QA Investigation Results

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


There are  8 surveys for this facility. Please select a date to view the survey results.

Surveys don't appear on this website until at least 41 days have elapsed since the exit date of the survey.



Initial Comments:

Based on the findings of an onsite unannounced Medicare recertification survey completed October 3, 2019, Dialysis Clinic, Inc. - Seven Fields 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 October 3, 2019, Dialysis Clinic, Inc. - Seven Fields 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) 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 review of facility policy and procedure, observation (OBS), and staff (EMP) interview, the facility failed to ensure two (2) of two (2) patients performed hand hygiene immediately after gloves were removed (OBS#5.1, & OBS#5.2), and failed to ensure one (1) of two (2) staff (EMP9) performed a glove change when going from a dirty task to a clean task (OBS#2.2).

Findings included:

Review of facility policy and procedure on October 3, 2019, at 10:47 a.m. showed, "HEMODIALYSIS CATHETER DRESSING CHANGE ... Procedure: ... 6. Carefully remove and discard the old dressing. ... 8. CHANGE GLOVES. ... 11. Clean skin at catheter exit site."

Review of facility policy and procedure on October 3, 2019, at 10:52 a.m. showed, "Standard Precautions/Infection Control for the Hemodialysis Unit PURPOSE: To establish guidelines for preventing the transmission of infection among chronic hemodialysis patients. ... Procedure Steps ... 4. Hand hygiene ...c. Hand hygiene is necessary after glove removal. d. Hand hygiene must be performed: ... Immediately after gloves are removed ... 5. Gloves ... b. Gloves should be changed: ... When going from a 'dirty' area or task to a 'clean' area or task."

Observation (OBS#5.1) of discontinuation of dialysis with arteriovenous fistula (AVF) on September 30, 2019, at 10:32 a.m. at station 10 revealed EMP6 remove needles from patient's arm, and cover the needle sites with folded gauze dressing and tape. The patient held pressure to the bandages with gloved right hand to stop bleeding. Once bleeding had stopped, the patient removed the glove from his hand, and did not perform hand hygiene. The patient left the station, weighed himself on the scale, and then left the facility. Interview with EMP6 at 10:37 a.m. confirmed findings.

Observation (OBS#5.2) of discontinuation of dialysis with AVF on September 30, 2019, at 10:42 a.m. at station 4 revealed EMP4 remove needles from patient's arm, and cover the needle sites with folded gauze dressing and tape. The patient held pressure to the bandages with gloved right hand to stop bleeding. Once bleeding had stopped, the patient removed the glove from his hand, and did not perform hand hygiene. The patient left the station, weighed himself on the scale, and then left the facility. Interview with EMP4 at 11:07 a.m. confirmed findings.

Observation (OBS#2.2) of central venous catheter (CVC) exit site care on October 1, 2019, at 9:45 a.m. at station 16 revealed EMP9 remove dressing from patient's CVC exit site (dirty task). Without changing gloves, EMP9 proceeded to use clean swabs to disinfect patient's exposed CVC exit site (clean task). Interview with EMP9 at 9:59 a.m. confirmed no glove change between dirty and clean tasks.

Repeat from Medicare recertification surveys completed 11/21/2013, and 10/14/2016.







Plan of Correction:

1. All clinical staff will be re-trained by the Nurse Manager and/or Designee on the facility's "Standard Precautions/Infection Control for the Hemodialysis Unit" policy and the "Hemodialysis Catheter Dressing Change" policy by 10/31/19.

2. All clinical staff will review and sign acknowledgement of understanding of policies. A copy of the acknowledgment will be placed in the facility's education manual.

3. All staff will be educated on the importance of hand washing after removing glove(s) and changing gloves when going from a dirty task to a clean task.

4. All patients will be educated on the importance of hand washing after removing glove(s) by 10/31/19.

5. All patients will review and sign an in-service sheet confirming education and placed in patient's chart.

6. Initially, Nurse Manager and/or Designee will observe clinic staff/patients patients daily for one (1) week to ensure that staff is following proper infection control standards and to ensure that patients are using hand hygiene post glove removal. If standards are met, the clinic staff/patients will be observed weekly for four (4) weeks. If standards are met, the clinical staff/patients will be observed monthly for three (3) months. If standards are met, the clinic staff/patients will be observed quarterly. The audit results will be reviewed at monthly QAPI meetings.



