HospitalInspections.org

Based on a review of facility documents, medical record review (MR), and interview with staff (EMP) it was determined that Chan Soon-Shiong Medical Center at Windber failed to provide care in a safe setting by failing to follow their adopted policy related to IV sedation in conjunction with a nerve block (regional anesthesia) and by failing to maintain an electronic health record that permits accurate reflection of patient care in one of one patient (MR1).


Findings Include:


Windber Hospital, Inc. Administrative Policies and Procedures Policy Number 1.53 ... Subject: Patient Bill of Rights policy and procedure dated March 2017. "Purpose: To ensure that all patients understand their rights and responsibilities while a patient and how they will be treated professionally and personally in rendering care. ... Principle I A patient, as a human being, is entitled to be treated with dignity, respect, and consideration; and with recognition of his/her integrity as an individual. a. The organization's policies and procedures are formulated to afford the patient consideration and respect by the staff during the phase of the patients' care. b. The organization has procedures to ensure that patients' requests are received and properly considered as quickly as circumstances permit. ... f. The patient has the right to medical and nursing services without discrimination based upon race, color, national origin, religion, sex, gender identity, sexual orientation, disability, or means of payment. ... Principle II A patient is entitled to participate in making decisions affecting his/her healthcare, and well-being, to the extent that he/she is capable. ... d. The patient has the right to expect emergency procedures to be implemented without unnecessary delay. ... ."



Windber Medical Center Anesthesia Policies and Procedures Policy Number: 1.15 ... Subject: Conscious Sedation, dated August 14, 2017. "Purpose: To provide for a safe and consistent process in the delivery of care to patients receiving Conscious Sedation (Moderate Sedation) in conjunction with invasive and non-invasive procedures at Windber Medical Center. Policy: This policy has been developed to define various levels of sedation and anesthesia, and to specify who is qualified to supervise and/or provide each of these sedation/anesthesia levels. The remainder of this policy is to direct the care of the patient receiving Conscious Sedation which carries with its administration the risk of the patient entering a deeper sedation/anesthesia state and thus the risk of loss of protective reflexes and the loss of a patent airway. Responsibility: The Department Anesthesiology is responsible for development of practice standards related to Conscious Sedation. Standards are accomplished through collaborative initiatives with the departments providing the service. ... Definitions: For the purpose of clarification, the terms Minimal sedation (anxiolysis), Moderate sedation (Conscious Sedation), Deep Sedation, and General Anesthesia are defined as follows: ... 2) Moderate Sedation (Conscious Sedation) ... e) Cardiovascular function is usually maintained ... g) Requires physiologic monitoring as outlined in this policy ... Where Conscious Sedation can be performed: 5) Other Departments, approved by Anesthesia Department or Clinical Coordinator; only when Anesthesiologist is available is present to administer &/or supervise the administration Personnel Requirements: When the Department of Anesthesiology is not involved, a registered nurse must be present to administer conscious sedation during invasive and non-invasive procedures. During those times the following applies: ... 5) The RN must be present to monitor the patient throughout procedures performed with Conscious Sedation; the patient is not to be left unattended. The RN may assist for emergency needs. 6) Other Departments (approved by Anesthesia Department or Clinical Coordinator) must have an RN with ACLS or telemetry training monitor the patient; Medication to be administered by Anesthesiologist and remain present throughout the procedure. All Departments performing Conscious Sedation must have the following immediately available: ... 7. Monitor-Heart rate, EKG, Pulse Oximeter, Blood Pressure, and/or respiratory monitors; ETCO2 Temperature ... However, even small dosages of sedative drugs in the elderly and/or patients with severe systemic disease may create respiratory and/or cardiac depression. ... Combining medications for sedation such as opioid analgesics and benzodiazepines will generally provide for better sedation than is produced by the use of single agents only. However, combinations of sedative and analgesic medications have a synergistic effect and may rapidly produce deeper levels of sedation/anesthesia with the attendant risks of airway, respiratory, and cardiovascular problems. Care and vigilance are essential anytime those medications are administered for sedation; however, extreme care and vigilance are necessary when sedation is performed utilizing combinations of drugs (especially, opioid analgesics plus benzodiazepines). Conscious Sedation Pre-Procedure: A medical history must be recorded. This includes, but is not limited to documentation of: ... 10) Physical examination includes: a) Vital signs including height and weight ... Intra-Procedure: ... 4) Prior to administration of sedation, the following should occur: ... c) Initial set of vital signs are taken and recorded ... 7) The patient's vital signs will be monitored continuously throughout the procedure and recorded every 5 minutes or more frequently if necessary. Documentation will include vital signs, ETCO2, the patient's response to sedation, and the drugs given and their dosages. (see Appendix A & B) 8) Report any change in condition of patient to the physician STAT: a) 30% or greater change in systolic blood pressure b) Tachycardia or bradycardia c) Marked change in respiratory rate and/or pattern d) SpO2 <90% e) Marked change in patient responsiveness f) Signs and symptoms of allergy ... Post-Procedure: 1) During the initial recovery phase the patient will be monitored continuously until: a) Awake (or return to baseline mental status) b) Protective reflexes are intact c) Vital signs are stable d) SpO2> 90% (or return to baseline SpO2) on room air or supplemental oxygen. ... ." Attachment documentation entitled, "University of Virginia Health System Adult and Geriatric Sedation/Analgesia for Diagnostic and Therapeutic Procedures" revealed a list of medications that included but not limited to: Versed (midazolam) and Fentanyl (sublimaze).


Windber Medical Center Operating Room Policies and Procedures. Policy Number: 1:21... Subject: Holding Room Documentation ... Revised: October 2013. "Purpose: The patient's surgical record is a concise account of the patient's operative process. Policy: 1. The Holding Room record is completed in Meditech by a Registered Nurse on all patients prior to having surgery in the Surgery Department. A. Under Holding Room Tab, the nurse will document on the Pre-operative checklist, verifying the information listed as it pertains to each patient. B. The Holding Room Record will be completed and verified with information pertaining to each patient. Responsible: Registered Nurse. ... ."



