The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

MARIAN REGIONAL MEDICAL CENTER 1400 E CHURCH ST SANTA MARIA, CA 93454 June 13, 2019
VIOLATION: GOVERNING BODY Tag No: A0043
Based on interview, observation, and review of records the hospital failed to have a governing body which was effective in carrying out its responsibilities for the conduct of the hospital when it failed to ensure patient safety throughout the facility. The governing body failed to ensure the facility had pharmaceutical services that meet the needs of the patients with clear expectations for patient safety when safeguards to prevent medication retrieval errors were not effective (refer A-0489). The governing body failed to ensure the Quality Assurance and Performance Improvement program covered all areas of patient care including procedural sedation (refer to A-0263). The governing body failed to ensure that Anesthesia Services assumed full responsibility for all anesthesia administered in the hospital. (refer to A-1000).
The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality patient care in a safe environment.
VIOLATION: CARE OF PATIENTS Tag No: A0063
Based on observation, interview, and record review, the hospital failed to ensure policy and procedure (P&P) was implemented when Intravenous (IV) tubing's and IV sites were not labeled with date, time, and initialed by a licensed nurse for 9 of 58 patients. (Patients N404, N405, N406, N407, N408, N409, N603, N602, N600).

These failures had the potential to affect the patient's care and health condition.

Findings:

1. Review of the facility policy titled "Peripheral Intravenous Catheter Insertion and Maintenance (Adult)" dated 10/24/18, indicated, "...All IV tubing will be labeled with time, date and clinical staff's initials to identify when the tubing was hung. Peripheral IV dressings are changed every seven days and PRN."

(a) During an observation inside room 204 and concurrent interview with Telemetry Assistant Manager 1 (TAM1) on 6/10/19, at 3:02 PM, the TAM1 confirmed Patient N603's IV site was not labeled with date, time, and staff initial and should have been labeled.

(b) During an observation inside room 203 and concurrent interview with TAM1 on 6/10/19, at 3:10 PM, the TAM1 confirmed Patient N602's IV tubing was not labeled and should have been labeled.

(c) During an observation inside room 258 and concurrent interview with Intensive Care Unit Registered Nurse 1 (ICURN1) on 6/11/19, at 9:19 AM, the ICURN1 confirmed N600's IV site was not labeled and should have been labeled.










2. (a) During an observation inside room 406 and concurrent interview with the Med/Surg Assistant Manager (ANM3) on 6/11/19 at 8:27 AM, the ANM3 acknowledged Patient N405's IV site was not labeled with time and date and clinical staff's initials.

(b) During an observation inside room 405 and concurrent interview with the Med/Surg Assistant Manager (ANM3) on 6/11/19 at 8:30 AM, the ANM3 acknowledged Patient N406's IV site was not labeled with time and date and clinical staff's initials.

(c) During an observation inside room 410 and concurrent interview with the Med/Surg Assistant Manager (ANM3) on 6/11/19 at 8:40 AM, the ANM3 acknowledged Patient N407's IV site and IV tubing was not labeled with time and date and clinical staff's initials.

(d) During an observation inside room 424 and concurrent interview with the Med/Surg Assistant Manager (ANM3) on 6/11/19 at 8:50 AM, the ANM3 acknowledged Patient N404's IV site was not labeled with time and date and clinical staff's initials.

(e) During an observation inside room 448 and concurrent interview with the Med/Surg Assistant Manager (ANM3) on 6/11/19 at 9:12 AM, the ANM3 acknowledged Patient N408's IV site was not labeled with time and date and clinical staff's initials.

(f) During an observation inside room 440 and concurrent interview with the Med/Surg Assistant Manager (ANM3) on 6/11/19 at 9:29 AM, the ANM3 acknowledged Patient N409's IV site was not labeled with time and date and clinical staff's initials.
VIOLATION: PATIENT RIGHTS: INFORMED CONSENT Tag No: A0131
Based on record review and interview, the hospital failed to:
1. Ensure staff implemented its interpreter policies and procedures when Patient N 103's responsible representative was provided informed consent for patient's surgery.
2. Ensure staff implemented its interpreter policies and procedures when Patient N111 was provided treatment at the infusion center.
3. Ensure staff provided Patient N 111's Conditions of Admission (COAs-consent/authorization for treatment) in her preferred language.
4. Ensure staff provided Patient N110's Conditions of Admission (COAs-consent/authorization for treatment) prior to patient receiving his chemotherapy treatment in the infusion center.
5. Ensure staff offered/provided patients in the infusion center with the "Hospital billing Process Brochure" as indicated in the Conditions of Admission (COAs-consent/authorization for treatment) for three of 58 sampled patients (Patient N108, N109, and N110).
6. Ensure consent form was completely filled out prior to procedure for one of 58 sampled patients. (Patient N 602).

These failures placed patients at risk of not providing them the right to make informed decisions regarding surgical procedures or treatment.

Findings:

1. The hospital policy and procedure titled "Interpreter policy", dated 01/19, in the Procedure part of the policy indicated "3. Patients requiring interpreters will be identified at the time of registration or by staff on the unit...The patient's primary language will be recorded on the medical record (face sheet). 7. ...Documentation of interpreter services will be recorded in the patient medical record and shall include: name of requestor; date and time of interpretation, name of [Hospital's Name] qualified medical interpreter, vendor company name and interpreter name, telephonic interpreter ID number, and a brief description of content interpreted (i.e. Discharge instructions, surgical consent obtained through interpreter ...)"

During a review of Patient N103's (a minor) clinical record on 6/10/19 at 4:22 p.m., the patient's Face sheet (admissions information) indicated the primary language was Spanish. The patient's record did not contain any documentation that an interpreter was utilized by the surgeon to provide informed consent to patient's mother regarding the surgical procedure in order for mother to make an informed decision regarding the procedure.

During an interview with Patient N103 on 6/10/19 at 4:25 p.m., Patient confirmed her mother did not speak the English language, her primary language was Spanish. Patient was a minor therefore mother was consenting for all procedures and treatments.

During an interview with administrator (Admin 4) and concurrent review of Patient 103's record on 6/10/19 at 4:30 p.m. Admin 4 stated "No, there is no documentation or anything in the record indicating the surgeon used an interpreter to provide (informed) consent to her (patient's) mother."

During an interview with administrator (Admin 1) on 6/10/19 at 4:35 p.m. Admin 1 stated "I agree we don't know if an interpreter was used during the surgical consent, if the surgeon did not document this in his note or anywhere in the record is documented that an interpreter was used."

2. The hospital policy and procedure titled "Language Access for Limited English Proficient (LEP) Patients and Companions", dated 10/24/18, in the Guidelines part of the policy indicated " ...Interpreter services, including a Qualified Medical Interpreter when needed to provide meaningful equitable access to the facility's services, are required for patient assessment, consent, education, and discharge, including but not limited to the following: b. Obtaining informed consent or permission for treatment; f. Explaining procedures, test, treatments, treatment options ...; g. Explaining the administration and side effects of medications, including side effects and food or drug interactions"

In the Determination of LEP Status part of the policy indicated "1. The first access point in which a patient acquires services (registration, admissions etc.) shall incorporate the determination of language needs ... The patient shall be asked what their language is, which shall then be recorded in the patient's medical record ... 5. ...Should patients insist upon the use of a friend or family member for medical interpretations and that individual agrees to interpret for the patient, staff must additionally retain a qualified medical interpreter to participate in the exchange to ensure that it represents an accurate portrayal of the information to hospital staff and patients. This information shall be documented in the patient's medical chart and, if possible, staff shall obtain an interpreter services waiver ..."

In the Documentation of Services part of the policy indicated "The documentation of the provision of interpreter services will be recorded in the patient medical record and shall include: name of requestor; date and time of interpretation, name of [Hospital's Name] qualified medical interpreter, vendor company name and interpreter name, telephonic interpreter ID number, and a brief description of content interpreted."

During a medication administration observation on 6/12/19 at 12:10 p.m., in the Hope infusion center, Patient N111 was observed not communicating back with staff when spoken to her.

On 6/12/19 at 12:25 p.m., licensed nurse (LN 4) indicated she had explained to Patient N 111, the type of medication administered to her, what it does, the side effects, and the s/s she could experience while receiving the medication and when and what to report to her. However, LN 4 admitted not speaking the Spanish language and not utilizing an interpreter service, when this was explained to the patient.

On 6/12/19 at 12:30 p.m., surveyor approached Patient N111, introduce herself, stated the reason she was at the infusion center and asked permission to interview her. Patient N111 stated "No engles" [I do not speak English].

On 6/12/19 at 12:38 p.m., surveyor asked LN 3 (lead RN) in the infusion center that surveyor would like to interview Patient N111, perhaps interpreter services will be needed. LN 3 explained the hospital has an interpreter IPad, Cyracom telephone or qualified interpreters. But, they don't have those interpreter methods in the infusion center.

On 6/12/19 at 12:50 p.m., Patient N111's clinical record was reviewed with LN 3. The face sheet indicated patient's preferred language was Spanish. Notes in the record indicated medical assistant (MA) and infusion clerk (IC) had been interpreting for nurses etc. LN 3 was asked if MA and IC were qualified medical interpreters. LN 3 reply "No, they are not qualified medical interpreters." No other documentation found in the record that interpreter services had been utilized when communicating with patient.

During review of the infusion center interpreter services policy and procedure and concurrent interview with administrator (Admin 1) on 6/12/19 at 12:52 p.m., Admin 1 stated "I agree the infusion center needs to have the interpreting methods as stated in the policy."

3. During a review of Patient N111's clinical record and concurrent interview with the infusion clerk (IC) on 6/12/19 at 12:50 p.m., the "Conditions of Admission- Consent for Treatment and Authorization (COAs)", dated 6/12/19 were written in the English language. The IC acknowledged providing patient the COAs in the English language and not in the patient's preferred language.

4. The Infusion Center policy and procedure titled "Conditions of Admission", dated 1/22/18, in the Purpose part of the policy indicated "The primary intent of the COA form is to establish the conditions under which a patient is admitted to the hospital for inpatient or outpatient services ...The COA documents the relationship between the patient and the hospital, the patient's consent to the medical treatment ...and routine services..."

During a record review of Patient N110's clinical record and concurrent interview with the infusion center clerk (IC) on 6/12/19 at 11:30 a.m., the IC indicated patient had not been provided nor signed the Conditions of Admission- Consent for Treatment and Authorization (COAs) form yet. Patient N110 had been checked in to the infusion center for his chemotherapy treatment since 8:30 a.m. Patient's treatment was almost completed. IC stated "I'll have him sign his COAs before he gets discharge."

