Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed on 11/29/18, Conemaugh Physician Group was found to be in compliance with the following requirement(s) 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 conducted on November 27 through 29, 2018, Conemaugh Physician Group was identified 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(a) STANDARD
CONSTRUCTION
Name - Component - 00
The clinic ...is constructed, arranged, and maintained to insure access to and safety of patients, and provides adequate space for the provision of direct services.
Observations:
Based on observation, interview with patient and staff (EMP), the clinic failed to ensure the entrance doors to the clinic were constructed to allow safe entrance for seated patients in extra-wide wheelchairs and that the clinic area door hardware were constructed to allow safe exit by patients with limited hand range of motion or strength (Observation #1 of Patient #22).
Findings included:
According to ADA compliancy directory, 4.13.9 Door Hardware - handles, pulls, latches, locks, and other operating devices on accessible doors shall have a shape that is easy to grasp with one hand and does not require tight grasping, tight pinching, or twisting of the wrist to operate. 4.13.7 Two Doors in Series. The minimum space between two hinged or pivoted doors in series shall be 48 inches plus the width of any door swinging into the space.
www.ada.directory
On 11/27/18 at approximately 11:00 a.m., observed patient #22 attempt to enter clinic from parking lot. Entrance to building was a two hinged door in series to gain entrance to the public waiting and check-in area. Patient (with left lower limb prosthesis) seated in extra-wide wheelchair, had to stand, fold wheelchair to move into space between the two doors, then shift positioning to pull open a second door into the space, maneuver the wheelchair through door while a second bystander held open and then position wheelchair inside waiting room to again sit in wheelchair to approach the intake area to register for the visit. The space between the two doors did not allow swing space from the inner door plus the width of the person seated in a wheelchair to enter from the first door.
Patient #1 stated to surveyor upon questioning on ease of entrance to the building, "...glad there was someone in the parking lot to help...difficult to get through the two doors..."
During tour of clinical area on 11/27/18 between 11:45 a.m. and 12:30 p.m., observed round door knobs on clinic doors as well as exit doors to the public waiting area of the clinic. Door closures were round knobs that required tight grasp and twisting motion to open of which did not meet ADA standards.
During interview on 11/28/18 at approximately 10:00 a.m., EMP clinical director confirmed findings, "...an old building..." and stated to have observed patient #22 on 11/27/18 attempt to access patient rest room with difficulty maneuvering layout to enter while seated in wheelchair.
Plan of Correction:J0020 Construction -
Any door handles not in compliance will be replaced to meet 4.13.9 Door Hardware. A request will be submitted to Building Services and forwarded to the landlord for approval to meet 4.13.7 Two Doors in Series. Door handles will be changed by 1/11/2019 and entrance door will be corrected by 1/11/2019. The Director of Operations for CPG will monitor for completion of installation work and along with the Director of Clinical Services for CPG will assess for continued access and ease of use of door handles and entrance by annual mock survey and annual review.
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 review of clinic policy, clinic testing logs, clinical records (CR) and interview with staff (EMP), the clinic failed to ensure staff performed quality control monitoring on laboratory equipment to ensure the accuracy of patient results and maintain documentation of quality controls performed for 2016, 2017, 2018 or performed daily monitoring of refrigerator/freezer storage units for vaccine and other biologics as policy required.
Findings included:
Review of clinic policy on 11/28/18 at approximately 11:55 a.m., revealed "LABORATORY POLICY...Effective 5/3/10, SCOPE...[name of clinic] ensures the proper procedures and followed within the laboratory so that quality and accuracy of the testing can we [sic.] guaranteed...Quality Assurance...External quality controls will be performed for each test as a new kit is opened...performed based on the manufacturer's recommendations...Internal quality controls will be reviewed with each test being performed and will be documented in the testing log...Quality control results will be documented in the laboratory long [sic.] and kept for a minimum of 2 years...The quality control information for each test and/or control will contain the date the control was run, all results...acceptable ranges...dates of opening of test, expiration date, and lot numbers...Record of maintenance of testing equipment will be kept for a minimum of 2 years...No outdated reagents, controls or supplies will be used...Room temperatures will be monitored daily and be logged in the laboratory temperature long [sic] ensure the room temperature remains between 68-87 degrees Fahrenheit...The Quality Assessment check list will be completed monthly, reviewed by the Medical Director...records kept a minimum of 2 years...Personnel Responsibilities...[name of clinic] staff will be responsible for the daily operations of the laboratory including: Performing quality controls, validations, performing patient testing, as well as proficiency testing. The Medical Director will be responsible for oversight of laboratory operations in the absence of the laboratory director... Personnel Training...Each employee performing laboratory testing will be trained on each test and method...the training log will be kept in the employee's personnel file...training will be held at least annually...if test procedure or manufacturer changes, all employees will be trained on the new procedure and documentation placed in their personnel file..."
Request made to EMP 4 for past control logs on 11/27/18 at approximately 1:45 p.m., "we put results in the patient's electronic record...don't use logs..." EMP 4 could not provide dates when testing or quality controls may have been done.
A review of Equipment Testing logs on 11/28/18 at approximately 11:20 a.m., revealed:
"Quality Control Log Sheet True Metrix Pro (Blood Glucose), Control Serum Lot # MV 2877, Expiration 10/31/2019. No data entered for level 1 [low] or level 2 [high] controls performed. No performed tests entered on log.
Quality Control Log Sheet Sofia Influenza A+B 128387, expiration 1/16/2020. No data entered for positive or negative controls performed. No performed tests entered on the form.
Quality Control Log Sheet One Step Pro+Strep A Cassette, Test Kit lot #130195, expiration date 5/4/2020, Positive Control Lot#122463, expiration date 1/19/24 with no result entered, Lot #122337, expiration date 1/19/26 with no result entered. No performed tests entered on the form.
Quality Control Log Sheet Siemens Multistix 10SG Urinalysis Strips, Negative Control Lot#801045, Expiration 7/31/2019, Positive Control Lot#804050, Expiration 10/31/2019. No control results entered on form. No performed tests entered on the form.
Logs not found for record of Occult Blood testing or Hemaglobin/Hematocrit testing.
Evidence for monthly review by Medical Director of control logs was not found.
A review of random selected clinical records between 11/27/18 and 11/28/18 revealed, a rapid step test was performed 9/18/18 (CR 5), 11/20/18 (CR 18) and a blood glucose was performed in office on 11/27/18 (CR 21).
Temperature monitoring logs for laboratory room temperatures were not found in clinic. During tour of laboratory area on 11/27/18 at approximately 12:30 p.m., evidence for ambient air monitoring was not found.
During interview on 11/28/18 at approximately 11:30 a.m., EMP 8 (operations manager) confirmed prior testing/quality control monitoring logs were not found and evidence for medical director monthly review of logs was not found.
Commercial grade refrigerator/freezer unit was observed in laboratory area for medication and lab specimen storage. Refrigerator was supplied with a fluid filled thermometer and a data logger (to record continuous temperature readings) placed on the top shelf and against the back wall of the storage unit. Compact freezer unit was located on counter top of the "dirty" work area. Unit contained fluid style thermometer and a data logger. Unit had evidence of ice build-up on the back wall.
Request made to EMP 4 on 11/27/18 at approximately 2:30 p.m., for temperature monitoring logs for the vaccine and medication storage units. EMP 4 stated, "...don't need to keep logs...now use the data logger..." On 11/28/18 at approximately 11:30 a.m., request made to EMP 8 and EMP 9 for evidence of temperature monitoring logs. "...[EMP 4] will need to upload ...as soon as free from patient care..." On 11/29/18 at approximately 10:30 a.m., request made again to EMP 8/EMP 9 for evidence of temperature monitoring performed on vaccine storage units.
Review on 11/29/18 at approximately 1:00 p.m., of a partial copy of "refrigerator" data logger files dated 1/9/18 through 3/15/18 failed to reveal any recorded results. EMP 9 confirmed print-out recorded an error code ("-50") without recording temperature readings as measured. EMP 8 stated, "...staff were to continue to log twice daily temps..." when the loggers were put in place in January 2018. "...additional training is needed for staff..." EMP 8 confirmed clinic did not have evidence for monitoring the vaccine/other biologic refrigerator or freezer units since 1/8/18.
