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Based on interview and record review, the facility failed to ensure the contract for Psychiatric Telemedicine Services was evaluated to ensure quality, and services were being provided in a safe and effective manner. This had the potential to result in the facility being unaware if the services, under the Psychiatric Telemedicine contract, were being provided in an safe and effective manner.

Findings:

On February 19, 2019, at 9 a.m., during the entrance conference, a list of the facility's contracted services was requested.

The list of contracted services indicated the facility had an agreement for Psychiatric Telemedicine Services.

The agreement indicated the Psychiatric Telemedicine Services were originally initiated on July 14, 2016, with amendments on November 14, 2017, and August 22, 2018.

There was no documented indication the quality of services provided under this contractual agreement had been evaluated by the facility to ensure services were being provided in a safe and effective manner for 2017, and 2018.

During an interview with the Deputy County Council [DCC] and the Executive Director Quality & Performance Improvement [EDQPI], on February 21, 2019, at 11:55 a.m., the DCC stated agreements/contracts were reviewed annually. The DCC stated the individual responsible for the agreement/contract would complete a "Request for Supply Service [RSS];" administration would review and sign off on the agreement/contract; the agreement/contract would be presented at Performance Improvement Patient Safety Committee; the Medical Executive Committee; and the County Board [Governing Body]. The DCC stated she was unable to find documentation of the contractual agreement being evaluated for quality, and that services were being provided in a safe and effective manner under the contractual agreement. The DCC stated the contractual agreement should have been evaluated annually to ensure services were being provided to patients in a safe and effective manner, and then should have gone through the approval process to include the Governing Body.

The facility policy and procedure titled "Contracting for Professional Services" last reviewed/revised August 25, 2016, revealed "... The requesting Department must appoint or designate an individual who will be responsible for monitoring the contractual activities/services for performance compliance. ... The CEO [Chief Executive Officer] - Health System shall submit quarterly reports to the Board on all agreements executed pursuant to the delegated authority."

Based on interview and record review, the facility's Arlington Campus failed to ensure a standardized notice titled, "Important Message" (IM) from Medicare was provided to two sampled patients (Patients 22 and 29) who were Medicare beneficiaries, or their legal representatives.

This failure resulted in Patients 22 and 29 or their representatives being uninformed of the necessary information to exercise their right to appeal a discharge.

Findings:

a. On February 20, 2019, at 1:59 p.m., Patient 29's record was reviewed with the Senior Administrative and Collections Clerk (SACC).

Patient 29 was admitted to the facility on February 14, 2019, with a diagnosis of Huntington's disease (causes the progressive breakdown of nerve cells in the brain). Patient 29 was a medicare beneficiary.

Patient 29's record revealed there was no documentation of the IM provided and signed within two days of admission.

Patient 29's record revealed there was no documentation of his refusal to sign the IM.

The SACC confirmed there was no IM provided and signed by Patient 29. The SACC further stated the IM should have been provided immediately upon admission and signed by Patient 29.

b. On February 20, 2019, at 2:12 p.m., Patient 22's record was reviewed with the SACC.

Patient 22 was admitted to the facility on February 15, 2019, with a diagnosis of psychosis (mental illness). Patient 22 was a Medicare beneficiary.

Patient 22's record revealed there was no documentation of the IM provided or signed within two days of admission.

Patient 22's record revealed there was no documentation of his refusal to sign the IM.

The SACC confirmed there was no IM provided and signed by Patient 22. The SACC further stated the IM should have been provided immediately upon admission and signed by Patient 22.

The facility's policy titled, "Important Message from Medicare Distribution," dated May 7, 2016, was reviewed. The policy indicated, "...All Medicare in-patients will receive the Important Message from Medicare (IM) at Admission and Discharge as required by the Center for Medicare and Medicaid Services (CMS) regulations...If the notice cannot be given at the point of admission for any reason, the notice will be issued to the patient and/or the patient's representative within 2 business days of admission...If the beneficiary refuses to sign the IM, hospital staff may annotate the notice to indicate the refusal. The date of refusal is considered the date of receipt of notice. Discharge Procedures (Follow-up Copy) The follow-up copy must be delivered to the beneficiary as far in advance of discharge as possible but no more than 2 calendar days before the planned date of discharge so that the beneficiary has meaningful opportunity to act on it."

Based on interview and record review, the facility's Arlington Campus failed to obtain a consent for the use of Abilify (anti-psychotic medication to treat behavior) for one sampled patient (Patient 24).

This failure had the potential for Patient 24 to receive anti-psychotic medication without being informed of the plan of treatment, risks and benefits of the treatment, and without being given the opportunity to refuse such treatment.

Findings:

On February 19, 2019, at 4 p.m., the record for Patient 24 was reviewed with the Director of Behavioral Services (DBS).

Patient 24 was admitted to the facility on January 31, 2019, with a diagnosis of schizoaffective disorder (mental illness).

Patient 24 was prescribed Abilify tablet 5 mg (milligrams) oral daily on February 5, 2019, and discontinued on February 8, 2019.