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 and procedure, observation (OBS), and staff (EMP) interview, the facility failed to ensure staff wore personal protective equipment (PPE) only when in the treatment area for one (1) of one (1) staff member observed in the patient waiting area (EMP3).

Findings included:

Review of facility policy and procedure on October 3, 2019, at 10:52 a.m. showed, "Standard Precautions/Infection Control for the Hemodialysis Unit PURPOSE: To establish guidelines for preventing the transmission of infection among chronic hemodialysis patients. ... Procedure Steps 1. PPE [gown, gloves, mask] ... e. PPE must be removed before exiting the treatment area."

Observation on October 1, 2019, at 10 a.m. revealed EMP3 wearing mask, gown, and gloves (all PPE) in the patient treatment area. At 10:20 a.m., EMP3 removed his/her gown, retrieved a patient's belongings from station 2, and walked off the treatment area and into the patient waiting area wearing his/her gloves and mask. EMP3 then returned to the treatment area with another patient in a wheelchair, and wheeled them over to a dialysis station wearing the same gloves and mask. Interview with EMP3 at 10:25 a.m. confirmed findings. When asked why he/she wore his/her gloves off the treatment floor he/she replied, "Anytime there is patient contact [gloves are worn]."

Repeat from Medicare recertification survey completed 10/14/2016.










Plan of Correction:

1. All clinical staff will be re-trained by the Nurse Manager and/or Designee on the facility's "Standard Precautions/Infection Control for the Hemodialysis Unit" policy by 10/31/19.

2. All clinical staff will review and sign acknowledgement of understanding of policy. A copy of the acknowledgment will be placed in the facility's education manual.

3. Initially, Nurse Manager and/or Designee will observe facility staff daily for one (1) week to ensure that staff is following proper infection control standards and to ensure that staff is removing PPE before exiting the treatment area. If standards are met, the clinic staff will be observed weekly for four (4) weeks. If standards are met, the clinical staff will be observed monthly for three (3) months. If standards are met, the clinical staff will be observed quarterly. The 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 and procedure, observation (OBS), and staff (EMP) interview, the facility failed to disinfect items used in the dialysis station prior to moving them to a common clean area. The facility moved patients in their dialysis chairs from the dialysis station to a common area for the purpose of using a mechanical lift to transfer the patients to their wheelchairs. This practice was observed for two (2) of two (2) observations of dialysis supply management and contamination prevention, and included two (2) patients who had completed in-center hemodialysis (OBS#9.1, & OBS#9.2).

Findings included:

Review of facility policy and procedure on October 3, 2019, at 10:52 a.m. showed, "Standard Precautions/Infection Control for the Hemodialysis Unit PURPOSE: To establish guidelines for preventing the transmission of infection among chronic hemodialysis patients. ... Procedure Steps ... 6. Any item taken to the patient's dialysis station, ... [is]: cleaned and disinfected before being taken to a common clean area."

Observation (OBS#9.1) during completion of dialysis on September 30, 2019, at 11:15 a.m. revealed EMP5 wheel patient and dialysis chair out of station 16 to a common area. EMP5 and other staff members used a mechanical lift to transfer the patient from their dialysis chair to their wheelchair. Once the patient was transferred, staff wheeled the dialysis chair back to station 16. Interview with EMP5 after the observation confirmed findings, and that the patient's chair (with patient in it) was not disinfected prior to removing it from the station. When EMP5 was asked why it is done in this manner he/she said, "It's a safety issue, there is more room over there."

Observation (OBS#9.2) during discontinuation of dialysis with EMP1 (clinic manager) on October 1, 2019, at 1:55 p.m. revealed staff wheel the patient and dialysis chair out of station 15 to a common area. Staff members then used a mechanical lift to transfer the patient back to his wheelchair. Once the patient was transferred, staff moved the dialysis chair back to station 15. Interview with EMP1 at time of observation confirmed findings, and noted that it is not possible to disinfect the dialysis chair with the patient in it.













