QA Investigation Results

Pennsylvania Department of Health
FRESENIUS MEDICAL CARE GERMANTOWN DIALYSIS
Health Inspection Results
FRESENIUS MEDICAL CARE GERMANTOWN DIALYSIS
Health Inspection Results For:


There are  13 surveys for this facility. Please select a date to view the survey results.

Surveys don't appear on this website until at least 41 days have elapsed since the exit date of the survey.



Initial Comments:


Based on the findings of an onsite unannounced recertification survey conducted on March 26 through March 29, 2019, FMC Germantown Dialysis was identified to have the following standard level deficiency that was determined to be in substantial 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:




494.62(d)(1) STANDARD
ESRD EP Training Program

Name - Component - 00
(d)(1) Training program. The dialysis facility must do all of the following:
(i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
(ii) Provide emergency preparedness training at least annually. Staff training must:
(iii) Demonstrate staff knowledge of emergency procedures, including informing patients of-
(A) What to do;
(B) Where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated;
(C) Whom to contact if an emergency occurs while the patient is not in the dialysis facility. This contact information must include an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls due to an emergency situation (unless the facility has the ability to forward calls to a working phone number under such emergency conditions); and
(D) How to disconnect themselves from the dialysis machine if an emergency occurs.
(iv) Demonstrate that, at a minimum, its patient care staff maintains current CPR certification; and
(v) Properly train its nursing staff in the use of emergency equipment and emergency drugs.
(vi) Maintain documentation of the training.

Observations:


Based on a review of the facility emergency preparedness plan, facility policy, patient medical records, and an interview with facility staff, the facility did not document training and testing of emergency preparedness training for patients for nine (9) of nine (9) medical records (MR): (MR# 2 through 10).
Findings include:
A review of the facility emergency preparedness program was conducted on March 28, 2019 at 1:00PM. A review of medical records was conducted on March 29, 2019.
A review of facility policy, FMS-CS-IC-II-130-013A, "Fire Drill" conducted on March 29, 2019 at 12:40 PM states: "Complete the Patient Participation in Fire and disaster Drills form 130-014D2 for each patient who participated in the drill and place a copy in the medical record." Page 2, Paragraph 2 reads: " Quarterly..facilities shall perform a fire drill for each shift of patients...".
A review of MRs was conducted on March 29, 2019 from 8:00 AM through 12:30 PM.
MR#2 admission date 10/23/18 did not contain documentation of a fire drill for the fourth quarter of 2018.
MR#3 admission date 11/19/18 did not contain documentation of a fire drill for the fourth quarter of 2018.
MR#4 admission date 2/17/15 did not contain documentation of a fire drill for the first (1), second (2) and fourth (4) quarters of 2018.
MR#5 admission date 6/24/17 did not contain documentation of a fire drill for the first (1), second (2) and fourth (4) quarters of 2018.
MR#6 admission date 10/9/10 did not contain documentation of a fire drill for the first (1), second (2) and fourth (4) quarters of 2018.
MR#7 admission date 5/1/17 did not contain documentation of a fire drill for the first (1), quarter of 2018.
MR#8 admission date 2/13/99 did not contain documentation of a fire drill for the first (1), second (2) and fourth (4) quarters of 2018.
MR#9 admission date 6/25/13 did not contain documentation of a fire drill for the first (1), third (3) and fourth (4) quarters of 2018.
MR#10 admission date 7/5/05 did not contain documentation of a fire drill for the first (1), second (2) and fourth (4) quarters of 2018.
An interview with the Clinical Manager on March 29, 2019 at 12:35 PM confirmed the above findings. the clinical Manager confirmed that the above cited policy is current.














Plan of Correction:

To ensure compliance the Facility Administrator (FA)/designee will educate all staff on:
- FMS-CS-IC-II-130-013A Fire Drill Policy
- FMS-CS-IC-II-130-013D2 Patient Participation in Fire Drills
Emphasis will be placed on ensuring that fire drills are completed for all patients quarterly. The meeting also focused on ensuring that all newly admitted patients will have a fire drill completed upon admission to the unit. The meeting will also reinforce the importance of completing the Patient Participation in Fire Drill form for all patients and placing the form in the patient's medical record.

Fire Drills will be completed for all patients and staff by 5/31/2019 and records of the drills will be available at the facility for review

Inservicing will be completed by 4/22/2019. All training documentation will be on file at the facility.

