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Based on review of Patient #10's medical record, interviews with staff, hospital policy and procedures, it was determined that the hospital failed to address the concerns of Patient #10's family. The hospital did not follow its own policy regarding providing written responses to the grievant. The Department also determined that the hospital failed to take action to prevent a similar even from occurring again. The hospital did not follow its own policy regarding proper documentation of investigations. These deficient practices increase the potential risk to patient safety if grievances are not properly investigated and preventative measures are not taken.

Findings include:

The policy titled "Patient-Family Grievance Complaints Policy" requires "...all grievances require a written response to the grievant...the unit director/department manager will provide a written response including: their name as the hospital contact person, the steps taken on behalf of the patient to investigate the complaint, the results of the complaint process, and date of completion (date of written response). A letter fitting this description was not found or provided to surveyors.

Review of correspondence and documents from the MIDAS event reporting system revealed that on
11/19/17, a grievance from the family of Patient #10 was entered into MIDAS. On 11/28/17, Employee #3 documented that Medical Staff #17 had already spoken to Medical Staff #12 regarding Patient #10. Additionally, they "...will await autopsy results and send for CV Peer Review for discussion ...." The disposition was then marked as closed.

The initial letter acknowledging receipt of the grievance from the family was sent by Employee #3 on 11/28/17. Employee #3 wrote "...I have forwarded your concerns to the appropriate Medical Staff Department for peer review. Although Arizona law does not allow us to share the outcome of that review, please be assured that we are addressing each area of the concerns specifically: 'inexperienced nurse taking care of fresh CABG patient, moving out of ICU too soon, NP not handling care of your husband well, Rapid Response never called, and the discussion of your [husband] and family by the NP in a public area (cafeteria)' ...."

On 02/12/18, Employee #3 forwarded a letter received from the lawyer representing the family of Patient #10 to the legal department of the hospital. No documentation was provided about any further conversations or communications, between the hospital and the family, in regard to the resolution of this complaint. A letter was not sent to the patient's family containing written notice of its decision, steps taken to investigate the grievance, the results of the grievance process, or the date of completion.

Employee #3 confirmed during an interview conducted on 09/04/18 that in regard to grievances, once the complainant has taken legal action, the grievance is closed and it becomes an open legal claim. Quality and risk management are no longer involved in the process.

Based on review of patient #9's medical record, hospital policies and procedures, documented hospital quality improvement activities, and staff interviews, it was determined that the hospital failed to the implement the following changes that were identified in the Root Cause Analysis and Risk Management Worksheet related to the laboratory error that occurred for Patient #9:

1. Change policy to reflect the position of not having multiple screens open at the same time
2. Educate all lab technicians

This deficient practice increases the risk of potential patient harm due to erroneous laboratory results.

Findings include:

Employee #17 documented the following in Patient #9's medical record on 10/19/2017 and 14:44 MST: "...Troponin: <0.4 ng/mL...10/18/2017 at 08:20 MST...Status: Modified...disregard previous result of 63.9, resulted in error...."

The "Risk Management Report Policy", created 9/1/2001 requires the following: "...documentation should reflect the complexity of the incident; the level of review, investigation, follow-up required to address the incident; and actions taken...Risk Management Department staff will review all electronic Risk Management Report entries and address the status once all Department Managers/Directors have marked the dispositions as "Closed". The Risk Management Report will be considered closed at this time...."

The "Risk Management Worksheet" 10/16/2017 for patient #9 included the following information: "...Status: Closed...Date Closed 10/20/2017...Comments: 10/19/2017: The technologist on 10/19 thought that this was a strange result based on the high one from the 10/18...Both samples were pulled and the one from 10/18 was re-run...The result was <0.04. The correct / normal results did come across the interface from the Chemistry Analyzer on 10/18...From there we were able to look in Cerner to see that this result was manually entered by the technologist and it was done while she had 2 result screens open (on different patients) and resulted the troponin as the last 3 digits of the sample number of the other patient's ABG...This result of 63.9 was verified and the patient was taken to the Cath lab for a procedure ...."

Employee #3 documented the following information on the Risk Management Worksheet on 11/20/2017 at 11:10, "...On 10/20/2017 I met with the lab personnel as a RCA...regarding how to prevent this human error from occurring...Actions to be taken are: 1) Attempt to have IT expedite the auto-verification issue from occurring 90-95% of the time...2) Change policy to reflect the position of not having multiple screens open at the same time...3) Education of all lab technicians regarding the resulting process with not having multiple screens open at the same time...4) Random audits of the lab techs...that will be reported to the QPSC as one of their Quality Metrics...5) Set up a meeting to discuss Troponin notification process to RN and physicians...."

