QA Investigation Results

Pennsylvania Department of Health
FRESENIUS MEDICAL CARE PENN HILLS
Health Inspection Results
FRESENIUS MEDICAL CARE PENN HILLS
Health Inspection Results For:


There are  7 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 August 4, 2017, Fresenius Medical Care Penn Hills was found not to be in compliance with the following requirement(s) 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, observations, and staff (EMP) interview, the facility failed to ensure patients performed hand hygiene after glove removal for three (3) of three (3) observations of patients holding their access sites (fistulas) with a gloved hand to stop bleeding (OBS5.1, OBS5.2, and OBS5.3).

Findings included:

Review of facility policy on August 1, 2017, at 9:30 a.m. showed, "Post Treatment Fistula Needle Removal .... FMS-CS-HT-II-320-025C ... Effective date 28-JAN-2015 ... Needle removal ... If patient is able to hold pressure on the site, assist patient in gloving hand. ... Patient, staff and/or care partner must wash hands following glove removal."

Observation (OBS5.1) of discontinuation of dialysis with an AV (arteriovenous) fistula on July 31, 2017, at 1:30 p.m. at station 6 revealed EMP6 remove needles from the patient's arm. EMP6 then applied gauze dressing and tape to both sites. The patient held pressure to his access site dressings with a gloved right hand. After the patient noted that bleeding had stopped he removed pressure from his needle sites. The patient then removed the glove from his right hand, and without performing hand hygiene left the treatment floor.

Interview with EMP6 after the observation on July 31, 2017, at 1:50 p.m. confirmed that patient did not perform hand hygiene after glove removal.

Observation (OBS5.2) of discontinuation of dialysis with an AV fistula on July 31, 2017, at 2:45 p.m. at station 12 revealed EMP3 remove needles from the patient's arm. EMP3 then applied gauze dressings and tape to both sites. The patient held pressure to his access site dressings with a gloved right hand. Once bleeding had stopped the patient removed pressure from access sites dressings. The patient then removed glove from right hand, and without performing hand hygiene vacated the station and left the treatment floor.

Interview with EMP3 after the observation on July 31, 2017, at 3:00 p.m. confirmed above findings.

Observation (OBS5.3) of discontinuation of dialysis with an AV fistula on August 1, 2017, at 2:30 p.m. at station 12 revealed the patient holding pressure to his access site dressings with a gloved right hand. Once the patient noted that bleeding had stopped EMP7 applied more tape to the patients gauze dressings. The patient then removed the glove from his right hand and exited the treatment floor.

Interview with EMP7 after the observation on August 1, 2017, at 2:45 p.m. confirmed that patient did not perform hand hygiene after glove removal and noted, "I have never heard of that."



Plan of Correction:

By 8/25/2017 a Poster will be placed in the lobby to remind and encourage patient compliance with Hand Hygiene.
By 8/28/2017 the Education Coordinator (EC) will re-educate all the direct patient care (DPC) staff on the following policies and procedure:
- FMS-CS-HT-II- 320-025C, Post Treatment Fistula Needle Removal Procedure.
- FMS-CS-IC-I-101-007A, Patient Education Policy
-FMS-CS-IC-II-155-090A, Hand Hygiene Policy
By 9/8/2017 all Patients will be re-educated on the above listed policies and procedures and all documentation will be present in the patients' medical record.
Emphasis will be placed on patients performing hand hygiene immediately after glove removal and following holding pressure on access sites. Additional Emphasis was placed on patient required education, documentation of education completion, monitoring and strategies for patient compliance attempted.
For ongoing compliance, the Clinic Manager (CM) or designee will complete daily audits for 2 weeks. If compliance is observed the audits will then be completed twice a week for 2 weeks. At that time if compliance is sustained the audits will be completed monthly following the Quality Assurance Improvement (QAI) auditing schedule. A Plan of Correction (POC) specific auditing tool will be used for the audit.
Any patients found to be non-compliant following reeducation, will have their physician made aware to assist with education and next steps to improve compliance.
Results of the audit will be summarized by the CM who will report the audit results at the monthly QAI meetings for ongoing guidance and sustained compliance.
Long Term Compliance regarding Patient hand hygiene will be monitored by the Clinical Manager or designee thru the use of the QAI clinical Practice Audit tool at the frequency dictated by the QAI Calendar.
All training documentation, Governing Body Minutes, and QAI Minutes will be available for review at the facility.



