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4301 B VISTA

PASADENA, TX 77504

PATIENT RIGHTS: GRIEVANCES

Tag No.: A0118

Based on interview and record review, the facility failed to fully investigate grievances, including a third party patient representative complaint, regarding inability to retrieve timely medical records (Patient ID #2) and regarding patient discharged home with a retained peripheral IV catheter (Patient ID # 8).

Findings included:

Record review of facility policy titled "Patient-Related Complaints/Grievances", last reviewed 06/2022 showed:
"B. Surgery Specialty Hospitals of America will implement an effective mechanism/process for receiving and acting on patient complaints/grievances. This will be done by initiation of a patient/visitor-complaint/grievance form by the person first informed on the issue ....
C. Definitions:
1. Complaint-an issue which can be resolved easily between patient/family/significant other and Surgery Specialty Hospitals of America and its agents/representatives.
2. Grievance-an issue with a magnitude that cannot be resolved easily between and patient/family/significant other and Surgery Specialty Hospitals of America and its agents/representatives."

"5.0 Procedure. C. All complaints/grievances will initially be managed on a department-specific basis. Complaints/grievances will be addressed by the person receiving the complaint .... The Managers and Directors are responsible for review and completion of the Patient/Visitor Complaint/Grievance form, with submission of such to the Administrator/CNO within 24-48 hours.

During a telephone interview on 11/15/22 at 11:00 am, Roster ID # 67, a paralegal for Law Offices of Roster ID #68, spoke to surveyor. She stated that the firm requested medical records for Patient ID# 2 on multiple occasions. She confirmed that a letter with affidavits and HIPAA form had been sent to the facility, initially on 12/22/2020 and then again March 31, 2021. She stated that Attorney Staff ID # 68 had also faxed a repeat letter with requests and affidavits and had told the facility in the letter he would be filing a complaint with Texas Department of Health and Human Services.

Interview and medical record review 11/15/22 at 11:20 am with HIM Manager, Staff ID # 54 with medical record review of Patient ID # 2 medical record. She confirmed that they received a faxed request for medical records with affidavits on 03/31/2021 for Patient ID # 2. She confirmed that the letter included the grievance of prior requests being ignored and that the law firm would be filing a formal complaint with the state. She verified that she did not investigate further, did not contact the firm and did not forward the complaint to the quality department. She stated the "process would then be for Share Care representative (third party company that was contracted for uploading and handling third party requests) to come on-site and process the records". She confirmed that on 04/01/21 the initial "R" was her initial confirming receipt of the record request. She stated that Share Care representative "HB" copied/uploaded the medical record on 04/23/21. She confirmed that this meant there was 17 business days between record receipt and processing. She stated that some charts could be delayed in processing due to "deficiencies" which could include incomplete medical records (lacking dates, time and/or signatures). She confirmed that the "Tracking of Accountable Disclosures" form, located in the medical record was blank and should have been completed.

Interview 11/15/22 at 10:55 am with CNO, Staff ID #51 conducted. He verified the patient grievance and complaint log that had been provided to surveyors was accurate. When questioned where the grievances could be located on the report provided since there were none listed for an entire calendar year, he stated "we don't have ant grievances." Upon further interview, he was asked what constitutes a grievance. He stated "Grievance is higher magnitude. Nothing we've seen qualifies as a grievance."

Interview 11/15/22 at 09:20 am with Director of Quality, Staff ID #57 confirmed that Patient ID # 8 complaint had not been handled as a grievance. She stated she had not received training on the differences between grievance and complaints and she had not sent any letters explaining patients/families of the process within 72. She had not sent any letters explaining steps taken to investigate the complaint/grievance or results of investigation within 10 days per facility policy.

PATIENT RIGHTS: TIMELY REFERRAL OF GRIEVANCES

Tag No.: A0120

Based on record review and interview, the facility failed to follow its own policy and procedures in identifying, addressing, and resolving complaints and grievances in 2 out of 8 patients reviewed from the grievance and complaint log (Patient #2 and #8).

