DAVID L. LAKEY, M.D. COMMISSIONER
May 16, 2008
TEXAS DEPARTMENT OF STATE HEALTH SERVICES 1100 West 49th Street. Austin, Texas 78756 P.O. Box 149347. Austin, Texas 78714-9347 1-888-963-711 1. www.dshs.state.tx.us
Vice President of Lone Star Division Davita Lufkin Dialysis Center
700 John Reditt Drive
Lufkin, Texas 75904
Dear Mr. McNeill"
Because some of the deficiencies identified at the licensing survey at Davita Lufkin Dialysis Center ESRD #452639/License#000230 on May 13, 2008 reflected a situation that was potentially serious or life-threatening risks to patients, a level three corrective action plan (CAP) is required pursuant to Texas Administrative Code (TAC) Section 117.81. Your facility must not re-open unless and until you receive written approval from the Texas Department of State Health Services (Department). This approval is conditional upon your providing written agreement and acceptance of this level three CAP. Please inform the Department of your decision no later than 5:00 pm on Monday May 19, 2008; Department staff are available should you have any questions regarding CAP implementation. The rule allows the corrective action plan to be guided by the Department and requires the appointment of a monitor(s) to supervise the implementation of the plan. The Department has consulted with the Texas ESRD Network 14 Medical Review Board in this matter. The Department has reviewed the findings of your survey and makes the following requirements:
Prior to the reopening of the facility the Department requires the facility to have in place the appointment of a Physician Monitor, Two Nurse Monitors and a Technical Monitor.
Immediately appoint a Physician Monitor to educate the current Medical Director as to the functions and responsibilities of monitoring facility operations and as a member of the quality management committee. The Department must approve the Physician Monitor you select for your facility; however the Department strongly suggests that you consider Dr. Charles Foulks, M.D., if available. A list of monitors is
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included. This process is outlined at 117.81(b) (8) including (A), (B) and (C). Special attention should be placed on Medical Director's responsibility and in Quality Management, identification of opportunities to improve and ensuring use of Quality Management tools and techniques. The Physician Monitor is to clearly establish the direct role in facility operations that is expected of Medical Director and the Physician Monitor is to participate in and direct the following:
- Review standing orders, protocols, and medical management practices and make recommendations for changes.
- Assist the Medical Director and facility in conducting a thorough mortality review to evaluate the statistically significant high Standard Mortality Rate.
- Develop appropriate protocols establishing parameters to identify pre, intradialytic and post-dialysis assessments and monitoring that require nursing and physician notification and intervention.
- Monitor facility operations and staff qualifications, training and practices including ongoing education and verification of competency.
- Actively participate or lead the quality management committee using profiling and pattern analysis.
- Periodically review documentation to support that patient care. staff are following the notification and protocols established for changes in patient's conditions.
- Ensure that all EMS transports, hospital admissions, and deaths are tracked, trended, analyzed and appropriate action plans are implemented as indicated.
- Submit monthly written reports to the Department and the ESRD Network on assessments, findings and progress.
Immediately appoint a team of two Nurse Monitors at a minimum to function in the unit. The Nurse Monitors are to take a leadership role and assist management to oversee the provision of nursing services and clinical operations to ensure patient safety, provision of care with dignity and respect and compliance with the ESRD Licensure Rules. The individuals selected as the Nurse Monitors may not currently have responsibilities at the facility or at any other facility owned or operated by Davita. The Department must approve the Nurse Monitors you select for your facility; however, the Department strongly suggests you consider Peggy Knudsen or Debbie King as the lead monitor and Kathy Gahm or Pam Parmer as the second Nurse Monitor with emphasis on education. A list of monitors is included. This process is outlined at 1l7.81(b) (8) including (A), (8) and (C).
One Nurse Monitor should review and revise as needed all staff training programs and materials and perform periodic reassessment of the staff's learning needs. A minimum of one of the Nurse Monitors will need to be present at the facility for 5 days/week for the entire first month of monitoring, further on-site presence will be determined by the Department after evaluation of the clinic situation with input from the Nurse Monitors and the EDRD Network.
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The Team of Nurse Monitors will need to do the following:
- Conduct a through assessment of all personnel to ensure staff is fully qualified and knowledgeable of their roles and responsibilities. The assessment needs to include the process of how facility staff communicates with each other and how their roles and responsibilities come together to ensure patient/staff safety and best care practices for the patient.
- Ensure training of staff is done.
- Conduct staff compliance assessments to ensure safe patient dialysis treatments
- Implement audits of the delivery of care to include adherence to the patient's dialysis prescription (e.g. correct dialysate, correct medications, physician's orders, appropriate nursing interventions including patient assessments and monitoring: and an effective process of physician notification for patient abnormal events, etc. These practice audits must be conducted daily X 2 weeks, then weekly X 4 weeks, then semi- monthly X4, and monthly X3. Results of these audits must be submitted in summary to DSHS Zone V office.
- Implement audits on the completeness and accuracy of Medical Record Documentation: daily X 2 weeks, then weekly X 4, then semi- monthly X4, and monthly X3. Results of these audits must be submitted summary to DSHS Zone V office.
- Conduct a through review of the entire facility operations to ensure patient safety and submit a written report with recommendations to the Governing Body, with a copy to DSHS Zone V office.
- Conduct assessment of facility's process for tracking/trending and actions taken on all adverse events for patients. Ensure process has safety nets to identify missing adverse events and that trending, analysis and action plans are developed. Adverse event trending must include but not be limited to emergency transfers, hospitalizations and deaths.
