HospitalInspections.org

Based on observation, it was determined the facility failed to ensure means of egress are unobstructed in the Operating Room Suite.

Findings include:

On 6/30/21 at 11:00 AM in the presence of Staff #5, cross-corridor doors were covered with a single sheet of plastic.

a. During an interview, Staff #5 stated, "the plastic was up to deter staff from using the corridor."

b. Staff #5 also confirmed no Interim Life Safety Plan was established for the temporary exit obstruction.

Based on observation, staff interviews, and review of facility documents, it was determined the facility failed to ensure surgical services are provided in accordance with acceptable standards of practice to minimizes the risk of surgical infections.

Findings include:

1. The facility failed to ensure surgical procedures are not performed in rooms located in the Cardiac Catherization Lab and failed to ensure surgical procedures are performed in a sterile environment. (Cross refer to Tag A-951).

A. Based on observation, staff interviews, and review of facility documents, it was determined the facility failed to ensure surgical procedures are not performed in rooms located in the Cardiac Catherization Lab and failed to ensure surgical procedures are performed in a sterile environment.

Findings include:

Reference #1: Facility document, "Plan for the Provision of Patient Care/Service" states, "Cardiac Catherization Lab... The hours of operation are 7 a.m. to 5:30 p.m., Monday through Friday for both inpatient and outpatient cardiac diagnostic procedures along with elective angioplasty under the New Jersey Demonstration Project, peripheral diagnostic and interventional procedures, and pacemaker procedures."

Reference #2: Facility document, "[Name of Facility] Department of Surgery Rules and Regulations" states, "... If a case requires general anesthesia, it must be referred to a member of the Department of Surgery and done in the operating room. ... ."

Reference #3: Facility policy, "Infection Control - Operating Room" states, "... Preparation and Practice... The circulating nurse establishes and maintains a safe environment for the patient adhering to strict aseptic and sterile technique. ... 8. The OR must be cleaned between each surgical operation... Responsibilities and Procedures for Care of Equipment and/or Materials... 1. Equipment and/or Materials... Items made for single use shall be discarded. ... c. Sterile supplies or medication shall be stored in a clean area. ... ."

1. During the entrance conference on 6/28/21 at 9:50 AM, Staff #1 confirmed the facility was performing surgical procedures in the Cardiac Catherization (Cath) lab due to the temporary closure of Operating Rooms (ORs) in the Main OR suite.

2. A tour of the Cardiac Cath Lab Suite on 6/28/21 at 2:25 PM revealed the following:

a. Surgical items, such as Styrofoam headrests, tubing in plastic bags, surgical equipment, canisters for the anesthesia machine, oxygen masks, and suction tubing were observed lying on a counter. The counter was cluttered, with no clean space observed.

(i) Upon interview at 2:30 PM, Staff #8 confirmed the surgical items remain on the counter between cases. He/she stated, "We leave the items on the counter so anesthesia (the Anesthesiologist) can grab them when they need them. We really don't have anywhere else to put them."

b. A corrugated box was located in the back of the room.

c. A bin containing bottles of sevofluorane (an anesthesia gas), mixed with other surgical supplies, was located on top of the anesthesia cart.

d. The radiology bed for Cardiac Cath Lab procedures was located in the center of the room. A surgical bed used by OR patients was observed approximately two (2) feet to the left of the radiology bed. Staff #6 confirmed the surgical bed is used for patients during surgical cases and is "always to the side" of the radiology bed.

(i) The positioning of the surgical bed prohibits laminar airflow from being directly over the patient and the surgical team, increasing the risk of potential surgical site infections.

3. Staff #1, Staff #5, Staff #6, and Staff #8 confirmed the above findings on 6/28/21 at 3:00 PM.

4. On 6/28/21, Staff #1 was notified that the above findings resulted in an Immediate Jeopardy (IJ). A copy of the completed IJ template was provided to the facility on 6/28/21 at 6:00 PM. An acceptable removal plan was received on 6/29/21 at 2:30 PM. All elements of the removal plan were implemented on 6/30/21, the last day of the survey, and the IJ was lifted.