Plan of Correction:

1. All clinical staff will be re-trained by the Nurse Manger and/or Designee on the facility's "Standard Precautions/Infection Control for the Hemodialysis Unit" policy. Training will include instruction on moving the mechanical lift to the station for use and disinfecting the equipment before leaving the station. This training will be completed by 10/31/19.

2. All clinical staff will review and sign acknowledgement of understanding of policy. A copy of the acknowledgment will be placed in the facility's education manual.

3. Prior to use of the mechanical lift to transfer patient, dialysis chair will be pulled away from wall to allow sufficient clearance for staff to safely bring mechanical lift to dialysis chair and open the base legs of lift to the widest position, attach lift sling loops to mechanical lift, elevate patient off dialysis chair, and replace dialysis chair with wheelchair.

4. Patient will be lowered into wheelchair.

5. Dialysis chair will remain in dialysis station for disinfection.

6. Mechanical lift will be cleaned and disinfected at station before being taken to a clean common area.

7. Initially, Nurse Manager and/or Designee will observe facility staff daily for one (1) week to ensure that staff is following proper infection control standards and to ensure that staff performs patient transfer via mechanical lift within the patient station. If standards are met, the clinic staff will be observed weekly for four (4) weeks. If standards are met, the clinical staff will be observed monthly for three (3) months. If standards are met, the clinical staff will be observed quarterly. The audit results will be reviewed at monthly QAPI meetings.



494.80(a)(1) STANDARD
PA-ASSESS CURRENT HEALTH STATUS/COMORBIDS

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

(1) Evaluation of current health status and medical condition, including co-morbid conditions.




Observations:

Based on review of facility policy and procedure, clinical records (CR), and staff (EMP) interview, the facility failed to ensure one (1) of one (1) diabetic peritoneal dialysis (PD) patient (CR6) had an assessment of co-morbid conditions. The facility failed to conduct monthly foot checks in accordance with its own policy. The facility failed to identify a diabetic patient's foot wound that necessitated hospitalization and amputation.

Findings included:

Review of facility policy and procedure on October 3, 2019, at 10 a.m.:

"PROCEDURE NO: 1001 ... DATE ISSUED: 7/10/18 ... Diabetic Monthly Foot Checks PURPOSE: To identify patients with diabetes who are at risk for foot ulcers and coordinate referrals as needed for early intervention. SUPPORTIVE DATA: Lower extremity complications in persons with diabetes have become an increasingly significant public health concern. These complications beginning with neuropathy and subsequent diabetic foot wounds frequently lead to infection and lower extremity amputation. Almost half of diabetic neuropathy may be asymptomatic underscoring the necessity of regular foot exams. (ADA, 2017) ... POLICY 1. Patients with a known diagnosis of Diabetes will have a monthly physical exam of the feet by a nurse, ... to monitor for skin integrity, and check for infection, while assessing for risk factors for foot ulcers. Monthly exam will include a visual inspection of the feet. ... PROCEDURE 1. Each month, all patients with a known diagnosis of diabetes will have their feet inspected by a nurse."

"DIABETIC FOOT CARE ASSESSMENT PROTOCOL ... EFFECTIVE DATE: 05/11/2015 ... POLICY: A foot assessment of diabetic patients should be done monthly by nursing personnel to monitor for complications. RATIONALE: Patients with infected feet frequently feel no pain because of neuropathy and have no systemic symptoms until late in a neglected course. The principal aim of assessment is to identify patients at risk of bacterial invasion and the possibility of gangrene [death of tissue] amputations. ... DOCUMENT THE ASSESSMENT WAS COMPLETED INCLUDING ANY PROBLEMS IDENTIFIED ON THE PATIENTS [sic] FLOWSHEET."

