QA Investigation Results

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


There are  10 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 on October 24, 2019, Dialysis Clinic, Inc. - Beaver was found to have the following standard level deficiency that was determined to be in substantial compliance with the following requirement 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)(2) STANDARD
EP Testing Requirements

Name - Component - 00
416.54(d)(2), 418.113(d)(2), 441.184(d)(2), 460.84(d)(2), 482.15(d)(2), 483.73(d)(2), 483.475(d)(2), 484.102(d)(2), 485.68(d)(2), 485.625(d)(2), 485.727(d)(2), 485.920(d)(2), 491.12(d)(2), 494.62(d)(2).

*[For ASCs at 416.54, CORFs at 485.68, OPO, "Organizations" under 485.727, CMHCs at 485.920, RHCs/FQHCs at 491.12, and ESRD Facilities at 494.62]:

(2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following:

(i) Participate in a full-scale exercise that is community-based every 2 years; or
(A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or
(B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event.
(ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed.

*[For Hospices at 418.113(d):]
(2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following:
(i) Participate in a full-scale exercise that is community based every 2 years; or
(A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or
(B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or a facility based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.

(3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following:
(i) Participate in an annual full-scale exercise that is community-based; or
(A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or
(B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an additional annual exercise that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or a facility based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed.


*[For PRFTs at 441.184(d), Hospitals at 482.15(d), CAHs at 485.625(d):]
(2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following:
(i) Participate in an annual full-scale exercise that is community-based; or
(A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or
(B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed.

*[For PACE at 460.84(d):]
(2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following:
(i) Participate in an annual full-scale exercise that is community-based; or
(A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or
(B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed.

*[For LTC Facilities at 483.73(d):]
(2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following:
(i) Participate in an annual full-scale exercise that is community-based; or
(A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise.
(B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an additional annual exercise that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed.

*[For ICF/IIDs at 483.475(d)]:
(2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following:
(i) Participate in an annual full-scale exercise that is community-based; or
(A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or.
(B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an additional annual exercise that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed.

*[For HHAs at 484.102]
(d)(2) Testing. The HHA must conduct exercises to test the emergency plan at
least annually. The HHA must do the following:
(i) Participate in a full-scale exercise that is community-based; or
(A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or.
(B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event.
(ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed.

*[For OPOs at 486.360]
(d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following:
(i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event.
(ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed.

*[ RNCHIs at 403.748]:
(d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following:
(i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed.

Observations:


Based on review of facility documentation, drills, and staff (EMP) interview, the facility failed to conduct drills in accordance with this standard at least annually. The facility failed to conduct a full-scale community based exercise or full-scale facility based exercise. The facility failed to conduct an additional exercise to include a second full-scale community or facility based exercise, and a table top exercise designed to challenge the emergency plan.

Findings included:

Review of facility's emergency preparedness binder and documentation on October 24, 2019, at 1:50 p.m. showed, "ATTENDANCE SIGN-IN SHEET" for a "Disaster Drill-Fire / Building Evacuation" dated 6/11/2019. There was nothing to show this fire drill was a full-scale exercise that involved a disaster that would impact the facility's operations in their given community. There was also an "ATTENDANCE SIGN-IN SHEET" for a handout concerning "How to respond, when an active shooter is in your vicinity" that was dated February 2019. This handout was not a full-scale exercise or a table top exercise.

Neither document showed the facility conducted a full-scale community based exercise or full-scale facility based exercise, a second full-scale community or facility based exercise, and a table top exercise designed to challenge the emergency plan for the years 2017, 2018, and 2019.

Interview with EMP6 on October 24, 2019, at 2 p.m. confirmed the two aforementioned documents represent the only exercise the facility has conducted since these regulations were in effect (November 15, 2017).







Plan of Correction:

The Nurse Manager will present an overview of a table top exercise designed to challenge the emergency plan to the Governing Body for approval within 30 days. This initial table top for 2019 will occur by 12/06/2019 and include details of the exercise specific to the emergency plan for the facility, sign-in sheets for attendance, and after-action written assessments which will also be shared with the Governing Body at the next monthly meeting (evidenced by Gov. Body Minutes).
The AOD and Nurse Manager and Nurse Educator will attempt to enlist community resources for a full scale community based exercise by 11/30/2019. If that is not possible they will develop an appropriate full scale facility based exercise that will be completed by prior to 12/30/2019. Results of these exercises will also be share with the Governing Body as evidenced in their meeting minutes.


