HospitalInspections.org

Based on observation, interview, record review, the facility failed to have an effective governing body legally responsible for the conduct of the hospital when:

1. The hospital failed to ensure that a hospital wide quality assurance performance improvement program (QAPI-data driven program that focuses on systems of care, outcomes of care, and quality of life) was implemented when the hospital did not identify and complete a root cause analysis (systematic process for identifying problems or events and an approach for responding to them) when P1 1's medication reconciliation (the process of identifying the most accurate list of all medications that a patient is taking and comparing that list against a physician's admission, transfer, and/or discharge orders to avoid medication errors) was not completed for Pt 1 and resulted in Pt 1 not receiving medication needed to control atrial fibrillation (AFib- an arrhythmia that occurs when the upper chambers of the heart [atria] beat irregularly and fast), which led to Pt 1 having AFib with rapid ventricular response (RVR- occurs when the rapid contractions of the atria cause the ventricles [the lower chambers of the heart] beat too fast) which led to Pt 1's transfer to a higher level of care, prolonged her hospital stay and placed her at increased risk for stroke. (Refer to A-283)

2. The GB did not ensure the hospital had an organized medical staff responsible for the quality of medical care provided to patients when hospital failed to follow the bylaws, rules and regulations, and policies of the medical staff for privileging (authorizations granted to healthcare professionals, such as physicians or surgeons, by a hospital's governing board to practice medicine and perform specific procedures within the hospital) Allied Health Professional (AHP, Nurse Practitioner [NP], Physician Assistant [PA], or Certified Registered Nurse Anesthetist [CRNA]) staff when 16 of 20 sampled AHPs (NP 1, PA 1, CRNA 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14,) did not have evidence they completed the required concurrent proctoring (objective evaluation of a provider's clinical competence by someone) prior to performing procedures independently, and the hospital did not have a process in place to track compliance with the proctoring requirements. (Refer to A339)

Because of the potential for serious harm to patients who received care from an Allied Health Professional (AHP - Nurse Practitioner (NP), Physician Assistant (PA), or Certified Registered Nurse Anesthetist (CRNA- a registered nurse trained to provide anesthesia [medical intervention that prevents patients from feeling pain during procedure and surgery]) who were not tracked and monitored for required proctoring by medical staff office and may not have been qualified to perform services to patients and because CRNA 1, CRNA 2, CRNA 3, CRNA 4, PA 1 and NP 1 performed services on patients without first providing proof of concurrent proctoring to ensure qualified and met privileging requirements, an Immediate Jeopardy (IJ a situation in which the provider's noncompliance with one or more conditions of participation has caused or is likely to cause serious injury, harm, impairment, or death to a patient) situation was called for A339 42 CFR 482.22(a) on 7/31/24 at 11:25 a.m. with the Chief Medical Officer (CMO), Chief Nursing Officer (CNO), President and Market Leader (PML), Director of Clinical Quality Improvement (DQ), and the Manager of Quality Improvement (QIM). The IJ (immediate Jeopardy) template was provided to the facility. The hospital submitted an IJ Plan of Removal (Version One) on 7/31/24 at 2:51 p.m. and it was not accepted. The hospital submitted an IJ Plan of Removal (Version Two) on 8/1/24 at 8:14 a.m. and it was not accepted. The hospital submitted an IJ Plan of Removal (Version Three) on 8/1/24 at 1:32 p.m. and it was not accepted. The hospital submitted an IJ Plan of Removal (Version Four) on 8/1/24 at 3:54 p.m. it was reviewed and accepted at 4:57 p.m. with the DQ. On 8/1/24 and 8/2/24 the survey team validated that staff were able to look up AHPs to see what privileges they had and see if concurrent proctoring was still needed, observations done in surgical department to confirm concurrent proctoring was being done, and education as to why this was important was interviewed to. Review of concurrent proctoring forms and surgery schedule for 8/1/24 and 8/2/24 indicated there was overlap seen of the same proctor being used and the DQ, CMO and MSD confirmed the proctor was only in the room during the most important times and not the whole surgery. The DQ, CMO, and MSD confirmed this was the process being used and stated the Medical Staff Bylaws and policies were being updated and felt this was safe care their patients. They provided a written statement signed by the CMO and the President of Medical Staff (MSP) indicating above, and MSD stated she would add a statement at the bottom of the proctor forms that the proctor must check attesting that they were present during the most important times of the cases. On 8/2/24 at 3 p.m. while onsite the IJ was removed with CMO, DQ, QIM and MSD.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe and responsible manner for staff and patients.

Based on interview and record review, the facility failed to ensure care was provided in a safe setting for three of five sampled patients (Pt 40, Pt 41 and Pt 42) when;

1. One of one patient (Pt 40) did not have physician order for violent restraint renewed every four hours in accordance with hospital policies and procedures (P&P).

This failure had the potential for unnecessary and unsafe use of restraints in violation of Pt 40's rights.

2. Two of two patients (Pt 40 and Pt 41) on restraints did not have restraint assessments completed in accordance with hospital policies and procedures (P&P).

This failure had the potential for Pt 40 and Pt 41 to have injury from restraints.

3. Two of two patients (Pt 41 and Pt 42) had no physician order for violent restraints in accordance with hospital policies and procedures (P&P).

This failure had the potential for Pt 41 and Pt 42 to have the wrong type of restraint and monitoring.

Findings:

1. During a review of Pt 40's "History and Physical (H&P)," dated 7/9/24, the H&P indicated, " ...Patient is a 23 [year old] male with a past medical history of alcohol abuse ... Patient is aggressive and violent right now ..."

During a concurrent interview and record review on 7/30/24 at 3:12 p.m. with Manager (MG) 4, Pt 40's "Physician Orders (PO)," dated 7/9/24 and "Flowsheets, Restraints Violent (FRV)," dated 7/9/24 were reviewed. The PO indicated, " ...Restraints violent or self-destructive adult ... Ordering user: [Name of physician] 07/09/24 [8:27 a.m.] ... Frequency: Routine Continuous x 4 hours 07/09/24 [8:28 a.m.] ... Restraint type: Velcro Restraint ... Location: All Extremities ... Restraint reason: Danger to self, Danger to others ..." MG 4 stated, Pt 40's PO for violent restraints expired four hours after the start of the order (at 12:27 p.m.). The PO indicated, " ...Restraints violent or self-destructive adult ...Ordering user: [Name of RN] 07/09/24 [5 p.m.] ... Frequency: Routine Continuous x 4 hours 07/09/24 [12:28 p.m.] ... Restraint type: Velcro Restraint ... Location: All Extremities ... Restraint reason: Danger to self, Danger to others ..." MG 4 stated, the next physician orders entered for violent restraint was placed on 7/9/24 at 5 p.m. (a time lapse of 4 hours and 33 minutes after the previous order expired). The PO indicated, " ...Restraints violent or self-destructive adult ...Ordering user: [Name of RN] 07/09/24 [5:03 p.m.] ... Frequency: Routine Continuous x 4 hours 07/09/24 [4:28 p.m.] ... Restraint type: Velcro Restraint ... Location: All Extremities ... Restraint reason: Danger to self, Danger to others ..." MG 4 stated, the physician order for violent restraint expired at 12:27 p.m. and physician order for violent restraint was not renewed before the expiration time. MG 4 stated, there was no documentation a physician saw Pt 40 when the physician order for violent restraints was placed at 5 p.m. (4 hours and 33 minutes after the order expired). MG 4 stated, the FRV on 7/9/24 indicated Pt 40 remained on violent restraints from 12:31 p.m. to 4:39 p.m. and no other restraint documentation was completed after 4:39 p.m.

During an interview on 7/31/24 at 9:45 a.m. with MG 4, MG 4 stated the licensed nurse should have received an order from the physician and entered the order before the first order expired. MG 4 stated, the licensed nurse did not following the policy and procedure (P&P).

2. During a review of Pt 40's "History and Physical (H&P)," dated 7/9/24, the H&P indicated, " ...Patient is a 23 [year old] male with a past medical history of alcohol abuse ... Patient is aggressive and violent right now ..."

During a concurrent interview and record review on 7/30/24 at 3:12 p.m. with Manager (MG) 4, Pt 40's "Physician Orders (PO)," dated 7/9/24 and "Flowsheets, Restraints Violent (FRV)," dated 7/9/24 were reviewed. The PO indicated, " ...Restraints violent or self-destructive adult ...Ordering user: [Name of physician] 07/09/24 [8:27 a.m.] ... Frequency: Routine Continuous x 4 hours 07/09/24 [8:28 a.m.] ... Restraint type: Velcro Restraint ... Location: All Extremities ... Restraint reason: Danger to self, Danger to others ..." MG 4 stated, Pt 40's PO for violent restraints expired four hours after the start of the order (at 12:27 p.m.). The PO indicated, " ...Restraints violent or self-destructive adult ...Ordering user: [Name of RN] 07/09/24 [5 p.m.] ... Frequency: Routine Continuous x 4 hours 07/09/24 [12:28 p.m.] ... Restraint type: Velcro Restraint ... Location: All Extremities ... Restraint reason: Danger to self, Danger to others ..." MG 4 stated, the next physician orders entered for violent restraint was placed on 7/9/24 at 5 p.m. (4 hours and 33 minutes after the previous order expired). The PO indicated, " ...Restraints violent or self-destructive adult ...Ordering user: [Name of RN] 07/09/24 [5:03 p.m.] ... Frequency: Routine Continuous x 4 hours 07/09/24 [4:28 p.m.] ... Restraint type: Velcro Restraint ... Location: All Extremities ... Restraint reason: Danger to self, Danger to others ..." MG 4 stated, the physician order for violent restraint expired at 12:27 p.m. on 7/9/24 and Pt 40 remained on violent restraints after 12:27 p.m. MG 4 stated, there were no violent restraint assessments completed from 4:39 p.m. to 6 p.m. on 7/9/24. MG 4 stated, there was no documentation when Pt 40's violent restraints were discontinued. MG 4 stated, Pt 40 was not assessed for readiness to discontinue restraints every hour and Pt 40's restraints should have been assessed every hour.

During a concurrent interview and record review on 7/31/24 at 9:50 a.m. with MG 4, Pt 40's "Physician Orders (PO)," dated 7/9/24 and 7/10/24, and "Flowsheets, Restraints Non-violent (FRNV)," dated 7/10/24 were reviewed. The PO indicated, " ...Restraints non-violent or non-self destructive adult ...Ordering user: [Name of RN] 07/09/24 [6:06 p.m.] ... Frequency: Routine Continuous x 24 hours 07/9/24 [6:06 p.m.] ... Restraint type: Soft Restraint ... Location: Right Wrist, Left Wrist ... Restraint reason: Interference with medical treatment ..." The PO indicated, " ...Restraints non-violent or non-self destructive adult ...Ordering user: [Name of RN] 07/10/24 [5:57 p.m.] ... Frequency: Routine Continuous x 24 hours 07/10/24 [5:58 p.m.] ... Restraint type: Soft Restraint ... Location: Right Wrist, Left Wrist ... Restraint reason: Interference with medical treatment ..." MG 4 stated, there was no documentation the physician saw Pt 40 when the restraint order was renewed on 7/10/24 at 5:57 p.m. MG 4 stated, non-violent restraint assessments were not completed for Pt 40. MG 4 stated Pt 40's restraints should had been assessed every two hours after 5:57 p.m. until the restraints were discontinued on 7/11/24 at 2:52 a.m. MG 4 stated, non-violent restraint assessments should have been completed every two hours until it was discontinued.

During a review of Pt 41's "History and Physical (H&P)," dated 6/15/24, the H&P indicated, " ...a 39-year-old male with [past medical history] of depression, bipolar, schizophrenia and multiple personality disorder ..."

During a concurrent interview and record review on 7/31/24 at 10:20 a.m. with MG 4, Pt 41's "Physician Orders (PO)," dated 6/20/24 and "Flowsheets, Restraints Violent (FRV)," dated 6/20/24 were reviewed. The PO indicated, " ...Restraints violent or self-destructive adult ...Ordering user: [Name of physician] 06/20/24 [8:36 a.m.] ... Frequency: Routine Continuous x 4 hours 06/20/24 [8:36 a.m.] ... Restraint type: Side Rails Up, Velcro Restraint ... Siderail #: 2 ...Location: Right Wrist, Right Ankle, Left Wrist, Left Ankle, All Extremities ... Restraint reason: Danger to self ..." The FRV indicated, " ... [8:36 a.m.] ... Clinical Justification ...Imminent risk of harm to self ... Restraint Type ...Velcro Restraint [Right] Wrist (V) ...Start ... Velcro Restraint [Left] Wrist (V) ...Start ... Velcro Restraint [Right] Ankle (V) ...Start ... Velcro Restraint [Left] Ankle (V) ...Start ..." MG 4 stated, violent restraint assessments were not completed every 15 minutes after 8:36 a.m. until Pt 41 was discharged at 2:39 p.m. to a psychiatric hospital. MG 4 stated, violent restraint assessments should have been completed every 15 minutes until Pt 41 was discharged. MG 4 stated, she expected licensed nurses to assess and document every 15 minutes when Pt 41 was on violent restraints. MG 4 stated, Pt 41 was not assessed for readiness to discontinue restraints every hour, and Pt 41's restraints should have been assessed every hour.

3. During a review of Pt 41's "History and Physical (H&P)," dated 6/15/24, the H&P indicated, " ...a 39-year-old male with [past medical history] of depression, bipolar, schizophrenia and multiple personality disorder ..."

During a concurrent interview and record review on 7/31/24 at 9:57 a.m. with Manager (MG) 4, Pt 41's "Physician Orders (PO)," dated 6/18/24 and "Flowsheets, Restraints Non-Violent (FRNV)," dated 6/18/24 were reviewed. The PO indicated, " ...Restraints non-violent or non-self destructive ...Ordering user: [Name of physician] 06/18/24 [1:06 p.m.] ... Frequency: Routine Continuous x 24 hours 06/18/24 [1:07 p.m.] ... Restraint type: Soft Restraint ... Location: Left Ankle, Right Ankle ... Restraint reason: Interference with medical treatment ..." The FRNV indicated, " ... [1:06 p.m.] ... Clinical Justification ...Removal of equipment; Pulling lines ... Restraint Type (NV) ...Soft Restraint [Right] Wrist (NV) ...Start ... Soft Restraint [Left] Wrist (NV) ...Start ... Soft Restraint [Right] Ankle (NV) ...Start ... Soft Restraint [Left] Ankle (NV) ...Start ..." MG 4 stated, the physician order for restraint was for the right and left ankles and did not include the right and left wrists. MG 4 stated, the right and left wrist restraints should not have been started.

During a concurrent interview and record review on 7/31/24 at 10:10 a.m. with MG 4, Pt 41's "Nursing Note (NN)," dated 6/18/24 at 1:04 p.m. was reviewed. The NN indicated, " ...Patient threatened to pull out IV, patient became aggressive and tore off his paper scrub top. [Physician] notified and ... called security at bedside ..." MG 4 stated, Pt 41 was aggressive. MG 4 stated, the physician order should have been entered as a violent restraint and not a non-violent restraint. MG 4 stated, a non-violent restraint to Pt 41's legs was not justified for Pt 41.

During a review of Pt 42's "Progress Note (PN)," dated 7/30/24, the PN indicated, " ...72 [year old male] with [past medical history] of ... history of [traumatic brain injury-an injury that affects how the brain works], bipolar type 1 disorder [causes extreme mood swings] who presented to [name of hospital] on 6/23/24 due to [altered mental status- a condition marked by an abnormal state of alertness or awareness] ..."

During a concurrent interview and record review on 8/1/24 at 9:34 a.m. with Registered Nurse (RN) 2, Pt 42's "Physician Orders (PO)," dated 8/1/24 and "Flowsheets, Restraints Non-violent (FRNV)," dated 8/1/24 were reviewed. The PO indicated, " ...Restraints non-violent or non-self destructive ...Ordering user: [Name of Nurse Practitioner] 08/01/24 [2:08 a.m.] ... Frequency: Routine Continuous x 24 hours 08/01/24 [2:09 a.m.] ... Restraint type: Soft Restraint ... Location: Right Wrist, Left Wrist, Right Ankle, Left Ankle ... Restraint reason: Interference with medical treatment ..." The FRNV indicated, " ... [2:09 a.m.] ... Clinical Justification ...Pulling lines; Pulling tubes ...trying to exit bed and swinging legs as if he may kick staff ... Restraint Type (NV) ...Soft Restraint [Right] Wrist (NV) ...Continued ... Soft Restraint [Left] Wrist (NV) ...Continued ... Soft Restraint [Right] Ankle (NV) ...Start ... Soft Restraint [Left] Ankle (NV) ...Start ..."

During an interview on 8/1/24 at 12:10 p.m. with Registered Nurse (RN) 2, RN 2 stated, a four-point restraint would be used to make sure a patient does not get out of bed and hurt oneself. RN 2 stated, Pt 42 required a four-point restraint because he was "thrashing and kicks around" due to his confusion.

During an interview on 7/30/24 at 12:16 p.m. with the Chief Nursing Officer (CNO), the CNO stated, a patient's condition determined what type of restraint to use. The CNO stated she expected the correct orders and documentation be completed for restraint use.

