drip was hung for Patient 202, infusing at a continuous rate of 2 mg/hr. Further review of the "PCA Flowsheet for Morphine," the flowsheet was missing documentation at 1:20 a.m., when the PCA infusion was stopped. The column for cumulative dose (mg) of Morphine received was left blank, and reservoir volume (ml) was left blank. The volume of Morphine infused (ml) to Patient 202 was documented as 4.7 ml. The waste was also documented in a comment note as 45.3 ml wasted. Further review of Patient 202's "PCA flowsheet for Morphine," indicated, the infusion started at 12:33 a.m. and was stopped at 1:20 a.m. for a total of 47 minutes. Per calculation of Morphine infused, 4.7 ml of Morphine infused to Patient 202 added to the 45.3 ml of Morphine wasted equals 50 ml, which is the total volume of the Morphine PCA bag. EM acknowledged that the documentation indicated Patient 202 received double the dose of Morphine that had been ordered by the physician. (Reference C-1049)

c) During a concurrent interview and record review on 2/7/24 at 09:07 a.m. with the EM, Patient 203's "PCA Flowsheet for Dilaudid (narcotic to treat moderate to severe pain)," dated 1/14/23 at 3:48 p.m., was reviewed and the flowsheet indicated, a new PCA bag of Dilaudid IV drip was hung for Patient 203, and had a patient bolus dose of 0.4 mg, with a lock out interval every 10 minutes. Further review of Patient 203's "PCA Flowsheet for Dilaudid," the flowsheet was missing documentation at 7 p.m., change of shift. The column for number of doses given of Dilaudid was left blank, the column for number of attempts for Dilaudid was left blank, cumulative dose (mg) of Dilaudid was left blank, volume infused (ml) milliliters of Dilaudid received was left blank. The only volume documented was the reservoir volume (ml) of Dilaudid ... EM acknowledged did not know how many times the patient pushed the button to receive the Dilaudid, when it was not documented, and further acknowledged did not know if Patient 203 was receiving an adequate amount of pain relief. (Reference C-1049)

d) During a concurrent interview and record review on 2/7/24 at 11:38 a.m. with the EM, Patient 204's medical record was reviewed. During review of Patient 204's "Pain Monitoring Flowsheet," dated 5/9/23 at 11:42 p.m., was reviewed and indicated, Patient 204's PCA Dilaudid IV drip was administered and there was no documentation of a pain scale assessment. Further review of Patient 204's "Pain Monitoring Flowsheet," on 5/10/23 at 12:42 a.m., 01:42 a.m., 2:42 a.m., and 3:42 a.m., the flowsheet indicated, there was no documentation of a pain scale assessment. EM acknowledged the pain scale assessment should be done hourly x 4 after the PCA infusion had started per the policy and procedure and further acknowledged the pain scale assessment was not done. (Reference C-1049)

e) During a concurrent interview and record review on 2/8/24 at 10:38 a.m. with the EM, Patient 205's "PCA Flowsheet for Morphine," dated 12/5/23 at 5:08 p.m. was reviewed and indicated, Patient 205 received an increase in the Morphine drip to 6.5 mg/hr, and at 6:35 p.m. received an increase in the Morphine drip to 7.5 mg/hr. During review of Patient 205's "Pain Assessment Flowsheet," dated 12/5/23 at 5:08 p.m., there was no behavioral pain scale documented, and at 6:35 p.m., there was no behavioral pain scale documented. The PCA Morphine drip had been increased two more times without knowing if Patient 205 was in pain. EM acknowledged the behavioral pain scale was not documented and further acknowledged the physician orders for titrating the PCA Morphine drip were not being followed. (Reference C-1049)

Based on interview and record review, the facility failed to follow their policy and procedures (P&P) and standards of practice for medication administration when:

1. Physician orders were not followed for PCA (patient-controlled analgesia for pain management that lets you decide when you will get a dose of pain medicine) titration of opioid (narcotics to treat pain) medication administration for Patient 205.

2. Oxygen therapy was continued without a physician's order for Patient 205.

3. Physician orders were not followed for the medication administration of Morphine (narcotic medication to treat moderate to severe pain) IVP (intravenous push) for Patient 205.

4. PCA opioid medication administration was not documented per policy and procedures for Patients 204, 203, 202, and 205.

5. Pain assessments were not done per PCA policy and procedures for Patients 203, 204, and 205.

6. PCA opioid medication waste was not documented per policy and procedure for Patient 203.

7. Medication error confirmed during PCA opioid medication administration for Patient 104.

8. MRI (magnetic resonance imaging scans images of the body using a large magnet and radio waves) contrast (liquid medication injected into the blood stream to make certain tissues and blood vessels show up more clearly and in greater detail) was opened and not discarded.

9. Patient 106 received Tylenol (medication to treat pain and fever) for fever and was not reassessed.

10. Patient 106 received Ativan (medication to treat anxiety) and was not reassessed.

These facility failures resulted in nurses not following physician orders, not following policy and procedures for medication storage, medication administration and documentation, medication pain assessments and re-assessments, and medication waste of opiates. These failures contributed to the medication error for Patient 104. The medication error may have contributed to the death of Patient 104 from an overdose of PCA opiates. These failures may have adversely affected Patients 202, 203, 204, and 205 by potentially causing medication errors when they received PCA opioid medications.

Findings:

1. During a review of the facility's policy and procedure (P&P) titled, "Pain Management," dated 9/2023, the P&P indicated in part, "To provide safe, appropriate, and efficacious use of pain management (analgesia) infusions and Patient Controlled Analgesia (PCA) ... to provide guidelines for proper monitoring, documentation, and maintenance ... to ensure patient safety and a smooth transition of pain control therapy throughout the continuum of care ... 1) Medication Orders ...B) When appropriate, medication orders will have titration guidelines with criteria for adjusting dosages such as lab results, vital signs, sedation level, and pain relief goals ..."

During a concurrent interview and record review on 2/8/24 at 10:36 a.m. with the education manager (EM), Patient 205's medical record was reviewed. The "Physician's Orders," dated 12/4/23, indicated, to administer PCA Morphine IV drip at a continuous rate of 0.5 mg/hr (milligram per hour). Titration parameters indicated, to increase the morphine drip by 1 mg/hr every 30 minutes PRN (as needed) using the behavioral pain scale with a score greater than 4. During review of Patient 205's "PCA Flowsheet for Morphine," dated 12/5/23 at 2:04 p.m., the flowsheet indicated, Patient 205 received an increase in the Morphine drip to 4.5 mg/hr. During review of Patient 205's "Pain Assessment Flowsheet," dated 12/5/23 at 2:04 p.m., there was no behavioral pain scale documented and the PCA Morphine drip had been increased. When EM was asked how you would know Patient 205 was having pain, if the behavioral pain scale was not documented. EM verbalized she did not know and acknowledged the physician order for titrating the PCA Morphine drip was not followed.

