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Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation 482.21 Quality Assessment and Performance Improvement Program was out of compliance.

Reference A0286 Patient Safety

The hospital failed to identify causative factors surrounding a patient safety event and implement preventative actions. The hospital failed to analyze patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital for 1 of 3 sampled patients (#1) to which a patient event occurred.

Based on review of Quality Assurance Performance Improvement program, staff interviews, document reviews, and medical record reviews, the hospital failed to identify causative factors surrounding a patient safety event and implement preventative actions. Specifically, the facility failed to analyze patient events, analyze their causes, and implement priorities for improvement and actions to improve performance for 1 of 3 sampled patients (#1) to which a patient event occurred.

Findings:

Patient #1's medical record noted the patient was admitted on April 14, 2022, for an outpatient surgical procedure "Laparoscopic Tubal Occlusion by Device" for the purpose of sterilization.

On 11/30/2022 T 9:46 AM, Surgeon A, who performed the procedure, noted that after the patient was brought into the Operating Room (OR), and after she was already put under anesthesia and prepped for the surgical procedure, Surgeon A began the procedure with use of the laparoscopic device. He then asked for the fallopian "rings" implant to be used for occlusion of the fallopian tubes. When the Circulating Nurse went to give him the implant, she observed the "rings" were expired, therefore could not be used.

On 11/30/2022 at 10:37 AM, Circulating Nurse G also noted after the patient was intubated and asleep, timeout done, and patient consent was read after procedure had already begun, she noticed the expiration date was expired on the back of the package of the "rings" implant, and alerted Surgeon A and the rest of the surgical team of the expired device. Nurse G stated they stopped the procedure, contacted the charge nurse and other management, and she went to the storage area and looked for a replacement to use but was unsuccessful as all the other same fallopian "rings" Surgeon A wanted to use were expired in the storage area. Upon return to the OR the Circulating Nurse stated she let Surgeon A know of other alternative devices available and the lack of same device being found. Both Nurse G and interview with Surgeon A noted at this time that he made the decision to proceed with a "salpingectomy" procedure (removal of the fallopian tubes) since the procedure had already begun and the implant was unusable because of the expired date of the device.

On 12/01/2022 at 11 AM, Quality Manager O and Risk Manager N noted when the event occurred in April 2022 an event report was placed and there was follow-up entered into their system but upon their review there was no documentation and/or evidence of the details for improvement process and no evidence of a follow-up to this event done. Quality Manager O and Risk Manager N did not become aware of this event until September 2022 when a grievance was received regarding the incident. Upon request of evidence of analysis, implementation of preventive actions and/or mechanisms both stated there was no evidence to support that any training, education, and/or in-services were done nor any evidence of changes and/or modifications to any systems for preventive actions implemented or in place after the event had occurred.

Based on the manner and degree of standard level deficiency referenced to the Condition, it was determined the Condition of Participation 482.51 was out of compliance.

Reference A0941 Organization of Surgical Services - The hospital failed to ensure patient safety by having expired supplies pulled for use in surgery for 1 of 4 sampled surgical patient medical records reviewed (#1).

Reference A0951 Operating Room Poicies - The hospital failed to ensure the maintenace of high standards of medial practice and patient care by not folloiwng their policy for assuring no outdated supplies remain in service for use in surgery for 1 of 4 sampled surgical patient medical records (#1) reviewed.

Based on interviews and medical record reviews, the hospital failed to ensure patient safety by having expired supplies pulled for use in surgery for 1 of 4 sampled surgical patient medical records (#1).

Findings:

Patient #1's medical record noted the patient was admitted on April 14, 2022, for an outpatient surgical procedure "Laparoscopic Tubal Occlusion by Device" for the purpose of sterilization.

On 11/30/2022 at 9:46 AM, Surgeon A, who performed the procedure, noted after the patient was brought into the Operating Room (OR), and after she was already put under anesthesia and prepped for the surgical procedure, surgeon A began the procedure with use of the laparoscopic device. He then asked for the fallopian "rings" implant to be used for occlusion of the fallopian tubes. When the Circulating Nurse went to give him the implant, she observed the "rings" were expired, therefore could not be used.

