QA Investigation Results

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


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Initial Comments:

Based on the findings of an onsite unannounced Medicare recertification survey completed December 15, 2020, Dialysis Clinic, Inc. - Grove City 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 December 15, 2020, Dialysis Clinic, Inc. - Grove City 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-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS

Name - Component - 00
Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled.

When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station.

Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients.


Observations:


Based on observation and staff (EMP) interview, the facility failed to ensure clean and dirty items were kept separate for two (2) of two (2) observations of hemodialysis (HD) when concentrate from the central delivery system was not used (station 5, and station 7).

Findings included:

Observation of patients receiving dialysis on 12/10/2020 from 9:30 a.m. to 12 p.m. revealed 12 in-center hemodialysis stations. The HD machines, at each of the 12 stations, had a lower shelf comprised of two areas designed to hold concentrate jugs (acid and bicarbonate) when concentrate is not provided by a central delivery system. Each of the HD machines had a red plastic sharps container located on the right side of the concentrate shelf. Staff were observed placing used sharps (needles/syringes) in these sharps containers.

At the time of above observations on 12/10/2020, two patients (stations 5, & 7) had jugs of acid concentrate (a clean item for that patient) located on the left side of the concentrate shelf. This arrangement placed the acid (clean supply being used by patient) adjacent to the sharps container (contaminated supply used for items from multiple patients). The tops of the sharps containers were open.

Further observation of stations (ready for use but no patient at station yet) revealed the acid jug on left side of concentrate shelf was touching the sharps container located next to it on the right side of concentration shelf.

Observation and interview with EMP1 (clinic manager) on the treatment floor on 12/10/2020 at 2:20 p.m. confirmed findings, "Used to have them [sharps containers] hanging on sides of machines."














Plan of Correction:

1. Effective 12/15/2020, sharp containers will no longer be placed on lower shelf of the dialysis machines and will be separated completely from concentrate jugs.

2. All clinical staff will be retrained by the Nurse Manager or Designee on the facility's "Standards Precautions/Infection Control for the Hemodialysis Unit" policy by 01/05/2021 with emphasis on maintaining separation of clean and dirty items by keeping them in their separate designated areas.

3. Nurse Manager or Designee will ensure that all clinical staff review and sign acknowledgement of understanding of policy. Acknowledgement will be placed in facility's education manual.

4. Initially, Nurse Manager or Designee will observe clinical staff on a daily basis for two (2) weeks to ensure that staff are following policy. If standards are met, the staff will be observed weekly for two (2) weeks to ensure that staff are following policy. If standards are met, the staff will be observed monthly for three (3) months. If standards are met, the staff will be observed quarterly. The audit results will be reviewed at monthly QAPI meetings.



494.30(a)(4)(i) STANDARD
IC-HANDLING INFECTIOUS WASTE

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-
(i) Handling, storage and disposal of potentially infectious waste;




Observations:


Based on review of facility policy and procedure, observation and staff (EMP) interview, the facility failed to follow standards for handling, storage and disposal of infectious waste. Specifically, the facility failed to ensure all of its dialysis stations had a means for sharps disposal for one (1) of one (1) peritoneal dialysis treatment station (PD1), and failed to ensure one (1) of 12 in-center dialysis sharps containers were maintained upright to prevent spillage (station 2).

Findings included:

Review of facility policy on December 12, 2020, at 9 a.m. showed, "Handling of Contaminated Sharps ... PURPOSE: To provide mechanism for safe disposal of sharps, glass, etc. and to reduce potential for employee injury. SUPPORTIVE DATA: ... 3. After use, needles should be dropped directly into contaminated sharps container (with syringe attached, if appropriate). ... C. Contaminated Sharps Containers ... 3. Needle containers are readily available where sharps are used & are located as close as feasible to the area of use. ... PROCEDURE STEPS ... 3. Place container in area where personnel are working with contaminated or clean needles. ... KEY POINTS ... Containers should be convenient for personnel using sharps. ... 5. Sharps containers must be maintained in an upright position to keep liquids and sharps inside."

Observation of patients receiving dialysis on 12/10/2020 from 9:30 a.m. to 12 p.m. revealed 12 in-center hemodialysis stations. The HD machines, at each of the 12 stations, had a lower shelf comprised of two areas designed to hold concentrate jugs (acid and bicarbonate) when concentrate is not provided by a central delivery system. Each of the HD machines had a red plastic sharps container located on the right side of the concentrate shelf. Staff were observed placing used sharps (needles/syringes) in these sharps containers.

At the time of above observations on 12/10/2020, the sharps container at station 2 was resting on its side (not upright), and situated over the edge of the concentrate shelf with its top open making it prone to spillage.

Observation and interview with EMP1 (clinic manager) on the treatment floor on 12/10/2020 at 2:20 p.m. confirmed findings, "Used to have them [sharps containers] hanging on sides of machines."