During a concurrent interview and record review on 2/8/24 at 10:38 a.m. with the EM, Patient 205's "PCA Flowsheet for Morphine," dated 12/5/23 at 5:08 p.m. was reviewed and indicated Patient 205 received an increase in the Morphine drip to 6.5 mg/hr, and at 6:35 p.m. received an increase in the Morphine drip to 7.5 mg/hr. During review of Patient 205's "Pain Assessment Flowsheet," dated 12/5/23 at 5:08 p.m., there was no behavioral pain scale documented, and at 6:35 p.m., there was no behavioral pain scale documented. The PCA Morphine drip had been increased two more times without knowing if Patient 205 was in pain. EM acknowledged the behavioral pain scale was not documented and further acknowledged the physician orders for titrating the PCA Morphine drip were not being followed.

According to "Fundamental of Nursing," by Potter and Perry, Eighth Edition, on page 336, under the section, "Physicians' Orders," indicated, "Nurses follow physician orders unless they believe the orders are in error or harm patients."

During a concurrent interview and record review on 2/8/24 at 11:01 a.m. with the EM, Patient 205's medical record was reviewed. Patient 205's "PCA Flowsheet for Morphine," dated 12/6/23 at 7:02 a.m., indicated, Patient 205 was receiving a dose of Morphine drip at a rate of 8.5 mg/hr. The "Physician's Orders," dated 12/6/23 at 9:10 a.m., changed the PCA Morphine order to administer PCA Morphine IV drip at a continuous rate, and to start at a rate of 10 mg/hr (milligram per hour). Titration parameters indicated, to increase the morphine drip by 1 mg/hr every 30 minutes when respiration rate is greater than 20. During review of Patient 205's "PCA Flowsheet for Morphine," dated 12/6/23 at 9:22 a.m., Patient 205 received a new dose of Morphine drip at an increased rate of 10 mg/hr. During review of Patient 205's "Vital Signs Flowsheet," dated 12/6/23 at 9:22 a.m., there were no respiration rates documented and the PCA Morphine drip had been increased. EM acknowledged respirations should have been documented before increasing the rate of PCA Morphine IV drip.

During a review of the facility's P&P titled, "Pain Management," dated 9/2023, the P&P indicated in part, "Responsibilities: ... 2) Nurse A) Prior to initiating the infusion, assess and document the following: rate of respirations, oxygen saturation, pain level, level of sedation, and mental status.

2. During a concurrent interview and record review on 2/7/24 at 12:30 p.m. with the EM, Patient 205's medical record was reviewed. The "Physician Orders," dated 12/2/23, indicated, to administer oxygen therapy by nasal cannula and to keep oxygen saturation above 92%. On 12/3/23, the physician discontinued the oxygen order when Patient 205 was admitted to the medical surgical unit. During further review of Patient 205's medical record, the "Vital Signs Flowsheet," dated 12/4/23, indicated, Patient 205 was still receiving oxygen therapy via a mask. When asked if Patient 205's physician wrote another order for oxygen therapy, EM verbalized she did not see any other order for oxygen therapy. EM acknowledged Patient 205 was receiving oxygen therapy without a physician's order.

3. During a concurrent interview and record review on 2/8/24 at 10:59 a.m. with the EM, Patient 205's medical record was reviewed. The "Physician Orders," dated 12/5/23 indicated, to administer Morphine 5-10 mg IVP every 4 hours for break through pain or tachypnea (rapid shallow breathing). During review of Patient 205's "Pain Monitoring Flowsheet," dated 12/5/23 at 9:51 p.m., Patient 205 received 8 mg of Morphine IVP. During review of Patient 205's "Vital Signs Flowsheet," and "Pain Assessment Flowsheet," dated 12/6/23 at 9:51 p.m., there were no respiration rates documented and no pain assessment documented. When EM was asked how you know Patient 205 was tachypneic or having pain when not documented. EM verbalized she did not know and acknowledged the physician order for Morphine IVP every 4 hours was not being followed.

According to "Fundamental of Nursing," by Potter and Perry, Eighth Edition, on page 336, under the section, "Physicians' Orders" indicated, "Nurses follow physician orders unless they believe the orders are in error or harm patients."

4. During a review of the facility's P&P titled, "Pain Management," dated 9/2023, the P&P indicated in part, "To provide safe, appropriate, and efficacious use of pain management (analgesia) infusions and Patient Controlled Analgesia (PCA) ... to provide guidelines for proper monitoring, documentation, and maintenance ... to ensure patient safety and a smooth transition of pain control therapy throughout the continuum of care ... Infusions: 6) At the beginning of each shift, the following will be documented in the medical record: C) Analgesia infusion setting ... 7) At the end of shift, clear and document shift totals, boluses administered, and bolus attempts by the patient ... Patient Controlled Analgesia (PCA) and Continuous Infusion: 5) Initiate analgesia infusion flowsheet with documentation of number of doses given and number of attempts documented every shift ... 6) Verify pump setting at the beginning of each shift and during or immediately after receiving hand off communication ..."

During a concurrent interview and record review on 2/6/24 at 4:05 p.m. with the education manager (EM), Patient 204's medical record was reviewed. During review of Patient 204's "PCA Flowsheet for Dilaudid," dated 5/9/23 at 11:04 a.m., the flowsheet indicated, a new PCA bag of Dilaudid IV drip was hung for Patient 204 and was infusing at a rate of 1.25 ml/hr (milliliters/hour). Further review of the "PCA Flowsheet for Dilaudid," indicated, the flowsheet was missing documentation. The column for cumulative dose (mg) of Dilaudid received was left blank, the column for volume infused (ml) of Dilaudid received was left blank, and the column for reservoir volume (ml) of Dilaudid was left blank. When EM was asked how do you know how much Dilaudid Patient 204 received from the PCA bag, EM verbalized flow sheet is incorrect we can't tell how much volume has been infused by flow sheet. Further review of Patient 204's of "PCA Flowsheet for Diluadid," dated 5/10/23 at 1806 until 5/11/23 at 0113 volume 25.3 minus volume infused was 5.6 volume left should be 19.7 and is documented as 16.1 which is incorrect unable to determine what happened to the 3.6 ml. EM confirmed staff are not following the policy to determine how much was infused to the patient and how much was wasted. Asked about documentation training of PCA for the nurses, we ask them about documenting the rate of infusion but we don't have them simulate documentation on the flow sheet. EM verbalized when a new PCA bag is hung, the nurses should be documenting the IV totals and clear the PCA pump in order to verify how much Dilaudid the patient received. EM further verbalized at change of shift, nurses should be documenting IV totals, clearing pumps with the oncoming nurse, verifying how much Dilaudid the patient received, and verifying the physician orders.

