St Francis-Downtown

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 36779 Based on observation, interview, and review of patient records, QAPI documents and hospital policy, the hospital failed to implement measures to ensure patient safety after a cytology specimen was misidentified for one of four patient records reviewed for laboratory services, Patient 1 (P1), and P1 underwent a second cystoscopy procedure based on the incorrect diagnosis from the misidentified cytology slide. Findings included: Cross Reference A286 Patient Safety - The hospital failed to ensure laboratory services met the needs of it’s patients when a cytology specimen was misidentified for one of four patient records reviewed, Patient 1 (P1) reviewed for laboratory specimens.”

“LABORATORY SERVICES CFR(s): 482.27 The hospital must maintain, or have available, adequate laboratory services to meet the needs of its patients. The hospital must ensure that all laboratory services provided to its patients are performed in a facility certified in accordance with Part 493 of this chapter. This Condition is not met as evidenced by: 36779 Based on observation, interview, and review of patient records, the hospital failed to ensure laboratory services met the needs of it’s patients when a cytology specimen was misidentified for one of four patient records reviewed, Patient 1 (P1) reviewed for laboratory specimens. P1 underwent a second cystoscopy due to the incorrect diagnosis from the misidentified cytology specimen. Findings included: During an observation of the Laboratory Department on 10/28/25 at 1:06 PM, Cytologist 1 (C1) was interviewed. C1 explained the process of receiving and processing cytology specimens. C1 stated they made the Thin Prep slides (a type of cytology slide prepared using a liquid-based method that creates a thin, even layer of cells for microscopic examination) in a machine called a Hologic. C1 stated the slide goes into the Hologic machine with the vial containing the specimen pellet (created after centriguge of the specimen) and the machine creates the slide with the specimen on it (Thin Prep). C1 stated they write on the slides by hand and label them with (including but not limited to) the patient last name and first initial, accession number (unique identifier given to a specimen when it arrives in the laboratory), and specimen source. C1 stated they have multiple vials at the machine waiting because the machine only creates one Thin Prep slide at a time. When asked how many would be on the counter waiting for the Hologic machine, C1 stated, “Maybe five.” When asked if the process had changed recently, C1 stated previously they would hand label all of the slides for multiple vials and they would be “all lined up” sitting on the counter by the Hologic machine. C1 stated, now they hand label one slide at a time, so multiple vials may be sitting on the counter by the Hologic machine, but they label one slide at a time. In an interview with the Medical Laboratory (Lab) Scientist (MLS) on 10/20/25 at 12:20 PM, he/she stated P1 had a surveillance cystocscopy in August of 2025 and when Cytology processed the urine sample they had another slide for another patient who had multiple slides. The MLS stated P1’s slide showed malignant cells so P1 was schedued for another cystoscopy procedure later that month and when the doctor saw no tumor he/she stopped and talked with the Pathologist. The MLS stated, “That’s when they figured it out.” On 10/30/25 at 10:50 AM, Pathologist 1 (Path1) was interviewed. Path1 stated she/he remembered the case with P1 and confirmed she/he was the Pathologist involved. Path1 stated she/he first became aware of the incident with P1 when the Laboratory Medical Director told her/him the surgeon did a cystoscopy procedure on P1 as a result of the misidentified specimen indicating malignancy and when the urologist looked at the bladder and did not see a tumor he/she notified the Laboratory Medical Director. Path1 stated, “Luckily [he/she] notified the lab quickly enough and they still had the urine specimen” and they prepped slides from the original samples and found P1’s cytology slide was prepared with another patient’s specimen. P1’s record was reviewed on 10/30/25 at 1:27 PM. Review of the section titled, “Labs” revealed, “Cytology...Final result...Diagnoses...Malignant neoplasm of overlapping sites of bladder...Collected...08/04/25...Specimen source...Urine...” and “Cytology...Edited