QA Investigation Results

Pennsylvania Department of Health
FRESENIUS MEDICAL CARE OVERBROOK
Health Inspection Results
FRESENIUS MEDICAL CARE OVERBROOK
Health Inspection Results For:


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Initial Comments:



Based on the findings of an onsite unannounced Medicare recertification survey conducted May 18, 2021 through May 20, 2021, Fresenius Medical Care Overbrook was identified to have the following standard level deficiency that was determined to be in substantial compliance with the following 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:




494.62(d) STANDARD
EP Training and Testing

Name - Component - 00
§403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d).

*[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, "Organizations" under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years.

*[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually.

*[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i).

*[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years.

Observations:



Based on a review of medical records (MR), facility policy, and an interview with the covering clinical manager and operations director, the facility did not follow its policy regarding the performance of fire drills for five (5) of ten (10) active MR's. (MR# 4, 5, 7, 8, and 9.)

Findings include:

A review of agency policy " Fire Drill " was conducted on May 20, 2021 at approximately 11:00 am. Policy states: " Fire Drills: Quarterly, all FKC facilities shall perform a fire drill for each shift of patients and staff ... "

A review of MR's was conducted on May 19, 2021 at approximately 9:30 am.

MR #4, admission date: 7/3/15, did not have fire drills conducted for the second, third and fourth quarters of 2020.

MR#5, admission date: 1/24/13, did not have fire drills conducted for the second, third and fourth quarters of 2020.

MR#7, admission date: 10/28/13, did not have fire drills conducted for the second, third and fourth quarters of 2020.

MR#8, admission date: 4/3/15, did not have fire drills conducted for the second, third and fourth quarters of 2020.

MR#9, admission date: 10/10/16, did not have fire drills conducted for the second, third and fourth quarters of 2020.

An interview with the covering clinical manager and operations director on May 20, 2019 at approximately 1:15 pm confirmed the above findings.









Plan of Correction:

For immediate compliance, Fire Drill will be completed for all patients and staff by 06/11/2021 and records of the drills will be at the facility for review.

For ongoing compliance, the Clinic Manager (CM) or designee will educate all staff on:

- Fire Drill Policy

Emphasis of the meeting will be on ensuring that fire drills with patients and staff are performed quarterly.

Inservicing will be completed by 06/18/2021. All training documentation will be on filed at the facility.

To ensure ongoing compliance with the quarterly fire drill schedule the CM/designee will develop a calendar for the year clearly identifying the weeks that the fire drills are to be held. This calendar will be posted at the nurse's station. The CM will also have the weeks of the fire drills for the remainder of the year marked off in his/her email appointments and on the Quality Assessment Improvement (QAI) calendar.

The QAI committee will be informed of the weeks that the drills are scheduled for the remainder of the year. The results of the fire drills when conducted will be reviewed by the CM at the monthly QAI meeting. Sustained compliance will be monitored by the QAI committee.

Completion date: 06/18/2021



Initial Comments:

Based on the findings of an onsite unannounced Medicare recertification survey conducted on June 5, 2018 through June 8, 2018, Us Renal Care Pottstown 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 of the clinical area, facility policy and an interview with the covering facility manager and director of operations, the facility did not follow its policy with regard to changing gloves and performing hand hygiene for four (4) of twenty (20) observations (Observations #2, 6, 8, and 11), and did not follow its policy with regard to fingernails. (Observations #1 and 3).

Findings include:

Policy "Hand Hygiene" was reviewed on May 20, 2021 at approximately 11:30 am. Policy states: "Policy: Hand hygiene includes either washing hands with soap and water or using a waterless alcohol-based antiseptic hand rub with 60-90% alcohol content...Hands will be...decontaminated using alcohol-based rub or by washing hands with antimicrobial soap and water when... Before or after direct contact with patients...Before performing any invasive procedure such as vascular access cannulation...After removing gloves...Caution Regarding Fingernails: Do not wear artificial fingernails, extenders, or nail wraps when having direct contact with patients..."

Observation of the clinical area was conducted on May 18, 2021 from 9:45 am - 12:15 pm.

Observation #1. PCT #1 noted to have artificial fingernails.

Observation #2. At 09:55 am, PCT #2 cleansed patient's AV site at station #5, left station for supplies and returned; did not change gloves or use hand sanitizer.