1. MR1 was noted to contain a Progress Note "Time Out" Verification.
Procedure: Lumbar plexus block is handwritten in. Start Time is handwritten 0955.
Room Number: handwritten in as PACU
(Typed) Time Out Verification of Correct Patient, Procedure, Site, Position, Implants, or Special Equipment @ ________ is left blank.
Nurse: ...
Physician: illegible signature noted below and off to the right.
handwritten below "Physician" 0920. 158/83 - 87-15 95%

MR1 was noted to contain a Progress Note, dated 11/20/17, untimed.
The top half of the paper is a preprinted protocol with areas designated to select left or right and to enter medication amounts.
" ... Anesthesia For Lumbar Plexus Block. 75Y years old.
The box for Male has been checked
for Right [ ] Left [ ] Total Hip Replacement (the Right box has been checked)
Dr is left blank
Requested: Right [ ] Left [ ] (Right has been checked)
Lumbar Plexus Block for post-op pain management.
H & P Reviewed, informed consent obtained, sterile cleaning and draping, nerve stimulator used.
Total: 0.5% Naropin (20 ml has been handwritten in)
0.5% Marcaine/Epi (5 ml has been handwritten in)
Handwritten in - IV sedation by 1 mg Versed & 50 mg Fentanyl.
Pre- printed typed note- Patient tolerated procedure, no complications noticed.
Diagnosis: S/P Right [ ] Left [ ] Right has been checked. Total Hip Replacement

Handwritten at -920. 158/83 87-15 95%
Handwritten - 11/20/17 at 1230. N Block started at 955 AM. Pt at LLP [left lateral position] Sterile procedure 150 mm Block placed. M Twich (sic) obtained by N stimulator at 1 mAmp. 20 ml 0.5% Naropin and 5 ml 0.5% Bupivicaine and epi inj after procedure
pt VSS responsive. @1018 in Holding Area found no response, no pulse. CPR and resuscitation started. pt intubated. Pulse + SaO2 go up to 100%, Transfer to ICU for ICU care. At 1030 AM. (at 1030 AM has been written in above the word "care") Remaining intubated and mechanical ventilation. CBC, cardiac enzymes, Chem 7, CT CXR ordered. pt still not responsive. c/o critical care. Noted to contain the statement "Electronically Signed by EMP8 on 11/21/17 at 1425.



2. A request was made for the facility's policy/procedure or protocol for nerve blocks (regional anesthesia) on April 24, 2018, at approximately 10:00 AM.

Interview with EMP1 on April 24, 2018, at approximately 1:30 PM revealed, "We do not have a policy on blocks."


3. An interview was conducted with EMP1 on May 31, 2018, at 9:15 AM. EMP1 stated that a Nerve Block is itself considered a procedure, and confirmed that MR1 had no evidence of an EKG strip being completed before, during or after the patient's IV sedation to place a nerve block prior to their surgical procedure, and that there is only one set of vital signs which was completed prior to the patient's sedation and block at 9:20 AM. EMP1 stated that the patient's nerve block procedure under sedation was actually conducted in the PACU, however, MR1 revealed documented evidence that the patient's nerve block procedure was conducted in the Holding Room. EMP1 stated that the IV sedation/nerve block procedure electronic documentation can not be modified to reflect that nerve blocks are actually conducted in the PACU, not in the Surgical Suite Holding Area.


Cross Reference:

482.51 (b)(4) Post-Operative Care
482.52 Anesthesia Services
482.21 (c)(1)(iii) Program Activities

Based on a review of facility documents, and interview with staff (EMP) it was determined that Chan Soon-Shiong Medical Center at Windber failed to take timely performance improvement action following an event in which an unattended and unmonitored patient coded on November 20, 2017, in the Surgical Suite Holding Area, post IV sedation with opioids and benzodiazepines, in conjunction with a nerve block prior to elective surgery, in one of one medical record. (MR1)

Findings include:

Windber Medical Center Anesthesia Policies and Procedures Policy Number 1.34 ... Subject: Performance Improvement Plan ... Revised: 07/2014. "Purpose: 1. Ensure the delivery of safe anesthesia to all patients at Windber Medical Center 2. Continually improve the quality of care of patients receiving anesthesia services at Windber Medical Center ... 4. Identify systematic problems with anesthesia care at Windber Medical Care and implement strategies to prevent their further occurrence 5. Continually improve the practice of anesthesia care at Windber Medical Center. Policy: The Department of Anesthesiology Performance Improvement Plan will be under the direction of the Medical Director of Anesthesia Services or his/her designee. The performance improvement effort will include: 1. Ongoing information collection, analysis and reporting of adverse patient outcomes to appropriate departments and committees within the hospital ... 6. Description if occurrence. All information will be reviewed by the Medical Director of Anesthesia services or his/her designee. A monthly report will be submitted to the Medical Center's Performance Principal Partner. A quarterly report will be submitted to the hospital's Surgical Case Review Committee. Sentinel Events will be reported immediately to the Performance Improvement Principal Partner. Problem areas will be analyzed and appropriate corrective actions implemented to ensure positive patient outcomes at Windber Medical Center. Responsible Anesthesia Personnel ... ."


Rules and Regulations of the Medical Staff of Windber Medical Center dated November 28, 2017, revealed, "... Section 10.04 Surgical Care Evaluation Committee ... duties The committee shall be responsible for surveillance of the Operating Room & ASU Statistics including Unplanned Observations & Admissions, Performance Improvement (ASU, OR PACU), Anesthesia Report, including Acute Pain Management, Conscious Sedation Report, and Anesthesia Indicators, Infection Control, Surgical Site Infections, Atlas Quarterly Reports with case Reviews, CORE Measures Report. ... Meetings The Committee shall meet at least quarterly as part of the Medical Care Evaluation/Quality Assurance Committee and submit their report to the Medical Executive Committee. ... ."

Job description for EMP9 revealed, "Schedule 1 Detailed Description of Clinical and Administrative Services ... 4. Chief of Anesthesiology, Physician shall serve as Chief of Anesthesiology and shall perform the following administrative duties: ... Be responsible for the clinical coordination, supervision and operation of the Anesthesiology Department and shall ensure that the Anesthesiology Department is operated in accordance with Hospital rules and policies: ... Be responsible for developing and implementing a quality assurance program consistent with standards of any accreditation entity with which Hospital participates and other licensure and regulatory agency requirements ... Advise the Hospital and its administration and medical staff regarding the appropriateness of the use of the Anesthesiology Department and its facilities and services; ... ."