494.60(d)(1) STANDARD
PE-NURS STAFF TRAINED IN ER EQUIP & MEDS

Name - Component - 00
Staff training must be provided and evaluated at least annually and include the following:
(iii) Ensuring that nursing staff are properly trained in the use of emergency equipment and emergency drugs.


Observations:

Based on review of facility policy, governing body meeting minutes, observation and staff (EMP) interview, the facility failed to ensure two (2) of two (2) registered nurses interviewed were familiar with emergency procedures and medications (EMP1, and EMP8).

Findings included:

Flash tour observation on July 31, 2017, at 10:53 a.m. revealed that the facility had the emergency medications benadryl (a medication for allergic reactions) and dextrose (a medication for low blood sugar) on the treatment floor and available for use. During observation surveyor specifically asked EMP1 what medications the facility kept to treat anaphylaxis (severe allergic reaction) and he/she noted that the facility only had benadryl available to treat anaphylaxis.

Review of facility policy on August 4, 2017, at 9:38 a.m., "Complications of Hemodialysis - Management and Prevention of Allergic Reaction/Anaphylaxis ... FMS-CS-IC-II-125-015A ... Effective Date 03-OCT-2012 ... The following steps should be followed to treat a suspected allergic or anaphylactic reactions: 1. Notify the R.N. ... 3. Notify the physician to obtain orders for intervention. Note: the most common medications given are diphenhydramine [benadryl] (for mild reactions), or epinephrine subcutaneously and solumedrol IV for severe reaction."

Review of facility policy on August 4, 2017, at 9:58 a.m. showed, "Emergency Medications, Equipment and Supplies ... FMS-CS-IC-II-130-007A ... Effective Date 28-JAN-2015 ... PURPOSE The purpose of this policy is to provide guidelines for staff when determining and maintaining emergency equipment and supplies. ... Policy Emergency supplies are maintained at this dialysis facility for use in life threatening circumstances such as cardiac and respiratory arrest. The following minimum emergency supplies and equipment must be on the premises at all times, ... and immediately available: ... Emergency medications ... It is the responsibility of the Medical Director in conjunction with the Governing Body and medical staff to determine the medications and equipment that are to be kept in an emergency cart/box ... Emergency Medications ... The Pharmacy and Therapeutics Committee and the Medical Advisory Board identified a reasonable selection of medications to manage emergency situations such as allergic reactions, hypoglycemia, and cardiac arrest pending arrival of EMS when the physician is present or under the direct order of a physician. The medications and recommended quantities include: Sodium Bicarbonate 8.4% 50ml [milliliter] syringe or Sodium Bicarbonate 50ml vial plus syringe quantity 2 ... Calcium Chloride 10% 10ml prefilled syringe quantity 2 ... Epinephrine 10cc 1:10000 quantity 2 ... Atropine 10ml=1mg prefilled syringes or Atropine 5ml=0.5mg prefilled syringe."

During interview with EMP8 (registered nurse) on August 4, 2017, at 10:25 a.m. he/she confirmed that the facility only had benadryl available to treat anaphylaxis.

On August 4, 2017, at 11:50 a.m. surveyor asked EMP1 (clinic manager/registered nurse) and EMP10 (administrator and governing body member) to clarify emergency medications to be kept at the facility per the medical director or in accordance with facility policy.

Review of governing body meeting minutes on August 4, 2017, at 12:00 p.m., revealed no list of approved emergency medications.

On August 4, 2017, at 12:05 p.m. EMP10 reviewed the governing body meeting minutes and noted that the emergency medication list was approved during the 1/19/17 governing body meeting but at this time he/she was unable to locate an approved list of emergency medications, "The doctors pick what medications they want ... it is usually up to them", "was done this year [2017] and [EMP1] is looking for a list of medications [medical director (EMP9)] picked."

On August 4, 2017, at 12:10 p.m. EMP1 noted, "Some of the medications we had in our box we have gotten away from."

On August 4, 2017, at 12:15 p.m. EMP1 brought surveyor a bag of medications containing epinephrine ampules and vials of solumedrol (both medications can be used to treat allergic reactions). EMP1 confirmed he/she was not aware that clinic had them onsite.

On August 4, 2017, at 12:30 p.m. EMP1 confirmed he/she could not find a list of emergency medications approved by the medical director.