To ensure ongoing compliance with quarterly fire drills, the CM/designee will develop a Fire Drill tracking calendar for 2019 with the weeks that the fire drills are to be held clearly identified. This calendar will be posted at the nurse's station. The CM will also have the weeks of the fire drills for 2019 marked in the computer's electronic calendar. The Fire Drill Tracking calendar will be reviewed in QAI.
The Quality Assessment Improvement (QAI) committee will be informed of the weeks that the drills are scheduled for 2019. The results of the fire drills, when conducted, will be reviewed by the CM at the monthly QAI meeting for ongoing oversight.
Issues of non-compliance will include re-education and counseling by the Director of Operations (DO).
Completion date: 5/31/2019

494.30(a)(4)(ii) IC- DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL (V-122)
The Education Coordinator (EC) or designee will re-educate all the direct patient care (DPC) staff on:



Initial Comments:


Based on the findings of an unannounced Medicare recertification survey conducted March 26, 2019 through March 29, 2019, FMC Germantown 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 Regional Quality Manager, it was determined, the facility failed to ensure infection control procedures were followed by cleaning and disinfecting the waste buckets for six (6) of thirty two (32) hemodialysis machines observed. (Machine #'s 8, 12, 15, 22, 24, and 29).

Findings include:

1. A review of policy number FMS-CS-IC-II-105-007C entitled, "Priming Bucket Disinfection" On March 28, 2019 at approximately 1:00 PM, was conducted. Section 6, Paragraph 1, reads "Clean all surfaces of the priming bucket...with a wipe that has been wetted with 1:100 Bleach solution...".

2. Observations were made in the patient treatment area on March 26, 27, and 28, 2019 between the hours of 10:00 AM and 12:00 PM .

On March 26, 2019 at approximately 10:35 AM, it was observed that Patient Care Technician #1, did not disinfect the waste bucket at dialysis machine # 8, prior to the start of the next dialysis treatment.

On March 26, 2019 at approximately 10:45 AM, it was observed that Patient Care Technician #2, did not disinfect the waste bucket at dialysis machine # 24, prior to the start of the next dialysis treatment.

On March 26, 2019 at approximately 11:05 AM, it was observed that Patient Care Technician #1, did not disinfect the waste bucket at dialysis machine # 15, prior to the start of the next dialysis treatment.

On March 27, 2019 at approximately 10:10 AM, it was observed that Patient Care Technician #3, did not disinfect the waste bucket at dialysis machine # 12, prior to the start of the next dialysis treatment.

On March 27, 2019 at approximately 10:15 AM, it was observed that Patient Care Technician #4, did not disinfect the waste bucket at dialysis machine # 22, prior to the start of the next dialysis treatment.

On March 27, 2019 at approximately 10:17 AM, it was observed that Patient Care Technician #5, did not disinfect the waste bucket at dialysis machine # 29, prior to the start of the next dialysis treatment.

3. An interview with the Regional Quality Manager was conducted on March 28, 2019 at approximately 2:00 PM. The Regional Quality Manager 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 Education Coordinator (EC) or designee will re-educate all the direct patient care (DPC) staff on:
- FMS-CS-IC-I-105-007C Prime Bucket Disinfection Procedure

The emphasis of the meeting will be on ensuring that all surfaces of the prime bucket are cleaned and disinfected with 1:100 bleach rag after each patient treatment.
In-servicing is scheduled to be completed by 4/22/2019.
All training documentation will be on file at the facility.
The FA/designee will perform daily audits for 2 weeks on the DPC staff until evidence of improved compliance is observed. If compliance is observed the audits will then be completed 2 times/week for 2 weeks. At that time if compliance is sustained, the audits will then be completed monthly following the QAI program. A Plan of Correction (POC) specific auditing tool will be used for the audits.
Staff found to be non-compliant will be re-educated and counseled.
The CM will review the audits and report the findings monthly at the QAI Committee meeting for ongoing guidance and sustained compliance.
Completion date: 5/6/2019.



494.60 STANDARD
PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT

Name - Component - 00
The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment.


Observations:


Based on observation and review of policies, and interview with Charge Nurse, the facility failed to provide and monitor a sanitary environment to ensure that expired medications are not dispensed to one hundred and one (101) persons treaded in the in-center hemodialysis facility.