The medication was administered on the following days:
February 5, 2019, at 11:59 a.m.,
February 6, 2019, at 8:33 a.m.,
February 7, 2019, at 8:49 a.m., and;
February 8, 2019, at 8:35 a.m.

There was no documented indication a consent for the use of Abilify 5 mg was obtained and verified by the facility prior to the administration of the medication.

Patient 24 was prescribed Abilify tablet 10 mg oral daily on February 9, 2019, and was discontinued February 19, 2019.

The medication was administered on the following days:
February 9, 2019 at 8:26 a.m.,
February 10, 2019, at 8:59 a.m.,
February 11, 2019, at 8:39 a.m.,
February 12, 2019, at 8:40 a.m., February 13, 2019, at 8:27 a.m.,
February 14, 2019, at 8:45 a.m.,
February 15, 2019, at 8:33 a.m.,
February 16, 2019, at 8:36 a.m.,
February 17, 2019, at 8:19 a.m.,
February 18, 2019, at 8:12 a.m., and
February 19, 2019, at 8:35 a.m.

There was no documented indication a consent for the use of Abilify 10 mg was obtained and verified by the facility prior to the administration of the medication.

The consent for the use of Abilify 10 mg was signed by Patient 24 on February 19, 2019, at 12:20 p.m., ten days after it was administered, and subsequently discontinued by the physician.

In a concurrent interview with the DBS, the DBS confirmed the consent was not obtained prior to administration of the Abilify and should have been.

The facility policy and procedure titled, "Informed Consent:Psychoactive Medications," dated May 8, 2018, was reviewed. The policy indicated, " A
process that takes place between a patient and his or her practitioner. The treating health care provider discloses appropriate information to a competent patient so that the patient may make a voluntary choice to accept or refuse treatment...Before medication in a psychoactive class is given, the psychiatrist MUST give the patient or legal guardian the legally required information: Benefits and probable and possible side effects. Nature of their mental illness, behavior, reason for the medications...Any alternatives to the medication...The psychiatrist must obtain the patient's signature on the appropriate consent form BEFORE the first dose of medication given."

Based on interview and record review, the facility's Arlington Campus failed to ensure one Physician's Assistant (PA) 1, had Crisis Prevention Intervention Training (CPI - Nonviolent crisis intervention training designed to teach methods for managing difficult situations and disruptive behaviors). This failure had the potential to negatively impact the safety of both patients and staff in the facility.

Findings:

A review of PA 1's credentialing file was conducted on February 20, 2019. PA 1 was hired on February 9, 2017, to work in the facility's emergency department. Further review of PA 1's file failed to show he took CPI training since his hire.

An interview was conducted with the Executive Director of the Arlington Campus on February 20, 2019, at 2 p.m. The Executive Director stated PA 1 and all staff at the Arlington Campus must take CPI training for safety within six months of their hire date.

A review of the Medical Staff Bylaws, Rules and Regulations dated 2018, through 2019, was conducted. Article V addressed the responsibilities of Allied Health Professionals (to include Physician Assistants). Section 5.5, Item b, indicated Allied Health Professionals shall, "Retain appropriate responsibility within their area of professional competence for the care and supervision of patients at the hospital for whom they are providing services."

Based on observation, interview, and record review, the facility failed to ensure monitoring and documentation were complete for one patient (Patient 53) who was placed in restraints. This failure increased the risk for the patient to sustain undue harm and injury.

Findings:

On February 19, 2019, at 10:00 a.m., during a tour, Patient 53 was observed without restraints on.

On February 21, 2019, Patient 53's record was reviewed. Patient 53 was admitted on February 11, 2019, with diagnoses to include acute renal failure (kidney failure). The record indicated on February 19, 2019, at 12:10 a.m., Patient 53 became confused, combative, and was pulling at intravenous (IV- directly into the vein) lines. Registered Nurse (RN) 6 documented she received an order for and placed Patient 53 in bilateral soft wrist restraints (cloth restraint device to limit movement of the arms or hands).

There was no documentation Patient 53 was reassessed from February 19, 2019, at 12:10 a.m. (when the restraint were applied) until February 19, 2019, at 6:04 a.m., (5 hours and 54 minutes) later.

The document titled "Non-Violent, Non-Self Destructive Restraint Log" was reviewed on February 21, 2019. The log indicated Patient 53's restraints were removed at 8:23 a.m. on February 19, 2019. There was no documentation that indicated when the patient's behavior/situation no longer required restraint use.

On February 21, 2019, during an interview with Nursing Director (ND) 1, she stated RN 6 should have completed the assessment and documentation on Patient 53 after placing him in restraints. ND 1 stated there should have been complete documentation including assessments, every two hour checks, and documentation of restraint removal.

On February 21, 2019, a facility policy and procedure titled, "Restraints and Seclusion," dated March 20, 2018, was reviewed. The policy indicated:

"...Restraints Procedures For The Management Of Non-Violent Behavior...

...Orders for restraint for the management of Non-Violent Behavior shall remain in effect until the patient's behavior or situation no longer requires restraint...

