QA Investigation Results

Pennsylvania Department of Health
DELAWARE VALLEY DIALYSIS CENTER
Health Inspection Results
DELAWARE VALLEY DIALYSIS CENTER
Health Inspection Results For:


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Initial Comments:

Based on the findings of an unannounced Medicare recertification survey conducted May 13 through May 16, 2019, Delaware Valley Dialysis Center 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 May 13 through May 16, 2019, Delaware Valley Dialysis Center 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:




494.100(b)(2),(3) STANDARD
H-FAC RECEIVE/REVIEW PT RECORDS Q 2 MONTHS

Name - Component - 00
The dialysis facility must -
(2) Retrieve and review complete self-monitoring data and other information from self-care patients or their designated caregiver(s) at least every 2 months; and
(3) Maintain this information in the patient ' s medical record.


Observations:

Based on review of facility policies/procedures, documentation and medical records, and based on interview with a home dialysis program licensed practical nurse (LPN-employee #4), the administrator/nurse manager (employee #1) and the group administrator (employee #10), the facility failed to ensure review of the home treatment records included a review for compliance with assessment of patient condition and compliance with treatment orders for one (1) of two (2) peritoneal dialysis (PD--dialysis performed through a tube inserted into the abdomen) patients. (Patient #2)

Findings include:

On May 16, 2019 at 3:21 PM, review of facility policy 5-01-29, titled "Daily Home Treatment Record", revealed the following:
"Purpose: To provide guidelines for proper documentation of home peritoneal dialysis treatments and to collect data needed to assess the patient's response to peritoneal dialysis treatments.
Policy: 1. Each peritoneal dialysis patient will be instructed to complete documentation of each treatment procedure on the Daily Home Treatment Record or by means of an electronic data card...
6. Home training teammate will review completed "Daily Home Treatment Records" to assist in evaluating the patient's progress and self-care decision making process. This review will be verified by the home training nurse documenting review in the medical record..."

On May 16, 2019 at 3:22 PM, review of facility policy 5-01-21, titled "Home Dialysis Monitoring and Ongoing Patient Education" revealed the following:
"Policy...1. The home hemodialysis facility will: a. Document in the patient's medical record that the patient, the caregiver, or both has received and demonstrated an adequate comprehension of the training by reviewing home patient clinical records for evidence of compliance with their training..."

On May 16, 2019 at 2:20 PM, review of the facility form titled "Daily Home Continuous Cycler Peritoneal Dialysis Record Baxter" revealed the following data collection items included, but were not limited to the following: PM (evening) WT (weight), BP (blood pressure), pulse/temp (temperature), number of dialysate bags utilized, AM (morning) WT, and AM BP.

Patient #2: On May 14, 2019 at 2:20 PM, review of the medical record revealed PD physician orders included, but were not limited to the following:
April 12, 2019: Five (5) dialysate (cleansing fluid) fills of 2,000 milliliters (ml) followed by one (1) 1,000 ml fill; and
April 20, 2019: Four (4) dialysate fills of 2,500 ml followed by one (1) 1,000 ml fill, dwell time 1 hour 23 minutes.
Review of the "Daily Home Continuous Cycler Peritoneal Dialysis Record Baxter" form revealed the patient failed to document the following:
-The number of dialysate bags utilized on April 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 29, and 30, 2019; and May 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10, 2019;
-PM WT on April 17 and 29, 2019 and May 3, 2019;
-BP on April 17 and 29, 2019;
-AM WT on April 17 and May 10, 2019; and
-AM BP on April 15, 16, 17, 18, 19, 20, and 25, 2019 and May 1, 2 and 3, 2019.
"Daily Home Continuous Cycler Peritoneal Dialysis Record Baxter" form documentation revealed a home training LPN (employee #4) signed the home training forms on May 1 and 15, 2019.
There was no medical record documentation which provided evidence that the review of the "Daily Home Continuous Cycler Peritoneal Dialysis Record Baxter" performed on May 1 and 15, 2019 included a review of compliance with documentation of the above referenced assessment items nor the number of dialysate bags utilized during the PD treatments.
During interview on May 16, 2019 at 12:49 PM, the home training LPN reported that the review of the "Daily Home Continuous Cycler Peritoneal Dialysis Record Baxter" performed on May 1 and 15, 2019 did not include a review for compliance with documentation of the above referenced assessment items nor the number of dialysate bags utilized during the PD treatments.