During a review of the facility's policy and procedure (P&P) titled, "Restraint/Seclusion for Patient Safety," revised November 2023, the P&P indicated, " ...POLICY: ... Restraint for Non-Violent or Non-Self-Destructive Behavior ... Restraint for Violent or Self-Destructive Behavior ...Discontinuation of Restraint ... PURPOSE: To provide guidelines for assessment and utilization of restraint or seclusion to promote healing when a non-violent and a non-destructive patient is unable to follow directions, or when the patient's behavior is violent or self-destructive and poses an immediate threat to self, staff, or others ... OUTCOME: When a restraint or seclusion is required, it is managed in such a manner that the rights of the patient are promoted, patient dignity is maintained as much as possible, and inherent risks are minimized ... DEFINITIONS: ... Patient Rights: The Patient's Bill or Rights and Responsibilities includes the patient's right to receive care in a safe setting, and to be free from restraint or seclusion of any form used as a means of coercion, discipline, convenience, or retaliation by staff ... Restraint: Any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of the patient to move their arms, legs, body, or head freely ... Non-Violent Restraints: Restraints used for acute medical or surgical care which supports the physical health and safety of the patient who is non-violent/non-self-destructive ... Violent Restraints: Restraints used to manage the patient's violent or self-destructive behavior jeopardizing the immediate physical safety of the patient, staff, or others ... Restraint for Non-Violent or Non-Self-Destructive Behavior ... To protect the patient from injury when patient is unable to follow directions (pulling at tubes, dressings, IV lines or other medical equipment that needs to be maintained) ... Licensed Independent Practitioner Evaluation and Order: ... Restraint orders will include reason, type of restraint to be used and time limits. The Licensed Independent Practitioner must see and evaluate the patient before entering a new order each day the patient remains in restraint ... Application of Restraints: ... Restraints must be implemented in accordance with safe, appropriate restraining techniques, hospital policy, state law and manufacturer's instructions. Restraints are applied by trained staff ... The Licensed Nurse records type of restraint, including time of application and removal in the EHR ... Monitoring: ... The Licensed Nurse assess the physical and physiological condition of the patient to ensure safety, comfort, and readiness for discontinuation of restraint and documents at least every two hours ... Monitoring is documented at least every two hours on the EHR. Assessment includes: ... Type of restraint ...Where restraint is applied on patient's body ...Skin circulation/restraint site assessment ...Nutrition/hydration ... Hygiene and elimination ...Cognitive/emotional response ...ROM positioning ...Safety ... Restraint or Seclusion for Violent or Self-Destructive Behavior ... To protect the patient when the patient's behavior, regardless of diagnosis, represents an emergency and jeopardizes the immediate physical safety of the patient, staff member or others ... Licensed Independent Practitioner Evaluation and Order: ... Orders may not exceed these maximum time limits: ... 4 hours for adults 18 years of age or older ... At the end of the time limit, the Licensed Nurse must contact the Licensed Independent Practitioner in person or on the phone and report the assessment and request the order be renewed based on an individualized patient assessment that the behavior still requires restraint or seclusion ... "Monitoring: ...The Licensed Nurse monitors the physical and physiological condition of the patient to ensure safety, comfort, and readiness for discontinuation of restraint or seclusion and documents at least every 60 minutes ... Monitoring occurs and is documented at least every 15 minutes. Monitoring may include, but is not limited to the following: ... Respiratory, circulatory ...Skin integrity ...Vital signs ... Nutrition/hydration ...Range of motion of the extremities ...Hygiene and elimination ...Level of distress and agitation ...Signs of injury associated with the application of restraint or seclusion ... Cognitive functioning ...Mental status ... Discontinuation of Restraint ...(both Non-Violent & Violent) ...The RN documents the patient's behavior at the time the restraint is discontinued ... APPENDIX B ...Fall Risk ...There is no evidence that falls decrease with the use of restraint. In fact, serious injury rates are higher in facilities that use restraint. Restraint use may contribute to falls through de-conditioning and muscle wasting, sensory deprivation, and exacerbation of underlying gait abnormalities. Some patients have suffered strangulation, impairment of circulation, nerve damage, rhabdomyolysis, and death as a result of being in restraint ..."

Based on interview and record review, the hospital failed to ensure that a hospital wide quality assurance performance improvement program (QAPI-data driven program that focuses on systems of care, outcomes of care, and quality of life) was implemented when the hospital did not identify and complete a root cause analysis (systematic process for identifying problems or events and an approach for responding to them) when P1 1's medication reconciliation (the process of identifying the most accurate list of all medications that a patient is taking and comparing that list against a physician's admission, transfer, and/or discharge orders to avoid medication errors) was not completed for Pt 1 and resulted in Pt 1 not receiving medication needed to control atrial fibrillation (AFib- an arrhythmia that occurs when the upper chambers of the heart [atria] beat irregularly and fast), which led to Pt 1 having AFib with rapid ventricular response (RVR- occurs when the rapid contractions of the atria cause the ventricles [the lower chambers of the heart] beat too fast) which led to Pt 1's transfer to a higher level of care, prolonged her hospital stay and placed her at increased risk for stroke. (Refer to A-283)

The cumulative effect of this systemic problem resulted in the hospital's inability to ensure the provision of quality healthcare in a safe environment.

Based on interview and record review, the hospital failed to develop a program to analyze indicators to improve health outcomes when home medication reconciliation (The process of identifying the most accurate list of all medications that a patient is taking and comparing that list against a physician's admission, transfer, and/or discharge orders to avoid medication errors) was not being monitored and caused harm to Pt 1, no root cause analysis (systematic process for identifying problems or events and an approach for responding to them) was completed.

There was no process in place to review and analyze quality indicators across the hospital. Data was collected in some individual departments, but the information was not reported up to the Quality Department and there was no review and analysis of the data for the Medication Error Reduction Plan (MERP) for medication reconcillation.

This failure resulted in the hospital not identifying and acting on critical incidents that could affect all inpatients' health and well-being.and had the potential to cause harm to any patient whose home medication list was not reconciled and had the potential to cause harm to any patient whose home medication list was not reconciled. (take out inlcude in failure.

Findings:

During a record review on 7/24/24 at 4 p.m., the hospital's EHR report of compliance with Admission Medication Reconciliation for 1/1/24 through 7/24/24 was reviewed. The report contained a list of twenty-six patient care areas in the hospital with a month by month percentage of compliance for each area. The report did not give an overall combined compliance rate each month for all areas, but listed the individual months for each area separately. The report indicated for nearly all of the areas, the monthly compliance rate for completion of the admission medication reconciliation (within 24 hours after admission) was between 0% and 50%. The report indicated for 3W (where Pt 1 and Pt 2 were admitted) Station 1, the percentage compliance with admission med rec for January and February 2024 was 0%, March 40%, April 33.3%, May 33.3%, June 33.3%, and for the 3W Station 2, the report indicated January 2024 100%, February 2024 50%, March 40%, April 50%, May 25%, and June 50%.

During a record review on 7/25/24 at 11:08 a.m. with the Medication Safety Coordinator (MSP), the MSP stated he was made aware about the report of the compliance rate for admission med rec completion for each area. The MSP stated he did not monitor or review the medication reconciliation compliance in any area of the hospital and did not have reports generated with this information. The MSP stated med rec was not part of the hospital's Medication Error Reduction Plan (MERP). The MSP stated he wrongly assumed the quality department was monitoring med rec data.

During an interview on 7/29/24 at 1:10 p.m., with the Manager of Regulatory and Accreditation (MRA) and the Director of Quality (DQ), the MRA stated medication reconciliation was not a performance improvement project but is going to be one and has shown improvement since a plan was put into place to figure out why it was not getting completed.
During an interview on 7/30/24 at 12:16 p.m., with the Chief Nursing Officer (CNO), the CNO stated the nurse or the pharmacy technician put in the patients home medication list, staff were hitting nurse reviewed instead of nurse complete so it can not be restarted by the physician until it is marked nurse completed, education will need to be done for everyone on this. The CNO stated it is important to have the home medication list done for a patient so patients do not miss their medications, duplicates are not put in, and there are no adverse interactions with any medications, "it could cause an adverse outcome to the patient if we do not continue them on their home medications".

During a review of the "Quality Assessment and performance Improvement Plan" for the year of 2024 was reviewed the plan indicated, "PURPOSE the purpose of the Quality Assessment and Performance Improvement (QAPI) Plan for [name of hospital] is to ensure that the governing body, medical staff, and professional service colleagues consistently endeavor to deliver safe, effective, optimal patient care and services in an environment of minimal risk. The plan allows for a systematic, coordinated, continuous, data-driven approach to improving performance, focusing on the processes and mechanisms that address these values ... The plan, established by the Hospital's Quality committee, with the support and approval of the governing body, has the responsibility for monitoring all aspects of patient care and services (including contracted services), from the time of the patient's initial participation with any of the services provided by [name of hospital] including diagnosis, treatment, recovery, and discharge activities. These activities are monitored to identify and resolve any breakdowns that may result in suboptimal patient care and safety while striving to continuously improve and facilitate patient outcomes ... ORGANIZATION ... designed to facilitate an effective system of monitoring, assessment, and evaluation of the care and services provided throughout the organization ... the Patient Safety and Quality Committee ... Provides oversight of Hospitals' patient safety, risk management, and grievance process ... Hospital Departments With the assistance from the Quality Department, each department or service annually selects quality indicators with a focus on indicators that are high risk, high volume, and/or problem prone ..."

Based on interview and record review the hospital failed to have an organized medical staff responsible for the quality of medical care provided to patients when hospital failed to follow the bylaws, rules and regulations, and policies of the medical staff for privileging (authorizations granted to healthcare professionals, such as physicians or surgeons, by a hospital's governing board to practice medicine and perform specific procedures within the hospital) Allied Health Professional (AHP, Nurse Practitioner [NP], Physician Assistant [PA], or Certified Registered Nurse Anesthetist [CRNA]) staff when 16 of 20 sampled AHPs (NP 1, PA 1, CRNA 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14,) did not have evidence they completed the required concurrent proctoring (objective evaluation of a provider's clinical competence by someone) prior to performing procedures independently, and the hospital did not have a process in place to track compliance with the proctoring requirements. (Refer to A339)

Because of the potential for serious harm to patients who received care from an Allied Health Professional (AHP - Nurse Practitioner (NP), Physician Assistant (PA), or Certified Registered Nurse Anesthetist (CRNA- a registered nurse trained to provide anesthesia [medical intervention that prevents patients from feeling pain during procedure and surgery]) who were not tracked and monitored for required proctoring by medical staff office and may not have been qualified to perform services to patients and because CRNA 1, CRNA 2, CRNA 3, CRNA 4, PA 1 and NP 1 performed services on patients without first providing proof of concurrent proctoring to ensure qualified and met privileging requirements, an Immediate Jeopardy (IJ a situation in which the provider's noncompliance with one or more conditions of participation has caused or is likely to cause serious injury, harm, impairment, or death to a patient) situation was called for A339 42 CFR 482.22(a) on 7/31/24 at 11:25 a.m. with the Chief Medical Officer (CMO), Chief Nursing Officer (CNO), President and Market Leader (PML), Director of Clinical Quality Improvement (DQ), and the Manager of Quality Improvement (QIM). The IJ (immediate Jeopardy) template was provided to the facility. The hospital submitted an IJ Plan of Removal (Version One) on 7/31/24 at 2:51 p.m. and it was not accepted. The hospital submitted an IJ Plan of Removal (Version Two) on 8/1/24 at 8:14 a.m. and it was not accepted. The hospital submitted an IJ Plan of Removal (Version Three) on 8/1/24 at 1:32 p.m. and it was not accepted. The hospital submitted an IJ Plan of Removal (Version Four) on 8/1/24 at 3:54 p.m. it was reviewed and accepted at 4:57 p.m. with the DQ. On 8/1/24 and 8/2/24 the survey team validated that staff were able to look up AHPs to see what privileges they had and see if concurrent proctoring was still needed, observations done in surgical department to confirm concurrent proctoring was being done, and education as to why this was important was interviewed to. Review of concurrent proctoring forms and surgery schedule for 8/1/24 and 8/2/24 indicated there was overlap seen of the same proctor being used and the DQ, CMO and MSD confirmed the proctor was only in the room during the most important times and not the whole surgery. The DQ, CMO, and MSD confirmed this was the process being used and stated the Medical Staff Bylaws and policies were being updated and felt this was safe care their patients. They provided a written statement signed by the CMO and the President of Medical Staff (MSP) indicating above, and MSD stated she would add a statement at the bottom of the proctor forms that the proctor must check attesting that they were present during the most important times of the cases. On 8/2/24 at 3 p.m. while onsite the IJ was removed with CMO, DQ, QIM and MSD.

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on observation, interview and record review, the hospital failed to follow the bylaws, rules and regulations, and policies of the medical staff for privileging Allied Health Professional (AHP, Nurse Practitioner [NP], Physician Assistant [PA], or Certified Registered Nurse Anesthetist [CRNA]) staff when 16 of 20 sampled AHPs (NP 1, PA 1, CRNA 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14) did not have evidence they completed the required concurrent proctoring (objective evaluation of a provider's clinical competence by someone) prior to performing procedures independently, and the hospital did not have a process in place to track compliance with the proctoring requirements.

This failure resulted in AHPs performing procedures for which they did not have validated current competency, and had the potential to cause patient harm.

Because of the potential for serious harm to patients who received care from an Allied Health Professional (AHP - Nurse Practitioner (NP), Physician Assistant (PA), or Certified Registered Nurse Anesthetist (CRNA- a registered nurse trained to provide anesthesia [medical intervention that prevents patients from feeling pain during procedure and surgery]) who were not tracked and monitored for required proctoring by medical staff office and may not have been qualified to perform services to patients and because CRNA 1, CRNA 2, CRNA 3, CRNA 4, PA 1 and NP 1 performed services on patients without first providing proof of concurrent proctoring to ensure qualified and met privileging requirements, an Immediate Jeopardy (IJ a situation in which the provider's noncompliance with one or more conditions of participation has caused or is likely to cause serious injury, harm, impairment, or death to a patient) situation was called for A339 42 CFR 482.22(a) on 7/31/24 at 11:25 a.m. with the Chief Medical Officer (CMO), Chief Nursing Officer (CNO), President and Market Leader (PML), Director of Clinical Quality Improvement (DQ), and the Manager of Quality Improvement (QIM). The IJ (immediate Jeopardy) template was provided to the facility. The hospital submitted an IJ Plan of Removal (Version One) on 7/31/24 at 2:51 p.m. and it was not accepted. The hospital submitted an IJ Plan of Removal (Version Two) on 8/1/24 at 8:14 a.m. and it was not accepted. The hospital submitted an IJ Plan of Removal (Version Three) on 8/1/24 at 1:32 p.m. and it was not accepted. The hospital submitted an IJ Plan of Removal (Version Four) on 8/1/24 at 3:54 p.m. it was reviewed and accepted at 4:57 p.m. with the DQ. On 8/1/24 and 8/2/24 the survey team validated that staff were able to look up AHPs to see what privileges they had and see if concurrent proctoring was still needed, observations done in surgical department to confirm concurrent proctoring was being done, and education as to why this was important was interviewed to. Review concurrent proctoring forms and surgery schedule for 8/1/24 and 8/2/24 there was overlap seen of the same proctor being used and the DQ, CMO and MSD confirmed the proctor was only in the room during the most important times and not the whole surgery. The DQ, CMO, and MSD confirmed this was the process being used and stated the Medical Staff Bylaws and policies were being updated and felt this was safe care their patients. They provided a written statement signed by the CMO and the President of Medical Staff (MSP) indicating above, and MSD stated she would add a statement at the bottom of the proctor forms that the proctor must check attesting that they were present during the most important times of the cases. On 8/2/24 at 3 p.m. while onsite the IJ was removed with CMO, DQ, QIM and MSD.

Findings:

During a record review on 7/23/24, the roster of the hospital's Medical Staff members (physicians) and AHP Staff members was reviewed, and a list of staff was selected and provided to the hospital in preparation for credential file review.

During an observation on 7/24/24 at 7:11 a.m., certified registered nurse anesthetist (CRNA) 1, assessed Patient (Pt) 17, discussed the anesthesia options with Pt 17 for her scheduled surgical procedure, and obtained Pt 17's signed consent.

During an observation on 7/24/24 from 7:37 a.m. until 8:43 a.m. in the outpatient surgical center operating room (OR) 1, CRNA 1 was the only anesthesia provider for Pt 17's entire surgery.

During a review of the Case Information (CI) record for Pt 17's surgery dated 7/24/24, the CI indicated that CRNA 1 was the Anesthesia Staff for Pt 17's surgery. There was no other anesthesia provider's name on the CI record. During a review of the Anesthesia Record (AR) for Pt 17's surgery dated 7/24/24, the AR indicated the Responsible (anesthesia) Provider was CRNA 1, and the type of anesthesia was general (when medications are administered to render the patient unconscious).

During an interview on 7/24/24 at 10:55 a.m. with the Manager of Surgical Services (MG) 1, MG 1 stated the surgery schedulers have to verify the doctor's privileges. MG 1 stated the practice coordinators can look up privileges if there is a question about the doctor's privileges, but the schedulers are the ones that look the privileges up when they schedule the surgeries.

