QA Investigation Results

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


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Initial Comments:

Based on the findings of an onsite unannounced Medicare recertification survey completed on November 17, 2023, Dialysis Clinic, Inc. 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 November 17, 2023, Dialysis Clinic, Inc. 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-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK

Name - Component - 00
Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory.


Observations:


Based on review of facility policy, observation, and staff (EMP) interview, the facility failed to ensure staff wore a mask when performing procedures during which spurting or spattering of blood might occur for one (1) of two (2) observations of initiation of dialysis with and arteriovenous fistula (OBS# 4.1).

Findings included:

Review of facility policy on November 16, 2023, at 10:45 a.m. showed:

"PROCEDURE NO: 301 ... Universal Precautions ... Facial Protection - Face shields provide protection for the eyes, nose and mouth. All areas of the face should be covered by whichever method is chosen. 39. Facial coverings may be either full facial shields or a mask used in conjunction with goggles."

"PROCEDURE NO: 104 ... CANNULATION OF ESTABLISHED ARTERIOVENOUS FISTULA (AVF) ... PROCEDURE ... 1. ... Put on PPE ... 9. Perform cannulation."

"PROCEDURE NO: 310 ... General Facility Infection Control ... POLICY: ... Staff members should wear gowns, face shields, eye wear, or mask to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur."

Observation (OBS#4.1) of initiation of dialysis with an AVF on November 15, 2023, at 8:50 a.m. revealed EMP10 (patient care technician) insert needles into patient's arm and initiate dialysis but EMP10 only wore protective eyewear and no mask to cover his/her nose and mouth. Interview with EMP10 and EMP9 (charge nurse) after the observation confirmed findings.







Plan of Correction:

1. All clinical staff will be retrained by the Nurse Manager or Designee by 12/8/2023 on the facility's "Policy 104: Cannulation of Established Arteriovenous (AVF) with Safety Needles," "Policy 301: Universal Precautions," & "Policy 310: General Facility Infection Control" with emphasis on wearing proper PPE, which includes gowns, gloves, face shield, and/or face mask with goggles to ensure that the staff's eyes, nose, and mouth are properly covered.

2. Nurse Manager or Designee will ensure that all clinical staff review and sign acknowledgement of understanding of policies. Upon completion of training and understanding of policies, acknowledgement will be placed in facility's education manual or each employee's personnel file.

3. Initially, Nurse Manager and/or Nurse Educator will observe staff on a daily basis for two (2) weeks to ensure that staff are following the wearing the proper PPE per the policies reviewed in regards to infection control standards. If the standards are met, the staff will be observed weekly for two (2) weeks to ensure that the staff continue to wear the proper PPE during initiation/termination of a patient's treatment. If the standards are met, the staff will be observed monthly for three (3) months. If those standards are met, the staff will be observed quarterly for two (2) months. All audit results will be reviewed at monthly QAPI meetings.


494.30(a)(1)(i) STANDARD
IC-IF TO STATION=DISP/DEDICATE OR DISINFECT

Name - Component - 00
Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient.
-- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient.
-- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient's station should be used only for that patient and should not be returned to a common clean area or used on other patients.



Observations:


Based on review of facility policy, manufacturer's directions for use, observation, and staff (EMP) interview, the facility failed to ensure single use items were dedicated or disposed of for 17 of 17 patients with arteriovenous fistulas (AVF) who required the use of a tourniquet (AVF1-17).

Findings included:

Review of facility policy on November 16, 2023, at 10:45 a.m. showed, "PROCEDURE NO: 310 ... General Facility Infection Control ... POLICY: ... 5. Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient."