Review of CR6 on October 2, 2019, at 10:30 a.m. showed patient was admitted to PD on 8/3/2016. The patient completed PD training and began dialyzing at home on or about 8/18/2016. The patient's diagnosis was, "Type 2 Diabetes mellitus w [with] chronic kidney disease." Review of "PERITONEAL DIALYSIS CLINIC VISIT[s]" showed patient was at facility (for labs and/or to see physician) on: 1/19, 2/6, 2/20, 3/6, 4/4, 4/5, 4/16, 5/7, 6/11, 6/14, 7/9, 7/26, 8/14, 8/30, and 9/10/2018. There were no monthly foot checks for the aforementioned time frame. During the next clinic visit on 10/2/2018, the PD nurse documented, "hurt [left] foot - [large] water blister." There were no other clinic visits after 10/2/2018, and patient was admitted to the hospital on 10/25/2018. The following hospital operative reports showed patient had several operations with resultant amputation of his fifth toe (metatarsal). The patient then suffered a below the knee amputation in April 2019. See below for more details.

Review of "DCI PROGRESS NOTES" showed, "Written Dictated: 11/1/18 ... Subject: Update regarding hospital admission ... Pt underwent 3rd surgery on foot today," and "Written/Dictated: 11/28/18 ... Pt was hospitalized late October to late November for foot ulcer that required partial amputation of 5th metatarsal."

Review of "[Hospital] DISCHARGE SUMMARY" showed patient was admitted from 10/25/2018 to 11/9/2018, "Final Diagnosis 1. SEPSIS 2. LEFT FOOT DIABETIC ULCER 3. LEFT 5TH METATARSAL AND CUBOID BONE OSTEOMYELITIS [infection in the bones of the foot] 4. LEFT FOOT CELLULITIS ... 6. DIABETES MELLITUS ... 10. DIABETIC NEUROPATHY." Review of "[Hospital] OPERATIVE REPORT" showed, "DATE OF PROCEDURE: October 24, 2018 ... PROCEDURE: ... proximal half of fifth metatarsal resected [removed]," "[Hospital] OPERATIVE REPORT ... PROCEDURE DATE: 10/26/2018 ... POSTOPERATIVE DIAGNOSIS: Necrotizing fasciitis [infection that destroys human tissue/flesh] grade 4 diabetic foot infection fifth left lateral. ... PROCEDURE: ... Attention was then directed to the left fifth metatarsal where an excessive amount of necrotic [dead] tissue with foul odor was noted. ... The fifth metatarsal was necrotic ... The majority from the base to at least mid-shaft of the metatarsal was removed in toto [overall]," "[Hospital] OPERATIVE REPORT DATE OF PROCEDURE: October 28, 2018. ... POST OPERATIVE DIAGNOSIS: 1. Diabetic foot infection with gas gangrene of the left foot. 2. Osteomyelitis of the left foot fifth metatarsal. PROCEDURE PERFORMED: Irrigation, drainage and debridement of left foot infection with debridement of soft tissue, muscle, bone and application of wound vac all on the left foot ... He is still at great risk for losing more of his left foot," and "[Hospital] OPERATIVE REPORT ... DATE OF PROCEDURE: November 1, 2018 ... SPECIMEN: The fifth digit as well as remaining fifth metatarsal was removed [amputated] and sent to Pathology and for culture."

During an interview with EMP11 on October 2, 2019, at 10:30 a.m. he/she confirmed no monthly foot checks documented for above time frame. EMP11 also confirmed patient suffered a left below the knee amputation (BKA) on 4/2/2019. Surveyor requested more information about CR6 to include when patient's wound was first identified, and the reason why no foot checks were completed by PD nursing staff.

Review of additional information from EMP11 on October 3, 2019, at 9:30 a.m. showed the documents contained handwritten note, "The policy [for] monthly foot [checks] on diabetic PD pts [patients] was not in place prior to the adoption of the new P+P [policy and procedure] manual 11/18." The information provided was reviewed, and the findings are included in the above clinical record (CR6) review.

Review of "[Hospital] DISCHARGE SUMMARY" dictated on 4/10/2019, showed, "DISCHARGE SUMMARY Final Diagnosis 1. LEFT FOOT OSTEOMYELITIS. 2. LEFT FOOT GANGRENE. 3. LEFT BKA."