B. Based on staff interviews and review of facility documents, it was determined the facility failed to ensure the Chair of the Department of Surgery develops and implements policies and procedures regarding the use of the Cardiac Cath Lab and Minor Treatment Rooms for surgical procedures.

Findings include:

Reference: Facility document, "[Name of Facility] Department of Surgery Rules and Regulations" states, "... Leadership... The responsibilities of the Chair are specified in the Bylaws of the Medical Staff... and require that the Department Chair is responsible for the following... All clinically related activities of the Department... The development and implementation of policies and procedures that guide and support the provision of services... ."

1. Upon interview on 6/28/21 at 10:00 AM, Staff #1 confirmed that beginning June 11, 2021, the facility performed surgical procedures requiring general anesthesia in Minor Treatment Rooms (MTRs) #1 and #2 and the Cardiac Cath lab, due to the temporary closure of ORs in the Main OR suite.

a. The use of MTRs #1 and #2 for surgical cases requiring general anesthesia was discontinued subsequent to a Department of Health (DOH) survey conducted on 6/22/21.

2. Upon interview on 6/29/21 at 2:45 PM, Staff #24 stated the decision to utilize MTRs #1 and #2 and the Cardiac Cath Labs for surgical cases, was made after collaborative discussions with the facility's Leadership personnel that included Staff #23, the Chair of the Department of Surgery.

3. During a telephone interview with Staff #23 on 6/30/21 at 10:35 AM, Staff #23 identified him/herself as the Chair of the Surgery Department and a member of the OR Advisory Committee. Staff #23 confirmed he/she was involved in the decision to permit surgical procedures requiring general anesthesia to be performed in MTRs #1 and #2 and the Cardiac Cath labs.

a. Upon interview, Staff #23 stated the facility was capable of performing surgical cases requiring general anesthesia in MTRs #1 and #2 and the Cardiac Cath Labs "because the spaces have gas lines to hook up to the anesthesia machines." Staff #23 stated, "Not all cases go in those rooms. Only select cases go in those rooms. Every day I go over the OR schedule to determine what cases can go in those rooms."

b. Staff #23 was asked if he/she developed criteria to determine what cases would be performed in MTRs #1 and #2 and the Cardiac Cath Labs. Staff #23 stated, "Yes, I developed criteria, but it's in my head. I never wrote it down. I know what's appropriate and everything is run by me. I'm available 24/7 so I didn't feel I had to write anything down."

c. Staff #23 was asked how surgeons and surgical teams were made aware of the criteria used to determine which surgical procedures would be performed in MTRs #1 and #2 or the Cardiac Cath Labs. He/she stated, "If the surgeons have an issue, they know they can call me and we can discuss it. Then, as the process goes on we refine it. They get the information when they call me. I can't say that I spoke to every one of my medical staff, but we haven't gotten any complaints from doctors."

d. Upon interview, Staff #23 confirmed there was no written criteria for the use of MTRs #1 and #2 or the Cardiac Cath Labs that was disseminated to all surgeons and surgical teams.

Based on review of three (3) of four (4) medical records (#4, #9, #12), staff interviews, and review of facility documents, it was determined the facility failed to ensure a review of the patient's condition, immediately prior to the induction of anesthesia, includes documentation of changes to the patient's condition from the previous pre-anesthesia evaluation.

Findings include:

Reference: Facility document, "Rules and Regulations of the Department of Anesthesiology" states, " ... Anesthesia Patient Services ... 2. A review of the patient's condition immediately prior to induction of anesthesia is required. ... together with an appraisal of any changes in the patient's condition compared with that noted on previous visits."

1. Review of Medical Record #4 on 6/30/21 at 2:05 PM, revealed the following:

a. The patient arrived to the facility on 6/17/21 for an outpatient procedure. The "Pre-Operative Anesthesia Evaluation" form dated 6/17/21 states, "Pre-Proc. Eval (Must be completed day of procedure only)." The following boxes, indicating whether there were changes from the patient's previous pre-anesthesia evaluation, were left blank:

(i) Pt. re-evaluated and following changes noted

(ii) None

2. Review of Medical Record #9 on 6/30/21 at 11:40 AM, revealed the following:

a. The patient arrived to the facility on 6/22/21 for an outpatient procedure. The "Pre-Operative Anesthesia Evaluation" form dated 6/22/21 states, "Pre-Proc. Eval (Must be completed day of procedure only)." The following boxes, indicating whether there were changes from the patient's previous pre-anesthesia evaluation, were left blank:

