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700 NE 13TH STREET

OKLAHOMA CITY, OK 73104

PATIENT RIGHTS

Tag No.: A0115

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

I. Ensure a safe physical environment for one of one (Patient #24) patients with suicidal and self-harm ideations and resulted in the ingestion of a screw, and

II. Provide a safe environment for seven (Patients #24, 25, 26, 27, 28, 29 and 30) of 12 patients on suicidal precautions by:

a. not removing communication board with removable screws, access to equipment cords (including call lights and window blinds), and hand held shower heads, window blinds with cords, trash containers with plastic liners.

b. not searching personal belongings including wood carvings that could be used as a weapon or to self-harm, and hydrogen peroxide brought in by a family member. (Refer to Tag A-144)


This failed practice posed an Immediate Jeopardy to suicidal and self-harm patients, and had the likelihood to result in the increased risk of self-harm to Patient #24 with 2:1 (2 patients to 1 staff) monitoring and environmental safety risks.


On 02/28/19 at 12:41 pm, the hospital CEO and members of the hospital leadership team were notified an Immediate Jeopardy was identified.


On 03/01/19 at 9:25 am, the hospital submitted a written plan of removal including:

Environment

* Place all suicide precaution (SP) as close to the nursing station as possible

* RN/Support person conduct environmental assessment at each entry to room to identify new risk

* Remove Patient Communication Board, cut blind cords, remove hand held shower heads in currently occupied rooms and an additional 39 rooms designated for potential admissions.


Policy

* All SP patients would be 1:1 direct observation with safety attendant for Moderate and High Suicidal Screen.

* Re-educate changes to policy BH.002, titled "Suicide and Harming Behavior Precautions: Patient Management" with focus on changes, SPEC (Suicidal Precautions Environmental Checklist) process, patient/visitors valuable and belongings.

* Amendment of SPEC sheet to highlight removal of telephone cords, call light cords, plastic bags, trash liners, and securing personal belongings.

* E-mail to all employees Policy BH.002 changes


Education:

* 1:1 training for every SA (Safety Attendant) and Registered Nurse (RN) caring for a patient on SP on 02/28/19 and ongoing.

* Provided evidence of sign-in sheets at unit huddle reviewing the policy changes to BH.002 (Suicide Precautions) and A/P (Chain of Command).

* Handover documentation (nurses reporting patient information to another nurse) audit validating information regarding environment and patient behavior was shared during handover using an RN signed the Suicide Precaution Flowsheet.

* Development and implementation of pocket card resource.

* Huddle sheet deployed to inpatient and emergency department leaders.

* Development of education for evaluators and all staff related to suicide precautions.

* Pocket cards regarding suicide precautions were made and distributed to RN's and all other staff.


Patient/Visitors Belongings and Valuables:

* Re-educate regarding policies. Policy titled: Patient's Personal Belongings and Valuables available.


On 03/01/19 at 3:09 pm, the surveyors verified the removal of the immediacy by:

A. Observation

Observed suicide patient rooms at OU Medical Center 300, 350, 425, 426, 465, 500, 512, 580, 650, 651, 667, 671, ED 11, ED 12, Observation 4, 5, 6, 7, 2061, 2077, 266, 2021; The Children's Hospital rooms 9180, 9168, 9138, 9148, 9134, 8160, 8158, 8140, 8132, 8130; Labor and Delivery 12, ED 7, ED 8 for removal of communication boards, cut blind cords, hand held shower head removed in currently occupied rooms.

B. Interview with staff

* Ensured education regarding 1:1 observation of suicidal patients was completed

* Regarded SPEC sheet and how the patient's environment would be safe on admission, during shift change and how safety of patient was documented in the medical record.

* Regarded searching, inventorying and documenting a suicidal patient's belongings and belongings brought by family and how to secure personal belongings.

PATIENT RIGHTS: CARE IN SAFE SETTING

Tag No.: A0144

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

I. Provide 1:1(one safety attendant to one patient) monitoring for one (Patient #24) of seven patients with suicidal ideation/homicidal ideation/self-harm, resulting in Patient #24 ingesting a screw.

II. Provide a safe environment for seven (Patients #24, 25, 26, 27, 28, 29, and 30) of 12 patients on suicidal precautions by:

a. not removing communication board with removable screws, access to equipment cords (including call lights and window blinds), and hand held shower heads, window blinds with cords, and trash containers with plastic liners

b. not searching personal belongings


These failed practices posed an Immediate Jeopardy to the suicidal patients' health and safety resulting in serious harm to patient #24, and had the likelihood to result in the increased risk of self-harm for patients with suicidal/self-harm ideations, with no environmentally safe room.


Findings:


A policy titled, "Suicide Precautions: Patient Management (02/2019)," stated in part that the hospital would create an environment of care to foster the accurate identification and successful management of patients at an increased risk for suicide or self-injurious behaviors ... Safety Attendant was aware of the following safety precautions during constant direct observation of the patient:

"Patient must be in direct sight while in the bathroom and/or shower.

* Initiate search of patient and patient's personal possessions with another hospital employee.

* Remove potentially harmful objects and/or contraband per Suicide Precaution Environmental Checklist (SPEC) sheet.

* Itemize the patient's personal belongings and valuables. If family is available, send belongings home. If family is not available notify Security.

* Do not allow any object or package to be brought in by visitors. This will be evaluated on a case by case basis.

* Reassess the patient's environment every shift with SPEC sheet and communicate all findings with oncoming Safety Attendant".


I. Patient #24's medical record showed:

Patient was admitted with an extensive history of abuse, neglect, methamphetamine use, and multiple episodes of self-harm requiring frequent hospitalization after ingesting a pencil and injuring self with a metal object.

On 02/18/19 at 8:01 pm, "Patient Transfer Orders" showed Suicide Level 2 Line of Site Observation.

On 02/19/19 at 8:26 pm, "Columbia Suicide Severity Rating Scale (C-SSRS) showed "safety attendant present, 1:1 with a C-SSRS Risk Level - High".

On 02/21/19 at 7:42 pm, patient attempted to cut wrist with a zip tie.

On 02/25/19 at 10:42 am, patient swallowed part of a biohazard bag requiring the Heimlich maneuver and attempted to swallow an apple juice straw. The curtains and bedding were removed after threat of hanging and jumping from window.

On 02/25/19 at 3:00 pm, patient swallowed a metal screw used to mount the communication board to the wall.

On 02/26/19 10:56 am, patient broke piece of the window blinds and shaped it into a sharp utensil.

On 02/27/19 at 8:36 am, "ePOM Orders (electronic physician order entry)" showed 1:1 Monitoring and Observation.


