Initial Comments:
Based upon the findings of an unannounced onsite Medicare recertification survey conducted on May 13 - 14, 2024 and May 16 -17, 2024, Lebanon County Dialysis was identified to have the following standard level deficiency that was determined to be in substantial compliance with the requirements of 42 CFR, Part 494.62, Subpart B, Conditions for Coverage for End-Stage Renal Disease (ESRD) Facilities-Emergency Preparedness.
Plan of Correction:
494.62(b)(9) STANDARD Dialysis Emergency Equipment Name - Component - 00 §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:]
(9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available.
Observations:
Based on review of agency policy, emergency AED cart logs, and interview with facility administrator, agency clinical staff failed to document completed daily AED equipment checks in nineteen (19) of ninety-one (91) calendar open clinic days in four (4) calendar months of AED logs reviewed.
Findings include:
Review conducted of agency policy 1-02-08 Emergency Equipment Checks revealed: "3. The following equipment checks will be performed by a licenses nurse teammate to verify the designated equipment is available and functional: Daily - Check Status Indicator for green check for Zoll AED."
Review conducted on May 17, 2024, at approximately 9:30 AM, of Daily Zoll AED Logs #1- 4 revealed: Log #1 February 2024, missing AED checks on 2/17/24 (Saturday), and 2/28-29/24 (Wednesday, Thursday). Log #2 March 2024, missing AED checks on 3/16/24 (Saturday), 3/20-21/24 (Wednesday, Thursday), 3/26/24 (Tuesday), 3/28/24 (Thursday) and 3/30/24 (Saturday). Log #3 April 2024, missing AED checks on 4/3-4/24 (Wednesday, Thursday), 4/11/24 (Thursday), 4/15/24 (Monday), 4/18/24 (Thursday), 4/25-26/24 (Thursday, Friday), and 4/29/24 (Monday). Log #4 May 2024, 5/4/24 (Saturday) and 5/7/24 (Tuesday).
Interview conducted on May 17, 2024, at approximately 10:00 AM, with facility administrator confirmed above findings.
Plan of Correction:The Facility Administrator or designee held in-services for all clinical teammates starting on 05/17/24. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-02-08 "Emergency Equipment Checks" with emphasis on but not limited to: 1) emergency equipment, including, but not limited to, oxygen, airways, suction, automated external defibrillator (AED), and artificial resuscitator (ambu bag), and emergency drugs will be on the premises at all times. 2) Equipment checks will be performed by a licensed nurse teammate to verify the designated equipment is available and functional. Daily: Check Status Indicator for green check for Zoll AED; Manufacturer's AED pads are present on cart. Verification of attendance is evidenced by teammate's signature on in-service sheet. The Facility Administrator or designee will perform audits to verify supplies are available and checks are being performed: daily for two (2) weeks, then weekly for two (2) weeks, then ongoing compliance will be monitored monthly per policy. 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 Assurance and Performance Improvement meetings known as Facility Health Meetings. The Facility Administrator will report progress, as well as any barriers to maintaining compliance. Action plans will be evaluated for effectiveness and new plans developed when needed until sustained compliance is achieved. Supporting documentation will be included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
Initial Comments:
Based on the findings of an unannounced onsite Medicare recertification survey conducted on May 13-14, 2024 and May 16-17, 2024, Lebanon County Dialysis was identified 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) 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 observation, review of agency policy, and an interview with the End Stage Renal Disease (ESRD) administrator, the ESRD clinic failed to ensure the patient care technicians (PCTs) changed gloves and performed hand hygiene while being observed providing dialysis treatments (Observations #1- #4,).
Findings include:
Observations conducted on May 13, 2024, at approximately 9:00 AM to 12:35 AM, on dialysis treatment floor revealed:
Observation #1 - at approximately 9:10 AM, PCT (EF#5) was observed at treatment station #6 was wearing disposable gloves, picked up an used IV cap from the floor, removed the patient's blanket and placed it in patient's home bag, touched the dialysis machine's screen several times with no change of gloves or hand hygiene performed, and then applied a new set of disposable gloves (double gloves now worn) over soiled set of gloves to continue patient care.
Observation #2 - at approximately 9:42 AM, PCT (EF#2) was observed in treatment station #2 engaged in initiation of patient dialysis treatment; EF#2 set-up chairside table with items need for initiation of treatment, proceeded to assess and clean patient's left lower arm fistula site, no change of disposable gloves or hand hygiene performed, opened inserting catheters, and proceeded to initiate dialysis treatment.
Observation #3 - at approximately 10:35 AM, PCT (EF#5) was observed at treatment station #11, initiating a patient's dialysis treatment wearing clean disposable gloves, then touching dialysis machine's screen, her stethoscope, and cleaned patient's fistula site with no glove change or hand hygiene observed; applied a new set of disposable gloves (double gloves now worn) over soiled set of gloves and proceeded with the treatment initiation.