Findings include:

Review of the Complaint and Grievance log revealed complaints and grievances were logged by phone calls and emailed concerns from staff. There was a computerized reporting tool which logged issues under the subheadings: "grievances, HCAHPS, Adverse Events, Rapid Response/Code, Restraints, Wounds/Pressure Ulcers." The log was provided in quarterly sections. There were no grievances recorded on any of the quarterly reports and no grievances reported in the QAPI reporting to the governing body minutes for meetings on 4/22/22 and 7/27/22.

Review of complaints and grievances from 12/1/21 to 11/16/22 revealed the process for determining what was a complaint versus s a grievance was not clearly identified and lacked proper identification, means for addressing and compliance with regulatory requirements for notification for resolution.

Record review of facility policy titled "Patient-Related Complaints/Grievances", last reviewed 06/2022 showed:
"B. Surgery Specialty Hospitals of America will implement an effective mechanism/process for receiving and acting on patient complaints/grievances. This will be done by initiation of a patient/visitor-complaint/grievance form by the person first informed on the issue ....
C. Definitions:
1. Complaint-an issue which can be resolved easily between patient/family/significant other and Surgery Specialty Hospitals of America and its agents/representatives.
2. Grievance-an issue with a magnitude that cannot be resolved easily between and patient/family/significant other and Surgery Specialty Hospitals of America and its agents/representatives."

"5.0 Procedure. C. All complaints/grievances will initially be managed on a department-specific basis. Complaints/grievances will be addressed by the person receiving the complaint .... The Managers and Directors are responsible for review and completion of the Patient/Visitor Complaint/Grievance form, with submission of such to the Administrator/CNO within 24-48 hours. .... I. Documentation of the grievance, steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, the hospital's decision and the date of completion, will be maintained in written or computerized format for a period of not less than two years."

Interview 11/15/22 at 09:20 am with Director of Quality, Staff ID #57 confirmed that Patient ID # 8 complaint regarding a retained peripheral IV catheter after discharge home had not been handled as a grievance. She stated she had not received training on the differences between grievance and complaints and she had not sent any letters explaining patients/families of the process within 72. She had not sent any letters explaining steps taken to investigate the complaint/grievance or results of investigation within 10 days per facility policy.

Interview 11/15/22 at 10:55 am with CNO, Staff ID #51 conducted. He verified the patient grievance and complaint log that had been provided to surveyors was "accurate". When questioned where the grievances could be located on the report provided, since there were none listed for an entire calendar year, he stated "we don't have any grievances." Upon further interview, he was asked what constitutes a grievance. He stated "Grievance is higher magnitude. Nothing we've seen qualifies as a grievance." He confirmed that no grievances process letters or grievance investigation/resolution letters had been mailed in the preceding year. He confirmed that the "investigation" process that had been typed and signed by him and provided as evidence of their investigation process, were generated the morning of the survey by him, to describe the investigation process. He validated that there was limited documentation of investigation timeline and process.

Interview and medical record review 11/15/22 at 11:20 am with HIM Manager, Staff ID # 54 with medical record review of Patient ID # 2 medical record. She confirmed that they received a faxed request for medical records with affidavits on 03/31/2021 for Patient ID # 2. She confirmed that the letter included the grievance of prior requests for medical records being ignored and that the law firm would be filing a formal complaint with the state. She verified that she did not investigate further, did not contact the firm and did not forward the complaint to the quality department.

PATIENT RIGHTS: GRIEVANCE REVIEW TIME FRAMES

Tag No.: A0122

Based on interview and record review the facility failed to adhere to its grievance policy for 2 of 6 sampled patients with documented grievances (Patient ID# 2 and 8).

A) Patient ID #2 representative submitted a letter to the facility about failure to respond to medical record request on 03/31/2021 and he did not receive evidence of investigation or a written response from the facility.
B) Patient #8 family member called post-discharge called and stated they had been discharged from the facility with a peripheral IV catheter (hep-lock) in place. She stated they lived far away and could not return to facility for retrieval of the device. There was no documented letter explaining grievance process, limited investigation and no resolution letter sent.

Findings included:

Record review of facility policy titled "Patient-Related Complaints/Grievances", last reviewed 06/2022 showed:
"B. Surgery Specialty Hospitals of America will implement an effective mechanism/process for receiving and acting on patient complaints/grievances. This will be done by initiation of a patient/visitor-complaint/grievance form by the person first informed on the issue ....
C. Definitions:
1. Complaint-an issue which can be resolved easily between patient/family/significant other and Surgery Specialty Hospitals of America and its agents/representatives.
2. Grievance-an issue with a magnitude that cannot be resolved easily between and patient/family/significant other and Surgery Specialty Hospitals of America and its agents/representatives."