Initial Comments:


Based on the findings of an onsite unannounced Medicare recertification survey completed October 24, 2019, Dialysis Clinic, Inc. - Beaver 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, observations (OBS), and staff (EMP) interview, the facility failed to ensure two (2) of two (2) patients observed holding access sites to stop bleeding performed hand hygiene immediately after glove removal (OBS#5.1, & OBS#5.2).

Findings included:

Note: As required by this regulation and the Centers for Disease Control and Prevention, for which these regulations are based upon, and reiterated here for clarity, "Examples of when hand hygiene should be performed: ... Immediately after gloves are removed." There is no patient exception to this rule, since there is a concern the patient, after removing glove used to stop bleeding, could touch items and other patients after leaving the station and prior to arriving at another location (sink, hand sanitizer dispenser).

Review of facility policy and procedure on October 22, 2019, at 12 p.m. showed, "GLOVE USAGE - HAND HYGIENE ... Hand hygiene is to be completed any time gloves are removed."

Observation (OBS#5.1) of discontinuation of dialysis with arteriovenous fistula on October 21, 2019, at 11:23 a.m., at station 3 revealed EMP3 remove needles from patient's fistula. EMP3 covered needle sites with folded gauze dressing, and the patient held pressure to bandages with a gloved hand to stop bleeding. Once bleeding had stopped, the patient removed glove from her hand, did not perform hand hygiene, and walked to the scale prior to exiting the treatment floor. Interview with EMP3 at the time of the observation confirmed findings.

Observation (OBS#5.2) of discontinuation of dialysis with arteriovenous fistula on October 21, 2019, at 1:30 p.m., at station 23 revealed EMP1 remove needles from patient's fistula. EMP1 covered the needle sites with folded gauze dressing, and the patient held pressure to the bandages with a gloved hand to stop bleeding. Once bleeding had stopped, the patient removed glove from his hand, did not perform hand hygiene, and left the facility. Interview with EMP1 at the time of observation confirmed findings.

Repeat deficiency from Medicare recertification surveys completed 10/08/2010, and 11/8/2013.












Plan of Correction:

The Nurse Manage or Designee will complete a training/in-service for all staff on required patient hand hygiene at end of treatment. The content of this training will be reviewed for approval by the Governing Body at the November monthly quality meeting (evidence in Minutes from meeting). This in-service will be administered to all staff prior to 11/30/2019 as evidenced by attendance sign-in sheet. The training specifically include patient use of hand gel, after holding their access, prior to patient exiting chairside. The Nurse Manager or Designee will audit performance of patient hand hygiene post-treatment at least 6 observations per day for at least 4 shifts per month until 100% compliance is documented. The Audits can then progress to 4 shifts each 3 months until 100% compliance achieved. All audit findings and documentation will be presented monthly to the Governing Body for their oversight, review, and/or recommendations as needed.
additionally, Nurse Manager or designee will develop patient education materials stressing acceptable practice including such content/handouts/visuals as approved in November Governing Body meeting--to be shared with all patients by 11/30/2019


494.30(a)(1)(i) STANDARD
IC-HBV-VACCINATE PTS/STAFF

Name - Component - 00
Hepatitis B Vaccination

Vaccinate all susceptible patients and staff members against hepatitis B.


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) hepatitis B susceptible patient admitted less than 90 days was offered the hepatitis B vaccine (CR2).

Findings included:

Review of facility policy and procedure on October 24, 2019, at 11:30 a.m. showed, "HEPATITIS STANDARDS PATIENT TESTING AND VACCINATION ... TESTING ... If HBsAg [hepatitis B antigen] and HBsAB [antibody] are negative patient will be offered the Hepatitis B vaccine series." Note: A person possesses hepatitis B immunity when the HBsAB result is equal to or greater than 10 (positive).

Review of CR2 on October 24, 2019, at 10 a.m. showed patient was admitted to the facility for incenter hemodialysis on 9/23/2019. Review of patient's "Immunization Summary" showed patient did not possess hepatitis B immunity (susceptible), "Last HBsAg 10/07/2019 Neg [negative] Last HBsAB 08/16/19 4 [not immune or negative]."