During an interview with licensed nurse LN 3 (lead nurse) on 6/12/19 at 12:25 p.m., LN 3 acknowledged and agreed the COAs needed to be provided and signed by patient before his treatment.

5. The Infusion Center policy and procedure titled "Conditions of Admission", dated 1/22/18, in the Purpose part of the policy indicated " ... The COA documents the relationship between the patient and the hospital, the patient's consent to the medical treatment ...and routine services, and documents financial responsibility for payment of hospital charges for services rendered."

A Review of the infusion center's "Conditions of Admission- Consent for Treatment and Authorization (COAs)" on page 5 of 6 indicated "You (patient) have been offered the Hospital Billing Process brochure."

During an interview with three of four patients (Patient N108, N109 and N110) in the infusion center on 6/12/19 between 11:00 a.m. to 12:10 p.m., the patients were asked if they had been offered or provided with the "Hospital Billing Process brochure". All three patients indicated they were not offered or provided with the brochure and they did not know what it was.

During an interview with licensed nurse LN 3 (lead nurse) on 6/12/19 at 1:02 p.m., LN 3 stated "We don't provide patients with the brochure (Hospital Billing Process brochure). Only, if is requested by the patients."





6. During a concurrent review of Patient N 602's clinical record and interview with Telemetry Registered Nurse 2 (TRN2) on 6/12/19, at 8:21 AM, the TRN2 reviewed and confirmed the informed consent was not completely filled out. TRN2 verified the following:

-The physician order dated 6/10/19 time stamped at 10:29 AM, indicated an order of procedure "Gastric Feeding Tube Placement with Procedural Sedation" including special instructions: When completing the consent form please list the entire procedure name.

- The consent titled "Consent to Surgery or Special Procedure" indicated in part: 1. Operation or Procedure to be Performed: Interventional Radiology G Tube Insertion [the entire procedure name was not listed as ordered and the Gastrostomy was abbreviated as G]. 2. Primary Surgeon: Dr. [was left blank] is your primary surgeon. 11. Acknowledgement and Signature: If signed by other than patient, indicate name and relationship: [The name of the person who signed and his/her relationship to Patient N 602 was left blank], Patient Unable to sign due to: [was left blank].

The hospital policy titled "Consent to Surgery or Special procedure and Consent to Blood Transfusion" dated 2/18, indicated the procedure including "...1. Fill in the full name of the operation/special procedure, using correct medical terminology. 3. Fill in the name of the primary surgeon. 7. Signature: The patient, parent or legally authorized representative shall sign consent and date and time..."
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
Based on observation, interview, and record review, the hospital failed to:

1. Ensure the hospital anesthesiologist (MD1) implemented the medication administration policy during anesthesia for one of 58 sampled patients (Patient N 112).

This facility failure resulted in the administration of the wrong medication, given the wrong route, leading to Patient N112's decompensation and brain death and compromised the patients safety while in the hospital.

2. Ensure staff fully implemented their "Fall Prevention and Management Policy" for one of 58 sampled patients (Patient N104).

This facility failure place Patient N104 at risk for falls and injuries.

Findings:

1. The hospital's policy and procedure entitled "Medication Administration", effective date 07/18, and in effect during Patient N112's surgical procedure, was reviewed. Section 11, titled, "Purpose" set forth the following; "To provide the patient safe administration of medications."

The same policy, under Section 111, Part F, set forth the following:
"Administer medications according to the "5 rights of Medication Administration";
1. Right patient
2. Right medication
3. Right dosing
4. Right route
5. Right time

During an interview with administrator (Admin 3) on 6/12/19 at 6:15 p.m., According to Admin 3, the anesthesiologist (MD 1) removed the Digoxin ampoule instead of the Bupivacaine ampoule that was stored in the same drawer, but, in different cassettes in the main OR ommnicell machine and injected the medication into Patient N112's spinal area during her elective surgery for hip arthroplasty (the surgical repair of a joint) on 3/13/19.

Digoxin (a medication that increases the force of contraction of the heart muscle) was given rather than the intended bupivacaine (a medication used to decrease feeling in a specific area). Further the Digoxin was given intrathecal (a route of administration for drugs via an injection into the spinal canal) rather than the intended anesthetic agent meant for intrathecal injection. Digoxin is not intended to be given intrathecal.

During the ORs Omnicell medication dispensing machine inventory, one digoxin vial/ampoule was missing from the medication cassette and there was an extra vial/ampoule of Bupivacaine in the medication cassette, confirming that MD 1 had administered the incorrect medication to Patient N112 during her surgical procedure.

A review of the laboratory document entitled "Therapeutic Drug Monitoring/Toxicology", with Digoxin Levels from 3/13/19 to 3/15/19 was conducted. The document indicated that on 3/13/19, Patient N112's digoxin level was 0.6. On 3/14/19, the digoxin level was 1.3. On 3/15/19 the digoxin level was 1.1. reference range was 0.8-2.0 for a patient taking Digoxin routinely, for Patient N112 the level should have been zero as this was not a medication the patient took routinely.

The "Pre-Anesthesia Note", dated 3/13/19 at 6:57 a.m., indicated Patient N112's medications prior to her surgical procedure were, Atenolol (treat high blood pressure), Diphenhydramine (treat allergies), Lisinopril (treat high blood pressure), Omeprazole (reduce the amount of acid in your stomach), Senokot (to treat constipation), and Rosuvastatin (reduce bad cholesterol).

The "Anesthesia Record," dated 3/13/19, indicated regional (spinal) and general anesthesia were performed by the anesthesiologist (MD 1) and that Spinal medication was administered to Patient N112 at 7:30 a.m., during the surgical procedure on 3/13/19.

2. The hospital policy and procedure titled "Fall Prevention and Management Policy", dated 12/13/17, in the Procedure part of the policy indicated "The RN will assess each patient's fall risk at the time of initial physical assessment, at the time of admission, every shift, upon transfer to another level of care ..." Further review of the policy indicated, that the John Hopkin's Fall Risk Assessment Tool will be completed for adult patients. For High Fall Risk patients with a score of 6 or greater to implement the interventions listed in (Appendix A-2). Some of the interventions listed in (Appendix A-2) included "Provide fall prevention education to patient/family. Apply yellow wristband. Utilize yellow slippers."

During an observation and concurrent interview with Patient N104 while in the holding area on 6/10/19 at 2:15 p.m. Patient was observed wearing yellow socks. However, no yellow wrist band was located on his wrists. Patient was asked, if he knew the reason he was wearing yellow socks. Patient reply, "No, I don't know. My feet were cold that's why I have this yellow socks."

During an interview with holding area licensed nurse LN 5 on 6/10/19 at 2:20 p.m., LN 5 acknowledged no yellow wrist band was located on patient's wrist. LN 5 stated "I will put one yellow wrist band on him (patient) now." Furthermore, LN 5 explained that when patients are found to be at high risk for falls the staff must apply yellow socks, yellow wrist bands and educate them ... as per their policy.

During an interview with Patient N104's family members (FMs -wife and daughter) on 6/10/19 at 2:25 p.m., FMs were asked, if the hospital staff had educated them on their fall prevention program interventions ...the wife and daughter confirmed "no staff had educated them on that (fall prevention program interventions)."

A review of Patient N104's clinical record was conducted on 6/11/19 at 10:05 a.m., the patient's John Hopkin's Fall Risk Assessment Tool indicated that on 6/9/19 patient was found to be at High Risk for fall with a score of 14. On 6/10/19 patient's score was 13. On 6/11/19 patient's score was 17. According to the John Hopkin's Fall Risk Assessment Tool, scores 0-5 is consider Low Fall Risk. Scores 6 or greater is consider High Fall Risk.
VIOLATION: QAPI Tag No: A0263
Based on observation, interview, and record review the hospital failed to develop, implement, and maintain an effective, ongoing, hospital wide, data-driven quality assessment and performance improvement program. The hospital's governing body failed to ensure that the program reflected the complexity of the hospital's organization and services; involved all hospital departments and services (including those services furnished under contract or arrangement); and focused on indicators related to improved health outcomes and the prevention and reduction of medical errors. There were no effective safeguards to prevent medication retrieval errors in place for all automated drug storage and distribution devices in the facility (refer to A-0506). The safety and quality of care provided by anesthesia services was not monitored in all areas (refer to A-0273).
The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality patient care in a safe environment.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on interview and record review the facility failed to ensure data was collected to monitor the effectiveness and safety of services and quality of care in all areas where anesthesia services were provided.

Findings:

Review of the facility policy titled "Scope of Services" for the Department of Anesthesia revealed anesthesia services were to be integrated into the facility's Performance Improvement Program.

During an interview on 6/13/2019 at 11:15 a.m. the chief nursing officer (CNO) stated no quality assurance data had been collected for monitoring the safety of anesthesia (medications that render a patient unresponsive and unconscious) services and quality of care in the endoscopy suite when conscious sedation (combination of medicines to help you relax and to block pain during a medical procedure) was performed by non-anesthesiologists. The CNO also stated the quality assurance data collected in the Emergency Department for cases of conscious sedation and deep sedation (drug induced loss of consciousness during which patients cannot be easily aroused but respond purposefully following repeated stimulation) by non-anesthesiologists had been reported to the Department of Medicine but not to the Department of Anesthesia, which was responsible for oversight according to the facilities policy titled "Scope of Services" for anesthesia.
VIOLATION: NURSING CARE PLAN Tag No: A0396
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

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

1. Individualize a care plan for 10 of 58 patients. (Patients N103, N104, N106, N400, N403, N404, N411, N505, N506, N601).

2. Ensure care plan was initiated upon admission for one of 58 patients. (Patient N600).

3. Develop a care plan for two of 58 patients. (Patient N100, N603, ).

These facility failures placed patients at risk for increased pain, falls, lack of care, and worsening pressure ulcers (injuries to skin and underlying tissue resulting from prolonged pressure on the skin).

Findings:

1a. During a review of Patient N 601's clinical record and concurrent interview with the Critical Care Director (CCD) on 6/11/19, at 10:45 AM, the CCD indicated Patient N 601 was admitted on [DATE] with diagnoses including subdural hematoma (collection of blood outside the brain usually caused by severe head injuries). The CCD indicated Patient N 601 had received pain medication since admission and confirmed the generic care plan for pain was initiated on 6/11/19 and should have been individualized and evaluated according to patient's need.