During another interview with EMP8 on August 4, 2017, at 12:30 p.m. surveyor showed him/her the bag of epinephrine and solumedrol provided by EMP1 and asked about the use of the medications and he/she noted , "We can't use epinephrine or solumedrol unless a physician is present."

Note: facility policy allows for the administration of epinephrine and solumedrol for severe allergic reactions without a physician physically present.

During phone interview with the facility medical director (EMP9) on August 4, 2017, at 1:00 p.m. surveyor asked him/her what emergency medications he/she approved to be kept in the facility and he/she noted that the crash cart would contain the emergency medications benadryl and glucose (a medication for low blood sugar). Surveyor then asked him/her when he/she approved the medications to be kept on hand at the clinic, "Since we started ... about three years ago." When surveyor asked if any other medications were to be kept on hand he/she said, "epinephrine ... probably also have bicarbonate and calcium." When asked if the facility had an EpiPen available for use at the clinic EMP9 stated, "Yes." When surveyor told him/her there was no EpiPen on site at facility EMP9 replied, "Hmm." Surveyor then read the list of medications to be kept on hand per facility policy and he/she replied, "I wasn't aware of that." EMP9 confirmed no approved list by him/her for emergency medications.

Interview with EMP1 on August 4, 2017, at 1:30 p.m. confirmed facility had no sodium bicarbonate, calcium chloride immediately available for use per facility policy and medical director interview; and the facility had no epinephrine 1:10000, or atropine immediately available for use per facility policy.



Plan of Correction:

By 8/31/2017 a Governing Body Meeting will be held to review: FMS-CS-IC-II-130-007A, Emergency Medication, Equipment & Supplies Policy, FMS-CS-IC-II-125-015A, Anaphylaxis Policy, FMS-CS-IC-II-130-007D1, FMC Recommended Medication checklist with the Medical Director and confirm a list of Medications approved to be available for emergency use.
By 9/8/2017 the Education Coordinator (EC) will re-educate all the direct patient care (DPC) staff on:
- FMS-CS-IC-II-125-015A, Anaphylaxis Policy
-FMS-CS-IC-II-130-007A, Emergency Medication, Equipment & Supplies Policy
- Developed Medical Director approved check list of Emergency Medications
Emphasis will be placed on knowledge of Clinic Emergency Medications, Equipment and supplies available. Additional emphasis was placed on the facility approved list of emergency medications and monthly review of all medication expiration dates.
The Clinical Manager or designee will develop a checklist of the Medical Director approved Emergency Medications, compliance will be monitored monthly and all findings will be summarized and reviewed in the QAI Meeting for ongoing guidance and sustained compliance.
Staff found to be non-compliant will be referred for reeducation and counseling.
All training documentation, Governing Body Minutes, and QAI Minutes will be available for review at the facility.



494.60(d)(3) STANDARD
PE-ER EQUIP ON PREMISES-02, AED, SUCTION

Name - Component - 00
Emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, must be on the premises at all times and immediately available.


Observations:

Based on review of facility policy, governing body meeting minutes, observation and staff (EMP) interview, the facility failed to ensure four (4) of eight (8) emergency medications were immediately available for use in accordance with facility policy.

Findings included:

Flash tour observation on July 31, 2017, at 10:53 a.m. revealed that the facility had the emergency medications benadryl (a medication for allergic reactions) and dextrose (a medication for low blood sugar) on the treatment floor and available for use. During observation surveyor specifically asked EMP1 what medications the facility kept to treat anaphylaxis (severe allergic reaction) and he/she noted that the facility only had benadryl available to treat anaphylaxis.

Review of facility policy on August 4, 2017, at 9:38 a.m., "Complications of Hemodialysis - Management and Prevention of Allergic Reaction/Anaphylaxis ... FMS-CS-IC-II-125-015A ... Effective Date 03-OCT-2012 ... The following steps should be followed to treat a suspected allergic or anaphylactic reactions: 1. Notify the R.N. ... 3. Notify the physician to obtain orders for intervention. Note: the most common medications given are diphenhydramine [benadryl] (for mild reactions), or epinephrine subcutaneously and solumedrol IV for severe reaction."

