HospitalInspections.org

26632

Based on observation, interview, and record review, the governing body failed to effectively govern the conduct of the hospital to ensue safe healthcare was provided to patients. Findings include:

1. The provider failed to ensure an effective data driven quality assessment and performance improvement program (QAPI) Condition of Participation (CoP) by:
*Identifying concerns for two of two provider-based departments (Mallard Pointe and Urology Clinic) had been recognized.
*Ensuring pharmacy had been involved with the QAPI process for ongoing monitoring and review of medication preparation and standing orders.
*Ensuring dialysis bacteria testing and monitoring had been conducted for hemodialysis machines and one of one reverse osmosis (RO) machine.
*Ensuring the infection control program was actively involved in one of one clinic (Urology) disinfection process for endoscopes and probes.

Refer to A263, A489, A747, and A940.

2. The provider failed to effectively follow the Nursing Services CoP to ensure:
*One of one sampled trauma patient (2) with a gunshot wound, had received the correct dose of etomidate (anesthesia medication) by one of one emergency room (ER) registered nurse (RN) U and one of one certified registered nurse anesthetist (CRNA) M.
*Etomidate used for general anesthesia by one of one CRNA M for one of one sampled trauma patient (2) had not been delegated to ER RN U.
*A medication error had been reported to the nursing supervisor by CRNA M after it had been discovered.
*The provider's reference for professional standards had been followed related to verbal medication orders.
*Patient 2's trauma record had been thoroughly reviewed after the patient had expired in the emergency room.
*Oversight and monitoring related to medication administration for one of one sampled patient (2) who had received trauma services for a gunshot wound.
*Trauma surgeon (X) and RN U had current advanced cardiovascular life support and basic life support certifications.

Refer to A385 and A489.

3. Phone interview on 7/14/22 at 2:40 p.m. with medical director I revealed:
*Issues that had been identified related to nursing services, infection control, lack of pharmacy oversight at Mallard Pointe, and high-level disinfection at the Urology Clinic were discussed.
*Had not had much involvement with any of the above areas.
-He stated they would immediately get to work addressing the issues identified.

4. Review of the revised April 2019 Governing Body Bylaws revealed:
*The board of directors ensured the objectives of making high quality health care resources were available to the community and provide exceptional health care services to patients.
*"The Quality Committee oversees the quality of care and patients safety of the organization. Responsibilities include adopting policies and plans to manage quality and patient safety, review clinical performance against established targets, review specific performance improvements activities, monitor patient satisfaction, and provide a forum for emerging issues such as newly released quality standards."

Based on observation, interview, record review, policy review, Quality Assessment and Performance Improvement (QAPI) plan review, the provider failed to meet the Condition of Participation for QAPI when they failed to:
*Include two of two provider based-departments (Mallard Pointe and Urology Clinic) in the QAPI process.
*Ensure pharmacy had been involved with the QAPI process for ongoing monitoring and review of standing orders for one of two provider-based departments (Mallard Pointe).
*Ensure procedures and monitoring were followed for bacterial water testing of the dialysis machines and portable reverse osmosis (RO) used to perform acute dialysis.
*Ensure the infection control program for acute dialysis, Mallard Pointe, and Urology Clinic had been included in the QAPI process.
Findings include:

1. Observations, interviews, record reviews, and policy reviews revealed the process for anesthesia during cataract surgery had not followed medication use guidelines. Mallard Pointe was not included in any pharmacy monitoring or quality assurance projects.

Refer to A489, finding A.

2. Observations, interviews, bacterial water testing record reviews, and policy reviews, revealed bacterial water testing for one of one portable RO machine for acute care dialysis had not been completed.

Refer to A747, finding A.

3. Interviews on 7/13/22 from 9:15 a.m. through 10:30 a.m. with RN Y, RN Z, and urology clinic director AA in the urology clinic revealed the manufacturer's instructions for leak testing flexible endoscopes and high-level disinfection with MetriCide OPA (ortho-Phthalaldehyde) Plus for the endocavity ultrasound probe had not been followed.

Interview on 7/14/22 at 2:30 p.m. with infection control coordinator O and director of quality L confirmed that neither program had an active role in overseeing the leak testing flexible endoscopes or high-level disinfection with MetriCide OPA Plus for the endocavity ultrasound probe in the urology clinic.

Refer to tag A940.

4. Interview on 7/14/22 at 3:30 p.m. with chief nursing officer (CNO) B and director of quality L revealed:
*There was no actual QAPI committee that met to discuss performance improvement (PI) projects.
*Each hospital department would have their own PI projects and QAPI was only involved if the department required assistance to set the project up.
*There was a hospital reporting site that most departments referred to for PI projects.
*The quality dashboard was shared with the medical executive committee (MEC) and the governing body during their meetings.
-No guidance was usually received on the QAPI program.
*Director of quality L would not have been able to manage all the QAPI projects each department might have started.
*She did not have a list of what QAPI projects were in place for the hospital departments.
*Each department was to monitor their own QAPI projects and director of quality L was available to assist as needed.
*They both attended the medical executive committee (MEC) meetings.
-The items on the quality dashboard were the only quality related information shared with the MEC.

5. Review of the provider's quality dashboard areas addressed from the first quarter of 2021 through the first quarter of 2022 revealed:
*Findings related to Mallard Pointe and the Urology Clinic had not been included.
*The only area for pharmacy services was for medication errors.
*The quality dashboard was the only QAPI item reviewed.

Review of the 5/18/22 medical executive committee (MEC) minutes revealed "Discussion was held around contributing factors to medication errors and how they are reported and investigated." No recommendations had been given.

