Initial Comments:
Based on the findings of an onsite unannounced follow-up survey completed on 4/21/2022, Washington Physicians Group 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 491.12, Subpart A, Conditions for Certification: Rural Health Clinics - Emergency Preparedness.
Plan of Correction:
491.12(d)(1) STANDARD
EP Training Program
Name - Component - 00
§403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.542(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1).
*[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, REHs at §485.542, "Organizations" under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:]
(1) Training program. The [facility] must do all of the following:
(i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
(ii) Provide emergency preparedness training at least every 2 years.
(iii) Maintain documentation of all emergency preparedness training.
(iv) Demonstrate staff knowledge of emergency procedures.
(v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures.
*[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following:
(i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles.
(ii) Demonstrate staff knowledge of emergency procedures.
(iii) Provide emergency preparedness training at least every 2 years.
(iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others.
(v) Maintain documentation of all emergency preparedness training.
(vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and
procedures.
*[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following:
(i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
(ii) After initial training, provide emergency preparedness training every 2 years.
(iii) Demonstrate staff knowledge of emergency procedures.
(iv) Maintain documentation of all emergency preparedness training.
(v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures.
*[For PACE at §460.84(d):] (1) The PACE organization must do all of the following:
(i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles.
(ii) Provide emergency preparedness training at least every 2 years.
(iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency.
(iv) Maintain documentation of all training.
(v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures.
*[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following:
(i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role.
(ii) Provide emergency preparedness training at least annually.
(iii) Maintain documentation of all emergency preparedness training.
(iv) Demonstrate staff knowledge of emergency procedures.
*[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following:
(i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
(ii) Provide emergency preparedness training at least every 2 years.
(iii) Maintain documentation of the training.
(iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment.
(v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures.
*[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following:
(i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
(ii) Provide emergency preparedness training at least every 2 years.
(iii) Maintain documentation of the training.
(iv) Demonstrate staff knowledge of emergency procedures.
(v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures.
*[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years.
Observations:
Based on review of agency policy, plan of correction and staff (EMP) interview, it was determined the facility failed to provide emergency preparedness training by the date within the plan of correction, for individual providing services for twenty-one of twenty-one staff.
Findings Included:
Review of agency policy on 4/21/2022 at approximately 9:30 AM revealed, " Emergency Preparedness Management Plan ...IV. EDUCATION The hospital staff, department managers and Administrative staff are routinely oriented and re-educated to the Emergency Plan. Initially, new employees are introduced to the Emergency Plan during the orientation program for new employees. Staff Department-specific and general response competencies are, at a minimum, annually assessed through regular drills. Updates to the Emergency Preparedness Management Plan and Emergency Plan are distributed to and reviewed by all departments. All emergency preparedness documents, and information are kept on file in each hospital department for ready reference and individual inspection..."
Review of the plan of correction (POC) on 4/15/2022 at 2:00 PM revealed: "...The training program will be an online training course using our established Net Learning compliance system. We will also incorporate our clinic evacuation plan as an onsite activity as well as review all policies and procedures regarding emergency preparedness. The review of policies and both trainings courses will be conducted every 2 years. This plan will be completed by 4/15/2022, and all staff will be trained by 4/15/2022. The facility will monitor its performance by assuring all staff will participate and complete the training. This is monitored by reports from the Net learning module, and from a roster taken at the onsite evacuation drill, and review of the policies and procedures policy review. The HVA analysis will be conducted annually (office Manager) to evaluate if our vulnerability has changed. The responsibility party for the initial HVA assessment and net learning training is the director of operations. Implementation and ongoing monitoring responsible party is the office manager."
An email was received on 4/21/2022 at approximately 4:08 PM which revealed. Per EMP2 " ...Due to the providers not being added to the net learning system, they were given the training on paper and will have these completed by April 30 ... " E0037 Emergency Preparedness Training Program 4/15/2022..."
An exit interview with EMP1 (Office Manager) and EMP2 (Director of Operations) on 4/21/2022 at approximately 1:05 PM confirmed the above findings.
