QA Investigation Results

Pennsylvania Department of Health
COMMONWEALTH DIALYSIS
Health Inspection Results
COMMONWEALTH DIALYSIS
Health Inspection Results For:


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Initial Comments:

Based on the findings of an unannounced Medicare recertification survey conducted August 20 through August 22, 2018, Commonwealth Dialysis was found to be in compliance with the requirements of 42 CFR, Part 494.62, Subpart B, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services - Emergency Preparedness.







Plan of Correction:




Initial Comments:

Based on the findings of an unannounced Medicare recertification survey conducted August 20 through August 22, 2018, Commonwealth Dialysis was identified to have the following standard level deficiencies that were determined to be in substantial compliance with the following requirements of 42 CFR, Part 494, Subparts A, B, C, and D: Conditions for Coverage for End-Stage Renal Disease Facilities.





Plan of Correction:




494.30 STANDARD
IC-SANITARY ENVIRONMENT

Name - Component - 00
The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas.


Observations:

Based on review of facility policies/procedures and documentation, observational tour, and interview with the biomedical supervisor and administrator, the facility failed to ensure one (1) of two (2) dirty sinks located in the hemodialysis treatment area were free of leakage from the drain.

Findings include:

On August 22, 2018 at 2:50 PM, review of the facility policy titled "Responsibilities of the Biomed (Biomedical) Department" revealed the following:
"Policy...Perform monthly biomedical audit and document findings to verify the facility is operating in accordance with DaVita policies and procedures..."

Observational tour conducted between August 20, 2018 at 10:15 AM and August 21, 2018 at 12:45 PM revealed clear fluids were leaking from the drain of the "Dirty Sink" located across from the laboratory processing area. The fluids were noted to be leaking onto the hemodialysis treatment area floor. The fluids included, but were not limited to, the fluids disposed of from the hemodialysis machine prime waste container,

On August 22, 2018 at 3:06 PM, review facility vaccination report documentation revealed the in-center hemodialysis patient population included a hepatitis B positive patient and hepatitis C positive patients.

During interview on August 21, 2018 at 1:55 PM, the biomedical supervisor confirmed that clear fluids were leaking from the drain of the "Dirty Sink" located across from the laboratory processing area, and that the repair of the leak would be completed by a plumber.

During interview on August 22, 2018 at 3:15 PM, the administrator confirmed clear fluids were leaking from the drain of the "Dirty Sink" located across from the laboratory processing area.




Plan of Correction:

V111
Biomed Service Specialist (BSS) contacted the plumber. The plumber replaced the basket strainer and new tailpiece to correct leak in dirty sink located across from the laboratory processing area. All work was completed on 08/24/18. The BSS will perform monthly biomedical audit and document findings to verify the facility is operating in accordance with DaVita policies and procedures. The results of the audits will be reviewed with the Medical Director in monthly Facility Health Meetings (FHM-QAPI) with supporting documentation included in the meeting minutes. The Facility Administrator (FA) is responsible for compliance with this plan of correction.



494.30(a)(1)(i) STANDARD
IC-HBV-VACCINATE PTS/STAFF

Name - Component - 00
Hepatitis B Vaccination

Vaccinate all susceptible patients and staff members against hepatitis B.


Observations:



Based on review of facility policies/procedures, documentation and personnel files, and based on interview with the administrator, the facility failed to ensure the hepatitis B vaccine was offered/administered upon hire to one (1) of eight (8) hemodialysis staff members who had direct contact with hemodialysis machines. (Employee #3)

Findings include:

On August 22, 2018 at 2:52 PM, review of the facility policy titled "Teammate Health Monitoring Program" revealed the following:
"Policy: 1. At no cost to teammates, DaVita will regularly monitor teammates for infectious diseases according to the current guidelines and/or recommendations established by the Centers for Disease Control...6. New teammates will be: Screened for Hepatitis B...Offered the Hepatitis B Vaccination (after bloodborne pathogen training)..."

On August 22, 2018 at 3:06 PM, review facility vaccination report documentation revealed the in-center hemodialysis patient population included a hepatitis B positive patient.

On August 20, 2018 at 12:35 PM, review of personnel files revealed the following:
Employee #3: The date of hire of the biomedical/water/hemodialysis machine technician was September 20, 2017. Hemodialysis competency documentation revealed infection control training was completed on September 28, 2017. Review of hepatitis B surface antibody and antigen results revealed the initial hepatitis B screening was performed on February 19, 2018, which was more than 4 months after both the date of hire and the date infection control training was completed. Hepatitis B screening results revealed employee #3 was susceptible to hepatitis B exposure.
There was no documentation in the personnel file that employee #3 was screened for hepatitis B surface antibody and antigen was performed upon hire, nor that the hepatitis B vaccine was offered/administered after infection control training was completed on September 28, 2017.

During interview on August 22, 2018 at 3:15 PM, the administrator confirmed that there was no documentation in the personnel file that employee #3 was screened for hepatitis B surface antibody and antigen was performed upon hire, nor that the hepatitis B vaccine was offered/administered after infection control training was completed on September 28, 2017.