The facility policy titled "Pain Management (Acute and Chronic) Assessment, Reassessment and Management" dated 3/18, indicated policy including " ...An individualized pain management plan will be developed in collaboration with the patient/family. Pharmacological and nonpharmacological interventions may be included in the pain management plan ..."

The facility policy titled "Care Plan: Interdisciplinary Plan of Care" dated 3/18 indicated procedure including "...All aspects of Patient Care should be linked with the Care Plan. Interdisciplinary Plan of Care interventions will be documented each shift..."

2a.During an observation of Patient N 600 inside room 258 and concurrent interview with the Intensive Care Unit Registered Nurse 1 (ICURN1) on 6/11/19, at 9:19 AM, the ICURN1 confirmed Patient N 600's left foot second toe wound and right forearm bruises, abrasions, and skin tear were present since admission.

Review of Patient N 600's clinical record on 6/11/19, at 3:43 PM, indicated an admission date of [DATE] and diagnoses including Mild Sepsis CA. The care plan for Impaired Skin Integrity was reviewed and noted to be dated 6/11/19, 7 days after admission. Concurrent interview with Critical Care Director (CCD) confirmed the above care plan was initiated on 6/11/19 and should have been initiated on 6/4/19.

The facility policy titled "Care Plan: Interdisciplinary Plan of Care" dated 3/18, indicated the procedure including "...All aspects of Patient Care should be linked with the Care Plan. The Care Planning process begins on admission. Care Plan must be initiated within 8 hours of patient admission to unit..."

3a.In a review of Patient N 603's clinical record and concurrent interview with Telemetry Registered Nurse 2 (TRN2) on 6/12/19, at 10:21 AM, TRN2 indicated Patient N 603 was admitted on [DATE], the pain medication was ordered on [DATE] and Patient N 603 had received the pain medication. TRN2 reviewed Patient 603's care plans and confirmed she was unable to locate the care plan for pain. TRN2 further indicated the care plans should be initiated upon admission.

The facility policy titled "Care Plan: Interdisciplinary Plan of Care" dated 3/18, indicated the procedure including "...All aspects of Patient Care should be linked with the Care Plan. The Care Planning process begins on admission..."





Findings:

1b. During a review of Patient N400's clinical record on 6/11/19 at 9:47 AM indicated the patient has a care plan for acute pain. The care plan does not address location pain nor it have an intervention for it; the interventions are the same compared to other patients with the same care plan. Care plan is not individualized regarding the patient's needs.

1c. During a review of Patient N403's clinical record on 6/11/19 at 10:12 AM indicated the patient has a care plan for acute pain. The care plan does not address the location of pain nor have an intervention for it, the interventions are the same compared to other patients with the same care plan. Care plan is not individualized regarding the patient's needs.

1d. During a review of Patient N404's clinical record on 6/11/19 at 11 AM indicated the patient has a care plan for acute pain. The care plan does not address the location of pain nor have an intervention for it, the interventions are the same compared to other patients with the same care plan. Care plan is not individualized regarding the patient's needs.

During an interview on 6/11/19 at 2:20 PM, the Med Surg Manager (MSM) indicated the way they make the care plan is by using a template for the needs of the patient being addressed. The MSM indicated there is a way to customize the interventions to fit the need of a specific patient but it did not reflect on the current care plans for the said patients. The MSM acknowledged care plans were not individualized.

1e. During a review of Patient's 411's clinical record and a concurrent interview with the Assistant Nurse Manager (ANM2) of Med/Surg Tele, Arroyo Grande campus on 6/11/19 at 10:30 indicated Patient 411 has a care plan for acute pain. The care plan does not address the location of the pain nor have intervention for it, the interventions are the same compared to other patients with the same care plan. The ANM2 acknowledged the care plan was not individualized.

The facility policy and procedure titled " Care Plan: Interdiciplinary Plan of Care" dated 3/18 indicated all aspects of care plan, such as teaching, inteventions, referrals, follow up, collaboration, changes in plan, etc. should be linked with the care plan.




1f. The hospital's policy and procedure titled "Care Plan: Interdisciplinary Plan of Care", dated 03/18, in the Purpose part of the policy indicated "A. The RN will develop/create an individualized care plan based on the ...assessment."

During a review of Patient N103's pain care plan and concurrent interview with licensed nurse LN 1 on 6/11/19 at 4:45 p.m., LN 1 was asked what were the interventions that were being performed for this 17 yr. old teenager. LN 1 explained all the interventions that nursing was performing for the patient. LN 1 was asked that if nursing staff was performing all these other interventions why those interventions were not documented or listed on Patient N103's pain care plan. The pain care plan was not individualized according to what was being implemented with the patient. LN 1 agreed that the care plan was not individualized with patient's personalized interventions.

During a concurrent interview with Admin 5 on 6/11/19 at 4:45 p.m., Admin 5 explained the care plans were created in the computer system at a macro level to capture the patient's diagnosis.

1g. During a review of Patient N104's falls prevention care plan and concurrent interview with administrator (Admin 1) on 6/11/19 at 4:45 p.m., Admin 1 acknowledged and agreed the fall prevention care plan interventions were not personalized or individualized as per patient's care needs. Admin 1 stated "I understand, I get it, the care plans need to be individualized according to the patient's care needs."

1h. During a review of Patient N106's (a 10 yr. old girl) pain care plan and concurrent interview with administrator (Admin 1) on 6/11/19 at 4:45 p.m., Admin 1 acknowledged the pain care plan documented interventions were exactly the same as of another patient (Patient N103). Admin 1 acknowledged and agreed the pain care plan interventions for two different patients cannot be the same. Admin 1 stated "I understand, I get it, the care plan interventions need to be individualized according to the patient's care needs."

3b. The hospital's policy and procedure titled "Care Plan: Interdisciplinary Plan of Care", dated 03/18, in the Purpose part of the policy indicated "A. The RN will develop/create an individualized care plan based on the admission assessment."

During a review of Patient N100's clinical record and concurrent interview with licensed nurse LN 2 on 6/10/19at 4:05 p.m., LN 2 was asked to show me the patient's pain care plan. Since, she had medicated patient with pain medication on 6/10/19 at 1:57p.m., 2:05 p.m., 2:20 p.m., & 2:27 p.m., while patient was in the post anesthesia care unit (PACU). LN 2 stated "I didn't start any pain care plan. I should have." No pain care plan was initiated by LN 2, even though, LN 2 had administered pain medication to patient while in PACU.












Findings:

1i. A review of Patient N505's clinical record on 6/12/19 at 9:45 A.M., indicated a Care Plan for acute pain was initiated. However, it did not mention other interventions specific to the patient's condition. The Care Plan is not individualized to cater to the patient's needs.

1j. A review of Patient N506's clinical record on 6/12/19 at 9:45 A.M., indicated a Care Plan for acute pain was initiated. However, it did not mention other interventions specific to the patient's condition. The Care Plan is not individualized to cater to the patient's needs.

During an interview on 6/12/19 at 10:20 A.M., the Assistant Nurse Manager (ANM2), and the Critical Care Director (CCD), both indicated that general templates are used to initiate care plans. They both agreed that the pain care plans could have been written more specifically. The CCD further states, "...it is cumbersome for staff to do that ...and staff does not have the capacity to write specifics, because the system won't allow it."

The facility policy and procedure (P&P) titled "Care Plan: Interdisciplinary Plan of Care" dated 3/18, indicated "The RN will develop/create an individualized care plan ..." and "All aspects of Patient Care, such as teaching, interventions, referrals, follow-up, collaboration, changes in plan, etc. should be linked with the Care Plan."

The facility P&P titled "Pain management (Acute and Chronic) Assessment, Reassessment and Management" dated 3/18 indicated "An individualized pain management plan will be developed in collaboration with the patient/family."
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
Based on interview and record review the facility failed to:

1. Ensure 1 of 3 sampled Patients' (Patient M -200) medication orders did not require clarification with the Patient's physician.

This facility failure had the potential for Patient M-200 to suffer unrelieved nausea/vomiting.

2. Clarify an unclear medication order for one of 58 sampled patients (Patient N505).

This facility failure has the potential to result in a medication error that compromises the safety of the patient.

Findings:

The facility policy and procedure titled, "Ordering and Prescribing Medications" dated 9/18 indicated "The prescribing practitioner will be contacted for clarification of any orders staff members feel are not legible or unclear in the electronic medical record."

Concurrent interview and clinical record review for Patient M-200 on 6/10/19 at 4 pm with the TeleLN revealed the following physician's order written on 5/31/19 at 10:01 pm: "Ondasetron (Zofran) 4 milligrams intravenous (IV) push injection every 4 hours, priority; routine. PRN (as needed) for nausea/vomiting 2nd choice, if first choice ineffective". Further review of Patient M-200's clinical record revealed that the physician had never prescribed a "first choice" medication to treat this patient's nausea and vomiting. The first dose of this Zofran had been administered to this patient on 6/1/19 at 9:35 am and this medication had been continually given to this patient until 6/5/19 (6 days) without any of the hospital's nursing staff obtaining a clarification order from this patient's physician.






2. During a review of Patient N505's clinical record on 6/12/19 at 10:30 A.M., the Medication Administration Record (MAR) indicated an order for Acetaminophen - Hydrocodone (Norco 5 mg - 325 mg tablet, give 0.5 - 1 tab, PO q4hr, PRN (as needed) Pain Scale (See Comments), FIRST DOSE INSTRUCTIONS: Start with 1 tab, assess response after 30 minutes; May repeat X1 dose after 30 minutes if pain goal not achieved; If 2 tabs effective, continue with 2 tabs for subsequent dosing (Max: 4000 mg acetaminophen per day).

During an interview on 6/12/19 at 10:30 A.M., the Assistant Nursing Manager (ANM2) and the Critical Care Director (CCD) both agreed that the order was confusing and should have been written better.

An interview on 6/12/19 at 3:40 P.M., Director of Pharmacy (DOP) stated that the medication order is "worded differently ...it is confusing ...the 0.5 throws me off."

An interview on 6/12/19 at 4:00 P.M., Staff Registered Nurse (LN6) stated, "I would start with half a tablet ...haven't seen this order at all ...where is the 0.5 tab?" Medical /Surgical Manager (MSM) stated, "it's confusing ...I don't know."

An interview on 6/12/19 at 4:10 P.M., Assistant Nurse Manager (ANM3) agreed that the medication order is unusual, and stated, "I have not seen this order before ...not familiar with this at all."