"5.0 Procedure. C. All complaints/grievances will initially be managed on a department-specific basis. Complaints/grievances will be addressed by the person receiving the complaint .... The Managers and Directors are responsible for review and completion of the Patient/Visitor Complaint/Grievance form, with submission of such to the Administrator/CNO within 24-48 hours. .... I. Documentation of the grievance, steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, the hospital's decision and the date of completion, will be maintained in written or computerized format for a period of not less than two years."

A1) Record review of complaint intake # TX00379847 revealed documentation by Patient ID# 2 representative, of an initial request for medical records which was sent to the facility on 12/22/20. Patient #2 representative provided documentation of repeat request for record which was sent on 03/31/21 with a letter accompanying medical record requests, affidavits and consents stating that he would be filing a formal complaint due to lack of facility response to a prior request for records in December 2020. The medical record had the letter faxed on 03/31/21 and initiated with an "R" and stated received 04/01/21 by Staff ID #54.

A2) Interview and medical record review 11/15/22 at 11:20 am with HIM Manager, Staff ID # 54 with medical record review of Patient ID # 2 medical record. She confirmed that they received a faxed request for medical records with affidavits on 03/31/2021 for Patient ID # 2. She confirmed that the letter included the grievance of prior requests for medical records being ignored and that the law firm would be filing a formal complaint with the state. She verified that she did not investigate further, did not contact the firm and did not forward the complaint to the quality department.

B1) Record review of complaint log revealed documentation by unknown staff member that Patient ID #8 representative called to report patient had been discharged home without removal of a peripheral IV catheter. The family member stated they lived far away and could not return to the facility for removal. There was no documented investigation of the sequence of events leading to this complaint and no grievance notification letter or resolution letter documented.

B2) Interview 11/15/22 at 09:20 am with Director of Quality, Staff ID #57 confirmed that Patient ID # 8 complaint regarding a retained peripheral IV catheter after discharge home had not been handled as a grievance. She stated she had not received training on the differences between grievance and complaints and she had not sent any letters explaining patients/families of the process within 72 hours. She had not sent any letters explaining steps taken to investigate the complaint/grievance or results of investigation within 10 days per facility policy. She stated occasionally that a "form apology letter" has been sent.

PATIENT RIGHTS: NOTICE OF GRIEVANCE DECISION

Tag No.: A0123

Based on interview and record review the facility failed to provide notice of grievance decision, per the facility's grievance policy, for 2 of 6 sampled complainants with documented grievances (Patient ID# 2 and 8).

A) Patient ID #2 representative submitted a letter to the facility about failure to respond to medical record request on 03/31/2021 and he did not receive evidence of investigation or a written response from the facility.
B) Patient #8 family member called post-discharge called and stated they had been discharged from the facility with a peripheral IV catheter (hep-lock) in place. She stated they lived far away and could not return to facility for retrieval of the device. There was no evidence of written response.

Refer to Tag A122 for evidence.

PATIENT RIGHTS: INFORMED CONSENT

Tag No.: A0131

Based on interview and record review, the facility failed to obtain appropriate informed consent for patients receiving surgical services in 15 of 23 records reviewed (ID#s 3-17)

Findings include:

Record review of facility policy titled " Informed Consent," dated 6/2022 showed the following information:
At surgery Specialty Hospitals of America the patient's medical record will contain evidence of the patient's informed consent prior to performance of any procedure or treatment for which it is normally appropriate, unless the patient needs immediate care to save his/her life.
Procedure:
A Determination of Risk:
1. Those risks which must be disclosed are referenced and attached in "List A" of the Texas Medical Disclosure Panel.

B. Documentation of consent
1. Once the provider has explained the procedure to the patient, the consent form may be signed in the Admitting Office or on the Patient Care Unit. The patient's signature is attesting to the fact that he/she has received sufficient information and is "informed."

D. Witnessing Signature
2. The signature of the person signing the Informed Hospital Consent will be witnessed by a professional hospital employee (preferably a nurse who will be caring for the patient).