Observation #3. PCT #6 noted to have artificial fingernails.

Observation #6. At 10:37 am, PCT #3 took off gloves at station #17 and went to station #12 without washing hands/using hand sanitizer prior to donning new gloves.

Observation #8. At 10:40 am, RN #2 primed iv tubing at station #17 for iv medication, took off gloves, left station and did not wash hands or use hand sanitizer prior to donning new gloves when returning to station #17.

Observation #11. At 11:57 am, PCT #5 at station #20, after performing CVC site care, did not wash hands or use hand sanitizer after removing gloves and prior to donning new gloves for connection to dialysis machine.

An interview with the covering facility manager and director of operations on May 20, 2021 at 1:15 pm confirmed the above findings.

















Plan of Correction:

To ensure compliance, the CM or designee will re-educate all the direct patient care (DPC) staff on the following policy:

- Hand Hygiene

Special emphasis was placed on ensuring that hand hygiene is performed per policy including when leaving the patient station for supplies or going to another patient station. The in-service also reviewed the importance of ensuring that hand hygiene is performed any times gloves are removed and before donning new gloves. The meeting will also review that artificial nails may not be worn by any staff while providing direct care to patients.

The in-servicing will be completed by 06/18/2021, with documentation of the training on file at the facility.

The CM or designee will perform daily audits on the DPC staff for two (2) weeks. At that time if compliance is observed the audits will then be completed 2 times/week for 2 weeks to ensure that compliance is maintained. At that time, if compliance is sustained, the audits will then follow the monthly QAI schedule. A plan of correction (POC) audit tool will be used for the audits.

Staff found to be non-compliant will be re-educated and referred for counseling.

The CM will review the audit results and report the findings to the QAI Committee at the monthly meeting. Sustained compliance will be monitored by the QAI committee.

Completion Date: 06/18/2021



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 observations, facility policy, and an interview with the covering clinical manager and director of operations, the facility failed to ensure that non-disposable items taken into the dialysis station were cleaned and disinfected before being used on another patient for one observation (Observation #12).

Findings include:

A review of policy "Checking Conductivity and pH of Final Dialysate with the pHoenix Meter" was conducted on May 20, 2021 at approximately 9:50 am. Policy states, "Testing with pHoenix Meter:...Do not take the pHoenix Meter to the patient station. If brought to the patient station, disinfect with bleach before removing from the station to prevent cross contamination..."

Observation #12: At 1106, PCT #4, took pHoenix meter to station #14 and kept it in her hand while obtaining sample for conductivity test in a separate cup, then returned to nurse ' s station to test. PCT did not sanitize meter prior to next use.

An interview with the covering clinical manager and director of operations on May 20, 2021 at approximately 1:15 pm confirmed the above findings.







Plan of Correction:

To ensure compliance, the CM or designee will re-educate all the DPC staff on the following policy:

- Checking Final Conductivity and pH of Final Dialysate with the pHoenix Meter

Special emphasis will be placed on ensuring that the pHoenix meter is not to be taken into the patient stations. The meeting will also reinforce the importance of ensuring that any non-disposable items taken into the patient stations are cleaned and disinfected before returning the item to storage.

The in-servicing will be completed by 06/18/2021, with documentation of the training on file at the facility.

The CM or designee will perform daily audits on the DPC staff for 2 weeks. At that time if compliance is observed the audits will then be completed 2 times/week for 2 weeks to ensure that compliance is maintained. At that time, if compliance is sustained, the audits will then follow the monthly QAI schedule. A POC audit tool will be used for the audits.

Staff found to be non-compliant will be re-educated and referred for counseling.

The CM will review the audit results and report the findings to the QAI Committee at the monthly meeting. Sustained compliance will be monitored by the QAI committee.

Completion Date: 06/18/2021



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, review of policy and procedures, and an interview with the covering clinical manager and director of operations, it was determined, the facility failed to ensure infection control procedures were followed for the cleaning and disinfecting of the Hansen connectors for (one) of twenty-three (23) hemodialysis machines observed (Dialysis machine at station #18) and the waste containers for two (2) of twenty-three (23) hemodialysis machines observed (Dialysis machines at station #'s 18 and 21).