During a concurrent interview and record review on 2/7/24 at 09:07 a.m. with the EM, Patient 203's medical record was reviewed. During review of Patient 203's "PCA Flowsheet for Dilaudid," dated 1/14/23 at 3:48 p.m., the documentation indicated a new PCA bag of Dilaudid IV drip was hung for Patient 203, and had a patient bolus dose of 0.4 mg, with a lock out interval every 10 minutes. Further review of the "PCA Flowsheet for Dilaudid," the flowsheet was missing documentation at 7 p.m., change of shift. The column for number of doses given of Dilaudid was left blank, the column for number of attempts for Dilaudid was left blank, cumulative dose (mg) of Dilaudid was left blank, volume infused (ml) milliliters of Dilaudid received was left blank. The only volume documented was the reservoir volume (ml) of Dilaudid. When EM was asked how you know how much Dilaudid Patient 203 received from the PCA bag, EM verbalized she did not know. EM verbalized when a new PCA bag is hung, the nurses should be documenting the IV totals and clear the PCA pump in order to verify how much Dilaudid the patient received. EM further verbalized at change of shift, nurses should be documenting IV totals, clearing pumps with the oncoming nurse, verifying how much Dilaudid the patient received, and verifying the physician orders. EM acknowledged did not know how many times the patient pushed the button to receive the Dilaudid, when it was not documented, and further acknowledged did not know if Patient 203 was receiving an adequate amount of pain relief.

During further review of Patient 203's "PCA Flowsheet for Dilaudid," the flowsheet indicated on 1/15/23 at 11:30 a.m., a new PCA bag of Dilaudid IV drip was administered and the column totals were blank. EM acknowledged the nurses were not following PCA opioid medication administration policy and procedures for documentation.

During a concurrent interview and record review on 2/7/24 at 10:12 a.m. with the EM, Patient 202's medical record was reviewed. During review of Patient 202's "PCA Flowsheet for Morphine," dated 4/4/23 at 12:33 a.m., the documentation indicated, a new PCA bag of Morphine IV drip was hung for Patient 202, infusing at a continuous rate of 2 mg/hr. Further review of the "PCA Flowsheet for Morphine," indicated, the flowsheet was missing documentation at 1:20 a.m., when the PCA infusion was stopped. The column for cumulative dose (mg) of Morphine received was left blank, and reservoir volume (ml) was left blank. The volume of Morphine infused (ml) to Patient 202 was documented as 4.7 ml. The waste was also documented in a comment note as 45.3 ml wasted. EM was asked if the 4.7 ml was the volume Patient 202 received, EM verbalized she did not know, and further verbalized there was not enough information documented on the flowsheet. EM verbalized nurses should be documenting the IV totals. During a review of Patient 202's "Physician's Order," for the Morphine PCA, the order indicated the concentration of the bag was 1mg/ml for a total of 50 mg in a 50 ml bag. The physician ordered the Morphine to infuse at a rate of 2mg/hr which calculated to 2ml/hr. Further review of Patient 202's "PCA flowsheet for Morphine" indicated, the infusion started at 12:33 a.m. and then was stopped at 1:20 a.m. for a total of 47 minutes. When asked if Patient 202 should only have received as much as 2 ml of Morphine, when the infusion was going for less than an hour, EM verbalized she did not know. EM was informed that 4.7 ml infused to Patient 202 is more than double the dose that the physician ordered. When informing EM that 4.7 ml of Morphine infused to Patient 202 is then added to the 45.3 ml of Morphine wasted, it equals 50 ml, which is the total volume of the Morphine PCA bag. EM acknowledged that the documentation indicated Patient 202 received double the dose of Morphine that had been ordered by the physician.

During further review of Patient 202's "Discharge Summary," dated 4/4/23, the discharge summary indicated, Patient 202 died on 4/4/23 at 1:43 a.m., 13 minutes after the PCA bag of Morphine was stopped.

During a concurrent interview and record review on 2/7/24 at 5:10 p.m. with the EM, Patient 205's medical record was reviewed. During review of Patient 205's "PCA Flowsheet for Morphine," dated 12/5/23 at 4:08 p.m., the flowsheet indicated, a new PCA bag of Morphine IV drip was hung for Patient 205 and was infusing at a rate of 5.5 mg/hr (milligram/hour). Further review of the "PCA Flowsheet for Morphine," the flowsheet was missing documentation. The column for cumulative dose (mg) of Morphine received was left blank, the column for volume infused (ml) milliliters of Morphine received was left blank, and the column for reservoir volume (ml) of Morphine was left blank. When EM was asked how you know how much Morphine Patient 205 received from the PCA bag, EM verbalized she did not know. EM verbalized when a new PCA bag is hung, the nurses should be documenting the IV totals and clear the PCA pump in order to verify how much Morphine the patient received. EM further verbalized at change of shift, nurses should be documenting IV totals, clearing pumps with the oncoming nurse, verifying how much Morphine the patient received, and verifying the physician orders.

During further review of Patient 205's "PCA Flowsheet for Morphine," the flowsheet indicated, on 12/5/23 at 6:35 p.m., on 12/6/23 at 12:17 a.m., and on 12/6/23 at 11:31 a.m., a new PCA bag of Morphine IV drip was administered, and the column totals were blank. EM acknowledged the nurses were not following PCA opioid medication administration policy and procedures for documentation.

5. During a review of the facility's P&P titled, "Pain Management," dated 9/2023, the P&P indicated in part, "To provide safe, appropriate, and efficacious use of pain management (analgesia) infusions and Patient Controlled Analgesia (PCA) ... to provide guidelines for proper monitoring, documentation, and maintenance ... to ensure patient safety and a smooth transition of pain control therapy throughout the continuum of care ... Infusions 5) Upon initiation of parenteral opioids patients will be monitored and documentation will be as follows: B) PCA: Pain scale assessment, sedation scale, respiratory rate, and side effects every 1-hour x 4, then every 2 hours x 2, then every 4 hours until PCA opioids are discontinued ..."