Completion of the consent (generic or provider specific)
C. The following areas must be completed on the informed consent:
1. Name of the provider and/or providers who will be doing the medical or surgical procedure
2. The patient's condition that requires this procedure as understood by the patient.
3. The patient will initial if he/she consents (do/do not) to the use of blood products.
4. If the patient consents to the use of blood or blood products, indicate if the is to the donor unknown blood that will be supplied by the blood bank or autologus blood only.
5. The risks of the medical and/or surgical procedure must be listed including those required from list A if applicable.
6. Enter the date and time the patient or other legally responsible person signs the consent.
7. The person witnessing the signature will sign the consent and enter the address of the hospital.
8. The provider will sign, date and tie the form prior to the medical or surgical procedure.
9. The informed consent will be written in simple sentences (4th grade comprehension level) and in the primary language of the patient.

Record review of the Texas Medical Disclosure Panel Informed Consent Chapter 601 List A showed the following information:
RULE §601.2 Procedures Requiring Full Disclosure of Specific Risks and Hazards--List A
(a) Anesthesia.
(1) Epidural.
(A) Nerve damage.
(B) Persistent back pain.
(C) Headache.
(D) Bleeding/epidural hematoma.
(E) Infection.
(F) Medical necessity to convert to general anesthesia.
(G) Brain damage.
(H) Chronic pain.
(2) General.
(A) Permanent organ damage.
(B) Memory dysfunction/memory loss.
(C) Injury to vocal cords, teeth, lips, eyes.
(D) Awareness during the procedure.
(E) Brain damage.
(3) Spinal.
(A) Nerve damage.
(B) Persistent back pain.
(C) Bleeding/epidural hematoma.
(D) Infection.
(E) Medical necessity to convert to general anesthesia.
(F) Brain damage.
(G) Headache.
(H) Chronic pain.
(4) Regional block.
(A) Nerve damage.
(B) Persistent pain.
(C) Bleeding/hematoma.
(D) Infection.
(E) Medical necessity to convert to general anesthesia.
(F) Brain damage.
(5) Deep sedation.
(A) Memory dysfunction/memory loss.
(B) Medical necessity to convert to general anesthesia.
(C) Permanent organ damage.
(D) Brain damage.
(6) Moderate sedation.
(A) Memory dysfunction/memory loss.
(B) Medical necessity to convert to general anesthesia.
(C) Permanent organ damage.
(D) Brain damage.
(7) Prenatal/Early Childhood Anesthesia. Potential long-term negative effects on memory, behavior, and learning with prolonged or repeated exposure to general anesthesia/moderate sedation/deep sedation during pregnancy and in early childhood.


Record review of TITLE 25 Health Services Texas Medical Disclosure Panel Informed Consent Chapter 601
RULE §601.9 Disclosure and Consent Form for Anesthesia and/or Perioperative Pain Management (Analgesia)
The Texas Medical Disclosure Panel adopts the following form which shall be used to provide informed consent to a patient or person authorized to consent for the patient of the possible risks and hazards involved in anesthesia and/or perioperative pain management (analgesia). Providers shall have the form available in both English and Spanish language versions. Both versions are available from the Health and Human Services Commission.

(1) English form.
Attached Graphic

(2) Spanish form.
Attached Graphic

Source Note: The provisions of this §601.9 adopted to be effective January 16, 2012, 36 TexReg 8557; amended to be effective December 5, 2012, 37 TexReg 7487; amended to be effective January 15, 2015, 39 TexReg 8577; amended to be effective December 24, 2017, 42 TexReg 7408; amended to be effective June 1, 2020, 45 TexReg 1997

Review of medical record for patients (ID#s 3-17) showed anesthesia consent that did not disclose all List A risks and did not use the above mentioned adopted form.

