Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed on 12/2/2019, Tyrone Hospital Rural Health Clinic was found to be in compliance with the requirements of 42 CFR, Part 491.12, Subpart A, Conditions for Certification: Rural Health Clinics - Emergency Preparedness.
Plan of Correction:
Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed 12/2/2019, Tyrone Hospital Rural Health Clinic 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 405, Subpart X and 42 CFR, Part 491.1 - 491.12, Subpart A, Conditions for Certification: Rural Health Clinics.
Plan of Correction:
491.6(b)(1) STANDARD
MAINTENANCE
Name - Component - 00
All essential mechanical, electrical, and patient-care equipment is maintained in safe operating condition;
Observations:
Based on a review of the agency policy, manufactures instructions, job descriptions, initial observation tour (OBV) and staff (EMP) interview the agency failed to maintain patient care equipment for one (1) of (1) OBV.
Findings included:
A review of the agency policy on 11/26/2019 at approximately 2:00 PM revealed, "Rural health Clinic Policy and Procedure Manual, Physical Plant and Environment Use of Autoclave/Equipment Sterilization 1. Sterilization. The clinic follows all manufactures' instructions in regard to the sterilization process. Below is an example of one of the sterilization process that is available to the rural health clinic. If at the time the clinic is utilizing a different technique, the manufacturer's guidelines are followed..."
A review of the agency policy on 11/26/2019 at approximately 10:18 AM revealed, the user's guide for the "M7 SpeedClave Steam Sterilizer...Steam Sterilization Monitoring Follow appropriate agency (state dental or medical board) for sterilization monitoring guidelines for your office. Additional information can also be obtained from CDC, AAMI, OSAP, and ADA regarding monitoring programs or other sterilization issues..."
A review of the agency policy on 11/26/2019 at approximately 2:00 PM revealed, "Rural health Clinic Policy and Procedure Manual...Job Title: Medical Assistant General Summary of Duties: Performs a variety of patient care activities to assist physicians and nursing staff. Supervision Received: Reports directly to Nursing Services supervisor ...Duties and Responsibilities...3. Prepares exam rooms and instruments for examination and testing. Stocks supplies. Sterilized instruments..."
An interview was conducted on 11/25/2019 at approximately 3:00 PM with EMP1 and EM2. The surveyor requested documentation of tracking for the autoclave maintenance and sterilization log sheets from 2018 and 2019. On 11/26/2019 at 10:00AM EMP1 confirmed no log sheet could not be found. The surveyor requested on 11/26/209 at approximately 10:10 AM from EMP2 any documentation from the last time and tracking logs were maintained. No documentation was provided.
An exit interview was conducted with the vice president of outpatient operations and the outpatient coordinator on 11/26/2019 at approximately 3:00 PM which confirmed the findings.
Plan of Correction:The Rural Health Clinic policy, Physical Plant and Environment Use of Autoclave/Equipment Sterilization, will be reviewed on an administrative level and updated; if appropriate. All staff will review the policy, Physical Plant and Environment Use of Autoclave/Equipment Sterilization, and documentation will be obtained for policy review.
All Tyrone Rural Health employees will receive education regarding the proper use of and appropriate monitoring log documentation for the M7 SpeedClave Steam Sterilizer. This education will be delivered to all staff utilizing the Relias Learning online system. A log of all employees receiving the education will be maintained electronically via the Relias Learning online system and will be available for review upon request.
A monitoring log will be developed for the M7 SpeedClave Steam Sterilizer and completed according to manufacturer specifications. This monitoring log will be kept in the general vicinity of the sterilizer for easy access.
The clinic administrator or designee will perform surveillance for the completion of the monitoring log on a weekly basis for four weeks then monthly for a period of six months. The surveillance of the monitoring log will be documented and maintained in the administrator's office. Random monitoring will occur after the initial six months and documented to assure compliance.
All items listed above will be completed on or by 02/19/2020.
491.6(b)(2) STANDARD
MAINTENANCE
Name - Component - 00
Drugs and biologicals are appropriately stored; and
Observations:
Based on review of policy and procedure, initial observations tour (OBV) and staff (EMP) interview, the facility failed to maintain a preventative maintenance program to ensure expired drugs and supplies were not available for use and were discarded for one (1) of one (1) (OBV).
Findings included:
A review of the agency policy on 11/26/2019 at approximately 2:00 PM revealed, "Rural health Clinic Policy and Procedure Manual, Physical Plant and Environment Drugs and Biologicals...Procedure Pharmaceuticals will be checked monthly to assure they are not outdated or deteriorated. A monthly check should be conducted to ensure that all expired drugs have been removed from the storage area. A sheet will be posted on the door of the storage cabinet. The individual who has checked that all pharmaceuticals are not expired will sign and date this sheet at the time of the monthly outdate check. All outdated medications will be disposed of (i.e. hazardous waste)..."
