QA Investigation Results

Pennsylvania Department of Health
FRANKLIN COMMONS DIALYSIS
Health Inspection Results
FRANKLIN COMMONS DIALYSIS
Health Inspection Results For:


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Initial Comments:


Based on the findings of an onsite unannounced Medicare recertification survey conducted on April 9, 2019 through April 12, 2019, Franklin Commons Dialysis was identified 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 April 9, 2019 through April 12, 2019, Franklin Commons 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 of suppliers of End-Stage Renal Disease (ESRD) Services.












Plan of Correction:




494.30(a)(4)(ii) STANDARD
IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL

Name - Component - 00
[The facility must demonstrate that it follows standard infection control precautions by implementing-
(4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-]
(ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment.



Observations:

Based on observation, review of policy and procedures, and interview with the Clinical Support Specialist, it was determined, the facility failed to ensure infection control procedures were followed by cleaning and disinfecting the waste containers and the patient treatment chairs for three (3) of sixteen (16) hemodialysis machines observed. (Machine #'s 2, 14, & 16).

Findings include:

Observations were made in the in patient treatment area on April 9, 2019 through April 11, 2019 between the hours of 9:30 AM and 11:30 AM .

1. A Review of policy number 1-05-01 titled, "Infection Control for Dialysis Facilities " was conducted on April 11, 2019 at approximately 1:00 PM. Section 3 (Facility Hygiene), Paragraph 43 reads " Teammates will thoroughly wipe down all non-disposable items and equipment ...with an appropriate disinfectant after every treatment."

2. On April 10, 2019 at approximately 10:45 AM, it was observed that Patient Care Technician # 4, did not disinfect the waste container at dialysis machine # 2, nor did she open the sides of the treatment chair, by the machine, and disinfect this area prior to the start of the next dialysis treatment.

On April 10, 2019 at approximately 11:00 AM, it was observed that Patient Care Technician # 4, did not disinfect the waste container at dialysis machine # 14, nor did she open the sides of the treatment chair, by the machine, and disinfect this area prior to the start of the next dialysis treatment.

On April 10, 2019 at approximately 11:10 AM, it was observed that Patient Care Technician # 5, did not disinfect the waste container at dialysis machine # 16, prior to the start of the next dialysis treatment.

3. An interview with the Clinical Support Specialist was conducted on April 11, 2019 at approximately 12:30 PM. The Clinical Support Specialist confirmed that the infection control procedures are to be followed according to policy, and that the above cited policy is in effect.





















Plan of Correction:

The Facility Administrator (FA) held a mandatory in-service for all clinical teammates (TMs) on 4/12/19 and 4/16/19 to review policy 1-05-01, Infection Control for Dialysis Facilities. Education included but was not limited to: (1) Prime bucket must be disinfected prior to the start of the next dialysis treatment. (2) Treatment chair is to have sides opened and fully reclined when disinfecting prior to the start of the next dialysis treatment. Verification of attendance at the in-service will be evidenced by TMs signature on in-service sheet. The FA or designee will conduct infection control audit daily for two (2) weeks, weekly for two (2) weeks and then monthly going forward during the infection control audits (Clean Sweep Audit). Instances of non-compliance will be addressed immediately. The FA will review results of the audits with TMs at homeroom meetings and with the Medical Director during the monthly Facility Health Meeting (FHM-QAPI) with supporting documentation included in the meeting minutes. The FA is responsible for the compliance with this plan of action.
Completion Date: 5/12/2019



494.80(b)(1) STANDARD
PA-FREQUENCY-INITIAL-30 DAYS/13 TX

Name - Component - 00
An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session.



Observations:



Based on a review of clinical records, policies and procedures and an interview with the Clinical Support Specialist, and the Administrator, the facility failed to ensure an initial "Comprehensive Interdisciplinary Assessment/Plan of Care" was completed within thirty (30) days or thirteen (13) outpatient hemodialysis treatments of the initial hemodialysis treatment for three (3) of six (6) hemodialysis patients. (Clinical record # 1, 4, and 6)

Findings include:

1. A review of the Facility Policy 1-14-01 titled " Interdisciplinary Team (IDT) Patient Assessment and Plan of Care,"was conducted on April 12, 2019 at approximately 11:30 AM. Page 4, paragraph 10 reads: "An initial Plan of Care, based on the findings from the comprehensive assessment will be completed on all patients new to dialysis within 30 calendar days (or 13 outpatient dialysis sessions for hemodialysis) after their first outpatient dialysis treatment at the facility".