Employee #3 provided a copy of the root cause analysis (RCA) that was conducted on 10/20/2017. The RCA contained the following documentation: "...most but not all techs have multiple screens open for efficiency and that was the way their workflow was developed...."

Employee #3 was unable to provide the "policy" that was updated to "reflect the position" of not having multiple screens open at the same time.

Employee #16 and employee #17 confirmed in an interview conducted on 9/6/2018 that 6 or 7 lab technicians have been hired since 12/2017. Employee #16 confirmed that the employees hired after 12/2017 have not received this training.

Employee #16 confirmed that the hospital is in the process of updating the system by implementing "auto-verification" in the clinical lab. The hospital's "chemistry" department is scheduled to implement "auto-verification" the week of 9/10/2018.

Based on review of Patient #10's medical record, interviews with staff, and hospital policy and procedure review, it was determined that the registered nurse failed to supervise and evaluate the nursing care for each patient as evidenced by at least five (5) instances when hospital staff could have considered calling a rapid response. This deficient practice increases the potential of harm to the safety of patients.

Findings include:

The policy titled "Rapid Response Team For Clinical Staff- Operating Practice" states to "...consider calling the RRT for one or more of the following:
-staff member or direct care RN is worried or concerned about the patient,
-acute change in heart rate or unexpected HR >140 or <40,
-acute change in systolic BP (SBP) or unexpected SBP >180 mmHg or less than 90 mmHg,
-acute change in respiratory rate (RR) or unexpected rate >28/min or less than 8/min,
-acute change in oxygen saturation or less than 90% despite supplementation,
-acute change in level of consciousness (LOC) ...."

Review of the medical record revealed the following situations when Employee #23 had reason to "consider calling the RRT":

-At 0100, Employee #23 called Medical Staff #3 for a change in status.
-On 11/10/17 at 0300 Patient #10's BP was 94/51. It was 130/74 at 0253. The patient was documented as experiencing "atypical pain, diaphoresis, and nausea." Employee #23 called Medical Staff #3 for a change in status.
-At 0400, the patient's BP was recorded at 79/50.
-At 0500, the patient's BP was recorded at 96/49 and respiratory rate was 32 breaths per minute. Employee #23 called Medical Staff #3 for a change in status.
-At 0700, Medical Staff #17 was called for a change in status and came to the bedside of Patient #10.

The policy titled "Level of Care and Monitoring Routines-Adults" indicates that for Progressive Care Monitoring Routines the following tasks must be completed every four hours: full assessment, cardiac rhythm interpretation, vital signs including blood pressure, heart rate, and respiration rate, temperature, oxygen saturation, pain assessment, central venous pressure, urine output, and IV sites checked. Intake and output (I & O) is totaled every 12 hours, and weights are taken every morning. Within this policy is a flow chart "Nurse to Provider Communication Tool" to aid nurses in determining if an issue is emergent, urgent, or nor-urgent. An Urgent concern is described as vital signs outside parameters, an acute change in condition (new or worsening stroke symptoms, new chest pain, arrhythmias, or increasing oxygen requirements), or if the issue poses a risk to the patient. For an Emergent concern, the main criteria is whether or not the patient needs to have a Rapid Response (RR) or Code Blue called. Both Emergent and Urgent concerns indicate a call to the provider.

Employee #23 revealed during an interview on 09/10/18, that s/he had called the provider (Medical Staff #12) and followed the orders received. The medical record indicates these calls took place on 11/10/17 at 0100, 0300, and 0500. Additionally, Employee #23 stated s/he also spoke to the charge nurse (Employee #36) who said that as long as s/he (Employee #23) had called the provider, s/he was OK.

The medical record indicates that Employee #23 completed a physical assessment on Patient #10 on 11/09/17 at 1900, and on 11/10/17 at 0000 and 0300.

The medical record indicates that hourly rounds were conducted for Patient #10 .

The medical record indicates that blood pressure, heart rate, respiration rate, oxygen saturation, pain assessment, and urinary output were recorded at least every four (4) hours. Temperature was recorded only one (1) time between 0100 and 0700.