During interview on May 16, 2019 at 3:27 PM, the administrator/nurse manager and group administrator confirmed that the review of the "Daily Home Continuous Cycler Peritoneal Dialysis Record Baxter" performed on May 1 and 15, 2019 did not include a review for compliance with documentation of the above referenced assessment items nor the number of dialysate bags utilized during the PD treatments for the above reference patient.




























Plan of Correction:

A mandatory in-service for all Home training clinical teammates (TMs) will be held by the Facility Administrator (FA) the week of June 3, 2019 to review policy 5-01-21 Home Dialysis Monitoring and Patient Education, 5-01-29 Daily Home Treatment Record and 3-02-07 Medical Records Quality Assurance. Education will include but was not limited to: 1) each peritoneal dialysis patient will be instructed to complete documentation of each treatment procedure on the Daily Home Treatment Record or by means of an electronic data card. 2) Home training TMs will review completed "Daily Home Treatment Records" to assist in evaluating the patient's progress and self-care decision-making process. This review will be verified by the home training nurse documenting review in the medical record. 3) The home hemodialysis facility will: a. Document in the patient's medical record that the patient, the caregiver, or both has received and demonstrated an adequate comprehension of the training by reviewing home patient clinical records for evidence of compliance with their training. TMs were instructed on the use of a newly designed flowsheets that includes the PD orders of number of dialysate fills per treatment. In addition, teammates were instructed to ensure that all patients are documenting vital signs and weights with each treatment. The FA or designee will conduct a monthly audit during clinic visits for two (2) months and then on ten percent (10%) monthly thereafter. Results of the audit will be reviewed with the Medical Director during Facility Health Meetings (FHM-QAPI) with supporting documentation with 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 administrator/nurse manager (employee #1) and the group administrator (employee #10), 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) trainer for three (3) of three (3) hemodialysis staff who had no prior dialysis experience. (Employees #5, #11 an #12)

Findings include:

On May 15, 2019 at 11:25 AM, review of the "Teammate Workbook...In-Center" form titled "Water Treatment Review" revealed the following:
"After sufficient guidance and practice and when the preceptor considers the teammate proficient, the registered nurse (RN) or biomed trainer overseeing the training will evaluate the new teammate's performance of the new skill..." On page 248 for the "Water Treatment Components: Ability to Identify and Explain Purpose" revealed the following instructions were included in column 3: "Satisfactory performance of skill by new teammate. Date and initial of RN Trainer".

On May 15, 2019 at 11:30 AM, review of "Procedural Skills Verification Checklist" for bicarbonate and acid concentrate preparation revealed the following: "3. For PCT's and nurses after sufficient guidance and practice, and when the preceptor considers the teammates proficient, the registered nurse overseeing the training will evaluate the new teammates performance of the new skill...Column three requires the signature of the registered nurse to verify satisfactory performance of skill..."

On May 16, 2019 at 3:20 PM, review of facility policy, 8-02-05, 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)...Patient Care Technician (PCT)...4. All new non-experienced DaVita teammates in the dialysis modality for which they have been hired will successfully complete the DaVita, Inc. educational requirements as outlined in detail in the applicable Training Program Manual. Key aspects of the program include...Patient Care Dialysis Technicians will complete a training program that is approved by the medical director and governing body and is under the direction of a registered nurse...Successful completion of the clinical component of the modality specific DaVita Clinical Training for New Teammates 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 is to be completed by the preceptor and the new teammate. A registered nurse will sign off satisfactory performance of new skills..."