Plan of Correction:J0022 Maintenance - Quality Controls -
Davidsville Rural Health Clinic staff members were not maintaining quality control monitoring on laboratory equipment to ensure the accuracy of patient results according to CLIA Regulation. TCT DGS 2.0 and Point of Care testing or the Drug and Biological Storage Policy. The Davidsville Rural Health Clinic cannot correct 2016, 2017. To correct and come into compliance with this policy a specimen refrigerator was obtained for the clinic and dirty and clean areas were adjusted to move the compact freezer to the "clean" area. The Davidsville Rural Health Clinic will be re-educated on the Drug and Biological Storage Policy that will include proper security, storage and disposal of drugs and biologicals. The handling of drugs and biologicals will be done in accordance with all state and federal OSHA guidelines. The Drug and Biological Storage Policy will be amended to include the reference source; Centers for Disease Control and Prevention Vaccine Storage & Handling Toolkit provides guidelines for the storage and monitoring of temperatures for vaccines. Education on the Drug and Biological Storage Policy, Laboratory Policy manual and the Centers for Disease Control and Prevention Vaccine Storage & Handling Toolkit will be completed for all staff members by the Director of Clinical Services for Conemaugh Physician Group by 1/11/2019.
The Davidsville Rural Health Clinic will be re-educated on the Davidsville Laboratory Procedure that states The Davidsville Rural Health Clinic provides the basic required CLIA waived tests as identified on CLIA Certificate of Waiver #39D0182188 as throat screen, pregnancy, whole blood glucose, hematocrit and dipstick urinalysis. Tests that are beyond the scope of the office are sent to a contracted reference laboratory. Referral laboratories operate in a manner consistent with CLIA regulations. All technical procedures utilized for patient care meet laboratory standards as required by state and federal accrediting agencies. The Conemaugh Physician Group Laboratory manual includes all manufacturer's information for proper storage and handling and temperature monitoring for reagents and lab supplies. Education on the Laboratory Procedure, Laboratory manual will be completed for all staff members by the Director of Clinical Services for Conemaugh Physician Group by 1/11/2019.
All staff members will be re-educated by the Clinical Services Director for the Conemaugh Physician Group to perform and maintain external (based on manufacturer's recommendations) and internal quality controls on each test being performed and record results in the laboratory monitoring log, they will be trained on each test and method, testing only with non-outdated reagents controls or supplies, room temperatures will be monitored and logged in the laboratory control log to ensure room temperature remains between 68 – 87 degrees, CDC guidelines for Vaccine Storage & Handling Toolkit January 2018 and education will be completed by 1/11/2019. Internal and external quality control logs will be maintained for all tests performed; throat screen, pregnancy, whole blood glucose, hematocrit and dipstick urinalysis. The purpose of these guidelines are to ensure the accuracy of point of care testing, patient results and to keep track of administered lab tests results and temperatures to ensure patient safety.
The Registered Nurse in the Davidsville Rural Health Clinic will monitor for completion of laboratory room temperature logs, internal and external quality control logs, outdated reagents outdated supplies and refrigerator/freezer temperatures and report on continuing compliance to the Director of Operations for Conemaugh Physician Group weekly times 4 and then monthly. The Registered Nurse in the Davidsville Rural Health Clinic will have the Medical Director review the control logs monthly and fax a copy of the signed review sheet to the Director of Operations for CPG monthly. The Registered Nurse in the Davidsville Rural Health Clinic will be designated the vaccination and medication coordinator for the clinic, the EMP 4 LPN will be designated as alternate in the absence of the primary coordinator (the Registered Nurse) and assist the Director of Operations to maintain quality and efficiency standards set within the clinic.
Maintaining laboratory room temperature logs, internal and external quality control logs, and refrigerator/freezer temperature monitoring will be included in the hiring orientation packet and reviewed with annual program evaluation in January of each year, competencies in March/April of each year, mock survey readiness in October/November of each year.
491.6(b)(2) STANDARD
MAINTENANCE
Name - Component - 00
Drugs and biologicals are appropriately stored; and
Observations:
Based on review of clinic policy, observation and interview with staff (EMP), the clinic failed to maintain a preventative maintenance program to properly store vaccines and biologicals, ensure expired drugs and supplies were not available for use and to perform daily temperature monitoring of refrigerator/freezer storage units for vaccine and other biologics as policy required.
Findings included:
During a tour of the clinic area on 11/27/18 between 11:40 a.m. and 12:30 p.m., the following was observed:
Utility/Supply room:
BD Vacutainer Serum blood collections tubes - (package of 100). Expired (exp.) 8/31/2018.
Box labeled "do not throw out" contents included, sterile scalpels expired 2017-10; SteriStrips [non-invasive wound closure product] exp. 2017-03; sterile staple removal kits exp. 10-13 (2); sterile female cath kit [tube to empty bladder] exp. 11-2011; Telfa-non-adherant pad sterile, 2017-08; Sterile Normal Saline Solution, 8.5 fluid ounce, bottle open and half empty, exp. 8-2016 with not beyond use date labeled; sheathed intravenous catheter 22 gauge/1 inch (4) exp. 2010-11.
Surgilube 4 ounce tubes [used for lubrication] exp. 07/17 (4) and exp. 2/18 (12).
Exam room 1:
Surgilube exp. 7/17
Hemocult Developer (used with kit to test for blood in stool) exp. 06/18
Exam room 2:
Surgilube exp. 7/17
Exam room 3:
Hemocult Developer exp. 6/18
Open Bottle - multidose vial Lidocaine (local anesthetic) 2 percent injection expired 1 Aug 2018; with written open date "7/1/18"
Exam room 4:
Chlamydia DNA culture (test for an infection) exp. 12/19/17.
Hemocult Developer exp. 09/18
Laboratory area:
Refrigerator:
Hepatitis B vaccine exp. 09 August 2018 (7 doses)
Humalog quickPen (insulin) exp. 09/2018 (one)
Soliqua (insulin) 100/33 exp 08/2018 (4 boxes)
Cardiosens/ultra II (electrode pads for electrocardiogram testing) exp. 11/1/18 (5 packages)
Freezer:
Varicella (vaccine to prevent chickenpox infection) Lot. #13068 exp. 14 Apr 2017 (7 doses)
Zostavax (vaccine to prevent shingles and postherpetic neuralgia) Lot. #M036613 exp. 2017 Nov 19 (1 box)
Autodispenser for medication:
sitting unsecured on top of dispenser was the following:
Amlodipine (used to treat hypertension) 5 mg exp. 9/18. (2 bottles)
Sivastin (used to lower cholesterol) 4 ounce exp. 10/18 (3 bottles)
Hydochlorizide (used to treat hypertension) 25 mg exp. 10/18 (2 bottles)
In addition, observed on the first shelf of the refrigerator, blood collection tubes with patient blood and a sample of patient urine surrounded by packages of HPV [human papillomavirus] vaccine, tuberculin skin testing solution (to test for tuberculosis), prevnar 13 [pneumococcal] vaccine, and flu vaccine.
Commercial grade refrigerator/freezer unit was observed in laboratory area for medication and lab specimen storage. Refrigerator was supplied with a fluid filled thermometer and a data logger (to record continuous temperature readings) placed on the top shelf and against the back wall of the storage unit. Compact freezer unit was located on counter top of the "dirty" work area. Unit contained fluid style thermometer and a data logger. Unit had evidence of ice build-up on the back wall.
During interview on 11/27/18 at approximately 1:45 p.m., EMP 4 stated the Lidocaine should not have been in the patient exam room cabinet, and disposed in a hazardous container in exam room 3, "recently duties have changed...one nurse is responsible to check rooms and make sure everything is there daily..." EMP 4 stated, expired meds left unsecured in laboratory area were waiting to be picked up and confirmed medications were accessible to be mistakenly used. EMP 4 confirmed expired vaccine/biologicals were in storage units and were accessible to be mistakenly used.
Request made to EMP 4 on 11/27/18 at approximately 2:30 p.m., for temperature monitoring logs for the vaccine and medication storage units. EMP 4 stated, "...don't need to keep logs...now use the data logger..."