Review of the medical record revealed that no blood pressures were recorded from 0501-0700. The blood pressure recorded at 0700 was 47/34.

At 0749, Patient #10 was transferred to the cardiovascular intensive care unit (CVICU). At 0758 a "Code Blue" was called for Patient #10.

Based on review of the Medical Staff Bylaws, Patient #9's electronic medical record, and physician interviews, it was determined that the hospital failed to ensure physicians documented progress notes in Patient #9's medical record on 10/17/2017 and 10/18/2017. This deficient practice poses the potential risk that the medical record would not contain pertinent information needed to provide care to the patient.

Findings include:


The "Medical Staff Bylaws, approved 5/2017" requires the following, "...Responsibilities of staff membership...They must provide continuing daily care of hospitalized patients...."

The electronic medical record did not contain a progress note or assessment from a physician on 10/17/2018 (one day post-op).

Physician #7 confirmed in an interview conducted on 9/10/2018 that s/he rounds on their patient every day and did examine the patient on 10/17/2018. Physician #7 confirmed that the medical record did not contain documentation related to the physician's visit on 10/17/2018.

The electronic medical record did not contain an assessment by a cardiologist prior to the angiogram on 10/18/2018.

Physician #5 confirmed in an interview conducted on 9/10/2018 that s/he completed a patient assessment prior to the angiogram on 10/18/2018. Physician #5 confirmed that the medical record did not contain the physician's note for the assessment that was completed prior to the angiogram on 10/18/2018.

Employee #3 confirmed in an interview conducted on 9/6/2018 that the hospital does not have an approved policy for medical record requirements. The policy that was provided during the on-site survey was not approved.

Based on hospital policy, medical record review, and staff interviews, it was determined the administrator failed to:

1. require pharmacy staff to accurately enter the physician's order for medications into the medical record for 3 of 3 patients (#1, 2 and 3) and
2. require the physician's order to contain "all elements" required for a medication order in 3 of 4 orders reviewed for patient #1.

This deficient practice increases the risk that medication is not administered per physician's order and increases the risk of patient harm.

Findings include:

The hospital policy, "Medication Orders Policy", approved 2/15/2017 requires the following, "...Orders for drugs shall be recorded in and maintained within the patient's medical record...Elements Required for Medication Orders: Name of patient, Date and time, Name of medication (generic or brand), Dose, frequency, and route, specific instructions for use (indication and / or symptom) for PRN medications...Exact strength or concentration of medication when applicable...'As Needed' (PRN) Orders...should be written to include a frequency associated with them...Orders without a frequency will be processed as a one-time order...'As needed' orders must be written to include the symptom or indication for use...."

The hospital policy, "Medication Administration Policy - Nursing", approved 3/7/2018 requires the following, "...NOTE: Outpatient departments are excluded from the standard administration times...Administration Time Frames: a. Time-critical scheduled medications must be given within 30 minutes before or after scheduled time i.e. Parenteral antibiotics...b. Non-time-critical scheduled medications must be administered within the following time frames: i. Medications prescribed daily, weekly or monthly may be administered 2 hours before or after the scheduled dosing time, for a total window that does not exceed 4 hours...Incomplete Medication Orders:...a...Medication orders that do not contain the elements noted in section 1 of this policy are incomplete and must be clarified...b. Orders such as "resume preoperative medications"... are incomplete...when such an order is written, nursing personnel will contact the prescriber and obtain complete medication orders that meet criteria in Section 1 of this policy...."

3 of 3 medical records reviewed (Patient #1, 2 and 3) contained medications that were ordered by the physician as a "scheduled" medication, yet the orders were entered into the system as "PRN".


Patient #1:

The scanned physician's order contained the following information:

"...7/26/2018...PREMEDS: Tylenol 650 mg PO...Benadryl 50 mg IV may repeat 50mcg IV Q 4-6 hours PRN...Normal Saline 1 liter prior to infusion over 1 hour...PROCEDURE/TREATMENT...Octagam 15 grams IV via Port, Heparin flush per Protocol. Split the Octagam 15 grams over 2 days...DURATION OF TREATMENT...12 months...PHYSICIAN SIGNATURE (signature present)...DATE: 7/26/2018...TIME: 9:48 am...."