2. A review of the Clinical record #1 was conducted on April 12, 2019, at approximately 9:05 A.M. The first hemodialysis treatment at this facility for the patient was June 14, 2018. The documentation showed an initial comprehensive interdisciplinary assessment/ Plan of Care was developed and implemented on August 6, 2019, fifty-three (53) days after the first outpatient dialysis session.

A review of the Clinical record # 4 was conducted on April 12, 2019, at approximately 10:40 A.M. The first hemodialysis treatment at this facility for the patient was July 15, 2018. The documentation showed an initial comprehensive interdisciplinary assessment/Plan of Care was developed and implemented on September 6, 2018, fifty-three (53) days after the first outpatient dialysis session.

A review of the clinical record # 6 was conducted on April 12, 2019, at approximately 11:30 A.M. The first hemodialysis treatment at this facility for the patient was August 9, 2016. The documentation showed an initial comprehensive interdisciplinary assessment/Plan of Care was developed and implemented on September 23, 2019, thirty-eight (38) days after the first outpatient dialysis session.

3. An interview was conducted with the Administrator on April 12, 2019 at approximately 12:30 P.M. The Administrator confirmed the above identified findings, and informed the surveyor that the above cited policy is current.

An interview was conducted with the Clinical Support Specialist on April 12, 2019 at approximately 12:35 P.M. The Clinical Support Specialist confirmed the above identified findings, and informed the surveyor that the above cited policy is current.




























Plan of Correction:

The FA held a mandatory in-service for the Interdisciplinary Team (IDT) on 4/15/19 and 4/16/19. The in-service included a review of policy 1-14-01, Interdisciplinary team (IDT) Patient Assessment and Plan of Care. Education included but was not limited to: (1) the initial comprehensive assessment must be completed on all new patients admitted to the facility within the latter of 30 calendar days or 13 hemodialysis treatments beginning with the first day of treatment. Attendance at in-service is documented on the In-service sign-in sheet. The IDT will review new admissions during IDT weekly Core Team meeting and enter the patients name and assessment /plan of care due dates onto the "New to Census assessment and plan of care Tracker" with communications to physicians during weekly rounds. The FA or designee will audit one hundred percent (100%) of new admissions monthly for three (3) months to verify initial assessment/plan of care for patients are in place and up to date and documentation is appropriate. Instances of noncompliance will be addressed immediately. The FA will review results with the Medical Director during monthly FHM-QAPI with supporting documentation included in the meeting minutes. The FA is responsible for compliance with this plan of correction.
Completion Date: 5/12/2019



494.80(b)(2) STANDARD
PA-F/U REASSESSMENT-WITHIN 3 MO OF INITIAL

Name - Component - 00
A follow up comprehensive reassessment must occur within 3 months after the completion of the initial assessment to provide information to adjust the patient's plan of care specified in 494.90.




Observations:


Based on a review of clinical records, policies and procedures and interview with the Administrator and the Clinical Support Specialist, it was determined, that the facility failed to ensure a " 90 day Reassessment " was completed within ninety (90) days of the initial hemodialysis assessment for one (1) of six (6) hemodialysis patients. (Clinical record # 6)

Findings include:

1. A review of the Facility Policy 1-14-01 titled " Interdisciplinary Team (IDT) Patient Assessment and Plan of Care,"was conducted on April 12, 2019 at approximately 11:30 AM. Page 4, paragraph 11 reads: "An initial Plan of Care, based on the findings from the comprehensive assessment will be completed on all patients new to dialysis within 30 calendar days (or 13 outpatient dialysis sessions for hemodialysis) after their first outpatient dialysis treatment at the facility".

Paragraph 12 reads: " After completion of the 90 day assessment, the Interdisciplinary Team will conduct an IDT meeting to make adjustments to the Plan of Care".

2. A review of the clinical record # 6 was conducted on April 12, 2019, at approximately 11:30 A.M. The first hemodialysis treatment at this facility for the patient was August 9, 2016. The documentation showed an initial comprehensive interdisciplinary assessment/Plan of Care was developed and implemented on September 23, 2019.

The 90 day Interdisciplinary Team meeting, relating to the Plan of Care adjustment, occurred on March 10, 2017, one hundred sixty one (161) days later.

3. An interview was conducted with the Administrator on April 12, 2019 at approximately 12:30 P.M. The Administrator confirmed the above identified findings, and informed the surveyor that the above cited policy is current.

An interview was conducted with the Clinical Support Specialist on April 12, 2019 at approximately 12:35 P.M. The Clinical Support Specialist confirmed the above identified findings, and informed the surveyor that the above cited policy is current.




