On 11/30/2022 at 10:37 AM, Circulating Nurse G noted after the patient was intubated and asleep, timeout done, and patient consent was read after procedure had already begun, she noticed expiration date was expired on the back of the package of the "rings" implant and alerted Surgeon A and the rest of the surgical team of the expired device. She did not recall the expiration date. Nurse G stated they stopped the procedure, contacted the charge nurse and other management, and she went to the storage area and looked for a replacement to use but was unsuccessful as all the other same fallopian "rings" Surgeon A wanted to use were expired in the storage area. Nurse stated she was out of the OR 10 to 15 minutes in search of the device and/or a substitute device as well as having calls made to other facilities to see if they might have the device they could use, but again without success. Upon return to the OR, Circulating Nurse G stated she let Surgeon A know of other alternative devices available and the lack of same device being found. Both Nurse G and Surgeon A noted at this time he made the decision to proceed with a "salpingectomy" procedure (removal of the fallopian tubes) since the procedure had already begun and the implant was unusable because of the expired date of the device.

Based on interviews, medical record reviews and policy reviews, the hospital failed to ensure high standards of medical practice and patient care by not following their policy for assuring no outdated supplies remain in service for use in surgery for 1 of 4 sampled surgical patient medical records (#1).

Findings:

Patient #1's medical record noted the patient was admitted on April 14, 2022, for an outpatient surgical procedure "Laparoscopic Tubal Occlusion by Device" for the purpose of sterilization.

On 11/30/2022 at 9:46 AM, Surgeon A, who performed the procedure, noted after the patient was brought into the Operating Room (OR), and after she was already put under anesthesia and prepped for the surgical procedure, Surgeon A began the procedure with use of the laparoscopic device. He then asked for the fallopian "rings" implant to be used for occlusion of the fallopian tubes. When the Circulating Nurse went to give him the implant, she observed the "rings" were expired, therefore could not be used.

On 11/30/2022 at 10:37 AM, Circulating Nurse G also noted after the patient was intubated and asleep, timeout done, and the patient consent was read after procedure had already begun, she noticed the expiration date on the back of the package of the "rings" implant was expired and alerted Surgeon A and the rest of the surgical team of the expired device. She did not recall the expiration date during the interview. She stated they stopped the procedure, contacted the charge nurse and other management, and she went to the storage area and looked for a replacement to use but was unsuccessful as all the other same fallopian "rings" Surgeon A wanted to use were expired in the storage area. Nurse G stated she was out of the OR 10 to15 minutes in search of the device and/or a substitute device as well as calling other facilities to see if they might have the device they could use, but again without success. Upon return to the OR, Circulating Nurse G stated she let Surgeon A know of other alternative devices available and the lack of the same device being found. Both Nurse G and Surgeon A said noted at this time, he made the decision to proceed with a "salpingectomy" procedure (removal of the fallopian tubes) since the procedure had already begun and the implant was unusable because of the expired date on the device.

Review of facility's "Sterile Supplies Monitoring Procedure" #CP28.01.02l PRO (DS), last reviewed 08/01/2021, noted the owner of the policy as the System Director of Surgical Services. This procedure noted the purpose of the procedure was to assure that no outdated supply is used, and package integrity is not compromised with Procedure therefore requiring: "A. Expired items and compromised packaged items will be removed from service. B. All sterile supplies issued from Sterile Processing or Materials Management are maintained in their proper/designated storage areas and are checked for self-life expiration and for integrity of package. C. Supplies are rotated to assist in assuring the use of the oldest supply first."

On 11/30/2022 at 1:22 PM, the System Manager of Supply Logistics I, Supervisor of Surgical Materials J, and Surgical Clinical Inventory Specialist L explained their current system in place was to ensure expired supplies are checked for and removed in a timely manner. They all confirmed there was no formal system in place stating the Sterile Processing Department had a person who actually came in and did regular visuals to look for expired supplies, but they left about a year ago and "that system just stopped when she left."