Review of facility policy on August 4, 2017, at 9:58 a.m. showed, "Emergency Medications, Equipment and Supplies ... FMS-CS-IC-II-130-007A ... Effective Date 28-JAN-2015 ... PURPOSE The purpose of this policy is to provide guidelines for staff when determining and maintaining emergency equipment and supplies. ... Policy Emergency supplies are maintained at this dialysis facility for use in life threatening circumstances such as cardiac and respiratory arrest. The following minimum emergency supplies and equipment must be on the premises at all times, ... and immediately available: ... Emergency medications ... It is the responsibility of the Medical Director in conjunction with the Governing Body and medical staff to determine the medications and equipment that are to be kept in an emergency cart/box ... Emergency Medications ... The Pharmacy and Therapeutics Committee and the Medical Advisory Board identified a reasonable selection of medications to manage emergency situations such as allergic reactions, hypoglycemia, and cardiac arrest pending arrival of EMS when the physician is present or under the direct order of a physician. The medications and recommended quantities include: Sodium Bicarbonate 8.4% 50ml [milliliter] syringe or Sodium Bicarbonate 50ml vial plus syringe quantity 2 ... Calcium Chloride 10% 10ml prefilled syringe quantity 2 ... Epinephrine 10cc 1:10000 quantity 2 ... Atropine 10ml=1mg prefilled syringes or Atropine 5ml=0.5mg prefilled syringe."

During interview with EMP8 (registered nurse) on August 4, 2017, at 10:25 a.m. he/she confirmed that the facility only had Benadryl available to treat anaphylaxis.

On August 4, 2017, at 11:50 a.m. surveyor asked EMP1 (clinic manager) and EMP10 (administrator and governing body member) to clarify emergency medications to be kept at the facility per the medical director or in accordance with facility policy.

Review of governing body meeting minutes on August 4, 2017, at 12:00 p.m., revealed no list of approved emergency medications.

On August 4, 2017, at 12:05 p.m. EMP10 reviewed the governing body meeting minutes and noted that the emergency medication list was approved during the 1/19/17 governing body meeting but at this time he/she was unable to locate an approved list of emergency medications, "The doctors pick what medications they want ... it is usually up to them", "was done this year [2017] and [EMP1] is looking for a list of medications [medical director (EMP9)] picked."

On August 4, 2017, at 12:10 p.m. EMP1 noted, "Some of the medications we had in our box we have gotten away from."

On August 4, 2017, at 12:15 p.m. EMP1 brought surveyor a bag of medications containing epinephrine ampules and vials of solumedrol (both medications can be used to treat allergic reactions). EMP1 confirmed he/she was not aware that clinic had them onsite.

On August 4, 2017, at 12:30 p.m. EMP1 confirmed he/she could not find a list of emergency medications approved by the medical director.

During phone interview with the facility medical director (EMP9) on August 4, 2017, at 1:00 p.m. surveyor asked him/her what emergency medications he/she approved to be kept in the facility and he/she noted that the crash cart would contain the emergency medications benadryl and glucose (a medication for low blood sugar). Surveyor then asked him/her when he/she approved the medications to be kept on hand at the clinic, "Since we started ... about three years ago." When surveyor asked if any other medications were to be kept on hand he/she said, " epinephrine ... probably also have bicarbonate and calcium." When asked if the facility had an EpiPen available for use at the clinic EMP9 stated, "Yes." When surveyor told him/her there was no EpiPen on site at facility EMP9 replied, "Hmm." Surveyor then read the list of medications to be kept on hand per facility policy and he/she replied, "I wasn't aware of that." EMP9 confirmed no approved list by him/her for emergency medications.

Interview with EMP1 on August 4, 2017, at 1:30 p.m. confirmed facility had no sodium bicarbonate, calcium chloride immediately available for use per facility policy and medical director interview; and the facility had no epinephrine 1:10000, or atropine immediately available for use per facility policy.



