QA Investigation Results

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


There are  11 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 Medicare recertification survey completed on 9/30/2019, Elizabeth 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 onsite unannounced Medicare recertification survey completed 9/30/2019, Elizabeth Dialysis was found 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(b)(2) STANDARD
IC-ASEPTIC TECHNIQUES FOR IV MEDS

Name - Component - 00
[The facility must-]
(2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and




Observations:


Based on a review of facility policies and procedures, observations and staff (EMP) interviews, the facility failed to ensure staff labeled multi-dose medication vials with the initials of the person opening the vial and the date the medication was opened for one (1) of one (1) multi-dose vials used during the preparation of intravenous medications.

Findings included:

A review of agency policy and procedure conducted on 9/25/2019 at approximately 11:25 AM revealed: "Policy: 1-06-04...TITLE: ADMINISTRATION OF EPOGEN, PURPOSE: To provide guidance for the safe, aseptic preparation and administration of Epogen. POLICY: 1. Adhere to medication guidance in policy: Medication Policy. 2. Doses are prepared by a licensed nurse whose scope of practice includes preparation and administration of parenteral medications...4. Epogen is stored under refrigeration at 2C to 8C (36F to 46F). Epogen multi-dose vials (i.e., an M10 vial) may be saved for up to 21 days after opening with proper storage and labeling. Each multi-dose vial is labeled with the initials of the person opening the vial and the expiration date..."

During a flash tour of the facility with (EMP4) clinical coordinator on 9/25/2019 at approximately 11:04 AM an already opened approximately half empty multi-dose vial of Epogen [medication] 20000 U[units 2 ml vial Lot# 1104515 Exp 05/21 was found in the medication refrigerator, and was not labeled with the initials of the person opening the vial or the date opened.

An exit interview with the two facility administrators on 9/30/2019 at approximately 2:03 PM confirmed the findings.








Plan of Correction:

The Clinical Coordinator (CC) or Facility Administrator (FA) will in-service all nurses by 10/18/2019 on Policy 1-06-01: Medication Policy with specific focus on: 1) Multi-dose vials should be labeled with the initials of the person opening the vial and expiration date. As part of in-service, surveyor observations were reviewed. Verification of attendance at in-service is evidenced by nurses signature on in-service sheet. The FA, CC or designee will conduct audits every shift daily for one (1) week, then three (3) times a week for one (1) week, then weekly for two (2) weeks, then monthly to verify compliance. Every nurse is to be audited at least three (3) times during this period. Any instance of non-compliance will be addressed immediately. Results of audit will be reviewed with Medical Director at monthly Facility Health Meeting (FHM-QAPI) with supporting documentation included in meeting minutes. The FA is responsible for compliance with this plan of correction.


494.40(a) STANDARD
RO-MEETS AAMI/MONITORED, RECORDED ON LOG

Name - Component - 00
5.2.7 Reverse osmosis: meets AAMI/monitored/recorded on log
Refer to RD62:2001, 4.3.7 Reverse osmosis: When used to prepare water for hemodialysis applications, either alone or as the last stage in a purification cascade, reverse osmosis systems shall be shown to be capable, at installation, of meeting the requirements of Table 1, when tested with the typical feed water of the user, in accordance with the methods of [AAMI] 5.2.2.

5.2.7 Reverse osmosis
Users should carefully follow the manufacturer's instructions for feed water treatment and monitoring to ensure that the RO is operated within its design parameters.

6.2.7 Reverse osmosis
All results of measurements of RO performance should be recorded daily in an operating log that permits trending and historical review.




Observations:


Based on the review of the facilities policy and procedures, daily waterlog sheets and staff (EMP) interviews the agency failed to follow the manufacturer's instructions for feed water treatment and monitoring to ensure that the RO is operated within its design parameters for one (1) of five (5) water and dialysate logs review.

Findings included:

A review of agency policy and procedure conducted on 9/25/2019 at approximately 11:25 AM revealed: "Policy 2-04-02 TITLE: DAILY WATER TREATMENT SYSTEM MONITORING...POLICY: 1. All observations and test results must be recorded on the approved daily water treatment log and required Snappy entries...5. All observations and test results will be within the limits specified on the Daily Water Treatment Log. If observation or test results are found outside the specified limits, follow the instructions given on the Daily Water Treatment Log for the parameter(s) in question. In addition to following the log form instructions, the teammate completing the log will notify the Facility Administrator/designee and biomed teammate assigned to the facility of any observation or test result found outside the limit specified on the daily water Treatment Log. 6. The initials and signature of the teammate performing and recording all observations and test results are entered where indicated on the Daily Water Treatment Log. A separate entry of time initials is provided for the teammate performing end of day hardness testing. 7. A licensed nurse reviews the Daily Water Treatment Log for completeness and verifies that all parameters are within specified limits. Upon satisfactory completion of this review, the licensed nurse initial and signs the log form where indicated..."

Review of "DAILY WATER LOG" from 7/15/2019 to 9/21/2019 was conducted on 9/26/2019 at approximately 9:40 AM which revealed, readings from the "Monitored Process or Component" category number "13 Pure Water Flow Rate (Prod. Water), L/min" and category "acceptable Limits ...>/= 15 L/min models 102-106." The facility ran two RO units. The daily water logs did not indicate which log was identified with what RO unit. The readings for the two RO unit logs were not documented within the acceptable limits on the following dates.

