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

CHRISTUS MOTHER FRANCES HOSPITAL 800 EAST DAWSON TYLER, TX 75701 April 24, 2018
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on document review and interview, the facility failed to


A. Identify a grievance, as such, in 1 (Patient #8) of 2 patients reviewed (Patients #8 and #9). Patient #8 was admitted to the Neonatal Intensive Care Unit (NICU) on 11/30/2017 at a gestational age of 26 weeks. Normal expected gestational age at the time of delivery is between 38-42 weeks. Infants born before 37 weeks gestational age are considered premature. On the afternoon of 4/26/2018, an interview with the mother of pt #8 indicated she arrived at the NICU on 3/5/2018 and found what looked like striped finger shaped bruising around the calf of her son's leg Pt ##8. She had to ask the day shift nurse, who explained that the night shift nurse had bruised her son's leg while attempting to complete a heel-stick to obtain blood for a laboratory test. The bruising was still visible at discharge.

Refer to A0118 for more information.




B. Assess and provide safe care for 1 (Patient #8) of 2 Neonatal patients (pt #8 and #9) reviewed. Patient #8 was admitted to the Neonatal Intensive Care Unit (NICU) on 11/30/2017 at 26 weeks' gestational age. (Normal gestational age is 38-42 weeks). An interview on 4/27/2018, with the mother of Pt #8 revealed that 1/1/2018 she observed a small area she described as a "skin tear". A review of the MR revealed the area was not a skin tear but was an abrasion to his upper lateral forehead. Interview on the morning of 4/24/2018 with the NICU Medical Director indicated the abrasion was very superficial and could easily have been made by the removal of tape.


On 4/27/2018, a telephone interview with the father also revealed that on 1/5/2018 a NICU RN, (Name unknown) entered their room with a syringe full of formula for their son (Pt #8's) feeding. The nurse placed the syringe on the keyboard of the computer desk while she prepared the pump to deliver the feeding. The father observed the label on the syringe of formula was not his son's name. He confronted the RN about the name. The RN confirmed she had printed the wrong name. She left the room returned with a label with pt#8's name on it. The label had been affixed over the previous pt's name. The first label was still partially visible beneath the corrected pt. labeled name. He also verified he saw no initials either on the label or the syringe that would indicate anyone had checked the content.


Interview with staff #33 revealed two (2) RN's are required to verify the infant's formula prior to delivery of the formula.


Further MR review indicated on 3/5/2018 pt. #8 received bruising in the shape of fanned fingers on his lower calf.

Refer to A0144 for more information
VIOLATION: PATIENT RIGHTS: GRIEVANCES Tag No: A0118
Based on interview and record review the facility failed to identify a grievance, as such, in 1 (Patient #8) of 2 patients reviewed.


This failed practice had the likelihood to effect all patients of the facility.


Findings included:


On the morning of 2018 in a small conference room the medical record (MR) for patient (pt) #8 was reviewed. Patient #8 was admitted to the Neonatal Intensive Care Unit (NICU) on 11/30/2017 at a gestational age of 26 weeks. Normal expected gestational age at the time of delivery is between 38-42 weeks. Infants born before 37 weeks gestational age are considered premature.


On the morning of 4/24/2018, an interview with the NICU Medical Director, staff #32 confirmed she had been made aware of the bruising on pt #8. She had gone to check on the baby. She voiced her concern to the mother and indicated she followed up with the unit supervisor, staff #33.


On the morning of 4/24/2018, an interview with the unit supervisor confirmed she had been made aware of the bruising to Pt #8. She further indicated she had taken pictures for pt #8's bruises.


On the afternoon of 4/26/2018, an interview with the mother of pt #8 indicated she arrived at the NICU on 3/5/2018 and found what looked like striped finger shaped bruising around the calf of her son's leg Pt ##8. She had to ask the day shift nurse, who explained that the night shift nurse had bruised her son's leg while attempting to complete a heel-stick to obtain blood for a laboratory test. The mother of pt #8 stated, "I was not notified about the bruising but found it when I got to the NICU and looked at my son". She indicated she was very upset. Further, she asked for her son to be discharge and on 3/7/2018, after 3.5 months in the NICU, her son was discharge home on a monitor. Prior to the discharge, the mother of pt #8 indicated, she had spoken with the unit supervisor who had taken pictures of her son's bruises. The unit supervisor told her they were for educational purposes. The mother of pt #8 also confirmed the bruising was still visible on the day of discharge. Pt #8's mother confirmed she had no communication with the hospital after they were discharged .