Review of the provider's revised June 2022 Quality Management Plan included:
*"The purpose of the organization's quality management plan is to provide a systemic, organization-wide approach to measuring and analyzing performance in order to improve patient outcomes."
*The quality management objectives included to:
-"Integrate performance improvement activities into day-to-day operations."
-"Apply performance improvement principles in the design of new services or processes."
-"Monitor performance through data collection, measurement, and analysis."
-"Provide criteria for prioritizing performance improvement projects."
-"Provide methods for improving and sustaining organizational performance."
*"Designated staff has responsibility for coordinating and monitoring activities and reporting levels of performance."
*"There is an ongoing evaluation of services through a collaborative and interdisciplinary approach that may include review by committees, projects teams, and departments. Departmental review and evaluation of key performance indicators assures broad participation in performance improvement activities."
*The performance improvement process was designed to accomplish the following:
-"Assess and measure performance."
-"Identify significant variations in performance."
-"Determine the need for corrective action."
-"Identify priorities for performance improvement."
-"Implement changes to improve performance."
*"The Director of Quality and Risk Management provides primary leadership to coordinate quality management activities across the organization."
*Participants who have responsibilities in performance improvement included:
-The board of directors.
-Administration.
-Medical executive committee.
-Chief nursing officer.
-All hospital employees.
-Department directors.
*Reports of findings, conclusions, recommendations, and actions take to improve performance were made available to the board of directors, administrative, management staff, medical staff, committees, project teams, and departments.
*Minimum reporting established by the board of directors required a quarterly display of a quality dashboard.
*The dashboard allowed for reporting performance on a variety of quality indicators.
*"Performance Surveillance System - Patient Care. Clinical Outcomes (Focus areas for Measurement Activity)." Those areas included:
-Adverse drug events.
-Surgical care.
-Dialysis.
*Clinical functions included:
-Infection control.
-Medication use.
-Medical staff peer review.
-Occurrence investigation.

Based on observation, interview, record review, and policy review, the provider failed to ensure:
*One of one sampled trauma patient (2) had received the correct dose of anesthesia medication by one of one emergency room (ER) registered nurse (RN) U and certified registered nurse anesthetist (CRNA) M.
*Medication used for general anesthesia by one of one CRNA M on one of one sampled trauma patient (2) had not been delegated to ER RN U.
*A medication error had been reported to nursing supervisor by CRNA M after discovery.
*Verbal orders had been repeated back to ensure accuracy to prevent a medication error.
*Oversight and monitoring related to nursing services had been provided during a trauma for one of one sampled patient (2) related to a gun shot wound.
*Trauma surgeon (X) and RN U had current advanced cardiovascular life support and basic life support certifications.
Findings include:


45383


1. Closed record review of patient 2's ER visit on 5/13/22 revealed:
*She had arrived at the ER on 5/13/22 at 4:40 p.m. via ambulance service with a gunshot wound to the right side of her head.
-Trauma activation had been requested by ambulance personnel prior to arrival at the ER.
*She had a pulse and blood pressure and was assisted with breathing via bag valve-mask.
-Intraosseous (IO) (IV started in a bone) (IV) had been initiated by ambulance personnel.
*Certified registered nurse anesthetist (CRNA) M had been waiting in the trauma room for patient 2's arrival.
*CRNA M performed rapid sequence intubation (RSI).
*Ketamine and etomidate (sedation medication) had been given in the ER, via IV prior to intubation.
*An incorrect dose of etomidate had been administered.

Review of patient 2's 5/13/22 progress notes by CRNA M revealed:
*Ketamine 100 milligram (mg) per 2 cubic centimeter (cc) and etomidate 10 mg per 5 cc to be given IO IV by RN U.
*"RN U had been noted to have given etomidate 22 mg per 11 cc instead for intubation."

2. Interview on 7/14/22 at 11:30 a.m. with CRNA M and chief nursing officer (CNO) B regarding medication given to patient 2 revealed CRNA M:
*Had been called to the ER for a trauma code and intubation.
*Had Ketamine and etomidate drawn-up in separate syringes.
*Would have administered medication she prepared.
-Due to the placement of the access in patient 2's leg, she had given a verbal order to RN U for etomidate 10 mg per 5cc IO but noticed she had given more than should have been given.
*Etomidate 22 mg per 11 cc should have been given.
*12 mg more of etomidate had been given to patient 2 than what had been ordered.
*Stated, "technically that was not an overdose of medication, it is still an appropriate dose."
*Had not thought it was a medication error and was not reported.
*Agreed it was not the dose she had ordered to give.
*Agreed the dosing documentation used by the provider for etomidate stated the dose exceeded the amount for an unstable patient.
*Stated, "I feel that she was stable enough for the dose of medication administered."
*Stated she could state that patient 2 was "hemodynamically stable."
-Agreed that the patient had a gunshot wound to her head, but her vitals signs had been stable.
*Had informed the ER physician of the amount of medication administered.

Interview on 7/14/22 at 12:20 p.m. with RN U and CNO B regarding IO medication administration revealed RN U:
*Had been given the order verbally to administer Ketamine and etomidate due to location of the IO IV in the patient's leg.
-RN U had been standing by the IO located on the patient's leg.
*Had been aware the medication was used for intubation.
*Stated it was common for her to administer those medications in the ER.
*Had verified what medications were in the syringes with CRNA M, but had not been given a specific dose to administer.
*Remembered CRNA M stopped her while administering etomidate.
*Believed she was to administer the whole syringe of etomidate, since there was no dose verbalized.
*Would have repeated verbal orders given back to the provider to prevent misunderstanding.
*Realized that too much medication had been administered after the trauma code was over.
*Agreed that she had not given the ordered dose.
*Agreed this was considered a medication error.
*Stated her advanced cardiovascular life support (ACLS) and basic life support (BLS) certifications had been expired since 2020.
*This was due to COVID-19.
* Refer to A043.

Interview on 7/14/22 at 2:15 p.m. with ER director V and CNO B regarding medication order and administration in the ER revealed ER director V:
*Had reviewed patient 2's ER record.
*Had not noticed any discrepancies.
*Had a trauma nurse leader that would have reviewed charts, but she was on leave.
*Was filling in for the trauma nurse leader in her absence.
*Stated, "Registered nurses would administer that medication under the supervision of a physician."
-Ketamine and etomidate.