Findings include:

A review of policy "Cleaning and Disinfection of the Dialysis Station" was conducted on May 20, 2021 at approximately 11:30 am. Policy states, "Externally disinfect the dialysis machine with 1:100 bleach solutions after each dialysis treatment. . ."

Observations were made in the in the clinical area on May 18, 2021 between the hours of 9:45 am and 12:15 pm .

1. At 10:00 am, it was observed that Patient Care Technician #5, did not clean the Hansen connectors and did not empty or disinfect the prime waste container of the dialysis machine at station #18, prior to the start of the next dialysis treatment.

2. At 10:02 am, it was observed that Patient Care Technician #6, did not empty or disinfect the prime waste container of the dialysis machine at station #21, prior to the start of the next dialysis treatment.

An interview conducted with the covering clinical manager and directof of operations on May 20, 2021 at approximately 1:15 pm confirmed the above identified findings.










Plan of Correction:

To ensure compliance, the CM or designee will in-service all DPC staff on:

- Cleaning and Disinfection of the Dialysis Station

- Use of Priming Buckets

The meeting will focus on ensuring that the prime buckets for the machines are emptied prior to the start of the next treatment. The meeting will review the importance of the prime bucket being cleaned and disinfected after it is emptied.

The CM or designee will perform daily audits on the DPC staff for 2 weeks. At that time if compliance is observed the audits will then be completed 2 times/week for 2 weeks to ensure that compliance is maintained. At that time, if compliance is sustained, the audits will then follow the monthly QAI schedule. A POC audit tool will be used for the audits.

Staff found to be non-compliant will be re-educated and referred for counseling.

The CM will review the audit results and report the findings to the QAI Committee at the monthly meeting. Sustained compliance will be monitored by the QAI committee.

Completion Date: 06/18/2021



494.30(a)(2) STANDARD
IC-STAFF EDUCATION-CATHETERS/CATHETER CARE

Name - Component - 00
Recommendations for Placement of Intravascular Catheters in Adults and Children

I. Health care worker education and training
A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections.
B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters.

II. Surveillance
A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site.

Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients.

VI. Catheter and catheter-site care
B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections].





Observations:



Based on observation of the clinical area, facililty policy and procedure, and an interview with the covering clinical manager and director of operations, the facility did not follow procedure for catheter care for one (1) of one (1) observations. Observation #1.

Findings include:

A review of facility procedure "Changing the Catheter Dressing Procedure" was conducted on May 20, 2021 at approximately 10:30 am states: "Timing of Exit Site Dressing Change: Catheter exit site disinfection and dressing change is to be completed prior to cap and hub connector disinfection..."

Observation of the clinical area was conducted on May 18, 2021 from approximately 9:45 am through 12:15 pm.

Observation #1. At 11:57 am, it was observed that Patient Care Technician #5 at station #20, performed catheter cap and hub connector disinfection prior to performing catheter exit site disinfection and dressing change.

An interview with the covering clinical manager and director of operations on May 20, 2021 at 1:15 pm confirmed the above findings.










Plan of Correction:

To ensure compliance, the CM or designee will in-service all DPC staff on:

- Changing the Catheter Dressing Procedure

The meeting will focus on ensuring that the catheter site cleaning and dressing change occur prior to the cap and hub are cleaned and disinfected.

The CM or designee will perform daily audits on the DPC staff for 2 weeks. At that time if compliance is observed the audits will then be completed 2 times/week for 2 weeks to ensure that compliance is maintained. At that time, if compliance is sustained, the audits will then follow the monthly QAI schedule. A POC audit tool will be used for the audits.

Staff found to be non-compliant will be re-educated and referred for counseling.

The CM will review the audit results and report the findings to the QAI Committee at the monthly meeting. Sustained compliance will be monitored by the QAI committee.

Completion Date: 06/18/2021



494.80(a)(2) STANDARD
PA-ASSESS B/P, FLUID MANAGEMENT NEEDS

Name - Component - 00
The patient's comprehensive assessment must include, but is not limited to, the following:

Blood pressure, and fluid management needs.




Observations:



Based on review of clinical records (CR), facility policy and an interview with the covering clinical manager and director of operations, the facility failed to follow its policy regarding blood pressure management for seven (7) of ten (10) CR's (CR #1, 2, 4, 5, 7, 9, and 10); did not follow its policy regarding vitals signs and treatment monitoring for five (5) of ten (10) CR's, (CR #1, 2, 3, 6, and 10); and did not follow its policy regarding post treatment assessment for eight (8) of ten (10) CR's, (CR #1, 2, 3, 4, 5, 6, 9, and 10).