- In conjunction with the Physician Monitor, Medical Director and Nursing Staff ensure that appropriate policies/procedures and protocols are in place and meet practice standards of care to include the following but not limited to :
- Reporting guidelines established by the facility:
- Assess all V/S as compared to the normal for the patient with appropriate identification of necessary reporting to nurse and/ or physician based on differences from patients normal ranges
- Clotting during dialysis
- Define prolonged post dialysis bleeding and establish procedures and timelines for responding and notifying physician
- Treatment related complications
- Utilizing protocols to determine when nursing and physician notification and intervention are indicated
- Adherence to Physician treatment ,orders and reporting of any deviations
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The team of monitors along with the clinical staff should participate in the Quality Assurance and Quality Improvement Process at the facility to ensure its effectiveness. The QA/QI process must include but is not limited to:
- A review of the 2007 Dialysis Facility Report provided to the facility by the University of Michigan Kidney Epidemiology and Cast Center (UM-KECC).
- Mortality rate analysis
- Expected vs. actual clinical outcomes.
- Conduct assessment/review of current policies/procedures and protocols to ensure all meet standards of practice/care. Changes should be facilitated through Governing Body if needed and make recommendations.
- At a minimum quality improvement monitoring must include the following:
- treatment related complications including:
- cardiac symptoms .
- hypo & hypertension
- past dialysis complications
- prolonged bleeding
- clotting during dialysis
- required ambulance transfer
- mortality review
- all emergency transfers including patients transferred past dialysis treatment from place of residence.
- Because there has not been a determination of one single issue that caused the adverse events (peaking in the month of April but also occurring from at least December 2007 to April 28, 2008) you must also immediately appoint a Technical Monitor. The individual selected as the technical monitor may not have current responsibilities at the facility or at any other facility owned or operated by Davita. The Department must approve the Technical Monitor you select for your facility; however, the Department strongly suggests you consider Scott Wright or Rick Rodriguez, if available.
- The Technical Monitor will review the facility's existing water treatment system, . dialysate delivery system and machine maintenance practices in addition to the technical policies, procedures, practices and training programs and make recommendations for improvements if needed.
The team of monitors will file a written initial report within 14 days to the Department an their initial assessment and continue to file monthly reports to the Department and the Medical Review Board of Network 14 of ongoing monitoring activities until completion of your Corrective Action Plan has been determined.
Lufkin Dialysis Facility will file written monthly reports with the Department and with the Medical Review Baard Network 14 until completion of your Corrective Action Plan has
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been determined and must ensure the governing body acts upon the Nurse, Physician and Technical Monitor(s) recommendations by developing a time frame for completion of the corrective actions. The facility reports must include monthly quality assurance meeting minutes, and governing body minutes to verify compliance with requirements at 117.33 and 117.34.
Because the severity of the deficiencies at your licensing survey were identified as level three, presenting potentially serious or life-threatening risks to patients, the Department further requires that you provide patients notice of the findings of this survey. This must be accomplished by posting the notices enclosed with this letter in the patient waiting room, and by providing this information to patients in groups or on an individual basis. You will need to be able to demonstrate via written documentation that this information was provided to each patient.
As previously stated, the team of monitors must be in place prior to reopening and an initial assessment by the team needs to be submitted to the Department prior to the opening date.
Should you have questions, please contact Joel Sprouls (email@example.com) at 903-533-5379.
Joel Sprouls, Manager
Health Facility Compliance Division-Zone V Texas Department of State Health Services 1517 West Front Street
Tyler, Texas 75702
Telephone: (903) 533~5227
cc: Network 14 MRB -Angie Wieler, Glenda Harbert (via email)
Derek Jakovich, Unit Director, Patient Quality Care Unit (via email) Manager Facility Licensing Group-Regulatory Licensing Unit (via email)
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NOTICE TO PATIENTS
THIS FACILITY RECENTLY HAD A TEXAS DEPARTMENT OF HEALTH LICENSING INSPECTION.
DURlNG THIS INSPECTION, MANY DEFICIENCIES WERE FOUND, SOME OF WHICH WERE SERIOUS. THE FACILITY HAS AGREED AND IS IN THE PROCESS OF CORRECTING THESE PROBLEMS.
A FOLLOW-UP VISIT WILL BE DONE BY THE HEALTH DEPARTMENT WITHIN 45 DAYS.
YOU HAVE THE RIGHT TO CHOOSE WHERE YOU RECEIVE TREATMENT. IF YOU ASK, THIS FACILITY WILL PROVIDE YOU INFORMATION AND ASSISTANCE REGARDING OTHER TREATMENT LOCATIONS.
IF YOU WANT MORE INFORMATION, PLEASE TALK TO ___ Clinic Manager _______________ .
DATED: May 13, 2008
A VIZO A P ACIENTES
ESTA CLINICA FUE INSPECCIONADA POR EL TEXAS DEPARTMENT OF HEALTH (DEPARTAMENTO DE SALUD) DACE POCO.
DURANTE ESTA INSPECCION DEL ESTADO SE DESCUBRIERONV ARIAS DEFICIENCIAS.
ALGUNAS DE ESTAS SON SERIAS. ESTA CLINICA SE HA PUESTO DE ACUERDO Y ESTA EN EL PROCESO DE CORREGIR ESTOS PROBLEMAS.
SE HARA UNA SEGUNDA INSPECCION POR EL DEPARTAMENTO DE SALUD DEL ESTADO DENTRO DE 45 DIAS.
USTED TIENE EL DERECHO DE ESCOGER DONDE RECIBE DIALISIS. SI USTED DESEA, ESTA CLINICA LEPUEDE DAR INFORMACION Y AYUDA TOCANTE A LOCALIZAR OTROS SITIOS DE TRATAMIENTO.
SI DESEA MAS INFORMACION FAVOR DE HABLAR CON __________________.
Fecha: May 13, 2008
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