Plan of Correction:

By 8/31/2017 a Governing Body Meeting will be held to review the following policies: FMS-CS-IC-II-130-007A, Emergency Medication, Equipment & Supplies Policy, FMS-CS-IC-II-125-015A, Anaphylaxis Policy, FMS-CS-IC-II-130-007D1, FMC Recommended Medication Checklist with the Medical Director and confirm a list of Medications approved by the Medical Director to be available for emergency use.
By 9/8/2017 the Clinical Manager (CM) or the Education Coordinator (EC) will educate all the Direct Patient Care (DPC) staff on the Medical Director approved list of Emergency Medications discussed in the Governing Body Meeting, its location, and maintenance and the following policies:
- FMS-CS-IC-II-125-015A, Anaphylaxis Policy
-FMS-CSIC-II-130-007A, Emergency Medication, Equipment & Supplies Policy
-Developed Medical Director approved check list of Emergency Medications
Emphasis will be placed on Emergency Medication, Equipment and supplies Policy, and the Medical Director approved Medications for use. Additional emphasis was placed on the location of the list and expiration dates and medication reordering prior to expiration.
The Clinical Manager (CM) or Designee will develop a checklist of the Medical Director approved Emergency Medications, compliance will be monitored monthly use a Plan of Correction specific audit Tool. All findings will be summarized and reviewed in the QAI Meetings for immediate and ongoing guidance and sustained compliance.
Staff found to be non-compliant will be referred for reeducation and counseling.
All training documentation, Governing Body Minutes, and QAI Minutes will be available for review at the facility.



494.90(a)(5) STANDARD
POC-VASCULAR ACCESS-MONITOR/REFERRALS

Name - Component - 00
The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement.


Observations:


Based on review of facility policy and procedure, observation (OBS) and staff (EMP) interview, the facility failed to evaluate vascular access sites to ensure hemostasis was achieved, and failed to apply clean bandage/gauze/tape to the site after dialysis treatment for two (2) of three (3) observations of discontinuation of dialysis with an arteriovenous fistula (AVF) (OBS5.1 & OBS5.3).

Findings included:

Review of facility policy and procedure on August 1, 2017, at 9:30 a.m. showed, "Post Treatment Fistula Needle Removal .... FMS-CS-HT-II-320-025C ... Effective date 28-JAN-2015 ... Fold gauze ... Position gauze over insertion site ... remove needle ... compress the needle exit site with two fingers. ... Apply pressure continuously for 10 minutes before checking hemostasis [bleeding has stopped]. 8. Once hemostasis is achieved: Remove gauze. ... Place Band-Aide, adhesive dressing or gauze dressing secured with clean tape."

Observation (OBS5.1) of discontinuation of dialysis with an AV (arteriovenous) fistula on July 31, 2017, at 1:30 p.m. at station 6 revealed EMP6 remove needles from the patient's arm. EMP6 applied gauze dressing and tape to both sites. The patient held pressure to his sites with a gloved hand. After the patient noted that bleeding had stopped he removed pressure from sites and EMP6 covered the patient's access sites bandages with more tape. The patient then left the treatment floor. EMP6 did not remove gauze and apply Band-Aide, adhesive dressing or gauze dressing.

Interview with EMP6 after the observation on July 31, 2017, at 1:50 p.m. confirmed that he/she did not change the patient's original gauze dressings nor did he/she visualize the patient's access in order to determine if bleeding had stopped.

Observation (OBS5.3) of discontinuation of dialysis with an AV fistula on August 1, 2017, at 2:30 p.m. at station 12 revealed the patient holding pressure to his access sites with a gloved right hand. Once the patient noted that bleeding had stopped EMP7 applied more tape to the patients gauze dressings. The patient then left the treatment floor. EMP7 did not remove gauze and apply Band-Aide, adhesive dressing or gauze dressing.

Interview with EMP7 after the observation on August 1, 2017, at 2:45 p.m. confirmed that he/she removed the patient's needles and applied tape and gauze over the patient's needle sites. EMP7 confirmed he/she did not check to make sure bleeding has stopped, and did not remove gauze and apply Band-Aide, adhesive dressing or gauze dressing.



Plan of Correction:

By 9/8/2017 the Education Coordinator (EC) will re-educate all the Direct Patient Care (DPC) staff on the following Procedure:
- FMS-CS-HT-II- 320-025C, Post Treatment Fistula Needle Removal Procedure
Emphasis will be placed on direct visual evaluation of the site to ensure hemostasis was achieved. Additional emphasis was placed on strict adherence to following policy prior to discharge on cannulation site dressings.
For ongoing compliance, the Clinic Manager (CM) or designee will complete daily audits for 2 weeks. If compliance is observed the audits will then be completed twice a week for 2 weeks. At that time if compliance is sustained the audits will be completed monthly following the Quality Assurance Improvement (QAI) auditing schedule. A plan of correction (POC) specific auditing tool will be used for the audit.
Staff found to be non-compliant will be referred for reeducation and counseling.
Results of the audit will be summarized by the CM who will report the audit results at the monthly QAI meetings for ongoing guidance and sustained compliance.
All training documentation, and QAI Minutes will be available for review at the facility.