The order scanned into the system for Octagam on 7/26/2018: Octagam 15 grams IV via Port...split the Octagam 15 grams over 2 days...." The order was entered into the system as:
"...PRN...immune globulin intravenous...10 gm...for Infusion Center Schedule Q Week PRN...Octagam only...."
"...PRN...immune globulin intravenous...5 gm...for Infusion Center Schedule Daily PRN...Administer per Physician order...immune globulin intravenous...."

The MAR identifies the immune globulin 5 gm was administered on:
7/26/2018, 8/2/2018, 8/9/2018, 8/16/2018, 8/23/2018, 8/30/2018, 9/6/2018

The MAR identifies the immune globulin 10 gm was administered on:
7/27/2018, 8/3/2018, 8/10/2018, 8/17/2018, 8/24/2018, 9/7/2018


Patient #2:

The EMR for Patient #2 contained the following orders:

"...cefTRIAXone 2 g Inj...for Infusion Center Schedule Daily PRN, order duration: 7 doses...Administer per Physician order. Previously arranged ECIC administration time for daily dosing...give via slow IV push over at least 4 minutes...."
"...cefTRIAXone 2 g Inj...IV Push, Q PM, order duration: 3 dose(s) / time (s), first dose 7/21/18 18:00 MST, stop date 7/24/18"
"...cefTRIAXone 2 g Inj...IV Push...for Infusion Center Schedule Q AM PRN...first dose 7/28/18...stop date 8/4/18...."
"...Vancomycin 1,750 mg, IV Piggyback, for Infusion Center Schedule BID PRN, infuse over 2 hr, order duration 30 day(s)...."
"...Vancomycin 2 gm, IV Piggyback, for Infusion Center Schedule BID PRN, infuse over 2 hr...first dose 7/20/18...stop date 8/17/18...."


Patient #3

The EMR for patient #3 contained the following:

A "Referral" on 1/26/2018 at 02:46 pm, with the following information: "...VANCO 750 MG IV Q 12 Hours, Cefepime 2 grams IV Q 12 hours...Pharmacist to adjust Vanco Dose. Trough goal 15-17 (Continue IV ABX for 3 weeks)...."

The following orders were entered into the electronic medical record:

"...cefepime 2 gm...for Infusion Center Schedule BID PRN...order duration: 42 dose(s)...."
"...Vancomycin 750 mg...for Infusion Center Schedule BID PRN...stop date 2/16/18...."
"...Vancomycin 1,250 mg...for Infusion Center Schedule Daily PRN...stop date 3/3/18...."
"...Vancomycin 1,500 mg...for Infusion Center Schedule Daily PRN...stop date 3/10/18...."
"...cefepime 2 gm...for Infusion Center Schedule BID PRN...."

The MAR for patient #3 contained the following information:

"...cefepime 2 gm, IV Piggyback, for Infusion Center Schedule BID PRN, infuse over 30 minute(s), order duration: 42 doses / time(s), first dose 01/26/18 16:23:00 MST...."
"...cefepime 2 gm, IV Piggyback, for Infusion Center Schedule BID PRN, infuse over 30 minute(s), order duration: 14 dose(s) / time(s), first dose 2/16/18 17:20:00...Administer per Physician order...."
"...cefepime 2 gm, IV Piggyback, for Infusion Center Schedule BID PRN, infuse over 30 minute(s), order duration: 12 dose(s) / time(s), first dose 2/24/18 8:39:00 MST, stop date 3/8/18...."
"...cefepime 2 gm, IV Piggyback, for Infusion Center Schedule BID PRN, infuse over 30 minute(s), order duration: 14 dose(s) / time (s), first dose 3/2/18 7:49:00 MST...Administer per Physician order...."
"...Vancomycin = 150 ml...for Infusion Center Schedule BID PRN...infuse over 60 minute (s), order duration: 3 weeks...first dose 01/26/18 17:02 MST, stop date 2/16/18 17:01:00 MST...."
"...Vancomycin 1,250 mg, IV Piggyback, for Infusion Center Schedule Daily PRN, infuse over 90 minute(s), order duration: 30 day(s), first dose 02/01/18 8:00:00 MST, stop date 03/03/18 7:59:00 MST...."
"...Vancomycin 1,500 mg, IV Piggyback, for Infusion Center Schedule Daily PRN, infuse over 90 minute(s), order duration: 30 day(s), first dose 2/8/18...."
"...Vancomycin 1,50 mg, IV Piggyback, for Infusion Center Schedule Daily PRN, infuse over 90 minute (s), order duration: 30 day(s), first dose 3/2/18 18:16:00 MST, stop date 4/1/18 18:15:00 MST...."