...Assessment and Monitoring of Restraint/Seclusion Used for the Management of Non-Violent Behavior. restraint used for the management of Non-Violent Behavior shall be subject to ongoing monitoring and assessment as specified in the patient's careplan. Monitoring and assessments shall occur at least every two hours.

...Restraint used for the management of Non-Violent Behavior shall be subject to ongoing monitoring and assessment as specified in the patient's plan of care. Monitoring and assessments shall occur at least every two hours.

...Documentation of Monitoring...

...Episodes of restraint and/or seclusion shall be documented as indicated on currently approved assessments, monitoring and ordering forms and electronic medical records..."

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

1. Ensure the implementation and monitoring of a Pharmaceutical Services action plan for the use and control of Propofol [an anesthetic medication used to produce relaxation and sleep before or during surgery] was currently in effect following an adverse drug reaction which occurred on January 23, 2019. This resulted in Patient 1 experiencing a respiratory and cardiac arrest, and subsequent death on February 1, 2019 [Refer to A0286];

2. Ensure safe and effective control and accountability of Propofol, a high-risk, high-alert intravenous [IV] injectable medication,
when:
a. Multiple bottles could be accessed and retrieved inappropriately from the Pyxis MedStation [ADDS - an automated drug delivery system] located in the Operating Room [OR] Core area of the Surgery Department [SD], without Pharmacy Department oversite;
b. The Pharmacy was unaware of the unauthorized location [Pre-Operative Holding area] where the bottle of Propofol was being hung for future administration; and
c. The Pharmacy was unaware anesthesiologists were accessing multiple bottles of Propofol intended for one patient use. The bottles were used for multiple patients without proper procedures taken to indicate they were transferred to other patients or returned back to the Pyxis [Refer to A0500]; and,

3. Ensure the contract for Psychiatric Telemedicine Services was evaluated to ensure quality, and services were being provided in a safe and effective manner [Refer to A0086].

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality health care in a safe and effective manner.

Based on interview and record review, the facility failed to ensure the implementation and monitoring of a Pharmaceutical Services action plan for the use and control of Propofol [an anesthetic medication used to produce relaxation and sleep before or during surgery] was currently in effect following an adverse drug reaction which occurred on January 23, 2019. This resulted in the facility not taking immediate action to prevent harm and death to other patients.

According to ISMP (Institute for Safe Medication Practices), "... High-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients. ..."

Findings:

On January 28, 2019, at 8:05 a.m., an unannounced visit was made for a facility reported adverse event which involved Patient 1.

Record review indicated the following:

Patient 1 was admitted to the facility on January 23, 2019, at 5:44 a.m., for an elective transurethral resection of a bladder tumor [procedure performed completely with a scope that is inserted through the urethra into the bladder which allows the bladder tumor to be removed from the bladder wall].

Patient 1 went to Same Day Surgery [SDS], on January 23, 2019, at approximately 6 a.m., where the following occurred:
- At 6:09 a.m., Patient 1's list of home medications was reviewed and updated.
- At 6:13 a.m., Patient 1's pre-operative check list was initiated.
- At 6:17 a.m., Patient 1's vital signs were taken, and a nursing assessment was completed.
- At 6:25 a.m., Ancef [an intravenous (IV) antibiotic medication] 2 grams in 50 ml [milliliters] was removed for Patient 1 from the Pyxis MedStation [ADDS - an automated drug delivery system].
- At 6:26 a.m., Gentamycin [an IV antibiotic medication] 80 milligrams in 100 ml, and an IV bag of 1,000 ml of Normal Saline, were removed for Patient 1 from the Pyxis MedStation.
- At 6:32 a.m., a left forearm peripheral IV was started, and the 1,000 ml of Normal Saline was running at 50 ml per hour.
- At 7:16 a.m., Patient 1 was transferred to the Pre-Operative Holding [POH] area.
- At 7:19 a.m., Patient 1 arrived at the Pre-Operative Holding area.

Patient 1 signed the "Informed Consent for Anesthesia" on January 23, 2019, at 8:15 a.m., with Physician 1 [Anesthesia Resident].

The Pyxis report indicated the following medications were removed from Pyxis MedStations, by Physician 1, for Patient 1, on January 23, 2019:

- At 6:52 a.m., one vial of Fentanyl [an opioid pain medication] 100 micrograms/2 milliliters [ml]; one vial of Dexamethasone [a corticosteroid medication that prevents the release of substances in the body that cause inflammation]10 milligrams/1 ml; and one bag of Acetaminophen IV [Tylenol] 1,000 mg/100 ml.

- At 8:27 a.m., two bottles of Propofol 1,000 mg/100 ml.

- At 8:34 a.m., one syringe of Rocuronium [a paralytic medication used to facilitate air way insertion] 50 mg/5 ml; and one vial of Propofol 200 mg/20 ml.

- At 8:35 a.m., one syringe of Phenylephrine NaCl [medication primarily used as a decongestant] 1 mg/10 ml; and one syringe of Lidocaine 2% [a local anesthetic medication] 100 mg/5 ml.

- At 8:43 a.m., one vial of Sugammadex [a medication used to reverse the effects of the muscle relaxant Rocuronium] 200 mg/2 ml; and two bottles of Propofol 1,000 mg/100 ml.