Chan Soon-Shiong Medical Center at Windber Patient Safety Program & Patient Safety Committee Bylaws ... August 2017, revealed "... Serious Events, Incidents & Infrastructure Failures Policy: It is the policy of Windber Hospital Inc. (Windber) to conduct a full investigation of all events which seriously compromise the quality of patient care as well as patient safety and to report these events, as appropriate to licensing and/or accrediting bodies, and to report serious events, incidents and infrastructure failures as required by the Pennsylvania Medical Care Availability and Reduction Medical Care Availability and Reduction of Error Act of 2002 (also known as 'MCare' or 'Act 13'). ... A Serious Event is defined as an event, occurrence or situation involving the clinical care of a patient that results in death or compromises patient safety and results in an unanticipated injury requiring the delivery of additional health care services to the patient. ... If it is determined that the event rises to the level of a Serious Event the following persons shall be notified: President & CEO, Patient Safety Officer, Clinical Quality Analyst, Risk Manager, and/or other appropriate hospital staff as needed based on the nature of the incident. This group shall also determine who will assign responsibility to coordinate the investigation of the event and if a Root Cause Analysis (RCA) or Failure Modes Effects Analysis (FMEA) is required. If a decision is made to conduct a RCA or FMEA it shall be completed within 45 days of that decision. ... RCA and FMEA Procedure: ... The Patient Safety Officer (or designee) will document the findings and recommendations of the group. ... Upon completion of the investigation the Team will prepare a written report and present its findings to the President & CEO, Director of Nursing, Patient Safety Officer, Risk Manager, and/or other appropriate hospital staff as needed based on the findings of the Team. ... ."


Windber Hospital Inc. Quality Policies and Procedures Policy Number 1.05 ... Subject: Sentinel Event ... Reviewed: December 2016, policy and procedure. "Purpose: It is the policy of Windber Hospital Inc. to conduct a full investigation of all events which seriously compromise the quality of patient care as well as patient safety. Policy: 1. A Sentinel Event is defined as an unexpected occurrence involving the death or serious physical or psychological injury, or the risk therof. Serious injury specifically includes loss of limb or function. The phrase 'or the risk thereof' includes any process variation for which a recurrence would carry a significant chance of serious adverse outcome. At least two of the following criteria should be met in order for the occurrence to be defined as a Sentinel. The event has resulted in an unanticipated death or major permanent loss of function. The event is associated with significant deviation from the usual processes for providing health care services or managing the organization. The event has undermined, or has significant potential for undermining, the public's confidence in Windber, Inc. 2. Determination of Sentinel And/Or Serious Events: The determination of whether an adverse occurrence is to be classified as a Sentinel and/or Serious Event shall be made by the Patine Safety Officer or designee, in collaboration with Risk Management, and Hospital Administration. Other key individuals may be called upon as appropriate to the nature of the occurrence. The Patient Safety Officer or designee will complete the investigation if the event is classified as sentinel and/or serious. It is recognized that when an event results in an unfavorable outcome, consideration of known complications, and/or patient information regarding the risk/complication through informed consent, will be utilized in determining if a Sentinel Event has occurred. 3. Criteria for Sentinel Events: The event has resulted in an unanticipated death or major permanent loss of function, not related to the natural course of the patient's illness or underlying condition. ... 5. Procedure: When a Sentinel Event has been determined to have occurred, a Root Cause Analysis (RCA) shall be completed within 45 days of the occurrence. ... Furthermore, the department directors, committees and/or panels charged with making reports, findings, recommendations or investigations pursuant to this policy shall be considered to be acting on behalf of the hospital and Board of Directors when engaged in such professional review activities and thus shall be deemed to be 'professional review bodies' as that term is defined by the Healthcare Quality Improvement Act of 1986. Responsible Patient Safety Officer or designee, in collaboration with Risk Management, and Administration ... ."

1. Surgical Care Evaluation Committee meeting minutes dated August 10, 2017, November 9, 2017, and February 15, 2018, and May 10, 2018, were reviewed.
It was noted in the February 15, 2018, or May 10, 2018, meeting minutes that there was no documented evidence of discussion or review of MR1 in which an unattended and unmonitored patient coded on November 20, 2017, in the Surgical Suite Holding Area, post IV sedation with opioids and benzodiazepines, in conjunction with a nerve block prior to elective surgery.


A telephone interview conducted with EMP9 on May 8, 2018, at approximately 10:30 AM revealed that EMP9 is a member of the Surgical Committee and that this event won't be discussed until the next Surgical Committee meeting. The next meeting is scheduled for August 8, 2018.

2. An interview with EMP1 on April 24, 2018, at approximately 1:30 PM revealed, "We do not have a policy on blocks, but we are drafting one, and EMP9 reviewed the case."
A request was made to review documented evidence of EMP9 case review. EMP1 provided a one page typed document that revealed a discussion of the event. EMP1 revealed, "We would classify this as a serious event. ... Serious event would depend upon the outcome, depend on the cause. All serious events have an investigation but do they all have a root cause or a structured FMEA."

EMP1 provided an undated one page, type written document entitled, "Root Cause Review" that discussed the event of MR1, the attendees to the review and that a recommendation was made to monitor all of the patients in the Holding area, effective immediately.

Cross Reference:
Anesthesia Services 482.52

Based on a review of facility documents, observation and interview it was determined that Chan Soon-Shiong Medical Center at Windber failed to ensure that an ICU/CCU patient was not left unattended for one of one patients.

Findings include:

Windber Hospital, Inc. CCU Policies and Procedures ... Policy Number: 5 Subject: Governing Policies ... Revised: March 2017 policy and procedure. "Purpose: The Critical Care Unit is a specialized unit, staffed and occupied to care for patients with a medical, post-surgical or traumatic condition, which is presently or potentially, life-threatening in nature. Objectives: 1. To provide continuous and comprehensive observation and detailed care during the acute phase of selective illness. ... ."


1. During the tour of PACU (Post Anesthesia Care Unit) on April 24, 2018, at approximately 9:15 AM, EMP4 was observed to open a door and enter the Nurses Station in PACU from a corridor that connects the PACU to the ICU/CCU. (Intensive Care/Cardiac Care Unit)

During a subsequent tour of ICU/CCU and review of assignment sheet, it was noted that there was a census of one patient and one RN assigned. EMP4 was assigned to care for the patient in the ICU/CCU.