Plan of Correction:The facility was not able to have all of the emergency preparedness education uploaded to the online net learning education system for the providers as anticipated. The education modules were printed and given to each provider to complete on 4/20/2022. Each provider was asked to complete the emergency preparedness education by 4/30/2022. The office manager is responsible for monitoring the completion of the Emergency training. Unfortunately some of the providers were not able to complete this by 4/30/22. After review with the office manager and the director of operations a continuation was granted to have this training completed by 5/15/2022. The OM manager will monitor the progress of completion. All staff and all providers have completed all of the education modules before the new date of 5/15/22. Each has signed an attestation verification form. Office manager is responsible to ensure the policy is followed and this training is completed every 2 years.
Initial Comments:
An onsite, unannounced follow-up survey completed 4/21/22, found that,Washington Physician Group had partially corrected but were identified to have the following remaining standard level deficiencies the were determined to be in substantial compliance with the following requirements of 42 CFR, Part 405, Subpart X and 42 CFR, Part 491.1 - 491.11, Subpart A, Conditions for Certification: Rural Health Clinics The deficiencies were cited as a result of a recertification survey completed 2/22/2022.
Plan of Correction:
491.6(b)(2) STANDARD
PHYSICAL PLANT AND ENVIRONMENT
Name - Component - 00
The clinic . . . has a preventive maintenance program to ensure that:
491.6(b)(2) Drugs and biologicals are appropriately stored; and
Observations:
Based on review of policy and procedure, plan of correction (POC), observations (OBV) and staff (EMP) interview, the facility failed to ensure medications were appropriately stored and supplies were not available for use and were discarded in accordance with manufacturer's directions for use.
Findings included:
Review of agency policy on 4/21/2022 at approximately 9:30 AM revealed, "POLICY: Medication Vial storage and Preparation Policy DATE: FEBRUARY 14, 2022 RESPONSIBLE PERSON(S): ALL (AGENCY) EMPLOYEES PURPOSE: To ensure medication vials are properly and safely stored in the clinic health care setting. Injectable medications are prepared to promote patient safety, prevent occupational exposure to blood borne pathogens and bacterial infections through the use of safe preparations and storage practices. PROCEDURE: Applies to all injectable vial medications storage and preparations. All members of the health care team will follow best practices guidance from the U.S. Centers of Disease Control and Prevention (CDC) and the Association for Professionals in Infection Control (APIC) regarding the safe use of needles, syringes and medication storage. ASEPTIC TECHNIQUE...Never store needles and syringes unwrapped because sterility cannot be ensured. Keep bulk unwrapped syringes in the original package (e.g., intradermal syringes)...MEDICATION VIAL STORAGE ...Label a multidose vial with a beyond-use-date must never be after the manufacturer specified expiration date.21...Inventory and Quality Control...Assigned staff member will conduct weekly inspections and document on the inspection Inventory form and report to the office manager the findings...Injectable medications cabinet medications are checked for outdates, and non labeled vials, as well as inventory control..."
Review of the plan of correction (POC) on 4/15/2022 at 2:00 PM revealed: "...Health clinic will create a Medication vial and preparation Policy to ensure proper storage if injectable medications and supplies are kept in a secure area. Monitoring activities will be conducted in the office to assure that patients are provided with medications that are safe and not past the effective date listed. All medication vials will be checked weekly for expirations dates and date of open container. This policy was written on 3/1/2022 and will be implemented on 3/11/2022. Staff will be training on 3/11/2022. A medication log will be documented weekly for compliance. All other office medical supplies will be checked monthly for expiration dates, any expired supplies will be disposed of in the proper manner. This A monthly log sheet will be used for quality assurance and compliance. The manager will perform spot checks quarterly to check compliance."
During a observation tour (OBV1) of the facility on 4/21/2022 at approximately 12:45 PM revealed the following multiple dose/single dose vials were open with no date or initials to confirm when the medication was opened for use.