Observation of facility's administrative area (near staff bathroom/breakroom) revealed a staff office room labeled, "DIETICIAN SOCIAL WORKER." Surveyors were given this space to work from on 12/11/2020. Observation of the room on 12/11/2020 at 2 p.m. revealed its size was approximately 10 feet by 20 feet. The floor of the office room was covered with wall-to-wall carpet (carpet cannot be wiped/disinfected from blood/dialysate). The office contained the following PD supplies and equipment: bags of dialysate, poles to hang dialysate from, two sinks (clean and dirty), a stethoscope, a box of new and unused syringes and needles, a treatment chair, and personal protective equipment (gown and face shield). However, the room did not have a sharps container (red puncture proof container for disposal of needles/syringes). See below for more information.
It was also noted that facility had conducted PD clinic on 12/10/2020 shortly after surveyor arrived on 12/10/2020. Telephone interview with EMP5 (PD nurse) on 12/14/2020 confirmed that the dietician and social worker office space is now the facility's PD training and support room. EMP5 confirmed he/she uses the office space to perform PD, instruct patients on PD, conduct lab draws (venipuncture to obtain blood specimen using a needle), and give medication injections using needles and syringes.

Interview with EMP1 (clinic manager) on 12/14/2020 at 1:42 p.m. confirmed facility moved its PD room into current office space, "It's only been a couple months. Moved from across the hall." EMP1 confirmed the office space did not contain a sharps container.











Plan of Correction:

1. Effective 12/15/2020, sharp containers will no longer be placed on lower shelf of the dialysis machines and separated completely from concentrate jugs, and a sharp container will be made available for use in the peritoneal dialysis treatment station.

2. Effective 12/15/2020, the staff office room labeled, "DIETITIAN/SOCIAL WORKER", will no longer be utilized as a peritoneal dialysis treatment station/room. The room labeled, "EXAM ROOM #1" (previous PD Room) will continue to be utilized as the peritoneal dialysis treatment station/room until the appropriate (hard surface) flooring is installed in the Dietitian/Social Worker office for use as a PD training and support room.

3. All PD Training and Support staff will be notified by 12/15/2020 that the Dietitian/Social Worker office is not to be used as the PD training and support room and that the previous PD room (EXAM ROOM #1) is to be utilized for providing PD training and support to our patients.

4. All clinical staff will be retrained by the Nurse Manager or Designee on the facility's "Standards Precautions/Infection Control for the Hemodialysis Unit" and "Handling of Contaminated Sharps" policies by 01/05/2021 with emphasis on maintaining separation of clean and dirty items by keeping them in their separate designated areas and with emphasis on having a sharps container available in the peritoneal dialysis treatment station for sharps disposal.

5. Nurse Manager or Designee will ensure that all clinical staff review and sign acknowledgement of understanding of policy. Acknowledgement will be placed in facility's education manual.

6. Initially, Nurse Manager or Designee will observe clinical staff on a daily basis for two (2) weeks to ensure that staff are following policy. If standards are met, the staff will be observed weekly for two (2) weeks to ensure that staff are following policy. If standards are met, the staff will be observed monthly for three (3) months. If standards are met, the staff will be observed quarterly. The audit results will be reviewed at monthly QAPI meetings.



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 and staff (EMP) interview, the facility failed to ensure all surfaces at the treatment station could be disinfected for one (1) of one (1) peritoneal dialysis station (PD1).

Findings included:

Observation of facility's administrative area (near staff bathroom/breakroom) revealed a staff office room labeled, "DIETICIAN SOCIAL WORKER." Surveyors were given this space (PD1) to work from on 12/11/2020. Observation of the room on 12/11/2020 at 2 p.m. revealed the space was approximately 10 feet by 20 feet with a carpeted floor (carpet cannot be wiped/disinfected from blood/dialysate). The office contained the following PD supplies and equipment: bags of dialysate, poles to hang dialysate from, two sinks (clean and dirty), a stethoscope, a box of new and unused syringes and needles, a treatment chair, and personal protective equipment (gown and face shield).
It was also noted that facility had conducted PD clinic on 12/10/2020 shortly after surveyor arrived on 12/10/2020. However, the observation on 12/11/2020 did not reveal the room contained a sharps container (red puncture proof container for disposal of needles/syringes). See below for more information.

Interview with EMP5 (PD nurse) on 12/14/2020 confirmed that the dietician and social worker office space (PD1) is now the facility's PD training and support room. EMP5 confirmed he/she performs PD with patients in the room to include lab draws and medication injections using needles and syringes.