Findings include:

On March 26, 2019, a review of facility policy for FMC Pharmacy Services, number ICG-RX-1-000-003-001A, effective 01 MAR 2013, entitled, "Expired Medications", revealed that, "Expired pharmaceuticals must not be dispensed to patients. The pharmacy storage areas, refrigerators, and warehouse will be checked monthly for expired products. A pharmacy technician will remove expired medications from the dispensing areas ...."

On March 26, 2019, a review of Facility Policy number, FMS-CS-IC-II-120-040A, revised 28-Jan-2015, entitled, "Medication Preparation and Administration." Page 3 revealed that, "the nurse must place the date and time a vial was opened on the medication label along with the nurse initials; Expiration dates for all stored medications are to be monitored on a monthly basis."

On March 26, 2019, from 9:30 AM. through 10:30 AM, a tour was conducted through out the treatment area..

On March 26, 2019, at approximately 9:45 AM., in the Medication refrigerator, located on the treatment floor, four (4) boxes of "Mircera" injectable (Medication) 30 mcg/0.3 ml., with the expiration date of 2 (February)-2019.

An interview with Charge Nurse was conducted on March 26, 2019 at approximately 10:15 AM. The Charge Nurse confirmed the above findings.
























Plan of Correction:

For immediate compliance, on 3/26/2019, all expired medications identified during the survey were disposed of. All other medications were audited for expiration dates at the same time.
The EC/designee will in-service all DPC staff on:
- FMS-CS-IC-II-120-040A Medication Preparation and Administration Policy
- FMS-CS-IC-11-120-035A Sequestering Medications Policy
The focus of the inservice will be on ensuring that all medications are labeled per policy when opened. The meeting will also reinforce the importance of ensuring that a medication is not expired before preparing the medication for use. Staff were also informed that a medication would now be checked monthly for expiration dates via a log which will be monitored by the charge nurse (CN).
The in-service will be completed by 4/22/2019. Documentation of the education will be on file at the facility.

The FA/designee will perform weekly audits for four (4) weeks until evidence of improved compliance is observed. At that time if compliance is sustained, the audits will then be completed monthly following the QAI program. A POC specific auditing tool will be used for the audits.
Staff found to be non-compliant will be re-educated and counseled.
The CM will review the audits and report the findings monthly at the QAI Committee meeting for ongoing guidance and sustained compliance.
Completion date: 5/31/2019.



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 Manager, 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 ten (10) hemodialysis patients. (Clinical record # 1, 2, and 3)

Findings include:

1. A review of facility policy titled, " Patient Assessment" on March 29, 2019 at approximately 12:55 PM states, " Each new admission to the dialysis facility is to have an individualized and comprehensive assessment completed by the interdisciplinary team within 30 days or 13 treatments after their first outpatient dialysis treatment at the facility. . . The purpose of the assessment is to gather criteria to develop the patient's treatment plan and expectations of care. . ."

2. A review of the clinical record #1 was conducted on March 29, 2019, at approximately 8:05 A.M. The first hemodialysis treatment at this facility for the patient was February 4, 2019. The documentation showed an initial comprehensive interdisciplinary assessment/ Plan of Care was developed and implemented on March 21, 2019, forty-seven (47) days after the first outpatient dialysis session.

A review of the clinical record #2 was conducted on March 29, 2019, at approximately 8:40 A.M. The first hemodialysis treatment at this facility for the patient was October 23, 2018. The documentation showed an initial comprehensive interdisciplinary assessment/Plan of Care was developed and implemented on December 20, 2018, fifty-eight (58) days after the first outpatient dialysis session.

A review of the clinical record #3 was conducted on March 29, 2019, at approximately 9:10 A.M. The first hemodialysis treatment at this facility for the patient was November 29, 2018. The documentation showed an initial comprehensive interdisciplinary assessment/Plan of Care was developed and implemented on January 24, 2019, fifty-eight (56) days after the first outpatient dialysis session.

3. An interview was conducted with the Administrator on March 29, 2019 at approximately 12:30 P.M. The Clinical Manager confirmed the above identified findings, and informed the surveyor that the above cited policy is current.





































Plan of Correction:

The EC/designee will in-serviced the members of the Interdisciplinary team (IDT) on:
- FMS-CS-IC-I-110-125A Comprehensive Interdisciplinary Assessment and Plan of Care Policy.
Emphasis will be placed on ensuring that the initial Comprehensive Interdisciplinary Assessment (CIA) and Plan of Care (POC) be completed on all new patients within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session.