- At 8:44 a.m., one bottle of Nitroglycerin D5W [a medication used to dilate blood vessels] 50 mg/250 ml; and one vial of Vasopressin [a medication used to decrease urine output and prevent loss of water from the body] 20 units/1 ml.

The record indicated the last update to the "Anesthesia Record" had been done on January 23, 2019, at 8:56 a.m.

There was no documented indication in the record as to when the IV Acetaminophen 1,000 mg/100 ml; Ancef 2 gm/50 ml; Gentamycin 80 mg/100 ml; and Propofol 1,000 mg/100 ml, had been hung/administered to Patient 1 on January 23, 2019.

On January 23, 2019, at 9:05 a.m., Patient 1 was discovered unresponsive and a Code Blue was initiated.

During an interview with Registered Nurse [RN] 2, on January 28, 2019, at 11:45 a.m., she stated she was the medication nurse for Patient 1's Code Blue. RN 2 stated Patient 1 was not on a cardiac/vital signs monitor when she arrived in the POH area. RN 2 stated, as the medication nurse for the Code Blue, she followed the patient's IV lines to see what was being administered, and she noted an empty bottle of Propofol connected to the IV line. RN 2 stated she disconnected the Propofol line and bar clamped the IV.

During an interview with Physician 4, on January 28, 2019, at 1:12 p.m., Physician 4 stated she was the first physician to arrive at Patient 1's bedside when the Code Blue was called. Physician 4 stated Patient 1 had his hands on his chest, there was no pulse, and advanced cardiac life support was initiated. Physician 4 stated she noticed a "white" IV line [indicative of Propofol being administered] at the patient's wrist and immediately disconnected the line. Physician 4 stated she "believed the bottle of Propofol was empty."

During an interview with Physician 2 [an Intern], on January 29, 2019, at 8:22 a.m., Physician 2 stated she was with Physician 1 on January 23, 2019. Physician 2 stated she spoke with Patient 1, and answered the pre-operative questions. Physician 2 stated they were waiting for the surgeons in the control room when Physician 1 said, "lets stream line the process since the surgeons were not there." Physician 2 stated she attached a "crows foot" adaptor to the patient's IV, Physician 1 prepared the Propofol IV line, and she attached the Propofol line to one of the "crows foot" ports. Physician 2 stated you can connect the Propofol line to the patient's IV in the POH area but you cannot "run" the medication in the POH area. Physician 2 stated when she plugged the Propofol drip line into Patient 1's IV, she did not check to be sure the bar clamp was closed and the roller clamp was closed.

During an interview with Physician 1, on February 4, 2019, at 2:45 p.m., Physician 1 stated the Acetaminophen was given on January 23, 2019, at approximately 8:10 a.m., the Ancef was started at approximately 8:20 a.m., and the Gentamycin at approximately 8:30 a.m. Physician 1 stated he hung the bottle of Propofol between 8:27 a.m., and 8:34 a.m., while Patient 1 was in the POH area to stream line the case because the surgeon had not arrived at the facility. Physician 1 stated this was not the first time he had hung Propofol in the POH area. In addition, Physician 1 stated because of where medications were located, medications that would be used on other patients during the day would be removed from the Pyxis MedStations under the first patient's name, and then transferred to other patients' during the day as used.

During an interview with the Executive Director Pharmacy & Ancillary Services [EDPAS], the Executive Director Quality & Performance Improvement [EDQPI], and the Director of Pharmacy [DOP], on February 20, 2019, at 12:11 p.m., they were asked what Pharmacy had done to control and monitor:
a. The use of Propofol [a high-risk, high-alert intravenous [IV] injectable medication]; and
b. The Anesthesia practice of removing multiple vials/bottles of medication under the name of one patient and then transferring the medication to another patient later in the day as the medication was used.

The DOP stated the facility was not currently monitoring the use of Propofol, and was not reviewing activity reports to determine if medications removed for one patient were used for that patient or another patient [reconciliation of medication use].

Based on interview and record review, the facility's Arlington Campus failed to ensure the urine drug screening (UDS - analyzes urine for the presence of certain illegal drugs and prescription medications) test was conducted as ordered by the physician for one sampled patient (Patient 24). This failure resulted in an incomplete initial assessment and the potential for inappropriate treatment.

Findings:

On February 20, 2019, at 9:40 a.m., Patient 24's record was reviewed with Registered Nurse (RN) 5. Patient 24 was admitted to the facility on January 31, 2019, with diagnoses including Schizoaffective (mental disease) disorder and a past history of using methamphetamine (very addictive stimulant drug).

A review of Patient 24's physician order dated January 31, 2019, at 7:28 p.m., indicated, "Urine Drug Screen."

Patient 24 was discharged on February 19, 2019.

There was no documented indication the UDS was done.

On February 20, 2019, at 9:48 a.m., an interview was conducted with RN 5.
RN 5 stated the UDS was ordered but was not done. RN 5 further stated there was no documented indication Patient 24 refused the test.

