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Tag No.: A0043
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Based on interview, observation, and document review, the Governing Body failed to develop and maintain effective systems that ensured that patients received high quality health care in a safe environment and failed to provide effective oversight of the hospital.
Failure to provide effective oversight to prevent substandard practices for Respiratory Services and Medical Staff services, and ensure patients are provided with care that meets acceptable standard of practice and meets the patient's healthcare needs in a safe environment risks poor health care outcomes, injury, and death.
Findings included:
Due to the scope and severity of deficiencies detailed under 42 CFR 482.12 Conditions of Participation for Governing Body, 42 CFR 482.22 Medical Staff, and 42 CFR 482.57 Respiratory Services, the Condition of Participation for Governing Body was NOT MET.
Cross Reference: A050, A0338, and A1151
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Tag No.: A0050
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Based on document review and interview, the Governing Body failed to ensure that physicians and licensed independent practitioners had evidence of required training and supporting references for requested privileges prior to approval for 3 of 3 Medical Staff files reviewed (Staff #502, #509, and #510).
Failure to verify education, experience, and specialized training placed all patients at risk for incomplete, incorrect, and inconsistently administered medical care.
Findings included:
1. Document review of the hospital's document titled, "Medical Staff Policies and Procedures," dated 06/17, showed that the Board of Directors has the final authority to grant medical staff appointment and clinical privileges.
Document review of the hospital's document titled, "Delineation of Privileges Internal Medicine," revised 06/17, showed that Critical Care Unit (CCU) Privileges must be requested and criteria includes:
-Applicants completing training within the past 5 years must provide documentation from their residency program or via the program director verifying completion of training or;
-Applicants out of training for more than 5 years will provide documentation of ongoing experience and competence in the management of critical care patients within the past 24 months via a reference letter from their Medical Director and can attest to their clinical skills and competence or;
-Applicants must provide documentation of completion of Intensive Care continuing education for physicians (CME's) that is approved by the Hospitalist Medical Director before attending patients in the ICU.
The document showed to maintain Privilege the applicant must demonstrate current competence and evidence of the performance management of critically ill patients in the past 12 months based on the results of ongoing professional practice evaluation and outcomes as the attending physician.
Document review of the hospital's document titled, "Medical Staff Bylaws," approved 10/17, showed that Physicians shall be qualified for Medical Staff membership only if they document their licensure, experience, background, training, ability, judgement, and physical and mental status.
2. On 07/24/19, Surveyor #5, the Medical Staff Coordinator (Staff #503), and the Interim Chief Administrative Officer (Staff #504) reviewed the credentialing file for 3 Physicians providing critical care management including ventilator management in the hospital's Critical Care Unit (CCU) (Staff #502, #509, and #510). Surveyor #5 found no evidence that the education, experience, and specialized training to manage critical care patients on ventilators were documented in the credentialing file.
3. Surveyor #5 observed that Staff #502 and #509 had requested non-complex ventilation management privileges. Surveyor #5 found no documentation or criteria defining non-complex ventilator management.
4. On 07/24/19 at 9:05 AM, during interview with Surveyor #5, Staff #504 stated that the hospital did not have a Medical Staff policy defining non-complex ventilator management, or criteria for transfer to a higher level of care specific to ventilator management. Staff #504 confirmed the hospital did not have a Pulmonologist on staff to assist with complex ventilator management.
5. At the time of the observation, Staff #503 and #504 confirmed the finding. Staff #504 stated that they recognized the issues in the hospital's physician credentialing process and this was why a new Medical Staff Coordinator was recently hired by the hospital.
6. On 07/24/19 at 1:15 PM, during interview with Surveyor #5, the Hospital's Board of Directors Chairman (Staff #511) stated that the Board of Directors did not get down to that specific level of review, and that they relied on input from the Medical Staff for approval of medical staff appointment, reappointment, and clinical privileges.
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Tag No.: A0338
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Based on interview and document review, the hospital failed to ensure that the medical staff operated in compliance with rules and by-laws approved by the governing body.
Failure of the medical staff to operate in compliance with the hospital's rules and by-laws puts patients at risk of substandard care and adverse outcomes.
Findings included:
1. Failure to provide appropriate leadership and supervision to the Respiratory Therapists, who provided hospital-wide services.
Cross Reference: A1153
2. Failure to provide evidence of education, experience, and specialized training for 3 of 3 physicians providing ventilator management for critically ill patients.