Interview with EMP6 on October 24, 2019, at 11:39 a.m. confirmed the patient was not offered the hepatitis B vaccine series, and the patient is not considered immune unless HBsAB is greater than 10 (patient's HBSAB was four [4]).









Plan of Correction:

Given that the electronic medical record does not automatically assign Engerix to AKI patients (even after they convert to ESRD), the Nurse Manager has completed a "New Patient Check List" which among other requirements outlines orders for Engerix for new patients as needed. This form is already being used and will be reviewed with the Governing Body at the November Quality Meeting for their comment and approval. This form will be used for all new patients going forward regardless of admission status and the Nurse Manager and/or Designee will audit all new parient's records for a completed New Patient Check List monthly for 6 months. When the performance/use of the new form demonstrates 100% the audit can be done one month per quarter for the following 6 months. All audit findings to be documented and shared with the Governing Body at the relevant monthly quality meeting (evidenced in the Minutes of those meetings)


494.30(b)(1) STANDARD
IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P

Name - Component - 00
The facility must-
(1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit;



Observations:


Based on review of facility policy and procedure, personnel files (PF), and staff (EMP) interview, the facility failed to implement its infection control policy and procedure for one (1) of one (1) recently hired employee (PF1). The facility failed ensure PF1 was screened for tuberculosis (TB) using a two-step skin test.

Findings included:

Review of agency policy and procedure on October 24, 2019, at 10:22 a.m. showed:

"TB Testing For Employees ... POLICY: ... 2. Upon hire, all staff will complete the TB risk assessment survey ... and receive a baseline TB screening which includes a Mantoux TB skin test [to check for active TB and includes use of PPD (purified protein derivative) serum] unless contraindicated."

"TB INFECTION CONTROL PLAN ... TWO-STEP TESTING: Two-step testing with healthcare workers should be used to reduce the likelihood that boosted reaction is misinterpreted as a newly acquired infection. All newly hired employed healthcare workers who have a negative reaction on the initial test given at the time of employment and have not had a documented negative PPD result during the 12 months preceding this initial test will receive a second test 1-3 weeks following the first test."

Review of personnel files was conducted on October 23, 2019, at 10:21 a.m.

PF1 was a registered nurse hired on 3/11/2019, and was observed providing patient care on 10/21/2019, and 10/23/2019. PF1 contained no two-step Mantoux TB skin test.

Interview with EMP6 on October 24, 2019, at 11:43 a.m. confirmed PF1 did not receive the Mantoux skin test.










Plan of Correction:

DCI Corporate policy 311 and 312 outline the requirements for the two-step testing. The involved employee is now scheduled for the 2nd step administration 11/13/2019. additionally the NM will implement a new employee checklist addition to document completion of TB testing in the employee file.
The Nurse Manager will ensure the policies are reviewed with the Governing Body November Quality Meeting for re-education and approval and will be evidenced in that Body's meeting Minutes. The Governing Body will also review/approve the change to the employee file checklist for TB testing prior to 11/30/2019



494.40(a) STANDARD
PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS

Name - Component - 00
9 Personnel: training program/periodic audits
A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory.

Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer.

The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs).

Periodic audits of the operators' compliance with procedures should be performed.

The user should establish an ongoing training program designed to maintain the operator's knowledge and skills.




Observations:


Based on review of facility policy and procedure, logs, personnel files (PF), and staff (EMP) interviews, the facility failed to ensure operators of water system equipment had annual observation of the work performed to determine compliance and competency with procedure, and failed to define the frequency of the audits for three (3) of three (3) personnel files reviewed responsible for mixing and disinfecting bicarbonate and the bicarbonate system (PF2, PF3, & PF4).

Findings included:

Review of personnel files was conducted on October 23, 2019, at 10:21 a.m.

PF2 was a patient care technician (PCT) hired on 12/12/2011. There was nothing to show PF2 ever had annual observation of the work performed to determine compliance and competency with procedure.

PF3 was a PCT hired on 6/28/2004. There was nothing to show PF3 ever had annual observation of the work performed to determine compliance and competency with procedure.

PF4 was a PCT hired on 11/14/2018. There was nothing to show PF4 ever had annual observation of the work performed to determine compliance and competency with procedure.

Review of water system treatment logs, "Bi-Carb Mixing log," and "Bi-Carb Disinfection Log Vinegar and Bleach," on October 24, 2019, at 9 a.m. showed PF2, PF3, and PF4, had each mixed bicarbonate used in hemodialysis, and disinfected the bicarbonate mixing system from June 2019 to October 2019.