Plan of Correction:

The FA held a mandatory in-service for the IDT team on 4/15/19 and 4/16/19 to review policy 1-14-01 Interdisciplinary Team Patient Assessment and Plan of Care with emphasis on but not limited to: (1) the initial comprehensive assessment must be completed on all new patients admitted to the facility within the latter of 30 calendar days or 13 hemodialysis treatments beginning with the first day of treatment. (2) A follow up comprehensive reassessment must occur within ninety (90) days of the initial assessment to provide information to adjust patient's plan of care if specific goals are not achieved. Verification of attendance is evidenced by TM signature on in-service sheet. The FA or designee will conduct audits on one hundred percent (100%) of the new admissions monthly for three (3) months to verify all ninety (90) day assessments/plan of care are up to date. Instances of noncompliance will be addressed immediately. FA will review results with the Medical director during monthly FHM. FA is responsible with compliance of this plan.
Completion Date: 5/12/2019



494.80(d)(1) STANDARD
PA-FREQUENCY REASSESSMENT-STABLE 1X/YR

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-
(1) At least annually for stable patients;





Observations:


Based on a review of clinical records, review of policies and procedures and interview with Administrator and the Clinical Support Specialist, the facility failed to ensure the comprehensive interdisciplinary assessment/plan of care was updated annually for one (1) of six (6) hemodialysis dialysis patients. (Clinical Record # 6)

Findings include:

1. 1. A review of the Facility Policy 1-14-01 titled " Interdisciplinary Team (IDT) Patient Assessment and Plan of Care,"was conducted on April 12, 2019 at approximately 11:30 AM. Page 4, Paragraph 12, reads:" Subsequent interdisciplinary reassessments should be completed within the 30 days following the initiation of the reassessment...This process would occur ...annually for stable patients".

2. A review of the Clinical record # 6 was conducted on April 12, 2019, at approximately 11:30 A.M. The first hemodialysis treatment at this facility for the patient was August 9, 2016. The documentation revealed a stable/annual comprehensive interdisciplinary assessment/Plan of Care was developed and implemented on November 6, 2017.

The next (annual) Interdisciplinary Team meeting, relating to the Plan of Care adjustment, occurred on January 25, 2019, eighty (80) days past the annual date, that the meeting/plan of care adjustments, which should have occurred by November 6, 2018.

3. An interview was conducted with the Administrator on April 12, 2019 at approximately 12:30 P.M. The Administrator confirmed the above identified findings, and informed the surveyor that the above cited policy is current.

An interview was conducted with the Clinical Support Specialist on April 12, 2019 at approximately 12:35 P.M. The Clinical Support Specialist confirmed the above identified findings, and informed the surveyor that the above cited policy is current.































Plan of Correction:

The FA held a mandatory in-service on 4/15/19 and 4/16/19 with the IDT team. This in-service included a review of policy 1-14-01 Interdisciplinary Team Patient Assessment and Plan of Care with emphasis on IDT comprehensive reassessment is to be done annually for stable patients. Verification of attendance is evidenced by TM signature on in-service sheet. The FA or designee will conduct a medical record audit on one hundred percent (100%) of the patients to identify and correct for any other outliers. Then the FA or designee will audit ten percent (10%) of current patients monthly to verify assessments/plan of care are completed annually for stable patients. Results of audit will be reviewed with the Medical Director during the monthly FHM-QAPI with supporting documents included in the meeting minutes. The FA is responsible for compliance with the plan of correction.
Completion Date: 5/12/2019



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 a review of facility policy, clinical record review and interview with the Facility Administrator and the Clinical Support Specialist, it was determined that the facility failed to follow its policy pertaining to completing a monthly comprehensive reassessment/Plan of Care of an unstable patient for one (1) of one (1) active unstable patient(s) reviewed (Patient # 2)

Finding include:

A review of the Facility Policy 1-14-01 titled " Interdisciplinary Team (IDT) Patient Assessment and Plan of Care,"was conducted on April 12, 2019 at approximately 11:30 AM. Page 1, paragraph 1,reads: "Purpose: To provide guidance for the development of patient assessment and plan of care for IDT teammates. Policy: Assessment: . . . 7. A comprehensive re-assessment of each patient and a revision in the plan of care will be conducted: . . . At least monthly for unstable patients . . . Plan of Care: Monthly (unstable patients) Assessment: Monthly until patient is determined by interdisciplinary team to be stable . . "

1. A review of Patient # 2's clinical record was conducted on April 12, 2019, at approximately 9:30 AM. The patient's starting date at the facility was February 4, 2015.