EMP4 confirmed that their patient was left unattended in the ICU/CCU and could not have been visualized from the adjoining corridor.



Cross Reference:
482.13(c) (2) Patient Rights, Care in a safe setting

Based on a review of facility documents, medical record (MR), and interview with facility staff (EMP) it was determined that Chan Soon-Shiong Medical Center at Windber failed to maintain an electronic medical record system that permits accurate information to be documented, and failed to ensure that handwritten entries were clearly written in such a way that they are not likely to be misread or misinterpreted, in one of one medical record (MR1).

Findings Include:

Rules and Regulations of the Medical Staff of Windber Medical Center dated November 28, 2017, revealed, "... Article B. Section I: General Patient Care ... 18. An invasive procedure shall be any surgical, endoscopic, or manipulative procedure which requires anesthesia or sedation. ... 21. All references to written documentation and authentication made in these Rules & Regulations shall also refer to electronic documentation and authentication. ... Article F. Section 5: Medical Records 1. The attending physician shall be held responsible for the preparation of a complete medical record for each patient. This record shall include identification data, chief complaint, personal history, family history, history of medical illness, physical examination, special reports such as consultations, clinical laboratory, x-ray, provisional diagnosis, medical or surgical treatment, pathological findings, progress notes, final diagnosis, condition on discharge, follow-up and autopsy report when available. No medical record shall be filed until it is complete, except on the order of the Medical Records Committee. ... 3. Procedures which meet criteria as a surgical or post-operative event should be reviewed by the Surgical Services Committee. ... Article K. Section 10 Medical Staff Committees ... Section 10.04 Surgical Care Evaluation Committee ... duties The committee shall be responsible for surveillance of the Operating Room & ASU Statistics including Unplanned Observations & Admissions, Performance Improvement (ASU, OR PACU), Anesthesia Report, including Acute Pain Management, Conscious Sedation Report, and Anesthesia Indicators, Infection Control, Surgical Site Infections, Atlas Quarterly Reports with case Reviews, CORE Measures Report. ... Meetings The Committee shall meet at least quarterly as part of the Medical Care Evaluation/Quality Assurance Committee and submit their report to the Medical Executive Committee. ... ."


Chan Soon-Shiong Medical Center at Windber Health Information Management Department Policies and Procedures Policy Number: 12.06 Subject: Content of Medical Record, dated June 2016. "... Policy: 1. Medical record documentation shall be maintained for any patient who receives assessment/treatment in any department of Windber Hospital, Inc. 2. The medical record shall be created in the normal course of patient care from initial assessment through conclusion of treatment. It shall be created in the sequence of the events as they occurred for each episode of care. 3. Documentation in the record shall be made by authorized staff and shall be sufficiently comprehensive to support the diagnosis, to justify the course of treatment and to accurately document the results and/or outcomes. ... 4. These entries shall be characterized by generally accepted documentation guidelines, including the following: ... Legible handwriting in ink or typewritten ... Dated and timed authentication (handwritten or by electronic signature approval with the author's credentials noted. Documentation made as close to the time of the actual event as feasible. Late entries appropriately indicated. Error corrections appropriately documented without obliteration of the original entry ... Medial Record Contents: ... Patient assessments, observations, reassessments, ... Patient response to treatments and medications. ... Progress Notes (physician, nursing, ancillary) ... Anesthesia documentation. Operative and other invasive or non-invasive procedure reports ... ."


Windber Medical Center Operating Room Policies and Procedures ... Subject: Standards of Administration Nursing Practice in the Surgery Department ... Revised: 7/2014. "... III. Standard III-Records and reports essential to providing safe care to surgical patients will be kept in the Operating Room and utilized. A. Records are kept of operations performed with pertinent information such as the following: 1. Members of the operating room team. 2. Pre and post-operative diagnosis. 3. Operative procedures. 4. Length of time. 5. Breaks in technique. ... B. Recorded information is periodically examined in order to assist in planning and organizing the operating room more efficiently. C. Records are used to provide information for reports done annually, yearly and monthly. D. An intra-operative record is kept on all patients with facts relating to direct care of each patient and filled in entirely. Some information includes: ... 9. Any complication or abnormal happening. ... ."


Windber Medical Center Department Policies and Procedures Policy Number: 1.06... Subject: Anesthesia Record, dated August 14, 2017. "Purpose: The objectives for maintaining the Anesthesia Record are to facilitate: 1. Optimal patient care by legible, accurate, informative documentation of the anesthetic management and associated changes in vital signs. Thus: A. Assure frequent assessment of the patient's status. ... Policy ... 2. Entries should be legible, accurate , and entered in a timely fashion. During emergency situations patient care obviously takes precedence. However, vital signs and drug administration should be recorded as soon as the patient's situation has stabilized. 3. Use a single line to cross out errors. Write in the word 'error' next to the line and initial. ... 5. lapses in monitored data (broken equipment, pulse oximeter having difficulty picking up signal, etc.) should be left blank on the graphic portion of the chart. However, there should be an entry explaining the reason for the missing data on the chart. 6. Fill out the chart as completely as possible. ... 24. The comments section (bottom) can be used for: A. Noting time of OR entry B. drug entries such as antibiotics, heparin, emergency drugs, etc. These can also be entered in the drug section at the top of the graphic. C. Reversal drugs E. Comments on problems during the case E. Comments on procedures F. Comments on positioning G. Additional information about intubation H. Induction information I. Extubation information J. Time of OR exit K. General note about patient at end of procedure L. Local anesthesia administered. ... ."


1 Review of medical record (MR1) dated November 20, 2017, revealed that the patient arrived in the Surgical Suite on 11/20/17 via Litter at 0915 ...
Into Holding at 0920. Out of Holding: [ left blank] ...
0940 Intravenous access by EMP7 x1 attempt
0955 .. Nerve Block ...
Holding Room Notes: 11/20/17 0927 by EMP2
0920-158/83-78-15 95% ... 0955 Nerve Block Done by EMP8 ...
1348 Pt taken to Holding area from PACU after nerve block done. Is drowsy. Answers appropriately. Monitor stable, positioned self for comfort ...
1444 Transfer to Holding Area from PACU at 1010 ... ."