On the afternoon of 4/24/2018 staff #32 was asked if she felt the complaint about the bruising to pt #8's leg had been resolved prior to his discharge. She said "Yes, I thought it was". When asked what had been done to investigate, or educate the nurse who bruised the baby. She indicated she "talked" with the nurse who was unaware a bruise had been left on the baby. When asked if re-education or inservicing had been conducted she replied, "Yes at our department training." A review of the attendees for the department training did not identify the Registered Nurse (RN) in question. A review of the on-line inservice also failed to identify the offending RN. The Unit supervisor confirmed she did not have documentation she had spoken with the RN who left bruises on pt #8 after attempting a heel-stick.


On 4/24/2018 in the afternoon the Policy and Procedure D-123.0, which addresses and clarifies the "Patient, Grievance/Complaint Resolution" was reviewed.


2.3 Definitions:

2.3.1 Complaint- An issue considered resolved by staff present when the patient is satisfied with actions taken on their behalf, or the nature of the complaint does not meet the definition of a grievance.

Post-discharge verbal communication regarding patient care that would routinely have been handled by staff present if the communication had occurred during the stay, are not required to be defined as a grievance.


Review of the facility's Complaint/Grievance policy revealed:

"2.3.2 Grievance- A formal or informal written (written communication is always considered a grievance) or verbal complaint (when a verbal complaint about patient care is not resolved at the time of the complaint by staff present) by a patient or patient representative, regarding any of the following:

2.3.2.1 The patient's care

2.3.2.2 Abuse of (sic) neglect

2.3.2.3 Issues related to the organization's compliance with the CMS Hospital Conditions of Participation (CoP) or

2.3.2.4 A Medicare beneficiary billing complaint related to rights.


2.4 When the patient care complaint cannot be resolved at the time of the complaint by staff present, is postponed for later resolution, is referred to another staff member for later resolution, requires investigation, and/or required further actions for resolution then the complaint is a a grievance."


On the morning of 4/24/2018, a discussion was held with staff #2, #3, and #5 about the above patient and the incident that occurred while in the NICU. All three indicated no previous events such as the above identified events had occurred, therefore, there was no indication the events would require quality oversight. Each staff agreed bruising would be considered an adverse event and that harm occurred.


Bruising, evidenced by three visible fingers imprinted on a premature infant's leg, could be interpreted as abuse. The facility failed to recognize the severity of the event or the complaint which was voiced by the mother, was a grievance.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
Based on interview and document review the facility failed to assess and provide safe care for 1 (Patient #8) of 2 Neonatal patients reviewed.

This failed practice had the likelihood to effect all neonatal patients of the hospital.


Findings included:

On the morning of 4/24/2018 in the conference room, with the assistance of hospital Information Technology (IT) staff, the medical record (MR) for patient's #8 was reviewed. Patient #8 was admitted to the Neonatal Intensive Care Unit (NICU) on 11/30/2017 at 26 weeks' gestational age. (Normal gestational age is 38-42 weeks).


An interview on 4/27/2018 with the mother of Pt #8 revealed that 1/1/2018 she observed a small area she described as a "skin tear". A review of the MR revealed the area was not a skin tear but was an abrasion to his upper lateral forehead.


Interview on the morning of 4/24/2018 with the NICU Medical Director indicated the abrasion was very superficial and could easily have been made by the removal of tape.


On 4/27/2018, a telephone interview with the father also revealed that on 1/5/2018 a NICU RN, (Name unknown) entered their room with a syringe full of formula for their son (Pt #8's) feeding. The nurse placed the syringe on the keyboard of the computer desk while she prepared the pump to deliver the feeding. The father observed the label on the syringe of formula was not his son's name. He confronted the RN about the name. The RN confirmed she had printed the wrong name. She left the room returned with a label with pt#8's name on it. The label had been affixed over the previous pt's name. The first label was still partially visible beneath the corrected pt. labeled name. He also verified he saw no initials either on the label or the syringe that would indicate anyone had checked the content.


Interview with staff #33 revealed two (2) RN's are required to verify the infant's formula prior to delivery of the formula.


Further MR review indicated on 3/5/2018 pt. #8 received bruising in the shape of fanned fingers on his lower calf.


On 4/24/2018, an interview with staff #33, the unit supervisor, indicated she had spoken with the Registered Nurse (RN), staff #37, who left bruising on pt. #8's leg. The RN in question indicated she was unaware she had bruised the baby.


Review of the "NICU Standards of Care", policy for infant blood draw is found below.

"i. Hospital approved thermal foot warmer will be placed on infant heel per manufacturer guidelines to ensure adequate limb temperature is achieved prior to all heel sticks."

ii. "Utilize the appropriate sized lancet based on the infants' weight and gestational age per manufacturer guidelines."


