QA Investigation Results

Pennsylvania Department of Health
DIALYSIS CLINIC, INC. - HASTINGS
Health Inspection Results
DIALYSIS CLINIC, INC. - HASTINGS
Health Inspection Results For:


There are  7 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 9/13/2019, Dialysis Clinic Inc. Hastings 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 9/13/2019, Dialysis Clinic Inc. Hastings 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(a)(1)(i) STANDARD
IC-HBV-ISOLATION (EXISTING FACILITY)

Name - Component - 00
Isolation of HBV+ Patients

To isolate HBsAg positive patients, designate a separate room for their treatment.

For existing units in which a separate room is not possible, HBsAg positive patients should be separated from HBsAg susceptible patients in an area removed from the mainstream of activity.


Observations:


Based on a review of facility documents and staff (EMP) interviews, it was determined that the facility which does not currently accept or treat hepatitis B positive patients failed to establish a patient transfer agreement with a local chronic facility which has capacity for isolation stations.

Findings Included:

During an interview with EMP1 on 9/3/2019 at approximately 11:38 AM the entrance conference questions were reviewed. EMP1 confirmed the facility had no isolation room and has never had a hepatitis B positive patient (question 12). The surveyor asked question number thirteen (13) from the entrance conference questions " If opened or expanded on or after 10/14/2008, does the facility have a waiver from CMS for the requirement of an isolation room? " EMP1 could not confirm when the facility was built. EMP3 could not confirm the date of when the facility was built, but provided a Pennsylvania Department of Health and Human Services with a " ...(X3) DATE SURVEY COMPLETED: 08/29/2007 ... " During an observation tour of the facility on 9/3/2019 at approximately 12:20 PM with EMP1, no isolation was available.

The surveyor informed EMP1 on 9/10/2019 at approximately 12:40 PM of the requirements for a waiver and or transfer agreement for patients with hepatitis B positive status to another facility which has an isolation room.

Review of Department documentation revealed facility opened 8/29/2007.

EMP1 provided two separate facility letters for acceptance on 9/10/2019 at approximately 12:50 PM from EMP3 (area operations director) which revealed, " (dated) September 3, 2019 ...To whom it may concern, Please accept this letter as confirmation that the (accepting agency) clinic is capable and willing to accept hepatitis B+ patients from the (agency) should you admit a hepatitis B+ patient or have a current patient seroconvert to hepatitis B+ ... "

An interview was conducted on 9/11/2019 at approximately 12:40 PM with the area operations director, nurse manager and regional technical manager which confirmed the above findings.














Plan of Correction:

1. A written transfer agreement will be established with two local chronic facilities which has capacity for isolation stations (completed during state survey letters dated 9/3/19).

2. An isolation waiver will be applied for per CMS requirements.

3. All facility staff will be notified of established transfer agreements in the event that a hepatitis B+ patient is admitted to the facility or have a current patient seroconvert to hepatitis B+.

4. All staff will review and sign acknowledgement of understanding of agreements. Acknowledgement will be placed in facility's education manual.

5. Area Operations Director and/or Designee will review waiver/transfer agreements annually to ensure adherence to 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 facility failed to ensure staff followed 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) set of water and dialysate logs review.

Findings included:

Review of facility policy and procedures on 9/6/2019 at approximately 1:10 PM revealed, PROCEDURE NO: 142.0 TechNet Water System Monitoring and Documentation PURPOSE: Define the documentation, monitoring, reporting and data entry requirements for the TechNet System were pertaining to water treatment systems ...All results of RO performances, pretreatments values, and quality testing must be recorded daily in an operation log that permits trending and historical review. A TechNet Water System log was developed for each individual clinic to meet these requirements. Email notifications are automatically generated each day for missing or out of range values and QA reports are automatically generated from entered data. POLICY ...5. All out of range data documented will be reported to the Chief Technician, Technical Manager, Nurse Manager and Administrator ... "

A review of the daily water logs was conducted on 9/6/2019 at approximately 11:40 AM from 6/29/2019 to 9/3/2019. On the following dates the reading were out of range for the following:
Post Booster Pump Pressure, Post Particulate Filter Pressure, Post Carbon Worker Pressure and Post Carbon Polisher Pressure.