Observations

On 02/25/19 at 2:47 pm, surveyor observed one safety attendant outside adjacent rooms 8158 and 8160. Patient #24 (in room 8160) was on suicide precautions at moderate level (constant direct observation, considered for 1:2 observation [one safety attendant for two patients]).


Interviews

On 02/26/19 at 9:33 am, Staff Y stated Patient #24 had removed a screw from the communication board and swallowed it; Patient #24 changed to level 3 (one safety attendant to one patient within arm's reach) the previous evening because patient became upset and threatened harm to self and others; was placed on 1:1 monitoring.

On 02/26/19 at 10:03 am, Staff Y stated, Patient #24 had a history of "swallowing things".

On 02/26/19 at 10:03 am, Staff D stated, debriefing was done with Staff Z, to make room safer for Patient #24 by moving patient closer to the nursing station for the protection of the patient and the sitter. Staff D stated, none of the rooms were set up for patients with suicidal ideations or homicidal ideations

On 02/26/19 at 10:53 am, Staff Y stated, the sitter thought Patient #24 was stretching when removing the screw from the communication board.

On 02/26/19 at 11:30 am, Staff MMM stated, "we still have ligature points and we document we were aware of them".


II. Physical Environment

A policy titled "Suicide Precautions: Patient Management (02/2019)", showed:

a) The RN caring for patients on inpatient units would implement the Survey Tally Act Reassess (STAR) Protocol prior to placing a patient in a room which included identification, documentation and removal of non-medically necessary equipment and supplies.

b) The SPEC stated the checklist was utilized when a patient was at moderate or high risk for suicide and contained categories of potential risks such as ligature points, strangulation objects, glass/metal/sharps, suffocation hazards, personal and other hazards and contraband.


Observation

On 02/26/19 at 11:00 am, the following non-patient care items were observed in rooms with patients who were on suicidal precautions (rooms #272, 426, 501, 578, 622, and 660): communication board mounted to the wall with four loose screws, equipment cords, hand-held shower head, cords on window blinds, wood carvings that could be used as a weapon or to self-harm, and hydrogen peroxide brought in by a family member.


Interview

On 02/25/19 at 2:40 pm, Staff Y stated, that "trash cans should be outside of suicidal patient rooms because the trash liners are a ligature risk".

On 02/26/19 at 10:03 am, Staff D stated, Patient #24 had a history of swallowing things and a debriefing was done with Staff Z to make the room safe for Patient #24.

On 02/26/19 at 10:53 am, Staff R stated, belongings were not checked when patient came from another place.

On 02/26/19 at 11:30 am, Staff MMM stated, "we still have ligature points and we document we were aware of them".

RN SUPERVISION OF NURSING CARE

Tag No.: A0395

Based on record review and interview, the hospital (OU Edmond) failed to ensure that nursing services were provided in accordance with acceptable professional standards of nursing practice as evidenced by failing to ensure that a RN (Registered Nurse) was assigned the circulating role for patients' operative invasive procedures in the Cath Lab (Cardiac Catheterization Lab), the only RN assigned to the Cath Lab procedure room was responsible for monitoring the patient during IV (intravenous) conscious sedation and analgesia.

Findings:

A review of the staffing pattern for the Cath Lab at OU Edmond with Staff AA and Staff CC revealed that only one RN was scheduled each day in the Cath Lab when the Cath Lab had scheduled procedures.

A review of the hospital policy titled, "Sedation and Analgesia by Non-Anesthesiologists," provided by administration as a current policy, revealed in part: The registered nurse and/or physician responsible for monitoring the patient, and documentation thereof, shall have no other responsibilities that would require the compromise of continuous monitoring or leaving the patient unattended.

In an interview on 02/25/19 at 2:00 p.m. with Staff AA and CC, they indicated that the Cath Lab had only one RN scheduled each day for Cath Lab procedures and the assigned RN in the room during the procedure was only responsible for the continuous monitoring of the patient during IV sedation and analgesia. They indicated that the Radiology Technicians functioned as the circulating nurses during patients' Cath Lab procedures.

In an interview on 02/25/19 at 2:10 p.m. with Staff DD, Radiology Technician, she indicated that she or another Radiology Technician was assigned the circulator duties and the documentation of the Cath Lab operative procedure record during patients' Cath Lab procedures. She indicated that the RN assigned to the Cath Lab procedures was administering the patients' IV conscious sedation and was responsible for the continuous monitoring of the patients during the procedures.


A review of the Oklahoma Administrative Code Title 310: Oklahoma State Department of Health- Chapter 667. Hospital Standards Subchapter 25: Surgical Services 310:667-25-1. Department of surgery revealed in part: The department of surgery shall have effective policies and procedures regarding surgical privileges, maintenance of the operating rooms, and evaluation of the surgical patient.

(F) Circulating nurse.

(11) Surgical technicians and licensed practical nurses may be permitted to serve as "scrub nurses" under the direct supervision of a registered nurse; they shall not be permitted to function as circulating nurses in the operating room.


A review of the AORN (Association of periOperative Registered Nurses) Position Statement, Revised 2014, "One Perioperative Registered Nurse Circulator Dedicated to Every Patient Undergoing an Operative or Other Invasive Procedure", revealed in part: At a minimum, one perioperative RN circulator should be dedicated to each patient undergoing an operative or other invasive procedure and be present during that patient's entire intraoperative experience to ensure each patient is provided with safe, quality patient care in the perioperative arena. The Position Statement further states in part: The Code of Federal Regulations "Conditions of Participation for hospitals" (42 CFR §482) sets forth national staffing standards for hospitals receiving Medicare reimbursement. Under these regulations, the health care organization must have adequate numbers of qualified RNs to provide nursing care, which includes circulating duties. The Centers for Medicare & Medicaid Services interpretive guidelines in §482.51(a)(3) state, "The circulating nurse must be an RN." A licensed practical nurse or surgical technologist may assist an RN in carrying out circulating duties, in accordance with applicable state laws and medical staff-approved hospital policy, but the licensed practical nurse or surgical technologist must be under the supervision of the RN circulator who is in the operating suite and who is available to immediately and physically respond to provide necessary interventions in emergencies. The supervising RN would not be considered immediately available if the RN was located outside the operating suite or engaged in other activities or duties that prevent him or her from immediately intervening and assuming whatever circulating activities or duties were being provided by the licensed practical nurse or surgical technologist.