3. Review of the provider's emergency service registered nurse's job description dated August 2015 revealed:
*Administration of prescribed medication and treatments were in accordance with approved nursing techniques.
*The RN assessed patients, recorded significant conditions and reactions, and notified the supervisor or physician of patient's condition and reaction to drugs, treatments, and significant incidents throughout the progression of care.
*Nursing care for all patients were provided in accordance with established standards, policies, procedures, licensure, and scope of practice of the RN.
*Certificates, licenses, registrations required are as follows: cardiac pulmonary resuscitation (CPR), ACLS, emergency nurse pediatric course or pediatric advanced life support, and trauma nurse core course.

Review of certification of five trauma team staff employees revealed:
*Trauma surgeon X BLS and ACLS ceritfication had expired in 2021.
*RN U BLS and ACLS certification had expired in 2020.

Review of the provider's May 2018 Medscape Advance Cardiac Life Support rapid sequence induction for intubation revealed:
*"Negative outcomes have been seen with etomidate use for intubation in trauma patients; prospective data was used in this study. Retrospective studies have also shown an increase in mortality, though this may have resulted from patient selection."
*"Etomidate can provoke seizures in patients with a seizure history or with head injury."

Review of the provider's November 2021 safe medication administration practices revealed:
*"...A medication error refers to a mistake that occurs during the medication administration process. If a mistake occurs, it doesn't matter whether the patient suffered harm or there was a potential for injury-its still considered a medication error. "
*"Minimize the use of verbal orders, because they're especially susceptible to error."
*"Have the practitioner repeat and verify the verbal order."
*"Record the verbal order in the patient's medical record, and make sure to include the date and name of the practitioner who gave the verbal order, your name as the person who received and recorded the order, and the name of the person who implemented the order."
*"Read back the order to the practitioner as you've written it down to confirm correct documentation."

Review of provider's February 2022 Medical Staff Rules and Regulations revealed:
*Anesthesia: moderate or deep sedation and anesthesia may only be provided by qualified practitioners who have been granted clinical privileges to perform these services.
*Verbal/telephone orders are discouraged and should be reserved for those situations when it is impossible or impractical for the practitioner to write the order or enter it in a computer.
*Verbal orders are those orders given face-to-face by privileged practitioner to hospital personnel when it is impossible for the privileged practitioner to enter into the order entry system.

45383

A. Based on observation, interview, record review, and policy review, the provider failed to ensure pharmacy services had:
*Provided oversight, monitoring, a process for standing orders being used at Mallard Pointe, by one of one ophthalmologist H for cataract surgeries.
*Provided oversight and monitoring of medication used for irrigation during patient 1's cataract surgery.
*Provided oversight and monitoring of single-use vials of medications used on multiple patients.
Findings include:

1. Observation on 7/12/22 at 7:30 a.m. of registered nurse (RN) P administering eye drops to patient 1's right eye revealed:
*She used a syringe to administer eye drops.
*After she had administered the eye drops, she handed the syringe of medication to the certified registered nurse anesthetist (CRNA) M.
-CRNA M placed the syringe of medication in her front scrub pocket.

Observation on 7/12/22 at 8:10 a.m. of CRNA M administering medication revealed she had retrieved a syringe from her scrub uniform pocket and instilled two drops of medication to patient 1's right eye.

Review of patient 1's 7/12/22 cataract order revealed, "Sensorcaine 0.75% two drops in right eye; repeat in three or more minutes for four doses" had been ordered.

Interview on 7/12/22 at 9:40 a.m. with RN P regarding obtaining Sensorcaine 0.75% eye drops revealed:
*The medication had been provided from pharmacy in twenty milliliter (mL) single use vials.
*The medication would be drawn up in a three cubic centimeter (cc) syringe.
-Each patient would have had their own syringe of Sensorcaine.
*She stated that she did not date the Sensorcaine vial after opening; it would be discarded at the end of the day.
*The same single-use vial of Sensorcaine would be accessed multiple times, depending on the number of cataract surgeries.
*This had been the practice used at Mallard Pointe.

Interview on 7/12/22 at 9:50 a.m. with CRNA M regarding medication administration revealed:
*She typically would not administer medication that had been drawn up by another nurse.
*She had been sure of the contents in the syringe and administered the medication.

Interview on 7/12/22 at 4:10 p.m. with pharmacist G regarding route of administration for Sensorcaine 0.75% revealed:
*Sensorcaine 0.75% 20 mL single-use vials had been supplied to Mallard Pointe for surgical procedures.
*She had not been aware the medication was being administered as an eye drop and the vial was being accessed multiple times.
*She stated "they should not be dropping that medication in the eye, that would be a bad idea."
-It was not intended for ophthalmic use.
*She stated it should be discarded after single- use.
*The manufacturer's recommended route of Sensorcaine 0.75% administration was injection.
*She had not been aware that a provider had ordered Sensorcaine to have been administered via that route.

Interview on 7/12/22 at 4:30 p.m. with pharmacy director D regarding medication administration and supply for Mallard Pointe revealed, she:
*Had not seen the doctor's orders for procedures at Mallard Pointe.
*Stated the pharmacy does not verify the procedure orders for Mallard Pointe.
*Had not been aware of the route of administration and usage of Sensorcaine 0.75% by the staff at Mallard Pointe.
*Had never seen Sensorcaine administered directly to the eye before.
*Supplied Mallard Pointe with medications upon request and wasted controlled substances as needed.

Interview on 7/13/22 at 8:25 a.m. with director of anesthesia services E and CNO B regarding route of administration of Sensorcaine 0.75% revealed:
*The usage of medication would have been an "off label" use as an eye drop administration.
*They typically followed medication label instructions provided by the manufacturer.
*He had not been to Mallard Pointe in a long time, and had not been sure of the standing orders for cataract procedures.
*Keeping medication in a shirt pocket and administering medication that had been drawn up by another person, were not appropriate medication administration practices.