The in-service will be completed by 4/22/2019. Documentation of the education will be on file at the facility.

To ensure compliance the CM/designee will monitor all newly admitted patients CIA/POC's for timely completion using the QAI CIA/POC tracking work book as an auditing tool. The audits will be completed for the next six (6) months. If compliance is observed the auditing will the follow the monthly QAI auditing schedule

Issues of non-compliance by IDT team will result in reeducation and counseling.

Results of the audit will be summarized by the CM and will report the findings at monthly QAI meetings. The QAI committee will provide oversight for sustained compliance.

Completion date: 10/31/2019



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 clinical Manager, it was determined, that the facility failed to ensure a "Follow-up Reassessment " was completed within ninety (90) days of the initial hemodialysis assessment for one (1) of ten (10) hemodialysis patients. (Clinical record # 7)

Findings include:

1. A review of facility policy entitled, "Comprehensive Interdisciplinary Assessment (CIA) and Plan of Care" was conducted on March 29, 2019 at approximately 1:00 PM. Paragraph 1 reads: " An initial Comprehensive interdisciplinary assessment and plan of care must be conducted within the later of 30 days or 13 outpatient hemodialysis sessions beginning with the first outpatient session.
Paragraph 1, section 2 reads: "A follow up CIA must occur within 90 days".

2. A review of the clinical record #7 was conducted on March 29, 2019 at approximately 11:15 AM. The first hemodialysis treatment at this facility for the patient was May 1, 2017. The documentation showed an initial comprehensive interdisciplinary assessment was developed and implemented on May 12, 2017.

There was no documentation showing when the ninety (90) day re-assessment was conducted. There was no 90 day CIA/POC documentation contained in this clinical record.

The next CIA/POC contained in clinical record #7 is an annual CIA/POC dated September 28, 2018.

3. An interview was conducted with interview with the Clinical Manager on March 29, 2019, at approximately 12:30 PM. The Clinical Manager confirmed the above identified finding and informed the surveyor that the above cited policy is current.

























Plan of Correction:

The EC/designee will in-service the IDT members on:
- FMS-CS-IC-I-110-125A Comprehensive Interdisciplinary Assessment and Plan of Care Policy.
Emphasis will be placed on ensuring that the comprehensive reassessment occurs within 3 months after completion of the initial assessment to provide information to adjust the patient's plan of care.

The in-service will be completed by 4/22/2019 Documentation of the education will be on file at the facility.

To ensure compliance the FA/designee will monitor 90 Day CIAs for timely completion using the QAI CIA/POC tracking work book as an auditing tool. The audits will be completed for the next 6 months. If compliance is observed the auditing will the follow the monthly QAI auditing schedule

Issues of non-compliance by IDT team will result in reeducation and counseling.

Results of the audit will be summarized by the CM and will report the findings at monthly QAI meetings. The QAI committee will provide oversight for sustained compliance.

Completion date: 7/31/2019



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 Clinical Manager, the facility failed to ensure the comprehensive interdisciplinary assessment/plan of care was updated annually for two (2) of ten (10) hemodialysis dialysis patients. (Clinical Record #'s 4 & 5)

Findings include:

1. A review of facility policy entitled, "Comprehensive Interdisciplinary Assessment (CIA) and Plan of Care" was conducted on March 29, 2019 at approximately 1:00 PM. Paragraph 1 reads: " An initial Comprehensive interdisciplinary assessment and plan of care must be conducted within the later of 30 days or 13 outpatient hemodialysis sessions beginning with the first outpatient session.

Paragraph 1, section 2 reads: "A follow up CIA must occur within 90 days".

Paragraph 1, section 3 reads: "Comprehensive interdisciplinary assessments and modifications to the Plan of Care must be conducted 12 months after the completion of the 3 month assessment...".

2. A review of Clinical Record #4 on March 29, 2019 at approximately 10:05 AM revealed a start of care date as 2/17/2015. The patient was considered stable and the documentation showed the interdisciplinary team completed an annual assessment/plan of care dated 12/8/2017. The next annual assessment/plan of care was not completed until 1/4/2019. (Twenty seven (27) days late).