Based on interview and record review, the facility failed to ensure the intravenous [IV - administration of medication directly into a vein] administration of Levophed [a medication used to treat low blood pressures] was done per facility policy and procedure for one sampled patient [Patient 6]. This had the potential to result in the physician being unaware of Patient 6's status, and the Levophed being started without a current physician's order.

Findings:

On February 19, 2019, at 2:30 p.m., the record for Patient 6 was reviewed with Registered Nurse [RN] 1. Patient 6 was admitted to the facility on February 9, 2019, with diagnoses including ruptured right popliteal aneurysm [rupture of a major artery behind the knee], acute kidney injury, diabetes, and anemia [hemoglobin in blood is low].

On February 16, 2019, at 8:28 a.m., a physician's order was written to start Levophed 8 milligrams per 250 milliliters [32 mcg/ml (micrograms per milliliter)] IV with the following administration criteria:
- Start at 0.5 mcg/min;
- Titrate by 1 to 2 mcg/min every 3 minutes;
- Goal: MAP > [mean arterial pressure greater than] 60;
- Maximum rate: 47 mcg/min; and
- Contact prescriber if heart rate was greater than 120 beats per minute.

The physician's order did not contain information on restarting the Levophed if needed after the dose reached "0."

The flowsheets indicated the Levophed was started on February 16, 2019, at 8:30 a.m., was stopped at 11:03 a.m.,
and was restarted on February 16, 2019, at 7:40 p.m. [8 hours and 37 minutes after the Levophed had been discontinued].

There was no documented indication a new physician's order was written to restart/initiate the Levophed drip on February 16, 2019, at 7:40 p.m.

During a concurrent interview with RN 1, she stated the only order for a Levophed drip had been written on February 16, 2019, at 8:28 a.m., and no new order had been written on February 16, 2019, at 7:40 p.m., when the Levophed was started at 0.5 mcg/minute after being off for 8 hours and 37 minutes.

During an interview with Clinical Pharmacist [CP] 2, on February 19, 2019, at 3:15 p.m., she reviewed the record for Patient 6, and stated the RN should have obtained a new physician's order for the Levophed drip which was started on February 16, 2019, at 7:40 p.m.

The facility policy and procedure titled "Guidelines for the Administration of Parenteral Medications" last reviewed/revised by the facility December 26, 2018, revealed "... Titrate as specified, according to frequency and rate parameters to reach specified goal, including restarting as specified if needed after dose reaches "0" (zero). For Adult patients, if not otherwise specified. If the medication is titrated to zero and the patient remains in the desired target range for six hours or more then the titratable drip may be "discontinued" and a new order is needed by the prescriber. ..."

Based on interview and record review, the facility failed to ensure the provision of pharmaceutical services, to meet the needs of the patients, existed as evidenced by the facility's failure to:

1. Ensure the implementation and monitoring of a Pharmaceutical Services action plan for the use and control of Propofol [an anesthetic medication used to produce relaxation and sleep before or during surgery] was currently in effect following an adverse drug reaction which occurred on January 23, 2019 [Refer to A0286]; and,

2. Ensure safe and effective control and accountability of Propofol, a high-risk, high-alert intravenous [IV] injectable medication,
when:
a. Multiple bottles could be accessed and retrieved inappropriately from the Pyxis MedStation [ADDS - an automated drug delivery system] located in the Operating Room [OR] Core area of the Surgery Department [SD], without Pharmacy Department oversite;
b. The Pharmacy was unaware of the unauthorized location [Pre-Operative Holding area] where the bottle of Propofol was being hung for future administration; and
c. The Pharmacy was unaware anesthesiologists were accessing multiple bottles of Propofol intended for one patient use. The bottles were used for multiple patients without proper procedures taken to indicate they were transferred to other patients or returned back to the Pyxis [Refer to A0500].

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of pharmaceutical services in a safe and effective manner.

Based on interview and record review, the facility failed to ensure safe and effective control and accountability of Propofol, a high-risk, high-alert intravenous [IV] injectable medication, when:
a. Multiple bottles could be accessed and retrieved inappropriately from the Pyxis MedStation [ADDS - an automated drug delivery system] located in the Operating Room [OR] Core area of the Surgery Department [SD], without Pharmacy Department oversite;
b. The Pharmacy was unaware of the unauthorized location [Pre-Operative Holding area] where the bottle of Propofol was being hung for future administration; and
c. The Pharmacy was unaware anesthesiologists were accessing multiple bottles of Propofol intended for one patient use. The bottles were used for multiple patients without proper procedures taken to indicate they were transferred to other patients or returned back to the Pyxis.

This resulted in the unsafe use and ineffective control of Propofol.

According to ISMP (Institute for Safe Medication Practices, a nationally recognized organization devoted to preventing medication errors), "High-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients..."

Findings:

In an interview on February 19, 2019, at 10:05 a.m., the Director of Pharmacy (DOP) recounted the incident that occurred on January 23, 2019, in which, an Anesthesia Resident [Physician 1] removed a 100 milliliter bottle of Propofol from the OR Core Pyxis, and connected it to Patient 1 in preparation for the procedure prior to transfer from the Pre-Operative Holding (POH) area to the OR. The Propofol was inadvertently infused to Patient 1 without the knowledge of the facility staff, resulting in cardiac arrest and the subsequent death of Patient 1, on February 1, 2019.