Interview with EMP1 (clinic manager) on October 3, 2019, at 1:42 a.m. confirmed findings. EMP1 confirmed no monthly foot checks completed for the months prior to patient's first amputation of his fifth metatarsal. Another interview with EMP1 on October 3, 2019, at 2:36 p.m. confirmed PD staff were unaware of patient's foot wound until the patient brought it to their attention on 10/2/2018.























Plan of Correction:

1. All Home Training staff will be re-trained by the Home Training Nurse Manager and/or Designee on the facility's "Diabetic Monthly Foot Checks" policy and the "Diabetic Foot Care Assessment" protocol by 10/31/19.

2. All staff will review and sign acknowledgement of understanding of policy and protocol. A copy of the acknowledgment will be placed in the facility's education manual.

3. All Home Training staff will document on the monthly flowsheet that a foot assessment has been performed per policy for all diabetic patients.

4. Initially, Home Training Nurse Manager and/or Designee will audit treatment flowsheets monthly for (4) four months to ensure that staff is following policy standards and to ensure that staff is performing a foot assessment of diabetic patients monthly. If standards are met, the treatment flowsheets will be audited quarterly. If standards are met, the treatment flowsheets will be audited semi-annually. The audit results will be reviewed at monthly QAPI meetings.



494.80(a)(2) STANDARD
PA-APPROPRIATENESS OF DIALYSIS RX

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

(2) Evaluation of the appropriateness of the dialysis prescription,




Observations:


Based on review of facility policy and procedure, clinical records (CR), and staff (EMP) interview, the facility failed to ensure the patient's peritoneal dialysis prescription considered the patient's peritoneal transportation rate as determined by the peritoneal equilibrium test (PET) for one (1) of one (1) peritoneal dialysis (PD) record reviewed (CR6).

Findings included:

Review of policy and procedure on October 2, 2019, at 2 p.m. showed, "PROCEDURE NO: 804.0 ... DATE ISSUED: 7/15/18 ... Standard Peritoneal Equilibrium Test (PET) PURPOSE: Establish the transport characteristics of the patient's peritoneal membrane to provide information for the PD prescription to meet specific needs for each patient. SUPPORITVE DATA: A peritoneal dialysis (PD) prescription must take into consideration the peritoneal transport rate (determined by peritoneal equilibrium testing [PET]), ... Note: The peritoneal transport rate varies from person to person. POLICY: 1. A physician's order is needed for a ... (PET) ... 3. The PET will be performed on each patient within 4 to 6 weeks of training and when the prescribed fill volume has been reached."

Review of CR6 on October 2, 2019, at 10:30 a.m. showed patient was admitted to PD on 8/3/2016. The patient completed PD training and began dialyzing at home on or about 8/18/2016, and is currently actively dialyzing at home on PD modality. Review of physician orders showed, "Date: 8-3-16 ... PERITONEAL DIALYSIS STANDING ORDERS ... Peritoneal Equilibrium Test (PET) To be performed: No less then [sic] 30 days after patient has initiated home PD therapy."

Interview with EMP11 on October 2, 2019, at 11:30 a.m. confirmed CR6 has not yet had a PET completed.











Plan of Correction:

1. All Home Training staff will be re-trained by the Home Training Nurse Manager and/or Designee on the facility's "Standard Peritoneal Equilibrium Test (PET)" policy by 10/31/19.

2. All staff will review and sign acknowledgement of understanding of policy. A copy of the acknowledgment will be placed in the facility's education manual.

3. A standard peritoneal equilibrium test will be performed on all new patients admitted to the home program for PD training within 4 to 6 weeks of training and when the prescribed fill volume has been reached. Home Training staff will document on the monthly flowsheet that a (PET) test has been performed on patient.

4. The Home Training Nurse Manager will review all patient records to ensure that a (PET) test has been performed on any patient not meeting adequacy (KTV).

5. A standard peritoneal equilibrium test will be performed on any PD patient that is not currently meeting adequacy (KTV). Home Training staff will document on the monthly flowsheet that a (PET) test has been performed on patient.