During an interview on 7/24/24 at 11:25 a.m. with the Lead Surgery Scheduler (SS), the SS stated the issue of proctoring is between the surgeons and medical staff office (MSO). The SS stated surgery scheduling does not deal with or monitor proctoring, MSO handles it and would let surgery scheduling know.

During an observation on 7/25/24 at 9:34 a.m. in OR 4, CRNA 2 (a CRNA) assisted Pt 16 onto the OR table and initiated Pt 16's anesthesia. CRNA 2 was the only anesthesia provider for Pt 16's entire surgery.

During a review of the Case Information (CI) record for Pt 16's surgery dated 7/25/24, the CI indicated that CRNA 2 was the Anesthesia Staff for Pt 16's surgery. There was no other anesthesia provider's name on the CI record. During a review of the Anesthesia Record (AR) for Pt 16's surgery dated 7/25/24, the AR indicated the Responsible (anesthesia) Provider was CRNA 2, and the anesthesia type was spinal (a local anesthetic is placed directly in the intrathecal space in the lumbar spine. Used for procedures involving the lower abdomen, pelvis, and lower extremities).

During a concurrent interview and record review on 7/25/24 at 1:45 p.m. with the Director of Medical Staff Services (DMSS), CRNA 1's credential file was reviewed. The DMSS stated the AHPs are not members of the medical staff but the medical staff process for credentialing, privileging, proctoring, appointment, and reappointment is followed for the AHPs as indicated in the medical staff bylaws, policies and procedures, and rules and regulations. Review of CRNA 1's credential file indicated CRNA 1 was a CRNA who completed his initial AHP staff application on 1/10/23 and was appointed to the Provisional (temporary) AHP staff on 6/1/23. The DMSS stated prior to the appointment date, CRNA 1 was granted temporary clinical privileges from 4/10/23 to 5/31/23 due to the meeting schedule of the Board of Trustees, who have the final approval for appointments of the AHP staff and the Medical Staff. The DMSS stated all initial appointments to the AHP staff are Provisional, and the provisional AHP appointment lasts a minimum of six months, and no longer than two years. A review of CRNA 1's "CRNA Privilege Form" completed with his initial appointment to the AHP Staff, indicated CRNA 1 requested and was granted CRNA Core Privileges which included Pre-anesthesia Evaluation and Anesthesia Care Plan, Intraoperative Care, and Post-operative Care. The privilege form indicated for the initial appointment there was a requirement for proctoring (the process of observation, by a proctor [an AHP or physician with privileges at least equivalent to the privileges granted to the person to be proctored] in order to evaluate the AHP's proficiency in the exercise of the clinical privileges initially granted). The privilege form indicated the first four cases performed by CRNA 1 were to be concurrently proctored (proctoring that requires the proctor to be physically present during the care of a patient to observe the performance of the procedure by the AHP being proctored). The privilege form indicated after the four concurrently proctored cases were completed, there was a requirement for retrospective proctoring (review of the medical record following a procedure or period of patient care to assess the quality of performance and documentation). The DMSS stated both concurrent and retrospective proctoring require the proctor to complete a written report evaluating the performance of the person being proctored and to turn that evaluation in to the MSO. The forms completed during the proctoring of CRNA 1 were requested. The DMSS stated no completed proctor forms were submitted to the medical staff office for CRNA 1. The DMSS stated that despite the medical staff office not having evidence that required proctoring was completed, CRNA 1 did not have any privilege restrictions. The DMSS stated she did not know how many cases CRNA 1 had performed independently. The DMSS stated the MSO had not been able to follow up on the proctoring status of the AHPs. The DMSS stated the hospital's credentialing database (MSOW) has a place to indicate the proctoring requirements for each AHP and their progress towards completion of proctoring, however that information had not been obtained and entered into MSOW yet, so it was not available to anyone wanting to access this information.

During a concurrent interview and record review on 7/25/24 at 3:15 p.m. with the DMSS, Physician Assistant (PA) 1's credential file was reviewed. PA 1 was a Physician Assistant (PA) in the Emergency Department (ED) who was initially appointed to the Provisional AHP Staff on 2/1/22 and was reappointed as regular AHP Staff on 2/1/24. Review of the privilege request form completed for PA 1's reappointment, indicated PA 1 requested and was granted procedural privileges to perform thoracentesis (a needle or tube is inserted to remove fluid from around the lung; the needle/tube is removed after the procedure), chest tube insertion (a tube is inserted into the area between the chest wall and the lungs to drain air, blood, bile, pus, or other fluids, and left in place), paracentesis (a procedure to remove fluid from the peritoneal cavity [the space within the abdomen that contains the intestines, the stomach, and the liver]), lumbar puncture (a procedure to obtain and sample cerebrospinal fluid from the spinal cord in the lumbar spine), and central line placement (insertion of a catheter into a large [central] vein in the neck, upper chest or groin). The DMSS stated six proctored cases were required for each of these non-core privileges. The record of proctored cases was requested. The DMSS stated she does not have any information about how many cases, if any, had been proctored for each of the privileges. The DMSS stated PA 1 did not have any restrictions on her privileges and the information regarding the proctoring requirements and status of completion had not yet been entered into MSOW.

During a concurrent interview and record review on 7/25/24 at 3:25 p.m. with the DMSS, NP 1's credential file was reviewed. The file indicated NP 1 was a Nurse Practitioner in Cardiovascular Surgery who was initially appointed to the provisional AHP staff in 2021 and was reappointed to the regular AHP Staff on 6/1/23. Review of NP 1's privileges indicated NP 1 had RN First Assistant (RNFA) privileges for surgery, NP core privileges and procedural privileges, and also cardiology/vascular surgery non-core privileges. NP 1 had no restrictions on her privileges. Review of the privilege information in MSOW confirmed NP 1 had the same privileges as what was reflected on the paper privilege form in the credential file. MSOW did not have any proctoring information. The DMSS provided evidence that the proctoring requirements for the RNFA privileges had been completed. The proctoring requirements for the core privilege "Discharge Patients" required review of the first three cases discharged, with completion of a written evaluation. The DMSS stated she did not have any proctor forms, evaluations, or other evidence to indicate this requirement had been completed. For the NP procedural privileges which included paracentesis, thoracentesis, central line placement, chest tube insertion, lumbar puncture, and removal of a tunneled catheter (a central venous catheter that is tunneled through a space under the skin and has both and entry and an exit site which provide stability to allow long term use), the proctoring requirements were six cases for each procedure, except for lumbar puncture which required five proctored cases. The DMSS stated she did not have any proctor forms for any of these procedures. The non-core NP privileges for cardiology and vascular surgery included chest tube removal, removal of temporary pacing wires (inserted during cardiac surgery and left in place for the post operative period in case the patient develops an abnormal heart rhythm), endoscopic vein harvest (EVH-a procedure to remove a vein in the leg for use in coronary artery bypass graft [CABG] surgery), radial artery (RA) harvest (a procedure to remove a blood vessel [RA] in the arm for use in CABG surgery) and percutaneous removal of an intra-aortic balloon pump (IABP- a device placed in the aorta [large artery that carries blood away from the heart to the rest of the body] in order to help the heart pump blood). The DMSS provided NP 1's proctor forms for removal of chest tubes and removal of temporary pacing wires. The DMSS stated did not have any evidence of proctored cases for percutaneous removal of an IABP which required two proctored cases, the EVH procedure which required three proctored cases, or the RA harvesting procedure which required three proctored cases. The DMSS stated she does not have any information regarding the status of NP 1's proctoring for these procedures, and does not know how many of these procedures NP 1 had performed.

During a concurrent interview and record review on 7/29/24 at 10:40 a.m. with the DMSS, CRNA 2's credential file was reviewed. The credential file indicated CRNA 2 was a CRNA who was given temporary privileges on 6/10/24 and was appointed to the Provisional AHP staff on 7/1/24. A review of CRNA 2's "CRNA Privilege Form" completed with his appointment to the AHP Staff, indicated CRNA 2 requested and was granted CRNA Core Privileges which included Pre-anesthesia Evaluation and Anesthesia Care Plan, Intraoperative Care, and Post-operative Care. There were no restrictions on CRNA 2's privileges. The privilege form indicated for the initial appointment there was a requirement for concurrent proctoring of the first four cases performed by CRNA 2, followed by retrospective proctoring of four additional cases. The DMSS provided evidence of one concurrently proctored case which was completed on 7/11/24. The DMSS stated CRNA 2 was being proctored on the other three required cases on 7/29/24. The DMSS stated she does not know how many cases CRNA 2 had performed without a proctor.

During a review of the Surgery Log (A list of all surgeries and procedures done in the hospital and outpatient center, along with the names of the surgeons and anesthesia providers responsible for each case) for 6/1/24 through 7/31/24, the log indicated CRNA 2 was the anesthesia provider for eighteen cases from 7/10/24-7/28/24 (does not include the proctored case on 7/11/24), prior to completing all of the required concurrent proctored cases.

During a concurrent interview and record review on 7/29/24 at 11:25 a.m., with the DMSS, the DMSS provided an update on the proctoring status of CRNA 1. The DMSS stated she had contacted the anesthesia medical director (AMD) on 7/25/24, and on 7/26/24 the AMD provided four completed concurrent proctor forms dated 1/3/24, 1/15/24, and two dated 1/26/24 and four retrospective proctor forms. The DMSS stated the forms were not provided in a timely manner to the MSO, and the MSO did not have a system in place to follow up on the AHP staff's outstanding proctoring requirements.

During a concurrent interview and record review on 7/29/24 at 11:50 a.m., with the DMSS, the DMSS stated the AMD had been following up on the proctoring status of all of the provisional CRNAs and had submitted some completed proctor forms to the MSO. The status of CRNA 3 and CRNA 4 proctoring was reviewed. The DMSS stated CRNA 3 was granted temporary privileges on 4/10/23 and was appointed to the provisional AHP staff on 6/1/23, and CRNA 4 was granted temporary privileges on 4/8/24 and was appointed to the provisional AHP staff on 5/1/24. The DMSS stated the AMD had provided the proctor forms for CRNA 3 and CRNA 4 the morning of 7/29/24. A review of the proctor forms indicated the forms were not completed properly and were missing the AHP's full name, the date of the procedure and the type of proctoring (retrospective or concurrent). The DMSS confirmed these forms would not be accepted and they would be sent back to the AMD. There was no record of other proctored cases for CRNA 3 or CRNA 4.

During an interview on 7/29/24 at 1:40 p.m. with the DMSS, the DMSS provided an update on the proctoring status of PA 1 and NP 1. The DMSS stated the medical director of the ED (EDMD) was contacted about PA 1 and the need for documentation of the cases that were proctored for PA 1. The DMSS stated that a new proctoring plan for PA 1 was put in place for each of the five procedures until there is validation that proctoring requirements have been completed. The DMSS stated after the review of NP 1's file on 7/25/24, the DMSS contacted NP 1 by email about her privileges and required proctoring. The DMSS stated NP 1 indicated she does not perform thoracentesis, paracentesis, central line placement, removal of a tunneled catheter, or radial artery harvesting and withdrew her request for those privileges. The DMSS stated NP 1 was put back on proctoring for review of three discharges, and for concurrent proctoring of three cases of endoscopic vein harvest, and two cases of IABP removal. The DMSS stated at the time of appointment, all members of the AHP staff and the medical staff are made aware of the requirements for proctoring. The DMSS stated the proctoring policies had not been followed.

During an interview on 7/30/24 at 4:55 p.m. with the Director of Quality (DQ), an updated list of all of the AHPs and the status of their proctoring was requested. The DQ stated this would take time because it is a manual process to get this information.

During an interview on 7/30/24 at 5 p.m. with the DMSS, the DMSS stated it would not be possible at this time to assess and report the proctoring status of all of the provisional AHPs because that information has not been entered into MSOW so each AHPs file would have to be reviewed for the proctor forms. The DMSS stated the MSO staff is focusing on updating MSOW with the current proctoring status of the provisional CRNAs first, and then will work on the NPs and PAs. The DMSS stated that currently there were approximately forty provisional members of the AHP staff require follow up to determine what proctoring has been done, what forms have been turned in, and what still needed to be completed. The proctoring requirements for each AHP and their progress towards completion had to be updated in MSOW so the information could be available to the staff in the hospital.

During a record review on 7/30/24, the "Anesthesia Daily Schedule-Next Day" was reviewed. The schedule indicated CRNA 5 was scheduled to be proctored for four cases on 7/31/24. Review of the CRNA roster indicated CRNA 5 was granted temporary privileges on 7/8/24 and had not completed any concurrently proctored cases. During a review of the Surgery Log for 7/2024, the log indicated CRNA 5 was the anesthesia provider for twenty cases prior to being scheduled for the four required concurrently proctored cases on 7/31/24.

During a record review on 7/30/24, the "Anesthesia Daily Schedule-Next Day" was reviewed. The schedule indicated CRNA 6 was scheduled to be proctored for three cases on 7/31/24. Review of the CRNA roster indicated CRNA 6 was granted temporary privileges on 4/10/23, was appointed to the provisional AHP staff on 6/1/23, and had not completed any concurrently proctored cases. During a review of the Surgery Log for 6/1/24-7/30/24, the log indicated CRNA 6 was the anesthesia provider for thirty cases prior to being scheduled for any concurrently proctored cases.

During a record review on 7/31/24, the CRNA roster was reviewed. The roster indicated CRNA 7 was granted temporary privileges on 4/8/24, was appointed to the provisional AHP staff on 5/1/24, and had not completed any proctored cases. During a review of the Surgery Log for 6/1/24-7/31/24, the log indicated CRNA 7 was the anesthesia provider for sixteen cases.

During a record review on 7/31/24, the CRNA roster was reviewed. The roster indicated CRNA 8 was appointed to the provisional AHP staff on 10/1/23, and had completed two of the four required concurrently proctored cases, no date of completion recorded on the roster. During a review of the Surgery Log for 6/1/24-7/31/24, the log indicated CRNA 8 was the anesthesia provider for forty-four cases in those two months without having first completed the required concurrently proctored cases.

During a record review on 8/1/24, the CRNA roster was reviewed. The roster indicated CRNA 9 was granted temporary privileges on 3/4/24, was appointed to the provisional AHP staff on 4/1/24, completed the required concurrently proctored cases on 7/30/24 and the proctor forms were turned into the MSO on 7/30/24. During a review of the Surgery Log for 6/1/24-7/31/24, the log indicated CRNA 9 was the anesthesia provider for ninety-six cases in those two months without having first completed the required concurrently proctored cases.

During a record review on 8/1/24, the CRNA roster was reviewed. The roster indicated CRNA 10 was granted temporary privileges on 6/10/24, completed the required concurrently proctored cases on 7/31/24, and the proctor forms were turned into the MSO on 7/31/24. During a review of the Surgery Log for 6/1/24-7/31/24, the log indicated CRNA 10 was the anesthesia provider for seventeen cases without having first completed the required concurrently proctored cases.

During a record review on 8/1/24, the CRNA roster was reviewed. The roster indicated CRNA 11 was granted temporary privileges on 6/10/24, completed the required concurrently proctored cases on 7/29/24 and the proctor forms were turned into the MSO on 7/30/24. During a review of the Surgery Log for 6/1/24-7/31/24, the log indicated CRNA 11 was the anesthesia provider for forty-five cases without having first completed the required concurrently proctored cases.

During a record review on 8/1/24, the CRNA roster was reviewed. The roster indicated CRNA 12 was appointed to the provisional AHP staff on 6/1/23, completed the required concurrently proctored cases on 7/30/24 and the proctor forms were turned into the MSO on 7/30/24. During a review of the Surgery Log for 6/1/24-7/31/24, the log indicated CRNA 12 was the anesthesia provider for twenty-eight cases in those two months without having first completed the required concurrently proctored cases.

During a record review on 8/1/24, the CRNA roster was reviewed. The roster indicated CRNA 13 was granted temporary privileges on 3/4/24, was appointed to the provisional AHP staff on 4/1/24, and completed three of the four required concurrently proctored cases, no date of completion recorded on roster or date the proctor forms were turned into the MSO. During a review of the Surgery Log for 6/1/24-7/31/24, the log indicated CRNA 13 was the anesthesia provider for fifty-four cases in those two months without having first completed the required concurrently proctored cases.

During a record review on 8/1/24, the CRNA roster was reviewed. The roster indicated CRNA 14 was granted temporary privileges on 6/3/24, was appointed to the provisional AHP staff on 7/1/24, completed the required concurrently proctored cases on 7/29/24, and the proctor forms were turned into the MSO on 7/30/24. During a review of the Surgery Log for 6/1/24-7/31/24, the log indicated CRNA 14 was the anesthesia provider for one hundred five cases without having first completed the required concurrently proctored cases.