An interview on 6/12/19 at 4:45 P.M., the DOP stated she was able to talk to the ordering physician and confirmed a clarification should have been done prior to administering the medication. DOP indicated an order clarification was not done.

The facility policy and procedure titled, "Ordering and Prescribing Medications" dated 9/18 indicated "The prescribing practitioner will be contacted for clarification of any orders staff members feel are not legible or unclear in the electronic medical record."
VIOLATION: BLOOD TRANSFUSIONS AND IV MEDICATIONS Tag No: A0409
Based on record review and interview, the hospital failed to ensure staff followed its blood transfusion policy and procedures when blood was administered to one of 58 sampled patients (Patient N104).

This failure had the risk of the patient receiving blood products without staff being aware whether the patient had been consented.

Finding:

The hospital policy and procedure titled "Blood and Blood Components Administration", dated 04/15, in the Nursing Practices Standards part indicated "1. It will be the responsibility of the nurse to obtain written verification of the patient's informed consent for the transfusion."

The hospital policy and procedure titled "Informed Consent", dated 03/18, in the Nursing Documentation part indicated "1. Nursing will witness the signatures of the patient or patient's legal representative on the consent form. 2. The RN or LVN who witnessed the patient sign the consent form will sign and date the consent form."

During a review of Patient N 104's clinical record and concurrent interview with administrator (Admin 1) on 6/11/19 at 10:43 a.m., the document titled "Consent for Blood Transfusion", was undated, and unwitnessed. Another document titled "Consent For /Refusal of Blood Transfusion", dated 6/10/19 was also unwitnessed by staff, indicating they had not verified the patient had been consented by the physician for the administration of blood. A physician's order for Plateletpheresis (blood products), dated 6/10/19 was located in the record. In the Blood Transfusion flowsheet part of the record indicated the blood products were administered between 12:00p.m., to 1:00 p.m. Admin 1 explained the nurse who administered the blood products needed to ensure the blood consent was completed properly, by witnessing the consent s/he was indicating s/he has verified the patient had been consented for the blood transfusion.
VIOLATION: CONTENT OF RECORD Tag No: A0449
Based on observation, interview, and record review, the facility failed to ensure policy and procedure (P&P) were implemented when pain assessment and reassessments were not documented for 15 of 58 patients. (Patients N100, N102, N103, N301, N305, N306, N307, N400, N401, N402, N411, N503, N600, N601, N604).

These failures had the potential for patient's pain management not to be met.

Findings:

1. The facility policy titled "Pain Management (Acute and Chronic) Assessment, Reassessment And Management" dated 3/18, indicated the policy "...Pain management clinical practice expectations include pain history/assessment, assessment/reassessment, patient/family education, and individualized pain management plan using appropriate scale. All patients will receive individualized pain assessment and effective pain management. Pain reassessment will be performed following the implementation of pain management interventions to determine effectiveness based on intervention type, onset, and action. Suggested pain reassessment intervals include: IV (intravenous): approximately 15 minutes after administration, PO (per oral medication): approximately 60 minutes after administration, Subcutaneous: approximately 30 minutes after administration..."

1 a (1) During a medication administration observation for Patient N 601 inside room 251/1 with the Intensive Care Unit Registered Nurse 2 (ICURN2) on 6/11/19 at 8:43 AM, indicated, ICURN2 administered Norco 5/325 mg 1 tablet to Patient N 601 due to headache.

A review of Patient N 601's clinical record and concurrent interview with Critical Care Director (CCD) occurred on 6/11/19 at 10:45 AM. The CCD reviewed the physician order of Norco 5/325 mg 1 to 2 tablet by mouth for moderate to severe pain. Start with 1 tablet, assess response after 30 minutes, may repeat times 1 dose after 30 minutes if goal not achieved. The CCD confirmed the reassessment for Patient 601's response was not documented in the Medication Administration Record (MAR) due at 9:13 AM on 6/11/19.

1a (2) A review of Patient N 600's clinical record and concurrent interview with CCD occurred on 6/11/19 at 3:07 PM. The CCD confirmed the MAR indicated Acetaminophen 650 mg 1 tablet by mouth was administered on 6/4/19 at 5:59 PM for pain and did not indicate reassessment of pain after one hour.

1 a (3) A review of Patient N 604's clinical record and concurrent interview with Telemetry Registered Nurse 2 (TRN2) occurred on 6/12/19 at 4:54 PM. The TRN2 confirmed the MAR indicated Acetaminophen 650 mg 1 tablet by mouth as needed for pain was administered on 6/10/19 at 3:27 AM and the treatment response was reassessed after more than two hours and should have been assessed after one hour.





1 b (1) During a review of Patient's N401's clinical record and a concurrent interview with the Licensed Nurse (LN7) and Med/Surg Manager (MSM) on 6/10/19 at 2 PM. LN7 navigated the clinical record and it indicated the patient was given Norco (a narcotic pain medication) 5/325 milligrams (mg) 2 tabs every 4 hours as necessary. LN7 and MSM confirmed no post pain reassessment was documented on the clinical record. The Patient given Dilaudid (a narcotic pain medication) 0.4 mg intravenous (IV) at 6/9/10 at 10:40 AM, LN7 and MSM confirmed no post pain reassessment was documented.

1 b (2) During a review of Patient's N402's clinical record and a concurrent interview with LN7 and the MSM on 6/10/19 at 2:30 PM. LN7 navigated the clinical record and it indicated the patient was given Dilaudid (a narcotic pain medication) 1 milligram (mg) IV every 2 hours as necessary on 6/9/19 at 9 PM. and 6/10/19 at 12:56 AM. LN4 and MSM confirmed no Post pain reassessments were documented on the clinical record. Dilaudid 4 mg by mouth every 4 hours as necessary was given to the patient on 6/9/19 at 6:15 AM, LN4 and MSM confirmed no post pain reassessments was documented.

1 b (3) During a review of Patient's N400's clinical record and a concurrent interview with LN7 and the MSM on 6/11/19 at 3 PM. LN7 navigated the clinical record and it indicated the patient was given Morphine (a narcotic pain medication) 2 mg IV for pain 6/10. LN7 and MSM confirmed no post pain reassessment was documented on the clinical record.

1 b (4) During a review of Patient's N411's clinical record and a concurrent interview with the Assistant Nurse Manager Med/Surg Tele (ANM2) on 6/10/19 at 2:30 PM. ANM2 navigated the clinical record and it indicated the patient was given Oxycodone (a narcotic pain medication) 5 mg by mouth for a pain of 10/10 on 6/10/19 at 8:46 PM. ANM2 confirmed no post pain reassessment was documented.








The hospital's policy and procedure titled "Pain Management (acute and Chronic), Assessment, Reassessment And Management", dated 03/18, in the Policy part of the policy indicated "H ...Suggested pain reassessment intervals include: Intravenous-15 minutes after administration. In the Procedure part of the policy indicated "D. Assess pain with any report of pain, with procedures/interventions likely to result in pain, and as determined by individual patient status/needs. Pain assessment components include: a. Location, b. Characteristics, c. Frequency, d. Pain level, e. Comfort-function goal."

1 c (1) During a review of Patient N100's pain flowsheet documentation and concurrent interview with licensed nurse (LN 2) on 2/10/19 at 3:54 p.m., the flowsheet indicated patient reported pain in four occurrences between 1:55 p.m., and 2:29 p.m. However, there was no documentation of the pain assessment components (e.g. Location, Characteristics, Frequency ...). LN 2 acknowledged the documentation and stated "I didn't document the location ...I should have".

1 c (2) During a review of Patient N102's pain flowsheet documentation and concurrent interview with administrator 1 (Admin 1) on 2/13/19 at 10:35 a.m., the flowsheet indicated that from 6/10/19 at 2:43 p.m., to 6/11/19 at 11:00 a.m., patient reported pain six different occurrences. However, there was no documentation of the pain assessment components (e.g. Location, Characteristics, Frequency ...). Further review indicated, Patient was medicated with Fentanyl 50 mcg intravenous push at 2:07 p.m., same medication administration occurred at 2:43 p.m., for both times, there was no 15-minute pain re-assessment documented. Admin 1 acknowledged and agreed the pain assessment and re-assessment documentation should be as per their policy and procedure.

1 c (3) During a review of Patient N103's pain flowsheet documentation and concurrent interview with administrator 1 (Admin 1) on 2/13/19 at 10:39 a.m., the flowsheet indicated no documentation at all on 6/10/19 at 12:53 a.m., and at 6/10/19 at 9:55 a.m., when patient was medicated with Tylenol 1000 mgs IV as indicated per the medication administration record. On 6/10/19 at 2:16 p.m., and at 8:10 p.m., on 6/11/19 at 12:29 a.m., and at 8:02 a.m., the flowsheets indicated no documentation on the pain assessment components (e.g. Location, Characteristics, Frequency ...) when the patient was medicated as indicated per the medication administration record. Admin 1 acknowledged and agreed the pain assessments documentation should be as per their policy and procedure.








Review of nursing standards of care in Elsevier Mosby Potter-Perry "Fundamentals of Nursing" 6th Edition page 1240 in the section Assessment indicated " ...deciding on appropriate interventions, and evaluating the client's response (outcomes) to the interventions are contingent on the fundamental activity of a factual, timely, accurate pain assessment." The same reference and section on page 1241 further indicated " ...the nurse primarily assesses the location, severity, and quality of the pain."

1 d (1) Reviewed the IViews (Flow Sheets - electronic documentation of patient pain assessment date, time, intensity level, location, and pain scale) and the "Medication Administration Records" (MARs) for Patient N301 and concurrently interviewed the Manager of Labor and Delivery (Admin 2) on 6/11/19 at 4:45 p.m. The Admin 2 navigated Patient N301's Flow Sheets and MARs for the dates that follow. On 6/10/19 at 9 p.m. 400 mg Ibuprofen (a non-narcotic pain relieving medication) was given by mouth for an assessed pain intensity level of 3/10 (0 = no pain/10 = most pain). The initial pain assessment did not include the location of Patient N301's pain. The follow-up pain assessment (reassessment) dated 6/10/19 at 9:30 indicated a pain intensity level of 1/10 with no pain location assessment. The Admin 2 reviewed and confirmed Patient N301's Flow Sheets dated 6/10/19 did not include an assessment or reassessment of pain location and should have.