(i) Pt. re-evaluated and following changes noted

(ii) None

3. Review of Medical Record #12 on 6/30/21 at 12:18 PM, revealed the following:

a. The patient arrived to the facility on 6/28/21 for an outpatient procedure. The "Pre-Operative Anesthesia Evaluation" form dated 6/28/21 states, "Pre-Proc. Eval (Must be completed day of procedure only)." The following boxes, indicating whether there were changes from the patient's previous pre-anesthesia evaluation, were left blank:

(i) Pt. re-evaluated and following changes noted

(ii) None

4. Staff #1, Staff #2, Staff #3, Staff #5, and Staff #24 confirmed the above findings on 6/30/21 at 3:30 PM.

A. Based on review of two (2) of four (4) medical records (#4, #9), staff interviews, and review of facility documents, it was determined that the facility failed to ensure that pre-operative anesthesia evaluations are performed by anesthesiologists.

Findings include:

Reference: Facility document, "Rules and Regulations of the Department of Anesthesiology" states, "... Duty Description... Physician Anesthesiologist... B. Specific Duties... 7. Develop the patient's individualized anesthesia plan based upon the medical and surgical history and physical and the pre-anesthesia assessment. ... Anesthesia Patient Services... 1. The pre-anesthesia evaluation of a patient by a physician is required, with appropriate documentation in the patient's medical record... ."

1. Review of Medical Record #4 on 6/30/21 at 2:05 PM, revealed the following:

a. The patient arrived to the facility on 6/17/21 for an outpatient procedure. On the "Pre-Operative Anesthesia Evaluation" form, the section marked "Preop Evaluation by" was signed on 6/17/21 at 12:05 PM.

(i) Review of staff signatures on the anesthesia record indicated that the "Pre-Operative Anesthesia Evaluation" form was completed by a Certified Registered Nurse Anesthetist (CRNA), not a physician anesthesiologist.

2. Review of Medical Record #9 on 6/30/21 at 11:40 AM, revealed the following:

a. The patient arrived to the facility on 6/22/21 for an outpatient procedure. On the "Pre-Operative Anesthesia Evaluation" form, the section marked "Preop Evaluation by" was signed on 6/22/21 at 7:20 AM.

(i) Review of staff signatures on the anesthesia record indicated that the "Pre-Operative Anesthesia Evaluation" form was completed by a CRNA, not a physician anesthesiologist.

3. Staff #1, Staff #2, Staff #3, Staff #5, and Staff #24 confirmed the above findings on 6/30/21 at 3:30 PM.


38289

B. Based on staff interview, review of ten (10) of fifteen (15) medical records (#1, #2, #3, #5, #6, #8, #10, #11, #13, #14), and review of facility policy and procedure, it was determined the facility failed to ensure pre-anesthesia evaluation forms are complete.

Findings include:

Reference: Facility policy, "Perioperative Care: Pre-operative Phase" states, " ... Patient Assessment and Anesthesia Care Plan: The patient is assessed prior to the start of the procedure and an anesthesia care plan is developed which addresses the needs of each individual patient... Elements of the assessment include, but are not limited to the following: Review of medical and surgical history... Review of laboratory testing... Review of cardiac studies, if any... Review of radiologic reports, if any... Physical examination of the patient... Assessment of the patient airway... Patient interview... Determination of ASA Classification based on ASA Guidelines... ."

1. Review of Medical Record #1 on 6/29/21 revealed the following:

a. On the "Pre-Operative Anesthesia Evaluation" form signed on 6/14/21 at 7:56 AM, the following sections were left blank:

(i) Hx (History) Anesth. (Anesthesia) Problem.

(ii) The section that discussed postop (postoperative) pain management.

2. Review of Medical Record #2 on 6/29/21 revealed the following:

a. On the "Pre-Operative Anesthesia Evaluation" form signed on 6/14/21 at 1:30 PM, the following sections were left blank:

(i) PONV (post-operative nausea vomiting).

(ii) The section labeled "Data" did not indicate that the medical evaluation had been reviewed.

