HospitalInspections.org

Based on record review and interview, the facility failed to

A.) Protect the patient's right to make informed decisions on their care in 3 (Patient #59,#227 and #228) of 16 surgical patients reviewed. The facility failed to ensure that patients or their representatives were provided with risks and benefits prior to surgical procedures performed. Also, the facility failed to follow their own policy and procedures on Informed consent.

B.) Identify the name of the anesthesiology in the Patient Disclosure and Concent for Surgical Procedure.

C.) ensure that informed consent had been completed and documented for 2 of 2 patients (Patient #56 and Patient #57) observed in the outpatient infusion center (Kirby Glen).

This deficient practice had the likelihood to cause harm to all patients receiving surgical procedures at the facility.

Findings:

A review of Patient #59's record revealed:

There was a facility document titled, "Disclosure and Consent -Anesthesia and/or Perioperative Pain Management (Analgesia)." The consent listed, "General Anesthesia, Deep, and Moderate" as the procedure. There was a patient signature signed by the patient on 3/26/2019 at 2315 (11:15 PM). The Anesthesia signature line was blank. There was no further documentation in the chart to indicate that Anesthesia explained the risks and benefits of the procedure to the patient or their representative. The consent had been witnessed by a registered nurse the day before the procedure and prior to anesthesia discussing the type of anesthesia the patient would receive.


A review of Patient #227's record revealed:

There was a facility document titled, "Disclosure and Consent Medical and Surgical Procedures". The consent listed, "Colonoscopy with anesthesia, interventions" as the procedure. The physician signature line was signed 3/27 11:35 PM. The Physician signature to the update history and physical indicated the update was completed 11.5 hours after the procedure was started. Also, further review of the time showed there was a mark over the 12:35. The 2 was marked over with a (1) to make the time a 11:35 and the PM was circled to indicate evening time. The patient was in the procedure room at 11:50 AM and procedure started at 12:00 noon.


A review of the facility policy titled, "Disclosure and Consent for Medical and Surgical Procedures (Informed Consent) (System)" effective date May 2018 revealed the following:

"D. The attending practitioner, the practitioner providing the medical treatment or performing the surgical procedure, including transfusion of blood and blood components, the practitioner's associate, or a practitioner under the Responsible Practitioner's supervision is responsible for discussing the process of and obtaining Informed Consent from the patient or his/her Surrogate Decision Maker.

PROCEDURES

1. Requirements for Disclosure and Consent

Informed Consent is one type of informed decision that a patient or his/her Surrogate Decision Maker may need to make with respect to a medical treatment or surgical procedure related to his/her plan of care.

a. In order for the patient or his/her Surrogate Decision Maker to make an informed decision, it is necessary to provide adequate information about the planned medical treatment or surgical procedure in a manner that he/she can understand.

b. Written Informed Consent from the patient or his/her Surrogate Decision Maker is required for medical treatments and surgical procedures as indicated below except in medical emergencies.

e. Anesthesia and Analgesia

i. Types of Anesthesia and Analgesia are listed as either List A or List B Procedures.

ii. Refer to section 1.c.v for List A Procedures and section 1.d. iii for List B Procedures.

iii. If a treatment or procedure involves Anesthesia or Analgesia, the "Disclosure and Consent - Anesthesia and/or Perioperative Pain Management (Analgesia)" must be used in addition to the appropriate Disclosure and Consent form listed above for medical treatments and surgical procedures, hysterectomy or radiation therapy.

Discussion for Informed Consent

a. Medical Treatments or Surgical Procedures

The attending practitioner, the practitioner performing the treatment or procedure, the practitioner's associate, or a practitioner under the Responsible Practitioner's supervision conducts the Informed Consent discussion with the patient or his/her Surrogate Decision Maker.

b. Anesthesia and/or Analgesia

An Anesthesia provider and/or the Operating practitioner administering the Anesthesia and/or Analgesia conducts the Informed Consent discussion with the patient or his/her Surrogate Decision Maker. Non-physician health care providers, such as a Certified Registered Nurse Anesthetist (CRNA) or an Anesthesiologist Assistant (AA), are also qualified to conduct the Informed Consent process for Anesthesia and/or Analgesia if they are credentialed and privileged to administer Anesthesia.

c. The Informed Consent responsibility may not be delegated to members of the nursing staff or other members of the hospital's workforce.

d. Verify that the consent form is completed and patient or his/her Surrogate Decision Maker signed the Informed Consent form prior to commencing the medical treatment or surgical procedure.

e. Sign, with date and time, the statement on the consent form that the medical treatment or surgical procedure including the risks, benefits and alternative were explained to the patient or his/her surrogate Decision Maker prior to commencing the medical treatment or surgical procedure. Etc."


An interview with Staff RN #8 on 3/27/2019 after 1:00 PM confirmed the above findings.


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On the morning of 3-27-2019, patient care in the Kirby Glen outpatient infusion area was observed.

Patient #56 was to receive chemotherapy treatment. Patient #57 was to receive Intravenous Immunoglobulin (IVIG - a blood product given for the treatment of a number of health conditions). Both treatments require the physician to explain the risks and benefits of the treatments and document that informed consent was obtained. Nursing staff may witness the patient's signature for informed consent after the physician has explained the treatment.

Review of Medical Staff Rules and Regulations, Section 4.0 General Conduct of Care; 4.1. Consents; 4.1.2. Responsibility of Member; 4.1.2.3 stated:
"Any request of the Member for the nursing staff to obtain a patient's signature for authorization for treatment shall be communicated as an order, signed by the Member, and include any information which is to be inserted or included on the form. Such order does not relieve the Member from the obligation to provide informed consent."

Review of the Policy and Procedure Title: Disclosure and Consent for Medical and Surgical Procedures (Informed Consent) (System), Effective Date: May 2018, page 16, item 12, stated:

"Filing Consent Form in the Medical Record

a. When the consent form is complete and signed by the patient and others, as applicable, place the consent form in the patient's medical record prior to conducting the treatment or procedure that required Informed Consent.

b. Prior to the treatment or procedure, obtain the signature, date and time of the practitioner who discussed the proposed treatment or procedure with the patient or his/her Surrogate Decision Maker.

c. A facsimile or copy of a consent form that was signed by the patient or his/her Surrogate Decision Maker while in the physician's private office is acceptable and will be treated as if it were an original copy of the consent form provided the patient or his/her Surrogate Decision Maker verbally verify:

i. The signature of the patient or his/her Surrogate Decision Maker; and

ii. The authenticity of the consent form on the day of the medical treatment or surgical procedure."


RN #113 was observed initiating care for Patient #56 and Patient #57, and interviewed. RN #113 showed a copy of a consent for Patient #56's treatment that had been signed by the herself and the patient. RN #113 was asked where the physician signed, as there was no block for a physician's signature. RN #113 explained that the physician consents the patient while in the private office. Once the patient arrives at the outpatient infusion area, the RN verifies with the patient that the physician explained the treatment and then has the patient sign the consent.

Prior to initiation of care for Patient #57, the patient was interviewed by the surveyor. Patient #57 was asked if the physician had explained the treatment. Patient #57 stated, "No. He just said I needed to have this done to help my immune system." RN #113 was advised that the patient was claiming the physician had not told her about the treatment.

RN #113 began to prepare the consent on the computer. When choices for Blood Products were displayed on the computer, RN #113 was asked if the box for IVIG would be checked. RN #113 stated no. RN #113 explained that she was consenting the patient to receive all blood products and that the consent would be good for a year. That way, if the patient had to go to the Emergency Room or if the physician added additional blood products during the course of treatment, a consent would be on file. RN #113 printed a consent for "Transfusion of blood or blood products (components of blood including plasma, platelets, red blood cells, fibrinogen, or others) are provided to increase the amount of these blood products in your blood stream when they are below a reasonable level for your health." The consent did not contain information about the patient's diagnosis of "D81.9 Combined Immunodeficiency" as listed on the patient orders.