In the careplan dated January 4, 2019, the patient is listed as "Unstable". The patient is also listed as "Unstable" for the month of March 2019. This plan of care is dated March 29, 2019.

There was no comprehensive assessment/plan of care for an unstable patient, contained in Clinical Record # 2, for the month of February 2019.

2. An interview was conducted with the Facility Administrator on April 12, 2019 at approximately 1:00 PM. The Facility Administrator confirmed the above identified findings, and informed the surveyor that the above cited policy is current.

3. An interview was conducted with the Clinical Support Specialist on April 12, 2019 at approximately 1:05 PM. The Clinical Support Specialist confirmed the above identified findings, and informed the surveyor that the above cited policy is current.































Plan of Correction:

The FA held a mandatory in-service on 4/15/19 and 4/16/19 with the IDT team. The in-service included a review of policy 1-14-01 Interdisciplinary Team Patient Assessment and Plan of Care with emphasis on reassessment for unstable patient must be completed monthly until patient is determined by the IDT to be stable. The team was instructed to assess unstable patients every month. Verification of attendance is evidenced by TM signature on in-service sheet. The FA will audit one hundred percent (100%) of unstable charts monthly for three (3) months to verify assessment/ plan of care are completed and documentation is accurate. Instances of noncompliance will be addressed immediately. The FA will review results with the Medical Director at the monthly FHM-QAPI with supporting documentation included in the meeting minutes. The FA is responsible for compliance with this action.
Completion Date: 5/12/2019



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 Machine Disinfection Logs, Facility policy, and an interview with the Clinical Support Specialist, it was determined, that the facility failed to ensure that the Facility Machine Disinfection Logs were completed in its entirety for the months of January and February 2019.

Findings include:

1. A review of the Facility policy entitled "Fresenius Dialysis Delivery cleaning and disinfection Policy" was conducted on April 11, 2019, at approximately 1:30 PM. Page two (2), Paragraph six (6) reads: " Facilities will develop a specific Dialysis Delivery System Cleaning and Disinfection Log....Cleaning and disinfection of dialysis delivery systems will be documented on this log".

2. A review of the Dialysis Delivery System Cleaning and Disinfection Log for the month of January 2019 was conducted on April 11, 2019, at approximately 12:00 PM.

There was no documentation contained on this log, for the following machines, for the following dates:


January 3: 1,4,10,11,12,16, and 18
January 5: 1,4,5,7,10,11,12,16, and 18
January 10: 4, 10, and 18
January 12: 6, 10, and 16
January 17: 4, 7, 8, 10, and 16
January 19: 8, 10, and 16
January 24: 5,7, 8,10,12,15, and 16
January 31: 5,7, 8,10,11,13, and 16

A review of the Dialysis Delivery System Cleaning and Disinfection Log for the month of February 2019 was conducted on April 11, 2019, at approximately 12:30 PM.

There was no documentation contained on this log, for the following machines, for the following dates:

February 2: 8, 10, 16, and 18
February 7: 1, 5, 8, 10, 16, and 18
February 9: 1, 10, and 16
February 14: 2, 8, 9, 10, 12, and 16
February 16: 2, 5, 8, 10, 16, and 18
February 23: 2, 8, 10, 16, and 18
February 28: 2, 7, 8, 9, 10, 12, and 15

3. An interview with the Clinical Support Specialist was conducted on April 11, 2019 at approximately 12:45 PM. The Clinical Support Specialist confirmed that the Dialysis Delivery System Cleaning and Disinfection Log is to be completed in its' entirety daily, and that the above cited policy is current.














Plan of Correction:

The FA held a mandatory in-service on 4/12/19 and 4/16/19 for all clinical TMs. This in-service reviewed policy 2-02-01 Fresenius Dialysis Delivery System Cleaning and Disinfection Policy. Teammates were educated on completing the disinfection log in its entirety. New disinfection log was developed to ensure compliance. Verification of attendance at the in-service will be evidenced by TM's signature on in-service sheet. The FA or designee will conduct machine disinfection log audits daily for two (2) weeks, weekly for two (2) weeks and then monthly going forward. Instances of noncompliance will be addressed immediately. The FA will review audits with TMs at homeroom meetings and with the Medical Director at the monthly FHM-QAPI with supporting documentation included in the meeting minutes. In addition, the FA will review his/her responsibility with Medical Director on 4/24/19 to ensure all TMs adhere to policy and procedures. The FA is responsible for compliance with this plan of correction.
Completion Date: 5/12/2019