On 11/28/18 at approximately 11:30 a.m., request made to EMP 8 and EMP 9 for evidence of temperature monitoring logs. "... [EMP 4] will need to upload ...as soon as free from patient care..."
Review of clinic policy on 11/28/18 at approximately 11:55 a.m., revealed "LABORATORY POLICY...Effective 5/3/10...no outdated reagents, controls, or supplies will be used..."
Medication Policy...1. All medications are to be stored in locked rooms or cabinets...3. All medications including emergency drug supplies should be checked monthly against an inventory list for outdating...This monthly check should be documented...4. Refrigerators and freezers will be...maintained at the appropriate temperatures as prescribed for the medications. The temperature will be monitored and recorded daily..."
According to the CDC (Centers for Disease Control and Prevention) Vaccine Storage and Handling Toolkit, January 2018, " ... Refrigerators should maintain temperatures between 2 degrees C (centigrade) and 8 degrees C ...Freezers should maintain temperatures between -50 degrees C and -15 degrees C ...Do not store vaccines in deli, fruit, or vegetable drawers, or in the door ...Avoid Placing Other Items in Vaccine Storage Units ...If other medications and biological products must be stored in the same unit as vaccines ...always store them below vaccines and on a different shelf. This prevents contamination...Placement of Temperature Monitoring Device...Place the buffered probe of the DDL in the center of the unit with the vaccine surrounding it...CDC recommends that DDLs (digital data logger) be set to measure and record temperatures no less frequently than every 30 minutes...check and record storage unit minimum and maximum temperatures at the start of each workday..."
On 11/29/18 at approximately 10:30 a.m., request made again to EMP 8/EMP 9 for evidence of temperature monitoring performed on vaccine storage units.
Review on 11/29/18 at approximately 1:00 p.m., of a partial copy of "refrigerator" data logger files dated 1/9/18 through 3/15/18 failed to reveal any recorded results. EMP 9 confirmed print-out recorded an " error code -50" without recording temperature readings as measured. EMP 8 stated, "...staff were to continue to log twice daily temps..." when the loggers were put in place in January 2018. "...additional training is needed for staff..." EMP 8 confirmed clinic did not have evidence for monitoring the vaccine/other biologic refrigerator or freezer units since 1/8/18. EMP 8 produced the CDC (Centers for Disease Prevention and Control) Storage and Handling Toolkit and stated, "staff are expected to follow the guidelines..." Clinic Policy did not identify Toolkit as the adopted guidelines for storage and handling of drugs and biologics.
Plan of Correction:J0023 Maintenance -
Davidsville Rural Health Clinic staff members were not maintaining refrigerator and freezer temperatures. The Davidsville Rural Health Clinic cannot correct 2016, 2017. To come into compliance with this policy the handling of drugs and biologicals will be done in accordance with all state and federal OSHA guidelines. The Davidsville Rural Health Clinic will be re-educated on the Drug and Biological Storage Policy that will include proper security, storage and disposal of drugs and biologicals. The Drug and Biological Storage Policy will be amended to include the reference source; Centers for Disease Control and Prevention Vaccine Storage & Handling Toolkit provides guidelines for the storage and monitoring of temperatures for vaccines. The purpose of these guidelines are to ensure the accuracy of refrigerator and freezer temperatures to ensure patient safety. Education on the Drug and Biological Storage Policy, Laboratory Policy manual and the Centers for Disease Control and Prevention Vaccine Storage & Handling Toolkit will be completed for all staff members by the Director of Clinical Services for Conemaugh Physician Group by 1/11/2019.
The Registered Nurse in the Davidsville Rural Health Clinic will monitor refrigerator and freezer temperatures according to the Drug and Biological Storage Policy, and report compliance to the Director of Operations for Conemaugh Physician Group weekly for four weeks and then monthly. The Registered Nurse in the Davidsville Rural Health Clinic will be designated the vaccination and medication coordinator for the clinic, the EMP 4 LPN will be designated as alternate in the absence of the primary coordinator (the Registered Nurse) and assist the Director of Operations to maintain quality and efficiency standards set within the clinic.
Maintaining refrigerator and freezer temperature monitoring will be included in the hiring orientation packet and reviewed with annual program evaluation in January of each year, competencies in March/April of each year, mock survey readiness in October/November of each year.
491.7(a)(2) STANDARD
BASIC REQUIREMENTS
Name - Component - 00
The organization's policies and its lines of authority and responsibilities are clearly set forth in writing.
Observations:
Based on review of organizational chart, job descriptions, and interview with staff (EMP), the clinic's lines of authority and responsibilities were not clearly set forth in writing and did not reveal who was responsible for the day-day operations of the clinic.
Findings included:
Surveyor unable to enter clinic on 11/27/18 at approximately 10:30 a.m., told to wait by the front office staff till a nurse was available. At approximately 10:55 a.m., EMP 4 came to waiting room door and stated, did not understand purpose of a rural health clinic certification survey and that patient care took priority, "why are you here? ...will have to wait ...you didn't make an appointment ...we are busy..." After a third request to front office staff at approximately 11:22 a.m., to speak with physician or someone in charge, surveyor was told practice manager was not in today and physician was aware of surveyor presence. EMP 9 arrived at approximately 11:30 a.m., from an off-site location and apologized for the delay. EMP 9 (clinical director for multiple medical practices) confirmed, the practice manager (EMP 8) was not onsite or available.
Organizational chart reviewed on 11/27/18 at approximately 11:45 a.m., failed to reveal a practice manager position/clinic manager position or ownership oversight of the clinic. Per the organizational chart authority for the clinic originated with the medical director who then directed all staff (CRNP, RN, LPN, office assistants). Surveyor was unable to determine by review of chart what position was responsible for day-day operations of the clinic.
Verification of Clinic Data - Rural Health Clinic Program form completed by EMP 9 on 11/27/18 attested to DLP Conemaugh Physician Practice, LLC ownership of clinic site. Governing body of physician practice was not identified on the organizational chart.
Job description, Certified Nurse Practitioner [CRNP], read "Reports to Medical Director..."
Job description, Physician Assistant, read "Reports to Director of Primary Care/Specialty..."
Job description, RN [registered nurse], read "Reports to Medical Director..."
Job description, LPN [licensed practical nurse], read "Reports to Office Manager..."
Job description, Medical Office Assistant, read "Reports to Office Manager..."
Job description, Front Office Assistant, read "Reports to Office Manager..."
Job description not found for office manager.
During interview on 11/27/18 at approximately 3:30 p.m., EMP 9 confirmed organizational chart required an update.
Plan of Correction:J0032 – Basic Requirements
Davidsville Rural Health Clinic staff members failed to provide clear lines of authority and responsibility of who is responsible for the day-to-day operations of the clinic. The policy manual will be updated to include clear lines of authority and responsibility to ensure all staff members understand who is responsible. The Organizational Chart will be updated and placed in the RHC policy and procedure manual. The job descriptions will be updated to reflect clear lines of authority and responsibility and that staff members of the Davidsville RHC report to the Director of Operations for Conemaugh Physician Group. The Director of Operations for Conemaugh Physician Group is responsible for the day-to-day operations of the clinic. All staff members report to the Director of Operations for Conemaugh Physician Group. All staff members will be re-educated by the Clinical Services Director for the Conemaugh Physician Group by 1/11/2019 on the Director of Operations for Conemaugh Physician Group is responsible for the day-to-day operations of the clinic.
Education for authority and responsibility for the day-to-day operations of the Davidsville Rural Health Clinic will be included in the hiring orientation packet and reviewed with annual program evaluation in January of each year. The Director of Operations will review the orientation packet and ensure the monitoring and compliance of the training for the day-to-day operations of the Davidsville Rural Health clinic.
491.8(b)(2) STANDARD
PHYSICIAN RESPONSIBILITIES
Name - Component - 00
(2) In conjunction with the physician assistant and/or nurse practitioner member(s), participates in developing, executing, and periodically reviewing the clinic's ... written policies and the services provided to Federal program patients.
Observations:
Based on review of Policy & Procedure manual and interview with staff (EMP), the clinic failed to demonstrate the physician had participated in periodical review of the clinic's written policies and the services provided to Federal program patients for 2018 or years previous to 2017.