Interview on 7/13/22 at 11:47 a.m. with ophthalmologist H regarding administration route of Sensorcaine 0.75% revealed:
*He had used a retired physician's order of Sensorcaine 0.75% topically as an eye drop.
*Patients experienced good pain relief with the usage of Sensorcaine as an eye drop.
*His order for usage of Sensorcaine was an "off label" usage, and agreed that education should have been provided to patients.
*He was not aware the single-use vials of Sensorcaine were being accessed multiple times by staff.
*Stated, "the chance of contamination with usage of single-use vial is low."
-"It's a sterile procedure accessing a vial."
*He had not been questioned by staff regarding the route of administration for Sensorcaine.

Interview on 7/14/22 at 2:22 p.m. with surgery and Mallard Pointe director Q and CNO B regarding ophthalmologist H's cataract orders revealed:
*The orders had not been in policy stat (process for approval of protocol orders) for approval for protocol orders.
*Had been unsure why the orders had not been approved for protocol orders.
-Protocol order would have been reviewed by pharmacy services and brought to the medical executive committee for approval.
*Agreed that ophthalmologist H's cataract order should be protocol orders.
-Staff had not thought about that.
*They agreed Ophthalmologist H uses the same set of orders for each cataract patient and has for many years.
*He had treated approximately eight patients per week for the last five years.
*Their pharmacy provided the medication for his procedures.

Review of provider's October 2019 Protocol Orders revealed:
*"Protocol orders will be developed using evidence based practice."
*Protocols will be approved by nursing leadership, pharmacy leadership, and medical staff.
*Protocol order that is a department specific order, it will be approved by the department chair.
*Protocol orders will be reviewed at least annually and as needed.
*Protocol orders will be dated, timed and authenticated promptly in the patient's medical record by the ordering practitioner or practitioner responsible for the care of the patient.

2. Observation on 7/12/22 at 8:37 a.m. of RN S removed an unmarked saline bag from operating room (OR) three to administer to patient 1.

Review of the 7/12/22 report of operation for patient 1 dictated by ophthalmologist H revealed:
*A 500 mL bag of normal saline containing 0.4 milligram (mg) of epinephrine 1:1000, 4.0 mg of Gentamicin, and 5 mg of Vancomycin had been used to irrigate patient 1's right eye.

Interview on 7/14/22 at 10:45 a.m. with RN T regarding medication mixed in normal saline 500 mL bags revealed:
*She had added epinephrine 1:1000, 4.0 mg of Gentamicin, and 5 mg of Vancomycin to the normal saline bag that morning before the procedure.
*This was the normal routine at Mallard Pointe.
-Order with prescribed medication for patient 1 had not been provided initially with standing orders, RN T verbally described order used for irrigation bag.
*She agreed Ophthalmologist H used this medication with every procedure and has for many years.

Phone interview on 7/14/22 at 10:45 a.m. with RN S revealed:
*She used a compounded bag of solution to irrigate patient 1's eye during the cataract surgery.
*She believed she had marked the bag of saline showing the different medications in the bag.

Review of the provider's November 2021 Medical Staff Bylaws revealed the providers:
*"Perform medication usage evaluation studies."
*"Perform practitioner analysis related to medication use."
*Medical Staff would develop and measure indicators for prescribing and ordering of medications and preparing and dispensing of medications.
*"Establish standards concerning the use and control of investigational medication and of research in the use of recognized medication."

B. Based on observation, interview, record review, and policy review, the provider failed to ensure:
*There was monitoring and accountability of medications stored in one of two anesthesia carts in one of two operating rooms (OR) located at Mallard Pointe.
*One of two sharps container located in one of two ORs at Mallard Pointe had been secured from unauthorized staff.
Findings include:

1. Observation and interview on 7/12/22 at 7:20 a.m. in OR 3 with certified registered nurse anesthetist (CRNA) M, RN K, and RN W revealed:
*There was a free-standing sharps-container, sitting on the floor.
*There were multiple vials full of a white, milky substance.
*CRNA M had confirmed the vials were Propofol.
*Propofol was a medication at high-risk for diversion.
*The OR was unlocked and maintenance and other staff not authorized to access Propofol had access to the OR.
*They removed what they needed for a procedure and discarded the rest in the sharps container.

2. Observation on 7/12/22 at 8:45 a.m. in OR 1 revealed:
*The anesthesia cart had been left unlocked and unattended.
*In the cart there was:
*11 vials of Propofol.
*One vial of Ketamine.
*One vial of Precedex.
*12 vials of Toradol.
*All four medications had the capability to alter a patient's mental status.
-They were considered high-risk medications as they were subject to diversion.

Interview on 7/12/22 at 9:15 a.m. with CRNA M revealed she thought she had locked the anesthesia cart in OR 1.
*She agreed the anesthesia should have been locked.

Interview on 7/12/22 at 9:30 a.m. with RN K revealed:
*The anesthesia cart was to be locked at all times.
*She collaborated with pharmacy to order and restock medications.
*They do not keep a record of what medications are stored in the anesthesia cart.
*They have a list of par (standard level) of medications for:
-The anesthesia room.
-The post-operative room.
-OR 3.
-OR desk.
*They did not have a list for the medications in the anesthesia cart in OR 1.
*They did not have a list of the current amounts of these medications kept in OR 1.
*She agreed, Propofol, Ketamine, Precedex, and Toradol were not controlled medications but they could be subject to diversion.

Interview on 7/12/22 at 4:22 p.m. with pharmacy director D revealed:
*She had not been in the OR at Mallard Pointe.
*She goes to Mallard Pointe to deliver medications.
*Anesthesia carts were to be locked when unattended.
*Sharps containers were to be secured.
*Diversion could happen with the medications in the anesthesia cart.
-It would be useful to keep an accurate listing of what is supposed to be in the anesthesia cart.
*They keep scheduled two narcotic medications double-locked per pharmacy regulations.
*She agreed they still needed to follow federal regulations related control and accountability of medications.