Result...FINAL...Specimen Information...Urine...AMENDED REPORT...After repeating the technical portion of the evaluation with repreparation of a new ThinPrep slide from the original patient specimen, the diagnosis is amended to the following...NEGATIVE FOR HIGH GRADE UROTHELIAL CARCINOMA...” Review of the Operative Note dated 08/21/25 revealed, “PREOPERTIVE DIAGNOSES...History of nonmuscle invasive urothelial cancer of bladder, now with positive urine cytology...PROCEDURES PERFORMED... Cystoscopy with bilateral ureteral washings, bilateral retrograde pyelograms, bilaterial diagnostic ureteroscopy, random bladder biopsies, transurethral resection of the bladder neck and prostatic urethra... INTRAOPERATIVE FINDINGS...The entire bladder appeared normal...” Review of the Office Visit Progress Notes dated 09/08/25 revealed, “...Patient is here today for follow-up after his cystoscopy with bilateral ureteral washings, bladder biopsies and prostatic urethral biopsy on 08/21/2025. All cytology washings and biopsies were negartive for malignancy. This procedure was performed because patient previously had a urine cytology come back that was positive. I [Urologist] received a call from our pathology department that they rereviewed the initial cytology slide and in fact it is not positive...””

“PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) (a) Standard: Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities, The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ... (3) That clear expectations for safety are established. This Standard is not met as evidenced by: 36779 Based on observation, interview, and review of patient records, QAPI documents and hospital policy, the hospital failed to implement auditing or monitoring to determine effectiveness of interventions after a cytology specimen was misidentified for one of four patient records reviewed for laboratory services, Patient 1 (P1). P1 underwent a second cystoscopy procedure based on the incorrect diagnosis from the misidentified cytology specimen. Findings included: During an observation of the Laboratory Department on 10/28/25 at 1:06 PM, Cytologist 1 (C1) was interviewed. C1 explained the process of receiving and processing cytology specimens. C1 stated they made the Thin Prep slides (a type of cytology slide prepared using a liquid-based method that creates a thin, even layer of cells for microscopic examination) in a machine called a Hologic. C1 stated the slide goes into the Hologic machine with the vial containing the specimen pellet (created after centriguge of the specimen) and the machine creates the slide with the specimen on it (Thin Prep). C1 stated they write on the slides by hand and label them with (including but not limited to) the patient last name and first initial, accession number (unique identifier given to a specimen when it arrives in the laboratory), and specimen source. C1 stated they have multiple vials at the machine waiting because the machine only creates one Thin Prep slide at a time. When asked how many would be on the counter waiting for the Hologic machine, C1 stated, “Maybe five.” When asked if the process had changed recently, C1 stated previously they would hand label all of the slides for multiple vials and they would be “all lined up” sitting on the counter by the Hologic machine. C1 stated, now they hand label one slide at a time, so multiple vials may be sitting on the counter by the Hologic machine, but they label one slide at a time. In an interview with the Medical Laboratory (Lab) Scientist (MLS) on 10/20/25 at 12:20 PM, he/she stated P1 had a surveillance cystocscopy in August of 2025 and when Cytology processed the urine sample they had another slide for another patient who had multiple slides. The MLS stated P1’s slide showed malignant cells so P1 was schedued for another cystoscopy procedure later that month and when the doctor saw no tumor he/she stopped and talked with the Pathologist. The MLS stated, “That’s when they figured it out.” On 10/28/25 at 2:42 PM, review of the hospital’s analysis of the incident revealed, “Two patients with cytology specimens collected on 8/4/2025 had results that raised suspicion of switched results...We believe the TP’s [Thin Preps] for the pancreatic malignancy and benign urine cytology may have been swapped...Feedback from Cyto-tech after investigation...It was determined the mix-up occurred at the vial to slide step as Cyto-tech was able to go back to vials (which are kept for 2 weeks) and was able to remake slides...Action Items to Address Root Cause...Standardization of Cytology specimen processing: only 1 vial and 1 slide at a time to be processed at the bench to reduce possibility of mislabeling/mixing specimen...Owner(s)...