Findings included:
Review on 11/28/18 at approximately 3:05 p.m., of clinic's policy and procedure manual revealed signature sheet which read, "The [name of practice group] Policy and Procedure Manual has been reviewed and approved by the following: RHC/Medical Director [physician name typed in], PA/APRN: [name typed in for PA-C, Physician Assistant], Practice Manager: [name typed in] with Review Date: 6/1/17 [hand written date entered]" Additional name entered for CRNP (nurse practitioner) "joined 12/1/17 ..." with PA-C noted as left 8/31/17.
Evidence for annual review by staff in 2018 was not found. Request made to EMP 8 and EMP 9 for previous reviews, with evidence not found, "should be here ...can't find..." and confirmed evidence for annual review by the physician in 2018 was not found at time of survey.
Plan of Correction:J0047 Physician Responsibilities
The Davidsville Rural Health Clinic staff cannot correct years prior to 2017 but a program evaluation meeting occurred 12/7/2018 lead by the Clinical Services Director for the Conemaugh Physician Group and included a review of Policy & Procedure manual. It was signed as reviewed by all staff members in attendance to include Rural Health Clinic Medical Director and the CRNP nurse practitioner, the non-clinic healthcare provider and community member.
To protect patients in the future the Policy & Procedure manual will be reviewed with annual program evaluation in January of each year, and will be completed by 1/11/2019. All staff members will be re-educated by the Clinical Services Director for the Conemaugh Physician Group by 1/11/2019 on the annual program evaluation. The Director of Operations will include the education on hire with orientation and will monitor that the annual program evaluation is completed each program year.
491.8(b)(3) STANDARD
PHYSICIAN RESPONSIBILITIES
Name - Component - 00
(3) Periodically reviews the clinic's ... patient records, provides medical orders, and provides medical care services to the patients of the clinic ... .
Observations:
Based on review of the clinic policy and interview of staff (EMP), the clinic failed to ensure the physician performed periodic reviews of the clinic's patient clinical records cared for by non-physician provider EMP 2 (nurse practitioner).
Finding included:
Review on 11/29/18 at approximately 11:30 a.m., of clinic's policy manual did not reveal a policy that specified physician to perform the periodic review of the clinical records of patients cared for by non-physician practitioners, nor was a frequency with a maximum interval between clinical record reviews established.
Request made to EMP 8 and EMP 9 for evidence of the last physician's periodic review of clinical records for the nurse practioner providing care to patients at the clinic, with none found. The surveyor was informed the practice manager performs the clinical record reviews for the annual program evaluation.
During interview on 11/29/18 at approximately 12:30 p.m., medical director confirmed to not perform a formalized review of clinical records for patients cared for by EMP 2, "...we talk and discuss any findings or concerns...practice act does not require counter-signature..."
Plan of Correction:J0048 Physician Responsibilities
Davidsville Rural Health Clinic staff members failed to ensure the physician performed periodic reviews of the clinic's patient clinical records cared for non-physician provider, nurse practitioner according to Review of Clinic Records policy. The Davidsville Rural Health Clinic staff cannot correct years prior to 2017.
To come into compliance the Review of Clinic Records policy was updated to reflect the number of medical records that must be reviewed for the program year. The Davidsville Rural Health program evaluation meeting occurred 12/7/2018 lead by the Clinical Services Director for the Conemaugh Physician Group and included a review of Policy & Procedure manual. It was signed as reviewed by all staff members in attendance to include Rural Health Clinic Medical Director and the CRNP nurse practitioner the non-clinic healthcare provider and community member. The Davidsville Rural Health Clinic staff members were educated that they will audit at least a 5% sample of patient records for each provider that include open and closed medical records. The Rural Health Clinic Medical Director will audit the medical record reviews of patients cared for by the Rural Health Clinic's nurse practitioner. The Davidsville Rural Health Clinic's Registered Nurse will be responsible for making sure a 5% sample of medical records to include open and closed records is completed monthly for each provider. The Davidsville Rural Health Clinic's Registered Nurse will be responsible to fax completed medical record reviews to the Director of Operations for Conemaugh Physician Group monthly.
Policy & Procedure manual will be reviewed with annual program evaluation in January of each year, and will be completed by 1/11/2019.
491.8(c)(1) - (2) STANDARD
PHYSICIAN ASST/NURSE PRACT. RESPONSIBILITIES
Name - Component - 00
(1) The physician assistant and the nurse practitioner members of the clinic's ... staff:
(i) Participate in the development, execution, and periodic review of the written policies governing the services the clinic ... furnishes;
(ii) Participate with a physician in a periodic review of the patients heath records.
(2) The physician assistant or nurse practitioner performs the following functions, to the extent they are not being performed by a physician:
(i) Provide services in accordance with the clinic ' s ... policies;
(ii) Arranges for, or refers patients to, needed services that cannot be provided at the clinic ... ; and
(iii) Assures that adequate patient health records are maintained and transferred as required when patients are referred.
Observations:
Based on review of Policy & Procedure manual and interview with staff (EMP), the clinic failed to demonstrate the certified registered nurse practioner (CRNP) participated in periodic review of the clinic's written policies and the services provided to Federal program patients and participated with a physician in the periodic review of the patients health records.
Findings included:
Review on 11/28/18 at approximately 3:05 p.m., of clinic's policy and procedure manual revealed signature sheet which read, "The [name of practice group] Policy and Procedure Manual has been reviewed and approved by the following: RHC/Medical Director [physician name typed in], PA/APRN: [name typed in for PA-C, Physician Assistant], Practice Manager: [name typed in] with Review Date: 6/1/17 [hand written date entered]. " Additional name entered for CRNP "joined 12/1/17..." with PA-C noted as left 8/31/17. The surveyor could not determine the date EMP 2 (nurse practitioner) reviewed and approved the clinic's Policy and Procedure Manual.
During interview on 11/28/18 at approximately 3:30 p.m., EMP 8 confirmed addition of name to the previously created document did not reflect date when nurse practitioner reviewed and approved the clinic's policies and procedures.
During interview on 11/29/18 at approximately 12:30 p.m., medical director and nurse practitioner confirmed periodic reviews of clinical records was not done as a formal process with documented evidence for review.
Plan of Correction:J0051
Davidsville Rural Health Clinic staff members failed to demonstrate that the nurse practitioner had participated in periodical review of the clinic's written policies and the services provided to Federal program patients or participated with the physician in the periodic review of patients' health records.
The Davidsville Rural Health Clinic staff attended a program evaluation meeting on 12/7/2018 lead by the Clinical Services Director for the Conemaugh Physician Group and included a review of Policy & Procedure manual. It was signed as reviewed by all staff members in attendance to include Rural Health Clinic Medical Director and the CRNP nurse practitioner the non-clinic healthcare provider and community member. The Davidsville Rural Health Clinic staff members were educated that they will audit at least a 5% sample of patient records for each provider that will include open and closed medical records. The Rural Health Clinic's nurse practitioner will participate in the medical record reviews of patients and document those reviews. The Davidsville Rural Health Clinic's Registered Nurse will be responsible for making sure a 5% sample of medical records to include open and closed records is completed monthly for each provider. The Davidsville Rural Health Clinic's Registered Nurse will be responsible to fax completed medical record reviews to the Director of Operations for Conemaugh Physician Group monthly.
Policy & Procedure manual will be reviewed with annual program evaluation in January of each year, and will be completed by 1/11/2019.
491.9(b)(2) STANDARD
PATIENT CARE POLICIES
Name - Component - 00
The policies are developed with the advice of a group of professional personnel that includes one or more physicians and one or more physician's assistants or nurse practitioners. At least one member of the group is not a member of the clinic ...staff.
Observations:
Based on review of policy and procedure manual and interview with staff (EMP), the clinic failed to ensure policies were developed with the advice of a group of professional personnel that included at least one non-clinic healthcare practitioner.