Review of medical record for patient (ID#3) showed no time surgical and anesthesia consent was obtained for date of service 11/14/2022.
Review of medical record for patient (ID#4) showed no patient signature obtained on the anesthesia consent and no time documented on the surgical and anesthesia consent for date of service 11/14/2022.
Review of medical record for patient (ID#5) showed no patient signature obtained on the anesthesia consent and no time documented on the surgical and anesthesia consent for date of service 11/14/2022.
Review of medical record for patient (ID#6) showed no patient signature obtained or time documented on the anesthesia consent for date of service 8/30/2022.
Review of medical record for patient (ID#7) showed no time documented on the anesthesia consent for date of service 6/29/2022, 8/1/2022 and 8/3/2022.
Review of medical record for patient (ID#14) showed no witness signature on procedure consent or date of service 11/10/2022.
Review of medical record for patient (ID#17) showed no patient signature obtained on the anesthesia consent for date of service 11/14/2022.

Interview with facility administrator on 11/15/2022 at 0819, she stated that it is the expectation that all consents be signed, dated and timed appropriately. She was unaware of the adopted Texas Medical Disclosure Panel adopted for for anesthesia consent. She stated that all of the forms currently in use were approved by the governing body as well as Healthcare Facilities Accreditation Program (HFAP).

PATIENT RIGHTS: ACCESS TO MEDICAL RECORD

Tag No.: A0148

Based on record review and interviews, the facility failed to follow state regulations, including patient's rights for timely medical record access and retrieval, for 1 of 6 charts reviewed within 15 business days of the request (Patient ID #2).

Findings Included:
Record review of complaint intake # TX00379847 revealed documentation attachments by Patient ID# 2 representative, of an initial request for medical records which was sent to the facility on 12/22/20. Patient #2 representative provided documentation of repeat request for record which was sent on 03/31/21 with a letter accompanying medical record requests, affidavits and consents stating that he would be filing a formal complaint due to lack of facility response to a prior request for records in December 2020. The medical record had a copy of this letter with fax received on 03/31/21 and initiated with an "R" and stated received 04/01/21 by Staff ID #54.

Record review of State of Texas Health and Safety Code Section 241.154(a) stated Sec. 241.154. "REQUEST. (a) On receipt of a written authorization from a patient or legally authorized representative to examine or copy all or part of the patient's recorded health care information, except payment information, or for disclosures under Section 241.153 not requiring written authorization, a hospital or its agent, as promptly as required under the circumstances but not later than the 15th day after the date the request and payment authorized under Subsection (b) are received, shall:
(1) make the information available for examination during regular business hours and provide a copy to the requestor, if requested; or
(2) inform the authorized requestor if the information does not exist or cannot be found."

Record Review of facility policy "Patient Right to Access Protected Health Information", last reviewed 11/2019, stated "The staff should act on the request as soon as possible. The staff must act on the request within 30 days if the information is accessible and maintained onsite."

During a telephone interview on 11/15/22 at 11:00 am, Roster ID # 67, a paralegal for Law Offices of Roster ID #68, spoke to surveyor. She stated that the firm requested medical records for Patient ID# 2 on multiple occasions. She confirmed that a letter with affidavits and HIPAA release forms had been re-sent to the facility, initially on 12/22/2020 and then again March 31, 2021. She stated that Attorney Roster ID # 68 had also faxed a repeat letter with requests and affidavits and had told the facility in the letter he would be filing a complaint with Texas Department of Health and Human Services.

Interview and medical record review 11/15/22 at 11:20 am with HIM Manager, Staff ID # 54 with medical record review of Patient ID # 2 medical record. She confirmed that they received a faxed request for medical records with affidavits on 03/31/2021 for Patient ID # 2. She confirmed that the letter included the grievance of prior requests being ignored and that the law firm would be filing a formal complaint with the state of Texas Department of Health and Human Services. She verified that she did not investigate further, did not contact the firm and did not forward the complaint to the quality department. She stated their process "would then be for Share Care representative (third party company that was contracted for uploading and handling third party requests) to come on-site and process the records". She confirmed that on 04/01/21 the initial "R" was her initial confirming receipt of the record request. She stated that Share Care representative "HB" copied/uploaded the medical record on 04/23/21. She confirmed that this meant there was 17 business days between record receipt and processing. She stated that some charts could be delayed in processing due to "deficiencies" which could include incomplete medical records (lacking dates, time and/or signatures). She confirmed that the "Tracking of Accountable Disclosures" form, located in the medical record was blank and should have been completed. She stated she was not aware that state law required a response in 15 days.