(iii) The section that discussed a patient re-evaluation that states, "Must be completed day of the procedure only."

(iv) The CRNA failed to print out his/her completed name under his/her signature.

3. Review of Medical Record #3 on 6/29/21 revealed the following:

a. On the "Pre-Operative Anesthesia Evaluation" form signed on 6/15/21, the following sections were left blank:

(i) The time that the "Pre-operative Anesthesia Evaluation" form was completed.

(ii) Allergies/Reactions.

(iii) Post-op Nausea or Vomiting.

(iv) The section that discussed postop pain management.

(v) The section labeled "Data" did not indicate that the medical evaluation had been reviewed.

b. The section labeled "Pre-Proc. (pre-procedure) Eval. (evaluation)" was missing the following elements:

(i) Completion of the patient re-evaluation with any changes.

(ii) Current vital signs including: blood pressure, heart rate, oxygen saturation, respiratory rate, and temperature.

(iii) The time the patient had last eaten.

4. Review of Medical Record #5 on 6/29/21 revealed the following:

a. On the "Pre-Operative Anesthesia Evaluation" form signed on 6/16/21 at 10:50 AM, the following sections were left blank:

(i) The section that discussed postop pain management.

(ii) The section labeled "Data" did not indicate that the medical evaluation had been reviewed.

(iii) The CRNA failed to print out his/her completed name under his/her signature.

5. Review of Medical Record #6, on 6/30/21, revealed the following:

a. On the "Pre-Operative Anesthesia Evaluation" form signed on 6/18/21 at 10:31 AM, the following sections were left blank:

(i) The section that states, "The following plan including risks/benefits/alternatives/complications discussed with & accepted by."

(ii) The section labeled "Data" did not indicate the medical evaluation had been reviewed.

(iii) The section labeled "Pre-Proc. Eval." was missing the patient's temperature.

b. On the "Pre-Operative Anesthesia Evaluation" form that was completed on 6/18/2021 at 9:10 AM, the following sections were left blank:

(i) Hx (History) Anesth. (Anesthesia) Problems.

(ii) The section labeled "Pre-Proc. Eval." was missing the completion of the patient re-evaluation with any changes.

6. Review of Medical Record #8 on 6/30/21 revealed the following:

a. On the "Pre-Operative Anesthesia Evaluation" form signed on 6/14/21 at 6:49 PM, the following sections were left blank:

(i) The section that discussed postop pain management.

(ii) The section labeled "Data" did not indicate the medical evaluation had been reviewed.

(iii) The section labeled "Data" did not indicate the patient's PT/INR/PTT lab values. The patient had a history of thrombocytosis and the PT/INR/PTT lab values were available at the time of the evaluation.

(iv) The Anesthesiologist failed to print out his/her completed name under his/her signature.

7. Review of Medical Record #10 on 6/30/21 revealed the following:

a. On the "Pre-Operative Anesthesia Evaluation" form signed on 6/24/21 at 1:30 PM, the following sections were left blank:

(i) Post op Nausea Vomiting.

(ii) The section that discussed postop pain management.

(iii) The section labeled "Pre-Proc. Eval." was missing the completion of the patient re-evaluation with any changes.

8. Review of Medical Record #11 on 6/30/21 revealed the following:

a. On the "Pre-Operative Anesthesia Evaluation" form, signed on 6/28/21 at 8:04 AM, the following sections were left blank:

(i) Hx (History) Anesth. (Anesthesia) Problems.

(ii) The patient's age, height, and weight.

(iii) The section that discussed postop pain management.

(iv) The section labeled "Data" did not indicate the medical evaluation had been reviewed and did not have the lab values of the patient's hematocrit, platelets, PT/INR/PTT, and glucose.

(v) The section labeled "Pre-Proc. [pre-procedure] Eval. [evaluation]" was missing the completion of the patient re-evaluation with any changes.

(vi) The Anesthesiologist failed to print out his/her completed name under his/her signature.

9. Review of Medical Record #13 revealed the following:

a. On the "Pre-Operative Anesthesia Evaluation" form signed on 6/28/21 at 12:34 PM, the following sections were left blank:

(i) Hx (History) Anesth. (Anesthesia) Problems.