6. Initially, Home Training Nurse Manager and/or Designee will audit treatment flowsheets monthly for (4) four months to ensure that staff is following policy standards and to ensure that staff is performing (PET) test per policy. If standards are met, the treatment flowsheets will be audited quarterly. If standards are met, the treatment flowsheets will be audited semi-annually. The audit results will be reviewed at monthly QAPI meetings.



494.100 STANDARD
H-IDT RESP FOR SERVICES=IN-CENTER PTS

Name - Component - 00
A dialysis facility that is certified to provide services to home patients must ensure through its interdisciplinary team, that home dialysis services are at least equivalent to those provided to in-facility patients and meet all applicable conditions of this part.


Observations:

Based on review of facility policy and procedure, clinical records (CR), and staff (EMP) interview, the facility failed to ensure one (1) of one (1) diabetic peritoneal dialysis (PD) patient (CR6) had home services that were at least equivalent to those provided to in-facility patients.

Findings included:

Review of facility policy and procedure on October 3, 2019, at 10 a.m.:

"PROCEDURE NO: 1001 ... DATE ISSUED: 7/10/18 ... Diabetic Monthly Foot Checks PURPOSE: To identify patients with diabetes who are at risk for foot ulcers and coordinate referrals as needed for early intervention. SUPPORTIVE DATA: Lower extremity complications in persons with diabetes have become an increasingly significant public health concern. These complications beginning with neuropathy and subsequent diabetic foot wounds frequently lead to infection and lower extremity amputation. Almost half of diabetic neuropathy may be asymptomatic underscoring the necessity of regular foot exams. (ADA, 2017) ... POLICY 1. Patients with a known diagnosis of Diabetes will have a monthly physical exam of the feet by a nurse, ... to monitor for skin integrity, and check for infection, while assessing for risk factors for foot ulcers. Monthly exam will include a visual inspection of the feet. ... PROCEDURE 1. Each month, all patients with a known diagnosis of diabetes will have their feet inspected by a nurse." The aforementioned policy and procedure was provided by EMP11 (PD nurse) as PD specific policy, but was not implemented until November 2018, and after PD patient experienced negative outcome (see below for details).

Provided by EMP1 (clinic manager) as in-center specific policy: "DIABETIC FOOT CARE ASSESSMENT PROTOCOL ... EFFECTIVE DATE: 05/11/2015 ... POLICY: A foot assessment of diabetic patients should be done monthly by nursing personnel to monitor for complications. RATIONALE: Patients with infected feet frequently feel no pain because of neuropathy and have no systemic symptoms until late in a neglected course. The principal aim of assessment is to identify patients at risk of bacterial invasion and the possibility of gangrene [death of tissue] amputations. ... DOCUMENT THE ASSESSMENT WAS COMPLETED INCLUDING ANY PROBLEMS IDENTIFIED ON THE PATIENTS [sic] FLOWSHEET."

Review of CR6 on October 2, 2019, at 10:30 a.m. showed patient was admitted to PD on 8/3/2016. The patient completed PD training and began dialyzing at home on or about 8/18/2016. The patient's diagnosis was, "Type 2 Diabetes mellitus w [with] chronic kidney disease." Review of "PERITONEAL DIALYSIS CLINIC VISIT[s]" showed patient was at facility (for labs and/or to see physician) on: 1/19, 2/6, 2/20, 3/6, 4/4, 4/5, 4/16, 5/7, 6/11, 6/14, 7/9, 7/26, 8/14, 8/30, and 9/10/2018. There were no monthly foot checks for the aforementioned time frame. During the next clinic visit on 10/2/2018, the PD nurse documented, "hurt [left] foot - [large] water blister." There were no other clinic visits after 10/2/2018, and patient was admitted to the hospital on 10/25/2018. The following hospital operative reports showed patient had several operations with resultant amputation of his fifth toe (metatarsal). The patient then suffered a below the knee amputation in April 2019. See below for more details.