Review of the hospitals investigation into the bruise on NICU pt. #8 failed to identify a statement from the night nurse explaining how pt. #8 was left with bruising on is calf. Educational documentation provided by the hospital for the nursing department related to safe care of infants and risk of bruising, failed to capture the signature of the offending nurse, indicating attendance. The nursing supervisor could provide no coaching or other document RN #37 was aware of the injury that she had inflicted. There was no teaching of this nurse to insure future bruising of infants would likely not reoccur. The hospital failed to investigate the bruising and failed to monitor for future bruising of NICU infants.
VIOLATION: QAPI Tag No: A0263
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**



Based on document review and interview the facility failed to:

A. Fully implement an action plan that was developed as a result of an unexpected post surgical patient death.

A review of patient #3's medical record revealed:

H&P by MD #9 at 8/1/2017 11:56 AM

"HISTORY OF PRESENT ILLNESS:

This is a delightful [AGE]-year-old gentleman who I saw five years ago and had a moderately elevated calcium score who comes back now with the worsened calcium score over 1000. His calcium score has gone up despite had been on Lipitor 20 mg and LDL in the 90s. He has got no overt angina. He does have some exertional shortness of breath but overall doing very, very well from cardiac standpoint. His main concern is that the calcium score went up and that he is on high-dose Crestor in the past and he has some LFT abnormalities.

Discussed doing catheterization, angiography and percutaneous intervention with the patient in depth. Discussed risks, benefits and alternatives. The patient understands the decision to proceed is entirely theirs. Discussed continuing with medical therapy and not doing this procedure, but patient wishes to proceed with this invasive procedure. The patient understands that the risks include, but are not limited to, death, MI, CVA, emergency surgery, damage to blood vessels, limb loss and amputation, kidney damage and possible need for dialysis, making the condition worse and not better, and bleeding including need for transfusion. The patient understands these risks and still wants to proceed with the procedure."


H&P by MD #9 at 8/2/2017 8:48 AM

"Cardiology History & Physical

Chief Complaint: Angina, abnormal stress
Pt presented for elective heart cath showing severe 3VD, normal LVEF. Plan for urgent CABG.


Op Note signed by MD #11 at 8/9/2017 8:02 AM

Date of Surgery: 08/03/2017

OPERATIVE PROCEDURES:

1. Bypass from the ascending aorta to the obtuse marginal, right artery using reversed autogenous saphenous vein, bypass to the anterior descending artery using the left internal mammary artery without the use of cardiopulmonary bypass.

2. Interrogation of bypass grafts with the Medi-Stim transit time flow measurement device ....

At the end of the procedure, sponge and instrument counts were correct. The patient tolerated the procedure well and was taken to the ICU with stable vital signs."


Significant Event by Staff #12 at 8/4/2017 5:42 AM

"At approx 0335, Pt became Bradycardic. Upon verbal and physical stimulation, PT's HR and BP increased, however, pt was unarousable. Precedex @ 0.6mcg/kg/hr and Levophed @ 1.6mcg/min were stopped. The code button called, with Physician #13 arriving and CRNA intubating. Then a Code Stroke was called, Physician #11 notified, pt was taken to CT with 2 RNs and RT."



Procedures filed by Physician #14 at 8/4/2017 5:07 AM

Initial report created on 8/4/2017 5:12:51 AM CDT

"EXAM: CT Angiography Head with Intravenous Contrast

IMPRESSION:
Pneumocephalus, which appears to be distal arterial in location.
Hypoperfusion is observed in the areas of pneumocephalus.
Background: Pneumocephalus (PNC) is the presence of air in the intracranial cavity."


Procedures filed by Physician #14 at 8/4/2017 5:22 AM / Draft: Not Electronically Signed


Addendum created by Physician #14 on 8/4/2017 5:22:14 AM

"Physician #11 was informed of suspected cerebral air embolism at 8/4/2017 5:21 AM CDT.

FINDINGS:

Serpiginous foci of air are seen in the cerebrum bilaterally outlining the sulci. These areas demonstrate hypoenhancement relative to the other portions of brain and primarily affect bilateral frontal, parietal and occipital lobes. No mass is visualized. No hemorrhage.

Bilateral carotid siphons, proximal MCAs, ACAs, PCAs, basilar artery and vertebral arteries are patent.


IMPRESSION:

Pneumocephalus, which appears to be distal arterial in location.

Hypoperfusion is observed in the areas of pneumocephalus."



NEUROLOGY CONSULT

Consults by Physician #15 at 8/4/2017 10:23 AM

"Chief Complaint: code stroke

Patient #3 is an 47 y.o. male referred for the above chief complaint. Patient is unable to provide the history and is accompanied by his family who assists. Additionally, history is supplemented by review of the medical record and per discussion with other treating providers. He has a history of CAD, DLD, OSA and anxiety and is POD#1 s/p CABG. He awoke from this surgery doing well and was neurologically intact. Overnight he acutely decompensated and there was concern for stroke. Vitals were stable without evidence of hypotension. He underwent a head CT with concern for possible pneumocephalus (although there is discrepancy regarding this read). CTA was unrevealing for large vessel infarct. He was not a tpa candidate given recent surgery. Neurology was consulted this morning to assist in management and evaluation of stroke.