Employee #12 confirmed in an interview conducted on 9/6/2018 that all of the orders received in the Infusion Center are entered into the EMR, as PRN.

Employee #11 confirmed in an interview conducted on 9/6/2018 that all of the orders for the infusion center are entered into the electronic medical record as PRN so there is "no time limit" on the order so staff can obtain the medication. Employee #11 confirmed that the hospital's "PRN" policy requires that the order identify the medication as PRN.

Employee #18 confirmed in an interview conducted on 9/11/18 at 11:09 a.m. that "PRN" design feature allows the administration time to vary based on that patient's schedule, and the PRN indicator is for schedule flexibility because it allows wide open access to the drugs.

Hospital staff could not provide a policy related to the "standard administration times" for medication in the infusion center.

Based on review of hospital policies/procedures, documents, medical record review and staff interviews, it was determined that hospital staff failed to document that the physician was notified regarding medication administration errors for 2 of 3 records reviewed (patient #2 and #3). This deficient practices poses the potential risk that physician's would not be informed of the patient's condition to provide care in response to the medication error.

Findings include:

The hospital policy, "Medication Errors Corporate Policy" approved 2/15/2017 requires the following, "...Physician(s) will be notified within 12 hours of an incident occurrence if the patient incident warrants. This notification of the physician will be documented...."

The hospital policy, "Medication Administration Policy - Nursing" approved 3/7/2018 requires the following, "...A MIDAS Risk Management Medication Error report is completed for all medication errors. Refer to Medication Errors Corporate Policy. Point of Emphasis: Notify physician immediately when the situation involves a critical medication or an adverse drug event...."


Patient #2:

The "Risk Management Worksheet" (MIDAS Report) for Patient #2, 7/21/2018, contains the following documentation, "...Rocephin was given B.I.D. instead of QD, for 3 days on 7/18, 19, and 21...at 0800 and 1800...should have been given Q.p.m. only X 7 days...."

The medical record contained the following order: "...cefTRIAXone 2 g INJ...for Infusion Center Schedule Daily PRN, order duration: 7 doses...Administer per Physician order.

The medication administration record confirmed that Patient #2 received cefTRIAXone twice a day on 7/18/18, 7/19/18 and 7/20/18 as follows:

Administration times:

Start Date / Time End Date / Time
7/17/18 19:08 MST (20 mL) 7/17/18 19:14 MST
7/18/18 10:27 MST (20 mL) 7/18/18 10:31 MST
7/18/18 18:20 MST (20 mL) 7/18/18 18:24 MST
7/19/18 08:15 MST (20 mL) 7/19/18 08:19 MST
7/19/18 18:15 MST (20 mL) 7/19/18 18:19 MST
7/20/18 08:24 MST (20 mL) 7/20/18 08:28 MST
7/20/18 17:38 MST (20 mL) 7/20/18 17:42 MST

Employee #12 confirmed in an interview conducted on 9/7/2018 that Patient #2's medical record did not contain documentation that the physician was contacted regarding the medication error.

Employee #3 confirmed in an interview conducted on 9/11/2018 that the medical record did not contain documentation that the physician was notified of the medication error.


Patient #3:

Patient #3's "Risk Management Worksheet" on 2/4/2018, contains the following information, "...PT TO BE GIVEN VANCO 1260 QD, PT HAD RECEIVED AM DOSE OF VANCO ON 02/03/18, HOWEVER WAS GIVEN A PM DOSE AS WELL ON 02/03/18...."

Patient #3's medical record contained the following Vancomycin order for 2/3/18: "...Vancomycin 1,250 mg, IV Piggyback, for Infusion Center Schedule Daily PRN, infuse over 90 minute(s), order duration: 30 day(s), first dose 02/01/18 8:00:00 MST, stop date 03/03/18 7:59:00 MST...."

The information obtained from the medical record confirmed that the patient received Vancomycin 1,250 mg on 2/3/18 at 08:48 and also on 2/3/18 at 20:13.

Employee #12 confirmed in an interview conducted on 9/7/2018 that the medical record did not contain documentation that the ordering physician was notified of the medication errors for patient #3.

Employee # 3 confirmed in an interview conducted on 9/11/2018 that patient #'3's electronic medical record did not contain documentation that the physician was notified of the medication error.