Pre & Post Anesthesia Evaluation dated 11/20/17, lists Proposed Surgery as Hip ORIF,
No prior surgery or anesthesia complications, ...
Lungs - illegible, ... Gastrointestinal system has no check marks noted,
Miscellaneous has no check marks noted ... Current Medication is illegible ...
Pertinent Laboratory and Diagnostic Studies is illegible
Comments: lists wt 272 H 5.11
ASA Status #3 is circled
Planned Anesthesia has a check mark in front of General Anesthesia and in front of Spinal and has a check in front of "N Block", which is handwritten in
A check mark in noted in front of Risks/Benefits Explained and Accepted, with illegible signature noted.
Patient Examined immediately Pre-op, has an illegible signature with a time of 900
Patient Re-examined & chart reviewed in OR, has an illegible signature with a time of 93
Post Anesthesia Note has a date of 11/20/17 with an illegible signature and time of 1030 with "transfer ICU" handwritten in above the time, obstructing the 2nd digit making it difficult to decipher as a zero or some other number.


MR1 Anesthesia Record dated November 20, 2017, It is noted that the Anesthesia Record does not contain a signature and the handwritten entries were documented in such a way that they are likely to be misread or misinterpreted. It was noted to contain many areas that are left blank or have a line drawn diagonally through the areas, such as Pre and Post-Op Diagnoses, Procedure, Anesthesiologist, Surgeon, Monitors, Type of Anesthesia, Data, Positions, Total Fluids.
There are areas with handwriting on:
CRNA: ...
Induction: Blade No. #3 illegible, #4 MAC.
Attempts: x2 x illegible
Tube: 750@2 cm.
Cuff Air, Sylet, Direct Vision and Atraumatic, all have check marks in their designated boxes.
The area designated for medications and vital signs is noted to be blank and have the words "See Note" handwritten in.
Bottom Right of the Anesthesia Record is an area entitled "Comments" The handwriting is difficult to read because words have been written above other words, there are words scribbled out, words underlined and words in the bottom margin below the designated area and words in the right hand margin that go up the side of the page.
"Pt evaluated by CRNA prior to block in PACU [PACU is noted to be written vertically in the right margin].
1018-Then met pt in holding area. [holding area is underlined] for surgery. ["for surgery" is written under the word "area"]. Tried to ... [word is scribbled out] ... arouse [is written in under the scribbled out word] and determined that pt unresponsive. RN in attendance also. Dr. ... present in passing [the word "passing" is written underneath "present in" and is underlined]. Began to Bag [Began CPR is squeezed in under the words "to bag"] Ventilate pt. No pulse present. Obtained crash cart and ETT by Dr. ... x1 with scope.
Continued Bag ventilation.[this is written in the lower right margin under the word "scope"]
Bottom margin is documented as - "ETT placed. See above note. Epi given x 2. See times on Code sheet. Tachy rythem (sic) returned. Transferred to ICU. Afib on monitor on arrival & [illegible]."

Progress Note "Time Out" Verification
Procedure: Lumbar plexus block is handwritten in. Start Time is handwritten 0955.
Room Number: handwritten in as PACU
(Typed) Time Out Verification of Correct Patient, Procedure, Site, Position, Implants, or Special Equipment @ ________ is left blank.
Nurse: ...
Physician: illegible signature noted below and off to the right.
handwritten below "Physician" 0920. 158/83 - 87-15 95%

Progress Notes 11/20/17, untimed. The top half of the paper is a preprinted protocol with areas designated to select left or right and to enter medication amounts.
" ... Anesthesia For Lumbar Plexus Block. 75Y years old.
The box for Male has been checked
for Right [ ] Left [ ] Total Hip Replacement (the Right box has been checked)
Dr is left blank
Requested: Right [ ] Left [ ] (Right has been checked)
Lumbar Plexus Block for post-op pain management.
H & P Reviewed, informed consent obtained, sterile cleaning and draping, nerve stimulator used.
Total: 0.5% Naropin (20 ml has been handwritten in)
0.5% Marcaine/Epi (5 ml has been handwritten in)
Handwritten in - IV sedation by 1 mg Versed & 50 mg fentanyl.
Pre-printed statement - "Patient tolerated procedure, no complications noticed."
Diagnosis: S/P Right [ ] Left [ ] Right has been checked. Total Hip Replacement

Handwritten at -920. 158/83 87-15 95%
Handwritten - 11/20/17 at 1230. N Block started at 955 AM. Pt at LLP [left lateral position] Sterile procedure 150 mm Block placed. M Twich (sic) obtained by N stimulator at 1 mAmp. 20 ml 0.5% Naropin and 5 ml 0.5% Bupivicaine and epi inj after procedure
pt VSS responsive. @1018 in Holding Area found no response, no pulse. CPR and resuscitation started. pt intubated. Pulse + SaO2 go up to 100%, Transfer to ICU for ICU care. at 1030 AM. (at 1030 AM has been written in above the word "care") Remaining intubated and mechanical ventilation. CBC, cardiac enzymes, Chem 7, CT CXR ordered. pt still not responsive. c/o critical care. Noted to contain the statement "Electronically Signed by EMP8 on 11/21/17 at 1425.

Second page of Progress Notes dated 11/20/17 at 1725.
Anesthesia ICU Care note 1725 pt transferred to CCU after resuscitation @ Holding area. ... spontaneous breath, mental status still is comatose PE: pupil symmetrical small. RR: 24 BP 150/67 HR 82 SaO2 100% discussion with pt's family plan to transfer to UPMC for further evaluation. 1645 pt had 2 mg Versed IV for jerky move. ... ."

An interview was conducted on May 31, 2018, with EMP1. EMP1 confirmed that the documentation in MR1 stated that the patient's IV sedation/nerve block procedure was conducted in the Holding Room, however, all their nerve blocks are actually placed in the PACU. EMP1 explained that their electronic health record system only permits them to document nerve blocks under the tab for the Holding Area, and can not be modified. ... EMP1 also confirmed that the "Comment" section of the Anesthesia Record on MR1 was somewhat illegible.