6/29/2019
7/1/2019 to 7/6/2019
7/8/2019 to 7/13/2019
7/15/2019 to 7/20/2019
7/22/2019 to 7/27/2019
7/29/2019 to 8/3/2019
8/5/2019 to 8/10/2019
8/12/2019 to 8/17/2019
8/19/2019 to 8/23/2019

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

An interview was conducted on 9/11/2019 at approximately 12:40 PM with the area operations director, nurse manager and regional technical manager which confirmed the above findings.





















Plan of Correction:

1. All clinical staff will be re-trained on the facility's "TechNet Water System Monitoring and Documentation" procedure.

2. All staff will review and sign acknowledgement of understanding of policy. Acknowledgement will be placed in facility's education manual.

3. Initially, Technical Manager will audit water treatment logs daily for one (1) week to ensure that staff is following proper procedure for notification of any out of range water treatment readings. If standards are met, the Technical Manager will audit weekly for four (4) weeks. If standards are met, the Technical Manager will audit water treatment logs monthly for three (3) months. If standards are met, the water treatment logs will be audited quarterly. The audit results will be reviewed at monthly QAPI meetings.



494.40(a) STANDARD
ACID CONC DIST-CONC LABELED & COLOR-CODED RED

Name - Component - 00
5.5.3 Acid concentrate distribution systems: labeled & color-coded red
Acid concentrate delivery piping should be labeled and color-coded red at the point of use (at the jug filling station or the dialysis machine connection).

All joints should be sealed to prevent leakage of concentrate. If the acid system remains intact, no rinsing or disinfection is necessary.

More than one type of acid concentrate may be delivered, and each line should clearly indicate the type of acid concentrate it contains.


Observations:


Based agency policy, observation (OBV) and staff interview (EMP), the facility ensure acid delivery system was closed to prevent contamination for two (2) of two (2) patients observed receiving dialysis at the station with jugs of acid concentrate (station 2, & station 3).

Findings included:

A review was conducted of facility policy on 9/11/2019 at approximately 11:00 a.m.which revealed, " Policy Number 2201 Phoenix Dialysis Machine SET-UP-PRIME-RECIRCULATE ...POLICY ...Machine Set-Up **Turn the power on or touch the set Key to deactivate sleep mode**1. Connect the ACID concentrate connector to the appropriate ACID CONCENTRATE PORT on the lower front of the machine. If using " Special dialysate " , connect the ACID concentrate connector to a concentrate wand and insert wand into dialysate container ... "

During Observation of " #9 Dialysis Supply Management and Contamination Prevention " on 9/10/2019 at 9:55 AM revealed, (OBS2) of the treatment floor a patients was at stations 2 had liquid acid concentrate jugs located directly on the facility's treatment floor. At the time of observation, the patients were receiving dialysis. The area on the machines designated for the storage of the acid concentrate jugs were angled and when staff (EMP4) was asked why the jugs were not placed into the designated area for jug storage. The jugs do not fit. EMP4 confirmed no caps have ever been used on the jugs of acid.

The jugs were located in front of the machines on the floor where staff would approach the machine for machine checks etc. The acid jugs were not capped (no lid) and the pick-up tubes/wands were inserted in the top, and angled slightly out since there was nothing holding them in place.

The acid jug observed at station 2 on 9/10/2019 at approximately 10:01 AM was labeled 2K (potassium) 2Ca (Calcium) There was no lid covering the jug, and the pick-up tube was simply resting in the opening of the jug at an angle, and only secured by gravity. EMP5 confirmed the jugs are usually on the floor and no caps are on the jugs.

