HospitalInspections.org

Based on review of facility documents, medical records (MR), and staff interview (EMP), it was determined the facility failed to provide the therapeutic radiation dose prescribed by the physician for one of two applicable medical records reviewed (MR1).

Findings include:

Review on November 14, 2013, of the facility's "Clinical Consultation Policy," last reviewed March 23, 2012, revealed "Purpose: This policy outlines the clinical process of radiation therapy. It labels what constitutes a radiation oncology consultation and treatment planning ... V. The Physician must then, plan the treatments, including appropriate beam selection, method of delivery, doses, sequencing with other treatments, communication with and supervision of the radiation physicist and dosimetrist. VI. A Radiation Oncologist's prescription should include: Volume to be irradiated, description of portals, radiation modality, dose per fraction, number of total fractions, total tumor dose ... VII. Simulations are to be done with or under instruction of the Radiation Oncologist. Simulations are to be performed by radiation therapists. The Radiation Oncologist is to approve calculations for treatment parameters made by the physicists, dosimetrist, or radiation therapist. ... VIII. These calculations are to be independently checked and clearly marked before the third treatment and anytime a change is made. ..."

Review on November 6, 2013, of MR1 revealed the patient presented to the Patterson Cancer Center on May 13, 2013, for radiation therapy. MR1 contained a physician order for a therapeutic radiation dose of 180cGy. MR1 received a dose of 200cGy.

Interview with EMP1 on November 6, 2013, at approximately 12:00 PM, confirmed MR1 contained a physician order for a therapeutic radiation dose of 180cGy. Further interview confirmed MR1 received a dose of 200cGy.

Interview with EMP1 on November 6, 2013, at approximately 12:00 PM, confirmed the physician order is the treatment plan for radiation therapy.

Interview with EMP4 on November 7, 2013, at approximately 10:15 AM, confirmed MR1 contained a physician order for a therapeutic radiation dose of 180cGy. Further interview confirmed MR1 received a dose of 200cGy.

Interview with EMP2 and EMP3 on November 14, 2013, at approximately 2:15 PM, confirmed the physician order is the treatment plan for radiation therapy.

Based on review of facility documents and staff interview (EMP), it was determined the facility failed to complete a Quality and Performance Improvement Plan to evaluate and monitor compliance in the Radiation Oncology Department following the implementation of a time out policy developed as a result of a patient receiving an incorrect dose of radiation.

Findings include:

Review on November 6, 2013, of the facility's "Quality and Performance Improvement Plan," last reviewed and revised February 1, 2013, revealed "Purpose: The purpose of the Quality and Performance Improvement Plan for Charles Cole Memorial Hospital, with its subsidiaries and affiliates, (referred to as Cole Memorial) to affirm commitment to, and describe the organization's approach to quality, safety and performance improvement. It provides a framework to ensure a systematic, organization-wide program that is goal directed, data-driven, and responsive to changes, so that care, treatment and services provided are continuously improved. Implementation Culture and Leadership The plan is firmly anchored in the organization's Mission, Vision, and guiding Principles, which are foundational statements providing guidance and direction for its work. To best serve patients and their families, Charles Cole Memorial Hospital pursues a culture of excellence that provides care consistent with these statements. ... Quality Date, Management, and Initiatives Quality management staff collaborate with others to fulfill responsibilities of collecting and analyzing data on performance, outcomes and other activities, and then communicating findings. Analysis is performed to identify trends, patterns and performance levels that suggest opportunities for improvement, to [sic] that improvement has been achieved and sustained. At a minimum, data is collected and aggregated quarterly or as otherwise noted, regarding the following: ... patient perceptions of the safety and quality of care treatment and services ..."

Review on November 7, 2013, of the facility documentation completed May 13, 2013, revealed MR1 and MR2 arrived at the Patterson Cancer Treatment Center on May 13, 2013, for prostate radiation therapy. Further review revealed the facility administered MR2's prostate radiation therapy to MR1, resulting in an overdose of radiation to MR1.

Interview with EMP2 and EMP3 on November 6, 2013, at approximately 2:45 PM confirmed MR1 and MR2 arrived at the Patterson Cancer Treatment Center on May 13, 2013, for prostate radiation therapy. Facility staff administered MR2's prostate radiation therapy to MR1, resulting in an overdose of radiation to MR1. Further interview with EMP2 revealed the facility implemented a new time out process as the result of this occurrence.

Interview with EMP5 on November 7, 2013, at approximately 3:30 PM revealed the facility should have initiated a Quality and Performance Improvement Plan for the evaluation and monitoring for compliance of the new Time Out procedure implemented in the Radiation Oncology Department on September 24, 2013, in response to MR1 receiving MR2's prostate radiation therapy resulting in an overdose of radiation to MR1.

Review on November 7, 2013, of the facility's "Time Out Procedure for Radiation Oncology at Cole Memorial" implemented on September 24, 2013, following the overdose of radiation to MR1, revealed "Policy: To promote patient safety by providing guidelines for verification of correct patient, site, procedure, and dose. Procedure: ... 4. All 'Time Out' verification shall include the following: a. Verification of correct patient using two identifiers e.g. Photo ID [identification], date of birth, patient name b. Verification of correct side/site of procedure location c. Verification of correct positioning e.g. SSDs [source-to-surface distance] and Table Parameters d. Agreement on the procedure between personnel present and participating in the Time Out process. e. Time and Date f. Initials of persons participating in 'Time Out' g. Initials of person conducting 'Time Out' h. Initial T/O [time out] Treatment Chart under Time Out Section. ..."

A request was made of EMP3, EMP5 and EMP6 on November 6, 2013, of the facility's Quality and Performance Improvement Plan for the evaluation and monitoring for compliance of the new Time Out procedure implemented in the Radiation Oncology Department on September 24, 2013, in response to MR1 receiving MR2's prostate radiation therapy resulting in an overdose of radiation to MR1. None was provided.

Interview with EMP3 on November 7, 2013, at approximately 9:00 AM revealed the process for event reporting includes a review of the occurrence, determination of the responsibility for investigation, the type of investigation to be completed, and the development of a Quality Assurance (QA) plan to evaluate and monitor compliance.

Interview with EMP3, EMP5 and EMP6 on November 7, 2013, at approximately 9:30 AM confirmed the facility did not develop a QA plan to evaluate and monitor compliance with the Time Out procedure implemented by the Radiation Oncology Department in response to MR1 receiving MR2's prostate radiation therapy, resulting in an overdose of radiation to MR1.