Based on a review of medical records (MR), facility documentation and interview with facility staff (EMP), it was determined that Chan Soon-Shiong Medical Center At Windber failed to to follow their adopted policies related to patient handoff communication and to patient monitoring (vital signs and cardiac monitoring) following administration of IV sedation to place a nerve block prior to an elective surgical procedure, and by failing to conduct an ongoing assessment in eight of eight medical records (MR1, MR3, MR4, MR5, MR6, MR7, MR8 and MR9), and failed to ensure that a patient was in the care of a clinical member of the surgical team following administration of IV sedation to place a nerve block prior to an elective surgical procedure in one of one medical record (MR1).



Windber Medical Center Department Policies and Procedures Policy Number: 1.08 Subject: P.A.C.U. Nursing Standards policy and procedure, undated. "Purpose: To observe, assess, and care for patients post-operatively, as well as maintain the safety of the patient. Policy:1. The patient will have quality nursing care in the post-operative period with emphasis on observation of the total patient. 2. The patient will be safe from injury. 3. The patient will be protected from immediate post surgical and anesthesia complications. 4. The patient will return to the unit in stable condition and reasonable degree of consciousness after he has been discharged by the Anesthesiologist. 5. Patient's family will be made aware of the patient's postoperative status. Process: 1. Check and maintain airway patency. 2. Asculate [sic] breath sounds. 3. Observe level of consciousness. 4. Administer oxygen at 2-10 liters/minute via facemask or cannula, unless otherwise ordered. ... 7. Obtain blood pressure, pulse respirations, record every 15 minutes; unless otherwise indicated by patient's condition. 8. Attach patient to cardiac monitor and obtain strip; measure PR and QRS intervals. 9. Attach patient to pulse oximeter monitor. ... Outcome: 1. The patient is observed and monitored in the immediate postoperative period with physical and psychological needs met as evidenced by the P.A.C.U. documentation. 2. At all times the safety needs of the patient were met by the presence of side rails on the litter and the monitoring equipment as evidenced by the nurses documentation. 3. At all times the patient was protected from immediate and delayed complications as evidenced by data recorded from frequent observations of the operative site, dressings, vital signs and monitor readings...
Responsible RN, LPN ... ."


Windber Medical Center Department Policies and Procedures Policy Number: 1.03 Subject: EKG Monitoring in the P.A.C.U. policy and procedure, undated. "Purpose: To observe patient's heart pattern safely and accurately via electronic monitor Policy: Purpose: All patients immediately after surgery will be monitored for cardiac stability, (Patients 12 years of age and over). ... Procedure: ... 6. Documentation of patient's rhythm will be noted on PACU record. Any change in rhythm will be documented on PACU Sheet and intervention noted. 7. Refer to datascope manual for instructions on how to operate monitor. 8. Print EKG Strip from Monitor. Measure PR and QRS interval. Staple strip on plain sheet of paper and attach to patient's chart with addressograph stamp. Responsible RN, LPN ... ."


Windber Medical Center Operating Room Policies and Procedures ... Subject: Standards of Administration Nursing Practice in the Surgery Department ... Revised: 7/2014. "... the Standards of Administrative Nursing Practice in the Surgery Department provides a basic model of standards by which quality of administration of the operating room may be evaluated. They serve as guidelines for the development of a reliable means of providing good administrative care. Policy: ... II. Standard II-There shall be efficient utilization of the Operating Room Suite and personnel. A. New staffing patterns are based on the type and number of procedures and the Standards of Administration Nursing Practice in the Surgery Department length of operation. B. The staffing ratio of professional to non-professional workers insures direct professional nursing supervision of patient care and application of aseptic technique at all times. C. New staffing patterns are developed in consultation ... E. A plan is instituted when emergency surgery and extended procedures result in schedule delays. The plan includes notification of the appropriate personnel and units. ... H. There is an ongoing evaluation of Operating Room utilization which includes: 1. Type of case. 2. Length of case. 3. Time lapse between cases. 4. Reason for delays. ... ."



Windber Medical Center Operating Room Policies and Procedures Policy Number: 1.46 ... Subject: Responsibilities & Duties of Circulating Nurse in O.R. ... Revised: 07/2014, revealed "... Policy ... 2. Patient Care: A. The circulating nurse greets the patient in the Holding Area and identifies them by their name band and medical record number and or date of birth. The patient is asked what procedure he/she is having done and who their operating surgeon is. The operative permit is reviewed for completeness. She then communicates with the Holding Area nurse who has evaluated the patient according to the Surgical Checklist. The Pre-Operative Record is reviewed to assess the needs of the patient and plan the Intra-operative care. Remain the patient advocate through out the procedure. ... ."


Windber Medical Center Operating Room Policies and Procedures Policy Number 1.43 ... Subject: Quality Assurance Criteria for a Patient Having Surgery ... Revised: 01/2012, revealed "... Policy: Pre-Operatively: 1. All patients are taken to the Holding Area where they are identified verbally and with name band and birth date. The Surgical Consent is confirmed with the patient and schedule. ... 4. The Circulating Nurse for that patient greets the patient and identifies them and their surgical procedure verbally along with the I.D. band and patient's birth date. ... ."


Windber Hospital, Inc. Administrative Policies and Procedures Policy Number: 1.48.2 Subject: Hand Off Communication dated June 2017. "Purpose: The purpose of this policy is to provide an effective form of communication between healthcare providers regarding patient care. Policy: 1. Hand off communication is done primarily through verbal reporting. Taped report may be used under special circumstances. 2. Hand off communication may include, but is not limited to: ... Current patient condition and patient assessment ... Responsible All healthcare providers."


Windber Medical Center Operating Room Policies and Procedures Policy Number: 1.31 Subject: Standards of Nursing Practice in the Surgery Department policy and procedure, undated. "Purpose: These standards relate to the particular nursing practice for individuals who are experiencing surgical interventions in the operating room. ... The scope of this practice encompasses those nursing activities which assist the individual having surgical intervention. The nursing activities are directed toward providing continuity of care through preoperative assessment and preparation, intra-operative interventions and postoperative intervention. ... Policy: 1. Standard I-The collection of data about the health status of the individual is systematic and continuous. The data is recorded, retrievable and communicated to appropriate personnel. ... ."


Findings Include:

1. Policies related to care of a Patient in the Holding Area were requested but none were able to be provided.

Staff assignments for patients in Holding Area were requested but none were able to be provided.