Interview with EMP1 (clinic manager) on 12/14/2020 at 1:42 p.m. confirmed facility moved the PD room into the current office space, "It's only been a couple months. Moved from across the hall." Observation of previous PD room on other side of hallway revealed it had a laminate floor that would allow for disinfection of spills such as blood and dialysate.











Plan of Correction:

1. Effective 12/15/2020, a sharp container will be made available for use in the peritoneal dialysis treatment station.

2. Effective 12/15/2020, the staff office room labeled, "DIETITIAN/SOCIAL WORKER", will no longer be utilized as a peritoneal dialysis treatment station/room. The room labeled, "EXAM ROOM #1" (previous PD Room) will continue to be utilized as the peritoneal dialysis treatment station/room until the appropriate (hard surface) flooring is installed in the Dietitian/Social Worker office for use as a PD training and support room.

3. All PD Training and Support staff will be notified by 12/15/2020 that the Dietitian/Social Worker office is not to be used as the PD training and support room and that the previous PD room (EXAM ROOM #1) is to be utilized for providing PD training and support to our patients.

4. Nurse Manager or Designee will ensure that all clinical staff review and sign acknowledgement of understanding of policy. Acknowledgement will be placed in facility's education manual.

5. Initially, Nurse Manager or Designee will observe clinical staff on a daily basis for two (2) weeks to ensure that staff are following policy. If standards are met, the staff will be observed weekly for two (2) weeks to ensure that staff are following policy. If standards are met, the staff will be observed monthly for three (3) months. If standards are met, the staff will be observed quarterly. The audit results will be reviewed at monthly QAPI meetings.



494.60(b) STANDARD
PE-EQUIPMENT MAINTENANCE-MANUFACTURER'S DFU

Name - Component - 00
The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer's recommendations.



Observations:

Based on review of facility policy and procedure, manufacturer's directions for use, and maintenance records, and staff (EMP) interview, the facility failed to ensure two (2) of four (4) hemodialysis (HD) machine maintenance records reviewed were maintained according to the manufacturer's directions for use (HD1, & HD3).

Findings included:

Review of facility policy on December 15, 2020, at 9:05 a.m. showed, "PROCEDURE NO: 511.0 ... Maintenance of Equipment ... Policy: ... 2. All maintenance ... performed on dialysis or dialysis related equipment will follow current recommendations from the manufacturer for that particular piece of equipment."

Review of hemodialysis machine directions for use, "Phoenix Service Manual Maintenance" on December 15, 2020, at 8:56 a.m. showed, "9.6 Preventive Maintenance To keep the machine in good and safe working conditions, the following maintenance must be made by authorized technicians. ... The Phoenix Preventive Maintenance program is to be completed a minimum of ... at least one time a year ... There are currently two PM kits: 'Kit PH1 [level 1]' (spare parts used for maintenance ... 1 time in a year); 'Kit PH2 [level 2] (spare parts used for maintenance ... every 2 years.) ... Apply one preventive maintenance per year at least."

Hemodialysis machine preventive maintenance (PM) records were reviewed on December 14, 2020, at 8:39 a.m.

HD1 serial number PH24239 had annual PM on 10/30/2018 level 1; 10/25/2019 level 2; and 10/2/2020 level 2 (10/2/2020 PM should have been level 1).

HD3 serial number PH25759 had annual preventive maintenance on 7/26/2018 level 2; 7/24/2019 level 1; and 7/31/2020 level 1 (7/31/2020 PM should have been level 2).

Interview with technical manager (EMP 9) on December 14, 2020, at 9 a.m. confirmed HD1 had two successive level 2 PMs and HD3 had two successive level 1 PMs. EMP9 noted, as per manufacturer's directions for use, that HD machines are to have PMs that alternate annually between level 1 and level 2.












Plan of Correction:

1. All machine records will be reviewed and the appropriate level PM (Level 1 or 2) will be completed as appropriate to ensure that all machines are up to date.

2. The Technical Manager has established a "Preventive Maintenance Calendar/Schedule" to be completed by the technical staff to ensure that level 1 and level 2 PM's are performed and alternated annually.

3. All technical staff will be retrained by the Technical Manager or Designee on the facility's "Maintenance of Equipment" policy and the completion of the "Preventive Maintenance Calendar/Schedule" by 01/05/2021 with emphasis on performing annual PM's that alternate between level 1 and level 2 PM's.

4. Technical Manager or Designee will ensure that all Technical staff review and sign acknowledgement of understanding of policy. Acknowledgement will be placed in facility's education manual.

5. Initially, Technical Manager or Designee will audit Technical Calendar/Schedule on a daily basis for two (2) weeks to ensure that staff are following policy. If standards are met, the audit will be performed weekly for two (2) weeks to ensure that staff are following policy. If standards are met, the staff will be observed monthly for three (3) months. If standards are met, the staff will be observed quarterly. The audit results will be reviewed at monthly QAPI meetings.