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Based on documentation review, it was determined the Hospital's Internal Investigation of Patient #1's Serious Reportable Event (SRE)/wrong-site procedure identified issues related to use of the Universal Protocol and Pre-Procedure Checklist, but failed to examine Universal Protocol/Pre-Procedure Checklist practices throughout the Hospital/beyond those utilized for Patient #1.

Findings included:

The Standard of Care for the prevention of wrong-site, wrong-procedure and/or wrong person surgery (or other invasive procedure) is development, implementation and consistent utilization of a Universal Protocol that includes: 1.) a pre-procedure verification process to ensure all relevant documents and studies are available prior to the start of the procedure and that they are reviewed and determined consistent with each other, the patient's expectations, and the team's understanding of the intended patient, procedure and site, 2.) marking of the intended site of incision or insertion for all cases involving laterality, multiple structures, or multiple levels (minimally), and 3.) taking a "time out" immediately before the start of the procedure to conduct a final verification of correct patient identity, patient position and marked incision/insertion site, agreement on the procedure to be performed, and as applicable; availability of correct preoperative imaging, implants and/or special equipment.

A review of the Hospital Internal Investigation associated with Patient #1's SRE/wrong-site procedure revealed the Investigation determined: the ED was very busy when Patient #1's chest tubes were inserted; ED Physician #1 did not review the CT scan or the CT scan report to confirm laterality prior to the insertion of the right-sided chest tube; ED RN #1 did not verify that the CT scan or CT scan report was reviewed to confirm laterality prior to the insertion of the right-sided chest tube; the insertion site was not marked, and; the Pre-Procedure Checklist was not followed/utilized appropriately.

The Hospital Internal Investigation did not examine Universal Protocol/Pre-Procedure Checklist practices throughout the Hospital/beyond those utilized for Patient #1.

Based on documentation review, it was determined the Hospital had not (yet) fully implemented its Corrective Action Plan related to its Investigation of Patient #1's SRE/wrong-site procedure.

Findings included:

Please see Tag A 288 for information regarding the Hospital's Investigation of Patient #1's SRE/wrong-site procedure.

A review of the Corrective Action Plan related to the Hospital Internal Investigation revealed it called for:
> Mandatory forwarding of "wet-read" imaging and/or imaging reports to the ED from Radiology/Imaging.
> Investigation into the possibility of installing a PACS (electronic picture archiving and communication system) in the ED Trauma Room.
> Modification of the ED Pre-Procedure Checklist to make the final verification process related to the review of imaging a 2-step/2-discipline procedure.
> Counseling/re-education of ED Physician #1 and ED RN #1.
> Re-education of ED nursing and physician staff regarding the Universal Protocol/Pre-Procedure Checklist.

A review of the implementation of the Corrective Action Plan revealed that as of 12/30/10:
> A PACS was ordered for, but not (yet) installed in, the ED Trauma Room.
> The ED Pre-Procedure Checklist was under revision, but not (yet) revised/ready for use.
> Re-education of the ED physician staff regarding the Universal Protocol and Pre-Procedure Checklist had not (yet) occurred.

Based on review of 12 medical records, it was determined documentation related to invasive procedure laterality was not consistently documented on in accordance with the Standard of Care on documents utilized in the pre-procedure verification process, and physician documentation was not consistently legible.

Findings included:

Please see Tag A 288 for information related to the Standard of Care for the prevention of wrong-site, wrong-procedure and/or wrong person surgery (or other invasive procedure).

The Standard of Care for the prevention of wrong-site surgery (or other invasive procedure) prohibits the use of abbreviations and/or symbols for the words left and right on relevant documents and studies.

The Pre-Procedure Checklists associated with Patient #1's 12/12/10 chest tube insertions did not include the laterality of the intended chest tube placements.

Patient #2 was scheduled for, and underwent, a left eye cataract extraction with intraocular lens implant on 12/6/10. Documentation related to chief complaint and treatment on Patient #2's associated Short Stay Form History and Physical was illegible and the Pre-Procedure Checklist indicated the surgical procedure to be performed was a L eye cataract extraction w/IOL. Also, the physician signatures on the Short Stay Form History and Physical and Patient #2's 12/6/10 Consent for Surgery/Procedure and Pre-Procedure Checklist were illegible.

Patient #3 was scheduled for, and underwent a percutaneous needle biopsy of the right lung on 12/7/10. The associated Pre-Procedure Checklist indicated the procedure to be performed was a CT-guided lung biopsy and the Pre-Procedure Identification and Final Verification sections were blank. Also, Patient #3's 12/7/10 Radiology Procedure Flowsheet indicated the procedure to be performed was a CT-guided biopsy of the Rt. lung.

Patient #4 was scheduled for, and underwent, a left total knee replacement on 12/10/10. The associated Pre-Procedure Checklist indicated the surgical procedure to be performed was a L total knee replacement. Also, the physician signature on the Pre-Procedure Checklist was illegible.

The physician signature on Patient #7's 12/10/10 Consent for Surgery/Procedure was illegible.

The documentation and physician signature on Patient #8's 12/8/10 Surgical Day Care Local Procedure Room Physician Form and Consent for Surgery/Procedure was illegible.

Patient #10 was scheduled for, and underwent a left S1 injection on 12/16/10. The associated Interventional Radiology Schedule indicated Patient #10 was scheduled for FL for needle biopsy, aspiration or injection.

The physician signature on Patient #11's 12/13/10 Consent for Surgery/Procedure was illegible.

Patient #12 was scheduled for, and underwent, an excision of a left nasal mass and an excision of a right eyelid lesion on 12/10/10. The associated Surgical Day Care Local Procedure Room Physician Form indicated Patient #12 had a L intranasal mass and a R eyelid lesion. Also, the physician signature on the Surgical Day Care Local Procedure Room Physician Form was illegible.

Based on the review of 11 medical records, it was determined the Consents for Surgery/Procedure for 2 out of 9 patients who underwent invasive procedures involving laterality were not completed in accordance with the Standard of Care.

Findings included:

Please see Tags A 288 and A 450 for information related to the Standard of Care for the prevention of wrong-site, wrong-procedure and/or wrong person surgery (or other invasive procedure).

1.) Patient #2 was scheduled for, and underwent, a left eye cataract extraction with intraocular lens implant on 12/6/10. The associated Consent for Surgery/Procedure indicated the surgical procedure to be performed was a cat ext w/IOL insert os.

2.) Patient # 7 was scheduled for, and underwent, a left S1 transforaminal steroid injection on 12/10/10. The associated Consent for Surgery/Procedure indicated the procedure to be performed was a (L) S1 SWRB.

Based on documentation review, it was determined the informed consent obtained for the placement of Patient #1's chest tube was not documented in accordance with Hospital policy/procedure.

Findings included:

The Hospital's Policy/Procedure titled "Informed Consent" indicated informed consent should be obtained from the patient (or other authorized person) before surgical procedures involving entry into the body through an incision or one of the natural body openings and: a Consent Form should be completed at the time of the consent; verbal/telephone consents are acceptable only in situations where written consent is impractical; in an emergency situation where immediate treatment is required to preserve the life, limb or mental well-being of the patient, oral consent will be obtained, and; if time does not permit oral consent or oral consent cannot be obtained, the physician may initiate the required procedure without consent.

Documentation indicated ED Physician #1 obtained verbal informed consent for the placement of Patient #1's right-sided chest tube from Patient #1's Mother. Documentation also indicated: Radiologist #1 notified ED Physician #1 of the small left apical pneumothorax at 11:58 AM and the Pre-Procedure Checklist associated with the right-sided chest tube was initiated at 12:40 PM.