During a concurrent interview and record review on 8/2/24 at 12:30 p.m. with the DMSS, an updated provisional AHP roster was reviewed. The AHP roster was divided into CRNAs, PAs and NPs. The CRNA roster indicated there were twenty-four provisional CRNAs. The DMSS stated four of the CRNAs were placed on a leave of absence on 7/25/24 because they had not worked since being appointed to the provisional AHP staff. The roster indicated there were fourteen CRNAs who had completed the required proctored cases and six others who were in the process of completing proctoring. The DMSS stated over the previous couple of days the MSO staff had inputted the proctoring requirements for each AHP with provisional privileges into MSOW so staff will now be able to look up the AHPs to verify privileges and whether proctoring has been completed. Review of the PA and NP rosters indicated there were twelve provisional PAs and thirty-two provisional NPs. The PAs and NP roster spreadsheets did not contain the information regarding how many concurrent or retrospective proctored cases were completed, or when they were completed, or how many were still needed like the CRNA roster did. The DMSS stated the roster spreadsheet was created manually and the details were populated for the CRNAs by the MSO staff. The DMSS stated although the information regarding the proctoring is not on the spreadsheet for the PAs and NPs, the information about whether or not a PA or NP required concurrent proctoring has been entered into the MSOW database for staff to look up. MSOW was accessed to look up three PAs and three NPs off of the roster to validate the information regarding concurrent proctoring status was there.

During a review of the policy and procedure (P&P) titled, "Proctoring/Observation Requirements for Medical Staff Members," dated 7/28/17, the P&P stated, " ...each Provisional Staff member shall undergo a period of observation by designated monitors ...The observation shall be to evaluate the Member's proficiency in the exercise of clinical privileges initially granted and over-all eligibility to continued Staff membership and advancement within staff categories ...Definitions: Proctoring- The process of observation by a monitor/proctor, for the purpose of evaluation and appraisal of skills, performance, judgment and behavior of a practitioner ...Concurrent Proctoring- proctoring which requires the monitor to be physically present during the care of a patient undergoing a procedure for observation of performance [Same as direct observation and supervised privileges] ...Proctoring should include the complete management of the patient ...A written proctoring form will be completed by the proctor and returned to the Medical Staff Office no later than one week of direct observation of the procedure ...A report of proctoring progress shall be reported to the Medical Executive Committee and the Board of Trustees on a monthly basis ..."

During a review of the P&P titled, "Surgery Proctoring," dated 4/9/19, the P&P indicated, " ...All members, either provisional or active, who need to be proctored will assure that a proctor is aware of cases to be proctored. To facilitate the process, the medical staff office will notify the surgery scheduling staff of the need for that member to be proctored and who the assigned proctor will be. If and when the member falls below the threshold to fulfill the required number of minimum cases to be proctored, the department chairman will be notified who in turn, will contact the member. The member will not be allowed to continue to perform these procedures until the proctoring requirement is fulfilled. Proctoring will include evaluation of the preop, intraop, and postop management ..."

During a review of the hospital document titled, "Bylaws of the Medical Staff," dated 7/27/18, the document indicated, " ...General Policies applicable to Allied Health Professionals- No person shall be entitled to perform services solely because he or she holds a certain degree, is licensed to practice in this or any other state, is a member of any professional organization, is certified by any clinical board, or because such person had, or presently has, been able to perform services at another health care facility ...The AHP shall sign an agreement to abide by the Hospital and Medical Staff Policies/Procedures and the Bylaws of the Medical Staff ..."

During a review of the hospital's "Allied Health Professional Policy/Procedure Manual," dated 5/23, the manual indicated, " ...Requirements for Service Authorization and Criteria For Approval of Certified Registered Nurse Anesthetist [CRNA]-Proctoring of CRNAs: The applicant will be monitored for a minimum of four concurrent and four retrospective cases. The applicant will be given six months of provisional privileges to complete the monitoring process, following which a recommendation will be made to the appropriate committee to continue or discontinue monitoring ..."

During a review of the hospital's "Allied Health Professional Policy/Procedure Manual," dated 5/23, the manual indicated, " ...Duties of the Allied Health Professional- Upon appointment, each AHP shall be expected to: ...Comply with all Medical Staff and Hospital Bylaws, Rules and Regulations, and the Allied Health Professional Policies and Procedures ..."

Based on interviews and record review, the hospital failed to have a well-organized and effective nursing service when:

1. Licensed nurses did not have blood glucose (sugar in the blood) monitoring completed for one of one patient (Pt 22) according to the hospital's policy and procedure (P&P) titled, "Hyperglycemia/Hypoglycemia Treatment." (Refer to A398 finding 1).

2. Licensed nurses did not have baseline vital signs (blood pressure, heart rate/rhythm, respiratory rate, oxygen saturation) and pain assessment completed prior to a procedure for one of four patient (Pt 23) according to the hospital's P&P titled, "Sedation/Analgesia, Moderate." (Refer to A398 finding 2).

3. Licensed nurses did not provide one of two patient (Pt 23) discharge instructions in Spanish according to the hospital's P&P titled, "Discharge Planning." (Refer to A398 finding 3).

4. Licensed nurses did not complete an assessment in the initial recovery period for two of four patients (Pt 24 and Pt 25) according to the hospital's P&P titled, "Documentation, Endoscopy." (Refer to A398 finding 4).

5. Licensed nurses did not assess and document wound incision assessments when transferred to postpartum (mother-baby unit) for two of two patients (Pt 27 and Pt 28) per the hospital's P&P titled, "Postpartum Care." (Refer to A398 finding 5).

6. Licensed nurses failed to use an interpreter when signing a consent form for a cesarean section for one of one patient (Pt 27) according to the hospital's P&P titled, "Informed Consent/Consent Forms." (Refer to A398 finding 6).

7. Licensed nurses failed to follow their P&P to reduce the risk of skin breakdown when Pt 18 did not have a documented pressure relieving interventions every two hours on multiple shifts between 5/30/24 to 6/10/24 for the left heel in accordance with the facility policy. (Refer to A398 finding 7).

The cumulative effect of these deficient practices resulted in the facility's inability to provide care in a safe and effective manner.

Based on observation, interview, and record review, the hospital failed to ensure nursing staff followed hospital policies and procedures (P&P) when:

1.The "Medication Reconciliation", "Documentation", and "Emergency Department Arrival (Triage), Documentation, and Discharge," was not followed for Pt 1.

These failures resulted in medication reconciliation (The process of identifying the most accurate list of all medications that a patient is taking and comparing that list against a physician's admission, transfer, and/or discharge orders to avoid medication errors) not being performed properly and had the potential to cause harm to all patients. The failure to perform medication reconciliation for Pt 1 resulted in Pt 1 not receiving medication needed to control atrial fibrillation (AFib- an arrhythmia that occurs when the upper chambers of the heart [atria] beat irregularly and fast), which led to Pt 1 having AFib with rapid ventricular response (RVR- occurs when the rapid contractions of the atria cause the ventricles [the lower chambers of the heart] beat too fast) which led to Pt 1's transfer to a higher level of care, prolonged her hospital stay and placed her at increased risk for stroke.

2.Hospital nursing staff failed to follow their policies and procedures to reduce the risk of skin breakdown when Patient (Pt) 18 did not have a documented pressure relieving interventions every two hours on multiple shifts between 5/30/24 to 6/10/24 for the left heel in accordance with the facility policy.

These failures resulted in the worsening of left heel discoloration to unstageable (full thickness tissue loss in which the base of the ulcer is covered by slough [yellow, tan, gray, green, or brown]) pressure injury on the left heal and the potential delayed nursing care for the pressure injury.

3. One of one patient (Pt 22) did not have blood glucose (sugar in the blood) monitoring completed according to the hospital's P&P titled, "Hyperglycemia/Hypoglycemia Treatment."

This failure had the potential for Pt 22 to have continued low blood glucose levels and a decline in health status.

4. One of four patient (Pt 23) did not have baseline vital signs (blood pressure, heart rate/rhythm, respiratory rate, oxygen saturation) and pain assessment completed prior to a procedure according to the hospital's P&P titled, "Sedation/Analgesia, Moderate."

This failure had the potential to miss a change of condition for Pt 23.

5. One of two patient (Pt 23) did not receive discharge instructions in Spanish according to the hospital's P&P titled, "Discharge Planning."

This failure had the potential for Pt 23 to not understand how to care for herself after her procedure.

6. Two of four patients (Pt 24 and Pt 25) did not have an assessment completed in the initial recovery period after their procedures were completed according to the hospital's P&P titled, "Documentation, Endoscopy."

This failure had the potential to miss a change of condition for Pt 24 and Pt 25.

7. Two of two patients (Pt 27 and Pt 28) did not have their wound incision assessed and documented when transferred to postpartum (mother-baby unit) per the hospital's P&P titled, "Postpartum Care."

This failure placed Pt 27 and Pt 28's wound incision at risk for infection, deterioration, and/or wound separation.

8. One of one patient (Pt 27) did not have an interpreter used when signing a consent form for a cesarean section according to the hospital's P&P titled, "Informed Consent/Consent Forms."

This failure had the potential for Pt 27 to not understand the procedure she was having.

Findings:

1. During a concurrent observation and interview on 7/22/24 at 11:10 a.m. in the Emergency Department (ED) with the Director of the ED (DED), the DED stated the ED has a pharmacy that is open daily for day shift and pm shift from 7 a.m. until 11 p.m. The DED stated there is a Medication Reconciliation Tech (MRT- a pharmacy employee) scheduled on the day shift and on the pm shift and they start the medication reconciliation (med rec) process for the admitted and observation patients in the ED who are waiting to be moved to a hospital room. The DED stated on night shift when there is not a MRT scheduled, the day shift MRT should follow up in the morning if the patient is still in the ED, if not the med rec process is started by the nursing staff on the unit where the patient was admitted. The DED stated the nursing staff in the ED can start the process by asking the patient or family about medications taken at home. The DED stated if a patient or family member brought in a list of the home medications the nursing staff should make a copy of it and put it in the patient's chart. The DED stated the process of the MRT completing the home medication (Prior to Admission [PTA]) list is for patients that have been admitted to the hospital but are in the ED.

During an interview on 7/23/24 at 9:38 a.m. with Pt 1's family member (FM)1, FM 1 stated Pt 1 was 90 years old and lived at home with her husband. FM 1 stated Pt 1 had a history of back pain, Pt 1 was taken to the ED by ambulance on 7/1/24. FM 1 stated Pt 1's medical history included hypertension, atrial fibrillation, and Pt 1 had a pacemaker (an implanted medical device used to control an irregular heart rhythm). FM 1 stated Pt 1 had to wait in a bed in the hallway until a pacemaker representative come to the hospital the morning of 7/2/24. FM 1 stated while Pt 1 was in the ED, she brought in a list of Pt 1's medications and attempted to give the list to the nurse so the medications could be reviewed and ordered. FM 1 stated she was told by the nurse that they (the ED nurses) "don't do that [medication reconciliation]" and that "it will be done on the unit [inpatient floor in hospital], or pharmacy does it." FM 1 stated the nurses would not take the list of medications from her to put in Pt 1's chart. FM 1 stated after Pt 1 was moved to the inpatient bed on the third floor, FM 1 brought Pt 1's medication list, reviewed it and gave a copy of the list to Pt 1's nurse. FM 1 stated she did not find out until the late afternoon on 7/5/24 that the list of medications were never entered into Pt 1's record. FM1 stated Pt 1 did not receive her twice daily medication dronedarone(an antiarrhythmic medication used to treat atrial fibrillation and atrial flutter) for four days. FM 1 stated by that time Pt 1 was in A-fib with rapid ventricular response (RVR- occurs when the rapid contractions of the atria cause the ventricles [the lower chambers of the heart] beat too fast) a rapid response team (RRT- a group of healthcare professionals who are called upon to quickly respond to a patient's sudden decline in health or emergency situation) was called, and Pt 1 was transferred to the telemetry unit (unit in the hospital where patients undergo continuous cardiac monitoring). FM 1 stated no one gave her an explanation as to why the medications were not reconciled after she had provided a list of the medications to the nurse. FM 1 stated Pt 1 had to stay for several more days in the hospital.FM 1 stated she had serious concerns about the safety of patients at the hospital, and was surprised no one from the hospital ever contacted her after Pt 1's discharge to discuss what happened or to check on Pt 1's condition.


During a review of Pt 1's medical record, the ED Provider Note dated 7/1/24 at 8:40 p.m., indicated Pt 1 was a 90 year old woman with a history of chronic back pain, hypertension, cardiac surgery, and permanent pacemaker placement, who came to the ED by ambulance on 7/1/24 at 8:40 p.m. with complaints of lower back pain for the past three days. A review of the ED Patient Care Timeline dated 7/1/24 at 8:40 p.m. to 7/2/24 at 5:39 p.m., indicated Pt 1 was alert and oriented with a Glasgow Coma Scale (GCS- a system to assess a person's level of consciousness; scored from 3-15 with 15 being fully awake, responsive, and having no problems with thinking ability or memory) score of 15. The Timeline indicated Pt 1 had been scheduled for an outpatient Magnetic Resonance Imaging scan (MRI- uses a magnetic field and radio waves to create detailed images of organs and tissues in the body) but the MRI had not been done yet because Pt 1 has a pacemaker (an implanted medical device used to control an irregular heart rhythm. The pacemaker needs to be checked before an MRI to verify it is MRI compatible). The Timeline indicated the representative from the pacemaker supplier would evaluate Pt 1's pacemaker on 7/2/24 at 8 a.m. The Timeline indicated Pt 1's pacemaker was determined to be compatible with the MRI, the scan was completed at 11:34 a.m. on 7/2/24 and the results indicated Pt 1 had a L3 compression fracture (a break or crack in a vertebra [the bones that make up the spine]; L 3 refers to the one of the five vertebra that make up the lumbar spine [lower back]). The ED Provider note indicated Pt 1 required hospital admission and would have a kyphoplasty (minimally invasive procedure to treat vertebral compression fractures; a balloon is first inserted into the fractured bone to create a cavity or space, then cement is injected into the cavity) on 7/3/24. The ED Provider note for Pt 1 indicated, "Home Medications: Reviewed, Per Nurses Notes," there were no ED nurses notes addressing home medications. Admission orders for Pt 1 were placed on 7/2/24 at 3:16 p.m. by MD 8 which included an order for "Pharmacy General Consult." Review of Pt 1's history and physical (H&P) note by MD 8 dated 7/2/24 at 3:10 p.m., the H&P indicated, " ...Past medical history [PMH] of A-fib on [brand name medication used to reduce the risk of stroke and blood clots in people who have atrial fibrillation], Sick Sinus Syndrome [SSS- a type of heart rhythm disorder which affects the heart's natural pacemaker] status post pacemaker, L 2 compression fracture status post kyphoplasty in 2017 ..." Pt 1 was transferred to the third floor (3 West) on 7/2/24 at 5:39 p.m. On 7/2/24 at 6:45 p.m. FM 1 brought Pt 1's home medication list in to the hospital and gave it to RN 5. RN 5 passed the list on to RN 6 to enter into the EHR. On 7/3/24 Pt 1 had a kyphoplasty for a spinal compression fracture. On 7/5/24 Pt 1 had an epidural injection for pain management and during the procedure she developed A-fib with RVR, a rapid response team was called, Pt 1 was given intravenous metropolol (medication used to treat high blood pressure) and was transferred to the telemetry unit.


During an interview on 7/23/24 at 12 p.m. with ED Registered Nurse (RN) 8, RN 8 stated she prioritizes obtaining a home medication history for patients who are in the ED with mental health (MH) conditions. RN 8 stated while other patients who have admission orders will have med rec completed once they get to their hospital room, patients with MH conditions requiring admission may need to stay in the ED for days. RN 8 stated if a patient or family brings in a list of home medications she would take a copy and put it in the patients chart.

During an interview on 7/23/24 at 12:20 p.m. with the MRT, the MRT described her role in the med rec process for ED patients with inpatient admission or observation orders. The MRT stated she reviews the physician's progress notes and the Medication Dispense History (a report in the patient's electronic health record [EHR] that shows a record of what medications were prescribed and filled at outside pharmacies) and speaks with the patient. The MRT stated she asks the patient to name as many of their home medications as possible and then she reviews the printout of all of the medications and asks when the patient last took each medication. The MRT stated this information is entered into the "prior to admission [PTA] medication" section of the admission tab in the EHR. The MRT stated if the patient is unable to provide information regarding their home medications, she calls the family and/or the outside pharmacy listed on the report in order to obtain information about the patient's home medications. The MRT stated it is very helpful when the patient or family member brings in a list of the medications the patient is taking. The MRT stated the RN admitting the patient on the admitted unit will still need to review the medication list within the PTA medication section. The MRT stated the most difficult part of her job is there is only one MRT on during the day and one on the pm shift, and there is no one on at night. The MRT stated when she starts her shift in the morning she has the patients in the ED with admit or observation orders from the previous night in addition to the new patients that come in during the day. The MRT stated she organizes her work to do the patients in the order of how long they have been in the ED, however she frequently gets requests to prioritize a patient, and is not always able to get to every patient because of the number of patients.

