QA Investigation Results

Pennsylvania Department of Health
Health Inspection Results
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Initial Comments:

Based on the findings of an onsite unannounced complaint investigation conducted on August 1, 2018, Fresenius Medical Care Harston Hall was identified to have the following standard level deficiency that was 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:


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.


Based on a review of facility documentation and logs, facility policy, direct observation of the clinical area, and an interview with the interim clinical manager and operations director, the facility failed to ensure a safe and comfortable treatment environment by failing to consistently document daily treatment area tasks.

Findings include:

A review of facility documentation and daily logs located at the nurses station was conducted on August 1, 2018 at 1000.

There were areas of missed documentation as follows:
Water Softener Log July 2018 last shift water hardness not documented on 7/14, 18, 25, 27, 28/18.
Phoenix Meter Log July 2018:
One Phoenix Meter (no number assigned) located on right side of page did not have verification documentation for 7/4-7/7/18.
There was no documentation of machine disinfection for all machines on 7/5, 7/24, 7/25/18.
A review of policy FMS-CS-IS-510-020A on August 1, 2018 at 1410 states: The hemodialysis machine must be acid rinses and heat disinfected at the end of each treatment day except on the day of chemical disinfection...Documented evidence must be complete as defined by program management..."
The AED Daily Inspection/Manual Testing Log was missed on 7/24, 26/18.
The Glucose Log was missed on 7/16-18/18 "due to no [testing] strips" and 7/23/18.
There was one open Residual Chlorine vial and one open isopropyl (alcohol) vial that were not dated/initialed located at the nurses station observed 8/1/18 at 1010.

An interview with the clinical manager and operations director on August 1, 2018 at 1230 confirmed the above findings.

Plan of Correction:

Harston Hall POC
August 1, 2018
Complaint Survey


The Education Coordinator (EC) or designee will in-service all direct patient care (DPC) staff by: August 9, 2018
- FMS-CS-IC-II-140-126A Water Softener Policy
- FMS-CS-IC-II-140-126C3 Water Softener Monitoring Procedure
- FMS-CS-IC-II-140-126D1 Water Softener Log
- FMS-CS-IC-II-140-500C5 Phoenix Meter, Phoenix XL and Tri Station Care and Maintenance
- FMS-CS-IC-II-140-410A Hemodialysis Machines: Acid Clean, Chemical Rinse and Heat Disinfection Policy
- FMS-CS-IC-II-130-010A Use of the Automatic External Defibrillator Policy
- FMS-CS-IC-11-135-012A Blood Glucose Monitoring Device Policy
- FMS-CS-IC-II-140-800A Testing for Residual Bleach using Using WaterCheck™ RC Residual Chlorine Reagent Test Strips Policy

Emphasis of the meeting will focus on the following:
- The importance of ensuring that the hardness testing, including the end of the day test, is documented on the water softener log at the time the testing is completed
- The need to ensure that the Phoenix meters calibration is documented and that the serial number of the meter is on the log for identification verification
- That the hemodialysis machine disinfection is completed daily with documentation completed on the log at the time of the disinfection
- The inspection and documentation of the Automatic External Defibrillator is completed every day
- The Blood Glucose Monitoring Device is calibrated every day and documented on the log. The staff was also informed to notify the CM when the glucose testing strips were beginning to become low to prevent any risk of running out of the strips.
- The importance of ensuring that all supplies, including residual testing strips and alcohol vials, are labeled with the dates, time and initials per policy.

The inservice will be completed by August 9, 2018 and documentation will be on file at the facility.

The Charge Nurse (CN) or designee will perform daily audits for 2 weeks on the logs 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 Quality Assurance Improvement (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 Director of Operations (DO) will review the audits and report the findings monthly at the QAI Committee meeting. The QAI committee will report the audit results to the GB monthly for further guidance and ongoing oversight.
Completion date: September 14, 2018.