PATIENT SAFETY

Tag No.: A0286

Based on interview and record review, the facility, Governing Body and Medical Staff failed to complete a root cause analysis (RCA) for 1 of 1 adverse events (intra-operative patient death) reviewed (Patient ID #11).

Findings included:

Record review of facility's grievance and complaint log included a document provided by Chief Nursing Officer, Staff ID # 51 which had the following categories labeled "grievances, HCAHPS, Adverse Events, Rapid Response/Code, Restraints, Wounds/Pressure Ulcers." Patient ID #11 was listed under the "Rapid Response/Code" section.

Record review of "Adverse Event/Sentinel Event/Root Cause Analysis" policy, last reviewed 08/2020, revealed "C. Measures to be taken following review of event. 1. If determined to be an adverse/sentinel event, a team including those involved in the event shall be assigned to investigate and conduct a "root cause analysis (RCA), which will be completed within 25 days2. Provide for an opportunity for staff to openly discuss the event to allow for healing. 3. Report of RCA team meetings shall be forwarded to the Medical Executive Committee. 4. All documents of investigation and the "Root Cause Analysis" shall be secured confidentially in the Performance Improvement Department."

Record review of facility policy titled "Variance Reporting Procedure/Adverse Events", last reviewed 06/2022, revealed following information:
"Purpose: to standardize the reporting and investigation of all variances at Surgery Specialty Hospitals of America. This standardized reporting procedure will provide the hospital with information on trends for prevention of variances and loss. Assist in the determination of the claim's potential of occurrences by prompt notification of variances. It defines the following terms: Variance: A variance is broadly defined as any occurrence that is not consistent with the routine operation of the hospital. There are four categories of variances: Adverse event, Root Cause Analysis, Patient and Visitor. Adverse event are injuries resulting from medical care, as opposed to adverse outcomes arising from underlying disease. Root Cause Analysis: A step by step method of discovering the first fault or root cause of a problem or why something has gone wrong."

Record review of facility's Quality Committee meeting minutes from 07/12/22 mentioned the Patient ID #11 death in OR but failed to discuss need for complete RCA or investigative quality process.

Phone interview 11/14/22 400 pm with Staff ID #69 revealed she was present in the operating room for Patient ID #11. She stated there was no root cause analysis performed with staff who were present. She stated administration told them to "not talk about it."

Interview with Director of Quality (Staff ID #57) on 11/15/22 at 1130 am revealed that there was no formal investigation or root cause analysis performed after the death of a patient in operating room (Patient ID #11). She provided an investigation record which included a short statement, from Staff ID #66, a partner of the surgeon who performed the case (Staff ID # which stated

Interview with Chief Nursing Officer (ID# 51) on 11/15/22 at 12:00 pm revealed that in regard to the adverse advent (unexpected death of a patient in operating room) that occurred with patient (ID# 11) on 5/20/22, there was no documentation of a root cause analysis (RCA) performed regarding the event.

CONTROLLED DRUGS KEPT LOCKED

Tag No.: A0503

Based on observation, interview, and record review, the facility failed to ensure controlled substances were secure in 1 of 2 clinical areas (OR# 4).

Findings include:

Observation on 11/14/2022 at 1048 in OR #4 anesthesia provider (ID# 61) came into the room and placed his anesthesia kit in the anesthesia cart. He left the room approximately 1-2 minutes later without locking the anesthesia cart. The anesthesia kit contained Fentanyl, Versed and Ephedrine. Staff members (ID#s 60 and 64) had unauthorized access to this medication.

Record review of facility policy titled "Controlled Substances in anesthesia and surgery," dated 4/21 showed the following information:
The medications issued in the anesthesia kit (AK) will be used on one patient only. After each procedure, the AK will be returned to the AK drawer at the OR Pyxis Medstation. A second AK will be withdrawn for the next procedure. The policy failed to address the security of the controlled substances in the anesthesia kit.

Interview with facility administrator (ID# 52) on 11/15/2022 at 0819, she stated that is was not acceptable for controlled substances to be left unlocked and unattended in the OR.

INFECTION CONTROL SURVEILLANCE, PREVENTION

Tag No.: A0750

Based on observation, interview and record review, the facility failed to follow acceptable standards of practice when using multi dose medications in 2 of 2 clinical areas (OR#3 and OR#4)

Findings include:

Record review of facility policy titled "Immediate use Compounding & Single/multi dose vial usage," dated 4/21 showed the following information:
Injectable medications will be purchased as single-dose vials whenever possible to prevent transmission of infection. If multi-dose vials must be used, will be labeled with a defined expire date from the date if initial opening to ensure sterility of drug product.