During a concurrent interview and record review on 7/23/24 at 2:30 p.m. with RN 5, Licensed Vocational Nurse (LVN) 1, and the nursing director for the medical floor (DON) 2, Pt 1's medical record for 7/2/24 was reviewed. RN 5 and LVN 1 were assigned to care for Pt 1 when she was admitted from the ED to the third floor on 7/2/24. RN 5 and LVN 1 both stated they did not remember any specific details about Pt 1 since it had been three weeks since she was admitted, but they had reviewed the record. RN 5 stated Pt 1 arrived to her room on the third floor around 5:45 p.m. and Pt 1's daughter came in after 6 p.m. with a list of all of Pt 1's home medications. RN 5 stated she took the list of medications but did not start the medication reconciliation process at that time because it was almost shift change and she was preparing for report to the oncoming shift. RN 5 stated during report she handed off the med list to the oncoming RN and let him know the med rec still needed to be done. RN 5 stated she did not know what happened to Pt 1's med list after that. RN 5 stated the admitting nurse's role in med rec is to obtain the information about the patient's home medications, the dose and when they were last taken and input the information into the PTA med list in the EHR. RN 5 stated if a patient does not know their medications, she could call the family. RN 5 stated after the PTA med list is completed there is a place to check that they are reviewed. RN 5 stated she thinks the med list then goes to pharmacy and then the physician to order. RN 5 stated she was not sure of the process to follow if there is another PTA med to add after the meds are reviewed. RN 5 stated if the admitting nurse does not get the med rec started they would pass that information on during report so the oncoming RN would know it still needs to be completed. RN 5 stated she is not aware of a way a nurse would be alerted that med rec had not been done. RN 5 stated she would have to "use her judgment" if patient with a long medical history did not have any home medications noted in the medical record. RN 5 stated she took care of Pt 1 on another day but does not recall an issue with med rec. Review of the EHR "secure chat" messages for 7/2/24 on admission indicated at 6:42 p.m. the admitting physician (MD 8) sent a chat message, "[Please] reconcile her home meds so that I can resume them." RN 5 sent a reply at 6:49 p.m., "Yes, patient's daughter just brought the med list, oncoming nurse will put the meds in." At 7 p.m., MD 8 sent a chat message, "Please reconcile the meds so I can start them." The message was read at 7:04 p.m.by RN 5 and LVN 1. At 7:53 p.m. MD 8 sent a chat message, "Hi I requested the home meds to be reconciled here to resume them since the morning, can you do it [please]?" The oncoming RN (RN 6) responded at 7:54 p.m., "The a.m. nurse notified me about it. I put the meds already." At 7:55 p.m. MD 8 sent a chat message, "I still don't see them from my end." RN 6 responded at 7:56 p.m., "Let me verify." There was no further documentation in the chat or the nurses notes by RN 6 regarding Pt 1's medication list. The DON 2 stated RN 6 is a traveler nurse. DON 2 stated she does not have any information about what happened to the medication list or why RN 6 did not enter the medications because his communication in secure chat with MD 8 ended. DON 2 stated she would follow up with RN 6 to find out what happened. The DON 2 stated she did not know why Pt 1's nurses on 7/2, 7/3, 7/4 or 7/5 did not follow up on Pt 1's home medications.

During a review of Pt 1's medical record, the physician progress notes completed by MD 7 on 7/3/24, 7/4/24, 7/5/24, and 7/6/24 were reviewed. The progress notes indicated under the "Plan section" of the progress notes for 7/3/24 and 7/4/24, " ...[History] of Afib- No med rec available unfortunately; unclear why it has not yet been done ..." Review of MD 7's progress note for 7/5/24, indicated, " ...A fib RVR-unfortunately med rec not done despite family providing home med list ..."

During an interview on 7/24/24 at 10:20 a.m. with DON 2, DON 2 stated she had spoken with RN 6 about Pt 1's medication list, and RN 6's secure chat messages with MD 8. DON 2 stated RN 6 indicated on the night of 7/2/24, RN 6 was distracted and forgot to follow up on MD 8's question about Pt 1's home medications.

During an interview on 7/24/24 at 12:45 p.m. with RN 7, RN 7 stated she was the RN assigned to Pt 2 on 7/8/24. RN 7 stated Pt 2 was being discharged and part of the discharge process involved printing the after visit summary (AVS- a document which summarizes the patient's hospital stay, includes a list of the patient's medications, and identifies any medication changes, diet and activity instructions, follow up appointments, and information about the patient's medical conditions and discharge diagnosis). RN 7 stated the AVS cannot be printed unless the discharge medication reconciliation process has been completed. The AVS includes a list of all medications with the direction to start, continue, or stop and what time each of them should be taken next. RN 7 stated she did not notice a discrepancy between the indication for each medication and Pt 2's diagnoses or medical conditions. RN 7 stated she printed the AVS and reviewed it with Pt 2's daughter who was Pt 2's caregiver. RN 7 stated Pt 2's daughter told her that many of the medications on the AVS were not medications prescribed for Pt 2 before. RN 7 stated she reviewed each medication with Pt 2's daughter who indicated which meds Pt 2 was taking and which ones Pt 2 had not been taking. RN 7 stated on the printed AVS document she wrote an "X" next to each of the medications Pt 2 was not taking before giving the AVS document to Pt 2's daughter. RN 7 stated she sent a message through secure chat to the discharging physician (MD 6) informing him that there were medications on Pt 2's discharge medication list that Pt 2 does not take.

During a review of the secure chat messages in Pt 2's EHR dated 7/8/24, the EHR indicated a chat message was sent to MD 6 by RN 7 at 4:32 p.m. The message indicated, "Hi doctor I was going over the AVS with daughter, she said her mom (Pt 2) is not on any heart medications. She is saying she has never given her [apixaban], [atorvastatin], [dronedarone], Benazepril, Metoprolol. Would you happen to know if she should start taking these or should family follow up with PCP [primary care provider- patient's doctor]?" MD 6 responded in the chat at 4:36 p.m., "Follow with PCP. Those are her PCP meds on file."

During a review of Pt 2's "Reconciliation Audit" ( a report listing the med rec activity for each medication at admission and discharge) for 7/1/24-7/8/24, the audit indicated on 7/2/24 at 7:42 p.m., RN 6 entered five medications in the prior to admission (PTA) meds list (home medications) for Pt 2, and indicated the last dose taken had been on 7/1/24. The audit indicated MD 6 had completed the discharge reconciliation which included five of the medications to "Resume at Discharge." The medications were [apixaban (to reduce the risk of stroke and blood clots in people who have atrial fibrillation)], [atorvastatin (a medication used to treat high cholesterol)], metoprolol ( a medication designed to slow down the heart rate in individuals with A-fib), [dronedarone (a medication to help control irregular heart rhythm in patients with AFib] , and [Benazepril (treats high blood pressure]. A review of Pt 2's record indicated Pt 2 did not have A-fib, or hypertension and had not been prescribed these medications before.

During a review of the printed AVS with the discharge medication list, provided by RN 7 to Pt 2's daughter on 7/8/24, the discharge medication list had an "X" written (by RN 7) next to five of the eight medications ordered at discharge to indicate that Pt 2 does not take these medications. A review of Pt 2's home medication list entered into the EHR on 7/2/24, the home medication list included the same five medications Pt 2's daughter indicated Pt 2 did not take. The two lists were contradictory and indicated the medication were not reconciled correctly.

During a record review on 7/24/24 at 4 p.m., the hospital's EHR report of compliance with Admission Medication Reconciliation for 1/1/24 through 7/24/24 was reviewed. The report contained a list of twenty-six patient care areas in the hospital with a month by month percentage of compliance for each area. The report did not give an overall combined compliance rate each month for all areas, but listed the individual months for each area separately. The report indicated for nearly all of the areas, the monthly compliance rate for completion of the admission medication reconciliation (within 24 hours after admission) was between 0% and 50%. The report indicated for 3W (where Pt 1 and Pt 2 were admitted) Station 1, the percentage compliance with admission med rec for January and February 2024 was 0%, March 40%, April 33.3%, May 33.3%, June 33.3%, and for the 3W Station 2, the report indicated January 2024 100%, February 2024 50%, March 40%, April 50%, May 25%, and June 50%.

During a record review on 7/25/24 at 11:08 a.m. with the Medication Safety Coordinator (MSP), the MSP stated he was made aware about the report of the compliance rate for admission med rec completion for each area. The MSP stated he did not monitor or review the medication reconciliation compliance in any area of the hospital and did not have reports generated with this information. The MSP stated med rec was not part of the hospital's Medication Error Reduction Plan (MERP). The MSP stated he wrongly assumed the quality department was monitoring med rec data.

During a review of the hospital's Policy and Procedure (P&P) "Medication Reconciliation," dated 9/23, the P&P indicated, " ...The patient's medication record is assessed at all transition points including admission, transfer, and discharge. The patient's current home medications are accurately documented and reconciled to ensure continuity of care. Medication Reconciliation: The process of comparing the medication information the patient brought to the hospital with the medications ordered for the patient while in the hospital in order to identify discrepancies including but not limited to omissions, duplications, contraindications, unclear information and changes ...all patients with medication orders will have home medication history collected, documented, and reconciled ...The licensed nurse will be responsible for collecting the medications history. The pharmacist or Medication Reconciliation Pharmacy Technician stationed in the Emergency Department may assist in this process ...Medication history collection, documentation, and reconciliation will occur within 24 hours of admission ...The attending Licensed Independent Practitioner (LIP) will be responsible for performing admission medication reconciliation within twenty-four hours of admission and when a change in level of care occurs ...The discharging LIP will be responsible for performing discharge medication reconciliation ..."

During a review of the hospital's Policy and Procedure (P&P) "Documentation," dated 10/22, the P&P indicated, " ...The medical record is a complete and accurate record of each episode of care ...Admission: Medication history is completed within 24 hours of admission ..."

During a review of the hospital's P&P "Emergency Department Arrival (Triage), Documentation, and Discharge," dated 10/22, the P&P indicated, " ...Elements obtained during Secondary Assessment by RN/LVN to include patient screenings to be completed at bedside: A. Home Medications B. History ...Items that are part of the patient's medical record must be scanned into the computer, including but not limited to: Home Medication List ..."



49230


2. During a review of Patient (Pt )18's "History and Physical (H&P), dated 5/19/24, the H&P indicated, Pt 18 was a 59 year old female with history of Parkinson's (a progressive disorder that affects the nervous system - brain and spinal cord and the parts of the body controlled by the nerves, affects movement, often including tremors) not on medications, hypertension (high blood pressure), suicide attempt, insulin-dependent diabetes mellitus type2 (is a condition that happens because of a problem in the way the body regulates and uses sugar and requiring insulin), peripheral neuropathy (Weakness, numbness, and pain from nerve damage, usually in the hands and feet) and schizophrenia (is a serious mental health condition that affects how people think, feel and behave) who was brought into the ED by ambulance after ground-level fall. Pt 18 denied having loss of consciousness or having significant head trauma. Pt stated history of multiple ground level falls. H&P indicated in ED pt was noted to have right heel decubitus ulcer containing maggots.

During a review of Pt 18's "nurses note" dated 5/30/24 at 11:00 a.m., the "nurses note" indicated, "During the patient assessment I found patient's left heel to be purplish in color. I readjusted immobilizer (immobilize a body part using a splint, straps or cast to eliminate motion) on patients' leg, to prevent friction to heel, added abd [a sterile, all-purpose bandage and wound cleaning pad] cushion between skin and immobilizer and floated the patient's heel. At [5:00 p.m.] I reassessed patients' left heel and found no improvement. I ordered a wound consult and replaced the immobilizer with a smaller immobilizer to prevent further skin breakdown."

During a review of Pt 18's "Wound Care Subsequent Consult" dated 5/31/24, the "Wound Care Subsequent Consult" indicated " ...Asked to see pt for left heel discoloration. I saw the pt a few days and she had deep purple trauma to the ankle from rubbing against knee immobilizer. She now has a 5x5 area of deep purple discoloration the heel along with scattered transversely liner purple streaks. The main area is over the heel and appears as pressure, however the brace may have precipitated the issue or exacerbated it. Skin intact, small brace in use, and offloading in place. Discussed with pt and [physician name] ..."

During a review of Pt 18's "Wound Care Subsequent Consult" dated 6/10/24, the "Wound Care Subsequent Consult" indicated, " ...In to re-assess left heel and anterior foot wounds ...The left heel has progressed as expected to an unstageable ulcer (Full thickness tissue loss in which actual. depth of the ulcer is completely obscured by slough (yellow, tan, gray, green, or brown) and/or eschar (tan, brown, or black) in the wound bed) as evidenced by slough at wound base. Site cleaned with [normal saline] and [brand name] gel to wound bed followed by bordered foam to help with debridement as well as moist wound healing. Offloading with pillow ...Dr. Reyes notified ..."

During a review of Pt 18's "Wound Care Subsequent Consult" dated 6/25/24, the "Wound Care Subsequent Consult," indicated, " ...Removed dressing from left posterior heel that continues to be an Unstageable ..."

During a review of Pt 18's "Wound Care Subsequent Consult" dated 7/23/24, the "Wound Care Subsequent Consult," indicated, " ...In to re-assess left heel ulcer which is now resolved with 100% re-epithelialization (replacement of lost or damaged epithelium - superficial pink/ white tissue that migrates across the wound from the wound margin, hair follicles or sweat glands). Cleaned with [Normal Saline] and left open to air ..."

During a concurrent interview and record review on 7/23/24 at 11:00 a.m. with Director of Nursing (DON) 2 and wound nurse (WN) Pt 18's "Electronic Health Record (EHR)" was reviewed. The WN stated he was familiar with Pt 18 and Pt 18 was still here admitted in the hospital. The WN stated he saw the patient for wound consult on 5/31/24 about left heel discoloration. The WN stated he had seen the patient few days prior but does not recall the exact date. The WN stated Pt 18 did not have any purple discoloring on the left heel few days prior to 5/31/24. The WN stated on 5/31/24 when he saw the patient, Pt 18's left heel's skin was intact and offloading (Heel offloading strategies include positioning pillows so that the heel is not touching the bed or using devices such as boots designed to completely suspend the heel when the patient is in bed) was in place. The WN stated no other interventions were needed at that time. The WN stated he documented the assessment on 5/31/24 at 12:00 p.m. The "Wound assessment," by WN Indicated, " ...Wound Bed Tissue Assessment: Purple Intact, Peri Would assessment Ecchymotic [brusing caused by broken blood vessels leaking into tissue]; Intact ... wound length 5 (centimeter - CM-unit of measurement) ... width 5 (cm)." The WN stated he took the picture and documented his assessment on 5/31/24. The WN stated he saw the patient after that on 6/10/24 and documented his assessment again. The "wound assessment" on 6/10/24 at 1600 p.m. by WN indicated, " ...Wound Bed Tissue Assessment Sloughing; Intact ...Peri-Wound Assessment ...Intact Ecchymotic ..." The WN stated at that time he took the pictures, notified physician, received an order for wound care and worked with leadership to report pressure injury. The WN stated patient wound care and assessment was done by nursing staff on the unit between 5/31/24 and 6/10/24, the time from when the purple discoloration to unstable.

During a concurrent interview and record review on 7/23/24 at 11:36 a.m. with DON 2 and WN Pt 18's EHR was reviewed for wound assessment, skin assessment, and mobility section was reviewed for documented interventions to reduce pressure injury (sores, ulcers on skin that is under pressure) risk for Pt 18's. The WN stated under mobility section heels would have documentation for interventions for offloading. The WN reviewed the documentation under mobility section for pressure relieving interventions for left heel for the dates of 5/29/24 until 6/10/24, a day before the finding of purple discoloration of left heel up until the left heel was documented to have unstageable pressure injury. The WN stated documentation was inconsistent. The WN stated many shifts no interventions were documented. The WN validated on 5/29/24 from 12:01 a.m. until 5/30/24 at 4:00 p.m. no documentation of offloading or pressure relief interventions were documented. WN stated without these interventions' purple/discoloration can occur and without any documentation he was not able to tell if any interventions were in place. The WN stated this patient was high risk due to insulin dependent diabetes and already have a non-healing wound on right heel. WN then continued reviewing documentation for offloading or pressure relief interventions of left heel. WN stated no documentation in EHR was found for offloading or pressure relief interventions for left heel from 5/31/24 at 12:01 am to 5/31/24 at 4 p.m., from 6/1/24 at 12:01 a.m. till 6/1/24 at 7:00 a.m., from 8 to 12 p.m. on 6/2/24, from 6/5/24 at 6: p.m. to 6/6/24 at 7:00 a.m., from 6/6/24 at 10 p.m. to 6/7/24 at 2:00 a.m., from 6/8/24 at 4 p.m. to 10 p.m., from 6/8/24 at 10 p.m. to 6/9/24 at 8 a.m., from 6/9/24 at 6 p.m. to 6/10/24 at 8 a.m., from 6/11/24 at 8 a.m. to 4 p.m. WN stated these were the missed opportunities and per policy off-loading of left heel should have been done and documented every two hours. The WN stated potentially discoloration and progression of the wound to unstageable potentially could have been prevented if the appropriate pressure relieving interventions were in place. WN also reviewed all the wound pictures since admission on 5/19/24. WN stated after reviewing the picture that was taken on 6/2/24 that wound nurse should have been

Based on interview and record review, the hospital failed to ensure registered nurses (RNs) administered insulin in accordance with physician orders for one of the three sampled patients, Patient [Pt] 19 when Registered Nurses administered insulin continuous intravenous drip (the administration of a fluid into a blood vessel, usually over a prolonged period of time) for Pt 19 to treat hyperglycemia and the insulin dose rate was not titrated in accordance with the physician medication order of Insulin Algorithm (guidance to assist nurses in titrating insulin dose to maintain a goal blood glucose level) despite being verified by two nurses. Pt 19 had the potential for ineffective blood glucose (BG) management and received incorrect doses.