Cross Reference: A0340
Due to the scope and severity of deficiencies identified under 42 CFR 482.22 Conditions of Participation for Medical Staff are NOT MET.
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Tag No.: A0340
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Based on document review and interview, the hospital failed to ensure that physicians and licensed independent practitioners had evidence of required training and supporting references of competence regarding the management of critical patients including patients on ventilators.
Failure to verify education, experience, and specialized training placed all patients who required respiratory services at risk for incomplete, incorrect, and inconsistently administered respiratory services.
Findings included:
1. Document review of the hospital's document titled, "Delineation of Privileges Internal Medicine," revised 06/17, showed that Critical Care Unit (CCU) Privileges must be requested and criteria includes:
-Applicants completing training within the past 5 years must provide documentation from their residency program or via the program director verifying completion of training or;
-Applicants out of training for more than 5 years will provide documentation of ongoing experience and competence in the management of critical care patients within the past 24 months via a reference letter from their Medical Director and can attest to their clinical skills and competence or;
-Applicants must provide documentation of completion of Intensive Care continuing education for physicians (CME's) that is approved by the Hospitalist Medical Director before attending patients in the ICU.
The document showed to maintain Privilege the applicant must demonstrate current competence and evidence of the performance management of critically ill patients in the past 12 months based on the results of ongoing professional practice evaluation and outcomes as the attending physician.
Document review of the hospital's document titled, "Medical Staff Bylaws," approved 10/17, showed that Physicians shall be qualified for Medical Staff membership only if they document their licensure, experience, background, training, ability, judgement, and physical and mental status.
2. On 07/24/19, Surveyor #5, the Medical Staff Coordinator (Staff #503), and the Interim Chief Administrative Officer (Staff #504) reviewed the credentialing file for 3 Physicians providing critical care management including ventilator management in the hospital's Critical Care Unit (CCU) (Staff #502, #509, and #510). Surveyor #5 found no evidence that the education, experience, and specialized training to manage critical care patients on ventilators were documented in the credentialing file.
3. Surveyor #5 observed that Staff #502 and #509 had requested non-complex ventilation management privileges. Surveyor #5 found no documentation or criteria defining non-complex ventilator management.
4. On 07/24/19 at 9:05 AM, during interview with Surveyor #5, Staff #504 stated that the hospital did not have a Medical Staff policy defining non-complex ventilator management, or criteria for transfer to a higher level of care specific to ventilator management. Staff #504 confirmed the hospital did not have a Pulmonologist on staff to assist with complex ventilator management.
5. At the time of the observation, Staff #503 and #504 confirmed the finding. Staff #504 stated that they recognized the issues in the hospital's physician credentialing process and this was why a new Medical Staff Coordinator was recently hired by the hospital.
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Tag No.: A1151
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Based on interview, document review, and review of quality data, the hospital failed to develop and implement performance improvement activities and action plans to address identified areas of concern related to patient safety and quality of care (Item #1) and failed to meet the requirements for the Condition of Participation for Respiratory Services (Item #2).
Failure to develop and implement performance improvement plans and projects based on identified areas of concern revealed in quality data, and failure to meet established service requirements and responsibilities for Respiratory Services impaired the hospital's ability to provide quality care in a safe environment.
Findings included:
Item #1 Quality Improvement
1. Document review of the hospitals document titled, "Quality & Patient Safety Plan 2019," showed that the hospital's Quality & Safety Plan is a collaborative plan with Clinical Support Services, Clinical Programs, Risk Management, and Medical Staff. The plan integrates clinical services and departments impacting patient care. In 2019, each department will participate in one improvement project. The manager/director will use a template for the project, the Quality Committee will review/approve the proposed project to ensure it aligns with the strategic plan, and the manager/director will provide the Quality Committee updates on the project once it is approved. Changes are carried out in a planned manner per the hospital's Change Management Policy.
-Document review of the hospital's Quality document titled, "SWOT (Strengths, Weaknesses, Opportunities, and Threats) Analysis," dated 10/24/18, showed that weaknesses identified by the hospital's leadership and clinical staff included:
Insufficient Staffing
Equipment and supplies that did not meet demand
Lack of evidence based policies for Respiratory Therapy (RT) practice
Lack of ongoing education/skills fairs
Lack of leadership for the RT department
Lack of basic RT equipment
2. On 07/24/19 at 10:00 AM, Surveyor #5 reviewed the hospital's Respiratory Therapy SWOT Analysis dated 10/24/18 and reviewed the hospital's Quality Committee minutes and process improvement plans from 01/19 to 06/19. Surveyor #5 found no evidence the hospital addressed or developed action plans related to the quality concerns addressed in the SWOT analysis completed in 10/18.