Assessment:

-Ischemic CVA: MRI brain with watershed appearing infarcts. Imaging reviewed extensively with two separate radiologists. There is not a consensus regarding etiology of this event. Patient woke from surgery intact and this is not temporally related to surgery. ddx includes cholesterol emboli vs air emboli vs hypotension (no evidence of such). Air emboli in the venous system would be unlikely to cause strokes in the pattern noted on MRI. Air emboli in the arterial system would need to cross through a PFO which was not evident on TEE just performed."


Consults signed by Physician #16 at 8/5/2017 11:04 AM

"REASON FOR CONSULTATION:

Increased urine output, hypernatremia in a patient with history of stroke and coronary artery disease. HISTORY OF PRESENT ILLNESS:

Patient #3 is a [AGE]-year-old male who is status post bypass surgery and s/p CVA. He presented to Mother Frances for a catheterization, which revealed 3-vessel disease. He underwent a bypass surgery 2 days ago. Postop, he was extubated. Post extubation he was neurologically intact and then he had a rapid response and was noted to have a stroke, watershed infarct and he is currently intubated on a propofol drip. Early this morning at around 04:00 a.m., he started having increased urine output in the 900 to 1500 mL per hour and Endocrinology was consulted for increased urine output to rule out diabetes insipidus. He is currently sedated, intubated and unable to provide any history. His labs done at 04:00 in the morning showed a sodium of 151. He had normal sodium yesterday. He started having high sodium at 03:00 in the morning at 148. His osmolality serum was 318 at 04:00 a.m. Urine osmolality was found to be at 55. Urine specific gravity was 1.0 and prior labs done on 08/02/2017 showed normal sodium, normal specific gravity and normal serum osmolality. His last creatinine level was at 0.95 with a BUN of 12. He has known history of obstructive sleep apnea, [DIAGNOSES REDACTED] and history of early coronary artery disease in his family. He also has a history of anxiety disorder. He as hyperglycemia and is on insulin drip post-surgery. He is tachycardiac.

ASSESSMENT AND PLAN:

1. Diabetes insipidus. He has central diabetes insipidus most likely secondary to his stroke. He is critically ill. His high sodium, high urine output, low urine osmolality and low urine specific gravity is consistent with central DI. I have given him 1 mcg of DDAVP. His urine output has decreased since receiving the DDAVP. I will monitor his urine output hourly. Will monitor sodium, serum osmolality, urine osmolality and his creatinine very closely. He has put out in the last 3 hours over 4 liters prior to receiving DDAVP. Will give him NS 500 mL bolus, albumin 500 mL bolus and run the normal saline at 100 mL an hour and the increase the D5 NS to 100 cc per hr after his boluses and we will titrate the fluids based on his sodium, serum osmolality and urine output. We will make further adjustments based on his electrolytes and urine output. Discussed with his family, the critical nature of illness and the importance of monitoring his electrolytes and keeping them under control. Discussed the natural course, triphasic response with his family.

2. Hyperglycemia. He is currently managed on an insulin drip for his postsurgical hyperglycemia. We will check an A1c.

3. [DIAGNOSES REDACTED]. He is on a statin. We will monitor his lipids.

4. Coronary artery disease s/p ACB

5. CVA managed by Neuro and ICU team"


Discharge Summaries by Physician #17 at 8/8/2017 12:14 AM

"Death Summary

Cause of Death: Diffuse bilateral watershed cerebral infarcts with edema, herniation and brain death.

HPI: Patient #3 is a 47 y.o. male patient with a H/O HTN, [DIAGNOSES REDACTED] had a CABG on 08/0317. He did well post-surgery and had an uneventful post op care. This am, a code 44 was called because patient was found unresponsive. He remained hemodynamically stable and did not require CPR. He was intubated for airway protection and a code stroke was initiated. Critical care is asked to assist in further management. CT of the head was concerning for pneumocephalus.

Events:

8/3: To OR for OP CABG x3 vessel

8/4: acute mental status changes in the early morning - ETI, CT brain, MRI brain, EEG were obtained. There was significant discussion regarding the exact diagnosis - there was pneumocephalus shown on the initial CT brain but the MRI was more consistent with diffuse watershed infarcts. Neurology was consulted. Discussion was held between Physician #11, #15, #18, #19 and Physician #17.

