QA Investigation Results

Pennsylvania Department of Health
SOMERSET COUNTY DIALYSIS
Health Inspection Results
SOMERSET COUNTY DIALYSIS
Health Inspection Results For:


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Initial Comments:


Based on the findings of an unannounced onsite Medicare Re-certification survey and clinic relocation with addition of 8 in-center stations and 1 Home Peritoneal Dyalisys training room completed on September 23, 2022, Somerset County 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 unannounced onsite Medicare Re-certification survey and clinic relocation with addition of 8 in-center stations and 1 Home Peritoneal Dyalisys training room completed on September 23, 2022, Somerset County Dialysis was identified to have the following standard level deficiencies that were determined to be in substantial compliance with the following requirements of42 CFR, Part 494, Subpart A, B, C and D Conditions for Coverage of End-Stage Renal Disease (ESRD) Facilities.









Plan of Correction:




494.30(a)(1) STANDARD
IC-WEAR GLOVES/HAND HYGIENE

Name - Component - 00
Wear disposable gloves when caring for the patient or touching the patient's equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station.




Observations:


Based on reviews of facility policy, observations, and staff (EMP) interview, the facility failed to ensure hand hygiene was performed by patients who held access sites for three (3) of three (3) observations of Discontinuation of Dialysis and Post Dialysis Access Care for AV Fistula or Graft. (OBS 1-3.)


Findings included:


Review of facility policy on 9/20/2022 at approximately 1:30pm revealed: "...POST DIALYSIS VASULAR ACCESS CARE: FISTULA/GRAFT USING SAFETY FISTULA NEEDLES...Procedure...9. the patient will be encouraged to hold their own site if their condition permits. When the patient holds their cannulation sites, the patient will be offered gloves and perform hand hygiene when completed..."


OBS #1, conducted 9/19/2022 at approximately 9:50am, upon completion of dialysis treatment at station 16, patient held pressure to both access sites independently. Patient did not perform hand hygiene after holding sites and before exiting treatment floor.

OBS #2, conducted 9/19/2022 at approximately 10:15am, upon completion of dialysis treatment at station 14, patient held pressure to both access sites independently. Patient did not perform hand hygiene after holding sites and before exiting treatment floor.

OBS #3, conducted 9/19/2022 at approximately 12:45pm, upon completion of dialysis treatment at station 4, patient held pressure to both access sites independently. Patient did not perform hand hygiene after holding sites and before exiting treatment floor.

Interview with the Facility Administrator and Manager of Clinical Services on 9/20/2022 at approximately 2:00 pm confirmed the above findings.

Repeat deficiency: Previously cited 8/17/2021 and 9/3/2019



















Plan of Correction:

The Facility Administrator or designee held an in-service starting on 09/29/22 for all clinical teammates. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-05-01 "Infection Control for Dialysis Facilities" and Policy 1-04-01B "Post Dialysis Vascular Access Care: Fistula/Graft Using Safety Fistula Needles" with emphasis on but not limited to: 1. Infection control: 1) Gloves should be provided to patients and gloves and gown to visitors if these individuals assist with procedures such as self-cannulation or holding access sites. 2. Post dialysis vascular access care: 1) the patient will be encouraged to hold their own sites if their condition permits. When the patient holds their cannulation sites, the patient will be offered gloves and performs hand hygiene when completed. Rationale: Gloves and hand hygiene protects patient and family members from cross contamination. Verification of attendance at in-service will be evidenced by teammate's signature on the in-service sheet. Teammates will remind patients to perform hand hygiene when gloves are removed. The Facility Administrator or designee will conduct infection control audits to verify patients perform proper hand hygiene once gloves are removed after holding cannulation sites: daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with monthly infection control audits. Instances of non-compliance will be addressed immediately. The Facility Administrator will review audit results with teammates during homeroom meetings, and with the Medical Director during monthly Quality Assessment and Performance Improvement meetings known as Facility Health Meetings, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.


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 reviews of facility policy, observations, and staff (EMP) interview, the facility failed to disinfect all equipment/dialysis station per agency policy for three (3) of three (3) observations of Cleaning and Disinfection of the Dialysis Station. (OBS 1-3.)


Findings included:


Review of facility policy on 9/20/2022 at approximately 1:30pm revealed: "...INFECTION CONTROL FOR DIALYSIS FACILITIES...FACILITY HYGIENE...46. Equipment including dialysis delivery system, interior and exterior of the prime waste container, the dialysis chair and side table including opening the chair to reach crevices, ...will be wiped clean with a bleach solution of the appropriate strength after completion of procedures, before being used on another patient..."


OBS #1, conducted 9/19/2022 at approximately 10:10am, while performing cleaning and disinfection of station 16, failed to disinfect the exterior side facing surfaces of the treatment chair.