This failure resulted in not providing the medication as ordered by the physician and placed patient at risk of harm, and/or adverse outcomes.

Findings:

During a review of Pt 19's "CCH Hospitalist H&P" dated 7/18/24, the "CCH Hospitalist H&P" indicated, Pt 19 was a 71 year old male with significant history of unspecified Congestive heart failure (CHF - a long-term condition that happens when your heart can not pump blood well enough to give your body a normal supply), hypertension (high blood pressure), Coronary artery disease (CAD - condition which limits blood flow in your coronary arteries, which deliver blood to your heart muscle) with prior stenting (a small metal tube that is used to unblock a coronary artery), borderline diabetes (a chronic disease that occurs either when the body does not produce enough insulin or when the body cannot effectively use the insulin it produces). Patient presented to the emergency room with chief complaint of generalized weakness and intermittent dizziness/light headedness without syncope (passing out). 12 lead Electrocardiogram (EKG - test to record the electrical signals in the heart) showed A-fib (An irregular, often rapid heart rate that commonly causes poor blood flow) and patient was admitted to Telemetry (is a floor in a hospital where patients undergo continuous cardiac monitoring) and underwent Coronary artery bypass grafting (heart bypass surgery, is a medical procedure to improve blood flow to the heart).

During a review of Pt 19's physician "Medication Orders" dated 7/22/24, the "Medication Order" for insulin indicated, " ...insulin regular ...ordered dose: 0-20 units (unit of measurement)/[hour - (hr - unit of time)] Route: Intravenous Frequency: Continuous[at] 0-20 [milliliter (ml -unit of measurement)] /hr ...Admin instructions: GOAL EFFECT: BG range 140-170 [milligram (mg-unit of measurement) per deciliter (dL- unit of measurement of volume)]. Titration per insulin calculator ...Check BG hourly when initiating insulin infusion ..."

During a concurrent interview and record review on 7/26/24 at 1:27 p.m. with the Director of Critical Care (DON 3), Health Informatics 1 & Manager of Cardiovascular Intensive Care Unit (MG 7) Pt 19's medical record was reviewed. The "Medication Administration Record (MAR)" in medical record dated 7/22/24 to 7/24/24 for insulin administration indicated Pt 19 was started on the insulin continuous intravenous on 7/22/24 at 9:15 a.m. at the dose rate of 1 unit/hr. The MAR indicated Pt 19's insulin dose rate was changed to 0 units/hr on 7/23/24 at 9:08 p.m. and insulin was held until the order was stopped on 7/24/24 at 10:59 a.m. The MAR and electronic health record (EHR) did not indicate starting BG level and order for starting dose of 1 unit/hr. The MG 7 stated she was not able to find any documentation of BG or reason for starting the dose rate at 1 units/hr in EHR. MG 7 stated insulin was started in Operating room (OR) on 7/22/24 at 9:15 a.m. at 1units/hr and first dose rate change at 10:03 a.m. was also done in the OR. The dose rate was increased on 7/22/24 at 10:03 a.m. to 2 units/hr. MG 7 stated she was also unable to find any documentation of BG or physician order to support the first dose rate change. MG 7 stated after that patient arrived in Cardiovascular Intensive Care Unit (CVICU -Unit specializes in the care of critically ill patients with heart and vascular problems) and first BG check in CVICU was done at 10:43 indicating BG level of 171 and dose rate was changed to 0 units/hr. The MG 7 stated BG results upon arrival to CVICU on 7/22/24 was 171 and the dose rate for insulin should have remain unchanged at 2 units/hr per insulin infusion calculator as the goal was BG range 140-170 mg/dl instead of changing rate to 0 units/hr. The Insulin infusion dose rate remained at 0 units/hr and intravenous insulin remained off on 7/22/24 from 10:48 a.m. until 2:13 p.m. when it was restarted at 2 units/hr. MG 7 stated the dose rate change to 0 units/hr on 7/22/24 at 10:48 was an error. MG 7 state RN selected action "INITIATE" instead of "CONTINUE" therefore the calculator was using initiation formula instead of continuing rate calculation on insulin that was already infusion. MG 7 stated 12:00 p.m. and 1:00 p.m. BG results were not added in the MAR. MG 7 stated without accurate rate change action on 7/22/24 at 10:48 and not having documentation of subsequent BG level in MAR, the insulin infusion calculator was not calculating the correct dosage. MG 7 did the manual calculation using the insulin algorithm (guidance to assist nurses in titrating insulin dose to maintain a goal blood glucose level) and validated the starting dose and subsequent changes at 10:48 a.m. until 2:13 p.m. were not done correctly. MG 7 stated that she was unable to validate any subsequent dose rate would be accurate as the starting dose rate was not correct and subsequent BG were not entered in MAR. MG 7 stated insulin dose rate was changed four times on 7/22/24 after the initial dose rate of 0 units/hr at 10:48 a.m. and dose rate was changed eight times on 7/23/27 before insulin infusion was stopped. MG 7 stated BG results were not consistently documented every hour or as needed in MAR calculator and were required to calculate the next correct dose rate. MG 7 stated initial rate change in CVICU on 7/22/24 at 10:48 a.m. was incorrect and this would impact all subsequent 12 dose rate changes as they may not be calculated right. MG 7 stated she would need to review this with Medication Safety Pharmacist (MSP).

During a concurrent interview and record review on 7/26/24 at 2:00 p.m. with the MSP, Pt 19's MAR and EHR for the hospital visit of date 7/18/24 was reviewed for the insulin administration. The MSP stated it appears that the insulin was not started at the correct dose upon arrival to CVICU as the "INTIATE" function was selected instead of "continue". The MSP stated subsequent dose rate adjustments would not be correct if the BG results were not entered in the MAR every hour or as required per infusion administration guidelines. The MSP stated he would have to go back and figure this out using manual calculation. The MSP stated the dose rate changes does not add up and it appears an error was made during adjustments. The MSP stated the insulin titration does not align with physician "Medication order" for insulin.

During a concurrent interview and record review on 7/26/24 at 2:15 p.m. with the MG 8, Pt 19's MAR and EHR for the hospital visit of date 7/18/24 were reviewed for the insulin administration. MG 8 stated she was not able to validate with manual calculation using insulin algorithm that dose rate adjustments made utilizing the infusion dose calculator were correct. MG 8 stated she would need to work with MSP and MG7 to figure out the errors.

During an interview on 7/29/24 at 8:30 a.m. with the Director of Quality (DQ), the DQ stated after the chart review on 7/26/24 at 1:27 p.m. team have identified gaps and acknowledged that the RNs failed to follow policies or protocol. The DQ submitted a plan of correction which indicated corrective action hospital placed on the 7/26/24 after identifying gaps. The DQ stated the registered nurses (RNs) did not document and should have documented the blood glucose (BG) level within the Medication Administration Record (MAR) hourly. The DQ stated the RNs thought the BG was pulled automatically from point of care testing (POCT - is clinical laboratory testing conducted close to the site of patient care where care or treatment is provided) and other lab tests such as chemistry panel (blood tests that measure amounts of certain chemicals in a sample of blood) or ABG (measures the balance of oxygen, carbon dioxide and acid base balance in blood). The DQ stated failure to document the BG results hourly in MAR resulted in an incorrect infusion dose since the dosing calculation is based on the last documented BG in MAR which could be hours prior and not the last hour BG result as it was not documented. The DQ stated in addition RNs did not select appropriate action in calculation for initiation versus rate change which resulted in incorrect calculation which further led to incorrect dosing of insulin. The DQ stated this was significant failure and had the potential to harm patients. The DQ stated staff education and retraining was started immediately to avoid any harm to the patients.

During an interview on 7/29/24 at 9:53 a.m. with DON 3 & MG 7, DON3 stated after the record review on 7/26/24 at 1:27 p.m. they have been working on educating and retraining nursing staff. DON 3 stated they submitted the corrective action plan to DQ. The corrective plan that was submitted by DQ was something that DON3 and MG 7 worked on for the gaps identified during record review. DON 3 stated nursing staff was not following the correct process for documenting the blood glucose every hour on the MAR. The DON 3 stated they were not aware the MAR does not pull BG value automatically from within the electronic health record (HER). DON 3 stated this led to incorrect dosing as the calculator was using the last inputted value as oppose the newest BG that was not entered. DON 3 stated staff was also selecting wrong action in calculator initiate versus continue. DON 3 stated each action have different formula for calculations and by selecting wrong action, it led to errors in dosage calculation.

During a review of the facility's "plan of correction (POC)" dated 7/26/24, the POC indicated, " ...[Hospital name] acknowledges we did not follow our internal policies or protocol orders for patient [19]. The following is what should have occurred in for the care of patient and contributing factors ...The RN should have documented the blood glucose (BG) Level with in the Medication Reconciliation Administration (MAR) hourly, especially in the "Enter Protocol Action and Current POC Blood Glucose" ...RN thought the BG was pulled in from POCT, ABG, and/or chemistry ...failure to document the BG results hourly in the MAR will result in an incorrect infusion dose since the dosing calculations is based on the last documented BG in the MAR (which could be hours prior and not the last BG result required for the current infusion rate change) ...Additionally, the RN did not select the appropriate action of initiated verses rate change which results in an incorrect calculation which would lead to an inappropriate dosing of insulin ... The provider should not have adjusted the BG goal range, the two- options available to the provider from Yale insulin infusion calculator include either a goal rage is 120-170 or 140-180 (at this time, there does not appear to be an [EHR] warning/[Best practice advisory]BPA/hard stop when provider changes this BG Goal Range, however, despite doing this calculator will only keep the setting of original order) ...if a different BG goal range is desired by the provider, then they should consult with Pharmacy for a more appropriate insulin drip titration order to meet their BG range ..."

During a review of the facility's "policy and procedure (P&P)" titled, "Medication policies", Date reviewed February 2023, P&P indicated " ...1. Patients receive medications according to physician oders ...8. When ordering titratable IV medications, the prescriber will indicate the starting dose, titration frequency, titration dose, goal parameters, the maximum dose, and when to call the prescriber...Licensed nursing staff will use the "five rights": the right patient, the right drug, the right dose ...The Right Dose: Check the medication order and the appropriateness of the drug. If necessary, then calculate the dose and have another clinician calculate the dose as well."

Based on observation, interview, and record review, the hospital failed to have an active Infection Prevention and Control program which adhered to nationally recognized infection prevention and control guidelines for the surveillance, prevention, and control of Hospital Acquired Infections (HAI's) and other infectious diseases, when:

1.Hot lab room (rooms in nuclear medicine hospitals that have been specially designed to deliver, store, and prepare radioactive materials) walls had rough surface with black stains and paint chipped above and around the radiopharmaceuticals (radioactive agents that are used to help diagnose certain medical problems, only small amounts are given to the patient) storage. The Hot lab patient nourishment refrigerator inside flooring had brown deposits, yellow stains and was stocked with expired boxes of the orange juices. (Refer to A-0750 finding 1)

2.Used Transesophageal echocardiogram (TEE) probes (A thin, flexible tube-like instrument with a probe like a microphone which sends out ultrasonic sound waves used to look at tissues inside the body, usually done by inserting a probe with a transducer down the esophagus) were being cleaned in a ultrasound (sound waves to make pictures of organs, tissues, and other structures inside your body)/ Electro Cardio Gram - (ECG a test to record the electrical signals in the heart area) testing room in between patients, without the room being clean in between scopes cleaning and the next patient testing. (Refer to A-0750 finding 2)

3.Cardiovascular Operating Room (CVOR) satellite pharmacy (decentralized operating unit which has similar function with the central inpatient pharmacy) flooring had a hole with chunk of floor missing inside the sterile compounding (custom made -pharmaceutical preparation) area. The hole was approximately one inch deep and about two inches wide and appear to have dust particles in the hole. The flooring could not be disinfected in accordance with professional standards and had the potential to allow bacteria to harbor in the cracked and chipped surfaces and lead to patient infection. (Refer to A-0750 finding 3)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure staff competency in infection control principles and practices and the provision of quality patient care in a safe and sanitary environment.

Based on observation, interview, and record review, the hospital failed to maintain a clean and sanitary environment to avoid sources and transmission of infection when:

1.Hot lab room (rooms in nuclear medicine hospitals that have been specially designed to deliver, store, and prepare radioactive materials) walls had rough surface with black stains and paint chipped above and around the radiopharmaceuticals (radioactive agents that are used to help diagnose certain medical problems, only small amounts are given to the patient) storage. The Hot lab patient nourishment refrigerator inside flooring had brown deposits, yellow stains and was stocked with expired boxes of the orange juices.

These findings had the potential of cross contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) and the potential risk for infections in patient receiving nuclear image (radiopharmaceuticals are taken internally, for example, through inhalation, intravenously, or orally. Then, external detectors capture and form images from the radiation emitted by the radiopharmaceutical) testing at the facility.

2.Used Transesophageal echocardiogram (TEE) probes (A thin, flexible tube-like instrument with a probe like a microphone which sends out ultrasonic sound waves used to look at tissues inside the body, usually done by inserting a probe with a transducer down the esophagus) were being cleaned in a ultrasound (sound waves to make pictures of organs, tissues, and other structures inside your body)/ Electro Cardio Gram - (ECG a test to record the electrical signals in the heart area) testing room in between patients, without the room being clean in between scopes cleaning and the next patient testing.

This failure had the potential for exposure and transmission of diseases to every patient receiving testing after the probes were cleaned.

3.Cardiovascular Operating Room (CVOR) satellite pharmacy (decentralized operating unit which has similar function with the central inpatient pharmacy) flooring had a hole with chunk of floor missing inside the sterile compounding (custom made -pharmaceutical preparation) area. The hole was approximately one inch deep and about two inches wide and appear to have dust particles in the hole. The flooring could not be disinfected in accordance with professional standards and had the potential to allow bacteria to harbor in the cracked and chipped surfaces and lead to patient infection.

As a result of these failures, all patients and staff were at risk for transmission of infections (an infectious agent is transferred from a reservoir to a susceptible host) and cross contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) and increased the potential for hospital acquired infections.


Findings:

1. During a concurrent observation and interview on 7/22/24 at 2:44 p.m. with Director of Nursing (DON) 1, DON 2 & Nuclear Medicine Technician (NMT) 1 in the Hot lab room, noticed the back wall above the Radiopharmaceuticals ( radioactive agents that are used to help diagnose certain medical problems, only small amounts are given to the patient) storage in the room with black stains, paint chipping off and rough surface approximately 3 feet long and 2 feet wide. The second wall next to laminar flow hood (environment for the preparation of medication. These hoods work by filtering air through a high-efficiency particulate air (HEPA) filter, which removes particles and contaminants, including bacteria, viruses, and fungi, from the air) also had black stain, rough surface with paint chipping off. The wall behind eye wash station had shelf falling off from one side with holes that appears to where the shelf was screwed. The eye wash station was observed with white crusty deposits on the pipe. The patient nourishment refrigerator in Hot lab room was inspected next. The patient nourishment refrigerator had brown deposits and yellow stains all inside all over on the refrigerator floor. The refrigerator also had two boxes of orange juice, and both had expiration date of 2/11/24. The NMT stated Hot lab was secured area and only NMTs have access to it. The NMT stated she coordinates with the environment services (EVS) team and supervises them while the EVS team completes cleaning of the lab area. The NMT agreed that walls need cleaning and repair. The NMT stated currently the walls are not wipeable and rough surface could be a potential to Harbor germs and cause cross contamination. The NMT stated their focus always was on Radiopharmaceutical safety and did not submit work order for repairs. The NMT stated the walls have been in these condition needing repair for at-least last ninety days. The NMT stated the patient refrigerator needs cleaning and brown deposits were spilled juices. The NMT stated unable to comment on expired juices, but it should not be in patient refrigerator. The NMT stated EVS always have one of the NMTs supervising them and she was unsure how these items were missed.

During a concurrent observation and interview on 07/22/24 at 2:50 p.m. with the Manger of Imaging (MI) in the Hot lab room, the MI stated he was the manger over the nuclear medicine and hot lab area. MI stated he does not routinely round in the Hot lab room. The MI stated last time he was in the Hot lab room was during the last survey, more than three months ago. The MI stated he was unable to tell what the black deposits/stains were on the walls in the hot lab room, and it could be a potential for cross contamination. The MI stated his staff failed to submit work orders for repair and he expects no paint chips, cracks or holes in the walls that could be potential source for cross contamination. The MI then looked at the patient nourishment refrigerator and stated, "it looks dirty and not acceptable". The MI stated he would immediately work with his leadership team to repair the integrity of the walls, get eye wash station clean and clean patient nourishment refrigerator. The MI discarded the two expired juice boxes. The MI stated expired items are not safe for patients and could lead to infections.

During a concurrent observation and interview on 7/22/24 at 2:53 p.m. with DON 1 in the Hot lab room, DON 1 stated the condition of both walls needs repairs and could be a potential source for infection. DON 1 stated the refrigerator floor "definitely needs cleaning" and patient nourishment refrigerator should never be stocked with expired food product. The DON 1 stated potential risk for expired food reaching to the patient and causing harm to the patients.