1 d (2) Reviewed the Flow Sheets and MARs for Patient N305 and concurrently interviewed the Admin 2 on 6/12/19 at 4:48 p.m. The Admin 2 navigated Patient N305's Flow Sheets and MARs for the dates that follow. On 6/8/19 at 5:40 p.m. one tablet of 325 mg acetaminophen-5 mg hydrocodone (norco - narcotic pain relieving medication) was given by mouth for pain assessed at an intensity level of 5/10. The initial pain assessment and reassessment did not include pain location and pain was reassessed late after one hour thirty minutes instead of within one hour. Further investigation revealed Patient N305 was given 600 mg of ibuprofen on 6/9/19 at 9 p.m. for a pain level of 4/10 but location of pain was not assessed or reassessed. Again on 6/10/19 at 6:30 a.m. Patient N305 was assessed with a pain intensity level of 4/10 but no pain location was assessed or reassessed. The Admin 2 reviewed and confirmed Patient N305's Flow Sheets and MARs showed pain reassessment was not within one hour on 6/8/19 and should have been within one hour, and the initial pain assessments and reassessments on the Flow Sheets dated 6/8, 9, 10/2019 did not include pain location and should have included the pain location.

1 d (3) Reviewed the Flow Sheets and MARS for Patient N306 and concurrently interviewed the Admin 2 on 6/13/19 at 9:20 a.m. The Admin 2 navigated Patient N306's Flow Sheets and MARs on the dates that follow. On 6/9/19 at 5:30 a.m. Patient N306's pain intensity level was assessed at 1/10 on admission to unit but no location was assessed. On 6/9/19 at 8:15 a.m. 600 mg of Ibuprofen was given by mouth to Patient N306 for a pain intensity level of 2/10 with no pain location assessment and no pain location reassessment. On 6/10/19 at 3:05 p.m. Patient N306 was given 600 mg of Ibuprofen by mouth for a pain intensity level of 3/10 and no pain location was assessed or reassessed. The Admin 2 reviewed and confirmed Patient N306's pain assessments and reassessments on Flow Sheets dated 6/9, 10/2019 did not include the pain location and should have included pain location.

1 d (4) Reviewed the Flow Sheets and MARS for Patient N307 and concurrently interviewed the Admin 2 on 6/13/19 at 10 a.m. The Admin 2 navigated Patient N307's Flow Sheets and MARs on the dates that follow. On 6/9/19 at 5 p.m. Patient N307's pain intensity level was assessed at 2/10 and pain location was not assessed. On 6/10/19 at 3:15 a.m. 600 mg of Ibuprofen was given by mouth to Patient N307 for a pain intensity level of 1/10 with no pain location assessment and no pain location reassessment. On 6/10/19 at 9:16 a.m. Patient N307 was given 600 mg of Ibuprofen by mouth for a pain intensity level of 1/10 and no pain location was assessed or reassessed. On 6/11/19 at 3:37 a.m. 600 mg of Ibuprofen was given by mouth to Patient N307 for a pain intensity level of 2/10 with no pain location assessment and no pain location reassessment. The Admin 2 reviewed and confirmed Patient N307's pain assessments and reassessments on Flow Sheets dated 6/9, 10, 11/2019 did not include the pain location and should have included pain location.

During an interview with the Director of Perinatal Services (Admin 6) on 6/13/19 at 10:20 a.m., the Admin 6 indicated and confirmed it is the expectation for pain assessments and reassessments to include the location of patients' pain.








1 e (1). A review of Patient N503's clinical record on 6/11/19 at 1:30 P.M., indicated Patient's pain managed with oral Dilaudid 8mg. Pain reassessment seen for both entries made on 6/8/19 at 7:23 P.M. and 6/9/19 at 10:30 P.M. However, there was no record of pain reassessment for pain medication given 6/10/19 at 5:28 A.M.

During an interview on 6/11/19 at 1:45 P.M., the Director of Imaging Services (DIS), and Assistant Nurse Manager (ANM1) agreed that there should have been a pain reassessment documentation for the pain medication given to Patient N503 on 6/10/19 at 5:28 A.M.

A facility policy and procedure titled "Pain Management (Acute and Chronic) Assessment, Reassessment and Management" dated 3/18, indicated "Pain reassessment will be performed following the implementation of pain management interventions to determine effectiveness based on intervention type, onset, and action. Suggested pain reassessment intervals include ...PO: approximately 60 minutes after administration."
VIOLATION: CONTENT OF RECORD - INFORMED CONSENT Tag No: A0466
Based on record review and interview, the hospital failed to ensure staff completed informed consent properly for three of 58 sampled patients (Patient N100, N103 and N602).

These failures had the potential of not knowing when the consents were obtained from the patients and consents not being properly executed.

Finding:

The hospital's policy and procedure titled "Consent to Surgery or Special Procedures and Consent to Blood Transfusion", dated 02/18, in the Policy part indicated "D) A Consent to Surgery or Special Procedures and Consent to Blood Transfusion Form must be completed and signed by the patient prior to undergoing any surgical or invasive procedure ...or receiving any anesthesia." In the Procedure part indicated "7. Signature: The patient, parent or legally authorized representative shall sign consent and date and time."

1. During a record review of Patient N 100's record and concurrent interview with post anesthesia care unit (PACU) manager (PACUM) on 6/10/19 at 1:49 p.m., the consent titled "Anesthesia and Invasive Monitoring Information and Informed Consent Form", was observed without a date and time as to when the patient had signed this form. The PACUM acknowledged and agreed the consent needed to be dated and timed by the patient.

2. During a record review of Patient N 103's record and concurrent interview with post anesthesia care unit (PACU) manager (PACUM) on 6/10/19 at 2:05 p.m., the anesthesia consent titled "Informacion sobre anestesia y monitoreo invasivo y formulario de sonsentimiento informado", was observed without a date and time as to when the patient's consent had been signed. The PACUM acknowledged and agreed the consent needed to be dated and timed by the patient's representative.








3. In a review of Patient N 602's clinical record and concurrent interview with Telemetry Registered Nurse 2 (TRN2) on 6/12/19, at 8:21 AM, the TRN2 reviewed and confirmed the following:

The consent titled "Consent to Surgery or Special Procedure" indicated in part: 1. Operation or Procedure to be Performed: Interventional Radiology G Tube Insertion. 2. Primary Surgeon: Dr. [was left blank] is your primary surgeon. 11. Acknowledgement and Signature: If signed by other than patient, indicate name and relationship: [The name of the person who signed and his/her relationship to Patient N 602 was left blank], Patient Unable to sign due to: [was left blank].

The consent titled "Anesthesia and Invasive Monitoring Information and Informed Consent Form" indicated in part: Surgical Procedure: [was left blank]. Patient/legally authorized decision-maker sign, date, time [was left blank]. Witness sign, date, time [was signed without printed name, date and time]. Anesthesiologist sign, date, time [was signed without printed name, date and time].

The consent titled "Consent to Surgery or Special Procedure" an operation for "Neck exploration with drainage of right Para tracheal, possible abscess collection and possible left neck incision and drainage" indicated in part: 11. Acknowledgement and Signature: If signed by other than patient, indicate name and relationship: [The name of the person who signed and his/her relationship to Patient 602 was left blank], Patient Unable to sign due to: [was left blank].

The facility policy titled "Consent to Surgery or Special procedure and Consent to Blood Transfusion" dated 2/18, indicated the procedure including "...1. Fill in the full name of the operation/special procedure, using correct medical terminology. 3. Fill in the name of the primary surgeon. 7. Signature: The patient, parent or legally authorized representative shall sign consent and date and time..."
VIOLATION: CONTENT OF RECORD - OTHER INFORMATION Tag No: A0467
Based on record review and interview the facility failed to ensure a physician's verbal order of palliative consult was documented in the patient's record for one of 58 sampled patients. (Patient N600).

This failure resulted in Patient N 600 being evaluated for Palliative care without an authenticated physician order.

Findings:

In a review of Patient N 600's clinical record and concurrent interview with the Critical Care Director (CCD) on 6/11/19, at 2:43 PM, the CCD confirmed Patient N 600 was evaluated by a Palliative nurse 1 (PN1) on 6/10/19 and CCD could not locate the physician order for palliative care consult. CCD further indicated PN1 received a verbal order from the Hospitalist for palliative care referral for Patient N 600 and proceeded to evaluate the patient on 6/10/19. The PN1 failed to enter the verbal order electronically to Patient N 600's physician order. CCD explained "...When a nurse receive a verbal order, the nurse should read back the order, enter the order to the patient's record under physician's order, once transmitted electronically, the ordering physician will verify and co-sign that he/she did order it..."

The facility policy titled "Computerized Order Entry-Management of Orders in the Electronic Health Record (EHR)" dated 4/25/18, indicated a procedure including " ...Selecting "Verbal with Read-back" will send the order to the Provider's electronic inbox for authentication. Orders entered into the EHR are electronically authenticated, dated, and timed ..."
VIOLATION: Condition of Participation: Pharmaceutical Se Tag No: A0489
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on observation, interview, and record review the hospital failed to ensure that all drug storage areas were under competent supervision and that the medical staff and the pharmaceutical service was responsible for developing policies and procedures that minimize drug errors. This resulted in a non-pharmacist health care professional obtaining a medication from an automated drug storage and distribution device without effective safeguards in place. This medication retrieval error resulted in a fatal medication administration error (refer to A-144 and A-506). Effective quality control procedures (such as an independent second check by another individual or a secondary verification built into the system, such as bar coding) were not in place to prevent medication retrieval errors. [DIAGNOSES REDACTED] crash carts were not maintained according to facility policy (refer to A-0491, A-0500, and A-0951). Medication kits had not been approved for use by the Pharmacy and Therapeutics Committee (refer to A-0500). There was no documentation of pharmacist supervision compounding of 152 oral syringes (refer to A-0501).
The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality patient care in a safe environment.
VIOLATION: PHARMACY ADMINISTRATION Tag No: A0491
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview and record review, the hospital failed to ensure staff implemented their drug storage areas policies and procedures with the management of the OR (Operating Room) [DIAGNOSES REDACTED] cart.

This failure place patients at risk of not receiving the MH protocol drugs timely during a MH crisis.

Finding:

The hospital's policy and procedure titled "Drug Procurement And Inventory Control", dated 06/16, in the Inspection part of the policy indicated "All drugs storage areas (including [DIAGNOSES REDACTED] carts) within the hospital will be inspected monthly by a pharmacist and/or a pharmacy technician."