Interview with EMP9 (biomedical technician) on October 24, 2019, at 10:10 a.m. above personnel had not received annual observation of the work performed to determine compliance and competency with procedure.

Review of job descriptions on October 24, 2019, at 1 p.m. showed, "PATIENT CARE TECHNICIAN ... ESSENTIAL DUTIES AND RESPONSIBILITIES include the following: ... Operates and maintains the water treatment system."

Interview with EMP6 on October 24, 2019, at approximately 1 p.m. confirmed facility has no policy and procedure to determine the frequency of the audits.















Plan of Correction:

The Nurse Manager and Technical Manager will jointly author a Policy and Procedure outlining required components, training, cleaning, troubleshooting the bicarb mixing/delivery system and the water treatment system at the facility. This policy will also require documentation of demonstrated (observed) competency yearly for each individual using the bicarb mixing/delivery system.
A checklist outlining all of the requirements and steps has already been completed and the 3 PCT's involved have already been in-serviced on these required details. Going forward, evidence of each involved employee's annual observed competency sign-off will be found in their employee files.
Additionally, Policy H15 (performing Acid Clean on Machines) was in-serviced to all staff on 10/25.
Orientation checklist and training outlines for newly hired PCT's will also be updated to include at least annual observation of competency.
The Governing Body will ensure review, sign-off, and approve all training documentation at relevant monthly quality meetings. This will be evidenced in the November Quality Meeting Minutes and as needed after.



494.60(d)(1) STANDARD
PE-FIRE SAFETY-LIFE SAFETY CODE

Name - Component - 00
(1) Except as provided in paragraph (d)(2) of this section, dialysis facilities that do not provide one or more exits to the outside at grade level from the patient treatment area level must comply with provisions of the Life Safety Code (NFPA 101 and its Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4) applicable to Ambulatory Health Care Occupancies, regardless of the number of patients served.

Observations:


403.744 Condition of participation: Life safety from fire. (a) General. [Facility] must meet the following conditions: (1) Except as otherwise provided in this section - (i) The [Facility] must meet the applicable provisions and must proceed in accordance with the Life Safety Code."

Based on review of facility documentation, and interviews with staff (EMP), the facility failed to protect patients and employees from fire in accordance with Life Safety Code. The facility failed to conduct quarterly fire drills, and failed to ensure that all facility staff participated in quarterly fire drills for 2017, 2018, and 2019.

Findings included:

Per the 2012 NFPA 101 LIFE SAFETY CODE HANDBOOK, reviewed on October 24, 2019, at 3:45 p.m., "Chapter 21 New and Existing Ambulatory Health Care Occupancies ... 21.1.1.3 Total Concept. 21.1.1.3.1 All ambulatory health care facilities shall be designed, constructed, maintained and operated to minimize the possibility of a fire emergency requiring the evacuation of occupants. ... 21.7.1.1 The administration of every ambulatory health care facility shall have, in effect and available to all supervisory personnel, written copies of a plan for the protection of all persons in the event of fire, for their evacuation to areas of refuge, and for their evacuation from the building when necessary. 21.7.1.2. All employees shall be periodically instructed and kept informed with respect to their duties under the plan required by 21.7.1.2 ... 21.7.1.4* Fire drills in ambulatory health care facilities shall include the transmission of a fire alarm signal and simulation of emergency fire conditions. A.21.7.1.4 ... The purpose of a fire drill is to test and evaluate the efficiency, knowledge, and response of institutional personnel in implementing the facility fire emergency plan. ... Fire drills should be scheduled on a random basis to ensure that personnel in health care facilities are drilled not less than once in each 3-month period [quarterly]. ... 21.7.1.6 Drills should be conducted quarterly on each shift to familiarize facility personnel (nurses, interns, maintenance engineers, and administrative staff) with the signals and emergency action required under varied conditions. ... 21.7.1.8 Employees of ambulatory health care facilities shall be instructed in life safety procedures and devices."

Review of facility fire drills, and fire drill attendance sheets on October 24, 2019, at 1:50 p.m. showed fire drills occurred on 6/11/2019, 3/29/2019, 6/27/2018, 3/30/2018, 6/30/2017, and 3/8/2017. The drills did not occur quarterly (every 3 months), and did not included all staff. The facility's dietician did not attend the 3/29/2019, 6/27/2019, and 3/30/2018 drills. The facility's social worker did not attend drills from 6/11/2019, 6/27/2018, and 3/30/2018.