As the nurse started reading information contained on the consent, the patient stated, "I can't have blood. That's why I'm here. I had a bad transfusion a long time ago and that's why I have all these problems." RN #113 told the patient, "What I'm giving you today doesn't have blood in it so you'll be OK." RN #113 continued with the consent process and allowed the patient to review the orders that had been written by the physician. The patient, after looking at the orders, asked, "You mean I have to come here every month for the next year?" The nurse replied, "I'm sorry I'm the one who had to tell you." The nurse completed the consent process and had the patient sign the consent for all blood products.

After leaving the patient area, the nurse was asked if she was going to initiate the IVIG infusion at that time. RN #113 stated that she would initiate the treatment after placing Intravenous (IV) access and obtaining blood specimens to be sent off for the ordered labs. This was despite no physician signed consent, the patient stating the physician had not discussed the medications and her treatment with her, her confusion about the course of her treatment being every 4 weeks for one year, and objection to being consented for blood and all blood products due to a previous bad transfusion.

On the afternoon of 4-3-2019 at 1:30 PM, a meeting was conducted with hospital leadership concerning the physician's signature on consents. Staff #37 presented informed consent audit data for December 2018 and January through March 2019. The consent problem had been identified by Nursing and was being tracked. The physician's statement of consent and electronic signature was on the order that was placed for nursing to verify consent with the patient. When the physician placed the electronic order, the physician was certifying that he/she had discussed the treatment or procedure with the patient.

During the survey process, it was discovered that there was no electronic order for the nurse to verify consent placed by the physician when ordering treatment in the outpatient setting. Therefore, there was no documentation of the physician completing the consent procedure with the patient.


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Patient #228


Patient #228 was admitted to the hospital on 03/08/2019 with a diagnosis that included Acute Chronic Stage D Congestive Heart Failure. The patient was admitted and placed in the organ transplant list awaiting a heart.

A patient record review conducted on 04/03/2019 revealed that the patient had an Orthotopic Heart Transplant on 03/30/2019. Patient Disclosure and Consent for Surgical Procedure was signed by the patient and Cardiology Surgeon on 03/29/2019 at 6:06 PM.

Record review of Patient #228 revealed that on 03/30/2019 at 4:40 AM, a Disclosure and Consent for Anesthesia and Perioperative Pain Management (Anesthesia) was signed by the patient and the anesthesiologist who consented the patient. The anesthesia consent did not have the name of the anesthesiologist who was going to be administering the anesthesia during surgery. Page 7/7 of the anesthesia consent indicated that the anesthesia was administered by "BSL Anesthesiology Group".

On 04/03/2019 at 11:15 AM an interview was conducted with the Cardiac Chief of Anesthesia MD #192. During the interview the MD stated that the anesthesiology group has about 19 to 20 anesthesiologists assigned to his department and they cannot predict which one will administer the anesthesia.

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

A.) Follow Manufacturer's Direction for Use of dialysis machine and the Facility's Policy and Procedure to ensure air detectors (optical detection mechanism) is engaged during self-testing of a hemodialysis machine, prior to initiation of a patient's hemodialysis treatment, in 1 of 1 hemodialysis machine observed during self- testing. The clamp/ optical detection mechanism not engaged during pre- testing safety tests, puts all hemodialysis patients who receive hemodialysis treatment in the facility at risk of air getting into patients' blood stream during hemodialysis treatment, which can result in actual harm to patients. Hemodialysis Machine #26.

B.) Implement the facility's policy and procedure of weighing patients pre and post hemodialysis treatment, during hemodialysis of patients in 2 )Patient #133 and #153) of 3 hemodialysis Patient's clinical records reviewed.

C.) Ensure nursing interventions were put in place to prevent the risk of falls for 2 of 9 patients reviewed.


D.) Ensure pediatric crash cart had operable emergency equipment.


E.) Recognize chemical restraints/emergency behavioral medications (EBM) as restraints and prohibit the use of "as needed" (PRN) psychotropic medications for the use of restraint or seclusion found in 3(113, 121, and 117) of 3 patient charts reviewed.

F.)Ensure Quality Assurance Performance Improvement (QAPI) followed, tracked, or analyzed data on the usage of violent vs non-violent restraints including chemical restraints or the effectiveness of psychotropic medications in 648 patients listed on the restraint log from 12/18 to 3/19.

G.) Ensure policy and procedure offered a scope, scale, or standards for degrees of agitation, or aggression. The nurses made a medical judgment to administer a psychotropic medication subjectively without physician oversight.

H.) Follow the policy and procedure Restraint and Seclusion. Nursing failed to document patient's need for the medication, actions performed to de-escalate or meet the patients' needs before a psychotropic medication administration, effects of the medication, nursing reassessment, vital signs documented after the medication administration or a face to face in 3 (113, 121, and 117) of 3 charts reviewed.



Findings:

A.) Review of the Manufacture's Direction for Use for Fresenius 2000 K hemodialysis machine, Page 49 directs users as follows: "Standard Prime method: Warning the tubing beneath the venous drip chamber must be inserted in the venous line clamp and optical detection."

Review of the Facility's current Policy and Procedure on Hemodialysis Treatment, effective February 2019 directed staff as follows: "The setup of the machine will be according to manufacturer's guidelines."

Observation on 04/01/2019 at 9:15 a.m. revealed Registered Nurse (#169) was observed on the facility's hemodialysis unit in room #6, at Patient #133's bedside.

The Patient was lying on a (stretcher) and the Registered Nurse was preparing to initiate hemodialysis treatment on the Patient. The Patient told the Registered Nurse. "Make sure you set the timer for my saline because they forget and then I clot."

Observation of the room revealed a Fresenius 2008K hemodialysis machine # 26, set up with external blood lines and dialyzer. Observation revealed the pre- tested safety tests were completed and the hemodialysis machine was ready to initiate hemodialysis treatment on the patient.

Observation of the hemodialysis machine revealed, the external blood line tubing was not inserted into the venous line clamp and optical detector.

Interview with RN #169 during the observation, she stated, the hemodialysis machine was pre-tested and ready to initiate hemodialysis treatment on the Patient, but she was going to do central venous catheter care on the Patient. This central venous catheter is the line used during hemodialysis of the Patient.

The Surveyor immediately notified RN #169 and the Dialysis Unit's Director that the external blood line was not inserted in the venous line clamp and optical detector during pre- testing of the hemodialysis machine.

RN #169 stated "I will retest the machine."

Subsequent interview on 04/01/2019 at 9:45 a.m. with RN #169 stated; "My apology, I should have engaged the air detector prior during pre- testing of the hemodialysis machine. This could harm my patient. "

Interview on 04/01/2019 at 9:25 a.m. with Patient #133 revealed the staff sometime forgets to give his Normal Saline flushes and so he asked the nurse to set the clock so that his Heparin could be administered to him.

Failure of the RN to follow the Manufacture's Direction for Use puts the patient at risk for air entering his blood stream during hemodialysis of the patient. This failed practice has the potential to affect all patients receiving hemodialysis treatment in the facility.


B. WEIGHTS

Review of the facility's current policy and procedure on Hemodialysis Treatment, revised February 2019, directs staff as follows: "Hemodialysis treatment process by the dialysis nurse: Weigh patient pre and post dialysis. A pre- dialysis nursing assessment of the patient will be performed and documented in the electronic medical record (EMR) or Hemodialysis Documentation Flow sheet during downtime. Take baseline vital signs pre - dialysis."

PATIENT #133

Patient #133 was observed on 04/02/2019 at 11:20 a.m. in his room on the renal unit. The Patient was alert and oriented to person place, time, and situation.

Interview on 04/02/2019 at 11:21 a.m. with Patient #133 revealed, the RN did not weigh him prior to or after hemodialysis treatment on 04/01/2019.

Review of the Patient's clinical record (treatment sheet), revealed documentation which indicated the Patient received hemodialysis treatment in the hospital on 04/01/2019.

Review on 04/02/2019 of Patient #133's clinical record (Hemodialysis treatment sheet and nurses' notes) revealed no documentation of a pre or post treatment weights taken on 04/01/2019.