A review of AORN Guidelines for Perioperative Practice, 2018 edition- Guideline for Moderate Sedation/Analgesia- Recommendation III revealed in part: The perioperative registered nurse monitoring the patient receiving moderate sedation/analgesia should have no other responsibilities and should continuously monitor the patient's physiological and psychological status. A designated perioperative registered nurse should continually monitor the patient during administration of moderate sedation/analgesia. An additional perioperative registered nurse should be assigned to the circulating role during the administration of moderate sedation/analgesia. Two perioperative registered nurses should be assigned to a patient receiving moderate sedation/analgesia. AORN maintains that every surgical patient deserves a perioperative registered nurse for the duration of any operative or invasive procedure and supports the CMS guidelines that states, "The circulating nurse must be an RN".

CONTENT OF RECORD

Tag No.: A0449

Based on record review and interview, the hospital failed to ensure:

I. the RN documented the removal of objects that could be used for strangulation, glass/metal/sharps, suffocation hazards, ingestible hazards, other forms of contraband, ligature points and or strangulation objects that would be secured, and monitored on the SPEC (Suicide Precautions Environmental Checklist) for 12 (Patient #19, 24, 25, 26, 27, 28, 29, 30, 56, 57, 58, and 73) of 12 patients' with suicidal ideation/homicidal ideation, suicide attempt, physical aggression, and/or self-harming behaviors in the patient's electronic medical record (EMR).

II. the EMR (electronic medical record) reflected sufficient documentation of assessment, interventions, treatments, and patients' responses to demonstrate the patients' progress.


These failed practices:

I. Resulted in serious harm for one (Patient #24) patient with suicidal ideation and self-harming behaviors who were admitted to the hospital and subsequently swallowed a screw from the communication board, and had the likelihood to result in harm for all suicidal, physically aggressive and/or self-harming patients placed on suicide precautions.

II. had the likelihood of reducing the effectiveness of pain management.


Findings:

I. SPEC sheets

Review of policy titled "Suicide Precautions: Patient Management, dated 02/19" showed, patients would be screened for the risk of suicide, provided appropriate supervision to "minimize the opportunity for self-injury". The Registered Nurse (RN) would use the Columbia Suicide Severity Rating Scale (C-SSRS) to screen patients for suicide risk. Patients who screened at a moderate or high risk the RN would complete the SPEC sheet prior to placing the patient in a room. A Safety Attendant would be assigned to "provide the appropriate level of observation". The RN and Safety Attendant would review the SPEC sheet upon arrival of the patient, and at shift change and change in staff.


Review of policy titled "Documentation of Inpatient Nursing Care, dated 01/17 showed, "staff members were responsible for documentation of observations, care provided and data collected in an "accurate and timely manner" ...At the end of shift each staff member were to review their charting to ensure all documentation was completed.


Review of hospital document titled "Suicide Precaution Environmental Checklist (SPEC) sheet, updated 10/25/18" showed, the checklist would be used for patients who were screened at a moderate or high risk for suicide. Each category and item was to be assessed to identify all risks in a patient's room. All items were to be removed from the room unless medically necessary for patient care. The categories assessed included:

a. Ligature Points ("any item used to attach a cord, rope, or other material for the purpose of hanging or strangulation"): these included but were not limited to items that could not be removed such as bedframes, ceiling fittings, plumbing/piping fixtures, handles, locks, hinges/closures, shower rails, and other mounted items.

b. Strangulation Objections ("any item that can be used for the purpose of hanging or strangulation"): these included but were not limited to items such as call light cords, electrical cords, equipment cords/cables, tubing, sheets, towels, telephone cords, clothing (belts, neckties, shoelaces, etc.).

c. Glass/Metal/Sharps ("any item used to cut or cause harm to self or others"): these included but were not limited to items such as "hooks, hangers, screws", ceiling fittings, glass items/bottles, mirrors, etc.

d. Suffocation Hazards ("any item used to cover mouth/nose, thus preventing breathing"): these included but were not limited to "plastic bags, trash liners, medical waste, linen, soft bedding, pillows", etc.

e. Ingestible Hazards ("any intentional self-poisoning"): "medication, antimicrobial/alcohol hygiene solutions, batteries, etc.

f. Contraband ("any item that is illegal or can be used to harm self or others"): "prescription medications, illicit drugs, cigarettes/lighters, knives or other weapons".


Review of 12 (Patient #19, 24, 25, 26, 27, 28, 29, 30, 56, 57, 58, and 73) of 12 patient SPEC sheets showed the RN failed to document the following:

1. Patient #19 was a 14 year old female placed on suicide precautions with a documented high suicide risk level.

i. On 02/22/19, 02/23/19, and 02/25/19, categories were documented as "removed". There was no documentation in the patient's EMR of what items were removed, identification of ligature points, and strangulation objects that were fixed, how these fixed items were being monitored and who was made aware of the potential risks.


2. Patient #24 was a 14 year old female placed on suicide precaution with a documented high suicide risk level.

i. On 02/19/19 and 02/25/19, ligature points, strangulation objects, glass/metal/sharps categories, and other hazards were documented as "fixed (unable to remove)". There was no documentation in the patient's EMR of what ligature points, cordlike/strangulation objects, and glass/metal/sharps were fixed and unable to be removed, how these fixed items were being monitored and who was made aware of the potential risks. Plastics (Suffocation Hazards) category was documented as "removed". There was no documentation in the patient's EMR of what items were removed.

ii. On 02/20/19, 02/21/19, and 02/22/19, categories were documented as "removed". There was no documentation in the patient's EMR of what items were removed, identification of ligature points and strangulation objects that were fixed, how these fixed items were being monitored and who was made aware of the potential risks.


3. Patient #25 was a 26 year old female placed on suicide precautions due to self-harming behaviors.

i. On 02/22/19, categories were documented as "removed". There was no documentation in the patient's EMR of what items were removed, identification of ligature points and strangulation objects that were fixed, how these fixed items were being monitored, and who was made aware of the potential risks.

ii. On 02/23/19, ligature points category was documented as "fixed (unable to remove)". There was no documentation in the patient's EMR of what ligature points were fixed and unable to be removed, how these fixed items were being monitored, and who was made aware of the potential risks. Glass/metal/sharps category was documented as "removed," and there was no documentation in the patient's EMR of what items were removed from the patient's room.

iii. On 02/24/19, ligature points, glass/metal/sharps, and plastics categories ligature points, cordlike/strangulation objects, and glass/metal/sharps were documented as "fixed (unable to remove)". There was no documentation in the patient's EMR of what ligature points were fixed and unable to be removed, how these fixed items were being monitored, and who was made aware of the potential risks.