Observation of the facilities medication supply room and supply storage area on 11/25/2019 at 1:40 PM revealed the following expired medications and supplies.
Two (2) vials Varicella Virus Vaccine No 23956 Exp 2019 Sep 01, 1 single does 0.5 ml vial
One (1) Spiriva Respimat (Tiotropium Bromide) Inhalation Spray 1.25 mcg/actuation 4 Grams 28 Metered Inhalations Lot 608, Exp. Nov 18
Two (2) NDC 0006-4309-00 10 single dose 0.7 ml vials Sterile Diluent (Sterile Water) For Merck Sharp & Dohue Corp. Live Virus Vaccines Lot R022411, Exp 2019 NOV10
BBL culture Swab Collection & Transport System R 220099 (01) 18053326001977 Exp 2019-09-30 (White Cap)
BBL Culture Swab Collection & Transport System R 220109 (01) 18053326001885 Exp 2019-05-31
An exit interview was conducted with the vice president of outpatient operations and the outpatient coordinator on 11/26/2019 at approximately 3:00 PM which confirmed the findings.
Plan of Correction:The Rural Health Clinic policy, Physical Plant and Environment Drugs and Biologicals, will be reviewed on an administrative level and updated; if appropriate. All staff will review the policy, Physical Plant and Environment Drugs and Biologicals, and documentation will be obtained for policy review.
All Tyrone Rural Health employees will receive education regarding the process to properly review medications for expiration. A log of all employees receiving the education will be obtained and will be available for review upon request.
The clinic administrator or designee will perform surveillance for expired medications on a monthly basis for four months then semiannually. The surveillance of the expired medications will be documented and maintained in the administrator's office. Random monitoring will occur after the initial schedule listed above and documented to assure compliance.
All items listed above will be completed on or by 02/19/2020.
491.10(a)(3) STANDARD
RECORDS SYSTEM
Name - Component - 00
For each patient receiving health care services, the clinic ... maintains a record that includes, as applicable:
(i) Identification and social data, evidence of consent forms, pertinent medical history, assessment of the health status and health care needs of the patient, and a brief summary of the episode, disposition, and instructions to the patient;
(ii) Reports of physical examinations, diagnostic and laboratory test results, and consultative findings;
(iii) All physician's orders, reports of treatments and medications and other pertinent information necessary to monitor the patient's progress;
(iv) Signatures of the physician or other health care professional.
Observations:
Based on a review of the agency job descriptions, medical records (MR) and staff (EMP) interview, the clinic failed to show evidence of a signed consent form for seven (7) of twenty (20) MRs reviewed for office visits made (MR2, MR5, MR6, CR15, CR16, CR19 and CR20)
Findings Included:
A review of the agency job descriptions on 11/26/2019 at approximately 2:00 PM revealed, "Rural health Clinic Policy and Procedure Manual...Job Title Registered Nurse General Statement of Duties: Provides professional nursing care for clinic patients following established standards and practices. Supervision Received: Reports directly to the Nursing Services Supervisor...8. Maintains and reviews patient records, charts, and other pertinent information..."
A review of the agency job descriptions on 11/26/2019 at approximately 2:00 PM revealed, "Rural health Clinic Policy and Procedure Manual...Job Title: Licensed Practical Nurse General Summary of Duties: Provides professional nursing care under supervision for clinic patients. Supervision Received: Reports directly to the Nursing Services Supervisor...Duties and responsibilities...7. Maintains and review patient records, charts, and other pertinent information..."
A review of clinical records (CRs) conducted on 11/26/2019 at approximately 1:20 PM to approximately 2:25 PM which revealed MR2, MR5, MR6, CR15, CR16, CR19 and CR20 did not have a signed consent for treatment documented.
An exit interview was conducted with the vice president of outpatient operations and the outpatient coordinator on 11/26/2019 at approximately 3:00 PM which confirmed the findings.
Plan of Correction:The Rural Health Clinic will develop a policy specifically describing the need and frequency for patient consent. Consent will be obtained upon the initiation of treatment and subsequently on an annual basis. The consent will be maintained within the electronic medical record. The policy will identify staff responsible for obtaining patient consent. All staff will review the policy and documentation will be obtained for policy review.
All Tyrone Rural Health employees will receive education regarding the newly developed policy and the process to obtain consent utilizing the electronic medical record. A log of all employees receiving the education will be obtained and will be available for review upon request.
The clinic administrator or designee will perform surveillance for compliance of obtaining patient consent on a monthly basis for four months. The number of charts to be review will be a minimum of 25 charts per month. The surveillance of the consent completion will be documented and maintained in the administrator's office. Random monitoring will occur after the initial schedule listed above and documented to assure compliance.
All items listed above will be completed on or by 02/19/2020.
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