Further review of Patient # 133's clinical record (treatment sheet), dated 03/29/2019 revealed, the Patient received hemodialysis treatment on 03 /29/2019. Review of the Patient's clinical record revealed no documentation of a pre-treatment weight.


Patient #153

Review of the Patient #153's clinical record (treatment sheet), dated 03/31/2019 revealed the Patient received hemodialysis treatment on 03/31/2019 in the hospital.

Review on 04/02/2019 of Patient #15) clinical record revealed no documentation of a pre or post treatment weight taken on the patient 03/31/2019 during his hemodialysis treatment.

The Patients' clinical records were reviewed with the hospital's Charge Nurse for the hemodialysis unit. She confirmed that the Patients pre and post treatment weights were not done during hemodialysis treatment.



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E - H.

Review of Patient #113' s chart revealed he came into the Emergency Department on 2/25/19. Patient #113 was an 85-year-old male with an arrival complaint of abdominal pain. Patient #113 was given a diagnosis of Dementia without behavioral disturbance, Unspecified Dementia type, type 2 Diabetes, Essential Hypertension, and Acute cystitis without hematuria.

Review of the ED Physician notes dated 2/25/19, "Physical Exam: Constitutional: He appears well-developed and well nourished. No distress. Neurological: He is alert No cranial deficit."

Review of the ED Nurses Notes 2/25/19:

2/25/19 at 12:28PM, "Lower abdominal pain x and is restless. I asked pt if he is having chest pain-he said yes." There was no documentation in how the pain was addressed.

2/25/19 at 12:44PM, "Per Pt son at bedside PT has had abdominal pain for the last 2 days. The pain has been intermittent for the last few weeks. Pt has a HX of dementia and several CVAs in the past years. Pt is restless and pulling at heart monitor and BP cuff. Pt is not able to be comfortable in bed." There was no documentation on what the nurse did to alleviate discomfort or restlessness.

2/25/19 at 1:36PM, Pt refuses to stay in bed and wants to be in wheelchair.

2/25/19 at 4:15PM, Pt up out of bed walking in room, per son pt face does not look right "drooping on left side and his speech not right slurred" pt does have history of strokes in past. Pt only complaint of mid abdomen pain and does not feel right>Spoke with ____ (physician) in regards patients son wanting to speak with him about test and what was going on. had informed pt's son of ____ (physician) notified (sic).

2/25/19 at 6:02PM, Pt returned from Ct

2/25/19 at 7:15PM, Collected urine from pt and sent to lab. Son is upset about the wait and informed him of why and he was not happy with My answer. Again notified ____ (physician) of pt son being angry .(sic)

2/25/19 at 8:18PM, Son angry with ____ (physician) and yelling at him. ____ (physician) had pt son sign discharge and son yelling to speak with supervisor and son kept pushing pt out and complaining of the wait.(sic)"

Review of the "ED Provider Notes - ED Notes" revealed a comment documented on 2/25/19 at 12:41PM-

Plan VSS. At mental status baseline per caretaker. Abd benign, +UTI but no pyelo. The patient has been evaluated and is being discharged from the ED. There is no indication for emergent hospitalization or surgery at this time. I have explained to the patient and/or their family in detail their discharge instructions and need for urgent follow up with their Primary Care Doctor and/or Specialist, as not all diagnoses can be ruled out in one ED visit as some disease processes take more time to become apparent. I have discussed and reviewed any diagnostic studies that were performed and need for follow up for notable abnormalities. I have also instructed the patient and/or family to seek immediate medical care if their condition worsens, they do not improve as expected, or they experience any new symptoms. The patient is well-appearing and being discharged in stable condition. RN notes acknowledged, differences noted. All history and physical exam data obtained on date of service."

An order for Geodon (psychotropic) 10 mg injection was ordered on 2/25/19 at 1400 (2:00PM). There was no documentation found in the order or physician notes on why the patient was ordered a psychotropic medication. Review of the "All Orders" revealed the injection was given at 1427 (2:27PM). There was a nursing comment that the medication was administered in the "Left Upper". There was no description of what "Left Upper" was. There was no documentation found of the patients need for the medication, actions performed to de-escalate or meet the patients' needs before a psychotropic medication administration, effects of the medication, nursing reassessment, vital signs documented after the medication administration or a face to face.

Review of the policy and procedure for Restraint or Seclusion revealed the definition of a "Chemical Restraint - The use of any chemical, including pharmaceuticals, through topical application, oral administration, injection, or other means, for purposes of restraining an individual and which is not a standard treatment for the individual's medical or psychiatric condition. Chemical Restraints are used for the management of violent, self-destructive behavior.
Note: A psychoactive medication administered outside of the patient's current medication regimen, used to control the patient's behavior rather than for its therapeutic benefit would be considered a Chemical Restraint. For example, a patient currently taking Drug I becomes violent and de-escalation techniques are exhausted. Following assessment, to control the patient's violent behavior the Physician Orders Drug 2. If Drug 2 is not part of the patient's current regimen, or even in the same drug category as Drug I, this would be considered a Chemical Restraint to control the patient's violent behavior.

Note I: The patient has a right to be free of Restraint and also has a right to refuse medications, unless a court has ordered medication treatment. Additionally, in accordance with State law, some patients may be medicated against their will in certain emergency circumstances. Staff is expected to use the least restrictive method of administering the medication to avoid or reduce the use of force, when possible."

F. Assessment, Monitoring and Evaluation of the Patient in Violent/Self-Destructive Restraints or Seclusion or Those Receiving Chemical Restraint

1. Assessment and monitoring may only be conducted by qualified staff within the individual's scope of clinical practice and State law (e.g., checking vital signs, skin integrity, hydration, assisting with range of motion exercises, etc.):

1. Monitoring - Monitoring is performed by physicians or other LIPs or staff who has been trained in accordance with this policy to monitor the condition of patients in Restraint or Seclusion. Qualified staff, other than the RN, may perform monitoring activities and provide for general care needs within scope of practice and job responsibilities.

2. Assessment - Shall be conducted by a RN, QLP or LIP.

ii. The selection of an intervention and determination of the necessary frequency of assessment and monitoring is individualized, taking into consideration variables such as the patient's condition, cognitive status, and risks associated with the use of the chosen intervention and other relevant factors.

iii. For patients in violent/self-destructive Restraints and Seclusion or receiving Chemical Restraint, the following is monitored continuously and documented at least every 15 minutes:

1. Respiratory status:
2. Circulation;
3. Nutrition needs:
4. Hydration needs:
5. Elimination needs;
6. Level of distress/agitation;
7. Skin integrity
8. Signs of any injury
9. Readiness for discontinuation (is assessed, confirmed and documented by the responsible RN, QLP or LIP): and
10. Response to intervention, rationale for continued use."


Patient #121

Review of Patient #121's chart revealed she was admitted to the facility on 2/7/19. Patient came to the ED and stated she was suicidal. Patient #121 was admitted due to infected wounds under her breast. Patient #121 had a past medical history of the following:

MVA
Paraplegic immobility syndrome
Neurogenic bladder
Hx of AKA (above knee amputation)
Chronic Pain
Decubitus Ulcer
Schizophrenia
Osteomyelitis of multiple sites
Suicidal ideation
Wound abscess

Patient #121 had a psychiatric consult as follows:

Physician #176 documented on 2/9/19 at 2:44PM PSYCHIATRY CONSULT
2/7/2019 5:40 PM
2/9/2019 2:44 PM

IMPRESSION: Bipolar do, r/o schizophrenia. Extremely irritable but redirectable. Agreeable to restart psych meds, declines to provide further history.

RECOMMEND:
Titrate depakote to 500mg BID
Risperidone 2mg qhs
Celexa 20mg daily.
Geodon 20mg IM prn severe agitation.

Note pt usually calms down when left alone. Pt w hx of providing very limited cooperation and poor regard for hospital norms/policies. Any threatening or antisocial behavior should be reported to HPD for processions as the law sees fit. Avoid opiates and benzos unless there is absolute medical necessity for either one. In past admissions, prescription of controlled substance have let to disruptive and counter therapeutic behaviors on this patient. (sic)
Continue suicide precations for now. Hx of secondary gain and intentionally trying to prolong hospitalizations due to homelessness. Will continue to assess for safety.(sic)

Thank you for asking us to assist you in this patient's care. Will follow.