Observation of a supply cart designated for clean supplies during a treatment day on November 15, 2023, a 2 p.m. revealed many orange tourniquets piled onto and hanging from the cart. Interview with EMP12 (patient care technician) and EMP14 (nurse educator) at time of observation confirmed findings. EMP12 described the facility's process for handling the tourniquets: the tourniquets are supplied in bulk (one large bag containing quantity of 250) from a local hospital, the tourniquets are used on patients with arteriovenous fistulas during initiation of dialysis, and once dialysis is completed, the tourniquets are placed into a large container of disinfectant where they dwell for 20 minutes. The tourniquets are then placed on the supply cart for use on the next day's patients.

Review of the manufacturer's directions for use for tourniquets used by the facility was conducted on November 16, 2023, at 10:25 a.m. with EMP2 (clinic manager). The review showed, "Tourniquets (Non-Latex) ... Single patient use [not designed to be disinfected and reused]." Retrieved from https://www.halyardhealth.com/wp-content/uploads/MediChoice-Supplier-Diversity-Catalog.pdf









Plan of Correction:

1. All clinical staff will be retrained by the Nurse Manager or Designee by 12/8/2023 on the facility's "Policy 310: General Facility Infection Control" with emphasis on non-disposable items or single use items; such as, tourniquets are to be disposed of after used to initiate a treatment on a patient with an arteriovenous fistula (AVF).

2. On Thursday, November 16th, Nurse Manager removed and disposed of all tourniquets that were previously disinfected with brand new single use tourniquets.

3. On Friday, November 17th, Nurse Manager had an in-service and reviewed Policy 310 with all staff plus informed that moving forward, all tourniquets were to be disposed of after each use since they are a single use item.

4. Staff signed the acknowledgement of understanding of this policy and process. In addition, we printed out the Manufacturer's guidelines and recommendations for the single use tourniquets. Everything was presented to DOH Surveyor, Jeff Papay, on Friday morning prior to the Exit Interview with satisfaction and approval.

5. In addition to the above, the Nurse Manager and/or Nurse Educator will observe staff on a daily basis for one (1) week to ensure that staff are following the proper protocol of disposing of the tourniquets. If the standards are met, the staff will be observed weekly for two (2) weeks to ensure that the staff continue to dispose of the tourniquets after initiation of a patient's treatment utilizing their AVF. If the standards are met, the staff will be observed monthly for two (2) months. If those standards are met, the staff will be observed quarterly for two (2) months. All audit results will be reviewed at monthly QAPI meetings.


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 review of facility policy, observation, directions for use, and staff (EMP) interview, the facility failed to ensure one (1) of one (1) medication vial of Tubersol (TB1) was discarded after opening per facility policy and manufacturer's directions for use.

Findings included:

Review of facility policy on November 16, 2023, at 11 a.m. showed, "PROCEDURE NO 1115 ... Disposal of Medication Vials ... When a multi-dose vial has been opened, ... the vial should be dated, initialed, and discarded within 30 days, unless manufacturer specifies a shorter date. Refer to package insert."

A flash tour was conducted on November 14, 2023, at 8:45 a.m. with EMP2 (clinic manager). Observation of facility's medication fridge revealed an open vial of Tubersol medication (TB1). The vial was opened and used on 10/4/2023. Interview with EMP2 at time of observation confirmed findings and that the medication was last used on 11/13/2023.

Review of the medication vial's package insert on November 14, 2023, at 9 a.m. showed, "Tubersol ... STORAGE ... A vial of Tubersol which has been entered and in use or 30 days should be discarded."





Plan of Correction:

1. All clinical staff will be retrained by the Nurse Manager or Designee by 12/8/2023 on the facility's "Policy 1115: Disposal of Medication Vials" with emphasis on ensuring that when a multi-dose vial has been opened, then vial should be dated, initialed, and discarded within 30 days unless the manufacturer's guidelines specifies a shorter date.

2. Nurse Manager or Designee will ensure that all clinical staff review and sign acknowledgement of understanding of policies. In addition to the policy, we have placed a white/dry erase board on the medication refrigerator labeled "Multi-dose Medication Expiration Log." This list has some of the most common medications with the how many days the medication is viable along with the 1st date the vial was opened and the date the vial expires. This is an additional step to labeling the vial itself. Upon completion of training and understanding of policies, acknowledgement will be placed in facility's education manual or each employee's personnel file.