4. Patient # 26 was a 21 year old female placed on suicide precautions with a documented high suicide risk level.

i. On 02/20/19, 02/21/19, and 02/25/19, ligature points, strangulation objects, glass/metal/sharps, plastics, and other hazards categories were documented as "fixed (unable to remove)". There was no documentation in the patient's EMR of what ligature points were fixed and unable to be removed, how these fixed items were being monitored, and who was made aware of the potential risks.

ii. On 02/22/19 and 02/23/19, ligature points category was documented as "fixed (unable to remove)". There was no documentation in the patient's EMR of what ligature points were fixed and unable to be removed, how these fixed items were being monitored, and who was made aware of the potential risks. Strangulation objects, glass/metal/sharps and plastics categories were documented as "removed," and there was no documentation in the patient's EMR of what items were removed from the patient's room.

iii. On 02/24/19, ligature points category points category was documented as "not applicable". There was no documentation in the patient's EMR regarding why fixed ligature points that were unable to be removed were documented as not applicable, how these fixed items were being monitored, and who was made aware of the potential risks. Strangulation objects, glass/metal/sharps and plastics categories were documented as "removed," and there was no documentation in the patient's EMR of what items were removed from the patient's room.

iv. On 02/25/19 and 02/26/19, categories were documented as "removed". There was no documentation in the patient's EMR of what items were removed, identification of ligature points and strangulation objects that were fixed, how these fixed items were being monitored, and who was made aware of the potential risks.


5. Patient #27 was a 25 year old male placed on suicide precautions with a documented high suicide risk level.

i. On 02/21/19 and 02/23/19, ligature points category was documented as "fixed (unable to remove)". There was no documentation in the patient's EMR of what ligature points were fixed and unable to be removed, how these fixed items were being monitored, and who was made aware of the potential risks.

ii. On 02/24/19 and 02/25/19, strangulation objects, glass/metal/sharps and other hazards categories were documented as "fixed (unable to remove)". There was no documentation in the patient's EMR of what strangulation objects, glass/metal/sharps and other hazards were fixed and unable to be removed, how these fixed items were being monitored, and who was made aware of the potential risks. Plastics category was documented as "removed," and there was no documentation in the patient's EMR of what items were removed from the patient's room.

iii. On 02/26/19, categories were documented as "fixed (unable to remove)". There was no documentation in the patient's EMR of what ligature points, strangulation objects, glass/metal/sharps, plastics and other hazards were fixed and unable to be removed, how these fixed items were being monitored, and who was made aware of the potential risks.


6. Patient #28 was a 49 year old male placed on suicide precautions with a documented high suicide risk level.

i. On 02/15/19, 02/17/19, and 02/22/19, ligature points category was documented as "fixed (unable to remove)". There was no documentation in the patient's EMR of what ligature points were fixed and unable to be removed, how these fixed items were being monitored, and who was made aware of the potential risks. Strangulation objections, glass/metal/sharps, plastics and other hazards categories were documented as "removed". There was no documentation in the patient's EMR of what items were removed.

ii. On 02/16/19, ligature points, strangulation objects, glass/metal/sharps and plastics categories were documented as "removed". There was no documentation in the patient's EMR of what items were removed. Other hazards category was documented as "fixed (unable to remove)". There was no documentation in the patient's EMR of how these fixed items were being monitored and who was made aware of the potential risks.

iii. On 02/19/19, 02/21/19, 02/23/19, 02/24/19, 02/25/19, and 02/26/19, ligature points, glass/metal/sharps and/or other hazards were documented as "fixed (unable to remove)". There was no documentation in the patient's EMR of what ligature points, glass/metal/sharps, and other hazards were fixed and unable to be removed, how these fixed items were being monitored, and who was made aware of the potential risks.

iv. On 02/20/19, glass/metal/sharps category was documented as "fixed (unable to remove)". There was no documentation in the patient's EMR of what glass/metal/sharps were fixed and unable to be removed, how these fixed items were being monitored, and who was made aware of the potential risks. Ligature points, strangulation objects, plastics, and other hazards categories were documented as removed". There was no documentation in the patient's EMR of what items were removed.


7. Patient #29 was a 63 year old female placed on suicide precautions with a documented high suicide risk level.

i. On 02/25/19, ligature points and glass/metal/sharps were documented as "removed". There was no documentation in the patient's EMR of what items were removed. Strangulation objects, plastics, and other hazards were documented as "fixed (unable to remove)". There was no documentation in the patient's EMR of what strangulation objects, plastics, and other hazards were fixed and unable to be removed, how these fixed items were being monitored, and who was made aware of the potential risks.


8. Patient #30 was a 34 year old female who was placed on suicide precautions for self-harming behaviors.

i. On 02/19/19, ligature points and strangulation object categories were documented as "fixed (unable to remove)". There was no documentation in the patient's EMR of ligature points and strangulation objects were fixed and unable to be removed, how these fixed items were being monitored, and who was made aware of the potential risks. Glass/metal/sharps, plastics, and other hazards were documented as "not applicable". There was no documentation in the patient's EMR regarding why fixed glass/metal/sharp objects that were unable to be removed were documented as not applicable, how these fixed items were being monitored, and who was made aware of the potential risks. There was no documentation hazardous plastic materials commonly found in patient rooms such as plastic trash and liner liners were removed from the room.

ii. On 02/20/19, 02/22/19, and 02/25/19, ligature points category was documented as "fixed (unable to remove)". There was no documentation in the patient's EMR of what ligature points were fixed and unable to be removed, how these fixed items were being monitored, and who was made aware of the potential risks. Glass/metal/sharps, plastics, and other hazards categories were documented as "removed". There was no documentation in the patient's EMR of what items were removed.

iii. On 02/21/19, ligature points, strangulation objects, glass/metal/sharps, and plastics were documented as "fixed (unable to remove)". There was no documentation in the patient's EMR of what ligature points, strangulation objects, glass/metal/sharps, and plastics were fixed and unable to be removed, how these fixed items were being monitored, and who was made aware of the potential risks. Other hazards category was documented as "removed". There was no documentation in the patient's EMR of what items were removed.

iv. On 02/23/19 and 02/24/19, all categories were documented as "removed". There was no documentation in the patient's EMR of what items were removed.


9. Patient #56 was a female patient place on suicide precautions with a documented high suicide risk level.

i. On 02/21/19 and 02/23/19, ligature points, strangulation objects, glass/metal/sharps, and other hazards categories were documented as "fixed (unable to remove)". There was no documentation in the patient's EMR of what ligature points, strangulation objects, glass/metal/sharps, and other hazards were fixed and unable to be removed, how these fixed items were being monitored, and who was made aware of the potential risks. Plastics were documented as "removed". There was no documentation in the patient's EMR of what items were removed.

ii. On 02/22/19, all categories were documented as "fixed (unable to remove)". There was no documentation in the patient's EMR of what ligature points, strangulation objects, glass/metal/sharps, plastics, and other hazards were fixed and unable to be removed, how these fixed items were being monitored, and who was made aware of the potential risks.