ID: 31 y.o. female C.C: What do you want? H.P.I.: Pt w hx of schizoaffective bipolar do and polysubst use, decubitus ulcer and paraplegia for over 10, admitted for SI. Pt appears angry and bothered as I walk into the room. Yells at me at times and gets upset when I indicate that behavior is not acceptable, but able to calm down. She tells me she doesn't want to discuss any of her circumstances prior to admission and says that she is just tired of being homeless and paraplegic. Interested in housing. Agreeable to be restarted on psych meds that helped before, I offered the names and she was ok w therm. She then asks for ativan (much disruption about this in the past) and I made it clear we would not be using benzos as part of her treatment. UDS negative for all subtances. On chart review she's had people bring her drugs even when hospitalized, but it seems SA part is better controlled now. Pt denies any specific plan to hurt herself, does not want to talk to me any further. Does not appear to respond to AVH right now. Unable to perform 10 point review of systems due to lack of pt cooperation." (sic)


Review of the Nurses notes dated 2/11/19 at 10:16PM The house supervisor documented, "Paged to 54579 (patient's room phone). ___ (Patient #121) answered and I introduced myself. ___ (Patient #121) is upset and wanting something to calm her down. I looked at patient's EPIC chart, on the MD sticky note by Dr. ___ (Physician 176) it says to avoid opiates and benzo if possible. Patient started yelling on the phone to me. I listened and explained I would talk with bedside nurse about her request. Talked with Mini (night nurse) and patient has something ordered (patient wanting ativan which is not ordered) and will give to patient. Per bedside nurse patient is yelling in the room for medication."


Review of the nurses notes and flow sheets revealed there was no found documentation of the patient's behavior before the house supervisor called the patient. There was no documentation of de-escalation or other comfort measures provided. There were no documented vital signs to see if the patient was in pain, or withdrawal.


Review of Patient #121's chart revealed she was ordered Geodon 20mg IM on 2/9/19 prn severe agitation. The medication was administered on 2/11/19 at 2250 (10:50PM) under the nurse's discretion. There was no found documentation that the physician was consulted before administering a psychotropic medication for "yelling".


Interview with RN #216 confirmed the above findings. Staff #216 confirmed there was no scope, scale, or standards for degrees of agitation or aggression for a nurse to follow when administering PRN psychotropic medications.


Review of the Pfizer medical information insert revealed that there is no specific antidote to Geodon (ziprasidone) and it is not dialyzable. Geodon is NOT to exceed 40 mg a day. If the nurse followed the physician orders and administered Geodon 20mg IM PRN it would add up to 120mg a day. The patient would have received an overdose of 80mgs; twice the daily recommendation. This could have resulted in depressed respirations, hypotension, circulatory collapse and possible death if overdose is not detected.


Patient #117

Review of Patient #117's chart revealed he was admitted to the facility on 1/4/2019.

Patient #117 was ordered "Haldol 5 mg Intravenous every 6 hours PRN Agitation" on 1/7/19 at 1705. Review of the Medication Administration Record (MAR) revealed Patient #117 received an intravenous injection of Haldol 5 mg on 1/08/19 at 0043 (12:43AM) and again by the same nurse on 1/10/19 at 2225 (10:25PM).

Review of the nurse's notes "flowsheet" for 1/8/19 revealed no documentation of why the patient was given the Haldol or if the Haldol was effective. There was no documentation that a physician was notified.

Review of the nurse's notes "flowsheet" for 1/8/19 revealed Patient #117 was in bilateral wrist restraints when Haldol was administered. There was no documentation noted on the patient's behavior until 2252 (10:52PM) 25 minutes after the medication was administered. The nurse documented "Combative, irritable, and restless." There was no documentation found that MD was aware of Haldol administration at 2225 (10:52PM).

An interview was conducted with RN #154 on the morning of 3/28/19. RN #154 reported that he recently had a severely agitated patient in the ED that required an injection of Haldol due to her screaming and yelling but he did not document that as a restraint. RN #154 was not aware that it was a restraint. RN #154 stated, "I thought they had to be violent to be a restraint."

An interview was conducted with Staff #37 on 3/28/19 at 8:45AM. Staff #37 provided the surveyor with a restraint log that had non-violent and violent restraints. Out of 648 restraints listed on the log only 2 restraints were listed as violent. There were NO chemical restraints listed. Reported that QAPI committee had realized that the nursing staff are not reporting violent restraints including chemical restraints. Staff #37 reported that QAPI had just started to look into the issue last week but had no plans are process in place. Staff #37 reported that she was aware the process was broken and there was no face to face's being done in the restraint process and it needs to "be worked on." Staff #37 confirmed she was aware the physicians were writing chemical restraint orders as PRN.



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C.) Review of the facility provided Fall Management- Patient Care (dated March 2019) reflected, "C. High Risk Fall Precautions ... vi. Activate bed alarm/ chair alarm, if the following patient symptoms/signs are present:

a. Patient is impulsive and/or confused,

b. Patient is non-compliant with calling for assistance before getting out of bed,

c. Patient has altered mental status,

d. Patient overestimates his/her abilities or is forgetful of limitations,

e. Place yellow bed alarm sign on the patient's door ...."


An observation on the morning of 4/1/19, at 10:52 am, revealed Patient #82 laying on the floor of his room. A yellow sign was on the door, "High Fall Risk, Bed/Chair/Alarm". Further observation revealed the Patient's bed alarm was not alarming and all four side rails had been in the upright position. Patient #82 had been admitted on 2/6/19 with a diagnosis of Right sided paralysis, confused and non-verbal.

During an interview on the morning of 4/1/19, Staff #82 confirmed the findings and stated, "He was holding on to the rail, when I lowered it, he went all the way to the floor.... the four side rails were up."

During an interview on the morning of 4/1/19, on the inpatient unit, when asked if Patient #82's bed alarm was on Staff #171 stated, "It's off," and confirmed Patient #82's need for the bed alarm due to confusion.


An observation on the morning of 4/1/19, in room 215, revealed a yellow sign on Patient #134's door "High Fall Risk, Bed/Chair/Alarm". When asked if the bed alarm was on, Staff #172 stated, "Yes." When asked how you can tell if the alarm is set, Staff #172 determined the alarm was off. Staff #172, attempted to set the alarm two times more. The charge nurse instructed Staff #172 to hold the button down for a few seconds; Staff #172 did as she was instructed, the bed alarm beeped, which indicated the bed was alarmed.

During an interview on the morning of 4/2/19, Staff #132 stated, "We need to re-educate the staff on the bed alarms...."

During an interview on the morning of 4/2/19, Staff #170 stated, "We found most of our falls are related to toileting ... we placed bedside commodes in the rooms on the towers.... we didn't see as much of a decrease as we wanted.... In October we did a focus on the falls, we didn't want to wait for the annual training. We have been working on our audit tool, it wasn't standardized, we are planning on rolling it out at the annual training in the coming months."

During an interview on the morning of 4/3/19, Staff #170, stated, "... We review the incident reports .... We found the staff thought they had turned on the bed alarms.... The Hill-Rom representative provided training and information to the different units.... We are in the process of re-educating all the staff."


37322

D.) Record review of current facility policy "Code Blue Response at Baylor St. Luke's Medical Center, Patient Care" dated June 2018, stated the following definition:

Broselow Tape/Hinkle Pediatric Emergency Cart- An emergency resuscitation color-coded system that matches equipment and medication doses for the size of the infant or child.

Equipment: For patients under the age of 12 or less than 36 kg (kilogram), a Broselow Tape/Hinkle Pediatric Emergency Cart will be available in the patient care area.


Observation on 03/29/2019 at 10:10 a.m. at Pearland Emergency Center revealed the pediatric blades did not fit the laryngoscope handles in the pediatric emergency cart.