Findings include:

A review of policy "Patient Assessment and Monitoring" on May 20, 2021 at approximately 12:15 pm states: "Pre-Treatment Assessment and Data Collection: Pre-treatment: Direct patient care staff may collect pre-treatment weight, blood pressure (BP), pulse respirations, temperature, general observations, access, and complaints reported by the patient. If the PCT/LPN notes any changes or abnormal findings in the patient's condition or vascular access are observed or reported by the patient...the PCT must report the changes in the patient condition to a registered nurse who will further assess the patient prior to initiation of the treatment. An abnormal finding confirmed by the RN will be reported to the attending physician for assessment and intervention if necessary determined by the clinical judgement of the registered nurse. During Treatment: The RN will assess/re-assess any findings addressed pre or during treatment as needed. Post-Treatment: Non-licensed staff may collect post-treatment weight, BP, pulse, respirations, temperature, general observations, access, and complaints reported by the patient. The staff member who collects the information and evaluates the patient post-treatment will document their findings on the hemodialysis treatment record. If any changes or abnormal findings in the patient's condition, vital signs, or vascular access are observed or reported by the patient, the PCT/LPN must report the changes in the patient condition to the RN who will further assess the patient prior to discharge after the treatment. An abnormal finding confirmed by the RN will be reported to the attending physician if necessary as determined by the clinical judgement of the RN for assessment and intervention. The RN will assess/re-assess any findings addressed pre-treatment prior to discharge. Pre-Treatment assessment steps: Blood Pressure: Verify: Systolic BP greater than 180 mm/Hg and/or diastolic BP greater than 100 mm/Hg; Systolic BP less than or equal to 100 mm/Hg during treatment. Pulse: Verify pulses manually if automated readings display below 60 or greater than 100 beats per minute...Monitoring During Treatment: Obtain BP and pulse every 30 minutes or more as needed but not to exceed 45 minutes...BP: record BP. Recheck BP after a drop that requires interventions...Reposition electronic cuff or use a manual cuff for aberrant BP readings. Report to the nurse: Systolic BP greater than 180 mm/Hg; Diastolic BP greater thean 100 mm/Hg; BP less than or equal to 100 mm/Hg systolic. Pulse: Record pulse. Verify pulses manually if automated readings display below 60 or greater than 100 beats per minute. Report to the nurse patients whose heart rates have dropped below 60, risen above 100 or have become irregular...Post-Treatment:...Ensure vital signs and overall condition are stable for discharge..."

A review of CR's was conducted on 5/19/2021 from approximately 9:30 am - 1:30 pm.

CR #1, Admission date: 10/28/2020. Review of treatment sheets revealed the following:

On 5/7/2021, at 4:39 pm, BP recorded 84/78 by PCT. No comments were listed. No recheck of pressure was completed, no nurse notification documented, and no nurse documentation regarding BP was noted.

On 5/17/2021, vital signs were recorded at 6:04 pm and not again until 7:11 pm. No post treatment nursing evaluation was documented.

CR #2, Admission date: 1/21/2021. Review of treatment sheets revealed the following:

On 5/8/2021, at 3:02 pm, BP recorded 199/107 by PCT. Comments: "Resting comfortably, denies complaints". No recheck of BP was documented, no nurse notification was documented, and no nurse documentation regarding BP was noted.

On 5/11/2021, vital signs were recorded for pre-treatment at 10:41am by PCT and not again until 12:01 pm. At 1:50 pm, BP recorded 73/34 by PCT. Comments: "RN notified". No RN documentation regarding BP was noted.

On 5/18/2021, No post treatment nursing evaluation was documented.

CR #3 Admission date: 12/30/2020. Review of treatment sheets revealed the following:

On 5/8/2021, vital signs were recorded at 5:33 pm and not again until post- treatment vitals recorded at 6:58 pm.

On 5/15/2021, Post treatment nursing evaluation was documented at 4:26 pm by RN. Treatment was documented complete at 6:06 pm.

On 5/18/2021, No post treatment nursing evaluation was documented.