During a concurrent interview and record review on 2/7/24 at 10:14 a.m. with the EM, Patient 203's medical record was reviewed. During review of Patient 203's "Pain Monitoring Flowsheet" dated 1/14/23 at 3:48 p.m., Patient 203's PCA Dilaudid (narcotic to treat moderate to severe pain) IV drip was administered. Further review of Patient 203's "Pain Monitoring Flowsheet," on 1/14/23 at 4:48 p.m., 5:48 p.m., 6:48 p.m., and 7:48 p.m., there was no documentation of a pain scale assessment. EM acknowledged the pain scale assessment should be done hourly x 4 after the PCA infusion had started per the policy and procedure and further acknowledged the pain scale assessment was not done.

During a concurrent interview and record review on 2/7/24, at 11:38 a.m., with the EM, Patient 204's medical record was reviewed. During review of Patient 204's "Pain Monitoring Flowsheet" dated 5/9/23 at 11:42 p.m., Patient 204's PCA Dilaudid (narcotic to treat moderate to severe pain) IV drip was administered and there was no documentation of a pain scale assessment. Further review of Patient 204's "Pain Monitoring Flowsheet" on 5/10/23 at 12:42 a.m., 01:42 a.m., 2:42 a.m., and 3:42 a.m., indicated, there was no documentation of a pain scale assessment. EM acknowledged the pain scale assessment should be done hourly x 4 after the PCA infusion had started per the policy and procedure and further acknowledged the pain scale assessment was not done.

During a concurrent interview and record review on 2/7/24 at 12:10 p.m. with the EM, Patient 205's medical record was reviewed. During review of Patient 205's "Pain Monitoring Flowsheet," dated 12/4/23 at 12:56 a.m., 01:56 a.m., 02:56 a.m., 03:56 a.m., and 04:56 a.m., the flowsheet indicated, there was no documentation of a pain scale assessment. EM acknowledged the pain scale assessment should be done hourly x 4 after the PCA infusion had started per the policy and procedure and further acknowledged the pain scale assessment was not done.

6. During a review of the facility's P&P titled, "Medication Wasting and Pharmaceutical Waste," dated 7/2021, the P&P indicated in part, "Wasting of controlled medications if only a fraction of a scheduled medication is given, the remainder must be wasted ...Two licensed individuals must cosign for the wastage and must monitor the entire wasting process to ensure safe disposal and count accuracy ... wastage must be completed within 30 minutes, and documented in the automated dispensing cabinet (ADC) within 60 minutes of dispensing the medication ... the waste must be disposed of in the appropriate medication waste container ..."

During a concurrent interview and record review on 2/7/24 at 09:34 a.m. with the EM, Patient 203's medical record was reviewed. During review of Patient 203's "PCA Flowsheet for Dilaudid," dated 1/14/23 at 3:48 p.m., the documentation indicated a new PCA bag of Dilaudid IV drip was hung for Patient 203, and had a patient bolus dose of 0.4 mg, with a lock out interval every 10 minutes. Further review of the "PCA Flowsheet for Dilaudid," was missing waste documentation on 1/14/23 at 9:36 p.m., on 1/15/23 at 11:30 a.m., and on 1/15/23 at 7:07 p.m., when a new PCA bag of Dilaudid was hung. When asked where the nurses document the PCA waste volume, EM verbalized nurses sometimes make a comment or narrative note in the medical record but are supposed to document the waste in the ADC with two nurses. EM verbalized if PCA documentation is not complete then we cannot account for the whole PCA bag of Dilaudid. EM verbalized when a new PCA bag is hung, the nurses should be documenting the IV totals and waste. EM verbalized the ADC report for Patient 203 would show if the PCA wastes were documented. EM acknowledged there was no waste documentation in Patient 203's medical record for the PCA bags of Dilaudid.

During a concurrent interview and record review on 2/8/24 at 11:10 a.m. with the emergency department Nurse Coordinator (EDNC), Patient 203's automated dispensing cabinet ADC report dated 1/14/23-1/16/23, the report indicated there was no waste documented for the PCA bags of Dilaudid. EDNC confirmed the waste from the PCA bags of Dilaudid were not documented for Patient 203.

During a review of the facility's P&P titled, "Pain Management," dated 9/2023, the P&P indicated in part, "To provide safe, appropriate, and efficacious use of pain management (analgesia) infusions and Patient Controlled Analgesia (PCA) ... to provide guidelines for proper monitoring, documentation, and maintenance ... to ensure patient safety and a smooth transition of pain control therapy throughout the continuum of care ... Responsibilities: 2) Nurse D) If the analgesia infusion is discontinued for any reason, the nurse will remove the bag/syringe/cassette and tubing ... two licensed personnel will witness the wasting of unused solution and document in the (ADC) ..."

7. During a concurrent interview and record review on 2/6/24 at 3:40 p.m., with medical surgical manager (MSM) and patient safety director (PSD), Patient 104's medication error events were reviewed. According to clinical record Patient 104 presented to the emergency department (ED) on 11/30/23 at 4:25 p.m., with complaint of shortness of breath (SOB) and low oxygen saturation (70s%) Normal oxygen saturation > 94%. Diagnosis included Rhinovirus upper respiratory infection (URI) and Hypoxia (low oxygenation in lungs). Plan of care while in the ED was comfort measures with limited treatment for infection. On 12/1/23 Patient 104 was admitted into the medical surgical unit for comfort measures and limited treatment of URI. Patient was started on a morphine sulfate (opioid for moderate to severe pain) medication continuous administration utilizing a patient-controlled analgesic (PCA) pump on 12/1/23 at 1:28 p.m. Morphine medication PCA pump change of shift settings verification was performed by two registered nurses (RNs) at approximately 7:15 p.m. No change to PCA pump settings was performed at this time. Patient expired on 12/2/23 at 12:15 a.m.

During a review of Patient 104's "Physician's Orders," dated 12/1/23, the orders indicated, an order for Morphine sulfate 0.5 milligrams per hour continuous infusion. Morphine 1 milligram (mg)/1 milliliter (ml) in sodium chloride (50 mg/50 ml) PCA bag for comfort care was started on 12/1/23 at 1:28 p.m., by two RNs (RNs 2 & 3), the incorrect dose was programmed in the PCA pump.

At change of shift, five hours later at 7:00 p.m., two RNs (RN 2 & RN 4) verified orders and PCA pump settings (administration dose, volume infused, volume in bag). The two RNs did not notice the incorrect Morphine dose had been programmed in the PCA pump.

Patient 104's Morphine medication flowsheet indicated on 12/1/23 at 7:00 p.m., a cumulative dose of 2.8 mg, volume infused of 14 ml, and reservoir volume of 33.1 ml. RN 2 and RN 4 did not realize the Morphine medication dose, total mgs/mls infused was too much. The incorrect medication dose administered was found when RN 4 and RN 5 were witnessing the Morphine medication waste.