8/5: Developed DI - Physician #16, Endocrinology, was consulted to assist with management. -given DDAVP. Further deterioration in the patient's neurologic exam. Developed [DIAGNOSES REDACTED]- started on amiodarone

8/6: Levophed started for hypotension. Continuing to adjust fluids per Physician #16. Severe hypernatremia - Sodium reached high of 160 despite adjusting fluids. Physician #15 started brain death evaluation at 2:20 pm. Apnea test performed 18:20-18:40 after pCO2 was in the goal normal range. There were no spontaneous movements nor respirations. PCO2 increased from 40 to 82.5. It was at this time that the patient was declared brain dead. The friends and girlfriend were notified of the findings of the exam. Patient was on the donor registry so donor services spoke with those present and proceeded to assume care of patient #3.

Time of Death: 18:40"
Physician #17 8/11/2017


Record review revealed the patient was pronounced brain dead on 8/6/2017 at 18:40 (6:40pm). Patient was on the donor registry so donor services spoke with those present and proceeded to assume care of patient #3. The decedent was discharged on [DATE] at 6:42am for autopsy.

A review of a document titled "Action Plan Cardiac Patient" revealed "Action Item: Reinforce standing order to remove simple venous sheaths as soon as possible. Due Date 08/11/2017. Person Responsible: staff #20, #21 and physician #11. Other Notes/Updates: Order already in place. Reinforced with August staff meeting. Complete order set review underway. Date Closed 08/18/2017.


A review of a document titled "Variance Reporting/Reportable or Sentinel Event Reporting and Disclosure" revealed:

"The Hospital System should identify and respond to all events occurring in the organization or associated with services that the organization provides. Risk Management will work with associates/physicians/others to investigate the event. An appropriate response may include a thorough and credible root cause analysis, implementation of action items to reduce risk and monitoring of the effectiveness of those improvements."


A review of a document titled "Action Plan: CVICU", presented by staff #7 revealed no action was taken to reinforce standing order to remove simple venous sheaths as soon as possible.


A phone interview on 04/23/2018 with staff #3 revealed the document titled, "Action Plan Cardiac Patient" contained a column titled, Date Closed. The date in the column was 08/18/2017. Staff #3 explained the "Date Closed" was when the Risk Management Department finished developing the document and the Action Item had been assigned. Once the Action Plan leaves the Risk Management Department any follow up would be the responsibility of the person assigned the Action Item.


An email communication dated 4/23/2018 and timed 2:07pm with staff #5 revealed the Director of the unit was hospitalized at the time. The Director remembers the meeting did take place but does not have a hard copy of the minutes. The employee that was to transcribe the minutes is no longer an employee with us and we don't have typed minutes.



B. follow the Peer Review Policy. The Medical Executive Committee (MEC) did not approve outside 3rd party peer review.

A review of an email dated 4/24/2018, timed 5:41pm from staff #2 responding to the surveyors request for Quality Improvement Committee meeting minutes reflecting when and why a 3rd party was retained to review post-op stroke cases revealed:

"The AVP - Associate Vice President of Cardiovascular Services notified Dr. ______ (#8-Chief Medical Officer), Director of Quality (staff #22), Associate Chief Nursing Officer (staff #3), Dr. ______(#23), Dr. _____ (#24), Dr. ______( #11), Dr. _____( #25) on 7/19/17 that our STS (The Society of Thoracic Surgeons) data demonstrated increased stroke incidents and requested options for resources for an external peer review that needed to be conducted timely. The STS data was sent to this group also. Staff #23(Quality Reviewer) began working with the 3rd party reviewer to obtain a contract to allow for 3rd party external peer review. Minutes are not documented for peer review committee meetings."


A review of an e-mail from surveyor dated 04/25/2018 and timed 10:20 am, sent to staff #1, #2, and staff #3 again requesting the following information: "Are there Quality Improvement Committee meeting minutes reflecting when/why a 3rd party was retained to review post-op stroke cases?" Staff #2 responded, "No." Staff #2 continued the response with the same information as the response on 4/24/2018 at 5:41 pm



A review of the document titled "Peer Review Policy" revealed:

1.0 PURPOSE:

1.1 To define the process used to enable the TMFHS Medical Staff to assess the professional and clinical competence of privileged providers while utilizing the resulting data to improve clinical care, practice, and professional competence.

1.2 To clearly define the TMFHS Peer Review process as fair, consistent, timely, defensible, balanced, useful, ongoing and effective.


7.0 EXTERNAL PEER REVIEW

7.1 External Peer Review will take place under the following circumstances ONLY if deemed appropriate by the MEC:


Litigation or when dealing with a potential for legal action,

Ambiguity when dealing with vague or conflicting recommendations from internal reviewers or Medical Staff,

Committees if the conclusions from the review will directly affect the Practitioner's Medical Staff Membership or privileges,

Lack of internal expertise when no one on the Medical Staff has adequate expertise in the specialty under review or a "True Peer" is unavailable to review a case or when an unbiased opinion cannot be rendered by a local peer,

When a potential for Conflict of Interest exists and cannot be resolved by The MEC such as, the only practitioners on the Medical Staff are partners, associates or direct competitors of the practitioner under review.