3. On 07/24/19 at 2:15 PM, the Chief Nursing Officer (Staff #506) stated that the Respiratory Therapy Department was not integrated into the hospital's Quality Program. Staff #506 confirmed that no actions had been taken by the hospital related to care quality concerns identified in the SWOT analysis conducted in 10/18.
Item #2 Respiratory Care Services
1. The hospital failed to provide appropriate leadership and supervision to the Respiratory Therapists, who provided hospital-wide services.
Cross Reference: A1153
2. The hospital failed to develop and implement Respiratory Therapy equipment Quality Control measures as directed by hospital policy and procedure based on manufacturer's instructions.
Cross Reference: A1160
3. The hospital failed to implement its policy and procedure to ensure ongoing Respiratory Therapy staff clinical competency and equipment quality testing knowledge and skills.
Cross Reference: A1161
4. The hospital failed to ensure that respiratory therapy staff provided patient care based on a provider order.
Cross Reference: A1164
Due to the cumulative effect of these findings, the Condition of Participation at 42 CFR 482.57 Respiratory Services was NOT MET.
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Tag No.: A1153
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Based on interview and document review, the hospital failed to verify the Respiratory Service Director had the education, experience, and specialized training to supervise and administer Respiratory Care Services.
Failure to verify education, experience, and specialized training placed all patients who required respiratory services at risk for incomplete, incorrect, and inconsistently administered respiratory services.
Findings included:
1. Document review of the hospital's document titled, "Delineation of Privileges Internal Medicine," revised 06/17, showed that Critical Care Unit (CCU) Privileges must be requested and criteria includes:
-Applicants completing training within the past 5 years must provide documentation from their residency program or via the program director verifying completion of training or;
-Applicants out of training for more than 5 years will provide documentation of ongoing experience and competence in the management of critical care patients within the past 24 months via a reference letter from their Medical Director and can attest to their clinical skills and competence or;
-Applicants must provide documentation of completion of Intensive Care continuing education for physicians (CME's) that is approved by the Hospitalist Medical Director before attending patients in the ICU.
The document showed to maintain Privilege the applicant must demonstrate current competence and evidence of the performance management of critically ill patients in the past 12 months based on the results of ongoing professional practice evaluation and outcomes as the attending physician.
Document review of the hospital's document titled, "Medical Staff Bylaws," approved 10/17, showed that Physicians shall be qualified for Medical Staff membership only if they document their licensure, experience, background, training, ability, judgement, and physical and mental status.
2. On 07/24/19 at 9:05 AM, Surveyor #5, the Medical Staff Coordinator (Staff #503), and the Interim Chief Administrative Officer (Staff #504) reviewed the credentialing file for the Physician Respiratory Director (Staff #502). Surveyor #5 found no evidence that the education, experience, and specialized training to supervise and administer Respiratory Care Services were documented in the credentialing file.
3. At the time of the observation, Staff #503 and #504 confirmed the finding. Staff #504 stated that they recognized the issues in the hospital's physician credentialing process and this was why a new Medical Staff Coordinator was recently hired by the hospital.
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Tag No.: A1160
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Based on interview and document review, the hospital failed to implement its policies and procedures that guide Quality Control assurance for Pulmonary Function Testing equipment.
The hospital's failure to implement equipment Quality Control measures placed all patients who received respiratory services at risk for substandard care.
Findings included:
1. Document review of the hospital's document titled, "PFT (Pulmonary Function Testing) Lab Quality Control (QC) Policy and Instructions," no policy number, no approval date, showed that QC testing requires daily, weekly, and monthly checks and calibrations to verify specific quality measurements set by the manufacturer (Sensormedics). The specifications will ensure consistent and reliable results, which will help, reduce, or eliminate common testing errors. Testing included:
Daily: Flow sensors and body box
Weekly: Bio Spirometry and Lung Volumes (Plethysmography)
Monthly: Syringe Calibrations (Syringe Linearity and DLco)
Every 2 years: Storage and Maintenance of the Calibration Syringe
Recording and verification is logged on the "Weekly Quality Control Documentation" sheets, and all other QC records are kept on the Vmax system and records can be pulled and printed as requested.