The beyond-use date (i.e., discard date) dating on opened multi-dose vials (MDV) will be 28 days or sooner (if expiration date of the first puncture, unless the manufacturer specifies otherwise or contamination is suspected or observed.

Review of Centers for Disease Control and Prevention (CDC) guidelines for multi dose vials states the following: Multi-dose vials should be dedicated to a single patient whenever possible. If multi-dose vials must be used for more than one patient, they should only be kept and accessed in a dedicated clean medication preparation area (e.g., nurses' station), away from immediate patient treatment areas. This is to prevent inadvertent contamination of the vial through direct or indirect contact with potentially contaminated surfaces or equipment that could then lead to infections in subsequent patients. If a multi-dose vial enters an immediate patient treatment area, it should be dedicated for single patient use only. Examples of immediate patient treatment areas include operating and procedure rooms, anesthesia and procedure carts, and patient rooms or bays.

Observation in Operating Room (OR) #4 on 11/14/2022 at 1024 staff RN (ID #60) gave 1% Lidocaine to surgical technologist (ID # 64) open, unlabeled MDV. Then staff RN (ID# 63) came into the operating room and retrieved an opened unlabeled bottle of Nitroglycerin/Dextrose 5% 0.2mg/ mL Solution infusion Bottle 250mL. Patient (ID# 3) was present in the OR.

Interview with staff (ID # 60) at the time of observation stated that they typically will use multi-dose medications for multiple patients and procedures throughout the day and tat they must sanitize with an alcohol swab each time. She went on to say medications that come in large amounts such as the Nitroglycerin are shared between operating room to prevent wasting.

Observation in OR #3 on 11/14/2022 at 1058 showed an unlabeled bottle of Nitroglycerin/Dextrose 5% 0.2mg/ mL Solution infusion Bottle 250mL. Staff RN (ID#63) confirmed it was the bottle retrieved from OR # 3. Patient (ID# 5) was present in the OR.


Review of product label for the bottle of Nitroglycerin/Dextrose 5% 0.2mg/ mL Solution infusion Bottle 250mL showed the following information: Sterile. Single dose container

Interview with CNO (ID# 51) on 11/14/2022 at 1110, he stated that it was ok for staff to share multi-dose medications between room as long as the medication is labeled and an alcohol swab is used before use. He stated that he was unaware of CDC guidelines for multi-dose medications.

POST-ANESTHESIA EVALUATION

Tag No.: A1005

Based on observation, interview, and record review, the facility failed to perform and accurately document post-anesthesia evaluations in 4 of 17 patients, (ID# s 3, 4, 5 and 17)

Observation on 11/14/2022 at 0956 patient (ID# 4) arrived in PACU and was accompanied by operating room nursing staff. At this time anesthetic post-operative note stating systems within normal limits post anesthesia was signed dated and timed by anesthesia provider (ID# 61). The time documented for the post anesthesia evaluation was 1030 (future time).

Review of medical record for patient (ID# 5) showed anesthesia provider (ID# 61)
was providing anesthesia services during surgery at 1030 on 11/14/2022.

Review of medical record for patient (ID# 17) showed anesthesia provider (ID# 61)
was providing anesthesia services at 1030 on 11/14/2022. Post anesthesia eval for patient (ID#17) was not completed and no time was documented.

Review of medical record for patient (ID#3) for date of service 11/14/2022 showed no time documented for the post-anesthesia evaluation.

Review of medical record for patient (ID#5) for date of service 11/14/2022 showed no time documented for the post-anesthesia evaluation.


Record review of facility Medical Staff Rules and Regulations, dated 2021 showed the following information:
E. All clinical entries in the patient's medical record shall be accurately dated, times and authenticated by written signature or identifiable initials as on file in the medical staff office.

Interview with DON (ID# 51) on 11/14/2022 at 1110, he stated that it is not acceptable to "pre time" post anesthesia assessments and that the information was not accurate. Documentation should include accurate signature, dates and times.