The Morphine medication flowsheet dated 12/2/23 at 12:15 a.m., indicated a cumulative dose of 2.63 mg, volume infused of 13.15 ml, and reservoir volume of 19.9 ml (waste). The total medication infused from the initiation of the PCA pump should have been 5 mg or 5 mls (0.5 mg times 10 hours equal to 5 mgs). However, patient received a total of 27.15 mgs of Morphine in 10 hours instead of 5 mgs.

During the investigation of the medication error on 1/17/24, RNs 2, 4, and 5 indicated not being familiar with the use of a PCA pump due to the infrequent use of the pump.

The MSM and PSD acknowledged and confirmed a medication error occurred with the Morphine PCA pump medication administration for Patient 104 on 12/1/23. The patient received more medication than the amount ordered by the physician. The PSD further confirmed this medication error was not a PCA pump device malfunction.

8. During a concurrent tour of the mobile MRI trailer and Patient 101's MRI procedure on 1/31/24 at 3:30 p.m., the MRI contrast injector was observed loaded with contrast ready to be infused. Patient's procedure order was for MRI cervical spine without contrast.

During an interview on 1/30/24 at 3:45 p.m., with imaging technician (IT), IT reported the MRI contrast loaded in the contrast injector was not for Patient 101. The contrast was for Patient 102 who's MRI procedure was performed earlier this morning at 9:00 a.m. Patient 102's order was for MRI of liver with and without contrast however patient's kidney levels were elevated therefore the contrast was not administered and that's why the contrast was still sitting there. IT stated, "I should have discarded the contrast after patient's MRI procedure, and I did not."

During a concurrent interview and review on 2/1/24 at 9:15 a.m., with the imaging manager (IM), the MRI contrast information was reviewed. The IM acknowledged and confirmed the MRI contrast should have been discarded, if not used, after the patient's MRI procedure. This is a patient safety issue because having the contrast accessible (loaded in the injector) can potentially be administer to another patient by error.

9. According to Potter & Perry, Tenth Edition, Fundamentals of Nursing Practice, Chapter 31, pg 605-607, under Medication Administration, "Standards are actions that ensure safe nursing practice. Standards for medication administration are set by health agencies and the nursing profession .... Administering medications requires unique nursing knowledge and skills. You first determine that the medication ordered is the correct medication. As a nurse you need to assess the patient ... determine whether the patient should receive the medication at a given time, administer medication correctly, and then closely monitor their effects or response to medication ... Proper medication administration and monitoring response is an integral part of the nurse role."

During a concurrent interview and record review on 2/7/24 at 11:45 a.m., with the medical surgical unit manager (MSM), Patient 106's electronic medication record administration (e-MAR) was reviewed and indicated, Patient 106 was administered Tylenol 1000 milligrams on 12/24/23 at 2:30 p.m. The vital signs flowsheet indicated at 1:30 p.m., the patient's temperature was 99.7-degree Fahrenheit. Further review of the vital signs flowsheet indicated, there was no temperature reassessment one hour after the medication was administered. The MSM acknowledged this and confirmed the patient's temperature was not reassessed one hour later after the medication had been administered and it should have been.

10. According to Potter & Perry, Tenth Edition, Fundamentals of Nursing Practice, Chapter 31, pg 605-607, under Medication Administration, "As a nurse you need to assess the patient ... determine whether the patient should receive the medication at a given time, administer medication correctly, and then closely monitor their effects or response to medication ... Proper medication administration and monitoring response is an integral part of the nurse role."

During a concurrent interview and record review on 2/7/24 at 4:37 p.m. with the MSM, Patient 106's e-MAR was reviewed and indicated, Patient 106 was administered Ativan (anti-anxiety) 1 mg on 12/28/23 at 11:48 a.m., and there was no re-assessment of the medication after administration to assess for effectiveness. The physician's order was for Ativan 1 mg tablet by mouth every 4 hours as needed (PRN) for anxiety. MSM indicated not all medications need re-assessment after administration.

During a concurrent interview and review of the facility's P&P titled, "Medication Administration & Documentation policy," dated 10/2023, with the patient safety director (PSD), the PSD indicated understanding the concept or PRN medication administration however there was no policy addressing the PRN medication administration process.

The hospital failed to meet the regulatory requirements for the Condition of Participation: CFR 485.640 Infection Prevention and Control and Antibiotic Stewardship Program as evidenced by the following:

1. Based on interview the facility failed to ensure the facility's infection preventionist (IP) was appointed by the governing body (GB) and based on recommendations of the medical staff and nursing leadership.

The facility's failure had the potential of not hiring a qualified individual responsible for the infection prevention program or the IP position thus potentially jeopardizing the success of the infection prevention program. (Refer to C-1204)

2. Based on observation, interview, and record review, the facility failed to maintain infection control practices and processes when:
A. Hand hygiene was not performed by staff.
B. Glucometer (device used to measure blood sugar) was not cleaned/disinfected per policy and procedure in the Pre-op/PACU (Preoperative/Post-Anesthesia care unit).
C. Gloves were not worn when accessing IV (intravenous) tubing port for medication administration.
These failures had the potential to result in cross-contamination (the transfer of harmful bacteria) that could impact patients' health and safety and cause preventable healthcare associated infections (HAI) for patients in an already compromised condition. (Refer to C-1206)

3. Based on observation, interview, and record review, the facility failed to maintain a clean and sanitary environment when:
A. The dirty utility room in the emergency department (ED) was storing clean and dirty supplies together.
B. Sterile supplies were not being stored in a temperature-controlled environment in the ultrasound room.
C. The contrast injector machine was found dirty in the CT (computed tomography- imaging that uses a combination of x-rays and computer technology to produce images of inside the body) room. (Jen)
D. Cleaning was not performed correctly in between patients in the post anesthesia care unit (PACU).
E. Cleaning was not performed correctly in between patients in the GI (gastrointestinal) procedure room.
F. EVS (environmental services) daily terminal cleaning was not being monitored monthly.
G. EBOLA (a virus that causes severe bleeding, organ failure, and clean lead to death, and is spread through bodily fluid contact) education and training not being performed per infection control plan.
H. High level disinfection and sterilization of instruments were not being monitored per the infection control plan.
I. Construction site rounds for infection control issues were not done per the infection control plan.
J. During terminal cleaning of the GI procedure room, the cleaning product contact time was not being followed.
K. MRI machine not cleaned and disinfected with the correct wipes.
L. The negative pressure room alarm was disabled.
These failures had the potential to spread infections to patients and staff, and compromise the integrity, and the potential for contamination of sterile supplies. (Refer to C-1208)

The facility's failure had the potential of not hiring a qualified individual responsible for the infection prevention program or the IP position thus potentially jeopardizing the success of the infection prevention program.