494.90(d) STANDARD
POC-PT/FAMILY EDUCATION & TRAINING

Name - Component - 00
The patient care plan must include, as applicable, education and training for patients and family members or caregivers or both, in aspects of the dialysis experience, dialysis management, infection prevention and personal care, home dialysis and self-care, quality of life, rehabilitation, transplantation, and the benefits and risks of various vascular access types.


Observations:


Based on review of facility policy and procedure, clinical records (CR) and observation, and staff (EMP) interview, the facility failed to ensure two (2) of two (2) patients observed holding their access sites with gloved hands to stop bleeding, and who were admitted to the facility for more than 120 days, were provided infection control training upon admission and annually thereafter (CR5, and CR10).

Findings:

Review of facility policy on August 1, 2017, at 9:30 a.m. showed, "Post Treatment Fistula Needle Removal .... FMS-CS-HT-II-320-025C ... Effective date 28-JAN-2015 ... Needle removal ... If patient is able to hold pressure on the site, assist patient in gloving hand. ... Patient, staff and/or care partner must wash hands following glove removal."

Review of facility policy on August 2, 2017, at 1:30 p.m. showed, "FMS-CS-IC-I-110-125A ... Effective Date 04-Jul-2012 ... Comprehensive Interdisciplinary Assessment and Plan of Care ... Plan of Care Components ... The patient's individualized Plan of Care must include, but is not limited to the following: ... Patient Education and Training ... Include education and training for patients ... Include the following education and training: ... infection prevention and personal care."

Review of facility policy on August 2, 2017, at 1:35 p.m. showed, "Patient Education ... FMS-CS-IC-I-101-007A ... EDUCATING ALL PATIENTS ... Patient Education Steps ... 6. Document education of topics delivered ... Document Patient Education ... Patient education must be documented in the Patient's Medical Record as follows: New Patients-Education should be documented in the Education Record for New Patients ... Existing Patients-Education to be documented in the progress notes and/or Plan of care. ... All of the topics should be taught within the first 120 days. ... Topics Related to Infection Control ... Patients shall be trained and educated on infection control practices: ... Upon admission to the dialysis unit ... At least annually thereafter ... Patients shall be trained on the following topics: Personal hygiene and hand washing techniques."

Observation (OBS5.2) of discontinuation of dialysis with an AV fistula on July 31, 2017, at 2:45 p.m. at station 12 revealed EMP3 remove needles from the patient's (CR5) arm. EMP3 then applied gauze dressings and tape to both sites. The patient held pressure to his access site dressings with a gloved right hand. Once bleeding had stopped the patient removed pressure from access site dressings. The patient then removed glove from right hand, and without performing hand hygiene vacated the station and left the treatment floor.

Interview with EMP3 after the observation on July 31, 2017, at 3:00 p.m. confirmed above findings.

Observation (OBS5.3) of discontinuation of dialysis with an AV fistula on August 1, 2017, at 2:30 p.m. at station 12 revealed the patient (CR10) holding pressure to his access site dressings with a gloved right hand. Once the patient noted that bleeding had stopped EMP7 applied more tape to the patient's gauze dressings. The patient then removed the glove from his right hand and exited the treatment floor.

Interview with EMP7 after the observation on August 1, 2017, at 2:45 p.m. confirmed that patient did not perform hand hygiene after glove removal and noted, "I have never heard of that."

Review of CR5 on August 2, 2017, at 12:12 p.m. revealed patient was admitted to the facility on 10/9/15. CR5 did not contain initial or annual education for infection control.

Review of CR10 on August 2, 2017, at 1:03 p.m. revealed patient was admitted to the clinic on 10/17/09. CR10 did not contain initial or annual education for infection control.

Interview with EMP1 on August 2, 2017, at 1:58 p.m. confirmed the above findings.