Plan of Correction:

V126
One hundred percent (100%) of teammate (TMs) files were audited by the FA for documentation of proficiency as evidenced by the completion of the Water Treatment System Monitoring and/or Dialysate Preparation Competencies Checklist and the review of applicable policies and procedures. All procedural checklists were reviewed, updated if needed and signed off of by RN prior to the end of the audit. Going forward all TM records will be audited for completion by the FA or designee quarterly to verify compliance. Instances of non-compliance will be addressed immediately. The results of the audits will be reviewed with the Medical Director in monthly FHM-QAPI with supporting documentation included in the meeting minutes. The FA is responsible for compliance with this plan of correction.



494.80(d)(2) STANDARD
PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO

Name - Component - 00
In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted-

At least monthly for unstable patients including, but not limited to, patients with the following:
(i) Extended or frequent hospitalizations;
(ii) Marked deterioration in health status;
(iii) Significant change in psychosocial needs; or
(iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis.





Observations:

Based on review of facility policies/procedures, documentation and medical records, and based on interview with the administrator, the facility failed to ensure a comprehensive reassessment and care plan review for stability status was conducted within one (1) month of the previous assessment/care plan review for two (2) of two (2) patients who had been determined to be unstable. (Patients #1 and #3)

Findings include:

On August 22, 2018 at 2:54 PM, review of the facility policy titled "Interdisciplinary Teams (IDT) Patient Assessment and Plan of Care" revealed the following:
"Policy...Assessment: 7. A comprehensive assessment of each patient and a revision of the plan of care will be conducted...At least monthly for unstable patients..."

Patient #1: On August 21, 2018 at 9:58 AM, review of the medical record revealed the start of care/admission date was February 2, 2016.
Review of "IDT Patient POC (Plan of Care) Meeting Report" documentation dated February 19, 2016 revealed the patient was determined to be unstable due to psychosocial reasons.
"IDT Patient POC Meeting Report" documentation dated April 16, 2016, which was more than one month after the previous "IDT Patient POC Meeting Report" was completed, revealed the patient was determined to be stable.
There was no documentation in the medical record that a comprehensive assessment, nor "IDT Patient Meeting Report", had been completed in March 2018 to determine stability status.

Patient #3: On August 22, 2018 at 10:10 AM, review of the medical record revealed the start of care/admission date was February 10, 2015.
Review of "IDT Patient POC (Plan of Care) Meeting Report" documentation dated April 10, 2018 revealed the patient was determined to be unstable due to psychosocial reasons.
"IDT Patient POC Meeting Report" documentation revealed the next "IDT Patient POC Meeting Report" was completed on July 17, 2018, which was more than three (3) months after the previous "IDT Patient POC Meeting Report".
There was no documentation in the medical record that the a comprehensive reassessment, nor "IDT Patient Meeting Report" had been completed in May 2018 to determine stability status.

During interview on August 22, 2018 at 3:15 PM, the administrator confirmed that there was no documentation in the medical records that a comprehensive reassessment and care plan review for stability status was conducted within one (1) month of the previous assessment/care plan review for the above identified patients who had been determined to be unstable.





Plan of Correction:

V520
The FA will hold a mandatory in-service on 9/18/18 for the Interdisciplinary Team (IDT). The in-service will include but not limited to the review of policy #1-14-01 Patient Assessment and Plan of Care with emphasis on: 1) IDT is responsible for providing each patient with an individualized and comprehensive assessment documenting his/her needs; 2) the comprehensive assessment will be used to develop the patient's treatment plan and expectations for care; 3) patients deemed unstable will have comprehensive assessment followed by a plan of care completed monthly until deemed stable; 7) a comprehensive assessment and plan of care will reflect resolution of unstable issues and the patient will be deemed stable. Verification of attendance to in-service will be evidenced by TMs signature on in-service sheet.
On 8/31/18 the Governing Body (GB) met to review and approve the criteria for unstable patients. A copy of the unstable criteria was given to the clinical TMs for review. A log was created to keep track of plans of care for all patients stable and unstable. The log will be kept updated by the FA or designee. The FA or designee will audit all unstable care plans completed monthly for three (3) months to verify compliance. Instances of non-compliance will be addressed immediately. The results of the audits will be reviewed with the Medical Director in monthly FHM-QAPI with supporting documentation included in the meeting minutes. The FA is responsible for compliance with this plan of correction.



494.140 STANDARD
PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY

Name - Component - 00
All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility's staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility's staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions.