Interview on 7/13/22 at 8:25 a.m. with director of anesthesia services E and CNO B revealed:
*The anesthesia carts were to remain locked.
*Sharps containers were to be secured.
*They should monitor how much medication was kept in the anesthesia cart and its usage.

Phone interview on 7/14/22 at 2:40 p.m. with medical director I revealed:
*Surveyors discussed the issues found at Mallard Pointe and lack of pharmacy oversight at Mallard Pointe.
-He stated they would immediately get to work addressing the issues identified.

Review of the providers April 2022 and May 2022 Medical Executive Committee (MEC) minutes revealed:
*"Protocol orders are allowed within the CMS Conditions of Participation provided they meet the following criteria; the orders are created with physician and pharmacy input, indications for use of the protocol orders are clear to the staff that would be utilizing the orders, relatively low risk in the degree of patient assessment required to select as appropriate order and they are reviewed on a periodic basis."
-They had reviewed some pre-operation anesthesia orders for Mallard Pointe, these were not the protocol orders for Ophthalmologist H.

Review of the provider's June 2021 Medication Administration policy revealed, "The medication cart/room/storage area will be kept locked at all times when not in use."

Review of the provider's July 2020 Medication Storage and Security policy revealed:
*"It is the responsibility of authorized personnel to assure that the security of medications in the departmental storage areas is not compromised. Any breach in this security should be corrected immediately and report to the department director/ designee and Pharmacy Director/designee."
*"All medications will be checked monthly for short dating."
*"Departments with a large stock of medications will be checked by Pharmacy."
*"Anesthesia, Cancer Center, Mallard Point[e], Radiology, Respiratory Therapy, and Surgery will check their stock medications."

Review of the provider's May 2022 Wasting Controlled Substances policy revealed:
*Schedule III medications, "controlled substances have an accepted medical use but have a moderate potential for abuse, which may lead to low or moderate physical dependence or high psychological dependence..."
*"Proper wasting of controlled substances can also help prevent diversion. Although hospital pharmacies must adhere to strict U.S. Drug Enforcement Administration regulations on proper disposal of controlled substance inventory..."
*"Disposal of controlled substances may occur by 'sewering' (squirting them into a sink drain or by flushing them down a toilet), although 'sewering' may be prohibited by some state or local regulations, or by placing them in a commercially available tamper-resistant pharmaceutical waste container that renders them irretrievable and deactivates them to make them unusable."
*This was applicable to all controlled medications.

Review of the provider's September 2021 Protocol Orders revealed:
*"The term 'standing order(s)' is used interchangeably with protocol orders."
*"Protocol orders permits treatment to be initiated by license staff without a prior order. Treatment can be initiated when a patient's condition meets certain pre-defined clinical criteria."
*"Protocol orders will be developed using evidence based practice."
*"Protocols will be approved by Nursing leadership, Pharmacy leadership, and Medical Staff."
-"If the protocol order is a hospital wide protocol it will be approved by the Medical Executive Committee (MEC)."
-"If the protocol order is a department specific protocol it will be approved by the department chair."
*"Protocol orders will be reviewed at least annually and as needed."
*"Proof of approval and review will be documented on each protocol via policy stat, MEC, or Medical Committee meeting minutes."
*"Protocol orders will be dated, time and authenticated promptly in the patients medical record by the ordering practitioner or practitioner responsible for care of the patient."
*"Protocol orders will be entered into the patients medical record at the time of initiation, or as soon as possible."
*"Protocol orders shall adhere to the applicable elements for orders as outlined in the Practitioner Orders policy."

25107




42477

A. Based on interview, record review, policy review, and manufacturer's instructions, the provider failed to ensure:
*Bacterial testing and monitoring of hemodialysis machines and one of one portable reverse osmosis (RO) machine used to perform acute inpatient dialysis had been completed.
*Start-up RO machine checks and monitoring had been completed prior to patient use.
Findings include:

1. Interview on 7/13/22 at 9:20 a.m. with dialysis director J revealed:
*They offer acute dialysis services to patients at the hospital.
*Acute dialysis patients normally run in the outpatient chronic dialysis unit.
*Some patients received dialysis on the critical care unit (CCU).
*They had a portable RO machine and would hook up machines for patients to run on the CCU unit when needed.

Review of 2021 and 2022 bacteria cultures for dialysis machines and portable RO machine revealed:
*The portable RO machine had no documented bacteria cultures or bacteria testing for 2021 or 2022.
*There were twelve dialysis machines listed on the 2021 culture report, four machines had missing cultures.
*There were twelve dialysis machines listed on the 2022 culture report, four machines had missing cultures.

Review of additional documentation provided by dialysis director J revealed:
*He had received additional documentation from his biomedical staff.
*Portable RO machine had documented cultures for 2021 and 2022.
*There were still dialysis machines that did not have documented results.
*There were months in 2021 and 2022 with missing cultures.

Interview on 7/14/22 at 8:45 a.m. with dialysis director J revealed:
*They needed a more organized system to keep tract of the culture test results.
*There were some gaps in their documentation of dialysis machines and RO culture results.
*They were working to address the deficient practice right away.

Phone interview on 7/14/22 at 11:00 a.m. with dialysis medical director F revealed:
*She signed off on the bacteria cultures for the chronic unit, she was not sure about the bacteria cultures for acute dialysis.
-She was unable to recall receiving and signing the culture results for the acute inpatient dialysis machines or the portable RO.
*The water and dialysate quality should have been monitored.

Review of the provider's undated Portable RO Start-up protocol revealed:
*The following steps should have been completed when connecting the portable RO machine to the water source:
-RO checks would be completed.
-Conductivity would be documented.
-Percent rejection of RO machine would be documented.
-Hardness water sample would be obtained, checked, and documented.
-Chloramine water sample would be obtained, checked, and documented.
-Temperature would be documented.
*The portable RO start-up documentation had been missing for four of the ten documented acute dialysis runs.