The pediatric cart was noted to have different laryngoscope handles, (3-Heleflex, 1-Heine) and different blades (3-McIntosh, 2-Miller) thus, the laryngoscope blades did not fit into the laryngoscope handles making it unusable in the event of an emergency. It was also noted the laryngoscope did not have batteries and was not ready for use.

Interview on 03/29/2019 at 10:20 a.m. with Staff #116), he stated "I don't know. we have very few Broselow carts and haven't had to intubate a pedi patient in years".

Based on record review and interview, the facility failed to ensure mechanisms were in place and implemented to prevent potential abuse in all patients. The facility failed to screen two (2) of ten (10) employees reviewed to ensure they did not have a background history that indicated criminal, neglect, or abuse charges.


During review of personnel records the following observations were noted:

RN #214 did not have a background history in the personnel file. RN #214 has been employed at the facility since 1981.

RN #178 did not have a background history in the personnel file. RN #178 has been employed at the facility since 1991.

During an interview with RN #207 and Staff #195 on April 1, 2019 after 8:30 AM, it was revealed the facility did not currently have a process to screen long term employees. Staff #195 said, the facility screens all newly hired employees and any employee that was promoted. Staff #195 said, the facility had recently discovered the gap in the facility screening processes, specifically relating to long term employees and would be working on that process.

RN #207 and Staff #195 confirmed the above findings.



Review of the facility policy titled, "Applicant Background Checks Policy" with a revision date of 11/1/2018 revealed the following:

"Coverage/Eligibility:

Background screenings will be conducted for:

...Current employees under specific circumstances to meet business or regulatory needs ...

Human Resources Responsibilities:

...3. Where required by State Law, current employees will also be required to successfully complete updated criminal background check investigations in order to remain employed."

Based on observation, interview, and record review, the facility failed to ensure a patient's rights to be free from restraints or seclusion when 9 (Patients #227, #148, #138, #134, #137, #82, #135, #153 and #60) of 9 patients were being restrained by the use of four side rails being placed in an upright position without a documented reason. This practice places the patients at risk of entrapment in the rails and or injury from exiting over the top of the side rails.

Findings:

Review of the facility policy Restraint or Seclusion (dated March 2019) reflected, " ... St. Luke's uses Restraint only to provide for the immediate physical safety of the patient ... measures taken to protect the patient from falling out of bed... Note: Raising all four side rails in order to restrain a patient (as this may immobilize or reduce the ability of a patient to move his or her arms legs, body, or head freely) to ensure the immediate physical safety of the patient is considered a Restraint and is not exempt from policy requirements ...."

Observations made on the morning of 4/1/19, on the inpatient units, revealed Patients #134, #137, #82, #135, and #60 lying in bed with four side rails up. The patient's medical records do not reflect physicians' orders for the restraints or that the restraints were not in place for positioning.

During an interview on the morning of 4/1/19, on the in-patient unit, Staff #170 confirmed four side-rails would be considered a restraint.

During an interview on the morning of 4/2/19, in an administrative conference room, Staff #180 stated, "I do audits on all restraints .... Most of the restraints are on the ICU ... I do the audits weekly." When asked if Staff #180 observes the units for unordered restraint use, Staff #180 stated, "I am only reviewing the medical records." When informed of the numerous patients with four side rails up, Staff #180 stated, "Four side rails is a restraint."


Patient #227

Interview on 04/03/2019 at 8:54 a.m. with RN #183 revealed, Patient #227 was bedbound, confused with history of dementia, oriented to self and has to be turned and repositioned.

On 04/03/2019 at 9:00 a.m., revealed Patient #227 was observed in her room on the 9th floor. The Patient was lying in bed with 4 side rails up. The Patient had a yellow fall risk armband in place to her right arm. The bed alarm was activated and the bed was maintained the lowest level.

Interview on 04/03/2019 at 9:50 a.m., with the Unit's Nurse Manager revealed, Patient #227 does not have an order for restraint and should not have all 4 side rails up.

Interview on 04/03/2019 at 9:55 a.m., with RN #183 who was assigned to the Patient revealed, the 4 side rails were put in place by the night shift staff.


Patient #153

Interview on 04/03/19 at 9:15 a.m., with RN #182 revealed, the Patient #153 was previously in the medical intensive care unit with altered mental status but is now alert and oriented X 4.

On 04/03/2019 at 9:20 a.m., Patient #153 was observed in his room with 4 side rails up. The Patient was eating his breakfast unaccompanied. The Patient was alert and oriented to person, place , time, and situation. He was contracted in his upper extremities but was able to feed himself independently.

Interview on 04/03/2019 at 9:16 a.m., with RN #182 revealed, she stated Patient #153 was not a fall risk because the Patient was contracted and he has 4 side rails up.

Interview on 04/03/2019 at 9:45 a.m., with the Unit's Nurse Manager revealed, Patient #153 does not have a physician's order for restraint and so the four side rails of the bed should not be up.

Review of the Patient's Comprehensive Care Plan, dated 03/26/2019 revealed the following documentation, Problem:" Safety ensure armband on, uncluttered walking paths in room, adequate room lighting, call light and overbed table within reach, bed in low position, wheels locked, side rails up per policy and non- skid footwear provided."


Review of the Facility's Current Policy and Procedure on Restraint or seclusion revised March 2019 direct staff as follows: "Measures taken to protect the patient from falling out of bed (side rails during anesthesia recovery, during stretcher transport, when sedated, when experiencing involuntary movement, or on certain therapeutic beds). Note: Raising all four side rails in order to restrain a patient, (as this may immobilize or reduce the ability of a patient to move his or her arms, legs, body, or head freely) to ensure the immediate physical safety of the patient is considered a Restraint and is not exempt from policy requirement. "



33326

Based on observation, interview, and record review, the facility failed to ensure data collected was used to identify opportunities for improvement. The facility failed to track and measure success on performance improvement projects for the timeframe of December 2018-February 2019. The facility failed to:

A. Ensure the Performance Improvement committee (PIC) who had the responsibility of coordinating, implementing, and monitoring Performance improvement (PI) was effective.

B. Ensure PI's that were currently in place were being tracked and trended.

C. Ensure that high risk and problem-prone areas were focused on in dietary services, contracted services, infection control, surgery services, and pharmacy services.

D. Follow the Life Safety Management/EOC Plan as evidenced by findings on Environment of Care rounds were not tracked and trended. Data from EOC rounds was gathered and reported but no Performance Improvement resulted from that data.


Findings:


PERFORMANCE IMPROVEMENT COUNCIL (PIC) AND TIER SYSTEM

Review of a facility's "QUALITY MANAGEMENT PROGRAM AND PLAN-COMMITTEE REPORTING STRUCTURE" dated December 2018 revealed the following:

The Performance Improvement Council (PIC) was listed on the organization chart in a manner where not all department's information flowed through them. According to the chart the PIC functions were to coordinate, implement, and monitor PI priorities and activities using an interdisciplinary collaborative approach throughout the organization.

During an interview on 03/25/2019 after 9:34 a.m., Quality Staff #37, and #130 reported that the PIC portion of the quality was stopped December 2018 and would start back in April 2019. They did not understand why the last administration stopped it.

They stated that the following three non-formal quality tracks had been recently developed to help escalate concerns up to administration. They were:

Tier 1- Direct care staff daily huddles in each department where they talked about Performance improvements (PI).

Tier 2- Hospital leaders who met daily to discuss concerns, determined if education was needed and if policy changes were needed.

Tier 3- Senior leadership who met daily at 11:30 a.m. They looked at quality measures, hospital throughput, staffing, and CMS readiness.

Quality Staff #37 and #130 stated, there were no meeting minutes being kept at these meetings. At the Tier 2 level the information was put on spread sheets. The information was being tracked, but no trending was being done.

During an interview on 03/29/2019 after 10:00 a.m., Quality Staff #130 confirmed they were not tracking all the PI's on the huddle boards for the Tier I level.


DIETARY PERFORMANCE IMPROVEMENT PROJECTS

During an observation on 03/26/2019 after 9:28 a.m., the huddle board in the kitchen was checked and the following Performance improvement projects were listed:

1. Attendance
2. Tray delivery
3. Tray accuracy
4. Starting food waste. Helping save the hospital money ...

There was no mention of kitchen sanitation on the board.