CR #4 Admission Date: 7/3/15. Review of treatment sheets revealed the following:

On 5/15/2021, At 07:03 am, BP recorded 88/65 by PCT. Comments: "Denies complaints". No recheck was documented, no nurse notification was documented and no nurse documentation regarding BP was noted. Post treatment nursing evaluation was documented at 2:05 pm. Not listed as late entry. Patient's documented discharge time was 11:18 am by RN.

CR #5 Admission Date: 1/24/13. Review of treatment sheets revealed the following:

On 5/10/2021, at 12:05 pm, BP recorded 174/101 by PCT. Comments: "Resting comfortably, denies complaints". No recheck documented, no nurse notification documented, and no nurse documentation regarding BP was noted.

On 5/12/2021, at 12:02 pm, BP recorded 182/130 by PCT. Comments: "Denies complaints". No recheck documented, no nurse notification documented, and no nurse documentation regarding BP was noted.

On 5/14/2021, At 10:55 am, BP recorded 184/113 by PCT. Comments: "no complaints". No recheck noted, no nurse notification noted, and no nurse documentation regarding BP was noted. Post treatment nursing evaluation was documented at 5:25 pm. Not listed as late entry. Patient's documented discharge time was 2:52 pm by PCT.

CR #6 Admission Date: 3/5/2021. Review of treatment sheets revealed the following:

On 5/7/2021, Post treatment evaluation documented at 5:12 pm. Not listed as late entry. Patient's documented discharge time was 3:30 pm by PCT.

On 5/17/2021, treatment completion vital signs were documented at 3:58 pm. Post treatment vital signs were documented at 3:28 PM.

CR #7 Admission Date: 10/28/13. Review of treatment sheets revealed the following:

On 5/6/2021, at 12:00 pm, BP recorded 89/54 by PCT. Comments: "Resting comfortably". No recheck documented, no nurse notification documented. Nursing evaluation was documented at 12:09 pm with no mention of low BP.

On 5/13/2021, Pretreatment HR 43 documented at 11:41 am by PCT. Comments: "No complaints". Recheck documented at 11:47 am by PCT, same HR 43. No nurse notification documented, and no nurse documentation regarding HR was noted. At 12:08 pm, HR 44 documented by PCT. Comments: "Resting comfortably". No recheck documented, no nurse notification documented, and no nurse documentation regarding HR was noted.

CR #9 Admission Date: 10/10/16. Review of treatment sheets revealed the following:

On 5/5/2021, at 08:05 am, BP recorded 122/101 by PCT. Comments: "denies complaints". No recheck documented, no nurse notification documented, and no nurse documentation regarding BP was noted.

On 5/7/2021, Post treatment evaluation was documented at 3:05 pm. Not listed as late entry. Patient's documented discharge time was 9:21 am by PCT.

CR #10 Admission Date: 3/17/2021. Review of treatment sheets revealed the following:

On 5/5/2021, No post treatment nursing evaluation was documented.

On 5/7/2021, At 11:01 am, BP recorded 151/106 by PCT. Comments: "denies complaints". No recheck documented, no nurse notification documented, and no nurse documentation regarding BP was noted.

On 5/14/20201, at 10:03 am, BP recorded 185/101 by PCT. Comments: "resting comfortably, denies complaints". No recheck documented, no nurse notification documented, and no nurse documentation regarding BP was noted. At 11:03 am, BP recorded 178/103 by PCT. Comments: "Resting comfortably, denies complaints". No recheck documented, no nurse notification documented, and no nurse documentation regarding BP was noted. At 11:32 am, BP recorded 183/115 by PCT. Comments: "Resting comfortable, denies complaints". No recheck documented, no nurse notification documented, and no nurse documentation regarding BP was noted. At 2:09 pm, post treatment BP recorded 183/104 by PCT. No recheck documented, no nurse notification documented, and no nurse documentation regarding BP was noted. Post nursing evaluation documented at 5:33 pm had no mention of abnormal BP ' s. Not listed as late entry. Patient's documented discharge time was 2:11 pm by PCT.

On 5/17/2021, vital signs were recorded at 11:41 am and not again until 12:31 pm.

An interview with the covering clinical manager and director of operations on May 20, 2021 at 1:15 pm confirmed the above findings.




