3. Initially, Nurse Manager and/or Charge Nurse/RN will observe and initial the white board weekly on a Friday prior to the next week to ensure all multi-dose vials are properly disposed of on or prior to the expiration date. The Nurse Manager or Designee will audit the white board to ensure multi-dose vials are properly disposed of weekly for two (2) weeks then monthly for two (2) months. If the standards are met, the white board will be observed quarterly for one (1) month to ensure we have been properly disposing the multi-dose vials following our Survey. All 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, manufacturer's directions for use, logs, and staff (EMP) interview, the facility failed to ensure two (2) of two (2) pHoenix meters (P01710K & P13565) were operated in accordance with manufacturer's directions for use.

Findings included:

Review of facility policy and procedure on November 16, 2023, at 11:05 a.m. showed, "Phoenix Meter Disinfection, Calibration, Use and Storage PURPOSE: To assure the pHoenix Meter is properly ... calibrated ... prior to use. To assure that the dialysis machine's conductivity, pH and temperature are accurate when compared to an independent meter. ... 2. The meter will be verified against 14.0 mS conductivity and 7.0 pH standard solutions daily prior to use, ... Conductivity should read 14 mS +/- .1; pH should read 7 +/- .1. The meter will be recalibrated when the conductivity or pH are out of range."

Review of manufacturer's directions for use for facility's pHoenix meters on November 16, 2023, at 11:15 a.m. showed, "Test Instrument User's Guide For the ... pHoenix Meter ... MesaLabs ... Rev. L ... Test Instrument User's Guide ... Checking instrument calibration ... Verify accurate calibration of the conductivity and pH functions before use."

A review of "DAILY PHOENIX METER LOG[s]" was conducted on November 14, 2023, at 1 p.m. The review showed that P01710K was out of range on 9/27/2023 with a conductivity of 13.8 (acceptable range 14.1-13.9) and no recalibration. P13565 was out of range on 8/25, and 10/4/2023 with a conductivity of 13.8 on both days with no recalibration.

Interview with EMP6 (area technical manager) on November 14, 2023, at 1:42 p.m. confirmed above findings.







Plan of Correction:

1. All clinical staff will be retrained by the Technical Manager or Designee by 12/8/2023 on the facility's "Policy 243.2: Phoenix Meter Disinfection, Calibration, and Use and Storage," and "Daily Phoenix Meter Log." with emphasis on ensuring that the Conductivity reads 14.0 mS +/- .1 (13.9 to 14.1) while the pH should read 7.0 +/-.1 (6.9 to 7.1). If either Conductivity or the pH is out of range, then the meter will need calibrated per the Phoenix meter calibration guidelines.

2. Technical Manager or Designee will ensure that all clinical staff review and sign acknowledgement of understanding of policies. In addition to the Phoenix Meter policy and the Daily Phoenix Meter Log, all staff will perform the Phoenix Meter Level 1 Calibration, which will be evident by a completion of the Skills Checklist specific for the Phoenix Meter. Upon completion of training and understanding of policies, acknowledgement will be placed in facility's education manual or each employee's personnel file.

3. Initially, Technical Manager and/or designee will observe the Daily Phoenix Meter Log on a daily basis for two (2) weeks to ensure that staff are performing Level 1 calibration any time either the Conductivity or pH is out of range as defined above. If the standards are met, the Daily Phoenix Meter Log will be observed weekly for two (2) weeks to ensure that the staff recalibrate the Phoenix meter anytime the Conductivity or pH falls out of range. If the standards are met, the log will be observed monthly for three (3) months. If those standards are met, the log will be observed quarterly for two (2) months. The Charge Nurse and/or Designee will initial the log to confirm proper documentation and all audit results will be reviewed at monthly QAPI meetings.