During a concurrent observation on 7/23/24 at 9:09 a.m. with the Director of Patient Safety (DPS) in the Hot lab room, the DPS stated the walls needs cleaning and repair to avoid any potential for cross contamination. The DPS stated no expired product should be stored in patient nourishment refrigerator and surface areas in refrigerators must be kept clean to avoid any cross contamination. The DPS stated important for patient safety to ensure all food items are kept at appropriate temperature and used before expiry date. The DPS agreed potential for harm with expired food products if products are consumed by patients.

During a concurrent observation on 7/23/24 at 9:15 a.m. with the Director of Infection Prevention (DIP) in Hot lab room, the DIP stated she was aware of the observation from yesterday. The DIP stated the Hot lab wall area above storage of pharmaceuticals should have been a wipeable surfaces. The DIP stated bacteria can harbor in cracks, chipped area and create a risk for cross contamination. The DIP stated she was not able to comment on what the black stains/deposits on the walls were but stated it was not acceptable and does not meet IP expectations. The DIP stated the refrigerator with patient food should be kept clean and any deposits, stains, and spills inside should be clean routinely. The DIP stated it is important to remove expired food products from the patient care areas to avoid the risk of patient received expired food items that can lead to harm in patients.

During an interview on 7/23/24 at 9:20 a.m. with the MI, the MI stated he submitted the work orders yesterday after the observation on 7/22/24 at 2:50 p.m. and the facilities team already have a plan to repair walls as soon as possible. The MI stated the patient refrigerator has been cleaned. The MI stated historically he only rounded in the Hot lab room during surveys but going forward he will routinely round to ensure the environment is safe. The MI stated there was "absolutely no reason why the lab looked like this and had expired items in patient nourishment refrigerator."

During an interview on 7/30/24 at 12:16 p.m. with the Chief Nursing Office (CNO), the CNO stated the walls in the Hot lab room needed repair and had the potential risk for cross contamination. The CNO stated we follow safe food handling practices, and it was never ok to have expired product in patient nourishment areas. The CNO stated the refrigerator observation on 7/22/24 at 2:44 p.m. bottom floor inside the refrigerator looks "ugly", potential for infection and not acceptable in hospital settings. The CNO Stated she expects staff members are filling out work order and notifying leadership for any repair needed in their areas. The CNO stated she also expects staff is routinely checking for expired items and removing it.

2. During a concurrent observation and interview on 7/22/24 at 3:31 p.m. with DON 1 & Registered Diagnostic Cardiac Sonographer (RDCS - specialized kind of cardiovascular technologist who focuses on using ultrasound ( sound waves to make pictures of organs, tissues, and other structures inside your body) equipment to image a patient's heart) 1 in the Cardio Vascular Diagnostic Services (CVDS) department in ultra sound testing room number two, right next to sink, noticed two transesophageal echocardiogram (TEE) probes (A thin, flexible tube-like instrument with a probe like a microphone which sends out ultrasonic sound waves used to look at tissues inside the body, usually done by inserting a probe with a transducer down the esophagus) being set up for pre- clean. The sink had an open [brand name] beside pre- clean kit being filled with water and sponge inside. The RDCS stated that their team use this room two for pre cleaning of all TEE probes after being used on patients on different floor. The RDCS 1 stated majority of the TEE procedures are completed on a different floor in a dedicated procedure room in Cardiovascular Recovery Area. The RDCS 1 stated after the procedure is complete, their process was to bring the TEE probes down to room two and pre clean it before taking it down to Sterile Processing Department (SPD- is the area in a hospital where cleaning and sterilization of devices used in medical procedures takes place). The RDCS 1 stated room two gets used for Ultrasound /Electro Cardiogram (ECG- a test to record the electrical signals in the heart) testing and their team will clean TEE probes in between scheduled patients for ultrasound and ECG. The RDCS stated usually they see six to eight patients daily in the room two where they clean their probes in between seeing patients. The RDCS 1 stated this process of cleaning TEE probes in the ultrasound room 2 in between seeing patients for testing or ECG has been ongoing for almost a year. The RDCS 1 stated the room does not get terminally (a procedure required to ensure that an area has been cleaned/decontaminated) clean after the used probes are pre cleaned in the room's sink and prior to seeing next patient in that room. The RDCS 1 stated throughout the day they bring probes down in between patient's testing in ultrasound room two to do the pre cleaning. The RDCS 1 stated he does not foresee any concerns with pre cleaning the used probes in the testing rooms in between patients without the room being cleaned after pre cleaning scopes and seeing the next patient.

During a concurrent observation and interview on 7/22/24 at 3:35 p.m. with DON 1 in the CVDS department in ultrasound testing room number two, the DON 1 stated she was the director for the CVDS department. The DON 1 stated she was going to "re-look at the workflow with the department leadership team". The DON 1 stated she can understand the risk for cross contamination with pre cleaning of used probes in the sink of patient testing rooms and if the patient room is not thoroughly clean before seeing the next schedule patient after cleaning of probes. The DON 1 stated this process was set up by SPD and she will need to follow up with the hospital SPD team.

During an interview on 7/23/24 at 09:35 a.m. with the Manger of CVDS (MG 5), MG 5 stated after the observation yesterday on 7/22/24 at 3:35 p.m. her team had the chance to review the workflow. MG 5 stated that her team realized they were doing the pre cleaning of TEE probes that were used on patients in an area where they were also doing patient care. MG 5 stated CVDS team have stopped performing pre cleaning in the patient care area, in the ultrasound room 2, in between patient testing. MG 5 stated they now have dedicated room for pre cleaning of the probes. MG 5 stated the used probes should not be cleaned in the patient care area, in between patient testing, without cleaning the room in between as this had the potential for cross contamination and exposing patients to germs. MG 5 stated realized previous workflow had the "potential for infection control issue and the new process will eliminate that potential".

During an interview on 7/23/24 at 9:42 a.m. with the DIP, the DIP stated she was made aware of the process of pre cleaning of used TEE probes in between patient testing. The DIP stated the probes should not be cleaned in patient testing room in between patients or the room should have been terminally clean every time after the probe was pre cleaned in between patients. The DIP stated this new process is better and she was not aware of the previous process of pre cleaning until today. The DIP stated infection prevention team would have been concerned with the old process of cleaning TEE probes in between patient testing in ultrasound room two as it had the potential to cause harm to the patients by cross contamination.

During an interview on 7/30/24 at 12:20 p.m. with the CNO, the CNO stated she was made aware of the previous process before 7/23/24 for TEE cleaning. The CNO stated the process of pre cleaning TEE probes in between patient testing, in patient care area was not an acceptable practice. The CNO stated probes have specific set of instructions for use and the hospital should be following the instructions. The CNO stated cleaning probes in patient rooms has the potential to expose clean patients to hospital acquired infections.

3. During a concurrent observation and interview on 7/24/24 at 10:51 a.m. with Manager of pharmacy -regulatory and compounding (MG 6) in the Cardiovascular Operating Room (CVOR) satellite pharmacy (decentralized operating unit which has similar function with the central inpatient pharmacy), observed [brand name] positive pressure recirculating compounding aseptic isolator (hood with positive airflow that provides a safe and clean environment for compounding (custom made) of hazardous, sterile drug preparation. Positive pressure is used to ensure there is no entry of the surrounding environment into the closed system) behind the red line. The floor directly below towards the front of [brand name] positive pressure recirculating compounding aseptic isolator and inside the red line had a hole with chunk of floor missing. The hole was approximately one inch deep and about two inches wide and appear to have dust particles in the hole. The MG 6 stated everything inside the red line supposed to be clean and only essential personal with proper personal protective equipment (PPE - equipment worn to minimize exposure to hazards) are allowed. The MG 6 stated the floor with holes/cracks inside the red line and below the compounding area is not acceptable. The MG 6 stated he was not sure what was collecting inside the hole. The MG 6 stated germs can harbor and "risk for cross contamination". The MG 6 stated the floor need to be clean and disinfected to maintain sterility and holes and cracks would have the potential where germs can grow.

During an interview on 7/24/24 at 12:30 p.m. with the director of quality (DQ), the DQ stated not acceptable to have any chips or cracks in the flooring in sterile compounding areas. The DQ stated "huge risk for cross contamination". The DQ stated she had already escalated these concerns to senior leadership.

During an interview on 7/26/24 at 11:38 a.m. with the Director of Pharmacy (DOP), the DOP stated cracked floors, holes in the flooring were not acceptable in compounding area and inside the redline. The DOP stated the pharmacy team already repaired the flooring. The DOP stated she was unable to comment on why it was missed by the staff that works in the CVOP satellite pharmacy as it was clearly visible and right in the front. The DOP stated cracks and holes in the floor can foster an environment for bacteria growth. The DOP stated it was important for pharmacy team to ensure clean and sterile compounding environment to keep the patients safe.

During an interview on 7/30/24 at 12:22 p.m. with the CNO, the CNO stated the flooring in CVOR Satellite pharmacy needs to be intact. The flooring that was not intact was hard to clean and could be potential source for infections.
During a review of facility's policy and procedure (P&P) titled, "Compounding Sterile Preparation and Hazards Drugs," with a revised date August 2020, the policy indicated, " ...Cleaning schedule for Anteroom, Clean room and Segregated Compounding Areas ...Daily Cleaning ...Clean floors from furthest location in clean room out through ante-room (including pass-through floor -SPOROCIDAL AGENT ...Weekly Cleaning ...Floor (same as daily cleaning) ..."

During a review of the AORN publication Outpatient Surgery article, "How to Maintain a Clean OR Environment," dated 10/10/2007, the article indicated,"...To ensure a clean environment, evaluate the environment weekly or monthly for overall cleanliness as well as general condition...Are there cracks, nicks, or grooves on the floor? If so, repair them immediately to prevent bacteria from festering in the spaces..."

During a review of the Health Facilities Management article titled, "The role of maintenance in infection prevention," dated 8/16/19, the article indicated, "...Health care-associated infections (HAI) concerns to look for include: Damaged flooring in clinical areas. Damaged flooring does not provide a smooth, cleanable surface and can result in an infection prevention concern; Peeling paint or damaged wall surface. A wall surface that is not smooth is not cleanable..."



49538




1. Facility staff failed to identify a lifted floorboard in the pantry room on the Labor and Delivery unit.

This failure had the potential for bacteria build up.

Findings:

1. During a concurrent observation and interview on 7/22/24 at 3:08 p.m. with the Director of Women and Infant Services (DWIS) in the Labor and Delivery (L&D) pantry room, the floorboard was lifted from the floor. The DWIS stated, she was unsure if maintenance was aware of the lifted floorboard. The DWIS stated, it was an infection control issue and expected it to be fixed.

During an interview on 7/25/24 at 3:10 p.m. with the Director of Infection Prevention (DIP), the DIP stated, the lifted floorboard in the L&D pantry room was not wipeable and cleanable. The DIP stated, the area needed to be smooth to be able to clean. The DIP stated, it was an infection risk because there were gaps where bacteria could settle into the cracks and cervices. The DIP stated, she expected the floorboard to be fixed and have a smooth surface to be cleanable.

During a review of the facility's policy and procedure (P&P) titled, "Plant Maintenance," reviewed 3/17/23, the P&P indicated, " ...PURPOSE: To develop a program that reviews components of life safety on a consistent basis ... POLICY: Plant Maintenance department will utilize the work order program to identify the following life safety equipment and ensure that these devices are checked on a regular basis to comply with recommendations for National Fire Protection Agency (NFPA) ... PROCEDURE ... Slab to slab penetrations, corridor separation quarterly ... Damaged walls repaired ..."

Based on observation, interview and record review, the hospital failed to provide a well-organized surgical service in accordance with acceptable standards of practice when:

1. The complete expiration date of a titanium device was not read off prior to implantation surgery and resulted in an expired device being placed in Pt 11. (Refer to A-0951 finding 1)

2. Expired suture was available for use in the Operating Room (OR) and used on Pt 10 and the Surgeon elected not to remove it. (Refer to A-0951 finding 2)

3. Four of four surgical patients (Pt 43, Pt 44, Pt 45, and Pt 46) Operating Room Report (OP Reports) did not include the names of all staff in the room, nor did it include the in and out times of the anesthesia provider. (Refer to A-0951 finding 3)

4. A blue cauterization cart was used in the OR that had chipped paint and a reddish-brown substance that could be removed. (Refer to A-0951 finding 4)

5. An expired [brand name] certified airway exchange catheter (thin tube used in certain surgeries and medical procedures) was on the Anesthesia cart in the Obstetrics (OB) OR was found and had the potential to be used. (Refer to A-0951 finding 5)

6. Surgical/Procedural staff were seen wearing booties outside of procedural areas. (Refer to A-0951 finding 6)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe and responsible manner.

Based on observations, interviews, and record reviews the hospital failed to follow policies designed meant to maintain high standards of medical practice and patient care in their surgical services department for six of six patients, Patient (Pt) 10, Pt 11, Pt 43, Pt 44, Pt 45 and Pt 46) when:

1. Surgical staff failed to read the complete expiration date on one of one titanium device prior to being transplanted in Patient (Pt) 11. The device was scanned once transplanted and it was found to be expired by 10 days.

This failure placed Pt 11 at risk of device failure and possible infection due to transplanting an expired device.

2. Surgical staff failed to remove one of one expired suture from the operating room and the expired suture was used on Pt 10. Surgeon 2 was informed that the suture was expired and elected not to remove the expired suture.

This failure place Pt 10 at risk of obtaining an infection at the site due to suture not holding.

3. Four of four patients' (Pt 43, Pt 44, Pt 45, and Pt 46) Operating Room Reports (OP Reports - the surgery report that documents who is present in the OR during surgery and the time in and out for each staff member) dated 7/29/24 did not accurately reflect the name of the proctor for Certified Registered Nurse Anesthetist (CRNA) 2. According to the proctor report dated 7/29/24, CRNA 14 proctored CRNA 2. The OP reports for Pt 43, Pt 44, Pt 45, Pt 46 did not list CRNA 14 or in and out times and CRNA 2 was listed as the only anesthesia provider.

These failures did not provide Pt 43, Pt 44, Pt 45 and Pt 46 accurate information as to the CRNA that provided anesthesia services for their procedures.

4. Surgical staff failed to notice one of one blue cauterization cart in OR 4 had paint chipped off in multiple areas and a brown reddish substance that looked like rust around the front left wheel.

This failure had the potential to be a source of infection for any patients who had surgery with this cauterization cart in the room.

5. Surgical staff failed to identify one of one expired [brand name] certified airway exchange catheter (thin tube used in certain surgeries and medical procedures) on the Anesthesia cart in the Obstetrics (OB) OR.

This failure had the potential for an expired product to be used on a patient.

6. Two of two staff members wore blue procedural area scrubs on the second floor of the hospital outside of a procedural area with blue booties over their shoes walking in the hallway and not in accordance with hospital policy and procedure for surgical attire.

This failure had the potential to spread germs (microorganism which causes and spread disease) from the ORs to the hallways and from the hallways onto the OR floors.

Findings:

1.During a review of Pt 11's Face sheet (provides demographic information), dated 5/22/24, indicated Pt 11 was admitted on 1/23/24 at 5:49 a.m. as an inpatient for surgery, with a diagnosis of Arthrodesis status (a surgical procedure that fuses two bones in a joint) and a discharge date of 1/28/24.

During a review of Pt 11's Op (operative) Note dated 1/23/24, the Op Note indicated Pt 11 had the following procedure: Transforaminal Lumbar (L) Interbody Fusion L2-L3, L4-L5 (a surgical procedure that joins two or more vertebrae in the lower back using a bone graft spacer, screws, and rods), Revision Posterior Spinal Fusion L3-L4 (a surgical procedure that can be performed to improve pain and function), Posterior Spinal Fusion (a spinal surgery technique that can alleviate lower back pain and/or leg pain by removing a damaged spinal disc and fusing the pain-generating spinal segment), Instrumentation L2-L5 (a type of spinal fusion surgery that uses metal devices to stabilize the spine and help the fusion heal), and C-Arm (a medical imaging device that uses X-ray technology to visualize a patient's anatomy during surgery). Pt 11's Op Note indicated Implant "L4-L5: 8.5 x 28 x 10 mm (unit of measurement- millimeters) K2M Cascadia static titanium cage ... Addendum: At the end of the case after final implantations were placed, it was brought to my [Surgeon 1] attention that the implanted L4-5 titanium interbody cage had expired on 1/13/2024. Upon evaluation of the situation, I [Surgeon 1] determined that the risk of removing the interbody cage and replacing it outweighed the benefit ... The decision was made to keep the implant in place. The patient was informed of this postoperatively."

During an interview on 7/23/24, at 10:02 a.m., with the Director of Perioperative Services (DPS) stated the vendor brought in different sizes of the implant needed for Pt 11's surgery, "however it is the responsibility of the [surgical] team to vet (to carefully examine something or someone to ensure it is acceptable or suitable) those implants. We have safeguards in place, but there are certain things that don't scan and so our policy has always been that the circulator will validate; we'll show it to the scrub tech, who will announce it, the device and full expiration date." The DPS stated the vendor only stated the month and year of the implant and the surgical staff did the same, it was not noticed that the device was expired until it was scanned by the circulating nurse and by that time SUR 1 had already implanted it in Pt 11.