The hospital's policy and procedure titled "Crash Cart Policy", dated 02/19 in the Pharmacy Department Responsibility part of the policy indicated "a) A Pharmacist and/or a Pharmacy Technician will inspect the crash carts (including [DIAGNOSES REDACTED] carts) on a monthly basis ... " b) A Pharmacist and/or a Pharmacy Technician will restock and seal emergency medications supplies used throughout the facility." d) All medications will be listed on the top of the tray, on the crash (MH) cart inventory list ...".

During an observation of the operating room (OR) [DIAGNOSES REDACTED] (MH) Cart Inventory Checklist, and concurrent interview with the OR assistant manager (ORAM), on 6/12/19 at 8:25 a.m., the list indicated five Sodium Bicarbonate, 50 milliliters (mls) vials, were inside the cart. The cart was opened and a medications inventory was conducted. Only four Sodium Bicarbonate 50 mls vials were located inside the cart. The ORAM acknowledged and confirmed that only four vials of Sodium Bicarbonate were inside the MH cart. The ORAM was not able to demonstrate when the pharmacy had inspected the MH cart based on the MH cart logs.
VIOLATION: DELIVERY OF DRUGS Tag No: A0500
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation and interview the hospital failed to:

1. Ensure that these medications kits had been approved by the hospital's Pharmacy and Therapeutics Committee (P&T) prior to these supply kits being put into the hospital's ER for use and storage, as follows: Rapid Sequence Intubation (RSI) (used to secure a patient's airway), Maternal Obstetrics Hemorrhage kit (MOH) (used to treat excessive bleeding after child birth), and the (Alteplase) TNKase box (for the treatment of stroke patients)which had all been stored inside the hospital's emergency room 's Omnicell (Automated Drug Delivery Device), which is similar to Automated Transaction Machine (ATM) for drugs. The hospital also failed to ensure that the lists of contents on the outside of the RSI kits (one of three) matched the drugs which had been stocked inside one of the RSI kits. This had the potential for dangerous and unneeded medications to be stored in patient care areas. Inspection of the consolidated campus's Operating Room (OR), [DIAGNOSES REDACTED] Emergency drug supply revealed that the hospital had failed to ensure that these emergency drug supplies matched the hospital's policy and procedures for the treatment of [DIAGNOSES REDACTED].

This failure had the potential to put patients who develop [DIAGNOSES REDACTED] at risk of not being successfully treated by the hospital.

2. Ensure the Pharmacy and Therapeutics Committee (P&TC) confirmed the list of contents on the outside of epidural exchange kits (epidural kits - plastic box containing drugs injected by a medical doctor into the lower back to deaden pain from the waist down) matched the medication control sheet and the medications stocked inside the epidural kits.

This failure had the potential to cause patients to experience high levels of pain during childbirth and receive incorrect amounts of medications.

Findings:

1. Inspection of the hospital's emergency room (ER) medication storage room on 6/10/19 at 1:05 pm revealed several emergency drug supply kits (RSI, MOH, and the TNKase drug box), which had been used and stored inside the hospital's ER Omnicell (Automated Drug Delivery Device) for Nursing use and patient administration when needed. Interview with the hospital's DOP on 6/10/19 at 1:05 pm revealed that the DOP was unaware if these drug supplies (kits) had ever been approved by the Hospital's P&T Committee. Concurrent interview with the ER Assistant Nurse Manager (ERAM) revealed that this Nurse had worked at this hospital for three years without ever having the need to retrieve the TNKase drug box. During a second interview with the DOP on 6/11/19 at 8:10 am, the DOP confirmed that she was unable to provide evidence that the above drug supplies had ever received P&T approval. Review of the hospital's "Medical Staff by Laws", dated 1/2015, read the following duties for the P&T Committee: "The duties of the Pharmacy & Therapeutics Committee shall include: a. Assisting in the formulation of professional practices and policies regarding ...storage, distribution, use, safety, monitoring, and all other matters relating to drugs in the Hospital ... b. Evaluating the appropriateness, safety and effectiveness of drugs used in all areas of the Hospital ...d. Making recommendations concerning drugs to be stocked on the nursing unit floors and by other services ...". The hospital was unable to provide evidence that the P&T Committee had reviewed these drug supplies prior to these kits being put into the emergency room drug storage areas for use. Inspection of the RSI kits on 6/10/19 at 1:40 pm also revealed that the one of three RSI kits with a list of contents on the outside of the container, had not been filled with the matching drugs which had been listed on the outside of the container. The list on the outside of the RSI kit contained: "Atropine 0.1 mg (milligrams)/ml (milliliter) 10 mg syringe, Lidocaine 20mg/5ml syringe, Vecuronium 10 ml vial, and Sterile water for injection 10 ml", but none of these drugs could be found inside this drug kit when opened.


Inspection of the consolidated campus's OR on 6/13/19 at 3:00 pm revealed that the list and contents of drugs stored inside the hospital's [DIAGNOSES REDACTED] (MH) Kit did not match the list of drugs from the [DIAGNOSES REDACTED] Association of the United States (MHAUS) protocol, which the hospital outlines that it will use for the treatment of any patients who would develop [DIAGNOSES REDACTED]. A more detailed inspection of the hospital's MH kit on 6/13/19 at 3:00 pm revealed that 4 vials of Lasix (Furosemide) 40 milligram (mg) for injection were expected to be found inside the kit based on the list of contents on the outside of the drug tray, however after opening this drug supply only 3 vials of Lasix 40 mg/ 4ml were found inside this drug supply. When the OR Manager and the Surveyor went onto the MHAUS website on 6/13/19 and reviewed the list of drugs which MHAUS indicates should be present in the drug supply, Lasix for injection was not one of the drugs which should be present in the [DIAGNOSES REDACTED] kit. The hospital's policy and procedure entitled: "[DIAGNOSES REDACTED]", dated: "9/18", reads: "Policy Statement: A. The protocol from [DIAGNOSES REDACTED] Association of the United States (MHAUS) will be used to treat [DIAGNOSES REDACTED] (MH)."





Findings:

During an inspection of the hospital's L&D medication room Omnicell (automated drug delivery and storage device) on 6/11/19 at 9 a.m., the Omnicell contained approximately seven epidural kits with labels on the outside showing a list of medications stocked inside of the kits and ready for patient administration when needed. Epidural kit number ten was opened in the presence of the Admin 2 and observed for accuracy. A medication inventory control sheet was found inside epidural kit ten showing medications stocked inside. The outside content label was compared to the medication control sheet dated 6/7/19 and the medications inside epidural kit ten. The list on the outside of epidural kit ten contained: "Fentanyl 250 mcg, Lidocaine 2% PF 10 ml, Sodium Bicarbonate 50 meq/50 ml SDV, and Chloroprocaine 3% 30 ml." The medications stocked inside of epidural kit ten and the medication control sheet contained: Fentanyl 200 mcg, Lidocaine 2% PF 20 ml, no Sodium Bicarbonate, and Chloroprocaine 3% 20 ml. An additional drug not listed on epidural kit ten's outside label was listed on the inside control sheet and found stocked inside: Ketamine 50 mg/ml, 10 ml. The Admin 2 reviewed and confirmed epidural kit ten outside content label did not match the medications and medication control sheet found inside, was not safe for patient administration, and should be sent back to the Pharmacy Department for correction.

During a subsequent inspection of the hospital's L&D medication room Omnicell on 6/11/19 at 2:10 p.m. epidural kit number fifteen was opened in the presence of the Admin 2 and observed for accuracy. Epidural kit fifteen's outside label listed Chloroprocaine 3% 30 ml. Epidural kit fifteen outside content label was compared to the inside medications and medication control sheet and found to contain 20 ml instead of 30 ml of Chloroprocaine 3%. The Admin 2 reviewed and confirmed epidural kit fifteen outside contents label did not match the medication and medication control sheet, was unsafe for patient use, and should be sent back to the Pharmacy Department for correction.

During an interview with the DOP on 6/12/19 at 3:20 p.m., the DOP indicated and confirmed the P&TC's expectation for safety in medication administration to patient's is the outside medication label should match the inside medication control sheet and the medications stocked in epidural kits and sent back to the Pharmacy Department if found different.

Review of the hospital's "Medical Staff Bylaws" revised 11/2018 page 83 section a. and 84 section e. indicated the P&T duties shall include "Assisting in the formulation of professional practices and policies regarding drug ...storage, safety, monitoring, and all other matters relating to drugs in the Hospital ..." and "Developing and periodically reviewing a formulary or drug list for use in the Hospital."

Review of the hospital's policy and procedure titled "Drug Procurement and Inventory Control" revised 6/12/19 indicated "A report of inspection will be maintained by the Pharmacy Department to include Omnicell stocked items, i.e. Epidural Kits with proper labeling and integrity of kit contents.
VIOLATION: PHARMACIST SUPERVISION OF SERVICES Tag No: A0501
Based on review of the hospital Pharmacy's bulk tablet compounding log and review of the hospital's oral syringe compounding log the hospital's Pharmacy had failed to implement the hospital's policies and procedures. Failure to follow the hospital's policies and procedures could result in medication errors. Clinical record review at the hospital's Oncology Outpatient infusion center for one of three sampled Patients (M-202) the facility failed to ensure that all medication which had been prepared by a Pharmacy Technician had been checked by a Pharmacist as outlined in the hospital's policy and procedures.

This failure had the potential to cause a medication error for Patient M-202.

Findings:

Review of the hospital's Pharmacy's bulk tablet compounding log on 6/12/19 at 8:00 am revealed the following inconsistencies in regards to the hospital's policies and procedures:

1. On 6/10/19 a Pharmacist and a Pharmacy Technician had repackaged #60 Cefuroxime (Ceftin) 500 mg tablets. The manufacturer's expiration date on the original bottle was 2/28/2020 yet when the hospital's Pharmacy staff repackaged this medication, they assigned the repackaged tablets an expiration date of 6/10/2020. The Pharmacist extended the expiration date on these repackaged tablets by almost 4 months. Review of the hospital's policy and procedure entitled: "Labeling of Medications", dated 7/18, read: "C. Repackaged unit-of-use medication labels shall include at a minimum: ....6. Expiration -one year from the repackaging or manufacturer expiration whichever shorter."

2. Review of the hospital's bulk tablet manufacturing log on 6/12/2019 at 8:05 am revealed that Pharmacy staff had repackaged Misoprostol (Cytotec) 200 mcg with five tablets in each package. The Pharmacy staff had made 6 packages of (the 5 tablet Misoprostol. None of the repackaged tablets labels or the repackaging log contained a manufacturer's date for the expiration these repackaged tablets.