Review of "DCI PROGRESS NOTES" showed, "Written Dictated: 11/1/18 ... Subject: Update regarding hospital admission ... Pt underwent 3rd surgery on foot today," and "Written/Dictated: 11/28/18 ... Pt was hospitalized late October to late November for foot ulcer that required partial amputation of 5th metatarsal."

Review of "[Hospital] DISCHARGE SUMMARY" showed patient was admitted from 10/25/2018 to 11/9/2018, "Final Diagnosis 1. SEPSIS 2. LEFT FOOT DIABETIC ULCER 3. LEFT 5TH METATARSAL AND CUBOID BONE OSTEOMYELITIS [infection in the bones of the foot] 4. LEFT FOOT CELLULITIS ... 6. DIABETES MELLITUS ... 10. DIABETIC NEUROPATHY." Review of "[Hospital] OPERATIVE REPORT" showed, "DATE OF PROCEDURE: October 24, 2018 ... PROCEDURE: ... proximal half of fifth metatarsal resected [removed]," "[Hospital] OPERATIVE REPORT ... PROCEDURE DATE: 10/26/2018 ... POSTOPERATIVE DIAGNOSIS: Necrotizing fasciitis [infection that destroys human tissue/flesh] grade 4 diabetic foot infection fifth left lateral. ... PROCEDURE: ... Attention was then directed to the left fifth metatarsal where an excessive amount of necrotic [dead] tissue with foul odor was noted. ... The fifth metatarsal was necrotic ... The majority from the base to at least mid-shaft of the metatarsal was removed in toto [overall]," "[Hospital] OPERATIVE REPORT DATE OF PROCEDURE: October 28, 2018. ... POST OPERATIVE DIAGNOSIS: 1. Diabetic foot infection with gas gangrene of the left foot. 2. Osteomyelitis of the left foot fifth metatarsal. PROCEDURE PERFORMED: Irrigation, drainage and debridement of left foot infection with debridement of soft tissue, muscle, bone and application of wound vac all on the left foot ... He is still at great risk for losing more of his left foot," and "[Hospital] OPERATIVE REPORT ... DATE OF PROCEDURE: November 1, 2018 ... SPECIMEN: The fifth digit as well as remaining fifth metatarsal was removed [amputated] and sent to Pathology and for culture."

During an interview with EMP11 on October 2, 2019, at 10:30 a.m. he/she confirmed no monthly foot checks documented for above time frame, and no policy and procedure that applied to it (only for in-center). Surveyor requested more information about CR6 to include when patient's wound was first identified, and the reason why no foot checks were completed by PD nursing staff. Note: facility maintains separate home modality policy and procedure manual.

Review of additional information from EMP11 on October 3, 2019, at 9:30 a.m. showed the documents contained handwritten note from EMP11, "The policy [for] monthly foot [checks] on diabetic PD pts [patients] was not in place prior to the adoption of the new P+P [policy and procedure] manual 11/18." The information provided was reviewed, and the findings are included in the above clinical record (CR6) review.

Interview with EMP1 (clinic manager) on October 3, 2019, at 1:42 a.m. confirmed findings. EMP1 confirmed no monthly foot checks completed for the months prior to patient's first amputation of his fifth metatarsal. EMP1 confirmed policy and procedure provided by him/her was in-center specific.






Plan of Correction:

1. All Home Training staff will be re-trained by the Home Training Nurse Manager and/or Designee on the facility's "Diabetic Monthly Foot Checks" policy and the "Diabetic Foot Care Assessment" protocol by 10/31/19.

2. All staff will review and sign acknowledgement of understanding of policy and protocol. A copy of the acknowledgment will be placed in the facility's education manual.

3. All Home Training staff will document on the monthly flowsheet that a foot assessment has been performed per policy for all diabetic patients.

4. Initially, Home Training Nurse Manager and/or Designee will audit treatment flowsheets monthly for (4) four months to ensure that staff is following policy standards and to ensure that staff is performing a foot assessment of diabetic patients monthly. If standards are met, the treatment flowsheets will be audited quarterly. If standards are met, the treatment flowsheets will be audited semi-annually. The audit results will be reviewed at monthly QAPI meetings.