(ii) The patient's age, height, and weight.

(iii) The section that discussed postop pain management.

(iv) The section labeled "Pre-Proc. Eval." was missing the completion of the patient re-evaluation with any changes.

(v) The section labeled "Pre-Proc. Eval." was missing the patient's respiratory rate, temperature, and the time at which the patient had last eaten.

(vi) The Anesthesiologist failed to print out his/her completed name under his/her signature.

10. Review of Medical Record #14 revealed the following:

a. On the "Pre-Operative Anesthesia Evaluation" form signed on 6/15/21, the following sections were left blank:

(i) The time the "Pre-operative Anesthesia Evaluation" form was completed.

(ii) Hx (History) Anesth. (Anesthesia) Problems.

(iii) The section that discussed postop pain management.

(iv) The section labeled "Pre-Proc. Eval." was missing the following information: blood pressure, heart rate, oxygen saturation, respiratory rate, temperature, and the time which the patient had last eaten.

11. Upon interview on 6/30/21, Staff #1 confirmed the expectation is for the "Pre-Operative Anesthesia Evaluation" forms to be completely filled out.

Based on staff interview, review of ten (10) of fifteen (15) medical records (#1, #2 #3, #5, #6, #8, #11, #13, #14, #15), and review of facility policies and procedures, it was determined the facility failed to ensure complete intraoperative anesthesia records are maintained.

Findings include:

Reference #1: Facility policy, "Perioperative Care: Intra-operative Phase" states, "I. Procedure: A. During the intra-operative phase, the patient is continuously monitored and assessed by a qualified member of the anesthesia care team using parameters that are appropriate for the patient's condition and procedure to maximize patient safety and quality of care... ."

Reference #2: Facility document, "Rules and Regulations of the Department of Anesthesiology" states, " ... B. Intra-Anesthetic Period... 1. A record of anesthesia that conforms to the policies and procedures developed by the Medical Staff shall be made for each patient receiving sedation or anesthesia at any anesthetizing location. The Anesthesia Record shall note all pertinent events taking place during the induction of, maintenance of and emergence from anesthesia. ... ."

1. Review of Medical Record #1 on 6/29/21, revealed the "Anesthesia Record" was missing documentation in the following areas:

a. The "Supervising Clinician Signature" with a date and time, and the box that stated "Personally participated in emergence," was not filled out and signed.

2. Review of Medical Record #2 on 6/29/21, revealed the "Anesthesia Record" was missing documentation in the following areas:

a. In the section labeled "Post-Anesthesia Evaluation," the clinician's name was not printed under the signature.

b. In the section labeled "Signature of Responsible Clinician(s) at Induction," the area that noted the MD/DO Signature, printed name, and date and time were left blank.

3. Review of Medical Record #3 on 6/29/21, revealed the "Anesthesia Record" was missing documentation in the following areas:

a. The section labeled "IV Antibiotic Name" identified the medication "Ancef" was given, but did not indicate the dose of the antibiotic and the start time the antibiotic was given.

b. The section labeled "Emergence" did not indicate if the patient had "Adequate NIF, TV, SaO2, head lift," was "Suctioned/Extubated," or was "intubated," and if "O2 for transport" was needed. The section did not indicate where the patient was transported to and if the handoff protocol/checklist was followed. The post-procedure general condition area was not completed.

c. The section labeled "Post-Anesthesia Evaluation," was missing the assessment for the patient's mental status, Cardiac/Respiratory/Airway Status, Postop Nausea/Vomiting, Hydration and Pain.

d. The section labeled "Controlled Medications" was missing the totals of the medications given.

e. The "Supervising Clinician Signature" with a date and time, and the box that stated "Personally participated in emergence" was not filled out and signed.

4. Review of Medical Record #5 on 6/29/21 revealed that the "Anesthesia Record" was missing documentation in the following areas:

a. The section labeled "Position" was not completed.

b. In the section labeled "Post-Anesthesia Evaluation," the clinician's name was not printed under the signature.

c. The section labeled "Post-Anesthesia Evaluation" was missing the assessment for pain.

d. The section labeled "Controlled Medications" was missing the totals of the medications given.

e. In the section labeled "Signature of Responsible Clinician(s) at Induction," the area that noted the MD/DO Signature, printed name, and date and time were left blank.

f. The "Supervising Clinician Signature" with a date and time, and the box that stated "Personally participated in emergence" was not filled out and signed.