During an interview with the Executive Director Perioperative Services [EDPOS], on February 19, 2019, at 10:30 a.m., he stated an anesthesiology resident administering IV medications in the POH area was not a practice he had seen before. The EDPOS stated the nursing staff would need to be aware of any medications given in the POH area.

In an interview on February 19, 2019, at 10:50 a.m., Anesthesiologist 1 stated the only medications that could be given in the POH area would be injectable or oral Versed (a sedative).

Anesthesiologist 1 stated Anesthesia Residents taking out multiple bottles of Propofol from the OR Core Pyxis for multiple patients/cases throughout the day was not allowed.

In a subsequent interview, on February 19, 2019, at 11:10 a.m., Anesthesiologist 1 stated 100 milliliter bottles of Propofol were not stocked in the Operating Rooms in the Surgery Department [SD], and multiple bottles from the Pyxis OR Core would be taken out depending on the type and length of the surgery case. Anesthesiologist 1 stated any leftover vials would be transferred in the Pyxis to the next surgery patient. Anesthesiologist 1 stated sufficient bottles of Propofol were removed from the Pyxis OR Core to last through one procedure, in order to minimize the number of exits and entries into and out of the clean operating room environment, to prevent infection.

In an interview on February 19, 2019, at 3:15 p.m., Clinical Pharmacist [CP] 1 stated the Pharmacy Department was not currently monitoring the use of Propofol in the SD.

During an interview with CP 1, on February 20, 2019, at 11 a.m., CP 1 stated the Pharmacy Department was not aware of Anesthesia Residents taking Propofol to the POH area for patient use.

During an interview with the DOP, on February 20, 2019, at 12 p.m., the DOP agreed there was lack of control of IV Propofol and the Pharmacy Department was not aware of anesthesiology staff removing the Propofol bottles and taking them to the POH area, and connecting them to the IV tubing in preparation for surgery.

The DOP stated each OR had a Pyxis anesthesia cart [A-Cart], an ADDS similar to Pyxis MedStation but much smaller. The DOP stated, due to the size and the amount of medications the A Cart could hold, bulky bottles such as 100 milliliter bottles of Propofol were not stocked in the A-Cart.

The DOP stated the Pharmacy did not have the accounting procedure to know the movement of the multiple bottles of Propofol removed from the Pyxis.

On February 21, 2019, the following patients' records were reviewed, and it was noted that each of the multiple bottles of Propofol removed from the OR Core Pyxis, did not match the amount used for the patient they were intended:

1. Patient 70's anesthesia record indicated the procedure for an esophagogastroduodenoscopy [EGD - examination of upper part of the gastrointestinal tract] was started at 9:15 a.m., and ended at 9:35 a.m., on October 9, 2018, with 14.51 ml (milliliters) of Propofol infused throughout the procedure. The Pyxis transaction report indicated an Anesthesiologist removed six [6] 100-ml bottles of Propofol for Patient 70. The Pharmacy Department was not able to account for the difference;

2. Patient 71's anesthesia record indicated the procedure was started at 8 a.m., and ended at 7:30 p.m., on December 6, 2018, with 488.3 ml (less than five [5] 100 ml. bottles) of Propofol infused during the procedure. The Pyxis transaction report indicated an Anesthesiology Resident and a Registered Nurse removed seven [7] bottles of Propofol for Patient 71. The Pharmacy was not able to account for the difference;

3. Patient 72's anesthesia record indicated the procedure was started at 7:15 a.m., and ended at 5:30 p.m., on December 20, 2018, with 30 ml of Propofol infused during the procedure. The Pyxis transaction report indicated two Anesthesia Residents and two Registered Nurses removed a total of ten [10] bottles of Propofol between 6:30 a.m., and 3:16 p.m. The Pharmacy Department was not able to account for the difference; and

4. The Pharmacy transaction record indicated four [4] bottles of Propofol were removed from the OR Core Pyxis on January 24, 2019, at 6:37 a.m., for Patient 73, who did not have a procedure done. The Pharmacy was able to show the four bottles of Propofol were used for three other patients throughout the day without the Anesthesiologist documentation of the bottles being transferred to the
three other patients.

The facility policy and procedure titled "High-Alert Medications," dated May 22, 2017, indicated the following:

"High-Alert Medications. The Joint Commission defines High-Alert Medications as Medications that bear a heightened risk of causing significant harm to individuals when they are used in error...Standard medication safety measures at [the facility] include the following...Use of smart infusion pumps.

High-Alert Medications require heightened attention...other safety measures utilized to mitigate the risk of High-Alert Medications include...specific monitoring...

Sedative Infusions...Examples include...propofol...Infusions for this category of medications are restricted to critical care units. Smart infusion pumps utilized to administer intravenous infusions..."

The facility policy and procedure titled "Smart Infusion Pump System," last reviewed/revised by the facility June 15, 2018, indicated
"... Intravenous medications, solutions, and blood products for infusion shall be administered via a smart infusion pump. ..."