2. On 07/23/19 at 3:00 PM, Surveyor #5 and a Respiratory Therapist (Staff #505) reviewed the Quality Assurance testing log for the hospital's Pulmonary Function Test machine. Surveyor #5 observed:
a. Staff had not completed the daily flow sensors and body box QC testing daily. Staff #505 stated that the tests were only completed on days when patients were tested, but they were not always being completed. Staff #505 was unable to determine what days patients had tests completed.
b. Staff had had not completed the weekly Bio Spirometry and Lung Volumes (Plethysmography) QC had not been completed from 10/10/18 to 06/22/19 (a period of 8 months).
c. Staff had not completed the monthly DLco QC from 10/10/18 to 06/22/19 (a period of 8 months).
d. Staff had not completed the monthly Syringe Calibrations Syringe Linearity since 08/25/18 (a period of 10 months).
3. On 07/23/19 at 3:35 PM, Staff #505 verified the finding and stated that the staff did not have time to complete the quality testing. She stated that the hospital had not provided training and competencies for the past 2 years and that staff needed to be able to know how to do the testing.
4. On 07/24/19 at 1:00 PM, Surveyor #5 and the Chief Nursing Officer (Staff #506), reviewed and compared the daily quality testing logs to 7 patient Pulmonary Function Testing procedures. The review showed that for 6 of the 7 patients (Patient #505, #506, #507, #508, #509, and #510) staff did not complete the daily quality testing (02/07/19, 04/02/19, 04/26/19, 05/22/19, 05/24/19, and 06/11/19) prior to performing the patient procedures.
5. At the time of the finding, Staff #506 confirmed the finding and stated that there had not been a Respiratory Services Coordinator overseeing the department since 11/18, and that the Nurse Director oversight had recently changed.
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Tag No.: A1161
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Based on interview and document review, the hospital failed to implement its policy and procedure to ensure ongoing Respiratory Therapy staff clinical competency and equipment quality control testing skills.
Failure to ensure that Respiratory Therapy staff are qualified and competent to perform clinical care and equipment quality control testing risks inaccurate or inconsistent respiratory care services and puts patients at risk of serious harm.
Findings included:
1. Document review of the hospital's document titled, "Full Employee Performance Evaluation and Competency Assessment," Section V: Annual Healthstream and Skills fair, states for the evaluator to check all the appropriate boxes including: completed all required Healthstream modules (yes, no or not applicable), and attended annual skills fair (yes, no, not applicable), and attach the appropriate documentation. If any "no" boxes are checked indicate an Action Plan in the section below.
Document review of the hospital's document titled, "Confirmation of Employee Performance and Competency Form," no date, Section IV: Annual Healthstream and Skills fair, states for the evaluator to check all the appropriate boxes including: completed all required Healthstream modules (yes, no or not applicable), attended annual skills fair (yes, no, or not applicable), and attach the appropriate documentation. If any "no" boxes are checked, the evaluator is to indicate an Action Plan in the section below.
2. On 07/23/19 at 3:35 PM, during interview with Surveyor #5, a Respiratory Therapist (Staff #505) verified the surveyor finding that there were significant gaps in the Respiratory Therapy Quality Control testing for the Pulmonary Function Testing Machine. Staff #505 stated that the hospital had not provided training and competencies for the past 2 years and that staff needed to be able to know how to do the testing.
3. On 07/24/19, Surveyor #5 reviewed the employee files of 2 current Respiratory Therapists eligible for an annual review (Staff #505 and #508). The Performance and Competency Form for Staff #505 was dated 08/07/18. The Performance and Competency Form for Staff #508 was dated 12/17/18. Surveyor #5 found that the evaluator marked the annual evaluations for Staff #505 and #508 showing the staff had attended the annual Skills Fair. Surveyor #5 found no documentation of skills and competency from the Skills Fair as directed by the evaluation form.
4. On 07/24/19 at 4:20 PM, the Chief Nursing Officer (Staff #506) verified that the annual Confirmation of Employee Performance and Competency for the annual Skills Fair were marked completed by the evaluator for both Staff #505 and Staff #508. Staff #506 stated that there was no Skills Fair competency documentation because the hospital had not conducted an Annual Skills Fair for the Respiratory Services staff. She stated the hospital recognized there were gaps and this is why they were trying to hire a Respiratory Department Coordinator and why the Director Level oversight had recently changed.
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Tag No.: A1164
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Based on interview and document review the hospital failed to ensure that respiratory therapy staff provided patient care based on a provider order.