Review of the provider's July 2021 RO Water Quality Treatment and Monitoring policy revealed:
*A complete chemical analysis of post RO water should have been done annually and documented.
*A sample would be taken from a post RO water site and should have been sent to an approved lab for water analysis based on AAMI [the Association for the Advancement of Medical Instrumentation] Standards. The portable RO system should have had an annual analysis of product water.
*The bio-medical technician would oversee proper functioning and documentation of the RO water treatment system.

Review of the provider's March 2022 Acute Dialysis Policy revealed, "6. Machine checks will be done as normal including portable R.O. checks. Documentation is done on the patient flow record R.O. check list."

Review of the provider's July 2021 Microbiological Control and Sterilization policy revealed:
*"AAMI quality water will be maintained at all times and exceptions will have documentation as to actions taken and follow-up."
*"The Director and Medical Director will review all bacteriology and LAL [limulus amoebocyte lysate] reports."
*"Dialysis machines (dialysate): each machine done monthly with 1-2 machines sampled each week."
*"Portable RO-water monthly."
*"All bacteriology and LAL results will be trended on a Bacteriology Log Sheet (From Lab)."

Review of the Portable RO manufacturer's instructions revealed:
*The RO start-up log must be filled out completely each time the system is used.
*The user was responsible for monitoring of the water quality.

B. Based on observation, interview, record review, and policy review, the provider failed to ensure:
*Hand hygiene and glove use had been performed by one of one observed registered nurses (RN) (P) during one of one pre-operation assessment and medication administration for one of one sampled patient (1).
*Soiled, post-op surgical equipment was not carried through one of one clean supply room at the Mallard Pointe facility by one of one observed RN W.
*One of one observed RN P had not used a single-use medication vial for multiple patients receiving cataract surgery.
*One of one observed certified registered nurse anesthetist (CRNA) M had not taken a syringe that contained, anesthesia medication, out of her pocket and administered it to patient (1).
*Staff who had entered the operating rooms (OR) had clean personal protective equipment (PPE) on.
*Suction tubing had not been opened and connected prior to patient-use in one of two Mallard Pointe ORs and two of two Mallard Pointe post anesthesia care unit (PACU) bays.
Findings include:

1. Observation on 7/12/22 at 7:15 a.m. in OR 1 with RNs K and W revealed:
*Suction tubing had been hooked up and connected to a Yankauer suction tip.
-The paper around the Yankauer suction tip had been opened and left on to partially cover the attachment.
*There had been three partially used rolls of tape left on the anesthesia cart.
-The tape had visible lint and debris on the edges of the rolls of tape.

2. Observation on 7/12/22 at 7:25 a.m. of RN P administering pre-operative eye drops to patient 1 revealed she:
*Put the patient's blood pressure cuff and hair bonnet on.
*Pushed the patient's bangs up into the bonnet.
*Put on gloves without first performing hand hygiene.
*Administered more eye drops.
*Removed gloves, and assessed the patient's arm for intravenous (IV) access.
*Had not performed hand hygiene and put on a new pair of gloves and then placed an IV access in patient 1's left lower arm.

Interview on 7/12/22 at 7:35 a.m. with RN P revealed:
*They administer the eye drops every couple of minutes.
-They do not document the actual times eye drops were administered.
*She normally performed hand hygiene after removing and before putting on gloves.

Observation and interview on 7/12/22 at 9:39 a.m. with RN P revealed:
*They draw up Sensorcaine from a single-use vial.
-They would access the vial multiple times depending the number of procedures.
*She agreed the vial stated it was for single-use only.
*They do not date and time when the vial was opened.
*They were supposed to date and initial when the vial was opened.
*It is common practice among the staff to throw the vial away at the end of the day.
*She was unable to ensure the vial had always been thrown away at the end of the day.

3. Observation and interview on 7/12/22 at 7:45 a.m. with RN K and RN P revealed:
*An unidentified maintenance man walked up and asked about going into the OR.
*His mask was visibly soiled with brown smudges.
*RN K pointed out that he needed to have shoe covers on to walk back into the OR.
-He stated he was trying to check the fire-extinguishers.
*RN K and RN P stated they were unsure of who he was, they had never seen him before.
*RN K agreed he had a very soiled mask on.
-She had not asked him to change his mask before entering the OR.

4. Observation on 7/12/22 at 8:00 a.m. revealed RN P handed CRNA M a syringe of drawn-up medication. CRNA M placed that syringe of medication into her scrub pocket.

Observation 7/12/22 on 8:12 a.m. of CRNA M revealed, she took the medication syringe out of her scrub top, placed drops in patient 1's right eye and then placed the syringe back in her scrub pocket.

Observation and interview on 7/12/22 at 8:59 a.m. with CRNA M revealed:
*The medication in her scrub pocket was Sensorcaine 0.75% used to numb patient 1's eye.
*This has been her normal practice.
*She agreed this was not the practice that should have been followed.

5. Observation on 7/12/22 at 9:00 a.m. with RN W revealed she:
*Had a container which contained soiled OR room equipment.
*Carried the container through the OR's clean central supply room and across the hall to the sterilizing room.

6. Observation and interview on 7/12/22 at 9:05 a.m. with RN K in the PACU revealed:
*There were two suction canisters connected to suction tubing and Yankauer tip attachments.
*There was a risk for contamination.
-The Yankauer tips were sterile, should not have been connected to suction, and should have remained sterile until used.

7. Interview on 7/12/22 at 4:10 p.m. with pharmacist G revealed, the Sensorcaine was in single-use vials and should have been discarded after each use.

Interview on 7/13/22 at 8:25 a.m. with director of anesthesia services (E) and chief nursing officer (CNO) B revealed:
*Their policy was to always date and time medication vials.
*Staff should have only administered medications they had prepared themselves.