The acid jug observed at station 3 on 9/10/2019 at approximately 9:50 AM was labeled " Renal Pure C-108 Rockwell 2K (potassium) 2Ca (Calcium) There was no lid covering the jug, and the pick-up tube was simply resting in the opening of the jug at an angle, and only secured by gravity. The jug was setting on the floor.

The agency failed to maintain a closed system to prevent nonbacterial contamination and evaporation and to prevent leakage of concentrate. The agency policy did not indicate a closed acid system.

An interview was conducted on 9/11/2019 at approximately 12:40 PM with the area operations director, nurse manager and regional technical manager which confirmed the above findings.












Plan of Correction:

1. All concentrate jugs used for the dialysis treatment will be converted to a closed system with a cap to cover the jugs to prevent nonbacterial contamination and evaporation and to prevent leakage of concentrate.

2. All concentrate jugs used for the dialysis treatment will be placed in the machines concentrate holding shelf for storage during treatment.

3. Facility policy "Phoenix Dialysis Machine SET-UP-PRIME-RECIRCULATE" will be revised to state "....insert wand into the cap of the dialysate container."

4. All clinical staff will be re-trained on the facility's "Phoenix Dialysis Machine SET-UP-PRIME-RECIRCULATE" policy.

5. All staff will review and sign acknowledgement of understanding of policy. Acknowledgement will be placed in facility's education manual.

6. Initially, Nurse Manager and/or Designee will observe facility staff daily for one (1) week to ensure that staff is following proper policy. If standards are met, the clinic staff will be observed weekly for four (4) weeks. If standards are met, the clinical staff will be observed monthly for three (3) months. If standards are met, the clinical staff will be observed quarterly. The audit results will be reviewed at monthly QAPI meetings.



494.90(a)(1) STANDARD
POC-ACHIEVE ADEQUATE CLEARANCE

Name - Component - 00
Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis.


Observations:


Based on a review of facility policy, medical records (MR) and staff (EMP) interviews, it was determined that the facility failed to ensure patients received dialysis treatment as prescribed by the physician for one (1) of three (3) in-center dialysis MR reviewed (MR2).

Findings included:

A review was conducted of facility policy on 9/13/2019 at approximately 3:00PM which revealed, "SUBJECT: Patient Monitoring During Dialysis ...After treatment has been initiated, continuous monitoring of the patient is necessary ...2. Every 60 minutes a. BFR/DFR -Blood flow Rate (home screen) set at ordered rate, Dialysate flow rate (set from home screen) ... "

Review of MR2 was conducted on 9/11/2019 at approximately 9:38 AM which revealed the prescribed DFR was 800. A review of six (6) treatment sheets from 9/2/2019 to 8/21/2019 revealed:

On 9/2/2019, treatment began at 6:08 AM with the DFR at 600 and remained at this rate for the remainder of the treatment. Three staff initials are documented in the " Checked By Entered By " section of the " HEMODIALYSIS FLOWSHEET. "

Review of the MR's revealed there was no documentation in the MR's that the physician was notified of the inability to achieve the prescribed blood flow or that the physician had ordered the change. The surveyor confirmed with EMP1 that no special or axillary order allowed changes to the DFR for this patient.

An interview was conducted on 9/11/2019 at approximately 12:40 PM with the area operations director, nurse manager and regional technical manager which confirmed the above findings.













Plan of Correction:

1. All clinical staff will be re-trained on the facility's "Patient Monitoring During Dialysis" policy.

2. All staff will review and sign acknowledgement of understanding of policy. Acknowledgement will be placed in facility's education manual.

3. Initially, Nurse Manager and/or Designee will audit the treatment flow sheets daily for one (1) week to ensure that staff is following proper policy and that the patient is receiving the proper dialysis prescription as ordered by the physician. If standards are met, the flow sheets will be audited weekly for four (4) weeks. If standards are met, the flow sheets will be audited monthly for three (3) months. If standards are met, the flow sheets will be audited quarterly. The audit results will be reviewed at monthly QAPI meetings.