Failure to obtain a provider order for care risks inappropriate, incorrect, and inconsistently administered patient care and puts patients at risk of serious harm.
1. Document review of the hospital's policy titled, "Avea Ventilator BiLevel Positive Airway Pressure/BiPAP," no policy number, approved 09/17/17, showed that a physician order is required for Bi-level ventilation. The order must state the SaO2 to be maintained, inspiratory pressure (pressure support and peep), expiratory pressure, and breaths per minute specific to the Vt (volume) to be maintained with adjustment of inspiratory/expiratory pressure.
Document review of the hospital's policy titled, "Oxygen Therapy," no policy number, approved 09/06/16, showed that a provider order is required for all oxygen therapy except in cases of emergency.
2. On 07/24/19 from 2:00 PM until 4:00 PM, Surveyor #5 and a Clinical Informaticist (Staff #507) reviewed the discharged medical records for 4 patients (Patients #501, #502, #503, and #504) who were on ventilator support while hospitalized. The review showed:
a. Patient #501 was admitted on 02/07/19 for a post-surgical small bowel obstruction. The patient had a history of neck and brain cancer with radiation to the neck. The patient remained intubated post-surgery and was admitted to the hospital's Critical Care Unit (CCU). The record review showed:
On 01/30/19 at 6:35 AM, a Respiratory Therapist note showed that the patient was placed on initial ventilator setting assist control with a volume ventilation (VT) of 450 and a Fraction of Inspired Oxygen (FiO2) setting of 50%, a ventilator rate of 14 breaths a minute, and a Positive end-expiratory pressure (PEEP) of 5 centimeters of water. Surveyor #5 found no evidence that a provider ordered the patients ventilator settings.
On 07/30/19 at 1:35 PM, the patient's FiO2 was decreased to 30%. Surveyor #5 found no evidence a provider ordered the decrease in oxygen.
b. Patient #502 was admitted on 05/23/19 for chronic alcoholism, acute renal failure, and sepsis. She was admitted to the CCU and placed on a full-face mask BIPAP with BIPAP pressures of 16/5, SaO2 of 98%, VT of 349-450 and PIP of 16. Surveyor #5 found no evidence that a provider ordered the BIPAP settings.
On 05/23/19 at 11:35 PM, the patient experienced severe obstructive sleep apnea and dropped her oxygen level to 70%. The Respiratory Therapist adjusted the BIPAP pressures to 16/10. Surveyor #5 found no evidence that a provider ordered the change in the BIPAP settings.
On 05/25/19 at 7:37 AM, a Respiratory Therapist note states "per Dr. order I increased her settings to 22/6 and 35%. ABG to follow. Patient was very hard to arouse at this time." Surveyor #5 found no evidence a provider order was entered or cosigned by the provider.
On 05/25/19 at 7:30 PM, a Respiratory Therapist adjusted the BIPAP pressures and the FiO2. Surveyor #5 found no evidence that a provider ordered the change in the BIPAP settings.
On 05/27/19 at 7:35 AM, the patient was intubated and placed on a ventilator. The patient was placed on initial ventilator settings with assist control 22, VT 570, PIP 33, FiO2 30%. Surveyor #5 found no evidence that a provider ordered the initial ventilator settings.
Additional ventilator adjustments were made on 05/27/19 at 7:08 PM, 05/27/19 at 8:14 PM, 05/27/19 at 8:37 PM, 05/27/19 at 10:35 PM, and 05/28/19 at 1:31 PM. Surveyor #5 found no evidence that a provider ordered the ventilator settings changes.
On 05/30/19 at 8:02 PM, at Respiratory Therapist note showed that the respiratory rate was increased based on an order by the provider. Surveyor #5 found no evidence a provider order was entered or cosigned by the provider.
c. Patient #503 was admitted on 03/17/19 at 2:42 PM for respiratory failure. On 03/19/19 at 12:05 AM, the patient was intubated and placed on a ventilator. Surveyor #5 found no evidence a provider ordered the initial ventilator settings.
d. Patient #504 was admitted on 05/07/19 after a fall with rib fractures in ribs 5, 6, and 7. On 05/11/19 at 2:14 PM, the patient was intubated and placed on a ventilator. Surveyor #5 found no evidence a provider ordered the initial ventilator settings.
3. At the time of each observation, Staff #507 confirmed the findings and stated that the provider should have written an order for the initial ventilator settings and anytime a change was made.
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