Findings included:
Review on 11/28/18 at approximately 3:05 p.m., of clinic's policy and procedure manual revealed signature sheet which read, "The [name of practice group] Policy and Procedure Manual has been reviewed and approved by the following: RHC/Medical Director [physician name typed in], PA/APRN: [name typed in for PA-C, Physician Assistant], Practice Manager: [name typed in] with Review Date: 6/1/17 [hand written date entered]." Additionally, an undated notation was entered with hand-written name for CRNP (nurse practitioner) "joined 12/1/17..." and PA-C notated as "left 8/31/17." Document did not identify a non-clinic healthcare practitioner who participated in the development, review and approval of the clinic policy and procedure manual on 6/1/17.
During interview on 11/28/18 at approximately 3:30 p.m., EMP 8 and EMP 9 confirmed signature sheet did not include evidence for non-clinic healthcare practitioner participation in advisory capacity with the clinic professional staff.
Plan of Correction:J0056 Patient Care Policies
Davidsville Rural Health Clinic staff members failed to demonstrate that the policies were developed with the advice of a group of professional personnel that included at least one non-clinic healthcare practitioner.
The Davidsville Rural Health Clinic staff attended a program evaluation meeting on 12/7/2018 lead by the Clinical Services Director for the Conemaugh Physician Group and included a review of Policy & Procedure manual. It was signed as reviewed by all staff members in attendance to include Rural Health Clinic Medical Director and the CRNP nurse practitioner the non-clinic healthcare provider and community member. To maintain consistent review of the Policy & Procedure manual an annual review will occur January of each program year and the Policy & Procedure manual will be reviewed and approved by a non-clinic healthcare provider. The Davidsville Rural Health Clinic registered nurse will be responsible for making sure a new employee reviews the Policy & Procedure manual and will add their signature on a separate page to the Rural Health Clinic Policy & Procedure manual. Policy & Procedure manual review will occur for a new employee upon hire during the orientation period, and then be reviewed annually and will occur January of each program year.
491.9(b)(3) STANDARD
PATIENT CARE POLICIES
Name - Component - 00
The policies include:
(i) A description of the services the clinic ... furnishes directly and those furnished through agreement or arrangement;
(ii) Guidelines for the medical management of health problems which include the conditions requiring medical consultation and/or patient referral, the maintenance of health care records, and procedures for the periodic review and evaluation of the services furnished by the clinic ...; and
(iii) Rules for the storage, handling, and administration of drugs and biologicals.
Observations:
Based on review of clinic policy and procedure and interview with staff (EMP), the professional advisory group failed to ensure the rules for the storage, handling, and administration of drugs and biologicals defined the frequency for temperature monitoring of refrigerated/frozen drugs/biologicals, the recommended temperatures to maintain the respective storage units, or the monitoring of ambient air temperature for the storage areas for drugs, reagents, and lab supplies of the clinic.
Findings included:
Review on 11/28/18 at approximately 3:20 p.m., of "Drug and Biological Storage Policy ... Drug Storage...drugs must not be exposed to sunlight, bright artificial light, moisture, or extremes of temperature ...cold is defined as any temperature not exceeding 8 degrees C [centigrade]...Excessive heat is considered to be any temperature above 40 degrees C ... "
Policy did not identify temperature range in which drugs and biologics stored within the refrigerator or freezer were to be maintained, nor a monitoring frequency for the respective storage areas. Temperature monitoring for Reagents and lab supplies was not defined by the policy.
During interview on 11/29/18 at approximately 1:00 p.m., EMP 8 provided to surveyor the CDC (Centers for Disease Prevention and Control) Storage and Handling Toolkit and stated, "staff are expected to follow the guidelines..." Policy did not identify Toolkit as the adopted guidelines for storage and handling of drugs and biologics.
Plan of Correction:J0057 Patient Care Policies
Davidsville Rural Health Care staff members, and professional advisory group failed to ensure the rules for the storage, handling, and administration of drugs and biologicals defined the frequency for temperature monitoring of refrigerated/frozen drugs/biologicals, the recommended temperatures to maintain the respective storage units, or the monitoring of ambient air temperature for the storage areas for drugs, reagents and lab supplies of the clinic. The Davidsville Rural Health Clinic will be re-educated on the Drug and Biological Storage Policy that will include proper security, storage and disposal of drugs and biologicals. The handling of drugs and biologicals will be done in accordance with all state and federal OSHA guidelines. The Laboratory Policy manual includes all manufacturer's information for proper storage and handling and temperature monitoring for reagents and lab supplies. The Drug and Biological Storage Policy will be amended to include the reference source; Centers for Disease Control and Prevention Vaccine Storage & Handling Toolkit provides guidelines for the storage and monitoring of temperatures for vaccines. Education on the Drug and Biological Storage Policy, Laboratory Policy manual and the Centers for Disease Control and Prevention Vaccine Storage & Handling Toolkit will be completed for all staff members by the Director of Clinical Services for Conemaugh Physician Group by 1/11/2019.
To maintain the rules for the storage, handling, and administration of drugs and biologicals the Davidsville Rural Health Clinic Registered Nurse will monitor refrigerator and freezer temperatures, ambient room temperatures, out dated reagents, drugs and biologicals according to RHC policy and document and then send the report to the Director of Operations for Conemaugh Physician Group weekly for four weeks, and then monthly. The Registered Nurse in the Davidsville Rural Health Clinic will be designated the vaccination and medication coordinator for the clinic, the EMP 4 LPN will be designated as alternate in the absence of the primary coordinator (the Registered Nurse) and assist the Director of Operations to maintain quality and efficiency standards set within the clinic. Monitoring the rules for the storage, handling, and administration of drugs and biologicals will be included in the hiring orientation packet and reviewed with annual program evaluation in January of each year, competencies in March/April of each year, mock survey readiness in October/November of each year.
491.9(b)(4) STANDARD
PATIENT CARE POLICIES
Name - Component - 00
These policies are reviewed at least annually by the group of professional personnel required under paragraph (b)(2) of this section and reviewed as necessary by the clinic ....
Observations:
Based on review of policy and procedure manual and interview with staff (EMP), the clinic failed to ensure policies were reviewed annually by the advisory group of professional personnel that included at least one non-clinic healthcare practitioner.
Findings included:
Review on 11/28/18 at approximately 3:05 p.m., of clinic's policy and procedure manual revealed signature sheet dated 6/1/17. Document did not identify a non-clinic healthcare practitioner who participated in the development, review and approval of the clinic policy and procedure manual on 6/1/17. Evidence of additional reviews for policies and procedures were not found.
During interview on 11/28/18 at approximately 3:30 p.m., EMP 8 and EMP 9 confirmed signature sheet did not include evidence for non-clinic healthcare practitioner participation in advisory capacity with the clinic professional staff for the 2017 review of clinic's policy and procedure manual and previous reviews could not be found at time of survey.
Plan of Correction:J0058 Patient Care Policies
Davidsville Rural Health Clinic staff members failed to demonstrate that the policies were reviewed annually by the advisory group of professional personnel that included at least one non-clinic healthcare practitioner.
A non-clinic healthcare provider will participate in the development, review and approval of clinic policy and procedure manual by 1/11/2019. The Davidsville Rural Health Clinic staff cannot correct years prior to 2017.
To come into compliance and to demonstrate that the policies were reviewed annually by the advisory group of professional personnel that included at least one non-clinic healthcare practitioner the Davidsville Rural Health program evaluation meeting occurred 12/7/2018 lead by the Clinical Services Director for the Conemaugh Physician Group and included a review of Policy & Procedure manual. It was signed as reviewed by all staff members in attendance to include Rural Health Clinic Medical Director and the CRNP nurse practitioner the non-clinic healthcare provider and community member. To maintain consistent review of the Policy & Procedure manual an annual review will occur January of each program year and will include a non-clinic healthcare provider. The Davidsville Rural Health Clinic registered nurse will be responsible for making sure that a new employee reviews the Policy & Procedure manual and will add their signature on a separate page to the Rural Health Clinic Policy & Procedure manual. Policy & Procedure manual review will occur for a new employee upon hire during the orientation period, and then be reviewed annually and will occur January of each program year.