Plan of Correction:

To ensure compliance, the CM or designee will in-service all the DPC staff on policy:

- Patient Assessment and Monitoring

Emphasis will be placed on ensuring that any abnormal findings, including blood pressures (BP) and heart rate (HR), not within the acceptable limits must be reported to the Registered nurse (RN) with the DPC documentation of the RN notification. The meeting will also reinforce the need for the RN to complete an assessment with documentation of findings and any interventions taken, including physician notification. There must also be a follow up re-assessment to the intervention with complete documentation. The meeting will review the importance of ensuring that the patient's vital signs (VS) are taken every 30 minutes but no longer than 45 minutes while the patient is receiving treatment with timely documentation. The meeting will also reinforce that post treatment evaluations should be entered timely and if the note is entered late it should be noted as a late entry.

Inservicing will be completed by 06/18/2021. All training documentation is on file at the facility.

The CM or designee will perform daily audits for 2 weeks. At that time if compliance is observed the audits will then be completed 2 times/week for 2 weeks to ensure that compliance is maintained. At that time, the audits will then follow the monthly QAI schedule. A POC specific audit tool will be used for the audits.

Staff found to be non-compliant will be re-educated and referred for counseling.

The CM will review the audits and report the findings to the QAI Committee at the monthly meeting. The QAI committee will be responsible for further guidance and ongoing oversight.

Completion Date: 06/18/2021



494.80(a)(8) STANDARD
PA-DIALYSIS ACCESS TYPE & MAINTENANCE

Name - Component - 00
The patient's comprehensive assessment must include, but is not limited to, the following:

(8) Evaluation of dialysis access type and maintenance (for example, arteriovenous fistulas, arteriovenous grafts and peritoneal catheters).




Observations:



Based on review of clinical records (CR), facility policy, and an interview with the covering clinical manager and director of operations, the facility failed to document dialysis access assessment for nine (9) of ten (10) CR's (CR #1, 2, 3, 4, 6, 7, 8, 9, and 10).

Findings include:

Facility has no policy regarding Dialysis Access Management Documentation.

Dialysis Machines are set to record Access Treatment Summaries for Access Used that includes Pre-Treatment Evaluation, Cannulation Documentation, Maturation/Cannulation, During Treatment Evaluation, and Post Treatment Evaluations with Status and Signature, Date, and Time of reviewer.

A review of CR's was conducted on 5/19/2021 from approximately 9:30 am - 1:30 pm.

CR #1, Admission date: 10/28/2020. Review of treatment sheets revealed the following:

On 5/7/2021, Access Treatment Summary:
During treatment: signed at 4:23 pm by PCT. Treatment start was documented at 4:35 pm.
Post treatment: signed at 4:23 pm by PCT. Treatment end was documented at 8:11 pm.

On 5/10/2021, Access Treatment Summary:
During treatment: signed at 4:11 pm by PCT. Treatment start was documented at 4:19 pm.
Post treatment: signed at 4:11 pm by PCT. Treatment end was documented at 7:50 pm.

On 5/12/2021, Access Treatment Summary:
Post treatment: signed at 4:39 pm by PCT. Treatment end was documented at 7:48 pm

CR #2, Admission date: 1/21/2021. Review of treatment sheets revealed the following:

On 5/15/2021, Access Treatment Summary:
During treatment: signed at 11:21 am by PCT. Treatment start was documented at 11:57 am.
Post treatment: signed at 11:21 am by PCT. Treatment end was documented at 4:13pm.

CR #3 Admission date: 12/30/2020. Review of treatment sheets revealed the following:

On 5/6/2021, Access Treatment Summary:
Post treatment: signed at 4:34 pm by PCT. Treatment end was documented at 7:02 pm.

On 5/18/2021, Access Treatment Summary:
Pretreatment: signed at 12:42 pm by PCT. Treatment start was documented at 12:35 pm.
During treatment: signed at 12:43 pm by PCT. Treatment start was documented at 12:35 pm.

CR #4 Admission Date: 7/3/15. Review of treatment sheets revealed the following:

On 5/15/2021, Access Treatment Summary:
During treatment: signed at 6:44 am by PCT. Treatment start was documented at 6:53 am.
Post treatment: signed at 6:44 am by PCT. Treatment end was documented at 10:53 am.