Dietary operation manager #133, Dietitian #119 and Dietary Director #16 reported these were the 4 PI's they were currently working on. They had been working on them for about 2 months now. The staff stated that Sodexo (dietary contracted servicer) kept their own PI's and would provide a list.

Review of Quality minutes relating to dietary from January 2018 - February 2019 made no mention of kitchen sanitation issues, condensation issues with liquid dripping from the ceiling or problems with sewage back up that was found in the kitchen during the current survey. No list was provided during the survey to indicate PI's that Sodexo was currently working on.


CONTRACTED SERVICES

Review of a sample of contract evaluations on (Quest (lab), Sodexo (dietary), CAPS (pharmacy compounding service), and Steris (sterilization), and Infection Prevention and Management Associates Inc. revealed the last evaluations by the facility were dated 04/23/2018. All of the services were evaluated using the same general categories: quality, regulatory compliance, service delivery, and customer service.

During an interview on 03/26/2019 after 10:57 a.m., Quality Staff #37 and #130 reported that the last time contracted services reported to quality was April 2018. A request was made to see project improvements from contracted services. Staff #130 reported that if there were any fall outs/addendums with contracted services there would be no way to see it. They were not being documented.


SURGERY SERVICES

Review of quality minutes revealed the following retained surgical items:

05/2018 -lap sponge
06/14/2018- surgical towel
07/25/2018- cervical instrument
09/2018- the count sheet was revised and mandatory staff education was given.

During an interview on 03/28/2019 after 1:35 p.m., a request was made from Quality staff #130 to see the tracking and if this was still a Performance improvement. Staff #130 stated it was not brought forward as a PI project and there was no current tracking information on this problem.


INFECTION CONTROL

Review of infection control quality minutes from January 2018- December 2018 revealed the facility was not meeting the national average when it came to some of the following infections and ways to prevent infections:

Central line associated bloodstream infections
Catheter associated urinary tract infections
Clostridium difficile
Methicillin-resistant Staphylococcus aureus
Colon surgical site infections
Hysterectomy site infections
Isolation
Hand hygiene

During an interview on 03/28/2019 after 11:44 a.m., the Director of Infection control #18 confirmed the above findings.

Infection Control Director #18 stated the following as things they identified that were not being tracked and trended:

Chlorohexidine bathing preoperatively
Nasal decolonization
High level disinfecting- sterilization of equipment
Ultrasound transducers
Transportation of equipment
Equipment cleaning and competencies
Durable medical equipment

Infection control Director #18 stated, the reason for not tracking and trending the information was because of lack of resources. Infection control Director #18 stated there was 6 Infection Preventionist to an average hospital patient census of 540.


PHARMACY

During the survey from 03/25-27/2019 nursing staff revealed they were discarding narcotics in biohazard boxes which were not secure. Nursing staff were observed using paper narcotic inventory sheets also which were not being completed.

During an interview on 03/26/2019 after 9:41 a.m., Pharmacy Director #9 revealed that there was a problem with documentation of narcotic waste. The paper narcotic shift count reports were started in November 2018 as an intervention.

Pharmacy Director #9 stated, the information had not been taken to quality.

During an interview on 03/27/2019 after 1:48 p.m., Safety Officer #154 and Pharmacy Director #9 reported the following:

They identified they had a problem with narcotic disposal in 2016.

CSRX narcotic disposal system was what they had decided to use. The company who they had been contracted would be out next Thursday to install the new systems.

The facility's policy had been changed on yesterday for nursing staff to flush narcotics down the toilet.

These policies had been implemented, but all nursing staff had not been trained nor had the information been taken to Medical executive committee or Governing body.


Review of the facility's " Quality Manual 2019 " revealed the following:

"The QMS program include, but it not limited to the following:

A focus on indicators related to improved health outcomes and reduction of adverse events.

An outgoing process to demonstrate measurable improvement in indicators for which there is evidence of improved health outcomes and reductions in adverse events;

Measurement, monitoring, and analysis of quality and patient safety indicators, including adverse events, and other aspects of performance to assess processes of care, treatment, services, and operations provided; and

Continual improvement of health outcomes and reducing risk for patients."



35028

Record review of the document titled, Life Safety Management Plan, effective date January 2019 showed:

" ... 7.00 - Measuring and Improving Activities. Conditions in the environment are monitored to identify discrepancies and improve the safety and reliability of systems and processes...

7.03 - The Hospital Safety Officer, the Environment of Care Committee (EOCC), and the EOCC Sub-committees have established and implemented a process for ongoing monitoring of actual or potential risks in each of the management plans. To accomplish this task, data is collected and tracked and trended to see if any preventive of corrective actions need to be taken. Areas identified from each data is collected include, but are not limited to:

1) Periodic Surveillance Rounds
2) Emergency and incident reporting
3) Inspection, preventive maintenance and testing of applicable equipment.

The EOC management plans are reviewed annually and adjusted based on changes in the environment of care, incorporating code/standards revisions and the tracked and trended indicator data. External benchmarking data will be used to further evaluate the effectiveness of the EOC system. Quality Management Oversight is given an annual report of management plan effectiveness.

7.04 - Environment safety monitoring and response actives, as necessary, are reported to the appropriate EOC and Patient Care Committees and integrated into the overall program to improve the safety of Baylor St. Luke's Medical Center facilities for patients and all other occupants, and to enhance the healing environment."


Record review of the document titled, 2018 Environment of Care Rounds Update, dated 08/14/2018, showed data for 2018. This report documented:

" ...[the percent of] Compliance [for the following items]:

37% - facility structure in safe and good condition ...

46% - Sharps are secured - predominately 'IV Start Kits' and unlocked BMW (Biomedical Waste)

55% - Medications are secured - predominately saline flushes

64% - Furniture in safe and good condition ... "


In an interview with Staff #154 on 03/29/2019 at 9:30 AM, he stated the data collected on the quality indicators during the Environment of Care Rounds Update, dated 08/14/2018:

1) Was presented in the Workplace Safety Committee meeting;

2) Had not been tracked or trended; and

3) Should have been tracked and trended to identify opportunities for improvement.

Staff #154 also stated, there had been no tracking or trending of the quality indicators since August 2018 because environmental rounds had not been conducted.

Based on observation, interview, and record review, the facility's nursing staff failed to:

1.) Implement physician's orders to collect stools for occult blood and application of intermittent pneumatic compression device for patients in 1 (Patient #153) of 10 sampled patients.

2.) Ensure 5 (Patients #23, #24, #21, #2, #18) of 10 patients were assessed for pain on admission, ongoing throughout stay, and at discharge.


Findings:

On 04/03/2019 at 9:20 a.m., Patient #153 was observed in his room with 4 side rails up. The Patient was alert and oriented to person, place, time, and situation but contracted in his upper extremities. He had a Prevalon heel protector in place to both feet

Review on 04/03/2019 of the Patient's clinical record, revealed a physician's order dated 03/29/2019 for stool for occult blood.

Review of the Patient's clinical record revealed documentation which indicated, the Patient had bowel movements on 03/30/2019 at 1959 and 03/31/2019 at 2200.

Review of the Patient's clinical record revealed no indication that the stool specimen was collected and sent to the laboratory for occult blood test.

The Patient's clinical record was reviewed in the presence of the Unit's Nurse Manager and RN #101 who confirmed that there was no result on the Patient's clinical record for stool for occult blood.

Review of the Patient's clinical record, revealed a physician's order dated 03/27/2019 to "Place intermittent pneumatic compression device."

Observation of the patient on 04/03/2019 at 9:20 a.m., revealed no evidence of an intermittent pneumatic compression device in place to the patient's legs.

Interview on 04/03/2019 at 12.11 p.m. with RN #182 revealed, she said the Patient was transferred to the unit the previous day, from the Intensive Care Unit without the intermittent pneumatic compression device and there was none available in the patient's room. She stated "I missed the order."