OBS #2, conducted 9/19/2022 at approximately 10:45am, while performing cleaning and disinfection of station 14, failed to disinfect the backrest surface and the exterior side facing surfaces of the treatment chair. After cleaning blood pressure cuff, cuff fell on floor, failed to be disinfected, and was placed in storage rack on machine.

OBS #3, conducted 9/20/2022 at approximately 9:45pm, while performing cleaning and disinfection of station 3, failed to disinfect the exterior side facing surfaces of the treatment chair.


Interview with the Facility Administrator and Manager of Clinical Services on 9/20/2022 at approximately 2:00 pm confirmed the above findings.


Repeat deficiency: Previously cited 8/17/2021, 9/3/2019, and 8/25/2015















Plan of Correction:

The Facility Administrator or designee held an in-service starting on 09/29/22 for all clinical teammates. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-05-01 "Infection Control for Dialysis Facilities" with emphasis on but not limited to: 1) Equipment including dialysis delivery system, interior and exterior of the prime waste container, the dialysis chair and side table including opening the chair to reach crevices, blood pressure equipment ... as well as all work surfaces will be wiped clean with a bleach solution of the appropriate strength after completion of procedures, before being used on another patient. Verification of attendance at in-service will be evidenced by teammate's signature the in-service sheet. The Facility Administrator or designee will conduct infection control audits to verify teammates are performing equipment cleaning/disinfection appropriately per policy: daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with the monthly infection control audit. Instances of non- compliance will be addressed immediately. The Facility Administrator or designee will review audit results with teammates during homeroom meetings and with the Medical Director during monthly Quality Assessment and Performance Improvement meetings known as Facility Health Meetings, with supporting documentation included in the meeting minutes. The Facility Administrator 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 reviews of facility documentation, and staff (EMP) interview, the facility failed to ensure readings outside of parameters for Reverse Osmosis (RO) product water flow rate were reported to biomed technician and followed up with for two (2) of two (2) months reviewed. (7/20/2022-9/15/2022)


Findings included:


Review of facility daily water treatment logs on 9/15/2022 at approximately 10:40am revealed readings documented to be outside of facility parameters on 34 days. No documentation of notification to biomed technician.

Interview on 9/15/2022 at approximately 10:45am with Facility Administrator confirmed, "Yes, the expectation would be that any readings outside the range would be reported."



Interview with the Facility Administrator and Manager of Clinical Services on 9/20/2022 at approximately 2:00 pm confirmed the above findings.







Plan of Correction:

The Facility Administrator or designee held an in-service on for all clinical teammates starting on 09/29/22. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 2-04-02 "Daily Water Treatment System Monitoring" with emphasis on but not limited to: 1) Purpose: To verify the dialysis water system operates safely and reliably through daily observations and/or testing of specific component performance parameters. 2) All observations and test results will be within the limits specified on the Daily Water Treatment Log. If observations or test results are 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 assigned to the facility of any observation or test result that is found outside the limits specified in the Daily Water Treatment Log. 3) The licensed nurse reviews the Daily Water Log for completeness and verifies that all parameters are within specified limits. Upon satisfactory completion of this review, the licensed nurse initials and signs the log form where indicated. Verification of attendance is evidenced by teammate's signature on the in-service sheet. The Facility Administrator or designee will conduct audits of the water treatment log for accuracy and for notification and follow up for readings outside of parameters: daily for two (2) weeks, then weekly for two (2) weeks, and monthly for two (2) months. Instances of non- compliance will be addressed immediately. The Facility Administrator or designee will review audit results with teammates during homeroom meetings and with the Medical Director during monthly Quality Assessment and Performance Improvement meetings known as Facility Health Meetings, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.


494.100(b)(2),(3) STANDARD
H-FAC RECEIVE/REVIEW PT RECORDS Q 2 MONTHS

Name - Component - 00
The dialysis facility must -
(2) Retrieve and review complete self-monitoring data and other information from self-care patients or their designated caregiver(s) at least every 2 months; and
(3) Maintain this information in the patient ' s medical record.


Observations:


Based on review of facility policy, medical records (MR), and staff (EMP) interview, the facility failed to ensure ongoing monitoring of weight and blood pressure on patient flow sheets for two (2) of two (2) Home Peritoneal Dialysis (PD) MRs reviewed. (MR6 & 7)


Findings included:


Review of facility policy on 9/23/2022 at approximately 1:30pm revealed, "...FAILURE TO COMPLY WITH HOME DIALYSIS TRAINING PROGRAM OBJECTIVES...2. Home patients/caregivers are responsible for the following: ...Maintaining home treatment records; if home treatment records are maintained on paper, bringing to clinic visit for the nurse to review at least monthly....4. Document in patient's medical record non-compliance, interventions taken...5. If team actions are not successful, then further assistance will be sought from Facility Administrator/designee and the Medical director...

Review of MR6 on 9/19/2022 at approximately 12:00pm revealed Home PD began on 6/25/2022. Flowsheets dated 6/25/2022 through 8/1/2022 contained no documented patient weights. 7/14/2022-8/1/2022 contained no documentation of patient blood pressures. No flow sheets available for review after 8/1/2022. No documented revisions in Plan of Care to address patient adherence to documentation.