[name of Laboratory Manager (LM)]...Measure of Success...Auditing weekly by cyto-tech coordinator to report to lab manager...Status...Sign and read has been completed by all LTAs [Laboratory Technician Assistants]...Auditing by lab manager when rounding in department...Action Items...” On 10/30/25 at 9:14 AM, the Lab Manager was interviewed. When asked how the hospital was ensuring the change that was implemented (to label one slide at a time at the Hologic Thin Prep Processor) and the education to the cytology staff was effective, she/he stated, “[C1] audits the process.” The Director of Quality (DQ) was interviewed on 10/31/25 at 8:30 AM. The VP of Operations (VPO), LM and VP of Nursing (VPN) were present. When asked about the interventions put in place to prevent a misidentification of a cytology slide from happening again the DQ stated, “Quality will physically go in and check on the action plan...Check on audits...” When asked if any auditing had been done to assess the effectiveness of interventions, the DQ stated [name of VPO] would know. The DQ stated, “Lab would know about the auditing.” When asked what she/he would expect to see in the auditing, the DQ stated, “That they’re doing it as they said...[The VPO] or [the LM] can speak more to it.” Immediately after the phone interview ended, the LM, VPO, and VPN were interviewed together and asked for any documentation of any monitoring or audits as part of the QAPI process after the incident with P1. The LM replied and stated they do not have any documented evidence of audits or monitoring. In an interview with C1 on 10/31/25 at 9:47 AM, when asked if she/he had any documented evidence of audits or monitoring to determine if implemented measures were effective, she/he stated, “[LM’s name] would do that.” Review of the 2025 QAPI Plan on 10/31/25 revealed, “...Performance Improvement methodology...implement interventions, and sustain positive changes over time...” On 10/31/25, review of the policy titled, “Cytology Quality Assurance/Quality Control Plan,” revised 03/27/25 revealed, “...Our Quality Plan goals are to..Monitor and evaluate the ongoing and overall quality of the total testing process...””

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(10) The condition of the patient who is restrained or secluded must be monitored by a physician, other licensed practitioner or trained staff that have completed the training criteria specified in paragraph (f) of this section at an interval determined by hospital policy. This Standard is not met as evidenced by: 28883 Based on record review, interview, and review of the policy “Restraints for Nonviolent, Non-Self Destructive Patient Situations: Medical Use of Restraints”, hospital nursing staff failed to document a restraint assessment of Patient #6 (1 of 19 patients reviewed with restraints) timely, every 2 hours as per hospital policy. The findings included: The hospital admitted Patient #6 on 12/22/24 with diagnoses including Metabolic Encephalopathy, Hypoxemia, and Altered Mental Status. Review of the electronic medical record for Patient #6 with the Vice President of Nursing Services and the Director of Quality on 2/12/25 at 10:09 AM revealed the patient had orders for bilateral mitt restraints due to pulling lines and tubes. Review of the restraint flow sheets included information that on 1/5/25; nursing had documented restraint checks having been completed at 5:34 PM and again at 8:35 PM, which was greater than the 2 hours interval required by hospital policy. On 1/6/25, nursing had documented a restraint check for 04:00 AM and then for 07:00 AM. This was greater than the 2 hour interval required by hospital policy. During an interview on 2/12/25 at 10:30 AM, the Vice President of Nursing Services verified the finding. Review of the hospital policy entitled “Restraints for Nonviolent, Non-Self Destructive Patient Situations: Medical Use of Restraints”, dated 2/10/25, revealed “...Every 2 hours, perform the following: i. Continued Justification ii. Visual/Safety check iii. Circulation/Skin Integrity iv. Range of Motion v. Fluids vi. Food and Meal vii. Elimination e) Vital signs as indicated by patient status...”.”