10. Patient #57 was a female patient who was placed on suicide precautions.

i. On 02/25/19, ligature points and glass/metal/sharps categories were documented as "not applicable". There was no documentation in the patient's EMR regarding why fixed ligature points and glass/metal/sharp objects that were unable to be removed were documented as not applicable, how these fixed items were being monitored, and who was made aware of the potential risks.

ii. On 02/26/19, all categories were documented as "removed". There was no documentation in the patient's EMR of what items were removed.


11. Patient #58 was a male patient placed on suicide precautions with a documented high suicide risk level.

i. On 02/25/19, all categories were documented as "fixed (unable to remove)". There was no documentation in the patient's EMR of what ligature points, strangulation objects, glass/metal/sharps, plastics and other hazards were fixed and unable to be removed, how these fixed items were being monitored, and who was made aware of the potential risks.

ii. On 02/26/19, all categories were documented as "removed". There was no documentation in the patient's EMR of what items were removed.


12. Patient #73 was a female patient who was placed on suicide precautions.

i. On 02/24/19, ligature points, glass/metal/sharps and plastics were documented as "not applicable". There was no documentation in the patient's EMR regarding why fixed ligature points and glass/metal/sharp objects that were unable to be removed were documented as not applicable, how these fixed items were being monitored, and who was made aware of the potential risks. Strangulation objects and other hazards were documented as "removed". There was no documentation in the patient's EMR of what items were removed.

ii. On 02/25/19, all categories were documented as "removed". There was no documentation in the patient's EMR of what items were removed.

iii. On 02/26/19, all categories were documented as "fixed (unable to remove)". There was no documentation in the patient's EMR of what ligature points, strangulation objects, glass/metal/sharps, plastics, and other hazards were fixed and unable to be removed, how these fixed items were being monitored, and who was made aware of the potential risks.



On 03/01/19 at 10:29 am, Staff J stated, the RN was responsible for completing and documenting the SPEC sheet in the patient's medical record. Staff J stated, the Safety Attendant would assist in assessing the patient's room and removing any potentially hazardous objects from the room.


On 03/01/19 at 10:49 am, Staff K stated, the SPEC sheet in Meditech (the computerized system) provided a box for each category the RN could document items removed from the room or what was fixed and monitored. Staff K stated, the RN was responsible for completing the SPEC sheet in Meditech. Staff K stated, "generally we free-text what we actually remove from a patient's room".




41342


II. Pain Assessments

A review of the hospital's pediatric emergency department EMR did not show documentation of the patient's initial pain intensity level or response to interventions for three (Pt# 55, 56, and 58) of four patients.

Review of hospital policy titled "Medication Management (06/2018)" says that a patient's response to medication will be documented in the patient record.

Patient #55 complained of eye swelling on admission, 2/25/19 at 9:49 am. The nursing assessment, at 10:45 am, showed the patient had left eye swelling and pain.
1.Motrin 400mg was administered for pain, at 2:17 pm.

2.The record did not show a pain assessment was performed prior to the motrin administration.

3.The record did not show the patient's response to motrin.


Patient #56 complained of neck pain on admission, 2/25/19 at 9:24 am.

1.Morphine was administered at 1:37 pm.

2. The record did not show a pain assessment was performed prior to the morphine administration.

3.The record did not show the patient's response to morphine.


Patient #58 complained of abdominal pain on admission, 2/25/19, at 9:41 am. There was no pain intensity documentation in the medical record.

1.Motrin was administered for pain at 10:40 am.

2.The record did not show a pain assessment was performed prior to the motrin administration.

3. The record did not show the patient's response to motrin.

OPERATING ROOM POLICIES

Tag No.: A0951

Based on record review, observation, and interview, the hospital failed to ensure surgical services followed acceptable professional standards of practice governing surgical services and infection control practices by:

1. Failing to store sterile supplies in a manner and/or location to prevent compromising sterility and contamination by storing sterile supplies on open shelves in the hallways and the operating room (at OU Main, TCH [The Children's Hospital] and Out Patient Surgery Center).

2. Staff wearing head coverings (skull caps) that did not completely cover the hair on the head and neck in the semi-restricted and restricted areas (at OU Main and TCH).

3. Staff wearing surgical masks hanging around their necks in the semi-restricted and restricted areas (at OU Main and TCH).

4. Not performing a complete time out/fire risk assessment in the operating room (at TCH).


Document titled "OU Medical System OR RN Initial Competency Verification Form" states that personnel working in the OR (operating room) "wears long-sleeved jacket that is snapped, buttoned closed or zipped when not scrubbed. Covers head and facial hair, including sideburns and neck-line ...by wearing hat or hood that minimizes microbial dispersal."

The nationally accepted standards of practice as prescribed by the AORN requires:

a. All individuals entering the semi-restricted and/or restricted surgical or invasive surgical areas should wear a surgical mask when scrubbed personnel, sterile supplies and/or sterile equipment are present ...Surgical masks should be tied securely and discarded after each procedure or when soiled.

b. When in the semi-restricted or restricted surgical areas, all non-scrubbed personnel should wear a freshly laundered or single use long sleeved cover top or jacket snapped closed with the cuffs down to the wrists ...personal clothing that extends above the scrub top neckline or below the sleeve of the surgical attire should not be worn or should be laundered in a health-care-accredited laundry facility after each daily use.

c. All personnel should cover head and facial hair ...when in semi-restricted and restricted areas.

d. Sterilized items should be stored in a manner to ensure sterility. Sterilized items should have limited exposure to moisture and humidity to decrease the potential contamination of the sterilized items. Factors that contribute to contamination include air movement, humidity, temperature, location, traffic, presence of vermin, whether shelving is open or closed, and properties of the packaging material. Sterile packages should be stored under environmental controlled conditions.


02/26/19 at 8:30am, sterile supplies were observed stored in the semi-restricted hallways of the OR at OU Main. T-shirts were observed outside the scrub attire of staff, and staff not wearing long sleeved cover top or jacket while in the semi-restricted areas.

02/27/19 at 9:30 am, sterile supplies were observed stored in the semi-restricted hallway of TCH OR; this was temporary location pending remodel of storage room. Staff observed not wearing long sleeved cover top or jacket while in the semi-restricted areas.