37322

Review of the current facility policy "Pain and Opioid Management", dated 12/2018 stated:

All patients will be reassessed for pain and adverse effects of treatment within one hour after every intervention and outcome documented.

Outpatients are assessed for pain: Initial assessment is completed on arrival if indicated based on reason for visit and reassessed on an on-going basis as indicated and at discharge.


Review of current facility "Discharge of Patients from Emergency Services-Emergency Department (ED)" dated 01/2019, stated:

If patient given initial IM/IV (intramuscular/intravenous) medication prior to discharge the patient must be observed for a minimum of thirty minutes before being discharged to assess for any adverse medication reaction.

If patient has received a chemically sedating medication or anesthesia, they must have transportation through a designated driver.


Record review on 03/25/2018 at 1135, revealed the following:

Patient #23, 66-year-old female, was triaged on 03/24/2019 at 11:20 a.m. and medically screened at 1140 for nausea and vomiting in the emergency department (ED). Morphine 4 milligram (mg) was administered for a pain level of 7 at 4:04 p.m. Patient #23 was discharged home 4:12 p.m. from the emergency department, with her daughter.

Patient #24, 26-year-old male, was triaged at 5:48 p.m. and medically screened at 6:57 p.m. on 03/24/2019 for abdomen pain. Patient #24 received Benadryl 25 mg/IV at 9:22 p.m. and was discharged at 9:50 p.m. The documentation notes that Patient #24 was discharged by himself.

Patient #21, 41-year-old female, was triaged on 11/28/2019 at 11:44 p.m. and medically screened 2:50 a.m. on 11/29/2018 in the emergency department for abdominal pain. On 11/29/19 at 11:42 p.m., the pain level was assessed at 10 andPpatient #21 received Toradol 30 mg /IV at 03:20 a.m. on 11/30/2018 and was not reassessed until 05:24 a.m. Patient #21 transferred to observation on 05:41.

Patient #2, 31-year-old female, was triaged for abdominal pain on 11/29/18 arrived at 19:50 p.m., triaged 19:59 p.m., medical screened at 11:40 p.m., the pain level was not assessed until 02:18 a.m. with a level of eight (8). Morphine 2 mg, IV was ordered at 02:39 a.m. and administered at 04:41 a.m. for a pain level of nine (9). Upon reassessment the pain level was 4 at 04:58 a.m. Discharged home on 11/30/2018 at 05:28 p.m.

Patient #18, 81-year-old male, was triaged at 11/29/2018 at 11:06 a.m. and medically screened at 10:00 a.m. for leg and right foot pain. The pain level was assessed 11:08 a.m. of 5, Tylenol #3, one (1) tablet was given at 18:44 p.m. and reassessed at 18:49 p.m. with a level of 5. Patient #18 was discharged 18:51 p.m. with spouse.

Interview at 03/24/2019 at 1140 with RN #52, he stated, "we are supposed to reassess within the hour after giving narcotics. I would personally reassess within 15 minutes for patients with pain to ensure they have not had a reaction. We have to confirm these things before they are sent home".

Based on observation, interview, and record review, the facility failed to ensure adequate numbers of Registered Nurses for the care of patients at the Kirby Glen Center during 03/11-04/01/2019.

The facility failed to provide enough staff to supervise a patient who was receiving a blood transfusion (Patient #92).

The facility failed to provide enough staff to supervise patients who were receiving chemotherapy and blood transfusions.

The facility failed to have an accurate staffing plan for staff to follow.


This deficient practice had the likelihood to cause harm to all patients receiving treatments at the Kirby Glen Center.

Findings:

During an observation on 03/27/2019 after 10:31 a.m., Patient #92 was observed to have a blood transfusion started by RN #127. Patient #92 informed RN #127 it was his first time receiving blood.

RN #127 primed the intravenous tubing with normal saline and then started the blood transfusion. RN #127 explained the symptoms of a blood transfusion reaction to Patient #92 and stated she was starting a timer. RN#127 told Patient #92 that she would be back. RN #127 started the blood transfusion and left the room. RN #127 went to another patient's bay and closed the privacy curtain and took care of that patient. RN #113 and #115 were working on the unit. RN #113 was administering chemotherapy to a patient and the privacy curtain was pulled. RN #115 was in the phlebotomy room with the door closed.

At 10:48 a.m. (17 minutes later), RN #127 checked on Patient #92 and immediately left the room to go and help with the consent process on another patient.

At 11:00 a.m. (29 minutes later), RN#127 returned to Patient #92's room to take vital signs.


During interviews on 03/27/2019 after 11:00 a.m., the following was stated about staffing:

"We need help of at least 2 more nurses. If wound care is open the nurse's aide goes to help them. The average daily census is from 15-20 patients. A nurse could have up to 4 patients who are receiving blood, chemotherapy or injections."

"We have 2 nurses, but that's not enough. It always takes 2 nurses just to check off on blood and chemotherapy along with other duties."


Review of time sheets from 03/11-04/01/2019 revealed the following:

On 03/18/2019, there were 2 nurses scheduled. One nurse had a patient scheduled at 10:00 a.m. to receive chemotherapy and another patient scheduled at 10:30 a.m. to receive 2 units of blood. This did not include the other scheduled procedures.


On 03/19/2019, there were 2 nurses scheduled. One nurse had a patient scheduled at 9:30 a.m. to receive 2 units of blood and another patient scheduled at 10:00 a.m. to receive 2 units of blood.

On 03/22/2019, one nurse had a patient scheduled at 9:00 a.m. to receive 2 units of blood, and another patient scheduled at 9:30a.m. to receive chemotherapy, and another patient scheduled at 10:00 a.m. to receive 2 units of blood.

03/26/2019, there were 2 nurses scheduled. One nurse had a patient scheduled at 9:00 a.m. to receive 2 units of blood, and another patient scheduled at 9:30a.m. to receive chemotherapy. Another nurse had a patient scheduled at 10:00 a.m. to receive 2 units of blood, and another patient scheduled at 10:30a.m. to receive chemotherapy.

There were only two Registered nurses working 11 out of 16 days during this time frame. There was a nurse's aide added 6 out of 16 days.

Review of an undated "Staffing Plan for Kirby Glen" revealed there should be a "minimal level of 2 RN's at all times .... In general, at about 18-20 patients, a third RN is added."

Review of a facility's "Scope of Service" dated 02/13/2019 revealed the core staffing was to be a registered nurse and the patient ratio would be 1:4.

The staffing plans made no mention of using nurses' aides. There were discrepancies between the two staffing plans.

Based on observation, interview, and record review, nursing staff failed to:

A.) Supervise and evaluate care on 1 (Patient #92) of 2 patients observed for transfusion services at the Kirby Glen Center.

Patient #92 did not receive supervision immediately after the initiation of a blood transfusion for possible transfusion reactions. The facility failed to ensure timely vital signs after the initiation of the blood transfusion.


B.) Supervise and evaluate the nursing care for each patient, as Emergency department (Main ED) patients were not seen in order of acuity, physician's orders were not carried out in a timely manner and assessments/reassessments of patients were not performed according to facility policy on Patients #17, #160, and #162.

C.) Supervise and evaluate care for 1 (#52) of 10 patients' records reviewed that reflected pain medication orders that did not contain physician directive for use and the nurse did not clarify the order prior to giving the medication for pain.

Findings:

During an observation on 03/27/2019 after 10:31 a.m., Patient #92 was observed to have a blood transfusion started by RN #127. Patient #92 informed RN #127 it was his first time receiving blood.

RN #127 primed the intravenous tubing with normal saline and then started the blood transfusion. RN #127 explained the symptoms of a blood transfusion reaction to Patient #92 and stated she was starting a timer. RN#127 told Patient #92 that she would be back. RN #127 started the blood transfusion and left the room. The blood transfusion reaction form was placed underneath the mobile computer.

RN #127 went to another patient's bay and closed the privacy curtain and took care of that patient. RN #113 and #115 were working on the unit. RN #113 was administering chemotherapy to a patient and the privacy curtain was pulled. RN #115 was in the phlebotomy room with the door closed.