8. Interview on 7/14/22 at 2:21 p.m. with surgery and Mallard Pointe director Q and CNO B revealed:
*The hand-hygiene observations could have been better, they had expected staff to perform hand hygiene when taking off gloves and before putting on new gloves.

9. Review of the provider's March 2022 Infection Control Program- General Standards policy revealed:
*The "Program includes a system for identifying, reporting, evaluating and maintaining records of infections; including lab results of microbiology and serology."
*"Provisions for review and evaluation of aseptic techniques, isolation and sanitary techniques are employed in the hospital, as necessary."
*The policy had not addressed hand hygiene.

Review of the provider's February 2022 Medical Staff Rules and Regulations revealed, "All practitioners are responsible for complying with infection prevention policies and procedures in the performance of their duties."

C. Based on observation, interview, record review, and policy review, the provider failed to ensure:
*Infection control practices had been followed and monitored in the Mallard Pointe facility and the specialty clinic.
*The manufacturers' instructions for use (IFU) were followed for leak testing three of three flexible endoscopes, using Metricide OPA (ortho-Phthalaldehyde) Plus for high level disinfection for one of one endocavity ultrasound (US)probe, and immersion level for one of one endocavity US probe in high level disinfectant.
*Quality assurance and process improvement (QAPI) monitoring was completed for infection control practices at Mallard Pointe and the specialty clinic.
Findings include:

1. Interviews on 7/13/22 from 9:15 a.m. through 10:30 a.m. with RN Y, RN Z, and urology clinic director AA in the urology clinic revealed the manufacturer's IFU were not followed for leak testing flexible endoscopes, using Metricide OPA Plus for high level disinfection for the endocavity US probe, and immersion level for the endocavity US probe in high level disinfectant.

Interview on 7/14/22 at 2:30 p.m. with infection control coordinator O and QAPI coordinator L confirmed that neither program had an active role in overseeing the reprocessing of endoscopes or high-level disinfection with MetriCide OPA Plus in the Urology Clinic.

Refer to tag A940.

2. Observation and interview on 7/13/22 from 9:00 a.m. through 10:30 a.m. in the speciality clinic with director of ear, nose, and throat clinic (ENT) (C) revealed:
*She was the director of the ENT clinic and the speciality clinic.
*The dermatology clinic had 24 packages of sterile-processed supplies.
-The scissors and clamps had been fully closed and partially closed.
-They had two bottles of aluminum chloride solution and iron solution.
--Neither had an open date.
*The general surgery clinic had an open bottle of Iodoform packing that had not been dated when opened.
-There were two bottles of plain packing material that had been opened and not dated
*The general surgery clinic had 7 packages of sterile-processed scissors and clamps that had been fully closed.
*Director of ENT clinic C agreed staff are supposed to date items after they are opened.
-Fully closed sterile-processed instruments should have been re-sterilized to ensure all surfaces had been sterilized.

Interview on 7/14/22 on 3:45 p.m. with infection control coordinator O revealed:
*She worked part-time on infection control and part-time on QAPI.
-She felt that she could oversee both areas effectively.
*They completed hand hygiene audits every month.
*The unit directors were responsible for completing the audits on hand hygiene and at Mallard Pointe.
*She usually relied on staff to complete audits at the various hospital locations.

3. Interview on 7/13/22 at 9:15 a.m. with registered nurse (RN) Y regarding the cleaning and disinfection of flexible endoscopes in the urinary clinic revealed:
*The flexible endoscopes were leak tested at the beginning of the day prior to its first use.
*The scopes could have been used on multiple patients per day.
*The scopes were cleaned between patients but were not leak tested each time.

*Refer to A940.

Based on observation, interview, record review, review of the manufacturer's instructions for use, and policy review, the provider failed to:
*Perform a leak test after each use for three of three flexible endoscopes used in the Urology Clinic.
*Follow the reuse period of no more than thirty days for MetriCide OPA Plus (ortho-Phthalaldehyde) high level disinfectant for semi-critical medical devices.
*Test the strength of a high-level disinfectant prior to every use.
*Rinse one of one endocavity ultrasound probe after it had been high-level disinfected.
Findings include:

1. Interview on 7/13/22 at 9:15 a.m. with registered nurse (RN) Y regarding the cleaning and disinfection of flexible endoscopes in the Urology Clinic revealed:
*The flexible endoscopes were leak tested at the beginning of the day prior to its first use.
*The scopes could have been used on multiple patients per day.
*The scopes were cleaned between patients but were not leak tested each time.

Review of the manufacturer's flexible endoscope cleaning and disinfection guide revealed:
*"This guide is only a summary of the steps necessary to properly reprocess your endoscope. Follow the detailed steps outlined in the endoscope reprocessing manual that was included with your endoscope."
"1. Gently wipe the external surfaces of the insertion tube with a cloth moistened in detergent solution.
2. Disconnect the forceps/irrigation plug.
3. Fill a syringe with detergent solution and flush the solution through the instrument channel three times.
4. Attach the leakage tester to the venting connector on the endoscope.
5. Close the pressure release lever. Press the hand pump so that the pointer stays within the green area (needle in the gauge).
6. Immerse the entire endoscope in water, observe for thirty seconds while angulating the bending section (flexing the scope in different directions) and confirm that there is no continuous series of bubbles. Caution: If a leak is detected remove from water and contact Olympus.
7. Remove the endoscope from the water and release the air pressure in the endoscope."

Interview on 7/13/22 at 9:30 a.m. with urology clinical director AA and RN Y revealed:
*Urology clinical director AA was not aware they were not following the manufacturer's instructions for leak testing.
*If an endoscope failed the leak test it should immediately be removed from patient use.
*If a leak test was not performed every time, they would not have beeen able to remove damaged endoscopes before it was used on a patient.
*The cleaning and disinfecting of endoscopes should have been trained and monitored by the surgical services department for quality assurance and performance improvement (QAPI).
*Clinical director AA was not for sure if the cleaning and disinfecting of endoscopes was monitored by the infection control department.