5. Review of Medical Record #6 on 6/30/21 revealed that the "Anesthesia Record" was missing documentation in the following areas:

a. The section labeled "Invasive Lines" was left blank.

b. The section labeled "Post-Anesthesia Evaluation" was missing the assessment for pain.

c. The section labeled "Controlled Medications" did not have the correct total for the medication "Fentanyl" and the total amount given for the medication "Ketamine" was left blank.

d. In the section labeled "Signature of Responsible Clinician(s) at Induction" the MD/DO area was missing documentation indicating whether he/she had personally participated in the induction, and the date and time of the induction. The CRNA section was missing the time of the induction.

e. The "Supervising Clinician Signature" with a date and time, and the box that stated "Personally participated in emergence" was not filled out and signed.

6. Review of Medical Record #8 on 6/30/21 revealed that the "Anesthesia Record" was missing documentation in the following areas:

a. The section labeled "Controlled Medications" was missing the total amount given of the medication "Precedex".

b. In the section labeled "Signature of Responsible Clinician(s) at Induction," the MD/DO area was missing whether he/she had personally participated in the induction and the printed name of the clinician.

c. The "Supervising Clinician Signature" was signed but was missing the date, time and printed name of the clinician. The box that stated "Personally participated in emergence" was left blank.

7. Review of Medical Record #11 on 6/30/21 revealed that the "Anesthesia Record" was missing documentation in the following areas:

a. The "Anesthesia Time-Out" was not completed.

b. The "Post-Procedure General Condition" did not indicate the patient's respiratory rate.

c. The section labeled "Post-Anesthesia Evaluation" did not have the clinician's printed name.

d. The section labeled "Controlled Medications" was missing the totals of all medications given.

e. The section labeled "Signature of Responsible Clinician(s) at Induction," the MD/DO area was missing the printed name of the clinician.

f. The "Supervising Clinician Signature" was signed but was missing the time and printed name of the clinician.

8. Review of Medical Record #13 on 6/30/21 revealed that the "Anesthesia Record" was missing documentation in the following areas:

a. The "Anesthesia Time-Out" was not completed.

b. The section labeled "Emergence" did not indicate if the patient had "Adequate NIF, TV, SaO2, head lift," was "Suctioned/Extubated," or was "intubated," and if "O2 for transport" was needed. The section did not indicate where the patient was transported to and if the handoff protocol/checklist was followed. The post-procedure general condition area was not completed and the patient's temperature was not recorded.

c. The name of the surgeon was left blank.

d. The section labeled "Post-Anesthesia Evaluation" was missing the patient's temperature. The printed name of the anesthesiologist was left blank.

e. The section labeled "Controlled Medications" was missing the totals of all medications given.

f. In the section labeled "Signature of Responsible Clinician(s) at Induction," the MD/DO area was missing the printed name of the clinician.

g. The "Supervising Clinician Signature" was signed but was missing the time and printed name of the clinician.

9. Review of Medical Record #14 on 6/30/21 revealed that the "Anesthesia Record" was missing documentation in the following areas:

a. The section labeled "Invasive Lines" was left blank.

b. The section labeled "Post-Anesthesia Evaluation" was missing the assessment for mental status, cardiac/resp/airway status, postop nausea/vomiting, hydration, and pain.

c. The section labeled "Controlled Medications" was missing the totals of all medications given.

d. The "Supervising Clinician Signature" was signed but was missing the printed name of the clinician. The box that stated "Personally participated in emergence" was left blank.

10. Review of Medical Record #15 on 6/30/21 revealed that the "Anesthesia Record" was missing documentation in the following areas:

a. The time of the "Surgical Time-Out" was left blank.

b. The section labeled "Controlled Medications" was missing the totals of all medications given.

c. The "Supervising Clinician Signature" with a date and time, and the box that stated
"Personally participated in emergence" was not filled out and signed.

11. Upon interview on 6/30/21, Staff #1 confirmed that the expectation is for the "Anesthesia Records" to be completely filled out.