7.2 Individual practitioners cannot require MFH to obtain an External Peer Review unless it is deemed appropriate by The MEC.

7.3 The MEC may require External Peer Review in any circumstances deemed appropriate.

7.4 The Peer Review Coordinator will make arrangements for External Peer Review at the direction of The MEC.


A review of the document titled "Quality Improvement Plan FY 2017, V. Authority and Accountability" revealed, ... "Authority and accountability for assuring patient receive safe and effective care is delegated by the facility governing boards to the hospital and Medical Executive Committee ...
The Medical Executive Committee (MEC) is responsible for improving the quality, safety, and service provided by the medical staff and has oversight of clinical care improvement initiatives."


There was no documentation provided that the MEC had deemed the appropriateness of an external peer review due to data that demonstrated increased stroke incidents. An interview revealed that the Associate Vice President of Cardiovascular Services convened a group of Cardiovascular staff and physicians for a peer review. There were no meeting minutes, however, a 3rd party external peer review was obtained as a result of this internal peer review.


C. follow the Peer Review Policy and allowed for a conflict of interest by allowing Physician of Attribution to review their own cases. 3 of 4 physicians present at the peer review committee gave care to patients #1, #2, #3 and patient #4. There was no evidence provided by the facility the MEC was made aware of a conflict of interest.

A review of a document dated 11/08/2017 and titled Heart Hospital Peer Review Committee revealed four physicians (physicians #9, #23, #27 and physician #28) were present at the meeting. 3 of 4 physicians gave care to patients #1, #2, #3 and patient #4.

A review of an e-mail from surveyor dated 04/25/2018 and timed 10:20 am, sent to staff #1, #2, and staff #3, requested the following information:
Was there a Peer Review Committee Meeting as it related to the Action Plan developed following an unexpected death and stroke patients identified? Staff #2 responded "Yes. The 4 cases referred to Peer Review that were identified as having strokes." (Patient #1, #2, #3 and patient #4)


A review of the document titled "Peer Review Policy" revealed:

"1.0 PURPOSE:

1.1 To define the process used to enable the TMFHS Medical Staff to assess the professional and clinical competence of privileged providers while utilizing the resulting data to improve clinical care, practice, and professional competence.

1.2 To clearly define the TMFHS Peer Review process as fair, consistent, timely, defensible, balanced, useful, ongoing and effective.


3.0 DEFINITIONS:

Conflict of Interest exists when a member of the Medical Staff cannot render an unbiased opinion due either to involvement in the patient's care or because of a relationship with the practitioner involved as a direct competitor or partner. It is the obligation of the individual to disclose to the Peer Review Committee the potential conflict. It is the responsibility of the MEC or designee to determine whether the conflict would prevent the individual from participating and the extent of that participation. Individuals determined to have a conflict may not be present during Peer Review discussions or decisions other than to provide information if requested.

Physician of Attribution is the Physician or provider responsible for the clinical decision, act of omission or commission, and/or care provided."



D. to follow the Peer Review Policy and maintain records of the Peer Review Committee.

A review of the document titled "Peer Review Policy" revealed:

"4.0 POLICY

4.5 Peer Review conclusions are entered and stored in the appropriate database. Access to the Peer Review module is limited by password. Provider-specific Peer Review information may consist of information related to Quality and Utilization review data, Risk Management Incidents or Near Misses, Sentinel Events, and any correspondence to the Practitioner regarding commendations, comments regarding practice performance, or corrective action.

4.6 Peer Review information is available only to authorized individuals based upon their responsibilities as Medical Staff Leaders, committee members, or Hospital employees. However, they shall have access to the information only to the extent necessary to carry out their assigned responsibilities. Only the following individuals shall have access to provider-specific Peer Review information and only for purposes of quality improvement:

Individuals who survey for accrediting bodies with appropriate jurisdiction (e.g., the JCAHO or state/federal regulatory bodies)."

A review of an e-mail from surveyor dated 04/25/2018 and timed 10:20 am, sent to staff #1, #2, and staff #3 requesting Peer Review Committee Meeting Minutes as it related to the Action Plan and stroke patients identified. Staff #2 responded by email as follows, "Minutes are not documented for peer review committee meetings".


E. provide evidence that relevant patient care data was being maintain and discussed by the Hospital Quality and Safety Committee and/or the Hospital's Performance Improvement Committee. The facility failed to demonstrate there is an ongoing, effective Hospital Quality and Safety Committee and/or the Hospital's Performance Improvement Committee. The facility did not maintain Hospital Quality and Safety Committee and/or the Hospital's Performance Improvement Committee Meeting agenda, attendance documentation and/or minutes. Data being collected from The Society of Thoracic Surgeons (STS) and submitted to the National Adult Cardiac Surgery Database was being identified by the Quality Improvement Committee. The outcomes of this Committee was disseminated to staff #7 and not documented.