2. Interview on 7/13/22 at 9:45 a.m. with RN Z and urology clinical director AA regarding the cleaning and disinfection of the endocavity ultrasound probe revealed:
*The provider used MetriCide OPA Plus solution for high level disinfection of the endocavity ultrasound probe.
*The bottle of MetriCide OPA Plus solution was dated with the open date 6/20/22.
*When they needed to high level disinfect the endocavity ultrasound probe they would grab the bottle of MetriCide OPA Plus solution, test the solution once a day, and take the bottle to the procedure room where the endocavity ultrasound probe was located.
*They would clean the probe with water, wipe the probe with a towel, and then place the probe into the bottle of MetriCide OPA Plus.
*The opening of the MetriCide OPA Plus bottle would only allow the tip of the probe to be disinfected and not the whole probe.
-They confirmed the entire probe should have been disinfected and not just the tip.
*The probe was left in the MetriCide OPA Plus solution for twelve minutes. Then it was removed and the entire probe including the cord was wiped with a disinfectant wipe.
*Once the probe was wiped down it was either put into storage or was set up for the next patient by covering the probe with a latex sheath.
*When asked how long the solution in the bottle could be used for high level disinfection RN H referred to the label on the bottle that stated the solution in the bottle could be stored for up to 75 days.
*They were not aware the reuse time for the solution was not to exceed thirty days.
*There were times when the probe would have been used on multiple patients per day.
*They were not aware they should have tested the MetriCide OPA Plus solution every time a probe was disinfected.
*They were not aware of the rinsing procedure for the probe.
*They were not aware they were not following the manufacturer's instructions for use for MetriCide OPA Plus.
* The process of high-level disinfection for the endocavity ultrasound probe should have been trained and monitored by the surgical services department for QAPI.
*They were not sure if the cleaning and disinfecting of the endocavity ultrasound probe was monitored by the infection control department.

Review of the manufacturer's instructions for use for MetriCide OPA Plus revealed:
*The reuse period for MetriCide OPA Plus solution was not to exceed thirty days in manual reprocessing.
*Concentration of MetriCide OPA Plus solution during reuse life must be verified by the MetriCide OPA Plus solution test strip prior to each use to determine that the solution concentration was above the minimum recommended concentration.
*All instruments that had been put into MetriCide OPA Plus solution ahould have been rinsed with either a sterile water rinse or a potable water rinse procedure depending on the device.

Review of the manufacturer's instructions for use for ACUSON X300 Ultrasound Imaging System revealed the entire endocavity probe should have been immersed in high level disinfectant.

Review of the high-level disinfecting log from 3/10/22 to 7/13/22 revealed:
*There was only one test recorded per day.
*All tests had passed indicating the solution was above the minimum recommended concentration.
*MetriCide OPA Plus solution was in use from 4/6/22 to 6/13/22. A total of sixty-nine days.

3. Interview on 7/13/22 at 3:00 p.m. with Chief Nursing Officer B and Director of Ear, Nose, and Throat Clinic C revealed:
*They had been made aware the process of leak testing endoscopes and the use of high-level disinfection in the urology clinic was not to manufacturers' instructions.
*They were in the process of retraining the staff to follow the manufacturers' instructions for use for the cleaning and disinfection of flexible endoscopes and MetriCide OPA Plus solution.

4. Review of the training records for RN Y and RN Z reveled.
*RN Y had signed the clinic nurse orientation checklist on 1/16/18.
*There was no record of the orientation/competency checklist for flexible endoscope/cystoscope reprocessing.
*RN Z had signed the clinic nurse orientation checklist and the orientation/competency checklist for flexible endoscope/cystoscope reprocessing on 8/19/13.
*There were no other records of competencies or training for endoscope reprocessing or the use of MetriCide OPA Plus.

5. Interview on 7/14/22 at 2:20 p.m. with surgical director Q revealed they did not have an active quality assurance program for the urology clinic.

Interview on 7/14/22 at 2:25 p.m. with Urology Clinic director AA revealed:
*There was no quality assurance oversite for the processing of endoscopes or the use of MetriCide OPA Plus.
*There was no annual training or competencies to ensure the processes identified were completed to manufacturers' instructions.

6. Interview on 7/14/22 at 2:30 p.m. with the infection control coordinator O and QAPI coordinator L confirmed that neither program had an active roll in overseeing the reprocessing of endoscopes or high-level disinfection with MetriCide OPA Plus in the urology clinic.

7. Review of the May 2021 Cleaning, Disinfecting, and Sterilization of Instrumentation and Endoscopes policy revealed:
*" Purpose:
1. To render instruments and equipment free from micro-organisms.
2. To protect patients and personnel from potential hazards.
3. To minimize risk of surgical wound infections.
Policy:
1. All surgical instruments, powered instruments, and endoscopes shall be properly decontaminated, cleaned, and sterilized by appropriate methods according to established standards, guidelines and recommended practices by AAMI [Association for the Advancement of Medical Instrumentation] and AORN [Association of periOperative Registered Nurses] and manufacturer's instructions for use (IFU)."
*" Inspect the equipment surfaces for breaks in integrity that would impair either cleaning or disinfection. If equipment's integrity is compromised, remove it from patient use and follow your facility's process for caring for and reporting damaged equipment."
*" After exposing the equipment to the disinfectant solution for the required contact time, rinse the device thoroughly with water according to the manufacturer's instructions to remove toxic and irritating residues that can statin or damage tissues."
*" Before cleaning, some pieces of equipment require leak testing to detect breaches in the integrity of the device. Leak-test those items according to the device and the leak-testing equipment manufacturer's instructions."
*" Improper technique can cause pathogen transmission to another patient, resulting in a health care-associated infection. Skin irritation, allergic reaction, inhalation sensitivity, and other reactions may develop in response to use of a chemical high-level disinfectant."
*" Document the date and time, testing results, exposure time, and other required information according to your facility's disinfectant log sheet."