Observation #4 PCT (EF#2) observed at approximately 10:15 - 10:45 AM, silencing several dialysis treatment machines' alarms with a bare hand using a loose glove only covering her three or four finger tips.
Review conducted on May 13, 2024, at approximately 1:30 PM, of agency policy 1-05-01 Infection Control for Dialysis Facilities revealed: (page 1) "HAND HYGIENE 1. All teammates, Physicians and Non-Physician (NNP) will perform hand hygiene ... b. prior to gloving and immediately after removal of gloves, ... d. after patient and dialysis delivery system contact, ... f. between patients even if the contact is casual, g. before touching clean areas such a supplies, supply cart, and chairside keyboard/mouse. ...; 7. Disposable gloves will be worn when caring for the patient or touching the patient's equipment at the dialysis station ... a. Gloves should be changed when: ii. When going from a "dirty" area or task to a "clean" area or task ... ."
Interview conducted on May 13, 2024, at approximately 1:45 PM, with agency administrator confirmed the above findings.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 05/17/24. 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: [Hand Hygiene]: 1) All teammates, Physicians and Non-Physician (NPP) will perform hand hygiene... b. prior to gloving and immediately after removal of gloves... d. after patient and dialysis delivery system contact... f. between patients even if the contact is casual, g. before touching clean areas such as supplies, supply cart and chairside keyboard/mouse. [Disposable Gloves]: 1) Disposable gloves will be worn when caring for the patient or touching the patient's equipment at the dialysis station ... a. Gloves should be changed when: ii. When going from a "dirty" area or task to a "clean" area or task iii. Verification of attendance at in-service will be evidenced by teammates signature on in-service sheet. The Facility Administrator or designee will conduct infection control audits to verify teammates perform hand hygiene and glove wearing and glove changing per policy: daily for two (2) weeks, then weekly for two (2) weeks, then ongoing compliance will be monitored with the monthly infection control audits. 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 Assurance and Performance Improvement meetings known as Facility Health Meetings. The Facility Administrator will report progress, as well as any barriers to maintaining compliance. Action plans will be evaluated for effectiveness and new plans developed when needed until sustained compliance is achieved. Supporting documentation will be included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction. The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 05/17/24. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 8-04-01 "Physical Environment" and Policy 1-06-06 "Medications Requiring Refrigeration" with emphasis on but not limited to: A. Physical environment: 1) the dialysis facility will implement and maintain a program to verify that all equipment, including emergency equipment, dialysis delivery systems and the water treatment systems are maintained and operated in accordance with the manufacturer's recommendations. B. Medications requiring refrigeration: 1) The refrigerator is checked during facility normal operating hours, by a licensed nurse teammate or designee. Checks will be documented on the 'Medication Refrigerator Management Log'. a. Twice daily temperature checks located on the Digital Data Logger (DDL) display, at the beginning and end of the day. i. Verify that the temperature remains between 2° C and 8° C (36° F and 46°F)... d. Temperature excursions and issues noted during daily check will be noted on log with actions taken and outcome(s). Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet. On 06/17/2024, the medication refrigerator thermometer was installed by biomed upon arrival. The Facility Administrator or designee will conduct audits of the 'Medication Refrigeration Management Log' to verify thermometer is functional and documentation is accurate: 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 Assurance and Performance Improvement meetings known as Facility Health Meetings. The Facility Administrator will report progress, as well as any barriers to maintaining compliance. Action plans will be evaluated for effectiveness and new plans developed when needed until sustained compliance is achieved. Supporting documentation will be included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
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 upon observation, review of agency policies, and an interview with the ESRD administrator, it was determined the ESRD agency failed to ensure preventative maintenance or replacement of one (1) out of one (1) expired medication refrigeration temperature thermometer device (Observation 1).
Findings include:
Observation conducted on May 13, 2024, at approximately 11:30 AM, of dialysis treatment floor medication refrigerator revealed the Excursion-Trac refrigerator thermometer sticker on back of device expired on 3/29/24.
Review conducted on May 13, 2024, at approximately 1:00 PM, of agency policy 1-06-06 Medication Requiring Refrigeration revealed: (page 1) "Policy: ... 3. The refrigerator (temperature) is checked during normal operating hours, ... a. Twice daily temperature checks located on the Digital Data Logger (DDL) display at the beginning and end of the day."; and policy 8-04-01 Physical Environment reveals "...4. The dialysis facility will implement and maintain a program to verify that all equipment, including emergency equipment, dialysis delivery systems and the water treatment systems are maintained and operated in accordance with the manufacturer's recommendations... ."
Interview conducted on May 13, 2024, at approximately 1:30 PM, with agency administrator confirmed above findings.