A review of Clinical Record #5 on March 29, 2019 at approximately 10:45 AM revealed a start of care date as 6/24/2017. The patient was considered stable and the documentation showed the interdisciplinary team completed an 90 day assessment/plan of care dated 11/7/2017. The next annual assessment/plan of care was not completed until 11/29/2019. (Twenty two (22) days late).

3. An interview conducted with the Clinical Manager on March 29, 2018 at approximately 12:30 PM acknowledged the above findings, and informed the surveyor that the cited policy is current.































Plan of Correction:

The EC/designee will in-service the IDT members on:
- FMS-CS-IC-I-110-125A Comprehensive Interdisciplinary Assessment and Plan of Care Policy.
Emphasis will be placed on ensuring that the Comprehensive Assessment and care plan on all stable patients must occur within twelve (12) months of the completion of the 3 month assessment.

The in-service will be completed by 4/22/2019. Documentation of the education will be on file at the facility.

To ensure compliance the FA/designee will monitor all annual assessments/care plans for timely completion using the QAI CIA/POC tracking work book as an auditing tool. The audits will be completed for the next 6 months. If compliance is observed the auditing will the follow the monthly QAI auditing schedule

Issues of non-compliance by IDT team will result in reeducation and counseling.

Results of the audit will be summarized by the CM and will report the findings at monthly QAI meetings. The QAI committee will provide oversight for sustained compliance.

Completion date: 7/31/2019



494.180 STANDARD
GOV-ID GOV BODY W/FULL AUTHORITY/RESPONS

Name - Component - 00
The ESRD facility is under the control of an identifiable governing body, or designated person(s) with full legal authority and responsibility for the governance and operation of the facility. The governing body adopts and enforces rules and regulations relative to its own governance and to the health care and safety of patients, to the protection of the patients ' personal and property rights, and to the general operation of the facility.


Observations:


Based on a review of facility policy, employee records, and interview with the Education Coordinator, it was determined, that the Governing Body failed to ensure the health and safety of patients by failing to ensure all staff members were given a two step Tuberculin skin test upon hire as per company policy (Staff Members # Patient Care Technician (PCT ) # 1, PCT # 2, Dietician (DIET) #1, Registered Nurse (RN) # 1, RN# 2, RN # 3, and RN # 4).

Findings include:

1. A review of facility policy entitled "Employee Tuberculin Skin Testing Mantoux" was conducted on 3/28/19 at 2:15PM. Paragraph 3 reads: " TB skin test is required upon hire using the two step tuberculin skin test (TST) method".

2. A review of Employee records were conducted on March 28, 2019, between the hours of 12:10 PM through 1:55 PM.

RN #1, Date of Hire was 10-9-13. There was no written evidence of a tuberculin test being administered upon hire, contained in this record.

RN #2, Date of Hire was 9-10-18. There was no written evidence of a tuberculin test being administered upon hire, contained in this record.

RN #3, Date of Hire was 10-26-15. There was no written evidence of a tuberculin test being administered upon hire, contained in this record.

RN #4, Date of Hire was 8-15-16. There was no written evidence of a tuberculin test being administered upon hire, contained in this record.

PCT #1, Date of Hire was 1-29-18. There was no written evidence of a tuberculin test being administered upon hire, contained in this record.

PCT #2, Date of Hire was 4-23-18. There was no written evidence of a tuberculin test being administered upon hire, contained in this record.

DIET #1, Date of Hire was 4-28-14. There was no written evidence of a tuberculin test being administered upon hire, contained in this record.

3. An interview was conducted with the Education Coordinator on 3-28-19, at approximately 2:45 PM. The Education Coordinator confirmed the above findings and informed the Surveyor that the above cited policy is current.




















Plan of Correction:

To ensure compliance, the DO and the FA had a call with the Governing Body (GB) to review:
- FMS-CS-IC-II-155-180A Employee Tuberculin Skin Testing Mantoux Policy

Special attention will be placed during the call on ensuring that all new employees have a two-step tuberculin (TB) skin test completed upon hire.

The in-service will be completed by 4/22/2019. Documentation of the education will be on file at the facility.

The FA/designee will audit all new hires for the next 6 months for completion of the two-step TB testing. If compliance is noted at that time, the auditing will then be completed quarterly.

Issues of non-compliance will result in reeducation and counseling.

Results of the audit will be summarized by the FA and will report the findings at monthly QAI meetings. The QAI committee will inform the GB of the audit results to provide oversight for sustained compliance.

Completion date: 10/31/2019