02/27/19 at 10:00 am, sterile supplies were observed stored in the operating room of the Labor and Delivery rooms at TCH.

02/27/19 at 1:30 pm, sterile supplies were observed stored in the back hallway of outpatient surgery center.


Staff were unable to identify humidity and air exchange rates for each location. Staff EEE stated humidity levels and air exchanges are monitored and controlled by Facilities.


Document titled "OU Medical System OR RN Initial Competency Verification Form" states, there was surgical and procedural site verification process to verify the operative procedure, surgical site and laterality with the patient/patient's family. The process includes review of the surgical consent, confirmation and site marked. The time out process occurs in the operating room after the patient is prepped and draped and before the procedure begins.


Two of two (Patients #59 and 60) time out procedures (from the preoperative "briefing", time out/fire risk in the surgical suite to the "debriefing" at the end of the procedure) at TCH were incomplete. On 02/27/19, the following was observed:

a. Patient # 59: the Circulator (Staff GGG) performed an incomplete time out/fire risk assessment; the fire risk assessment, anticipated critical events, relevant images properly labeled and displayed, any equipment concerns, and confirmation of the sterilization indicators were not addressed in the time out.

b. Patient #60: Circulator (Staff HHH) did not include the fire risk assessment in the time out phase; cautery (an instrument used to destroy abnormal tissue by burning) and Chloraprep (a surgical skin preparation that contains alcohol and gives off flammable vapors) were utilized during the procedure.

Staff UU and Staff FFF stated there was a "Comprehensive Surgical Checklist" on the information board in each room that the circulators follow for the time out process. Staff UU (the clinical manager) was unsure why the checklist was not followed.


41506



Based on record review, observation, and interview, the hospital failed to ensure the hospital's Surgical and Invasive Services (at OU Edmond Cath Lab, OR, Endoscopy, and OU Medical Center IR department) followed acceptable professional standards of practice governing surgical/invasive services and infection control practices as evidenced by:

1) failing to ensure that staff adhered to acceptable standards of professional practice in surgical attire in the restricted and semi-restricted areas as evidenced by multiple observations of surgical attire breaches at OU Edmond's OR (Operating Room) and Cath Lab, and at OU Medical Center's IR (Interventional Radiology) department,

2) failing to store the reprocessed endoscopes in a drying cabinet that included a drying system that circulated HEPA (high efficiency particulate air) filtered air through the cabinets at all of the Endoscopy area locations of OU Medicine,

3) failing to ensure that staff followed manufacturer's IFU (Instructions for Use) for the enzymatic solutions, used in the decontamination of instruments and endoscopes prior to reprocessing the instruments and endoscopes, for temperature monitoring and immersion times, and failing to document the temperature of the solution and immersion times prior to use on the log sheets at OU Edmond's OR and Endoscopy departments,

4) failing to identify a semi-restricted area, according to professional standards of practice, in the IR department at OU Medical Center

5) failing to store sterile supplies in a manner and/or in a location to prevent compromising sterility and contamination as evidenced by storing sterile supplies for future procedures in open baskets on shelves in the back hallway in the OR at OU Edmond,

6) failing to ensure that sterile folded cotton blankets were not used as positioning devices during patient's procedures, and

7) failing to ensure that disposable blue towels were not used as instrument tray corner guards (protectors) without ensuring this practice was validated by the towel manufacturer's IFU for use as instrument tray corner guards in order to ensure maximum airflow and moisture management during sterilization.


Findings:

1) failing to ensure that staff adhered to acceptable standards of professional practice in surgical attire in the restricted and semi-restricted areas as evidenced by multiple observations of surgical attire breaches at OU Edmond's OR (Operating Room) and Cath Lab and at OU Medical Center's IR (Interventional Radiology) department,

Observations on 02/25/19 and 02/26/19, at OU Edmond Hospital revealed surgical attire breaches by surgeons and staff in the OR and the Cath Lab.

Observations on 02/28/19 at OU Medical Center revealed surgical attire breaches by physicians and staff in the IR department. The observations included:

-Observations in the semi-restricted and restricted areas of staff (Staff DD, EE, FF, and HH) wearing disposable head coverings in a way that did not cover their ears

-Observations in the semi-restricted and restricted areas of physicians and staff (Staff CC, LL, NN, OO, PP, and QQ) wearing disposable and non-disposable head coverings (surgeon hats) that did not completely cover the ears and all the hair on the head and neck

-Observations in the semi-restricted and restricted areas of physicians and staff (Staff CC, DD, GG, LL, NN, PP, QQ, RR, and UU) wearing T-shirts that were not completely covered by the surgical attire,

-Observations in the semi-restricted and restricted areas of physicians and staff (Staff BB, GG, II, JJ, KK, MM, and RR) wearing a home laundered cloth cap that was not covered or completely covered by a disposable head covering,

-Observations in the semi-restricted and restricted areas of non -scrubbed physicians and staff (Staff CC, DD, EE, FF, GG, HH, II, JJ, KK, MM, QQ, RR, and UU) not wearing a long-sleeved cover jacket that was buttoned down the front or wearing a home laundered jacket over the scrub attire,

- Observations in the semi-restricted and restricted areas of physicians and staff (Staff HH, JJ, LL, MM, OO, and PP) wearing their surgical masks hanging from around their necks.


The AORN Guidelines for Perioperative Practice, 2018 edition - Guideline for Surgical Attire:

Recommendation I revealed in part:

All individuals entering the semi-restricted and/or restricted surgical or invasive surgical areas should wear a surgical mask when scrubbed personnel, sterile supplies and/or sterile equipment are present. A surgical mask protects the patient from transfer of microorganisms. The mask should cover the mouth and nose and be secured in a manner to prevent venting. Surgical masks should not be worn hanging down from the neck. Surgical masks are intended to contain and filter droplets from the nasopharynx. The filter portion of the surgical mask harbors bacteria collected from the nasopharyngeal airway and should not be worn hanging from the neck. Surgical masks should be tied securely and discarded after each procedure or when soiled. A mask that is securely tied at the back of the head and behind the neck decreases the risk of staff transmitting nasopharyngeal and respiratory microorganisms to patients.

Recommendation I further revealed in part: When in the semi-restricted or restricted surgical areas, all non-scrubbed personnel should wear a freshly laundered or single use long sleeved cover top or jacket snapped closed with the cuffs down to the wrists. Wearing the long-sleeved jacket snapped closed prevents the edges of the front of the jacket from contaminating a skin prep area or the surgical sterile field. Long sleeved attire helps contain skin squames shed from bare arms. All personal clothing, not laundered by a health care-accredited laundry facility, should be completely covered by the surgical attire. Undergarments such as T-shirts with a V-neck, and shirts with sleeves which can be contained underneath the scrub top, may be worn; personal clothing that extends above the scrub top neckline or below the sleeve of the surgical attire should not be worn or should be laundered in a health-care-accredited laundry facility after each daily use.

