HospitalInspections.org

Based on record review and interview the facility failed to protect patients from harm by not ensuring that it's policies were being followed for identification of a patient prior to a lab procedure and an unauthorized person was allowed within the Laboratory for 1 of 1 Patients (Patient #1) in a sample of 10 records reviewed.

Findings:

A review of the facility policy titled, "Patient Rights and Responsibilities", last reviewed 09/21/2021, revealed: "...II. PURPOSE: Also known as "Patient Bill of Rights"...Rights Related to Safety: Patients shall have the right to receive care in a safe setting..."

A review of the facility policy titled, "Phlebotomy...Patient Approach and Consideration", last reviewed 03/11/2022, revealed: II. Patient Approach...B. Proper identification of the patient is mandatory. Before the procedure can take place, two forms of identification must be verified..."

A review of the facility policy titled, "Specimen Labeling and Handling", last reviewed 02/15/2022, revealed:...III. GUIDELINES/PROCEDURES A. Patient Identification: 1. Patient Who is Conscious a. Ask the patient to state his/her full name and date of birth...c. Report any discrepancy, however minor, to the responsible colleague in the area and have the patient identified by name and/or identification number before drawing any specimen..."

A review of the facility policy titled, "Restricted Laboratory Access", last reviewed 03/10/2022, revealed:..."Colleagues requiring access to the laboratory are granted badge or key code access as deemed appropriate by the laboratory managers...Recognizing the fact that the laboratory sees patients, some doors are left open during normal business hours to allow patients and visitors into laboratory waiting areas. These areas are monitored by colleagues who do not permit unauthorized access into the laboratory...At no time are unauthorized people allowed to be within the laboratory..."

A review of an Iris (computer-generated safety event) report that was entered by Laboratory (Lab)/Phlebotomy Manager I regarding an event (#481969) involving Patient (Pt.) #1 on 03/21/2023 at 10:00 AM revealed, "Individual (Pt. #1) presented in lab as a medical provider [Doctor Name] indicating she was there to work in Hematology (department in the lab). The lab colleague asked her to have a seat in the waiting room while she figured out who she was there to work with. Individual started to converse with an outpatient (Pt. #11) in the waiting room, Individual requested the outpatient accompany her into the draw room. Phlebotomist requested individual's name and date of birth prior to drawing the blood. Individual indicated she was [Doctor Name]. Individual told Phlebotomist she needed specific lab test and the tubes that were required. After the blood draw, the phlebotomist thought the individual knew the outpatient and left with him. Instead the individual entered the laboratory and knocked on the manager's door. Lab manager was meeting with a colleague and individual entered and shut the door. She called the lab manager by name and asked her if she remembered her. Lab manager recognized her as a former interview candidate for a phlebotomy position. Individual indicated she needed to meet with the lab manager. Lab manager said she was in a meeting with a lab colleague right now. Individual replied that I am a doctor now and looking for a job. Lab manager instructed individual open positions are posted online. Lab manager noticed a bandage on her arm and asked if she was an outpatient. Individual responded yes and then responded no I am an inpatient...Individual indicated she understood the application process and would apply online. Individual left manager's office and entered another lab office and addressed the clinical coordinator by name. Lab manager and clinical coordinator thought individual left the lab. Lab manager followed up with phlebotomist to understand how individual presented and how individual gained access to the lab. Individual did not leave the lab as thought, but went directly into the lab asking for a lab coat. The lab colleague asked what company the individual was from thinking she was there from [Hospital Name] and there to work in Hematology. The lab tech (technician) went to get her a lab coat. The Point of Care Facilitator for EWD (Eastern Wisconsin Division) overhear [sic] this and was suspicious because she did not recognize her from [Hospital Name]. Due to circumstances, the Point of Care Facilitator and Send out tech began to observe and followed individual out into the main hallway of the hospital. As lab manager was questioning the phlebotomist, the clinical coordinator of the lab presented with a concern that the individual was in the hallway in a [Hospital Name] logo lab coat. At the same time, lab manager contacted Security to assist. Lab manager asked her to remove the lab coat. Security arrived onsite and escorted her out of the hospital."

A review of follow-up documented by Lab Manager I regarding the "Safety/Security event" (#481969) that occurred on 03/21/2023 involving Patient (Pt.) #1 revealed, "This week there was an individual that came into the lab and was impersonating a medical provider. She indicated she was [Doctor Name] and here to work in Hematology. She also requested that she have lab work performed. She has been in our facility previously in other areas and demonstrated similar behavior. Our goal is to use this incident as a learning [sic] and make changes to improve the safety of the lab. There is a Root Cause Analysis (RCA) being performed and will continue to share learning's..."

During an interview on 04/05/2023 at 1:30 PM with Lab/Phlebotomy Manager I, when asked what the lab/phlebotomy process is when a person presents at the front desk for an outpatient lab draw, Manager I stated "What's supposed to happen: patient comes to the front window and gives name, date of birth and provider name, the office personnel goes into EPIC (electronic medical record system) to look under lab orders, once lab orders are verified then make a lab appointment, link the order, and then check the patient in." When asked if Pt. #1 gave information at the front desk on 03/21/2023 that matched in the EPIC system prior to getting a lab draw, Manager I stated, "There was no matching data that the patient gave."

During an interview on 04/05/2023 at 1:54 PM with Phlebotomist K, when asked what the process is regarding a patient that presents to the lab for a lab draw, Phlebotomist K states that patient comes directly to the Lab or from Registration, the Phlebotomist or Lab Receptionist lets them in and they go to the waiting room. Phlebotomist asks if they know the ordering Provider, if they are not in the system we ask if they are at the right hospital and also look in the EPIC (electronic medical record) in a faxed order section for orders, if there are no orders, we give the doctor a call to see if they can fax orders. When asked about labeling specimens, Phlebotomist K stated that the Phlebotomist double-checks that the name and date of birth are correct on the labels, then tubes are labeled and Phlebotomist writes the time of draw and initials. When asked about the Lab Safety Event involving an unidentified female who had labs drawn on 03/21/2023, Phlebotomist K stated "She gave me her name and date of birth, I told her I don't know what labs she needs; so she rattles off the tubes she needed and labs. I drew her labs and wrote her name and date of birth on the tubes and was going to look for orders after." Phlebotomist K confirmed that Pt. #1 was not identified in the EPIC system along with no lab orders in the system, Pt. #1 was identifying as a Doctor and was there to work in the Hematology Lab.

During an interview on 04/06/2023 at 12:36 PM with Medical Lab Technician T, when asked about his/her encounter with Pt. #1 in the Laboratory department, Technician T stated that he/she first saw Pt. #1 in the "CPA (central processing area) talking to someone, had a beanie and street clothes on. I walked over and heard her (Pt. #1) say to someone that she's working in Hematology and she asked for a lab coat." A lab colleague walked her down the lab hallway to the back of the lab to get a lab coat, she came back in the lab with a lab coat on. Technician T started questioning her, "she said she was leaving out the back lab door." Technician T and another lab colleague followed her out the back lab door down the hospital hallway that leads back to the main lab front desk, then Clinical Lab Coordinator [M] came out to intercept Pt. #1 in the hallway and brought her to his office where Security shortly came to escort her out of the hospital.

Proper identification verification of Pt. #1 did not happen prior to the Lab procedure (lab draw) taking place, and Pt. #1 was not authorized to be within the Laboratory per Hospital policies.