The facility policy and procedure titled "Guidelines for the Administration of Parenteral Medications," dated December 26, 2018,
indicated administration of Propofol infusion would only be allowed in adult critical care unit, emergency department, and post-acute care unit only.

The facility policy and procedure titled "Drug and Narcotics Reconciliation Policy," undated, indicated "... All other meds (medications) must remain intact and locked in pyxis in drawer 2.2 only until patient arrives in the operating area. No drugs of any kind will be taken for any patient not already called to the operating area for surgery. ..."

The ISMP's "High-Alert Medications in Acute Care Settings," updated in 2018, included Propofol as one of the high-alert medications, and indicated "... Use ISMP's List of High-Alert Medications in Acute Care Settings to determine which medications in your organization require special safeguards to reduce the risk of errors and minimize harm. Strategies may include ... Standardizing the ordering, storage, preparation, and administration of these medications. ... Limiting access to high-alert medications. ..."

Based on observation, interview, and record review, the facility failed to ensure surgical services polices and procedures were implemented and provided in accordance with acceptable standards of practice when:

1. Surgical instruments with visible debris were not brushed during the decontamination process in accordance with the manufacturer's written instructions for use (IFU);

2. The sterile processing department (SPD) was not being terminally (thoroughly) cleaned on a daily basis;

3. Three of three autoclaves in the core (center) of the operating rooms (ORs) were inoperable, and not maintained in clean and sanitary manner;

4. Endoscopes (long tubes used to examine the inside of the esophagus, stomach, and colon) used in the Gastrointestinal Laboratory (GI Lab) were not tested for leaks and flushed during the decontamination process, in accordance with the manufacturer's IFU; and,

5. Endoscope accessories were not stored in a manner to protect them from contamination and damage.

Findings:

1. On February 21, 2019, at 10:10 a.m., during a tour of the SPD, the SPD Technician (SPDT 1) was observed processing surgical instruments that had been used for an orthopedic surgical procedure. The following was observed:

a. The middle compartment of a three compartment sink was prepared with water and an enzymatic detergent used for cleaning surgical instruments;

b. The instruments (used and unused) were taken out of the instrument cart, one tray at a time. Multiple instruments had visible debris (blood and tissue) on them;

c. The instruments (used and unused) were rinsed with (sprayed) water in the (empty) right side compartment of the sink, and submerged in the enzymatic solution in the middle compartment of the sink;

d. After soaking for five minutes, the instruments were rinsed with (sprayed) water in the (empty) left side compartment of the sink, then placed on a rack for movement to the instrument washer. SPDT 1 did not brush any of the instruments, including the ones with visible debris, during the process.

In a concurrent interview, SPDT 1 stated she did not have to brush the instruments unless they had lumens (a hole in the middle running the length of the instrument). SPDT 1 stated she, "pretty much", got all of the debris off with the water sprayer, so she did not need to brush them.

The facility policies for surgical services were reviewed on February 21, 2019. The policies referenced the Association of periOperative Registered Nursing (AORN) as the standards they used.

According to the AORN Guideline for Cleaning and Care of Surgical Instruments:

Recommendation IX:
Surgical instruments and equipment should be cleaned and decontaminated according to the manufacturer's validated, written IFU.

The manufacturer's IFU for the orthopedic surgical instruments were reviewed on February 21, 2019.

According to the IFU:
Use a surgical scrub brush to remove visible debris.

During an interview with the SPD Manager (SPDM) on February 21, 2019, at 2:10 p.m., the SPDM stated based on the recommendations from the manufacturer, SPDT 1 should have brushed the surgical instruments that were visibly soiled.

2. During a tour of the OR on February 20, 2019, at 11:20 a.m., the Environmental Services Manager (EVSM) was interviewed. The EVSM stated all areas of the OR were terminally cleaned on a daily basis, except the SPD area. The EVSM stated the SPD area was, "cleaned," every day, but they did not perform a terminal cleaning.

The terminal cleaning logs were reviewed with the EVSM. The logs indicated all of the surgical services areas were being terminally cleaned on a daily basis, except for the SPD area.

The facility policies for surgical services were reviewed on February 21, 2019. The policies referenced the Association of periOperative Registered Nursing (AORN) as the standards they used.

According to the AORN Guideline for Environmental Cleaning:

Recommendation IV.a:
Terminal cleaning and disinfection of perioperative areas, including sterile processing areas, should be performed daily when the areas are being used;

Recommendation IV.c:
Terminal cleaning of operating and procedure rooms should include cleaning and disinfecting of all exposed surfaces, wheels and casters, storage cabinets, supply carts, furniture, light switches, door handles and push plates, telephones and mobile communication devices, computers accessories, chairs, stools, stepstools, and trash and linen receptacles; and,

Recommendation IV.e:
Sterile processing areas should be terminally cleaned. Sterile processing personnel conduct critical processes, such as decontaminating, assembling, and sterilizing surgical instrumentation, in support of operating and invasive procedure rooms. As such, the recommendations for terminal cleaning apply in sterile processing areas as in areas where surgical and other invasive procedures are performed. Furthermore, sterile processing areas where decontamination occurs have some of the highest risks for environmental contamination of all perioperative areas. Environmental cleaning in sterile processing areas is critical for reducing the risk of disease transmission from reservoirs of bloodborne pathogens and microorganisms in the decontamination environment.