At 10:48 a.m. (17 minutes later), RN #127 checked on Patient #92 and immediately left the room to go and help with the consent process on another patient.

At 11:00 a.m. (29 minutes later), RN#127 returned to Patient #92's room to take vital signs.

During an interview after 11:00 a.m., Staff #127 confirmed she was supposed to stay with the patient for the first 15 minutes or have someone supervise the patient. Staff #127 stated she was supposed to be completing the form during the transfusion. Staff #127 was shown the instructions on the pink sheet (Blood Transfusion Real-Time Checklist/Audit Tool).

Review of checklist revealed a category for pre-transfusion documentation, dual nurse verification, intra- infusion documentation, reaction documentation, symptoms of a possible transfusion reaction, and completion documentation.

There was instruction on the checklist that staff were to sign the sheet indicating it was used during the transfusion. There was instruction on the checklist that vital signs were to be taken 15 minutes after initiation of the blood transfusion.


28422

B. The clinical records for 10 emergency department patients were reviewed (patients #17 - #23, patient #160, and patient #162).

Patient #17 presented to the facility ED on 1-15-19 at 1:50 pm by private vehicle with a chief complaint of lung problems and shortness of breath. He was assigned an emergency severity index of 2. Online reference https://www.esitriage.com/esi-algorithm states "The Emergency Severity Index (ESI) is a five-level emergency department (ED) triage algorithm that provides clinically relevant stratification of patients into five groups from 1 (most urgent) to 5 (least urgent) on the basis of acuity and resource needs."

Patient #17 saw the physician at 1:59 pm. The physician ordered lab work, a chest x-ray, an EKG [electrocardiogram] a Proventil nebulizer treatment, a Duo-Neb nebulizer treatment and Solu-Medrol 125 mg intravenously. Although intravenous access was established within minutes of the order, the ordered medications were not administered until 5:18 pm. No documentation was provided to explain the 3 hour, 19 minute delay in carrying out the physician's orders.

The patient's vital signs were assessed at the following times:
* 1:53 pm
* 3:40 pm
No other documentation of vital sign assessment was found.

After waiting in the waiting room for 6 hours and 31 minutes, patient #17 was placed in ER room #A-06 at 8:30 pm. Additional medication was ordered at 8:56 pm and given at 9:06 pm.

Patient #17 was diagnosed and discharged from the emergency department at 9:49 pm. He was given prescriptions along with his discharge instructions.

A review of 2 additional clinical records revealed the following:

Patient #160 arrived at the ED on 1-15-19 at 3:14 pm. The patient was assigned an emergency severity index of 5. The patient was placed in an ED room at 3:54 pm, seen by the physician at 4:38 pm and discharged at 5:20 pm.

Patient #162 arrived at the ED on 1-15-19 at 4:28 pm. The patient was assigned an emergency severity index of 2. The patient was placed in an ED room at 4:35 pm, seen by the physician at 4:49 pm and discharged at 8:56 pm.


Facility policy titled "Discharge of Patient from Emergency Services - Emergency Department" states, in part:

"Policy
...
B. Vital signs including pain level will be assessed within one hour prior to discharge and any significant changes reported to provider."


Facility policy titled "Treatment Area Reassessment Guidelines - Emergency Department" states, in part:

"Procedures
...
2. Reassessments:

i. The frequency of reassessment is initially based on the patient's acuity and adjusted as the patient's condition improves or worsens.

ii. Reassessment parameters are based on the patient's presenting condition, and typically include but are not limited to pulse, respiratory rate, blood pressure, pulse oximetry and pain assessment minimally every four (4) hours."


Facility policy titled "Triage - Emergency Department" states, in part:

"Procedures

A. All patients arriving in Baylor St. Luke's Medical Center (BSLMC) Emergency Department (ED) or Community Emergency Centers (CECs) will be seen and evaluated by an RN for purposes of prioritizing patient care. The RN will assign the patient an appropriate triage acuity level based on the Emergency Severity Index (ESI)."


33589

Patient #52's record reflected: "3/26/19 ...

9:45 AM Pain Score: 10...9:46 AM Methadone 10 mg (given/milligrams)...Order: Methadone 10 Mg every 6 hours, PRN (as needed) for severe pain."

There was no pain scale associated to the Methadone order to discern when the medication was supposed to be used.

During record review and interview on 3/26/19 ending at 10:30 AM, the navigator, RN #97 confirmed the above finding and stated, "we are supposed to call the doctor for clarification, if an order doesn't include the pain scale."


The facility's 2 page, undated, laminated "Education" required, "Pain Assessment...Make sure the pain scale correlates with the type of pain medication the MD (doctor) ordered...if your patient has a pain scale of 7 you must get an order to correlate with that pain score..."


The facility's February 2019 "Medication Administration" policy required, "The RN is responsible for reviewing and performing any clarification of medication orders...once reviewed, the RN will acknowledge and release orders in the electronic health record..."

Based on record review and interview, the facility failed to ensure a current and up-to-date nursing care plan for each patient, in that,

2 (Pt #52, and #54) of 10 patients' record did not document a current and up-to-date nursing care plan.

Findings:

Patient #52's record reflected: "ED (Emergency Center) Provider Notes: 3/25/19...Chief Compliant...Urinary Retention over 2 weeks. Pt with lower abdomen pain...also concerned about blood pressure...71 year-old...Past Medical History...Hypertension...Physical Exam: (Blood Pressure) B/P 130/91...Pulse 107...Cardiovascular...Tachycardia......8:45 PM (Physician Name) accepts admit..."

Further review of the patient's inpatient medical record revealed there was no nursing care plan for urinary retention or cardiac issues.

During record review and interview on 3/26/19 ending at 10:30 AM, the navigator, RN #97 confirmed the above findings.

Patient #54's record reflected: "3/23/19 History and Physical...69 year-old...cirrhosis...ascites...getting paracentesis...dehydration...complaining of nausea and vomiting and inability to tolerate oral intake..."

During record review and interview on 3/26/19 ending at 3:20 PM, the navigator, RN #101 was asked if the patient had a wound. Personnel RN #101 confirmed a Stage II, Coccyx with foam dressing applied. Personnel RN #101 was asked for the nursing care plan for the wound. Personnel RN #101 stated, "I don't find one for the wound, no skin integrity started."

Based on record review and interview, the facility failed to ensure drugs were administered in accordance with hospital policies about pain management and follow-up, in that,

A) 2 (Patient #51, and #55) of 10 patients' medical record did not reflect pain medication given for a pain response when medication was ordered.

B) 1 (Patient #52) of 10 patient's medical records did not reflect pain management follow-up after pain medication administration.

Findings:


A) Patient #51's record reflected, "Pain Score: 5 (Five/score given by patient)...3/26/19...10:37 AM...Orders: Norco 325 mg for pain of 4-6..."

There was no pain medication given for their pain.

During record review and interview on 3/26/19 ending at 10:30 AM, the navigator, Personnel RN #97 confirmed the above finding.

Patient #55's record reflected: "3/26/19 ...

7:05 AM Pain Score: 9...Orders: Morphine 30 mg PO q 6 hours for scale 7-10/severe pain."

There was no pain medication given for their pain.

During a record review and interview on 3/26/19 ending at 3:20 PM, the navigator, RN #101 confirmed the findings.

The facility's December 2018 "Pain and Opioid Management" policy required, "Right to effective pain management and will be assessed for the presence of pain on admission, regularly throughout their stay, and on discharge...be reassessed for pain and adverse effects of treatment within one hours after every intervention and outcome documented."


B) Patient #52's record reflected: "3/26/19...

2:37 AM Pain Score: 10...2:37 AM Tramadol 50 Mg (milligrams/given)...

9:45 AM Pain Score: 10...9:46 AM Methadone 10 mg (given)..."

There was no reassessment for pain/adverse outcome/effects of treatment documented after either of these administrations.

During record review and interview on 3/26/19 ending at 10:30 AM, the navigator, RN #97 confirmed the above finding and stated, "we are supposed to reassess within 60 minutes."