2. An interview was conducted with EMP3 on April 24 at approximately 1:30 PM. EMP3 stated that whoever is the circulator in the room also cares for the patient in the Holding area. EMP3 stated that no one person is "assigned" to the Holding area. "... I don't really have enough staff to watch that patient area. No vital signs would be done in the Holding area unless the patient became lightheaded or dizzy. ... We were finishing up with our case when the patient (MR1) coded in the Holding area. I was in OR#2 with another case."


An interview was conducted with EMP2 during a tour of PACU (Post Anesthesia Care Unit) on April 24, 2018, at approximately 9:15 AM. EMP2 confirmed that their Dynamap does not have the capability to print out a cardiac monitor strip to place on the medical record.


An interview was conducted with EMP2 on April 24, 2018, at 9:30 AM and June 11, 2018, at approximately 11:00 AM. "If the patient does not have sedation on board, they are not monitored. .. patient (MR1) was monitored while we did the nerve block in PACU, then I disconnected them from the monitor and moved the patient to the Holding area. I did not connect the patient to a monitor in the Holding area. ... I knew that EMP8 gave the patient some IV sedation, I do not know what they gave. ... Once I move a patient to the Holding area, I would be relieved of their care. ... I would say, yes, that the patient (MR1) should have been on a monitor. There is not a designated person that I would give a report to about a patient that I moved to the Holding area. I just announce in the hallway, 'hey I am moving So and So to Holding area. Someone in the Office or out in the hallway of Holding would then take care of the patient. ... Patients in the Holding area would be cared for by the Charge Nurse. The nurse in the Office is the Charge Nurse."



A telephone interview was conducted with EMP6 on May 8, 2018, at 2:00 PM. "We do the blocks in PACU and then the patients are taken to the Holding area. ... EMP2 would assist with the block and then move the patient to the Holding area and check vital signs. EMP2 did not tell me that the patient (MR1) was there, I was in another room ... No, the patient was not on a monitor, it is common for blocks not to be on a monitor. When I came out I thought that the patient was sleeping, ... was laying on their side. I shook the patient and then I noticed they were not breathing. ... ."


A telephone interview was conducted with EMP7 on May 10, 2018, at 8:10 AM. "... The patient was on their side. We rolled the patient over and checked for a pulse very quickly. They were not breathing, we started CPR. The patient was not on a monitor. ... I was not aware of how long the patient stayed in the Holding area. That day there was probably about a 20 minute delay in starting the next case, so the patient was probably in the Holding area a little longer than usual. ... ."

An interview was conducted with EMP1 on May 31, 2018, at 9:15 AM. EMP1 stated that a "Block" is itself considered a procedure and confirmed that MR1 had no evidence of an EKG strip being completed before, during or after the patient's nerve block procedure, and that there is only one set of vital signs which was completed prior to the patient's procedure at 9:20 AM.

3. A sample of medical records (MR3 - MR9) of other patients undergoing a nerve block in conjunction with their operative procedure was selected and reviewed. The records failed to reveal documented evidence that the patients were monitored prior to, during or following the nerve block placement. MR6 - MR9 also failed to reveal documented evidence of vital signs following the block.


Telephone interview with EMP1 on July 6, 2018, confirmed the findings in MR3-MR9.




Cross Reference with CFR 482.13(c)(2) Patient Rights: Care in a Safe Setting
Cross Reference with CFR 482.52 Anesthesia Services

Based on a review of the medical record (MR), facility documentation and interview with facility staff (EMP), it was determined that Chan Soon-Shiong Medical Center at Windber failed to follow adopted anesthesia policies to ensure that a patient was monitored following IV sedation to place a nerve block prior to elective surgical procedure,and failed to take timely performance improvement action following an adverse patient event in one of one medical record (MR1).

Windber Medical Center Anesthesia Policies and Procedures Policy Number: 1.15 ... Subject: Conscious Sedation, dated August 14, 2017. "Purpose: To provide for a safe and consistent process in the delivery of care to patients receiving Conscious Sedation (Moderate Sedation) in conjunction with invasive and non-invasive procedures at Windber Medical Center. Policy: This policy has been developed to define various levels of sedation and anesthesia, and to specify who is qualified to supervise and/or provide each of these sedation/anesthesia levels. The remainder of this policy is to direct the care of the patient receiving Conscious Sedation which carries with its administration the risk of the patient entering a deeper sedation/anesthesia state and thus the risk of loss of protective reflexes and the loss of a patent airway. Responsibility: The Department Anesthesiology is responsible for development of practice standards related to Conscious Sedation. Standards are accomplished through collaborative initiatives with the departments providing the service. ... Definitions: For the purpose of clarification, the terms Minimal sedation (anxiolysis), Moderate sedation (Conscious Sedation), Deep Sedation, and General Anesthesia are defined as follows: ... 2) Moderate Sedation (Conscious Sedation) ... e) Cardiovascular function is usually maintained ... g) Requires physiologic monitoring as outlined in this policy ... Where Conscious Sedation can be performed: 5) Other Departments, approved by Anesthesia Department or Clinical Coordinator; only when Anesthesiologist is available is present to administer &/or supervise the administration Personnel Requirements: When the Department of Anesthesiology is not involved, a registered nurse must be present to administer conscious sedation during invasive and non-invasive procedures. During those times the following applies: ... 5) The RN must be present to monitor the patient throughout procedures performed with Conscious Sedation; the patient is not to be left unattended. The RN may assist for emergency needs. 6) Other Departments (approved by Anesthesia Department or Clinical Coordinator) must have an RN with ACLS or telemetry training monitor the patient; Medication to be administered by Anesthesiologist and remain present throughout the procedure. All Departments performing Conscious Sedation must have the following immediately available: ... 7. Monitor-Heart rate, EKG, Pulse Oximeter, Blood Pressure, and/or respiratory monitors; ETCO2 Temperature ... However, even small dosages of sedative drugs in the elderly and/or patients with severe systemic disease may create respiratory and/or cardiac depression. ... Combining medications for sedation such as opioid analgesics and benzodiazepines will generally provide for better sedation than is produced by the use of single agents only. However, combinations of sedative and analgesic medications have a synergistic effect and may rapidly produce deeper levels of sedation/anesthesia with the attendant risks of airway, respiratory, and cardiovascular problems. Care and vigilance are essential anytime those medications are administered for sedation; however, extreme care and vigilance are necessary when sedation is performed utilizing combinations of drugs (especially, opioid analgesics plus benzodiazepines). Conscious Sedation Pre-Procedure: A medical history must be recorded. This includes, but is not limited to documentation of: ... 10) Physical examination includes: a) Vital signs including height and weight ... Intra-Procedure: ... 4) Prior to administration of sedation, the following should occur: ... c) Initial set of vital signs are taken and recorded ... 7) The patient's vital signs will be monitored continuously throughout the procedure and recorded every 5 minutes or more frequently if necessary. Documentation will include vital signs, ETCO2, the patient's response to sedation, and the drugs given and their dosages. (see Appendix A & B) 8) Report any change in condition of patient to the physician STAT: a) 30% or greater change in systolic blood pressure b) Tachycardia or bradycardia c) Marked change in respiratory rate and/or pattern d) SpO2 <90% e) Marked change in patient responsiveness f) Signs and symptoms of allergy ... Post-Procedure: 1) During the initial recovery phase the patient will be monitored continuously until: a) Awake (or return to baseline mental status) b) Protective reflexes are intact c) Vital signs are stable d) SpO2> 90% (or return to baseline SpO2) on room air or supplemental oxygen. ... ." Attachment documentation entitled, "University of Virginia Health System Adult and Geriatric Sedation/Analgesia for Diagnostic and Therapeutic Procedures" revealed a list of medications that included but not limited to: Versed (midazolam) and Fentanyl (sublimaze).