Recommendation III revealed in part: All personnel should cover head and facial hair, including the sideburns, the ears and the nape of the neck, when in semi-restricted and restricted areas. Human hair can be a site of pathogenic bacteria such as MRSA (methicillin-resistant staphylococcus aureus). Hair acts as a filter when it is uncovered and collects bacteria. A clean surgical head covering or hood that confines all hair and covers the ears, scalp skin, sideburns and nape of neck, to include beards, should be worn in the semi-restrictive and restrictive areas. The head covering or hood should be designed to minimize microbial dispersal. Head coverings that fail to contain the side hair above and in front of the ears and hair at the nape of the neck and the ears should not be worn. Reusable head coverings (cloth head coverings) should be laundered in a health care-accredited laundry facility or completely covered by a disposable head covering, if they are home laundered.


In an interview on 02/25/19 at 2:05 p.m. with Staff AA, he indicated that the hospital had a policy on the wearing of surgical attire. He indicated that the Cath Lab department followed the AORN Guidelines.


In an interview on 02/26/19 at 11:30 a.m. with Staff EE, she indicated that the hospital had a policy on the wearing of surgical attire. She indicated that the OR followed the AORN Guidelines.


In an interview on 02/28/19 at 10:50 a.m. with Staff RR, she indicated that the hospital had a policy on the wearing of surgical attire. She indicated that the IR department followed the AORN Guidelines


In an interview on 02/27/19 at 10:40 a.m. with Staff SS and TT they indicated that the hospital had a policy on the wearing of surgical attire. They indicated OU Medicine followed the AORN Guidelines on surgical attire and that enforcement was sometimes a challenge.


2) failing to store the reprocessed endoscopes in a drying cabinet that included a drying system that circulated HEPA (high efficiency particulate air) filtered air through the cabinets at all of the Endoscopy area locations of OU Medicine,

An observation on 02/25/19 at 12:05 p.m. of the endoscope storage cabinet at OU Edmond, containing over 8 (eight) reprocessed endoscopes, revealed no HEPA- filtered air being circulated in the storage cabinet.

A review of AORN Guidelines for Perioperative Practice, 2018 edition - Sterilization and Disinfection: Flexible Endoscopes-

Recommendation IX revealed in part: Flexible endoscopes and endoscope accessories should be stored in a manner that minimizes contamination and protects the device or item from damage. Flexible endoscopes should be stored in a drying cabinet to facilitate drying, decrease the potential for contamination, and provide protection from environmental contaminants. Drying cabinets are to include a drying system that circulates HEPA-filtered air through the cabinet while filtered air under pressure is forced through the endoscope channels where the endoscopes are continuously dried, suppressing bacterial growth.


In an interview on 02/25/19 at 12:15 p.m. with Staff AA, he indicated that the endoscope storage cabinet had no HEPA- filtered air being circulated in the storage cabinet and he was not aware that HEPA filters were required. Staff AA indicated that the endoscopy department followed AORN Guidelines.


In an interview on 02/27/19 at 11:00 a.m. with Staff TT, Infection Control Officer, he indicated that there were no HEPA filters in any of the OU Medicine endoscopy departments. He indicated that OU Medicine followed the AORN Guidelines.


3) failing to ensure that staff followed manufacturer's IFU (Instructions for Use) for the enzymatic solutions, used in the decontamination of instruments and endoscopes prior to reprocessing the instruments and endoscopes, for temperature monitoring and immersion times and failing to document the temperature of the solution and immersion times prior to use on the log sheets at OU Edmond's OR and Endoscopy departments,

A review of the hospital policy titled, "Cleaning and Processing Flexible Endoscopes, Probes, and Accessories", as provided by administration as the most current policy, revealed in part: Flexible endoscopes and probes should be cleaned and stored in accordance with the manufacturer's written instructions.

A review of the manufacturer's IFU on the enzymatic solution used in the decontamination of the endoscopes in the Endoscopy department and in the decontamination of instruments in the OR at OU Edmond revealed in part: The instrument should be immersed for 1-5 minutes with a water temperature not to exceed 130 degrees Fahrenheit (55 degrees Centigrade).

A review of the endoscope daily cleaning log sheet, provided by Staff AA, revealed no documentation of the length of time the endoscope was immersed or the temperature of the enzymatic solution's water prior to the decontamination process.

In an interview on 02/25/19 at 12:05 p.m. with Staff AA and BB, endoscopy staff, Staff BB indicated that she does not time or document the length of time the endoscope was immersed or document the temperature of the enzymatic solution's water prior to the decontamination process. Staff BB was unable to verify that the enzymatic solution's manufacturer's IFU were followed during endoscope decontamination.

An observation of the OR decontamination room at OU Edmond, revealed enzymatic solution had been prepared and was noted in the sink in the decontamination room. No staff were observed in the room and no instruments were observed in the prepared enzymatic solution. There was no observation of an enzymatic solution log in the room.


In an interview on 02/26/19 at 2:00 p.m. with Staff EE and FF, Staff FF indicated that the OR did not have an enzymatic solution log and they were not documenting instrument immersion time or solution temperature prior to use. Staff FF did not know how long ago the enzymatic solution in the sink had been prepared. He indicated that it should be changed daily or whenever the solution became dirty. Staff EE indicated that the OR followed AORN Guidelines.


The AORN Guidelines for Perioperative Practice, 2018 edition - Guideline for Sterilization.

Recommendation IX revealed in part: Surgical instruments and equipment should be cleaned and decontaminated according to the manufacturer's validated, written IFU. Items cannot be assumed to be clean, decontaminated, or sterile unless the manufacturer's IFU are derived from validation testing and the user has followed those instructions. Instructions for use provide users with validated techniques for processing instruments. Cleaning of instruments (i.e., removal of organic and inorganic soil) is the first step in decontamination and can be accomplished through manual or mechanical processes. The instrument and cleaning solution manufacturers have determined the manual or mechanical steps and processes necessary to effectively clean a device. Cleaning solutions should be changed before they become heavily soiled, when the temperature of the solution does not meet the temperature specified in the manufacturer's written IFU, and as needed.

Recommendation XIV revealed I part: Documentation of instrument cleaning and disinfection processes should be maintained. Documentation provides data for the identification of trends and demonstration of compliance with regulatory requirements and accreditation agency standards. Effective management and collection of health care information that accurately reflects the patient's care, treatment, and services is a regulatory requirement and accreditation agency standard for both hospitals and ambulatory settings.