Interview with social worker (EMP11) on October 23, 2019, at 12:50 p.m. confirmed he/she has not participated in quarterly fire drills at the facility, "not always present when they do them here."

Interview with dietician (EMP13) on October 23, 2019, at 1:09 p.m. confirmed he/she has not participated in quarterly fire drills at the facility.

Interview with EMP6 on October 24, 2019, at 2 p.m. confirmed facility conducted fire drills every 6 months, and that the drills conducted did not include all staff.








Plan of Correction:

The nurse manager and/or designee will ensure that quarterly Fire Drills are completed with appropriate analysis and documentation given to the Governing Body for review, oversight, and feedback. At each patient fire drill the NM (or designee) will audit and document that all patients participated and received appropriate instructions. Patients missing from that shift/day will be given personal instruction at the next available treatment.
The same must occur for 'staff' Fire Drills. Although a challenge for some roles in a three-day-week clinic operation, it is important that all staff participate in the quarterly drills. Therefore as with absent patients, if an Dietitian or Social Worker cannot be present the day of the exercise, the nurse manager (or designee) will review all details at the next opportunity.
The documentation of Fire Drills quarterly, the participation as well as relevant notes/assessments and documentation must be overseen by the Governing Body and entered into that Body's meeting minutes when completed.
Finally, the clinic will conduct a staff Fire Drill prior to 11/30/2019.



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 ensure one (1) of two (2) staff observed initiating dialysis did not touch the access once it was disinfected (OBS#4.1).

Findings included:

Review of facility procedure on October 24, 2019, at 10:36 a.m. showed, "INSERTION OF NEEDLES ... 6. Cleanse area with approved anti-microbial and allow to dry, if indicated. ... DO NOT TOUCH the site once antimicrobial has been applied."

Observation (OBS#4.1) of initiation of dialysis with an arteriovenous fistula (AVF) was conducted on October 21, 2019, at 10 a.m. at station 16 with EMP2. At this time, EMP2 disinfected the patient's AVF, but touched the patient's AVF with a gloved hand prior to inserting the needles into patient's AVF. Interview with EMP2 after observation at 10:10 a.m. confirmed findings.





Plan of Correction:

The Nurse Manager and/or designee will ensure all staff are in-serviced on Needle Insertion Policy prior to 11/30/2019. The Nurse Manager and/or designee will also begin monitoring at least 10 needle insertions per month (varied staff) beginning 12/1/2019 for 6 months. If the performance is then demonstrated to be 100% the auditing can progress to one month per quarter of observations for the remainder of the year.
The Governing Body will receive all audit findings for their review, oversight, feedback, and/or approval monthly and as completed. This will be evidenced in the employee files (in-service) and also the Governing Body Meeting Minutes.



494.110(a)(2)(vi) STANDARD
QAPI-INDICATOR-MEDICAL INJURIES/ERRORS

Name - Component - 00
The program must include, but not be limited to, the following:
(vi) Medical injuries and medical errors identification.



Observations:


Based on review of facility policy and procedure, clinical records (CR7), observation (OBS) and staff (EMP) interviews, the facility failed to ensure an incident report was completed for one (1) of one (1) observed dialysis prescription error (CR7).

Findings included:

Review of facility's "Occurrence Reporting Chapter 2" on October 22, 2019, at 12 p.m. showed, "occurrences ... should be entered as soon as possible into the Darwin system or within 24 hours of the incident." The above document was provided as facility's process for reporting prescription errors. The document fails to mention dialysis prescription errors as a reportable event.

Review of facility policy and procedure on October 24, 2019, at 2 p.m. showed, "POLICY: 800 ... Quality Assessment Performance Improvement (QAPI) ... POLICY ... Medical injuries and medical errors identification (CMS V634); The intent of QAPI in addressing medical injuries and identification of medical errors is to minimize the number of occurrences and limit the number of occurrences and limit the number of patients and staff who are adversely affected by such occurrences. The facility must compile and the QAPI team must review reports and complaints related to any patient or staff injuries, and treatment or medication errors. The facility must trend any injuries or errors to identify the prevalence of occurrences, commonalities, and causes. The following list represents the minimum elements required by CMS and DCI to be reported/tracked. ... e. Errors in dialysis prescription delivery ... g) Use of incorrect dialyzer (single-use or reprocessed). ... The facility should collect and aggregate data regarding adverse occurrences, and there should be a mechanism to ensure all adverse events are recorded as soon as possible after they occur. The QAPI committee should analyze both isolated and repeated events in their review."