491.9(c)(2) STANDARD
DIRECT SERVICES - LABORATORIES
Name - Component - 00
Laboratory. These requirements apply to RHCs but not ... The RHC provides laboratory services in accordance with part 493 of this chapter, which implements the provisions of section 353 of the Public Health Service Act. The RHC provides basic laboratory services essential to the immediate diagnosis and treatment of the patient, including:
(i) chemical examinations of urine by stick or tablet methods or both (including urine ketones),
(ii) hemoglobin or hematocrit,
(iii) blood glucose;
(iv) examination of stool specimens for occult blood;
(v) pregnancy tests; and
(vi) primary culturing for transmittal to a certified laboratory.
Observations:
Based on review of clinic policies, laboratory service logs, direct observation and interview with staff (EMP), the clinic failed to provide the six required basic laboratory services or possess a CLIA (Clinical Laboratory Improvement Amendments) certificate for all the waived tests performed onsite.
Findings included:
Review on 11/28/18 at approximately 9:30 a.m., clinic policy titled, Provision of Services read, "...[hand written name of rural health clinic]...Basic laboratory services essential to the immediate diagnosis and treatment of the patient, including: (i) Chemical examinations of urine by stick or tablet method or both (including urine ketones); (ii) Hemoglobin or hematocrit; (iii) Blood glucose; (iv) Examination of stool specimens for occult blood; (v) Pregnancy tests; and (vi) Primary culturing for transmittal to a certified laboratory..." An undated hand written entry was evident for additional tests "Rapid Strep, Rapid Influenza..."
Additional policy provided on 11/28/18 at 11:55 a.m., Laboratory Policy with effective date of 5/3/10 which read "...[hand written previous name of clinic] laboratory is registered as a CLIA waived laboratory...The CLIA certificate of waiver will be displayed in the laboratory at all times...The following waived tests are performed onsite: Rapid Strep, Urinalysis by Dipstick, Urine Pregnancy test, Blood Glucose by finger stick, Rapid Flu, Fecal Occult Blood..."
During observational tour of clinic laboratory area on 11/27/18 at approximately 12:30 p.m., revealed CLIA Certificate of Waiver #39D0182188, effective 7/6/18 with waived tests identified for provision onsite as "throat screen [CLIA Waived], pregnancy [CLIA Waived], whole blood glucose [CLIA Waived], hematocrit [CLIA Waived] and dipstick urinalysis." Certificate did not include Rapid Flu or fecal occult blood.
During observational tour of clinic exam rooms 1, 2, 3 and 4 on 11/27/18 between 1:00 p.m. and 2:00 p.m., found supplies to obtain Fecal Occult Blood testing, and tour of laboratory revealed testing supplies for Rapid Flu testing.
During interview on 11/28/18 at approximately 10:00 a.m., EMP 8 and EMP 9 confirmed findings, "...will get CLIA [certificate] updated..." and EMP 8 stated, regarding hemoglobin or hematocrit testing, "...don't do them here...lab services [not operated by the RHC] draw blood onsite in the morning..."
Plan of Correction:J0061 Direct Services – Laboratories
To correct this and come into compliance Davidsville Rural Health clinic staff members have submitted a change to the Department of Health Bureau of Laboratories on 12/21/2018 to change the state permit and CLIA license to include rapid influenza testing. All staff members will be re-educated by the Clinical Services Director for the Conemaugh Physician Group by 1/11/2019 on the laboratory services provided by the Davidsville Rural Health Clinic. To maintain consistent review of the laboratory services an annual review will occur January of each program year and will include review of CLIA testing. The Davidsville Rural Health Clinic registered nurse will be responsible for making sure that a new employee reviews the Laboratory manual and will add their signature on a separate page to the Rural Health Clinic Policy & Procedure manual. Policy & Procedure manual review will occur for a new employee upon hire during the orientation period, and then be reviewed annually and will occur January of each program year. The Director of Operations will monitor that the annual program evaluation is completed each program year.
491.9(c)(3) STANDARD
DIRECT SERVICES - EMERGENCY
Name - Component - 00
The clinic ... provides medical emergency procedures as a first response to common life-threatening injuries and acute illness, and has available the drugs and biologicals commonly used in life saving procedures, such as analgesics, anesthetics (local), antibiotics, anticonvulsants, antidotes and emetics, serums and toxoids.
Observations:
Based on review of the clinic policy, direct observation, and interview with staff (EMP), the clinic failed to maintain drugs/biologics from the drug types of antibiotics, emetics, serums.
Findings included:
During tour of clinic patient care area and patient intake area on 11/27/18 between 11:40 a.m. and 12:30 p.m., poison control number was not observed posted at any phone utilized by staff.
During interview on 11/27/18 at approximately 2:30 p.m., EMP 4 confirmed emetic was not stocked as part of emergency kit; when questioned what staff do in case of ingested poisoning, "don't know...hasn't happened...we haven't talked about it...would call 911...they respond quickly..." EMP 4 confirmed poison control number was not posted anywhere, "...it used to be..." EMP 4 confirmed Epinephrine was the only injectable medication in the emergency kit, no antibiotics on site, or immune globulin in refrigerator stock.
Review on 11/28/18 at approximately 3:50 p.m., of clinic policy titled Rural Health Clinic Manual - CMS regulations, read "...7. Be able to provide first response emergency care including necessary drugs that include analgesics, anesthetics, antibiotics, anticonvulsants, antidotes and emetics, serums and toxoids..." Policy was not dated.
During interview on 11/29/18 at approximately 12:30 p.m., EMP 8 confirmed the clinic doesn't stock a lot of emergency response medications, would sent to hospital if needed. "Clinic isn't set up to do that..."
Plan of Correction:J0062 Direct Services – Emergency
The Davidsville Rural Health Clinic staff members down loaded a copy of the Mr. Yuk trademark with phone number 1-800-222-1212 and posted it in the clinic. The Director of Clinical Services purchased Mr. Yuk stickers and also posted those in the clinic. The Davidsville Rural Health Clinic staff members will be educated in the event of ingested poisoning to contact the Poison Control Center by 1/11/2019. To ensure that RHC staff members are aware it will be reviewed annually
The Davidsville Rural Health Clinic staff members will be educated in the event of ingested poisoning to contact the Poison Control Center. All appropriate staff members will be re-educated of our Rural Health Clinic Policy and Procedure Manual, Medical Emergency Plan by the Director of Clinical Services for Conemaugh Physician Group by 1/11/2019.
To ensure that the staff members competency in the knowledge of this policy continues all staff members will review this policy upon hire during their orientation period and then with the annual evaluation review in January of each year. The Davidsville Rural Health Clinic registered nurse will be responsible for making sure that a new employee reviews the Policy & Procedures manual. The Director of Operations will include the education on hire with orientation and will monitor that the annual program evaluation is completed each program year.
491.10(b)(1) STANDARD
PROTECTION OF RECORD INFORMATION
Name - Component - 00
The clinic ... maintains the confidentiality of record information and provides safeguards against loss, destruction, or unauthorized use.
Observations:
Based on observation, review of clinic policy and interview with staff (EMP), the clinic failed to provide safeguards against loss, destruction or unauthorized use of medical records stored in boxes or on a shelf in unsecured areas.
Findings included:
During tour of clinic on 11/27/18 at approximately 12:25 p.m., observed storage room next to Exam room #2 with five (5) stacked boxes of medical records propped against open door to storage room and an additional 4 rows of stacked boxes of medical records against the length of the wall. Utility cart located next to copier and shredder located in same same room had seven (7) boxes of medical records stacked. Additional clinical supplies were stacked on top of the boxed medical records. Surveyor observed, one patient file, with a death report visible to be read, was on top of the row of boxes against the right wall as entering the room. A portable fan was placed on top of the death report. Door could not be closed due to stack of boxes located against the door.
Observation of storage room next to exam room 5 contained a shelving unit holding approximately six (6) medical record files on the top shelf. Door was not secured.
During interview on 11/27/18 at approxiamtely 2:30 p.m., EMP 4 stated, "boxes are from clinic that merged with us...waiting for appointments..." EMP 4 did not know why additional patient files were located on shelving unit.
Review on 11/28/18 at approximately 9:30 a.m., of policy revealed, "Patient Health Records - Medical Records System...the Clinic maintains an EMR system...The clinic will maintain confidentiality...provides safeguards against loss, destruction or unauthorized use..." Policy did not address the paper medical records not yet incorporated into the electronic health record.