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure an effective system-wide infection control program thus resulting in the hospital's inability to provide an environment which was free from the transmission of infections and communicable diseases.

Based on interview, the facility failed to ensure the facility's infection preventionist (IP) was appointed by the governing body (GB) and based on recommendations of the medical staff and nursing leadership.

The facility's failure had the potential of not hiring a qualified individual responsible for the infection prevention program or the IP position thus potentially jeopardizing the success of the infection prevention program.

Finding:

During an interview on 2/7/24 at 9:18 a.m. with the individual who introduced himself as the facility's infection preventionist (IP) who reported being the IP for this facility since 2020. When asked who interviewed him for the IP position, he replied he was interviewed by a panel of three IP colleagues and the infection prevention director.

During an interview on 2/8/24 at 10:05 a.m. with the patient safety director (PSD), the PSD reported the individual who introduce himself as the facility IP, is not the facility IP, this individual is an assistant to the IP. The IP director is the responsible person for the infection prevention for this facility or IP for this facility. The Quality Vice President (QVP) was the person who hired the IP director. The PSD was asked to provide supporting documentation the IP director was appointed by the GB, or the IP director was appointed based on recommendations of the medical staff leadership and nursing leadership. The PSD was not able to provide supporting documentation.

During an interview on 2/8/24 at 10:19 a.m., with the QVP via telephone, the QVP was asked to provide supporting documentation the IP director was appointed by the GB, or the IP director was appointed based on recommendations of the medical staff and nursing leadership. The QVP confirmed not having any documentation supporting the IP director was appointed by the GB or the medical staff and nursing leadership.

Based on observation, interview, and record review, the facility failed to maintain infection control practices and processes when:

1. Hand hygiene was not performed by staff.

2. Glucometer (device used to measure blood sugar) was not cleaned/disinfected per policy and procedure in the Pre-op/PACU (Preoperative/Post-Anesthesia care unit).

3. Gloves were not worn when accessing IV (intravenous) tubing port for medication administration.

These failures had the potential to result in cross-contamination (the transfer of harmful bacteria) that could impact patients' health and safety and cause preventable healthcare associated infections (HAI) for patients in an already compromised condition.

Findings:

1. During a concurrent observation and interview on 1/31/24 at 4:13 p.m. with the med-surg manager (MSM) and the patient care technician (PCT 1), PCT 1 was observed taking vital signs without performing hand hygiene prior to donning gloves. MSM asked if hand hygiene is necessary prior to putting on gloves, MSM stated, "Isn't that considered a clean approach."

During a concurrent observation and interview on 2/7/24 at 8:46 a.m. with the surgical services manager (SSCM) and the registered nurse (RN 8), RN 8 was observed removing dirty gloves and not performing hand hygiene before putting on new gloves. Confirmed with SSCM staff not following facility policy and procedure (P&P).

During a concurrent observation and interview on 2/7/24 at 9:03 a.m. with SSCM and RN 10, RN 10 was observed donning gloves without performing hand hygiene. Confirmed with SSCM staff not following facility P&P.

During a review of the facility's P&P titled, "Hand Hygiene," dated 5/2023, the P&P indicated in part, "Hand hygiene (HH) is performed to remove microorganisms from the hands, fingers, nails and wrists to protect healthcare personnel, patients, and visitors from infection ... Clean hands using either CH-approved hand sanitizer of hand soap ... Before putting on gloves ... Immediately after removing gloves ..."

2. During a concurrent observation and interview on 2/1/24, at 10 a.m. with the SSCM and RN 7, RN 7 was observed cleaning a glucometer, RN 7 wiped down glucometer with a purple wipe then stated she would let dry for 3 minutes and place back in holder (docking station). RN 7 stated between patients I clean with Sani cloth purple tops before and after use for 2 minutes which is the contact time.SSCM was asked if staff had access to Manufacturer Instruction for Use (MFUs) for cleaning and disinfecting, SSCM stated I don't know. SSCM and MSM were asked if they were aware that there are usually two steps, one for cleaning and a second one for disinfecting the glucometer, both SSCM and MSM stated they weren't aware of that.


During a review of the facility's P&P titled, "Whole Blood Glucose by Nova StatStrip," dated 1/7/2018, the P&P indicated in part, "Clean the meter - Remove a fresh germicidal wipe from the canister, wipe the external surface of the meter thoroughly with a fresh germicidal disinfecting bleach wipe. Discard the used wipe ... Disinfect the meter - Using a new, fresh germicidal wipe, thoroughly wipe the surface of the meter (top, bottom, left, and right sides) a minimum of 3 times horizontally, followed by 3 times vertically ..."


During a review of the MFUs titled, "Nova StatStrip" dated 2/2014, indicated in part, "Meter Cleaning and Disinfection Procedure - Clean and disinfect after each patient use by following this protocol to help ensure effective cleaning and disinfection. Cleaning is not the same as disinfecting. Disinfecting means to kill or prevent the growth of disease carrying microorganisms. Warning: To ensure proper disinfection, it is important to clean the meter prior to disinfecting the meter ..."


During a concurrent interview and record review on 2/1/24 at 12:39 pm with SSCM, MFUs titled, "Nova StatStrip," dated 2/2014, and facility's P&P titled, "Whole Blood Glucose by Nova StatStrip," dated 1/7/2018. SSCM confirmed staff did not follow MFUs and policy for cleaning and disinfecting glucometer.


3. Review of the nursing textbook titled, "Fundamentals of Nursing, Ninth Edition," by Potter et al., published by Elsevier, © 2017, indicated, "ADMINISTERING MEDICATIONS BY INTRAVENOUS BOLUS ... Apply clean gloves ... During IV bolus administration there is risk of blood exposure ... ADMINISTERING INTRAVENOUS MEDICATIONS BY PIGGYBACK ... Apply clean gloves ... During IV administration there is a risk of blood exposure."

During a concurrent observation and interview on 2/1/24, at 9:35 a.m. with the emergency department manager (EDM) and the emergency room nurse (RN 6), RN 6 was observed during the medication administration of IVP (intravenous push) Zofran (a medication used to treat nausea and vomiting) for Patient 206. RN 6 was observed performing hand hygiene, drawing up the medication into a syringe, and using an alcohol swab to clean the IV port before administering the Zofran, but did not don gloves. RN 6 proceeded to administer the syringe of Zofran IVP without wearing gloves. EDM acknowledged RN 6 was not wearing gloves. When asked if gloves should be worn when administering medication into the IV, RN 6 and EDM were unaware that gloves needed to be worn for IVP medication administration. RN 6 and EDM were both informed that the current standard of practice is to wear gloves during IV medication administration and there is a risk of blood exposure.