3. On 4/1/19 a Pharmacist and a Pharmacy Technician had repackaged #60 Aspirin-Dipyridamole (Aggrenox) 25-200 mg tablets. The manufacturer's expiration date on the original bottle was 2/28/2020 yet when the hospital's Pharmacy staff repackaged this medication, they assigned the repackaged tablets an expiration date of 4/1/2020. The Pharmacist extended the expiration date on these repackaged tablets by over 1 month. Review of the hospital's policy and procedure entitled: "Labeling of Medications", dated 7/18, read: "C. Repackaged unit-of-use medication labels shall include at a minimum: ....6. Expiration -one year from the repackaging or manufacturer expiration whichever shorter."

Review of the hospital's Pharmacy oral syringe compounding log on 6/12/19 at 8:30 am revealed the following inconsistencies in regards to the hospital's policies and procedures:
For all 152 entries into the Hospital Pharmacy's Oral syringe compounding log between 1/24/19 and 6/6/19 the Pharmacy failed to record the manufacturer's expiration date for each drug which had been compounded.
The following are examples of the oral syringes which had been compounded by the Pharmacy without any evidence of a Pharmacist verification before these medications had been sent out to patient care areas:

1. Lidocaine Viscous 2% oral solution 10 milliliter (ml) syringes, #49 syringes had been compounded on 5/31/19 by a Pharmacy Technician, but there was no evidence that these syringes had been checked by a Pharmacist prior to being sent out to patient care areas. The hospital's policy and procedure entitled: "Pharmacist Order Verification", dated 4/15, read: "All medications sent to the patient care unit for first dose or stocking of the automated dispensing machines will be checked and initialed by the Pharmacist before being sent to the patient care unit." Review of the hospital's policy and procedure entitled: "Sterile and non-sterile compounding services", dated 1/18, read: "G. Labeling: ...j. Name or initials of individual who checked the product ...". No Pharmacist name or initials could be found in the hospital's oral compounding log.
2. Dexamethasone 4 mg/ml topical solution 2 milliliter (ml) syringes, #12 syringes had been compounded on 4/16/19 by a Pharmacy Technician, but there was no evidence that these syringes had been checked by a Pharmacist prior to being sent out to patient care areas. The hospital's policy and procedure entitled: "Pharmacist Order Verification", dated 4/15, read: "All medications sent to the patient care unit for first dose or stocking of the automated dispensing machines will be checked and initialed by the Pharmacist before being sent to the patient care unit." Review of the hospital's policy and procedure entitled: "Sterile and non-sterile compounding services", dated 1/18, read: "G. Labeling: ...j. Name or initials of individual who checked the product ...". No Pharmacist name or initials could be found in the hospital's oral compounding log.
3. Dexamethasone 4 mg/ml topical solution 2 milliliter (ml) syringes, #12 syringes had been compounded on 4/6/19 by a Pharmacy Technician, but there was no evidence that these syringes had been checked by a Pharmacist prior to being sent out to patient care areas. The hospital's policy and procedure entitled: "Pharmacist Order Verification", dated 4/15, read: "All medications sent to the patient care unit for first dose or stocking of the automated dispensing machines will be checked and initialed by the Pharmacist before being sent to the patient care unit." Review of the hospital's policy and procedure entitled: "Sterile and non-sterile compounding services", dated 1/18, read: "G. Labeling: ...j. Name or initials of individual who checked the product ...". No Pharmacist name or initials could be found in the hospital's oral compounding log.
4. Dexamethasone 4 mg/ml topical solution 2 milliliter (ml) syringes, #12 syringes had been compounded on 3/29/19 by a Pharmacy Technician, but there was no evidence that these syringes had been checked by a Pharmacist prior to being sent out to patient care areas. The hospital's policy and procedure entitled: "Pharmacist Order Verification", dated 4/15, read: "All medications sent to the patient care unit for first dose or stocking of the automated dispensing machines will be checked and initialed by the Pharmacist before being sent to the patient care unit." Review of the hospital's policy and procedure entitled: "Sterile and non-sterile compounding services", dated 1/18, read: "G. Labeling: ...j. Name or initials of individual who checked the product ...". No Pharmacist name or initials could be found in the hospital's oral compounding log.
5. Lactobacillus Reuteri NICU Probiotics 0.2 ml oral syringes, #101 had been compounded on 2/11/19 by a Pharmacy Technician, but there was no evidence that these syringes had been checked by a Pharmacist prior to being sent out to patient care areas. The hospital's policy and procedure entitled: "Pharmacist Order Verification", dated 4/15, read: "All medications sent to the patient care unit for first dose or stocking of the automated dispensing machines will be checked and initialed by the Pharmacist before being sent to the patient care unit." Review of the hospital's policy and procedure entitled: "Sterile and non-sterile compounding services", dated 1/18, read: "G. Labeling: ...j. Name or initials of individual who checked the product ...". No Pharmacist name or initials could be found in the hospital's oral compounding log.
6. Opticlear Tetrahydrolozoline 0.05% ophthalmic solution 15 ml, #2 syringes which had been made on 1/24/19 by a Pharmacy Technician, but there was no evidence that these syringes had been checked by a Pharmacist prior to being sent out to patient care areas. The hospital's policy and procedure entitled: "Pharmacist Order Verification", dated 4/15, read: "All medications sent to the patient care unit for first dose or stocking of the automated dispensing machines will be checked and initialed by the Pharmacist before being sent to the patient care unit." Review of the hospital's policy and procedure entitled: "Sterile and non-sterile compounding services", dated 1/18, read: "G. Labeling: ...j. Name or initials of individual who checked the product ...". No Pharmacist name or initials could be found in the hospital's oral compounding log.
7. Opticlear Tetrahydrolozoline 0.05% ophthalmic solution 15 ml, #2 syringes which had been made on 1/25/19 by a Pharmacy Technician, but there was no evidence that these syringes had been checked by a Pharmacist prior to being sent out to patient care areas. The hospital's policy and procedure entitled: "Pharmacist Order Verification", dated 4/15, read: "All medications sent to the patient care unit for first dose or stocking of the automated dispensing machines will be checked and initialed by the Pharmacist before being sent to the patient care unit." Review of the hospital's policy and procedure entitled: "Sterile and non-sterile compounding services", dated 1/18, read: "G. Labeling: ...j. Name or initials of individual who checked the product ...". No Pharmacist name or initials could be found in the hospital's oral compounding log.
8. Delsym extended release suspension 30 mg/5 ml, #25 had been made on 2/4/19, by a Pharmacy Technician, but there was no evidence that these syringes had been checked by a Pharmacist prior to being sent out to patient care areas. The hospital's policy and procedure entitled: "Pharmacist Order Verification", dated 4/15, read: "All medications sent to the patient care unit for first dose or stocking of the automated dispensing machines will be checked and initialed by the Pharmacist before being sent to the patient care unit." Review of the hospital's policy and procedure entitled: "Sterile and non-sterile compounding services", dated 1/18, read: "G. Labeling: ...j. Name or initials of individual who checked the product ...". No Pharmacist name or initials could be found in the hospital's oral compounding log.
9. Iron Drops (Ferrous Sulfate) 15 mg/1 ml oral syringes, #43 had been made on 2/4/19 by a Pharmacy Technician, but there was no evidence that these syringes had been checked by a Pharmacist prior to being sent out to patient care areas. The hospital's policy and procedure entitled: "Pharmacist Order Verification", dated 4/15, read: "All medications sent to the patient care unit for first dose or stocking of the automated dispensing machines will be checked and initialed by the Pharmacist before being sent to the patient care unit." Review of the hospital's policy and procedure entitled: "Sterile and non-sterile compounding services", dated 1/18, read: "G. Labeling: ...j. Name or initials of individual who checked the product ...". No Pharmacist name or initials could be found in the hospital's oral compounding log.

Review of the clinical record for Patient M-202 on 6/12/19 at Noon revealed that this patient's physician had written the following medication order: "Dexamethasone 10 mg, infuse in 100 milliliters Normal Saline over 20 minutes, along with Granisetron 1 mg (Kytril), infuse IV over 20 minutes ...." A Pharmacy Technician had prepared the Dexamethasone and Kytril Intravenous (IV) Solution, but the infusion center was unable to provide evidence that this IV medication had been checked by a Pharmacist prior to this medication being administered to this patient on 6/12/19 while the Patient received her treatment at the infusion center. The hospital's policy and procedure entitled: "Pharmacist Order Verification", dated 4/15, read: "All medications sent to the patient care unit for first dose or stocking of the automated dispensing machines will be checked and initialed by the Pharmacist before being sent to the patient care unit." Review of the hospital's policy and procedure entitled: "Sterile and non-sterile compounding services", dated 1/18, read: "G. Labeling: ...j. Name or initials of individual who checked the product ...". No Pharmacist name or initials could be found in the hospital's oral compounding log.
VIOLATION: UNUSABLE DRUGS NOT USED Tag No: A0505
Based on inspection of the hospital's emergency room (ER) Omnicell and interview with the with the ER Assistant Nurse Manager with the Director of Pharmacy (DOP) the hospital the hospital failed to ensure that expired medications were not available for patient administration. This had the potential to leave patients/staff exposed to acquiring Tuberculosis.

Findings:

Inspection of the hospital's emergency room Omnicell refrigerator on 6/10/19 at 1:50 pm revealed one vial of Purified Protein Derivative (PPD) which had been opened by Nursing staff on 2/19. The following information was found on the drug manufacturer's label: "Once entered (pierced with a needle), vial should be discarded after 30 days."

Interview with the ER Assistant Nurse Manager with the Director of Pharmacy (DOP) on 6/10/19 at 1:55 pm revealed that this vial of PPD should have been discarded by the facility's Nursing or Pharmacy staff after 30 days of being opened.
VIOLATION: AFTER-HOURS ACCESS TO DRUGS Tag No: A0506
Based on interview and observation the facility failed to ensure that effective quality control procedures were in place to prevent medication retrieval errors when non-pharmacist health care professionals were permitted to obtain medications from an automated storage and distribution device without supervision by pharmacy personnel. A non-pharmacist health care professional obtained medications from an automated drug storage and distribution device without effective safeguards in place resulting in a fatal medication administration error.

