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Tag No.: A0263
Based on document review and interview the hospital failed to ensure that the Quality Assessment and Performance Improvement (QAPI) program was hospital-wide and data-driven for all applicable Conditions of Participation. The hospital failed to ensure that the Nuclear Medicine and Outpatient departments consistently collected data through indicators focused on improving health outcomes and the prevention and reduction of medical errors. The failure to collect pertinent data for the Nuclear Medicine and Outpatient departments increased the likelihood that the hospital would not be able to determine if these two departments were focused on improving health outcomes and the prevention and reduction of medical errors. The findings are:
A. On 11/27/12 at 10:45 am the hospital was given a Request for Information to provide the master list of QAPI indicators used for all COP's provided by the hospital. On 11/29/12 at 3:30 pm a list of indicators by COP was provided to surveyors.
B. For the COP of Nuclear Medicine, the master list of indicators revealed that the hospital was only collecteing data concerning management of radioactive materials and radiation equipment readings that are required for the continuation of state licensure to possess and administer radiopharmaceuticals. No data was being collected that focused on improving health outcomes and the prevention and reduction of medical errors.
C. The master list of indicators provided on 11/29/12 reveals that the department for Outpatient Services did not collect data for those hospital services that were offered on both an inpatient and outpatient basis, such as surgery, radiology, outpatient and laboratory. The data collected did not separate the inpatient and outpatient data for these four services.Without this separation the hospital would be unable to determine how well the outpatient services were improving health outcomes and preventing and reducing medical errors based on their QAPI data collection process.
D. On 11/28/12 at 10:30 am the Director of Radiology stated, "The only data being collected by Nuclear Medicine Dept. is information needed to comply with the radiopharmaceutical license issued by the NM Dept. of Environment." At 2:30 pm on 11/18/12, the Corporate Compliance Officer confirmed that the hospital was not collecting any data in Nuclear Medicine other than that needed for the radiopharmaceutical license.
E. On 11/30/12 at 10:45 am the surveyor interviewed the QAPI Director concerning the lack of data indicators for Outpatient Services. She stated that the hospital did not separate out data for those COP's that provided both inpatient and outpatient services such as surgery, laboratory, radiology, and rehabilitation. She confirmed that the data for these four services represented both the inpatient and outpatient data combined together.The hospital has 12 outpatient clinics that fall under the hospital's provider number. The QAPI data revealed that for 3 of the 12 clinics, the QAPI program was collecting data on: (1) number of clinic visits and (2) patient satisfaction. No data was being collected that would speak to improving health outcomes and the prevention and reduction of medical errors. No data or indicators of any kind were being collected for the remaining 9 clinics.
Tag No.: A0273
Based on document review and interview the Governing Body failed to: (1) ensure that all hospital departments were participating in the Quality Assessment and Performance Improvement (QAPI) program, and (2) specify the frequency and detail of data collection for the QAPI program. The failure to include all hospital departments increased the likelihood that those hospital services not participating in the QAPI program could fail to improve health outcomes and not prevent or reduce medical errors. The failure to specify the frequency and detail of data collection for the QAPI program contributed to the failure to have a QAPI program with the participation of all hospital departments. The findings are:
A. On 11/27/12 at 10:45 am the hospital was given a request for a comprehensive list of all indicators being evaluated by the QAPI program. The hospital was not able to provide such a list until 11/29/12 at 3:15 pm. The indicator list revealed that the Nuclear Medicine Department was not collecting any data that could be used to improve health outcomes and to prevent or reduce medical errors. The only data collected on a consistent basis for the Nuclear Medicine department was related to required state compliance to possess a radiopharmaceutical license.
B. On 11/27/12 at 10:45 am the hospital was given a request for a comprehensive list of all indicators being evaluated by the QAPI program. The hospital was not able to provide such a list until 11/29/12 at 3:15 pm. Review of the indicators for Outpatient Services revealed that those hospital departments that offered both inpatient and outpatient services, such as surgical services, radiology, laboratory, and rehabilitation, did not have the data for those services offered on an inpatient and outpatient basis, separated so that the QAPI program could evaluate both the inpatient and outpatient trends for hospital departments offering both types of services.
C. On 11/30/12 at 12:00 pm the Director of QAPI was interviewed concerning the data being collected for the QAPI program by Outpatient Services. She confirmed that there was no separation of data for inpatient and outpatient, for hospital departments such as surgical services, radiology, laboratory, and rehabilitation. The hospital has 12 clinics that fall under the hospital's provider number. The QAPI data provided revealed that for 3 of the 12 clinics, the QAPI program was collecting data on: (1) number of clinic visits and (2) patient satisfaction. No data was being collected that would speak to improving health outcomes and the prevention and reduction of medical errors. No data or indicators of any kind were being collected for the remaining 9 clinics.
D. On 11/27/12 at 10:45 am the hospital was given a request for information asking for documentation to demonstrate that the Governing Body had specified the frequency and detail of data collection for the QAPI program. At the time of exit on 11/30/12 at 4:30 pm, no documentation had been provided.
Tag No.: A1036
Based on observation and interview the hospital failed to ensure that in-house preparation of radiopharmaceuticals was done by or under the direct supervision of an appropriately trained registered pharmacist or doctor of medicine or osteopathy. The failure to have the in-house preparation of radiopharmaceuticals done or prepared under the direct supervision of appropriately trained registered pharmacist or doctor of medicine or osteopathy increased the likelihood that an error could be made in the dosage of the radiopharmaceutical placing patients who receive the radiopharmaceuticals at risk for harm. The findings are:
A. On 11/29/12 at 11:15 am the Nuclear Medicine department and hot lab were inspected. During the inspection of the hot lab, NM Tech #1 opened a drawer containing empty medication vials and mentioned, "These are the empty vials we used when we have to make up a dose of a radiopharmaceutical." A discussion was then held with NM Tech #1 and the Director of Radiology concerning the in-house preparation of radiopharmaceuticals. NM Tech #1 stated that occasionally it was necessary to make up a dose of a radiopharmaceutical and that it was always done by the nuclear medicine technician. He further stated that no
appropriately trained registered pharmacist or doctor of medicine or osteopathy was present when an in-house radiopharmaceutical was prepared.
The Director of Radiology stated, "We don't use a generator to prepare the in-house dose of the radiopharmaceutical." He did confirm that no appropriately trained registered pharmacist or doctor of medicine or osteopathy was present when such doses were prepared.