On May 15, 2019 at 11:04 AM, review of personnel files revealed the following:
Employee #5: The date of hire of the RN was September 10, 2018.
There was no documentation in the personnel file which provided evidence that the RN had previous dialysis experience. There was no documentation in the personal file which provided evidence that the RN trainer completed the bicarbonate and acid concentrate "Procedural Skills Verification Checklist".
Employee #11: The date of hire of the RN was February 9, 2018. There was no documentation in the personnel file which provided evidence that the RN had previous dialysis experience. Review of the "Teammate Workbook...Water Treatment Review" skills verification checklist failed to reveal documentation was present under column 3 on page 248 which provided evidence that an RN verified satisfactory performance of the "Water Treatment Components: Ability to Identify and Explain Purpose", nor under "Pre-Treatment Timers". There was no documentation in the personal file which provided evidence that the RN trainer completed the bicarbonate and acid concentrate "Procedural Skills Verification Checklist".
Employee #12: The date of hire of the PCT was September 9, 2017. There was no documentation in the personnel file which provided evidence that the PCT had previous dialysis experience. Review of the bicarbonate and acid concentrate "Procedural Skills Verification Checklist" revealed a licensed practical nurse, not an RN trainer, verified satisfactory performance of bicarbonate and acid concentrate preparation.

On May 15, 2019 at 1:35 PM, review of facility logs revealed employees #5, #11 and #12 performed water treatment system monitoring and/or dialysate preparation in March, April and/or May 2019.

During interview on May 16, 2019 at 3:27 PM, the group administrator and administrator/nurse manager confirmed that verification of satisfactory performance of water treatment system monitoring and/or dialysate preparation by the RN trainer was not documented on the above referenced procedural skills checklists for the above identified employees.















Plan of Correction:

A mandatory in-service will be held for the clinical TMs by the FA the week of June, 3, 2019 to review policy 8-02-05 Training Programs for New Patient Care Provider TMs. All new non-experienced DaVita TMs in the dialysis modality for which they have been hired will successfully complete the DaVita, Inc. educational requirements as outlined in detail in the applicable Training Program Manual. Successful completion of the clinical component of the modality specific DaVita Clinical Training for New Teammates 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 is to be completed by the preceptor and the new teammate. A registered nurse will sign off satisfactory performance of new skills. Verification of attendance is evidenced by TM signature on in-service sheet.
The FA audited TM personal files for all who are responsible for mixing bicarbonate, Granuflo acid concentrate and daily water checks to verify annual competency checklist validation are complete and up to date.
TM #5 will not perform bicarbonate and acid concentrate procedures going forward. A completed Water Treatment Review and bicarbonate and acid concentrate Skills Verification Checklist was placed in TM#11's personal file. A RN trainer verified satisfactory performances.
A completed bicarbonate and acid concentrate Procedural Skills Verification Checklist was placed in TM#12's personal file. A RN Trainer verified satisfactory performances.
Going forward, a Procedural Skills Verification Checklist will be completed by a RN trainer to verify satisfactory performances for all TMs responsible for concentrate mixing and placed in personal file.
The FA or designee will perform quarterly audit of TM personal files to verify all required training is complete and up to date. Instances of non-compliance will be addressed immediately. The results of the audits will be reviewed with the Medical Director during FHM-QAPI with supporting documentation included in the meeting minutes. The FA is responsible for compliance with this plan of correction.



494.170 STANDARD
MR-COMPLETE, ACCURATE, ACCESSIBLE

Name - Component - 00
The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility.


Observations:

Based on review of facility policies/procedures, documentation and medical records, and based on interview with the administrator/nurse manager (employee #1) and the group administrator (employee #10), the facility failed to ensure medical record documentation provided evidence that the "IDT (Interdisciplinary Team) Patient POC (Plan of Care) Meeting Report" form was completed per facility policy for one (1) of two (2) patients who had been determined to be unstable for more than 30 days. (Patient #1)

Findings include:

On May 16, 2019 at 1:56 PM, review of facility policy 1-14-01, titled "Interdisciplinary Teams (IDT) Patient Assessment and Plan of Care" revealed the following:
"Policy...Assessment:...7. A comprehensive re-assessment of each patient and a revision of the plan of care will be conducted...At least monthly for unstable patients...
Plan of Care...14. The patient's plan of care will be completed by the facility's interdisciplinary team, including patient or personal representative and be signed by the team members including the patient or the patient's personal representative..."