3. During a tour of the OR on February 20, 2019, from 10:45 a.m. to 11 a.m., accompanied by the OR Manager (ORM), three autoclaves (cabinet sized sterilizers) were observed in the core (center) area between the ORs. One autoclave had a paper sign taped on it that read, "Do not turn on until further notice management notified." The sign was dated February 24, 2018 (one year earlier).

In a concurrent interview, the ORM stated all three of the sterilizers were broken, and they were not being used. The ORM stated they sent all of their instruments to the SPD for processing.

The autoclave marked, "Sterilizer #5," was observed with a pipe coming out of the bottom left side. A continuous drip of water was coming out of the pipe, draining into a hole in the floor that was covered with a metal grate. The pipe had large amounts of thick, bluish-green build-up on the bottom half. The hole in the floor and the metal grate had large amounts of rust colored staining throughout.

During an interview with the Infection Control Practitioner (ICP) on February 20, 2019, at 11:05 a.m., the ICP stated she told the Executive Director of Perioperative Services (EDPOS) about it every time she did her rounds, "for several months now," but it had not been fixed yet.

A document titled, "Infection Prevention and Control Rounds," was reviewed with the ICP on February 21, 2019. The document indicated the broken autoclave and running water was initially identified and documented on June 12, 2018. The document indicated, "IUSS (Immediate Use Steam Sterilizers) are clean," the non compliance box was marked, and a comment was written that indicated, "IUSS out of order in core area. The document further indicated, "IUSS (Immediate Use Steam Sterilizers) are functioning properly," the non-compliance box was checked, and a comment was written that indicated, Running water in core area."

In a concurrent interview, the ICP stated she used to do rounds every six months, but she had increased to every month. The ICP stated every time she did rounds, she sent the documented findings to the EDPOS and requested an action plan, but she had not received one.

The facility policies for surgical services were reviewed on February 21, 2019. The policies referenced the Association of periOperative Registered Nursing (AORN) as the standards they used.

According to the AORN Guideline for Environmental Cleaning;

Recommendation II:
The patient should be provided with a clean, safe environment.

4. During a tour of the GI Lab on February 19, 2019, at 10:45 a.m., The GI Technician (GIT 1) was observed processing an endoscope. The following was observed:

a. The contaminated scope was placed into a sink filled with water, attached to a device that forced air through it, and GIT 1 watched for bubbles to appear in the water (which would indicate there was a leak in the scope). GIT 1 did not move, handle, or manipulate the scope during the time the air was being forced through it;

b. The sink with the scope in it was filled with a diluted enzymatic solution, and GIT 1 cleaned the scope by brushing through each of the channels (openings). GIT 1 did not aspirate (pull) enzymatic solution through the channels;

c. The outside of the scope was rinsed with plain water. GIT 1 did not flush (push) plain water through the channels.

The facility policies for surgical services were reviewed on February 21, 2019. The policies referenced the Association of periOperative Registered Nursing (AORN) as the standards they used.

According to the AORN Guideline for Processing Flexible Endoscopes:

Recommendation V.a:
Leak testing should be performed in accordance with the manufacturer's IFU; and,

Recommendation VI.b:
Manual cleaning should be performed in accordance with the endoscope manufacturer's IFU.

The manufacturer's IFU for the endoscope were reviewed on February 21, 2019.

According to the IFU:
A. Leakage Testing
- Connect to an air source
- Confirm air is being emitted
- Completely immerse the scope in water
- "Observe for 30 seconds while angulating the bending section"

B. Manual Cleaning (after brushing the channels)
- Attach suction to the endoscope
- Immerse the distal (far) end into detergent
- "Aspirate detergent solution for approximately 30 seconds"

C. Manual Cleaning (after removing from detergent solution)
- Immerse endoscope in clean water
- Connect the injection tube
- "Use a 30 cc (milliliter) syringe to inject 90 cc of water through each side of the injection tube"

During an interview with the Manager of Perioperative Services (MPS) on February 21, 2019, at 2:30 p.m., the MPS stated GIT 1 should have processed the endoscope the way the manufacturer recommended.

5. During a tour of the GI Lab on February 19, 2019, at 10:45 a.m., accompanied by GIT 1, nine endoscopes were observed hanging vertically in a scope drying cabinet. There were no accessories observed hanging with the scopes.

In a concurrent interview, GIT 1 stated the accessories were in a drawer next to the cabinet. GIT 1 opened the drawer, and multiple endoscope accessories were observed in the bottom of the unlined drawer. The accessories rolled around in the drawer each time it was opened and closed.

The facility policies for surgical services were reviewed on February 21, 2019. The policies referenced the Association of periOperative Registered Nursing (AORN) as the standards they used.

According to the AORN Guideline for Processing Flexible Endoscopes:

Recommendation IX:
Flexible endoscopes and endoscope accessories should be stored in a manner that minimizes contamination and protects them from damage.