During hemodialysis prescription checks with EMP2 on October 21, 2019, at 1:55 p.m., it was noted that CR7 was not dialyzing with the correct dialyzer per his dialysis prescription. Review of CR7's dialysis prescription (flow sheet at machine), during the observation, showed patient was ordered a 180 size dialyzer but the patient was dialyzing with a larger 250 size dialyzer. EMP2 confirmed findings at time of observation.

Review of facility incident reports on October 22, 2019, at 2 p.m. did not show the above prescription error had been documented.

Interview with EMP2 on October 23, 2019, at 2:23 p.m. (48 hours later) confirmed he/she had not completed incident report concerning CR7's prescription error.

Interview with EMP6 (clinic manager) on October 24, 2019, at 11:41 a.m. confirmed no incident report for CR7's incorrect dialyzer/prescription because this type of event is not listed in above reviewed "Occurrence Reporting Chapter 2."










Plan of Correction:

The Nurse Manager and/or designee will ensure all staff are in-serviced on Policy 800...QAPI, prior to 11/30/2019. The Governing Body will receive all Risk-related findings/reports for their review, oversight, feedback, and/or approval monthly and as completed. The Governing Body must ensure that such required reports are timely or within 24 hours and advise as to appropriate follow-up response in any case going forward that this does not happen. This will be evidenced in the Governing Body Meeting Minutes.


494.140(f) STANDARD
PQ-H20 TREATMENT SYSTEM TECHS TRAINING

Name - Component - 00
Technicians who perform monitoring and testing of the water treatment system must complete a training program that has been approved by the medical director and the governing body.


Observations:


Based on review of personnel files (PF), logs, and staff (EMP) interviews, the facility failed to ensure operators of water system equipment completed a training program approved by the medical director and the governing body for three (3) of three (3) personnel files reviewed responsible for mixing and disinfecting bicarbonate and the bicarbonate system (PF2, PF3, & PF4).

Findings included:

Review of personnel files was conducted on October 23, 2019, at 10:21 a.m.

PF2 was a patient care technician (PCT) hired on 12/12/2011. There was nothing to show PF2 had completed a training program approved by the medical director and the governing body concerning bicarbonate mixing and bicarbonate system disinfection.

PF3 was a PCT hired on 6/28/2004. There was nothing to show PF3 had completed a training program approved by the medical director and the governing body concerning bicarbonate mixing and bicarbonate system disinfection.

PF4 was a PCT hired on 11/14/2018. There was nothing to show PF4 had completed a training program approved by the medical director and the governing body concerning bicarbonate mixing and bicarbonate system disinfection.

Review of water system treatment logs, "Bi-Carb Mixing log," and "Bi-Carb Disinfection Log Vinegar and Bleach," on October 24, 2019, at 9 a.m. showed PF2, PF3, and PF4, had each mixed bicarbonate used in hemodialysis, and disinfected the bicarbonate mixing system from June 2019 to October 2019.

Review of job descriptions on October 24, 2019, at 1 p.m. showed, "PATIENT CARE TECHNICIAN ... ESSENTIAL DUTIES AND RESPONSIBILITIES include the following: ... Operates and maintains the water treatment system."

During exit conference on October 24, 2019, at 2:30 p.m., with EMP6 (clinic manager), EMP10 (administrator), and EMP9 (biomedical technician), surveyor requested information on training for the above mentioned employees but none was provided or received.










Plan of Correction:

The Nurse Manager and Technical Manager will jointly author a Policy and Procedure outlining required components, training, cleaning, troubleshooting the bicarb mixing/delivery system and the water treatment system (including testing) at the facility. This policy will also require documentation of demonstrated (observed) competency yearly for each individual using the bicarb mixing/delivery system and completing system testing.
A checklist outlining all of the requirements and steps has already been completed and the 3 PCT's involved have already been in-serviced on these required details. Going forward, evidence of each involved employee's annual observed competency sign-off will be found in their employee files.
Additionally, Policy H15 (performing Acid Clean on Machines) was in-serviced to all staff on 10/25.
Orientation checklist and training outlines for newly hired PCT's will also be updated to include at least annual observation of competency.
The Governing Body will ensure review, sign-off, and approve all training documentation at relevant monthly quality meetings. This will be evidenced in the November Quality Meeting Minutes and as needed after.