Plan of Correction:

By 9/8/2017 the Education Coordinator (EC) will re-educate all the direct patient care (DPC) staff on the following Policies and Procedure:
- FMS-CS-HT-II- 320-025C, Post Treatment Fistula Needle Removal Procedure.
- FMS-CS-IC-I-101-007A, Patient Education Policy
-FMS-CS-IC-II-155-090A, Hand Hygiene Policy
-FMS-CS-IC-I-110-125A, Comprehensive Interdisciplinary Assessment and Plan of Care Policy
Emphasis will be placed on Comprehensive Interdisciplinary Assessment and Plan of Care Policy requirements in regards to documentation in the patient medical record, specifically related to infection prevention and personal care. Additional Emphasis was placed on the requirement to complete patient education according to policy within 120 days of admission and annual thereafter on all topics identified by policy at minimum ensuring all supportive documentation is present.
For ongoing compliance, the Clinic Manager (CM) or designee will complete daily audits for 2 weeks. If compliance is observed the audits will then be completed twice a week for 2 weeks. At that time if compliance is sustained the audits will be completed monthly following the Quality Assurance Improvement (QAI) auditing schedule. A plan of correction (POC) specific auditing tool will be used for the audit.
Staff found to be non-compliant will be referred for reeducation and counseling.
Results of the audit will be summarized by the CM who will report the audit results at the monthly QAI meetings for ongoing guidance and sustained compliance.
All training documentation, and QAI Minutes will be available for review at the facility.



494.150(c)(1) STANDARD
MD RESP-DEVELOP, REVIEW & APPROVE P&P

Name - Component - 00
The medical director must-
(1) Participate in the development, periodic review and approval of a "patient care policies and procedures manual" for the facility;



Observations:

Based on review of policy, governing body meeting minutes, observation and staff (EMP) interview, the medical director failed to participate in the development of a facility specific emergency medication policy that reflected current facility practice.

Findings included:

Flash tour observation on July 31, 2017, at 10:53 a.m. revealed that the facility had the emergency medications benadryl (a medication for allergic reactions) and dextrose (a medication for low blood sugar) on the treatment floor and available for use. During observation surveyor specifically asked EMP1 what medications the facility kept to treat anaphylaxis (severe allergic reaction) and he/she noted that the facility only had benadryl available to treat anaphylaxis.

Review of facility policy on August 4, 2017, at 9:38 a.m., "Complications of Hemodialysis - Management and Prevention of Allergic Reaction/Anaphylaxis ... FMS-CS-IC-II-125-015A ... Effective Date 03-OCT-2012 ... The following steps should be followed to treat a suspected allergic or anaphylactic reactions: 1. Notify the R.N. ... 3. Notify the physician to obtain orders for intervention. Note: the most common medications given are diphenhydramine [benadryl] (for mild reactions), or epinephrine subcutaneously and solumedrol IV for severe reaction."

Review of facility policy on August 4, 2017, at 9:58 a.m. showed, "Emergency Medications, Equipment and Supplies ... FMS-CS-IC-II-130-007A ... Effective Date 28-JAN-2015 ... PURPOSE The purpose of this policy is to provide guidelines for staff when determining and maintaining emergency equipment and supplies. ... Policy Emergency supplies are maintained at this dialysis facility for use in life threatening circumstances such as cardiac and respiratory arrest. The following minimum emergency supplies and equipment must be on the premises at all times, ... and immediately available: ... Emergency medications ... It is the responsibility of the Medical Director in conjunction with the Governing Body and medical staff to determine the medications and equipment that are to be kept in an emergency cart/box ... Emergency Medications ... The Pharmacy and Therapeutics Committee and the Medical Advisory Board identified a reasonable selection of medications to manage emergency situations such as allergic reactions, hypoglycemia, and cardiac arrest pending arrival of EMS when the physician is present or under the direct order of a physician. The medications and recommended quantities include: Sodium Bicarbonate 8.4% 50ml [milliliter] syringe or Sodium Bicarbonate 50ml vial plus syringe quantity 2 ... Calcium Chloride 10% 10ml prefilled syringe quantity 2 ... Epinephrine 10cc 1:10000 quantity 2 ... Atropine 10ml=1mg prefilled syringes or Atropine 5ml=0.5mg prefilled syringe."

During interview with EMP8 (registered nurse) on August 4, 2017, at 10:25 a.m. he/she confirmed that the facility only had benadryl available to treat anaphylaxis.

On August 4, 2017, at 11:50 a.m. surveyor asked EMP1 and EMP10 to clarify emergency medications to be kept at the facility per the medical director or in accordance with facility policy.