Refer to tag 0273





F. Based on document review the facility failed to assess, and analyze 2 of 2 adverse patient events (Pt #8 and #9) and failed to implement preventative actions for the staff involved to reduce future events.

Refer to tag 0286
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on document review and interview, the facility failed to provide evidence that relevant patient care data was being maintain and discussed by the Hospital Quality and Safety Committee and/or the Hospital's Performance Improvement Committee. The facility failed to demonstrate there was an ongoing, effective Hospital Quality and Safety Committee and/or the Hospital's Performance Improvement Committee. The facility did not maintain Hospital Quality and Safety Committee and/or the Hospital's Performance Improvement Committee Meeting agenda, attendance documentation and/or minutes. Data being collected from The Society of Thoracic Surgeons (STS) and submitted to the National Adult Cardiac Surgery Database was being identified by the Quality Improvement Committee. The outcomes of this Committee was disseminated to staff #7 and not documented.


Multiple attempts were made to review the meeting minutes for the Hospital Quality and Safety Committee and/or the Hospital's Performance Improvement Committee related to data being collected from The Society of Thoracic Surgeons (STS) and submitted to the National Adult Cardiac Surgery Database that showed an increase in strokes. The evidence revealed the Hospital Quality and Safety Committee and/or the Hospital's Performance Improvement Committee did not record meeting minutes for the requested time frame and event.

A review of an e-mail sent by surveyor to staff #1, #2, and #3, dated 04/24/2018 and timed 1:23 pm revealed:

"The requested information is in regards to the Conditions of Participation (COPs). Again, the COPs being review for compliance are:

Patient Rights
Quality of Care/Treatment
Nursing Services
Physician Services

To re-emphasize, this request is in no way intended to extract sensitive information that would jeopardize Tyler PD's investigation. The requested information should be readily available for inspection upon request by the State Surveyor.


It is the expectation the following documents requested will be gathered in a timely manner and returned by the end of the day.

1. Quality Improvement Committee meeting minutes reflecting when/why the CVOR Workgroup was formed.

2. Quality Improvement Committee meeting minutes reflecting when/why a 3rd party was retained to review post-op stroke cases.

3. Documents reflecting what action was taken to address the areas of concerns identified by 3rd party external reviewer.

4. Peer Review Committee Meeting Minutes as it related to the Action Plan and stroke patients identified.

5. As it relates to the Action Plan, documentation of the Spacelab meeting, the outcome of the meeting and proof the outcomes were implemented.

6. As it relates to the Action Plan, documentation of educating staff to remove simple sheaths ASAP. Staff #5 has explained the August Staff Meeting was not documented and/or didn't happen.


Please submit at this time any supporting documentation that the action item information was distributed to the intended staff and/or there was follow through with the plan."


A review of an e-mail from Staff # 2 dated 04/24/2018 and timed 5:41pm revealed:

"Here is the information that you requested earlier today. We aim to be transparent with you in order for you to complete this investigation, and we are happy to schedule a call with you tomorrow, or at your earliest convenience, if we need to provide additional clarification.

Thank you for working with us on this investigation.

1. Quality Improvement Committee meeting minutes reflecting when/why the CVOR Workgroup was formed.

On 10/2/17, a special called Medical Staff Peer Review meeting was held to review a global list of stroke cases and STS data. The list of patients that were reviewed were those identified by the Quality Improvement Committee from data from the STS database. A quality reviewer from the Quality department obtained this data for the purpose of this Medical Peer Review.

The members of this meeting included: Dr. _____(#8-Chief Medical Officer), Dr.______(#23), Dr. _______(#24), Dr. ______(#11), Dr. ______ (#30), CNO (#2), ACNO (#3), AVP-Associate Vice President of Cardiovascular Services(#7), RN, Peer Review Coordinator (#29).
This meeting began the initial discussion of a review process that led to the creation of the CVOR Workgroup.

Minutes are not documented for peer review committee meetings.


2 .Quality Improvement Committee meeting minutes reflecting when/why a 3rd party was retained to review post-op stroke cases.

"The AVP - Associate Vice President of Cardiovascular Services notified Dr. ______ (#8-Chief Medical Officer), Director of Quality (staff #22), Associate Chief Nursing Officer (staff #3), Dr. ______(#23), Dr. _____ (#24), Dr. ______( #11), Dr. _____( #25) on 7/19/17 that our STS (The Society of Thoracic Surgeons) data demonstrated increased stroke incidents and requested options for resources for an external peer review that needed to be conducted timely. The STS data was sent to this group also. Staff #23(Quality Reviewer) began working with the 3rd party reviewer to obtain a contract to allow for 3rd party external peer review. Minutes are not documented for peer review committee meetings.