494.150(c)(2)(i) STANDARD
MD RESP-ENSURE ALL ADHERE TO P&P

Name - Component - 00
The medical director must-
(2) Ensure that-
(i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers;



Observations:

Based on review of facility policy and procedure, observation (OBS), clinical records (CR3) and staff (EMP) interview, the medical director failed to ensure staff followed patient care policies for two (2) of two (2) observations of discontinuation of dialysis (OBS#5.1, & OBS#5.2).

Findings included:

Observation (OBS#5.1) of discontinuation of dialysis with arteriovenous fistula on October 21, 2019, at 11:23 a.m., at station 3 revealed EMP3 (patient care technician) remove needles from patient's fistula. EMP3 covered both needle sites with folded gauze dressing and betadine (disinfectant) soaked pads. The patient held pressure to bandages with a gloved hand to stop bleeding.

Interview with EMP3 at 11:30 a.m. confirmed betadine gauze placed directly on patient's needle sites, "Patient has bleeding problems."

Interview with patient (CR3) at 11:45 a.m. confirmed staff have used betadine on her access for "couple months."

Observation (OBS#5.2) of discontinuation of dialysis with arteriovenous fistula on October 21, 2019, at 1:30 p.m., at station 23 revealed EMP1 (registered nurse) remove both needles from patient's fistula. EMP1 covered the needle sites with folded gauze dressing, and the patient held pressure to the bandages with a gloved hand to stop bleeding. At this time, the patient requested betadine soaked gauze be used on his access, but EMP1 refused request and told patient an order was required for its use. Once bleeding had stopped, the patient removed glove from his hand, and EMP1 proceeded to obtain the patient's standing blood pressure. Interview with EMP1 at the time of observation confirmed he/she pulled both needles prior to obtaining patient's blood pressure.

Review of facility policy and procedure on October 22, 2019, at 12 p.m. showed, "FRESENIUS 2008 Series RINSE BACK PROCEDURE & Needle Take Offs ... 8. Obtain sitting and standing BPs [blood pressures] while the patient's venous line is still attached. 9. If patient is hypotensive, unclamp venous line and needle, turn on pump and administer desired amount of NS. 10. If or when VS's [vital signs] stable, disconnect the venous line and connect to lines on machine and flush venous port/needle with 10ml [milliliters] of NS [normal saline / medication]. ... 12. For arm access, pull needles ... and hold pressure on sites until bleeding has stopped. Patient may hold sites with gloved hand if able." The procedure does not mention the use of betadine.

Review of CR3 on October 22, 2019, at 1:30 p.m. did not show patient had physician order, or a plan of care that outlined the use of betadine on her access for a suspected bleeding problem.

Interview with EMP6 on October 24, 2019, at 10:40 a.m. confirmed no order or policy and procedure for use of betadine on CR3's access.

During a phone interview with the medical director (EMP8) on October 24, 2019, at 11:30 a.m. he/she confirmed he/she is aware of the use of betadine on patients' access to help stop bleeding. EMP8 confirmed no policy and procedure in place for this practice, and that physician orders are not used to implement the process either.

Repeat deficiency from Medicare recertification surveys completed 11/8/2013, and 11/17/2016.

















Plan of Correction:

The facility has updated/amended policy H-18 to reflect the approval "for excessive bleeding may use betadine or tip stop". This will be fully reviewed and approved at the November Governing Body Quality meeting as evidenced in that Body's meeting Minutes.

When approved by the Governing Body this order statement will be added to patient 'standing orders' that will be reviewed with nephrologist and signed for all patients by 12/15/2019.

The Nurse Manager or designee will audit appropriate (by policy) excessive bleeding care up to 10 episodes per month as possible. The audits will continue monthly for 6 months until performance is 100% at which point they may be done as 10 observations per quarter for the remaining 6 months of the year. All audit results will be shared with the Governing body monthly (reflected in that Body's monthly minutes) for their oversight, advice/feedback, and review.