4) failing to identify a semi-restricted area, according to professional standards of practice, in the IR department at OU Medical Center,

An observation of the IR department at OU Medical Center revealed a strip of red tiled floor in front of and slightly under the doors of each of the IR surgical suites, designating that the IR suites were restricted areas. There was no area designated as a semi-restricted area prior to entering each of the restricted surgical suites in the IR department. Each of the IR surgical suites opened directly into a hallway. The scrub sinks and the sterile supply storage area were also located in this hallway. Hospital staff were observed walking in this hallway in street clothes. There was no designation of this hallway being a semi-restricted area.


In an interview on 02/28/19 at 11:15 a.m. with Staff QQ and RR they indicated that the IR department did not have the hallway designated as a semi-restricted area anymore, after a remodeling of the area, and that the hallway directly outside of the IR surgical suites was not designated as semi-restricted anymore. Staff RR indicated that the IR department followed AORN Guidelines.


The AORN Guidelines for Perioperative Practice, 2018 edition - Guideline for Surgical Attire:

Recommendation IX revealed in part: Restricted areas in a surgical suite includes the OR, invasive and procedure rooms, and the clean core. People in the restricted areas are required to wear full surgical attire (scrub attire, head coverings, masks, and shoe covers as applicable) when sterile supplies are open and/or scrubbed personnel are present. The Semi-Restricted areas include the peripheral support areas of the surgical suite, the storage areas, the work areas, and corridors leading to the restricted areas of the surgical suite. People in the semi-restricted areas are required to wear surgical attire (scrub attire, head coverings, and shoe covers as applicable). The scrub sinks should be located in the semi-restricted or the restricted areas.


5) failing to store sterile supplies in a manner and/or in a location to prevent compromising sterility and contamination as evidenced by storing sterile supplies for future procedures in open baskets on shelves in the back hallway in the OR at OU Edmond,

An observation on 02/26/19 at 1:20 p.m. of the semi-restricted area of the OR revealed sterile supplies, in at least 12 plastic baskets, being stored on open shelves in a back OR hallway.


In an interview on 02/26/19 at 1:30 p.m. with Staff EE and II they indicated that sterile supplies for future OR procedures were pulled ahead of time and placed in baskets. They indicated that the back hallway was not temperature and humidity monitored in the same way as the sterile supply room. Staff II indicated that the OR followed AORN Guidelines.


A review of the AORN Guidelines for Perioperative Practice, 2018 edition- Guideline for Packaging Systems:

Recommendation III revealed in part: Sterilized items should be considered sterile until an event occurs to compromise the sterility of the sterile item such as, moisture penetration or unacceptable storage conditions, exposure to airborne and other environmental contaminants. The sterility of sterile items is event related and not time related. The sterility of an item does not change with the passage of time, but may be affected by particular events (such as, amount of handling) or environmental conditions (such as humidity, dust).


A review of AORN Guidelines for Perioperative Practice, 2018 edition - Guideline for Sterilization:

Recommendation XV revealed in part: Sterilized items should be stored in a manner to ensure sterility. Sterilized items should have limited exposure to moisture and humidity to decrease the potential contamination of the sterilized items. Factors that contribute to contamination include air movement, humidity, temperature, location of storage, traffic, presence of vermin, whether shelving is open or closed, and properties of the packaging material. Sterile packages should be stored under environmental controlled conditions.


6) failing to ensure that sterile folded cotton blankets were not used as positioning devices during patient's procedures

An observation on 02/26/19 at 1:50 p.m. of the sterile processing room at OU Edmond revealed several folded patient cotton blankets on the processing table.


In an interview on 02/26/19 at 1:50 p.m. Staff FF he indicated that the folded patient cotton blankets were packaged and sterilized and used as patient positioning devices during patient's surgical procedures. Staff FF indicated that the OR followed AORN Guidelines.


The AORN Guidelines for Perioperative Practice, 2018 edition - Guideline for Patient Positioning-

Recommendation V revealed in part: Perioperative team members should use OR beds, positioning equipment and devices, and support surfaces correctly. Positioning equipment and devices and support surfaces should be used in accordance with the manufacturer's IFU. Recommendation VII revealed in part: Perioperative team members should position patients on surfaces that reduce the potential for pressure injury. Patients should not be positioned on multiple layers of sheets, blankets, or other materials. Towels, sheets, and blankets should not be used as positioning devices. Using rolled or folded towels, sheets, or blankets as positioning devices increases pressure, contributes to friction injuries, and decreases the pressure-redistributing properties of the support surface.

Recommendation VIII revealed in Part: Perioperative team members should implement safe positioning practices. Patients undergoing surgical procedures are at increased risk for injury caused by compression or stretching of tissues during positioning. The patient who is sedated or has received a regional or general anesthetic may not be able to communicate or sense numbness, tingling, tissue temperature changes, or limitation of mobility; therefore, a proactive approach by the perioperative team is necessary to prevent positioning injury.


7) failing to ensure that disposable blue towels were not used as instrument tray corner guards (protectors) without ensuring this practice was validated by the towel manufacturer's IFU for use as instrument tray corner guards in order to ensure maximum airflow and moisture management during sterilization.

An observation on 02/26/19 at 1:50 p.m. of the sterile processing room at OU Edmond revealed stacks of folded surgical blue towels on the processing table.

In an interview on 02/26/19 at 1:50 p.m. Staff FF and KK they indicated that the folded blue towels were de-linted and were single use and disposable after use. Staff KK indicated that the folded blue towels were used under the 4 corners of the metal instrument trays prior to wrapping for sterilization to wick moisture away from the instrument tray after sterilization and to prevent break-through of the metal tray edges through the blue paper wrappers when storing on racks and with handling and transporting of the sterile instrument trays. Staff KK indicated that OU Edmond does not purchase the special instrument tray corner guard protectors. Staff FF indicated that the OR followed AORN Guidelines.


The AORN Guidelines for Perioperative Practice, 2018 edition - Guideline for Packaging System:

Recommendation I revealed in part: Manufacturers' IFU should be verified that the packaging system and packaging materials are intended for use with both the method(s) of sterilization and the specific equipment to be used.

Recommendation II revealed in part: Packaging systems and packaging materials should be compatible with the specific sterilization method for which they will be used. The interaction among packaging systems, packaging materials, medical devices, and sterilizer technologies is complex. Not all packaging systems and packaging materials are suitable for all methods of sterilization. Packaging systems and packaging materials for steam sterilization should permit steam penetration and adequate drying.