EMP 8 stated on 11/28/18 at approximately 12:30 p.m., the patient files located on the shelving unit were awaiting staff to scan into the respective electronic health records. EMP 8 locked door while surveyor present. Confirmed files were not secured with door unlocked. EMP 8 confirmed stacks of boxed medical records were obstructing the closure of the storage room in which they were located and were not secured, "...will have to work on that...space is limited here..."
Plan of Correction:J0072 – Protection of Record Information
To come into compliance with this policy the storage areas in the clinic were rearranged to move patient records to a locked location within the clinic. All staff members will be re-educated of our Rural Health Clinic Policy and Procedure Manual, Patient Health Records by the Director of Clinical Services for Conemaugh Physician Group by 1/11/2019.
To ensure that the staff members competency in the knowledge of this policy continues all staff members will review this policy upon hire during their orientation period and then with the annual evaluation review in January of each year. The Director of Operations will include the education on hire with orientation and will monitor that the annual program evaluation is completed each program year.
491.11(a) STANDARD
ANNUAL TOTAL PROGRAM EVALUATION
Name - Component - 00
The clinic ... carries out, or arranges for an annual evaluation of its total program.
Observations:
Based on review of clinic policy and procedure manual, clinic documentation, and interview with staff (EMP), the clinic failed to carry out or maintain evidence for a total program evaluation performed on an annual basis.
Findings included:
Review on 11/28/18 at approximately 3:50 p.m., of document from clinic's manual read "Program evaluation ...1. Annually the clinic reviews its policies and procedures and updates any policies as necessary. Participants in this meeting include all providers in the clinic which includes the physician(s) and midlevels. In addition the office manager must be present and one community (lay) person...2. The evaluation must include a review of current services including the number of patients it serves and a description of its services ...3. A sampling of medical records must be reviewed which includes open and closed medical records...At least five active and five closed records is recommended...4. A review must also include any quality of care issues that have been documented..."
Additional review revealed, policy titled "Quality Assurance and Annual Program Evaluation...An annual review of the clinic's policies and procedures will be conducted by the clinic's executive committee..." Document titled "Executive Committee" read "The Executive Committee is made up of a group of professional personnel that includes one or more physician and one or more PA/APRN and at least on member of the group is not a member of the clinic's staff. It is the responsibility of the Executive Committee to ensure the best and most appropriate service is provided to all of its patients, particularly in each of the clinical settings...The Executive Committee will personally review and evaluate services provided by the Rural Health Clinic. Document was not dated and not signed by medical director (EMP 1). Document was signed by PA (not currently employed by clinic), CRNP (EMP 2) and EMP 4 (as office manager). Non-RHC healthcare professional member of advisory group was not identified.
Review on 11/28/18 at approximately 3:00 p.m., of Annual Meeting minutes dated 7/21/17 failed to evaluate the utilization of clinic services, practitioners adherance to accepted standards of practice, staff adherance to patient care policies, infection control and Quality Control of laboratory services, preventative maintenance program that included the proper storage and monitoring of drugs and biologics, physical construction and emergency preparedness program. Evidence for annual meetings that evaluated the total scope of services for the rural health clinic was not found for review.
During interview on 11/29/18 12:30 p.m., EMP 8 and EMP 9 confirmed above findings and that documentation of prior annual program evaluations were not found at time of survey. EMP 8 stated, "I know they were done...EMP 10 arranged them...can't find reports..." Medical director confirmed to not possess documentation of prior program evaluations for surveyor review.
Plan of Correction:J0077 Annual Total Program Evaluation
To come into compliance with this policy the clinic conducted a partial program evaluation on 12/7/2018 with Davidsville Rural Health Clinic staff members, one member of the community, Director of Operations and the Director of Clinical Services and a non-clinic healthcare provider. Information presented at this meeting included the annual volume of patients by provider, utilization of clinic services, review of policies, annual wellness visit report, efficiency of closing encounters by providers report, transition of care- follow-up calls made to patients after an emergency room visit, health maintenance tracking by patient and scanning outside results to an external order to improve the ability of staff members in locating results timely. Education on refrigerator/freezer data loggers followed the meeting. Areas of improvement identified were staff assistance in review of open and closed records, increase percentage of transition of care follow-up visits and annual wellness visits. A continuation meeting for 2018 program evaluation will be completed by 1/11/2019. Annual program evaluation policy review will occur for a new employee upon hire during the orientation period, and then be reviewed annually and will occur January of each program year.
The Director of Operations will include the education on hire with orientation and will monitor that the annual program evaluation is completed each program year.
491.11(b)(1) STANDARD
EVALUATION REVIEW CRITERIA
Name - Component - 00
The utilization of clinic ... services, including at least the number of patients served and the volume of services;
Observations:
Based on the review of the clinic's policy, annual meeting documentation and interview with staff (EMP), the clinic failed to ensure the annual program evaluation included the number of patients served and the volume of services for 2017 or have evidence evaluating the utilization of services of the clinic on an annual basis.
Findings included:
Review on 11/28/18 at approximately 3:00 p.m., of Annual Meeting minutes dated 7/21/17 revealed no report of the utilization of clinic services. Template for annual evaluation report included category for review of encounters by type which was not completed and a CPT code analysis by provider which contained a service transaction report that did not show a distinction for providers. Report revealed a four month period Jan-April 2017 CPT codes, Procedure Quantity, Charge Amount, Payment Amount, Adjustment Amount with a running total. The report failed to show an analysis of the CPT code transaction report for the four month period of 2017 for the clinic. Report dated 7/21/17 did not reveal an analysis of number of patients serviced or the volume of services provided by the clinic over a specified 12 month period of time.
Review on 11/28/18 at approximately 3:50 p.m., of document from clinic's manual read "Program evaluation ...2. The evaluation must include a review of current services including the number of patients it serves and a description of its services ..."
During interview on 11/29/18 12:30 p.m., EMP 8 and EMP 9 confirmed finding and that documentation of prior annual program evaluations were not found at time of survey. Medical director confirmed to not have documentation of prior completed program evaluations for the clinic.
Plan of Correction:J0079 Evaluation Review Criteria
To come into compliance with this policy the clinic conducted a partial program evaluation on 12/7/2018 with Davidsville Rural Health Clinic staff members, one member of the community, Director of Operations and the Director of Clinical Services and a non-clinic healthcare provider. Information presented at this meeting included the annual volume of patients by provider, utilization of clinic services, review of policies, annual wellness visit report, efficiency of closing encounters by providers, transition of care- follow-up calls made to patients after an emergency room visit, health maintenance tracking by patient and scanning outside results to an external order to improve the ability of staff members in locating results timely. Education on refrigerator/freezer data loggers followed the meeting. Areas of improvement identified were staff assistance in review of open and closed records. A continuation meeting for 2018 program evaluation will be completed by 1/11/2019.
The Director of Operations will ensure the education on the Annual program evaluation and policy review will occur for a new employee upon hire during the orientation period, and then be reviewed annually and will occur January of each program year.
491.11(b)(2) STANDARD
EVALUATION REVIEW CRITERIA
Name - Component - 00
A representative sample of both active and closed clinical records; and
Observations:
Based on the review of the clinic's policy, annual meeting documentation and interview with staff (EMP), the clinic failed to ensure the annual program evaluation included a representative sample of both active and closed clinical records that included 5 percent of RHC's current patient or 50 records which ever was less for a specified year.
Findings included:
Review on 11/28/18 at approximately 3:00 p.m., of undated Medical Record Audit Forms completed by EMP 10 (previous clinical director), revealed five (5) clinical records reviewed for MD with patient visit dates of 5/15/17 and five (5) clinical records reviewed for PA-C (certified physician assistant) with patient visit dates of 5/15/17. Audits did not identify if records represented open or closed files. Additional undated audit forms found completed by EMP 8 (practice manager) revealed five (5) clinical records reviewed for MD with patient visit dates of 3/31/15 through 10/15/15 and five (5) clinical records reviewed for PA-C (physician assistant) with patient visit dates of 1/27/15 through 12/17/15. Audits did not identify if records represented open or closed files. Additional undated audit forms found completed by EMP 8 (practice manager) revealed five (5) clinical records reviewed for MD with patient visit dates of 1/24/18 and 4 for 11/26/18 and five (5) clinical records reviewed for CRNP (nurse practitioner) with patient visit dates of 8/15/18 through 11/26/18. Audits did not identify if records represented open or closed files.