Duplicate finding from last survey of 5/2023.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 05/17/24. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 8-04-01 "Physical Environment" and Policy 1-06-06 "Medications Requiring Refrigeration" with emphasis on but not limited to: A. Physical environment: 1) the dialysis facility will implement and maintain a program to verify that all equipment, including emergency equipment, dialysis delivery systems and the water treatment systems are maintained and operated in accordance with the manufacturer's recommendations. B. Medications requiring refrigeration: 1) The refrigerator is checked during facility normal operating hours, by a licensed nurse teammate or designee. Checks will be documented on the 'Medication Refrigerator Management Log'. a. Twice daily temperature checks located on the Digital Data Logger (DDL) display, at the beginning and end of the day. i. Verify that the temperature remains between 2° C and 8° C (36° F and 46°F)... d. Temperature excursions and issues noted during daily check will be noted on log with actions taken and outcome(s). Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet. On 06/17/2024, the medication refrigerator thermometer was installed by biomed upon arrival. The Facility Administrator or designee will conduct audits of the 'Medication Refrigeration Management Log' to verify thermometer is functional and documentation is accurate: 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 Assurance and Performance Improvement meetings known as Facility Health Meetings. The Facility Administrator will report progress, as well as any barriers to maintaining compliance. Action plans will be evaluated for effectiveness and new plans developed when needed until sustained compliance is achieved. Supporting documentation will be included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
494.150(c)(2)(i) STANDARD MD RESP-ENSURE ALL ADHERE TO P&P Name - Component - 00 The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers;
Observations:
Based on observation and review of employee files (EFs), agency policies, and interview with agency administrator, the medical director failed to ensure that clinical staff fully documented prepared patient intravenous (IV) medication labels on pre-drawn medication syringes in two (2) of two (2) observations; failed to ensure all clinical staff had current cardiopulmonary resuscitation certification (CPR) training in one (1) of four (4) EFs reviewed (EF#4).
Findings include:
Observation conducted on May 13, 2024, at approximately 9:30 AM, of prepared IV medications revealed: -MR#4's medication labeled syringes for Heparin Pork insulin 2400 units and 2000 units were missing the clinical registered nurse' initials and time of preparation. -MR#8's medication labeled syringes for Heparin Pork insulin 2000 units and 1200 units were missing clinical registered nurse' initials and time of preparation.
Review conducted on May 13, 2024, at approximately 12:30 PM, of agency 1-06-01 Medication Policy revealed: (page 4 of 7) "... 20. ... If the medication is not immediately administered or is to be administered by another teammate, the medication must be labeled with the patient name, name of medication, date, time prepared, dose, and initials of teammate preparing the medication."; and policy 8-02-04 Cardiopulmonary Resuscitation Certification (CPR) ... "Policy: 1. All direct patient care teammates (i.e. nurses and patient care technicians) except patient care technician trainees must have current BLS CPR/AED certification."
Review conducted on May 13, 2024, at approximately 2:00 PM, of employee files (EFs) revealed:
EF#4, date of hire 9/27/21, expired CPR card 3/2024.
Interview conducted on May 13, 2024, at approximately 2:15 PM, with agency administrator confirmed above findings.
Plan of Correction:On 05/21/2024, a Governing Body meeting with the Medical Director, Facility Administrator, Nursing Manager and Regional Operations Director was held to review the results of the survey ending on 05/17/24 The Governing Body reviewed Policy COMP-DD-017 "Medical Director Qualifications and Responsibilities" with the Medical Director, who acknowledges that he/she is responsible to ensure all policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and non-physician providers. Plans of correction have been developed and initiated to correct identified deficiencies and to sustain compliance. The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 05/17/2024. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-06-01 "Medication Policy" and Policy 08-02-04 "Cardiopulmonary Resuscitation Certification (CPR) with emphasis on but not limited to: A. Medication policy: 1) ... If the medication is not immediately administered or is to be administered by another teammate, the medication must be labeled with the patient name, name of medication, date, time prepared, dose and initials of teammate preparing the medication. B. CPR: 1) All direct patient care teammates (i.e., nurses and patient care technicians) except patient care technician trainees must have current BLS CPR/AED certification. 2) It is the responsibility of the teammate to maintain current BLS CPR/AED certification. Failure to do so will be grounds for termination of employment. 3) Documentation of BLS CPR/AED certification will be maintained in each patient care teammate's personnel file. Verification of attendance is evidenced by teammate's signature on the in-service sheet. The Facility Administrator or designee will conduct medication preparation and administration audits to verify syringes are proper labeled per medication policy: 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 immediately completed a one hundred percent (100%) teammate file audit for current CPR certification, with any needed updates scheduled for immediate completion, by 05/24/2024, including for the teammate identified by surveyor record review. Ongoing compliance will be addressed with quarterly teammate file audits. Teammate CPR was completed 06/06/2024 at the next available class. Instances of non-compliance will be addressed immediately. The Medical Director will review progress of teammate education, results of audits, and adherence to this plan of correction during monthly Quality Assurance and Performance Improvement meetings known as Facility Health Meeting. The Facility Administrator will report progress, as well as any barriers to maintaining compliance. Action plans will be evaluated for effectiveness and new plans developed if applicable to achieve sustained compliance. Supporting documentation will be included in the meeting minutes. The Facility Administrator on behalf of the Governing Body is responsible for compliance with this plan of correction.
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