3. Documents reflecting what action was taken to address the areas of concerns identified by 3rd party external review..

The external review report was discussed individually with physicians: Dr. _______ ( #8, Chief Medical Officer, Dr. _______(#23), Dr. ______ (#24).
The CVOR Workgroup met on 12/4/17 and the team discussed the external review report, under the "STS 2017 Harvest 3" topic on the agenda. These minutes have not yet been transcribed. Agenda previously provided to you. This discussion included the following items from the report:
Perfusion pressure - formula for MAP based upon patient's age recommended, Physician #23 discussed and implemented this practice with the perfusion team

CEA - surgeons already doing this and cerebral oximetry being used
Aortic calcification - surgeons aware and will use as appropriate
Preoperative risk assessment - STS risk score being done, issues addressed as needed


4. Peer Review Committee Meeting Minutes as it related to the Action Plan and stroke patients identified.
Minutes are not documented for peer review committee meetings.


5. As it relates to the Action Plan, documentation of educating staff to remove simple sheaths ASAP.

__________(#5-Risk Manager) has explained the August Staff Meeting was not documented and/or didn't happen. The staff meeting was held in August by the CVICU charge nurses because the clinical director was hospitalized .
The education content covered: Post-op orders indicate the removal of simple sheaths by specified timelines. Adherence to order sets was reinforced in this staff meeting. Minutes are not available as the director was hospitalized .


Due to the response from the CNO (#2) on 4/24/2018 that minutes are not documented for peer reivew committee meetings, this surveyor sent an email on 4/25/2018 at 12:19 pm requesting again if there were Quality Improvement Committee meeting minutes for the numbered documents listed above. The response from the facility was there were no Quality Improvement Committee meeting minutes but had surveyor refer back to the above explanations of what occurred.
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on document review and interview, the facility failed to assess, and analyze 1 of 2 adverse patient events and failed to implement preventative actions for the staff involved in the events related to pt. #8 .


This deficient practice had the likelihood to effect all patients of the Hospital.


Findings included:

On the morning of 4/24/2018 in the conference room, with the assistance of hospital Internet Technical (IT) staff the medical record (MR) for patient #8 was reviewed. Both twins, patient (Pt/pt.) #8 was admitted to the Neonatal Intensive Care Unit (NICU) on 11/30/2017 at 26 weeks' gestational age. (Normal gestational age is 38-42 weeks).


MR review indicated on 3/5/2018 pt. #8 received bruising in the shape of fanned fingers on his lower calf. MR did not include documentation the parents of pt. #8 had been notified regarding the bruising of their infant son.


Telephone interview with pt. #8's mother and father, on 4/26/2018 indicated she was not notified of the bruising to her son, but found it herself when she went to the hospital NICU to visit him. She questioned the day shift nurse. The day shift nurse had told her the bruising had been done by the night shift nurse (staff #37) who was collecting blood for a laboratory test from pt. #8's heel. The mother further indicated the unit supervisor came and took pictures and was told the pictures were for "educational purposes".

The mother of pt. #8 also revealed the physician had been notified, after she had identified the bruising or her sons leg. The physician also came to talk with her about it.

On 4/24/2018, an interview with staff #33, the unit supervisor indicated she had spoken with the Registered Nurse (RN), staff #37, who left bruising on pt. #8's leg. The RN in question indicated she was unaware she had bruised the baby.


Review of the "NICU Standards of Care" related to heel-sticks revealed:

"i. Hospital approved thermal foot warmer will be placed infant heel per manufacturer guidelines to ensure adequate limb temperature is achieved prior to all heel sticks.

ii. Utilize the appropriate sized lancet based on the infants' weight and gestational age per manufacturer guidelines."

Review of the hospitals investigation process revealed there was no statement of the event collected from the night nurse. There was no documentation that foot warmers were utilized to ensure adequate limb temperature prior to the heel stick. Educational documentation provided by the hospital for the nursing department, related to safe care of infants and risk of bruising, failed to capture the signature of the offending nurse, staff #37, which would indicate attendance in the training. The nursing supervisor could provide no coaching or other document with the staff nurse #37 that insured this nurse was aware of the injury that she had inflicted. There was no teaching of this nurse to insure future bruising of infants would not reoccur. There was no documented investigation or monitoring that had been implemented to insure bruising did not occur with other NICU babies.

On the morning of 4/24/2018 a discussion was held with staff #2, #3, and #5 about the above patient and the incident that occurred while in the NICU. All three indicated no previous events such as the above identified event had occurred, therefore there was no indication the event would require quality oversight. Each staff agreed bruising would be considered an adverse event and that harm occurred.

On 4/24/2018 in the morning an interview with the Medical Director of the NICU, staff #32, voiced her concern over bruising left by a nurse on a premature baby who was a NICU patient.