Kenalog-40 400 mg per 10 ml Multiple dose vial Lot AB56086 (expiration) Jun 2022
Marcaine 0.25 125 mg/50 ml Multi dose vial Lot 1756DD (expiration) 1 MAY 2022
Cyanocobalamin Injection USP 1000/ml Lot/Exp. 1216 MAY23
A capped needle and syringe were located next to the medication cyanocobalamin with an approximately 1 ml red liquid in the syringe unlabeled.
An exit interview with EMP1 (Office Manager) and EMP2 (Director of Operations) on 4/21/2022 at approximately 1:05 PM confirmed the above findings.
Plan of Correction:The plan of correction for Medication vial storage and preparation policy was reviewed with each MD, DO, CRNP, and PA in the office on 4/28/2022. Each provider was asked to read the policy and take the competency quiz. Each provider was instructed to follow the policy. On 4/29/2022 a remediation plan was given to the employee that failed to follow the policy. This policy is monitored by the office manager. It is the responsibility of the office manager to ensure this policy is being followed and quality assurance is compliant. The policy has been enforced and compliant since 4/29/2022.
491.7(a)(2) and (b)(1)-(2) STANDARD
ORGANIZATIONAL STRUCTURE
Name - Component - 00
491.7(a) Basic requirements.
(2) The organization's policies and its lines of authority and responsibilities are clearly set forth in writing.
(b) Disclosure. The clinic . . . discloses the names and addresses of:
(1) Its owners, in accordance with section 1124 of the Social Security Act (42 U.S.C. 132 A-3);
(2) The person principally responsible for directing the operations of the clinic . . .
Observations:
Based on review of policy and procedure, plan of correction, personnel file (PF) and staff (EMP) interview, the facility failed to complete mandatory annual training regarding the prevention of Tuberculosis (TB) transmission for twenty-one of twenty-one staff.
Findings included:
Review of the agency policy on 4/21/2022, at approximately 12:30 PM revealed: " 1. INTRODUCTION: The Purpose of the educational efforts are to disseminate information that will assist in preventing the transmission of Tuberculosis in the hospital setting and the community at large. EMPLOYEE EDUCATION: A. Mandatory Educational Programs: Mandatory annual educational programs regarding prevention of the transmission of TB in the workplace began in July, 1994. All employees at risk of exposure to Tuberculosis while providing patient care or other services are required to complete the program.
B. Healthcare Worker Training on Employment Includes: 1. The cause and modes of transmission of TB. 2. Definition of infectious. 3. The purpose of TB testing. 4. The sign and symptoms of TB. 5. The purpose of preventative therapy. 6. Selection, fit and use of personal protective equipment (see Respiratory Protection Section); and 7. Airborne precaution protocols. C. Trainers: 1. The infection Preventionist has been designated as trainers and will provide an annual employee education update that includes transmission and prevention.
Review of the plan of correction (POC) on 4/15/2022 at 2:00 PM revealed: "On 3/8/22 a e learning course was added to each staff member required annual net learning profile. This course covers and provides understanding and preventing Tuberculosis. Each employee will complete this by 4/15/22. The office manager is the responsibility party to implement and monitor progress of staff completion. Reports of completion will be completed from the Net Learning by the office manager to ensure all staff have completed the training and passed the test associated with this training. The office manager will monitor annually for this training completion by all staff."
An email was received on 4/21/2022 at approximately 4:08 PM which revealed. Per EMP2 "...Due to the providers not being added to the net learning system, they were given the training on paper and will have these completed by April 30...and J0062 Organizational structure (TB training/education) 4/15/2022."
An exit interview with EMP1 (Office Manager) and EMP2 (Director of Operations) on 4/21/2022 at approximately 1:05 PM confirmed the above findings.
Plan of Correction:Plan of correction for the facility in regards to TB training and education. The education training was not able to be uploaded to the providers online net learning modules. The education and training materials were printed and given to the providers on 4/20/22. All staff members completed this by 4/30/22.It is the responsibility of the office manager to ensure compliance, and that all training is completed. Unfortunately the providers were not able to complete by this date. After a discussion with the office manager and the director of operations a continuation request was granted to have this completed by 5/15/22. The office manager is responsible to ensure this training is completed. All of the training was completed by 5/15/2022.
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