During a review of the facility's policy and procedure (P&P) titled, "I.V. Push Medication Administration" dated 6/23, indicated in part ... " Procedure 1) Perform hand hygiene ...maintain aseptic technique and standard precautions (help prevent transmission of diseases that can be acquired by contact with blood, body fluids, non intact skin, and mucous membranes) ..."

During a concurrent interview and record review on 2/1/24, at 4:08 p.m., with EDM, The facility's policy and procedure for IV Push Medication Administration was reviewed. EDM acknowledged the policy indicated to take standard precautions when administering IVP medications and further acknowledged wearing gloves was part of standard precautions.

Review of the Centers for Disease Control and Prevention (CDC) website, https://www.cdc.gov/infectioncontrol/guidelines/isolation/recommendations.html#iv, accessed 2/15/24, the CDC recommendations indicated "IV. Standard Precautions. Assume that every person is potentially infected ... with an organism that could be transmitted in a healthcare setting and apply the following infection control practices during the delivery of health care ... IV.B.2.a. Wear gloves when it can be reasonably anticipated that contact with blood or other potentially infectious materials... could occur."

Based on observation, interview, and record review, the facility failed to maintain a clean and sanitary environment when:

1. The dirty utility room in the emergency department (ED) was storing clean and dirty supplies together.

2. Sterile supplies were not being stored in a temperature-controlled environment in the ultrasound room.

3. The contrast injector machine was found dirty in the CT (computed tomography- imaging that uses a combination of x-rays and computer technology to produce images of inside the body) room.

4. Cleaning was not performed correctly in between patients in the post anesthesia care unit (PACU).

5. Cleaning was not performed correctly in between patients in the GI (gastrointestinal) procedure room.

6. EVS (environmental services) daily terminal cleaning was not being monitored monthly.

7. EBOLA (a virus that causes severe bleeding, organ failure, is spread through bodily fluid contact, and can lead to death) education and training not being performed per infection control plan.

8. High level disinfection and sterilization of instruments were not being monitored per the infection control plan.

9. Construction site rounds for infection control issues were not done per the infection control plan.

10. During terminal cleaning of the GI procedure room, the cleaning product contact time was not being followed.

11. MRI machine not cleaned and disinfected with the correct wipes.

12. The negative pressure room alarm was disabled.

These failures had the potential to spread infections to patients and staff, and compromise the integrity, and the potential for contamination of sterile supplies.

Findings:

1. During a review of the facility's policy and procedure (P&P) titled, "Sterile Supplies," dated 9/2023, the P&P indicated in part, "D. Storage conditions for sterile supplies will be as follows: iv) Positioned so that the packaging is not crushed, bent, compressed, or punctured and so that their sterility is not otherwise compromised ...v) items will not be stored in wet or damp areas ...vii) closed or covered shelving is best to minimize dust on surfaces ..."

During a concurrent observation and interview on 1/31/24, at 3:48 p.m. with the emergency department manager (EDM), the dirty utility room was observed. Dirty instruments, dirty equipment, containers for waste and soiled linen, and a refrigerator were observed in the room. On top of the refrigerator clean supplies (culture and collection tubes) and sterile supplies (Covid and Influenza nasal collection swabs) for patient use, were observed being stored. The refrigerator sits right next to the counter where dirty instruments are stored. EDM acknowledged the dirty room was not the best place for storage of these supplies and further acknowledged the potential for the supplies becoming contaminated. EDM verbalized these supplies should be moved and stored in a clean area of the emergency department.

According to the AORN Guidelines titled, "Support Areas", dated 2023, the guidelines indicated in part ... "Support Areas: storage facilities for clean and sterile supplies are separate from with no direct connection to the soiled workroom or soiled holding room ... the soiled workroom may be the decontamination room or a holding room for dirty linen and garbage ..."

2. During a concurrent observation and interview on 1/31/24 at 4:45 p.m. with the radiology manager (RadM), the ultrasound room was observed. The storage cabinet contained clean and sterile supplies. A Thora-Para tray (used in the procedure for a thoracentesis (to remove fluid or air from around the lungs), ChloraPrep applicator (contains antiseptic solution to disinfect the skin and help prevent infections before medical procedures and surgery), and containers of Formalin (used as a preservative for skin tissue usually after a biopsy for laboratory testing) were observed. The Thora-Para tray manufacturers packaging indicated the tray need to be stored in a temperature-controlled room at a temperature of 68-77 deg F. The ChloraPrep applicator manufacturers packaging indicated the applicator needed to be stored between 59-86 deg F. The container of Formalin manufacturers packaging indicated the containers needed to be stored between 59-86 deg F. The RadM verbalized the ultrasound room was not a temperature controlled room. The RadM acknowledged the manufacturers packing instruction for storage of these supplies should be in a temperature controlled room.

During an interview on 2/1/24 at 4:05 p.m. with the facilities manager (FM), FM confirmed the ultrasound room is not monitored for temperature.

3. During a concurrent observation and interview on 2/1/24, at 11:10 a.m. with the radiology manager (RadM), the CT room was observed. The contrast injector machine was observed to have brown/red residue and sticky clear substance on the pole/pedestal, sticky clear substance on the pump, and paint peeling from the pole. The RadM acknowledged the contrast injector machine was dirty and sticky and stated, "Don't touch it." The RadM acknowledged the contrast injector machine should be cleaned in between patients.

During a review of the facility's, "Cleaning Responsibilities Table," the table indicated, "Electrical equipment, Electrical portion of IV poles, and medical/electrical equipment should be cleaned be clinical staff ..."

According to the manufacturers operations manual for the contrast injector machine, the operations manual indicated to wipe all the components with a soft cloth or paper towel dampened with cleaning solution ...warm water and a mild disinfectant are all that are required to clean the machine ..."

4. During a concurrent observation and interview on 2/7/24 at 8:46 a.m. with the surgical services manager (SSM) and registered nurse (RN 8), in the PACU between patients, RN 8 removed purple top wipes from container and started cleaning equipment, dropped wipes on the floor, picked up the wipes off the floor, and continued cleaning equipment with the dirty wipes. Confirmed with SSM staff are not following facility infection control practices.