Job description for EMP9 revealed, "... Detailed Description of Clinical and Administrative Services ... 4. Chief of Anesthesiology, Physician shall serve as Chief of Anesthesiology and shall perform the following administrative duties: ... Be responsible for the clinical coordination, supervision and operation of the Anesthesiology Department and shall ensure that the Anesthesiology Department is operated in accordance with Hospital rules and policies: ... Be responsible for developing and implementing a quality assurance program consistent with standards of any accreditation entity with which Hospital participates and other licensure and regulatory agency requirements ... Advise the Hospital and its administration and medical staff regarding the appropriateness of the use of the Anesthesiology Department and its facilities and services; ... ."


Rules and Regulations of the Medical Staff of Windber Medical Center dated November 28, 2017, revealed, "... Article B. Section I: General Patient Care ... 18. An invasive procedure shall be any surgical, endoscopic, or manipulative procedure which requires anesthesia or sedation. ... 21. All references to written documentation and authentication made in these Rules & Regulations shall also refer to electronic documentation and authentication. ... Article F. Section 5: Medical Records 1. The attending physician shall be held responsible for the preparation of a complete medical record for each patient. This record shall include identification data, chief complaint, personal history, family history, history of medical illness, physical examination, special reports such as consultations, clinical laboratory, x-ray, provisional diagnosis, medical or surgical treatment, pathological findings, progress notes, final diagnosis, condition on discharge, follow-up and autopsy report when available. No medical record shall be filed until it is complete, except on the order of the Medical Records Committee. ... 3. Procedures which meet criteria as a surgical or post-operative event should be reviewed by the Surgical Services Committee. ... Article K. Section 10 Medical Staff Committees ... Section 10.04 Surgical Care Evaluation Committee ... duties The committee shall be responsible for surveillance of the Operating Room & ASU statistics including unplanned Observations & Admissions, Performance Improvement (ASU, OR PACU), Anesthesia Report, including Acute Pain Management, Conscious Sedation Report, and Anesthesia Indicators, Infection Control, Surgical Site Infections, Atlas Quarterly Reports with case Reviews, CORE Measures Report. ... Meetings: The Committee shall meet at least quarterly as part of the Medical Care Evaluation/Quality Assurance Committee and submit their report to the Medical Executive Committee. ... ."


Findings Include:

1. Interview with EMP1 on May 31, 2018, at 9:15 AM stated that a Nerve Block is itself considered a procedure and confirmed that MR1 had no evidence of an EKG strip completed before, during or after the patient's IV sedation/nerve block procedure, and only one set of vital signs was completed, and that was prior to the patient's nerve block at 9:20 AM. EMP1 confirmed that although there is documentation of "VSS" (vital signs stable), their Dynamap machine does not have the ability to print out a strip for the record, and there are no handwritten vital signs documented to reflect what was showing on the monitor.


An interview was conducted with EMP9 on June 11, 2018, at approximately 10:45 AM.
"... We have a paper note where we document patient age, procedure, surgeon request, dose of med, consent. We do not have a specific spot for documentation of a Plexus Block ... IV sedation, we used to put that on the Anesthesia Record, under the nerve block documentation. ... purpose is to relax patient with versed and fentanyl for the needle placement. ... IV sedation peak is a few minutes. Versed peaks in three to five minutes, the half life is very variable with patient condition. ... With the blocks, there is always a nurse, standard monitor, oxygen. A nerve block is considered a minor procedure. Standard procedures are monitored. ... After the procedure you have to monitor the patient. Surgery was probably not started within 30 minutes after the block. ... Monitoring after any minor procedure should be 5-10 minutes until stable, at least one or two sets of vital signs. Monitor is always on in PACU, the monitor was not on after we moved the patient out of PACU. ... ."

2. Surgical Care Evaluation Committee meeting minutes dated August 10, 2017, November 9, 2017, and February 15, 2018, and May 10, 2018, were reviewed and it was noted that there was no documented evidence of discussion or review of MR1 in which an unattended and unmonitored patient coded on November 20, 2017, in the Surgical Suite Holding Area, post IV opioids and benzodiazepines to place a nerve block prior to an elective surgical procedure, in the February 15, 2018, or May 10, 2018, meeting minutes.


A telephone interview conducted with EMP9 on May 8, 2018, at approximately 10:30 AM revealed that EMP9 is a member of the Surgical Committee and that this event won't be discussed until the next Surgical Committee meeting. The next meeting is scheduled for August 8, 2018.

Interview with EMP1 confirmed the above findings.


3. Telephone interview with EMP10 on July 3, 2018, at approximately 11:15 AM was conducted to ascertain the drug classification of each of the four medications that MR1 received during the nerve block procedure on November 20, 2017. EMP10 stated that Naropin and Marcaine are both local anesthetics, Fentanyl is an opioid and Versed is a benzodiazepine.


Cross Reference:
482.13(c)(2) Patient Rights
482.51(b)(4) Post-Operative Care
482.21(c)(1)(iii) Program Activities