During an interview on 7/23/24, at 10:10 a.m., with OR Manager (MG) 1, MG 1 stated the implant used on Pt 11 is a product the hospital does not stock and the vendors have to bring them in. MG 1 stated the representative from the vendor read off the month and year of the implant to be used on Pt 11. MG1 stated the circulating nurse did not check the date, but she opened the implant, and gave it to the scrub tech who passed it to the surgeon. MG 1 stated the visual check and reading out loud of the expiration date was missed between the circulating nurse and the scrub technician. MG 1 stated when the circulating nurse scanned the implant it came up as expired. MG 1 stated the surgical team was notified the device was expired and the surgeon felt it was in the best interest of Pt 11 to leave it in, since it was only 10 days passed expiration. MG 1 stated the facility follows the Association of periOperative Registered Nurses (AORN) guidelines. MG 1 stated the facility now scans the expiration date on the implants before they are opened.

During an interview on 7/23/24, at 9:33 a.m., with Scrub technician (ST) 1, ST 1 stated she was the scrub technician in Pt 11's case. ST 1 stated she remembers the circulating nurse reading off the date for the first implant which the surgeon did not use. ST 1 stated the surgeon asked for a larger size implant. ST 1 stated the vendor representative left the room and brought back a larger size and the full expiration date was not read out loud by the vendor or the circulating nurse, and then the opened implant was placed on the sterile tray for use. ST 1 stated she loaded the implant and gave it to the surgeon and the surgeon placed it in Pt 11. ST 1 stated the implant expiration date was not scanned until after it was inside Pt 11. ST 1 stated the surgeon did not want to remove the implant.

During an interview on 7/23/24, at 1 p.m., with the Surgeon (SUR) 1, SUR 1 stated he does not check the expiration dates himself and depends on the staff at the hospital to do this. SUR 1 stated he made the decision to leave the titanium device implanted in Pt 11 when he learned that it was expired by two weeks because there is a risk of damaging the nerve if implants are removed and reinserted. SUR 1 stated Pt 11 has come in since surgery and there have been no signs of infection, he is recovering as expected. SUR 1 stated he informed Pt 11 of the expired implant that same day and the reason he decided to keep it in. SUR 1 stated since this happened, he now checks the date of expiration of the implants himself.

During an interview on 7/23/24 at 10:44 a.m., with the Infection Preventionist (IP) 1, the IP 1 stated using an expired implant puts Pt 11 at risk for infection, when a product is expired, the concern is efficacy and sterility of the implant.

During a review of the facility's policy and procedure (P&P) titled, "Circulating Team Member Responsibilities", dated 11/2023, indicated, "PURPOSE: To provide guidelines for safe, coordinated activities involved with patient care during surgical procedures by the circulating registered nurse (RN). Outcome: The RN provides a safe and sterile environment for the patient during surgical procedures... Policy: 1. It is the responsibility of the circulating nurse: A. To maintain standards to ensure aseptic technique at all times ... 2. During the surgical procedure... H. Charge for sterile processing department (SPD) supplies special equipment. Medications, implants, blades, and burs on appropriate chart sheet ... 3. Implants ... B. As implants are requested from the surgical scrub team. Implant information is. "Read-back" to the team prior to opening the package. 1) Verify correct implant and expiration date..."

During a review of the facility's P&P titled, "Scrub Team Member Responsibilities", dated 11/2023, indicated, "PURPOSE: To provide guidelines for optimal patient care and safety in the surgical room. Outcome: The scrub team member will provide a sterile, safe environment during a surgical procedure... Policy: One. A scrub person will be assigned to operative procedures and will be responsible for providing assistance to physicians and their assistance. If present during operative procedures... procedure: One. Prior to surgical. Procedure: ... B. Assist in organizing special supplies and equipment for cases prior to scrubbing... K. Reconfirm patient procedure implant availability... F. Inform. The circulator of implants used information to include but not limited to: 1. Lot # 2. Amount used 3. Size 4. Site... J. Perform sponge, sharp and instrument counts as appropriate when surgeon begins closure of surgical case... 4. Implants A. Ensure all implants are available prior to bringing the patient into the operating suite. B. As implants are requested from the surgeon, that information is given to the circulating nurse. C. Prior to the circulating nurse opening the implant, confirm the implant is correct and the expiration date by visual reading the package. D. "Read-back" to the surgeon prior to opening the package..."

2. During a review of Pt 10's Face sheet (provides demographic information), dated 2/8/24, indicated Pt 10 was admitted on 2/8/24 at 11:22 a.m. to the Outpatient Surgical Center (OSC) [name] with the following diagnosis of Collapsed vertebra in lumbar region.

During a review of Pt 10's Operative Report dated 2/8/24, the Operative Report indicated Pt 10 had a "permanent spinal cord stimulator implant" placed with no complications, performed by Surgeon (SUR) 2.

During an interview on 7/23/24, at 9:45 a.m. with Circulating Registered Nurse (CRN) 1, CRN 1 stated she was the CRN for Pt 10's surgery. CRN 1 stated SUR 2 had begun to suture Pt 10 as she voiced that the suture was expired. CRN 1 stated SUR 2 stated he was going to use the expired suture. CRN 1 stated the expectation is the expiration dates should be checked before the sutures come into the OR and the expiration dates are checked again by the scrub tech.

During an interview on 7/23/24, at 9 a.m. with SUR 2, SUR 2 stated, " ...The structure of the suture is minimal, it's optional. There's no clinical risk or benefit. I was given the suture, then they said it was expired. The clinical benefit was better to leave it in." SUR 2 stated the purpose of the expiration is the theoretical degradation (gradual deterioration) of the suture [name of suture]. SUR 2 stated there has not been any testing to show [name of suture] the rate these sutures degrade. SUR 2 stated he did not tell Pt 10 about the expired suture while the patient was in the hospital but did tell Pt 10 at her first post op visit that the suture used was expired. SUR 2 stated Pt 10 is "doing splendidly", and the wound has healed.

During an interview on 7/23/24, at 10:18 a.m. with MG 1, MG 1 stated Association of periOperative Registered Nurses (AORN) states sutures should not be used beyond expiration date.

During an interview on 7/23/24, at 10:12 a.m. with the DPS, the DPS stated on 2/8/24 she was made aware of the use of the expired suture used by SUR 2 on Pt 10. The DPS stated the OSC is an extension of [name of hospital] and had its own way of checking for expired supplies which multiple staff members were responsible for. The DPS stated the use of expired sutures did pose the risk of malfunction of the product or infection risk. The DPS stated they follow the hospital's policy and follow AORN standards, which include to check for expiration dates.

During an interview on 7/23/24, at 10:27 a.m. with the Manager of Infection Control and Prevention (MIP), the MIP stated she was made aware of the SUR 2 using the expired suture on Pt 10, shortly after the incident occurred. MIP stated expiration dates are important because the "Manufacturer will only guarantee sterility until that date" and if expired sutures are used it could be an infection risk to the patient.

During a review of the facility's policy and procedure (P&P) titled, "Outdating of Supplies in Procedural Area", dated 10/2022, indicated, "PURPOSE: To ensure that all supplies managed by CD's [central distribution] are current and have not expired. This policy applies only to those carts, cabinets, shelves, Omni cells and storage areas that are stocked and replenished by CD staff. Policy.: CD staff will be responsible only for verifying expiration dates in this flight carts, cabinet shelves, omni sells and storage areas that they replenish on a regular basis. Cards, cabinet shelves, Omni sells and storage areas containing supplies will be inspected for outdated products at least every 12 weeks. Any product, excluding consignment or graph tracker. That will be expiring in the following 90 days will be removed at the item's location. CD staff must communicate with CD supervisor, inventory supervisor and this applying chain System Administrator and the surgery materials coordinator went items have been flagged or removed from a location. All outdated consignments. Graph tracker or serial number tracking consignment. Items are to be removed. Taken to central distribution and documented in the team's log, the outdated item must be set aside for either the supply chain System Administrator or surgical. Materials coordinator to check. A list of mute items would be sent to specific areas. Management...."

During a review of the facility's policy and procedure (P&P) titled, "Circulating Team Member Responsibilities", dated 11/2023, indicated, "PURPOSE: To provide guidelines for safe, coordinated activities involved with patient care during surgical procedures by the circulating registered nurse (RN). Outcome: The RN provides a safe and sterile environment for the patient during surgical procedures.... Policy: 1. It is the responsibility of the circulating nurse: A. To maintain standards to ensure aseptic technique at all times. B. To have all necessary supplies and equipment in readiness for the operative procedure. C. To ensure all instruments, sharps and sponge counts are correct.... Procedure: 1. Prior to surgical procedure: ... I. Assist scrub member with solutions, equipment, supplies, and surgical counts.... 2. During the surgical procedure... H. Charge for sterile processing department (SPD) supplies special equipment. Medications, implants, blades, and burs on appropriate chart sheet..."

During a review of the facility's P&P titled, "Scrub Team Member Responsibilities", dated 11/2023, indicated, "PURPOSE: To provide guidelines for optimal patient care and safety in the surgical room. Outcome: The scrub team member will provide a sterile, safe environment during a surgical procedure.... Policy: 1. A scrub person will be assigned to operative procedures and will be responsible for providing assistance to physicians and their assistance. If present during operative procedures.... procedure: 1. Prior to surgical. Procedure: ... B. Assist in organizing special supplies and equipment for cases prior to scrubbing. C. Check equipment for proper functioning and ensure necessary equipment is available. D. Assist with opening of supplies... I. Set up surgical table in an organized way so equipment supplies can be used quickly and efficiently. J. Count sharps, sponges, and instruments with circulating nurse prior to procedure..."

3. During a concurrent interview and record review on 8/1/24, at 3:19 p.m., Pt 43, Pt 44, Pt 45, and Pt 46's Face sheet, Case Information, Anesthesia Record and Proctoring Forms were reviewed with the Director of Perioperative Services (DPS). The DPS stated the circulating nurse should be documenting anyone in the Operating Room (OR) and their in and out times while in the OR. The DPS confirmed both the name of the Proctor and the in and out times for the Anesthesia providers for Pt 43, Pt 44, Pt 45, and Pt 46 were missing on the Case Information (includes the names and roles of all staff present during surgery) and on the Anesthesia Records dated 7/29/24. The DPS confirmed Certified Registered Nurse Anastasis (CRNA) 2 as the only Anesthesia provider listed in the Operating Room (OR) and on the Anesthesia Records dated 7/29/24 for all four patients and per the Proctor form dated 7/29/24 CRNA 2 was proctored by CRNA 14.

During an interview on 8/2/24, at 12:30 p.m., with the Director of Anesthesia Services (AMD), the AMD stated when they are proctoring a provider the proctor does not usually put their name on the Anesthesia record. The AMD stated the circulating nurses should be documenting what providers are in the room along with the providers in and out times. The AMD stated the proctor's name is usually documented on the Proctor form. The AMD stated he expects the proctor forms to be filled in completely.
During a review of the facility's P&P titled, "Surgical Services Policy & Procedure" titled, "Documentation, Intraoperative" dated last reviewed Nov. 2023, indicated, "PURPOSE: To provide an accurate account of the intraoperative phase of the surgical patient's care. OUTCOME: Documentation is correctly and completely maintained during the intraoperative phase of the surgical patient's care. POLICY: ... 4. All persons involved in the surgical procedure will be documented to include full name, title, company, or school name if applicable, and the times in and out of the OR ... 3. Case Attendees A. All surgical team members are entered in this area, including their name, role, and times they begin and end patient care. B. Document the full name of sales representatives, students, anyone who is not on the list of Case Staff, Include company or school name if applicable ..."

4.During a concurrent observation and interview on 7/25/24 at 11:15 a.m., while in Operating Room (OR) 4 with the OR Manager (MG) 1, a blue painted cauterization cart was seen with multiple areas of chipped paint and reddish-brown areas on the metal handle and the front left wheel of the cart had reddish brown substance that came off when touched. MG 1 stated that the substance on the wheel of the cart looked like rust. MG 1 stated this cart was an infection risk to the patients that have surgery.

During an interview on 7/30/24, at 12:18 p.m. with the Chief Nursing Officer (CNO), the CNO stated equipment with rust should not be in the surgical suites, it should have been disposed of (referring to the blue cauterization cart). The CNO stated this is an infection risk to the patient.

During a review of the facility's policy and procedure (P&P) titled, "Circulating Team Member Responsibilities", dated 11/2023, indicated, "PURPOSE: To provide guidelines for safe, coordinated activities involved with patient care during surgical procedures by the circulating registered nurse (RN). Outcome: The RN provides a safe and sterile environment for the patient during surgical procedures.... Policy: 1. It is the responsibility of the circulating nurse: A. To maintain standards to ensure aseptic technique at all times. B. To have all necessary supplies and equipment in readiness for the operative procedure. C. To ensure all instruments, sharps and sponge counts are correct.... Procedure: 1. Prior to surgical procedure: ... I. Assist scrub member with solutions, equipment, supplies, and surgical counts...."

During a review of the facility's P&P titled, "Scrub Team Member Responsibilities", dated 11/2023, indicated, "PURPOSE: To provide guidelines for optimal patient care and safety in the surgical room. Outcome: The scrub team member will provide a sterile, safe environment during a surgical procedure.... Policy: 1. A scrub person will be assigned to operative procedures and will be responsible for providing assistance to physicians and their assistance. If present during operative procedures.... procedure: 1. Prior to surgical. Procedure: ... B. Assist in organizing special supplies and equipment for cases prior to scrubbing. C. Check equipment for proper functioning and ensure necessary equipment is available ..."

5. During a concurrent observation and interview on 7/22/24 at 4 p.m. with Manager (MG) 2 in the Labor and Delivery OR 1, the anesthesia cart had an expired [brand name] certified airway exchange catheter (thin tube used in certain surgeries and medical procedures). MG 2 stated, the catheter expired on 7/20/24 (2 days ago). MG 2 stated, it was the anesthesia technician's responsibility to check the anesthesia cart for restocking and expired products. MG 2 stated, the department does not have access to the anesthesia cart and the anesthesia technicians had the key. MG 2 stated, the catheter should have been pulled from the anesthesia cart because it was expired. MG 2 stated, it was important to go based on the manufacturer's expiration dates and the sterility of the product cannot be determined after the expiration date. MG 2 stated, the integrity of the catheter could be compromised, and it was a patient safety issue to use expired products.

During an interview on 7/25/24 at 12:17 p.m. with Anesthesia Technician (AT) 1, AT 1 stated, anesthesia technicians were responsible to change supplies in the "difficult airway cart (anesthesia cart)" AT 1 stated, there was no schedule of when the difficult airway cart was checked. AT 1 stated, every three months during downtime an anesthesia technician would go to check the anesthesia carts. AT 1 stated, the product could be compromised if used past the expiration date. AT 1 stated, he expected products to be replaced before the expiration date.

During an interview on 7/25/24 at 3:20 p.m. with the Director of Infection Prevention (DIP), the DIP stated, the sterility of a product is guaranteed before the expiration date and could pose an infection risk if used after the expiration date. The DIP stated, there should be multiple checks on expiration dates, but the end user was responsible to check for the expiration date before the product is used.

6. During a concurrent observation and interview on 7/22/24, at 11 a.m., with the Director of Perioperative Services (DPS), while on the second floor of the hospital outside of the elevators two of two staff members were seen in blue surgical attire and blue booties to cover their shoes walking down the hallway. The DPS stated the blue booties should not be worn outside of the procedural areas. The DPS stated there is a risk for cross contamination from the booties worn out of an OR into the hallways and from substances outside the ORs worn back into the ORs. The DPS stated it is an infection control risk.

During an interview on 7/30/24, at 12:16 p.m. with the CNO, the CNO stated the expectation for where surgical attire should be worn (i.e. booties) is behind the red line and not on the other side of the red line (indicating they should stay in the procedural areas). The CNO stated the risk to patients and staff when this is not done is cross contamination.

During a review of the facility's P&P titled, "Attire in Restricted and Semi-Restricted Areas" dated 10/2023, indicated, "PURPOSE: To provide guidelines for surgical attire including jewelry, clothing, shoes, head covering, masks, jackets, and other accessories worn in the restricted and semi restricted areas of the surgical or invasive procedure setting. To promote work safety and a high level of cleanliness and hygiene within the perioperative environment. Outcome: Appropriate attire is worn in the restricted and semi restricted areas of [name of hospital] ... POLICY: 1. Employees, physicians, vendors, and observers, including students entering restricted and semi restricted areas will wear clean [name of hospital] provided surgical attire that has been laundered by a health care accredited laundering facility ... PROCEDURE: 1. Restricted Areas: ... B. Headwear: ... ii. Cover hair completely and replace headwear when contaminated ... D. Footwear: ... iii. Shoes worn outside the facility must be covered by shoe covers before entering the restricted semi restricted area. Shoe covers must be removed prior to leaving the restricted semi restricted area... H. Jewelry and accessories... 6. Remove surgical masks, head coverings and shoe covers when leaving the semi restricted areas..."