Review of MR7 on 9/19/2022 at approximately 12:30pm: Flowsheets dated 7/5/2022 through 9/11/2022 contained no documented patient weights7/5/2022-8/22/2022 or 9/1/2022. 7/5/2022-8/28, 8/31/2022, and 9/3/2022 contained no documentation of patient blood pressures. No documented revisions in Plan of Care to address patient adherence to documentation.


Interview with the Facility Administrator and Manager of Clinical Services on 9/20/2022 at approximately 2:00 pm confirmed the above findings.









Plan of Correction:

The Facility Administrator or designee held an in-service on for all Peritoneal Dialysis clinical teammates starting on 09/28/22. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 5-01-07 "Failure to Comply with Home Dialysis Training Program Objectives" with emphasis on but not limited to: 1) Home patients/caregivers are responsible for the following: ... Maintaining home treatment records; if home treatment records are maintained on paper, bringing to clinic visit for the nurse to review at least monthly. 2) Document in patient's medical record non-compliance, interventions taken and patient/caregiver response. 3) If team actions are not successful, then further assistance will be sought from the Facility Administrator/designee and the Medical Director. Verification of attendance is evidenced by the teammate's signature on the in-service sheet. The Facility Administrator or designee will audit one hundred percent (100%) of the home treatment forms for the next three (3) months, to verify completeness of the Daily Home Treatment Record. Ongoing compliance will be monitored with the ten percent (10%) monthly medical records audit. The patient's plan of care should address any problems with adherence to this requirement. Instances of non-compliance will be addressed immediately. The Facility Administrator or designee will review audit results with the Medical Director during monthly Quality Assessment and Performance Improvement meetings known as Facility Health Meetings, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction


494.100(c)(1)(iv) STANDARD
H-PT CONSULTATION WITH IDT MEMBERS PRN

Name - Component - 00
Services include, but are not limited to, the following:
(iv) Patient consultation with members of the interdisciplinary team, as needed.




Observations:


Based on review of medical records (MR), and staff (EMP) interview, the facility failed to ensure patient consultation with physician conducted in accordance wih facility policy/procedure for one (1) of two (2) Home Peritoneal Dialysis (PD) MRs reviewed. (MR6)


Findings included:

Interview with Facility Administrator on 9/20/2022 at approximately 11:00am revealed, "[PD patients] usually come in twice a month. Labs are drawn at one visit and they are seen by the doctor the next."

Interview with Home PD nurse on 9/23/2022 at approximately 11:55am confirmed, "PD patients are scheduled for labs near the begining of the month and then seen by the doctor at clinic later in the month..."


Review of MR6 on 9/19/2022 at approximately 12:30pm revealed no documentation of physician consult with patient in the month of July.


Interview with Home PD nurse on 9/23/2022 at approximately 11:55am confirmed no documentation of July physician consult.






Plan of Correction:

The Facility Administrator or designee held an in-service on for all Peritoneal Dialysis clinical teammates starting on 09/28/22. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 5-01-22 "Routine Support Service" with emphasis on but not limited to: 1) A Peritoneal Dialysis Registered Nurse (RN) must supervise the clinic visit and provide Initial Patient Training, but may delegate certain tasks to Licensed Vocational Nurse (LVN)/Licensed Practical Nurse (LPN)/Patient Care Technician (PCT), as allowable by state regulation. 2) Support services will be provided on a monthly basis. 3) Clinic visits are the preferred method of routine support. 4) Clinic visits may include the following: a. Data collection and assessment of vital signs and weight, fluid balance, exit sit status, adequacy of dialysis, home flowsheets, home medications, laboratory results if not previously completed; b. Obtain laboratory specimens or make appropriate arrangements; c. Perform transfer set change, if due; d. Renal dietitian assessment; e. Social worker assessment; f. Monthly education. 5) Alternative support services may include: a. Laboratory draw in the clinic; b. Interdisciplinary team care plan meeting and co-ordination of home patient care: Development and periodic review of the patient's individualized comprehensive plan of care that specifies the services necessary to address the patient's needs and meets the measurable and expected outcomes per the patient plan of care; c. Collaboration with other health providers; d. Telephone support to patient / partner / caregiver. 6) All support services are documented in the patient's medical record. Verification of attendance is evidenced by the teammate's signature on the in-service sheet. The Facility Administrator or designee will audit one hundred percent (100%) of the home patient medical records treatment forms for the next three (3) months, to verify routine support is provided and documented, and patient assessment and plan of care is appropriate and up to date. Ongoing compliance will be monitored with the ten percent (10%) monthly medical records audit. Instances of non-compliance will be addressed immediately. The Facility Administrator or designee will review audit results with the Medical Director during monthly Quality Assessment and Performance Improvement meetings known as Facility Health Meetings, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.