Findings:

In interviews on 06/12/2019 and 06/13/2019 Admin 3 explained the facility had found that a medication retrieval error had occurred when an ampoule of digoxin was withdrawn from an automated storage and distribution device on 03/13/2019 instead of an ampoule of bupivacaine. The facility was able to verify a medication retrieval error from the automated storage and distribution device located in the surgical core had occurred because the device was missing an ampoule of digoxin. The digoxin removed from the device had apparently been administered to patient N112 instead of bupivacaine as was intended. This was confirmed when a blood test showed patient N112 to have digoxin in her system. Admin 3 stated the facility had previously provided spinal trays that had included a bupivacaine ampoule for use in providing spinal anesthesia for select cases. However, when the facility replaced these trays with spinal trays without bupivacaine, anesthetic for spinal cases needed to be withdrawn from an automated drug storage and distribution device.

Observations on 06/12/2019 at 2 p.m. of the automated storage and distribution device in the surgical suite revealed that when the drawer containing bupivacaine ampoules was opened there were multiple other medications readily available in other compartments in the same drawer.

In an interview on 06/13/2019 at 10:00 a.m. the MDLA for the facility stated there were no safeguards such as an independent second check by another individual or a secondary verification built into the system, such as bar coding, in place to verify that the correct medication had been removed from the drawer.

Observations made of the automated drug storage and distribution device on 6/12/19 at 2 p.m. revealed digoxin and bupivacaine ampoules had previously been stored in the same drawer. During observation further revealed the digoxin and bupivacaine ampoules stored in the drawer had been of a similar appearance; both were clear glass ampoules of the same size, both contained a clear liquid, and both were labeled in blue, and yet observation revealed that there were no labels on them or on the automated dispensing device warning of look-alike medications. As a result of this medication retrieval error digoxin was administered to patient N112 instead of bupivacaine.
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, and record review, the hospital failed to ensure the [DIAGNOSES REDACTED] (MH) policy and procedure was followed when the MH cart medications were not updated as per the [DIAGNOSES REDACTED] Association of the United States (MHAUS) protocol.

This failure had the risks of patients with MH crisis being administered unnecessary medications.

Finding:

The hospital's policy and procedure titled "[DIAGNOSES REDACTED]", dated 09/18, in the Policy Statement part of the policy indicated "A. The protocol from [DIAGNOSES REDACTED] Association of the United States (MHAUS) will be used to treat [DIAGNOSES REDACTED] (MH)."

During an observation of the operating room (OR) MH cart medication contents and concurrent interview with OR assistant manager (ORAM), on 6/12/19 at 8:25 a.m., four vials of Lasix (diuretic) medication were observed inside the MH cart. The MH cart inventory checklist also listed four vials of Lasix as one of their required medications for the MH protocol. The ORAM confirmed four vials of Lasix medication were inside the cart and listed on the checklist.

During an observation of the labor and delivery (L&D) MH cart medication contents and concurrent interview with administrator (Admin 2), on 6/12/19 at 9:15 a.m., four vials of Lasix (diuretic) medication and two normal saline 0.9% 1000 mls bags were observed inside the MH cart. However, no refrigerated cold saline solution was available. The MH cart inventory checklist also listed four vials of Lasix as one of their required medications for the MH protocol. Admin 2 confirmed four vials of Lasix medication and two normal saline bags were inside the cart, and listed on the checklist.

During an interview with administrator (Admin 1) and a concurrent review of the most recent [DIAGNOSES REDACTED] Association of the United States (MHAUS) protocol on 6/13/19 at 4:50 p.m., the Lasix medication was no longer one of the medications in the protocol. Admin 1 stated "Lasix is not in the MH protocol anymore; it must have been removed. I agree the HM cart medications/contents and the inventory list must be updated."
VIOLATION: ANESTHESIA SERVICES Tag No: A1000
Based on staff interview and review of administrative records, policies and procedures, and quality assurance documentation, the facility's Anesthesia Department failed to assume full responsibility for determining, implementing, and monitoring policies governing their scope of services. The facility policy for anesthesia services titled "Scope of Services" stated that the Anesthesia Department was "responsible for developing policies and procedures governing the provision of all categories of anesthesia services". The policy further states anesthesia services were to include the Emergency Department and special procedure areas such as the GI lab. In an interview on 06/13/2019 at 10 a.m. the MDLA for the facility confirmed the Anesthesia Department was responsible for the supervision and oversight of all anesthesia services provided in the facility. However, there was no documentation of the involvement of the Anesthesia Department and the quality assurance review of sedation practices in the Emergency Department and the endoscopy suite (refer to A-0273). As a result, policies and procedures on the provision of anesthesia services including informed consent and pre-anesthesia and post-anesthesia evaluation were not followed (refer to A-0466, A-1002, and A-1003).
The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality patient care in a safe environment.
VIOLATION: PRE-ANESTHESIA EVALUATION Tag No: A1002
Based on observation, interview and record review, the hospital failed to:
1. Ensure the anesthesiologist consented one of 58 sampled patients (Patient N102) for anesthesia services provided.
2. Ensure informed consent was obtained and documented by the physician prior to the procedure and procedural sedation as outlined in the facility policy and procedure for three of five patients (N204, N205, and N206).

These failure had the potential for violation of the patient's right to be informed by the physician of the risks, benefits, and alternatives to the procedure and sedation before consenting.

Findings:

1. During an observation of Patient N 102's arterial line, review of the anesthesia consent and concurrent interview with the post anesthesia care unit (PACU) manager (PACUM) on 6/10/19 at 2:35 p.m., the consent titled "Anesthesia and Invasive Monitoring Information and Informed Consent Form", was observed without the anesthesiologist signature, date and time. In the Invasive Monitoring Procedures part of the consent, the arterial catheter box was not marked indicating the patient was consented for an arterial line procedure. However, the patient had an arterial line in place after her surgical procedure. The PACUM acknowledged and agreed the consent needed to be signed, dated and timed by the anesthesiologist indicating the patient had been consented for the anesthesia services provided.

During another review of Patient N102's record and concurrent interview with administrator (Admin 1) on 6/11/19 at 1:35 p.m., Admin 1 confirmed Patient N102 had an arterial line inserted during her surgical procedure and the arterial line should have been marked on the anesthesia consent indicating patient was provided informed consent regarding this procedure by the anesthesiologist.

The hospital's policy and procedure titled "Informed Consent", dated 03/18, in the Policy part indicated "C. It is the treating physician's responsibility for obtaining informed consent. Patients with health care decision-making capacity will be given adequate information about the risks, benefits ...for any treatment ...anesthesia or special diagnostic or therapeutic procedure, which may involve significant risk of bodily harm, with the understanding that they may consent or refuse the intervention following disclosure." In the Procedure part V11 (F) (3) indicated "Physician documentation of the informed consent process will be either by the physician signature on the consent form attesting to the fact that the discussion took place ..."





Findings:

2. The facility policy and procedure titled "Informed Consent" dated 03/18, indicated "It is the treating physician's responsibility for obtaining informed consent. Patients with health care decision-making capacity will be given adequate information about the risks, benefits, and alternatives for any treatment, medical and surgical procedure, anesthesia or sedation, or special diagnostic or therapeutic procedure, which may involve significant risk of bodily harm, with the understanding that they may consent or refuse the intervention following disclosure ... ...The physician will document in the medical record that he or she had the informed consent discussion with the patient or the patient's legal representative ....Physician documentation will include a statement that the risks, benefits, and alternatives (including their risks and benefits) were disclosed and discussed with the patient or the patient's legal representative".

The facility policy and procedure titled "Management of Procedural Sedation" dated 06/27/18, indicated in Section Procedure (A)(1)(k), "Each patient will be assessed by a privileged physician prior to procedure ...documentation shall also include: Informed consent for sedation and the procedure".

The facility Rules and Regulations of the Medical Staff, dated January 2015, indicated in 3.1.2 "the practitioner who obtains the informed consent of the patient or legal representative shall document their conversation in the patient's medical record".

Clinical record review of the operative report for patient N204 dated 6/11/19, indicated patient had the following procedure: esophagogastroduodenoscopy ((EGD-- a test to examine the lining of the esophagus, stomach, and first part of the small intestine.) with intravenous (IV-into the vein) sedation. The record does not contain evidence informed consent obtained by the physician for the procedure or the moderate sedation prior to the procedure. During an interview and record review on 6/13/19 at 12:00, the chief nursing officer(CNO) confirmed the record did not contain informed consent documentation prior to the procedure.

Clinical record review of the operative report for patient N205 dated 6/7/19, indicated the patient had the following procedure: EGD and biopsy with IV sedation. The record does not contain evidence informed consent obtained prior to the procedure or the moderate sedation. During an interview and record review on 6/13/19 at 12:05 p.m., the CNO confirmed the record did not contain informed consent documentation prior to the procedure.

Clinical record review of the operative report for patient N206 dated 6/4/19, indicated the patient had the following procedure: EGD with IV sedation. The record does not contain evidence of informed consent obtained prior to the procedure and moderate sedation. During an interview and record review on 6/13/19 at 12:10 p.m., the CNO confirmed the record did not contain informed consent documentation prior to the procedure.
VIOLATION: ANESTHESIA RECORD Tag No: A1003
Based on interview and record review, the facility failed to document a completed pre-anesthesia evaluation of the patient's airway for one of five patients (N206) prior to the procedure.

This failure had the potential to result in an adverse patient outcome due to unanticipated airway complications during the procedure.

Findings:

The facility policy and procedure titled "Management of Procedural Sedation" dated 6/27/18, indicated in Section Procedure (A)(1)(k), "Each patient will be assessed by a privileged physician prior to procedure ...documentation shall also include: an assessment of the patient's airway (Mallampati Classification-a visual examination of the patient's airway used to determine if patient may have airway difficulty under sedation) and an ASA score (American Society of Anesthesiologists-- physical status classification used to assess the fitness of patients before surgery/procedures) ".

Clinical record review of the operative report for patient N206 dated 6/4/19, indicated the patient had the following procedure: esophagogastroduodenoscopy (EGD--a test to examine the lining of the esophagus, stomach, and first part of the small intestine with intravenous (IV into the vein) sedation. There is no evidence in the patient's record of an assessment by the physician of patient's airway using the Mallampati classification or ASA score.

During an interview on 6/13/19, at 10:10 a.m., the MD Leader Anesthesia (MDLA) indicated the Mallampati and ASA score assessments are an expectation of providers performing procedures using moderate sedation. These assessments provide important information about the patient's airway and can be indicative of potential airway problems during the procedure and sedation.

During an interview and record review on 6/13/19 at 12:15 p.m., the chief nurse executive (CNE) confirmed the record did not contain assessments of ASA score or Mallampati classification.