According to AORN guidelines for perioperative practice titled: "Environmental Cleaning" dated 2012 - 2021, indicated in part, "All personnel should take a precautionary measure to limit transmission of microorganisms when performing environmental cleaning and handling waste materials ... always consider floors in the perioperative practice setting to be contaminated ... healthcare personnel handling contaminated items or cleaning contaminated surfaces must wear personal protective equipment (PPE) to reduce the risk of exposure to blood, bodily fluids, and other potentially infectious materials ... hand hygiene should be performed when PPE is removed and as soon as possible after hands are soiled."

5. During a concurrent observation and interview on 2/7/24 at 9:03 a.m. with the surgical services manager (SSM) and registered nurse (RN 9), in the GI procedure room between patients, RN 9 cleaned dirty equipment with wipes, did not change gloves, then removed clean wipes from a clean container, and continued cleaning equipment. SSM confirmed RN 9 should not be going from clean to dirty back to clean without changing gloves and performing hand hygiene.

According to AORN guidelines for Perioperative practice titled: "Environmental Cleaning" dated 2012 - 2021, indicated in part, "All personnel should take a precautionary measure to limit transmission of microorganisms when performing environmental cleaning and handling waste materials ... perform cleaning activities in a methodical pattern that limits transmission of microorganisms ... cleaning should be progress from clean to dirty..."

6. During a concurrent interview and record review on 2/7/24 at 9:37 a.m. with the infection control practitioner (ICP), review of the facility's, "Infection Prevention & Control Annual Plan 2023," indicated, ICP should monitor EVS for daily and terminal cleaning once a month. ICP stated I missed quite a few months. Review of facility's "EVS Observation Tracking" excel spread sheet indicated, daily cleaning monitoring not done in January, February, May, August, September, October, November, December and terminal cleaning monitoring not done January, February, March, May, June, July, August, September, October, November, December.

During a concurrent interview and record review on 2/7/24, at 12:22 p.m. with the infection control director (ICD) and ICP, review of the facility's "Infection Prevention & Control Annual Plan 2023" indicated, ICP should monitor EVS for daily and terminal cleaning once a month. Confirmed with ICD the "Infection Prevention & Control Annual Plan 2023" was not followed.

7. During a concurrent interview and record review on 2/7/24, at 9:37 a.m. with the infection control practitioner (ICP), review of the facility's "Infection Prevention & Control Annual Plan 2023" indicated, one active drill and or tabletop exercise annual and annual education for staff for Ebola should be done. ICP stated I don't believe it was done.

During a concurrent interview and record review on 2/7/24 at 12:22 p.m. with the infection control director (ICD) and ICP, review of the facility's "Infection Prevention & Control Annual Plan 2023," indicated, one active drill and or tabletop exercise annual and annual education for staff for Ebola should be done, confirmed with ICD the "Infection Prevention & Control Annual Plan 2023" was not followed.

8. During a concurrent interview and record review on 2/7/24, at 9:37 a.m. with the infection control practitioner (ICP), review of the facility's "Infection Prevention & Control Annual Plan 2023" indicated, HLD and Sterilization use monitoring tool to observe the identified areas quarterly confirmed with ICP it was not done.

During a concurrent interview and record review on 2/7/24 at 12:22 p.m. with the infection control director (ICD) and ICP, review of the facility's "Infection Prevention & Control Annual Plan 2023" indicated, HLD and Sterilization use monitoring tool to observe the identified areas quarterly should be done, confirmed with ICP it was not done.

9. During a concurrent interview and record review on 2/7/24 at 9:37 a.m. with the infection control practitioner (ICP), review of the facility's "Infection Prevention & Control Annual Plan 2023" indicated, Construction site rounds done per ICP but unable to provide documentation anywhere. Confirmed with ICP if it is not documented unable to determine if or when it was done.

10. A review of the facility's policy and procedure (P&P) titled, "Surgical Suite Terminal Cleaning - SOP," dated 7/2023, indicated in part,"Wipe walls, ledges, and other surface areas ... with HBV 499 disinfectant (make sure walls are saturated for 10 min dwell time)"

During a concurrent observation and interview on 2/7/24 at 11:35 a.m., in the GI procedure room, with the environmental services manager (EVSM) and environmental services (EVS 1), EVS 1 performed terminal cleaning using 499 Oasis HBV (cleaning & disinfecting product) with a 10-minute contact time (time product must remain wet to be effective). EVS applied 499 Oasis HBV to wall, confirmed with EVSM the product did not remain wet for 10 minutes, that the terminal cleaning process for contact time was not met.

11. During a concurrent tour of the mobile MRI trailer and interview with the imaging technician (IT) on 1/31/24 at 3:40 p.m., the IT reported the MRI machine is clean and sanitize with the purple top Sani-Cloth wipes.

On 2/1/24 at 9:04 a.m., the imaging manager (IM) provided MRI cleaning and disinfectant information which indicated the MRI machine must be cleaned and disinfected with CAVIWIPES Bleach. The IM acknowledged and confirmed the staff has been using the incorrect wipes to clean and disinfect the MRI machine.

12. During a tour of the medical surgical unit accompanied by the MSM on 2/2/24 at 9:24 a.m. room 501, a negative pressure room was observed. A type of hospital room designed to prevent airborne microorganisms in the room from entering hallways and corridors. The MSM reported patients that need airborne isolation (i.e., tuberculosis TB-contagious disease) are place inside this room because the room is a negative pressure room. The door is always closed to prevent cross contamination (contagious air traveling to the unit). If the door is open for a long period of time, the door alarm will start alarming (loud noise) to notify the staff the room needs to be checked and to close the door. The anteroom and room doors were opened to test the door alarm. After the door was open for a long time, the alarm did not make any noise. On 2/2/24 at 9:45 a.m., the facilities manager (FM) with the MSM present, attempted to trouble shoot the door alarm, however, the door alarm still did not make any noise. The FM confirmed the negative pressure room door alarm was not functioning properly. The MSM and FM agreed that if the door alarm is not alarming (making loud noise) the door could be open for a long time without staff being aware resulting in cross-contamination.

On 2/2/24 at 10:36 a.m., the FM reported the room door alarm was disabled and did not know how long the alarm had been disabled.

A review of the facility P & P titled, "Aerosol Transmissible Disease Control Plan," dated 10/2023, indicated, "To reduce the risk of potential airborne exposure to infectious diseases under the CAL/OSHA aerosol transmissible diseases (ATD) regulation ... requiring airborne infection isolation (AII) ...14 (A) patients who are suspected or known to have an ATD will be directed to a designated AIIR with the door closed. Airborne Infection Isolation Room or area (AIIR)-A room or other enclosure that is maintained under negative pressure to adjacent areas so that air contaminated with infectious particles does not escape the room."