Review of governing body meeting minutes on August 4, 2017, at 12:00 p.m., revealed no list of approved emergency medications. Further review of governing body meeting minutes revealed, "NOTICE OF ADOPTION BY THE GOVERNING BODY ... The Policies and procedures in this Governing Body Manual have been approved and adopted by the facility Governing body. ... Executed this 19th day of January, 2017." Review of governing body meeting minutes for 1/19/2017 revealed that EMP1 (clinic manager/registered nurse) EMP9 (medical director), and EMP10 (administrator) were in attendance. "The following Policies and Procedures Manuals as revised through 1/19/17 are approved as the current updated and effective manuals: ... Policies and Procedure Manual: ... emergency medication procedure are reviewed and approved. ... The facility specific ... emergency medication procedure are reviewed and approved for the current calendar year."

On August 4, 2017, at 12:05 p.m. EMP10 reviewed the governing body meeting minutes and noted that the emergency medication list was approved during the 1/19/17 governing body meeting but at this time he/she was unable to locate an approved list of emergency medications, "The doctors pick what medications they want ... it is usually up to them", "was done this year [2017] and [EMP1] is looking for a list of medications [medical director (EMP9)] picked."

On August 4, 2017, at 12:10 p.m. EMP1 noted, "Some of the medications we had in our box we have gotten away from."

On August 4, 2017, at 12:15 p.m. EMP1 brought surveyor a bag of medications containing epinephrine ampules and vials of solumedrol (both medications can be used to treat allergic reactions). EMP1 confirmed he/she was not aware that clinic had them onsite.

On August 4, 2017, at 12:30 p.m. EMP1 confirmed he/she could not find a list of emergency medications approved by the medical director.

During another interview with EMP8 on August 4, 2017, at 12:30 p.m. surveyor showed him/her the bag of epinephrine and solumedrol provided by EMP1 and asked about the use of the medications and he/she noted, "We can't use epinephrine or solumedrol unless a physician is present." Note: facility policy allow for the administration of epinephrine and solumedrol for severe allergic reactions without a physician physically present.

During phone interview with the facility medical director on August 4, 2017, at 1:00 p.m. surveyor asked him/her what emergency medications he/she approved to be kept in the facility and he/she noted that the crash cart would contain the emergency medications benadryl and glucose (a medication for low blood sugar). Surveyor then asked him/her when he/she approved the medications to be kept on hand at the clinic, "Since we started ... about three years ago." When surveyor asked if any other medications were to be kept on hand he/she said, " epinephrine ... probably also have bicarbonate and calcium." When asked if the facility had an EpiPen available for use at the clinic EMP9 stated, "Yes." When surveyor told him/her there was no EpiPen on site at facility EMP9 replied, "Hmm." Surveyor then read the list of medications to be kept on hand per facility policy and he/she replied, "I wasn't aware of that." EMP9 confirmed no approved list by him/her for emergency medications.

Interview with EMP1 on August 4, 2017, at 1:30 p.m. confirmed facility had no sodium bicarbonate, calcium chloride immediately available for use per facility policy and medical director interview; and the facility had no epinephrine 1:10000, or atropine immediately available for use per facility policy.



Plan of Correction:

By 8/31/2017 the Director of Operations (DO) and the Clinical Manager (CM) will have a Governing Body Meeting with the Medical Director to discuss Medical Director Responsibilities as defined in the Conditions for Coverage.
In the Meeting emphasis will be placed on the Medical Director responsibilities to clearly identify drugs that will be available in the facility for emergency use and ensure that the Registered Nursing (RN) staff are aware of the medication adopted by the GB for emergency use and the location where the medications will be stored.
In addition the DO and CM will review with the Medical Director the following policies:
- FMS-CS-IC-II-125-015A, Anaphylaxis Policy
-FMS-CSIC-II-130-007A, Emergency Medication, Equipment & Supplies Policy
-Developed Medical Director approved check list of Emergency Medications
The CM or designee will perform monthly audits the emergency cart following the QAI calendar.

Staff found to be non-compliant will be referred for counseling and progressive discipline.

The CM will review the audits and report the findings to the QAI Committee at the monthly meeting. The QAI committee will report the audit results to the GB monthly for further guidance and sustained oversight.
All training documentation, QAI Minutes, and Governing Body Minutes will be available for review at the facility.