CR #6 Admission Date: 3/5/2021. Review of treatment sheets revealed the following:

On 5/5/2021, Access Treatment Summary:
During treatment: signed at 7:51 pm by PCT. Treatment end was documented at 3:11 pm.
Post treatment: signed at 7:51 pm by PCT. Treatment end was documented at 3:11 pm.

On 5/7/2021, Access Treatment Summary:
Post treatment: signed at 12:10 pm by PCT. Treatment end was documented at 3:25 pm.

On 5/10/2021, Access Treatment Summary:
During treatment: signed at 3:08 pm by PCT. Treatment start was documented at 3:04 pm.
Post treatment: signed at 3:09 pm by PCT. Treatment end was documented at 7:10 pm.

On 5/12/2020, Access Treatment Summary:
During treatment: signed at 3:22 pm by PCT Treatment start was documented at 3:14 pm.
Post treatment: signed at 3:23 pm by PCT. Treatment end was documented at 7:33 pm.

CR #7 Admission Date: 10/28/13. Review of treatment sheets revealed the following:

On 5/11/2021, Access Treatment Summary:
Post treatment: signed at 2:52 pm by PCT. Treatment end was documented at 3:10 pm.

On 5/13/2021, Access Treatment Summary:
During treatment: signed at 11:46 am by PCT. Treatment start was documented at 11:41 am.
Post treatment: signed at 11:46 am by PCT. Treatment end was documented at 3:01 pm.

CR #8 Admission Date: 4/13/15. Review of treatment sheets revealed the following:

On 5/7/2021, Access Treatment Summary:
Post treatment: signed at 4:17 pm by PCT. Treatment end was documented at 7:05 pm.

On 5/10/2021, Access Treatment Summary:
Post treatment: signed at 6:32 pm by PCT. Treatment end was documented at 7:21 pm.

On 5/12/2021, Access Treatment Summary:
Post treatment: signed at 6:26 pm by PCT. Treatment end was documented at 7:11 pm.

On 5/14/2021, Access Treatment Summary:
During treatment: signed at 8:48 pm by PCT. Treatment end was documented at 6:59 pm.
Post treatment: signed at 8:48 by PCT. Treatment end was documented at 6:59 pm.

On 5/17/2021, Access Treatment Summary:
Post treatment: signed at 4:31 pm by PCT. Treatment end was documented at 7:03 pm.

CR #9 Admission Date: 10/10/16. Review of treatment sheets revealed the following:

On 5/5/2021, Access Treatment Summary:
Post treatment: signed at 6:40 am by PCT. Treatment end was documeted at 8:57 am.

CR #10 Admission Date: 3/17/2021. Review of treatment sheets revealed the following:

On 5/10/2021, Access Treatment Summary:
During treatment: signed at 9:56 am by PCT. Treatment start was documented at 9:47 am.
Post treatment: signed at 9:56 am by PCT. Treatment end was documented at 2:15 pm.

On 5/12/2021, Access Treatment Summary:
During treatment: signed at 9:54 am by PCT. Treatment start was documented at 9:49 am.
Post treatment: signed at 9:54 am by PCT. Treatment end was documented at 2:10 pm.


An interview with the covering clinical manager and director of operations on May 20, 2021 at 1:15 pm confirmed the facility failed to document dialysis access assessment.












Plan of Correction:

To ensure compliance, the CM or designee will in-service all the DPC staff on policy:

- Patient Assessment and Monitoring

Emphasis will be placed on ensuring that accesses are evaluated prior to, during and after treatment. Abnormalities noted by the DPC staff will be reported to the Registered nurse (RN). The meeting will also reinforce the need for the RN to complete an assessment with documentation of findings and any interventions taken, including physician notification. There must also be a follow up re-assessment to the intervention with complete documentation. The meeting will also reinforce that post treatment evaluations should be entered timely and if there the note is entered late if should be noted as a late entry.

Inservicing will be completed by 06/18/2021. All training documentation is on file at the facility.

The CM or designee will perform daily audits for 2 weeks. At that time if compliance is observed the audits will then be completed 2 times/week for 2 weeks to ensure that compliance is maintained. At that time, the audits will then follow the monthly QAI schedule. A POC specific audit tool will be used for the audits.

Staff found to be non-compliant will be re-educated and referred for counseling.

The CM will review the audits and report the findings to the QAI Committee at the monthly meeting. The QAI committee will be responsible for further guidance and ongoing oversight.

Completion Date: 06/18/2021