7/15/2019, 7/16/2019, 7/17/2019, 7/18/2019, 7/19/2109, 7/20/2019, 7/22/2019, 7/23/2019,7/24/2019, 7/25/2019, 7/26/2109, 7/27/2019, 7/29/2019, 7/30/2019,7/31/2019 8/1/2019, 8/2/2019, 8/3/2019, 8/5/2019, 8/6/2019, 8/7/2019, 8/8/2019, 8/9/2019, 8/10/2019 8/12/2019, 8/13/2019, 8/14/2019, 8/15/2019, 8/16/2019, 8/17/2019, 8/19/2019, 8/20/2019 8/21/2019, 8/22/2019, 8/23/2019, 8/24/2019, 8/26/2019, 8/27/219, 8/28/2019, 8/29/2019 8/30/2019, 8/31/2019, 9/2/2019, 9/3/2019, 9/4/2019, 9/5/2019, 9/6/2019, 9/7/2019, 9/9/2019, 9/10/2019, 9/11/2019, 9/12/2019, 9/12/2019, 9/13/2019, 9/14/2019, 9/16/2019, 9/17/2019, 9/18/2019, 9/19/2019, 9/20/2019 and 9/21/2019.

No documentation was provided by the agency to confirm the readings were reported as outside the acceptable limits at the time daily readings were conducted, or when review of the daily water treatment logs was completed.

An exit interview was conducted with the two facility administrators on 9/30/2019 at approximately 2:03 PM which confirmed the findings.







Plan of Correction:

All Teammates (TMs) responsible for water quality monitoring and testing will be in-serviced by the FA and/or Biomedical Service Specialist (BSS) by 10/28/2019. Education will include but not be limited to: 1) A detailed review, demonstration and in-service with BSS oversight of newly adopted Facility Specific policy and guidelines for log entries relative to Pure Water Flow Rate (Prod. Water) L/min for both primary and secondary CWP RO systems. 2) FA verification of teammate understanding and application of aforementioned policy. Verification of attendance will be evidenced by TM signature/date on in-service form. FA, CC, BSS or designee will perform audit of both primary and secondary RO logs daily for five (5) days, then three (3) times per week for two (2) weeks, then weekly for 2 weeks, and finally monthly and ongoing. This audit will be focused on ensuring that Pure Water Flow Rate (Prod. Water) L/min volume from both CWP RO primary and secondary systems are within defined parameters, and that any incidence of values outside of parameters are documented properly, including notification of BSS and FA. Parameters specific to the log entry line item Pure Water Flow Rate (Prod. Water) L/min for both primary and secondary CWP RO system logs are redefined as Facility-Specific policies exclusive to each relevant RO system (and this facility only), based on guidance obtained direct from the manufacturer, Marcor. These parameters were drafted and approved by Governing Body on 10/23/2019. All relevant log sheet entries for Pure Water Flow Rate (Prod. Water) L/min from 10/28/2019 forward will reflect newly adopted parameters for the primary and secondary CWP RO systems. Results of audits will be reviewed and presented to 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.


494.80(a)(2) STANDARD
PA-APPROPRIATENESS OF DIALYSIS RX

Name - Component - 00
The patient's comprehensive assessment must include, but is not limited to, the following:

(2) Evaluation of the appropriateness of the dialysis prescription,




Observations:



Based on a review of facility policies and procedures, medical records and staff (EMP) interviews, the facility failed to communicate with physicians when blood flow rates (BFR) required adjustment beyond the current physicians' orders for one (1) of four (4) in-center hemodialysis medical records (MR) reviewed (MR1).

Findings included:

A review of agency policy and procedure conducted on 9/25/2019 at approximately 11:25 AM revealed: " Policy: 12-3-07 TITLE: INTRADIALYTIC TREATMENT MONITORING PURPOSE: To guide treatment checks, monitoring during dialysis and documentation for every patient in conformity with his/her individual plan of care. POLICY: 1. Home hemodialysis treatment training sessions are performed under the guidance of the home hemodialysis nurse. 2. Treatment checks should be completed at least every thirty (30) minutes or as prescribed by the physician. 3. At a Minimum, obtain and document the following: Blood pressure, Heart rate, Blood and dialysate flows, arterial and venous pressures, fluid removal and/or replacement ...Vascular access visible and line connections intact, Patient status and subjective will-being, Patient ' s face visible ... "

MR #1 start of care 5/22/2019, was reviewed on 9/27/2019, at approximately 11:50 AM. A review of the patients Kardex and post treatment sheets dated 9/9/2019 through 9/23/2019 revealed the physician ordered a BFR of 450 ml/min order date 8/14/2019. Blood flow was delivered lower than prescribed on 9/13/2019 at 350 ml/min starting at 6:31 AM until 9:15 AM. Three different staff members documented conducting checks during the treatment.

No documentation was available to confirm any standing order that allowed for adjustment of the patient's BFR. There was no documentation in MR1, to confirm the patient's inability to achieve blood flow or a reported was submitted to the physician.

An exit interview was conducted with the two facility administrators on 9/30/2019 at approximately 2:03 PM which confirmed the findings.







Plan of Correction:

Direct patient care TMs will be in-serviced on Policy 1-03-08 Pre Intra Post Treatment Data Collection Monitoring and Nursing Assessment and Policy 1-04-5 Blood Flow Problems by the CC or FA by 10/18/2019. Education will include but not be limited to: 1) identity, prescription and machine settings are verified by TM prior to initiation of treatment with the exception of blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment. 2) If Blood Flow Rates are not achieved, TMs will notify a licensed nurse. The licensed nurse will assess the patient, their vascular access and extracorporeal circuit to determine intervention. The licensed nurse will assess the effectiveness of the interventions and determine the need to reduce blood flow and extend treatment time then notify nephrologist for further evaluation and/or interventions. The licensed nurse will document findings and interventions in patient's medical record. Verification of attendance will be evidenced by TM signature on in-service form. The FA or designee will audit twenty percent (20%) of the flow sheets daily for five (5) days, then weekly for four (4) weeks then ten percent (10%) monthly going forward. Results of audits will be reviewed with the team in homeroom meetings and presented to 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.