On May 21, 2019 at 10:00 AM, review of emailed policy 3-02-02, titled "Medical Record Documentation Guidance" revealed the following:
"Policy...Documentation Guidance...5. All entries must be accurate. Inaccurate records can adversely affect patient care...8. Document accurately and concisely but completely..."

Patient #1: On May 13, 2019 at 1:15 PM, review of the agency document titled "ESRD Core Survey Facility Data" revealed the patient was determined to be unstable due to psychosocial reasons on February 27, 2019 and April 9, 2019. There was no documentation that the patient was identified as unstable in January nor March 2019.
Between May 14, 2019 at 1:41 PM and May 16, 2019 at 10:56 AM, review of the medical record revealed peritoneal dialysis (dialysis performed through a tube inserted into the abdomen) physician orders were obtained on July 31, 2018.
Review of medical record documentation revealed the following as documented on the "IDT Patient POC Meeting Report" forms:
January 2019:
-Patient Goals Summary: Unstable;
-Date form printed: 01/14/2019;
-IDT POC Meeting Date: 01/11/2019; and
-Dates entered next to physician, PD program registered nurse (RN), dietician, social worker and patient signature: 01/16/2019.
February 2019:
-Patient Goals Summary: Unstable;
-Date form printed: 02/27/2019;
-IDT POC Meeting Date: 02/13/2019; and
-Dates entered next to physician, PD RN, dietician, social worker and patient signature: 03/20/2019.
March 2019:
-Patient Goals Summary: stable/unstable not selected;
-Date form printed: 03/25/2019;
-IDT POC Meeting Date: 03/13/2019;
-The PD RN's signature was included on the form but there was no date entered next to the signature;
-There was no physician, dietician, social worker, nor patient signature listed on the form.
April 2019:
-Patient Goals Summary: stable/unstable not selected;
-Date form printed: 04/10/2019;
-IDT POC Meeting Date: not entered;
-The PD RN, dietician and patient signatures were included on the form but there was no date entered next to the signatures; and
-There was no physician nor social worker signature listed on the form.
May 2019:
-Patient Goals Summary: Stable;
-Date form printed: 05/01/2019;
-IDT POC Meeting Date: 05/01/2019;
-The administrator/nurse manager signed the form but failed to date the form; and
-There was no physician, PD RN, dietician, social worker, nor patient signature listed on the form.
Review of email documentation on May 20, 2019 at 2:30 PM revealed the administrator/nurse manager documented that the "missing" POC's were located. The administrator/nurse manager indicated that the POC's were not properly filed in the medical record. The administrator/nurse manager provided an electronic screenshot which indicated that the POC's were completed on January, February, March and April 2019 but the screenshot failed to provide evidence that the above referenced "IDT Patient POC Meeting Report" forms were completed per facility policy.

During interview on May 16, 2019 at 3:27 PM, the administrator/nurse manager and group administrator confirmed that there was no documentation in the above referenced medical record which provided evidence that the "IDT (Interdisciplinary Team) Patient POC (Plan of Care) Meeting Report" form was completed per facility policy.












Plan of Correction:

A mandatory in-service will be held for the Interdisciplinary Team (IDT) by the FA the week of June 3, 2019 to review policy 3-02-01 Medical Records Maintenance and policy 1-14-01 Interdisciplinary team (IDT) patient assessment and plan of care. Education included but was not limited to: 1) a comprehensive re-assessment of each patient and a revision of the plan of care will be conducted at least monthly for unstable patients. 2) The patient's plan of care will be completed by the facility's interdisciplinary team, including patient or personal representative and be signed by the team members including the patient or the patient's personal representative and placed in the medical record. 3) TMs must document accurately, concisely and completely. Verification of attendance will be evidenced by TM signature on in-service sheet.
The FA and designee will conduct weekly audits for one (1) month and then monthly for two (2) months on patient care plans to verify all Interdisciplinary team (IDT) care plans are completed including the signature page. Results of the audit will be reviewed with the Medical Director during FHM-QAPI with supporting documentation with the meeting minutes. The FA is responsible for compliance with this plan of correction.