Observations:

Based on review of facility policies/procedures, documentation and personnel files, and based on interview with the clinical coordinator and the administrator, the facility failed to ensure documentation was maintained in the personnel file that water treatment system monitoring and dialysate preparation (bicarbonate and acid mixtures) competencies were verified by a registered nurse (RN) for four (4) of six (6) hemodialysis staff who had completed orientation. (Employees #6, #7, #9 and #10)

Findings include:

On August 22, 2018 at 2:50 PM, review of the facility policy titled "Training Programs for New Patient Care Provider Teammates" revealed the following:
"Policy...1. Patient Care Provider Teammates for the purpose of this policy will mean...Registered Nurses (RN)...Licensed Practical or Vocational Nurses (LPN/LVN)...Patient Care Technician (PCT)...Successful completion of the clinical component of the DaVita Orientation Program includes documentation of proficiency as evidenced by the completion of the Procedural Skills Verification Checklist and the review of applicable policies and procedures. This checklist if to be completed by the preceptor and the new teammate. A registered nurse will sign off satisfactory performance of new skills

On August 20, 2018 at 12:35 PM, review of personnel files revealed the following:
Employee #6: The date of hire of the RN was June 26, 2017.
Employee #7: The date of hire of the RN was November 16, 2017.
Employee #9: The date of hire of the PCT was October 19, 2017.
Employee #10: The date of hire of the PCT was October 19, 2017.
There was no documentation in the personnel files that a RN verified competency for water treatment system monitoring and/or dialysate preparation for employees #6, #7, #9 and #10.

On August 20, 2018 at 2:30 PM, review of facility logs revealed employees #6, #7, #9 and #10 performed water treatment system monitoring and/or dialysate preparation in July and/or August 2018.

During interview on August 22, 2018 at 3:15 PM, the clinical manager reported that water treatment system monitoring and/or dialysate preparation competencies were verified by the clinical manager, but confirmed that verification of satisfactory performance of water treatment system monitoring and/or dialysate preparation by the clinical manager was not documented on the procedural skills checklist.

During interview on August 22, 2018 at 3:15 PM, the administrator confirmed that there was no documentation in the personnel file that verification of satisfactory performance of water treatment system monitoring and/or dialysate preparation by the clinical manager was not documented on the procedural skills checklist.








Plan of Correction:

V681
This oversight was discovered on 2/19/18 and re-testing was done on 2/19/18. Going forward The FA or designee will audit one hundred percent (100%) of the new TMs records will be audited monthly to ensure new TMs will be screened for Hepatitis B and offered the Hepatitis B Vaccination after blood borne pathogen training. The results of the audits will be reviewed with the Medical Director in monthly FHM-QAPI with supporting documentation included in the meeting minutes. The FA is responsible for compliance with this plan of correction.



494.150(c)(2)(i) STANDARD
MD RESP-ENSURE ALL ADHERE TO P&P

Name - Component - 00
The medical director must-
(2) Ensure that-
(i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers;



Observations:

Based on review of facility policies/procedures and documentation, and based on interview with the biomedical supervisor and the administrator, the medical director failed to ensure disinfection of the reverse osmosis (water purification device) was documented on the "Water System Disinfection Log Sheet" in 2018. (January through July 2018)

Findings include:

On August 22, 2018 at 2:50 PM, review of the facility policy titled "Responsibilities of the Biomed (Biomedical) Department" revealed the following:
"Policy...1. The responsibilities of the Biomed Department include: Repair and maintain, with support documentation, all dialysis delivery machines, RO (reverse osmosis) water treatment systems...used in the provision of care to patients a recommended by the equipment manufacturer's specifications and DaVita policies/procedures..."

On August 21, 2018 at 1:48 PM, review of "Water System Disinfection Log Sheet" documentation dated January 27, February 24, March 22, April 24, May 22, June 26 and July 24, 2018 failed to reveal that the RO had been disinfected in 2018.

During interview on August 21, 2018 at 1:55 PM, the biomedical supervisor reported that the RO is to be disinfected quarterly. The biomedical supervisor reported that the RO had been disinfected quarterly in 2018, but confirmed RO disinfection was not documented on the above referenced "Water System Disinfection Log Sheet(s)".

During interview on August 22, 2018 at 3:15 PM, the administrator confirmed RO disinfection was not documented on the above referenced "Water System Disinfection Log Sheet(s)".




Plan of Correction:

V715
The FA will review Policy 2-03-03 Water Treatment System Disinfection by 9/18/18. Education will include but not be limited to: 1) the responsibilities of the Biomed Department include: Repair and maintain, with support documentation, all dialysis delivery machines, RO (reverse osmosis) water treatment systems...used in the provision of care to patients a recommended by the equipment manufacturer's specifications and DaVita policies/procedures; 2) chemically-disinfected direct feed systems are disinfected monthly and include both the reverse osmosis (RO) machine and the distribution system. Verification of attendance to in-service will be evidenced by TMs signature on in-service sheet.
A Governing Body meeting will be held prior to 9/21/18 with the Medical Director, FA and Regional Operation Director (ROD) to review the statement of deficiencies from CMS survey ending on 8/22/18. The Medical Director responsibilities were review with medical director, emphasizing the importance in executing his roles and responsibilities to ensure TMs adhere to policies, procedure and deficiencies identified need to be corrected timely with the support of the facility team. Plans of correction have been developed and initiated to correct identified deficiencies and sustain compliance. Medical Director will review progress of TM education, results of audits, and adherence to this plan of correction during monthly Facility Health Meetings. FA will report progress, as well as any barriers to maintaining compliance, with supporting documentation included in the meeting minutes. Action plans will be evaluated for effectiveness, new plans developed as applicable to achieve one hundred percent (100%) compliance with TM adherence to policy and procedure. FHM-QAPI minutes will reflect. The FA is responsible for compliance with this plan of correction.