Review on 11/28/18 at approximately 3:50 p.m., of document from clinic's manual read "Program evaluation ...3. A sampling of medical records. At least five active and five closed records is recommended ..."
Surveyor was unable to correlate the clinical record audits performed on an unknown date to a specific program evaluation.
During interview on 11/29/18 at approximately 12:30 p.m., EMP 8 and EMP 9 confirmed audit forms did not identify dates of completion, if the records represented open or closed files and that policy did not direct the number of record reviews correlated to the volume of patients serviced in a specified time period.
Plan of Correction:J0080
To come into compliance with this policy the clinic conducted a partial program evaluation on 12/7/2018 with Davidsville Rural Health Clinic staff members, one member of the community, Director of Operations and the Director of Clinical Services and a non-clinic healthcare provider. Information presented at this meeting included the annual volume of patients by provider, utilization of clinic services, review of policies, annual wellness visit report, efficiency of closing encounters by providers, transition of care- follow-up calls made to patients after an emergency room visit, health maintenance tracking by patient and scanning outside results to an external order to improve the ability of staff members in locating results timely. Education on refrigerator/freezer data loggers followed the meeting. Areas of improvement identified were staff assistance in review of open and closed records. A continuation meeting for 2018 program evaluation will be completed by 1/11/2019.
The Director of Operations will ensure the education on the Annual program evaluation and policy review will occur for a new employee upon hire during the orientation period, and then be reviewed annually and will occur January of each program year. The Davidsville Registered nurse, and the two licensed practical nurses were assigned to audit 8, 8, and 9 charts respectively for Dr. Reynolds and 5 each for CRNP monthly and will fax their completed reviews monthly to the Director of Operations on the third Friday of each month.
Physician will review CRNP's charts.
Those numbers which were an approximation of a 5% sample for each provider.
To ensure the safety of the patients at least 50 records will be randomly selected from 2018 and going forward a 5% sample will be completed.
The registered nurse will be responsible for getting the chart audits reviewed by Physician prior to faxing.
The Director of Clinical Operations and the Operations Manager of Primary Care will audit 10 charts from this practice also to evaluate if patient care policies are followed on a monthly basis
491.11(c)(1) STANDARD
PURPOSE OF EVALUATION
Name - Component - 00
The utilization of services was appropriate;
Observations:
Based on the review of the clinic's policy, annual meeting documentation and interview with staff (EMP), the clinic failed to ensure the annual program evaluation evaluated the effectiveness of services to meet the needs of the population serviced.
Findings included:
Review on 11/28/18 at approximately 3:00 p.m., of Annual Meeting minutes dated 7/21/17 provided to surveyor as the annual program evaluation. Minutes revealed no report of the utilization of clinic services. Template in policy and procedure manual for annual evaluation report included a category for review of encounters by type which was not completed and a category for CPT code analysis by provider which was contained a service transaction report that did not show a distinction for providers. Report revealed a four month period Jan-April 2017 CPT codes, Procedure Quantity, Charge Amount, Payment Amount, Adjustment Amount with a running total. The report failed to show an analysis of the CPT code transaction report for the four month period of 2017 for the clinic.
The annual meeting report dated 7/21/17 did not reveal an analysis of number of patients serviced or the volume of services provided by the clinic over a specified 12 month period. Report did not identify numbers of referred services. The surveyor was unable to evaluate the effectiveness of the clinic's services to meet the needs of the community.
Review on 11/28/18 at approximately 3:50 p.m., of document from clinic's manual read "Program evaluation ...2. The evaluation must include a review of current services including the number of patients it serves and a description of its services ... " The policy did not direct a process to analyze the data produced by the report.
During interview on 11/29/18 12:30 p.m., EMP 8 and EMP 9 confirmed above finding and that documentation of prior annual program evaluations with analysis for utilization of services was not found at time of survey. Medical director confirmed to not have documentation of prior completed program evaluations.
Plan of Correction:J0083
To come into compliance with this policy the clinic conducted a partial program evaluation on 12/7/2018 with Davidsville Rural Health Clinic staff members, one member of the community, Director of Operations and the Director of Clinical Services and a non-clinic healthcare provider. Information presented at this meeting included the annual volume of patients by provider, utilization of clinic services, review of policies, annual wellness visit report, efficiency of closing encounters by providers, transition of care- follow-up calls made to patients after an emergency room visit, health maintenance tracking by patient and scanning outside results to an external order to improve the ability of staff members in locating results timely. Education on refrigerator/freezer data loggers followed the meeting. Areas of improvement identified were staff assistance in review of open and closed records. A continuation meeting for 2018 program evaluation will be completed by 1/11/2019 and number of referred services by provider.
The Director of Operations will ensure the education on the Annual program evaluation and policy review will occur for a new employee upon hire during the orientation period, and then be reviewed annually and will occur January of each program year.
491.11(c)(2) STANDARD
PURPOSE OF EVALUATION
Name - Component - 00
The established policies were followed; and
Observations:
Based on review of clinic documentation and interview with staff (EMP), the surveyor was not able to assess if the clinic evaluated on an annual basis whether RHC (rural health clinic) policies were followed.
Findings included:
Annual program evaluations were not found for 2016 or any previous year and 2018.
Review on 11/28/18 at approximately 3:50 p.m., of document from clinic ' s manual read " Program evaluation ...1. Annually the clinic reviews its policies and procedures and updates any policies a necessary... "
During interview on 11/29/18 12:30 p.m., EMP 8 and EMP 9 confirmed finding and that documentation of prior annual program evaluations were not found at time of survey. Medical director confirmed to not have documentation of prior completed program evaluations.
Plan of Correction:J0084
The clinic cannot correct years 2016 or 2017. The clinic shall conduct an annual program evaluation that includes utilization of clinic services, which includes at least the number of patients served and volume of patients, a representative sample of both active and closed clinical records, and review of the clinic's health care policies. To come into compliance with this policy the clinic conducted a partial program evaluation on 12/7/2018 with Davidsville Rural Health Clinic staff members, one member of the community, Director of Operations and the Director of Clinical Services and a non-clinic healthcare provider. Information presented at this meeting included the annual volume of patients by provider, utilization of clinic services, review of policies, annual wellness visit report, efficiency of closing encounters by providers, transition of care- follow-up calls made to patients after an emergency room visit, health maintenance tracking by patient and scanning outside results to an external order to improve the ability of staff members in locating results timely. Education on refrigerator/freezer data loggers followed the meeting. Areas of improvement identified were staff assistance in review of open and closed records. A continuation meeting for 2018 program evaluation will be completed by 1/11/2019.
The Director of Operations will ensure the education on the Annual program evaluation and policy review will occur for a new employee upon hire during the orientation period, and then be reviewed annually and will occur January of each program year.
491.11(c)(3) STANDARD
PURPOSE OF EVALUATION
Name - Component - 00
Any changes are needed.
Observations:
Based on review of clinic documentation and interview with staff (EMP), the surveyor was not able to assess if the clinic evaluated on an annual basis whether RHC (rural health clinic) evaluated policies and procedures for need to change.
Findings included:
Annual program evaluations were not found for 2016 or any previous year and 2018.
Review on 11/28/18 at approximately 3:50 p.m., of document from clinic's manual read "Program evaluation ...1. Annually the clinic reviews its policies and procedures and updates any policies a necessary... "
During interview on 11/29/18 12:30 p.m., EMP 8 and EMP 9 confirmed finding and that documentation of prior annual program evaluations were not found at time of survey. Medical director confirmed to not have documentation of prior completed program evaluations.
Plan of Correction:
J0085
To come into compliance with this policy the clinic conducted a partial program evaluation on 12/7/2018 with Davidsville Rural Health Clinic staff members, one member of the community, Director of Operations and the Director of Clinical Services and a non-clinic healthcare provider. Information presented at this meeting included the annual volume of patients by provider, utilization of clinic services, review of policies, annual wellness visit report, efficiency of closing encounters by providers, transition of care- follow-up calls made to patients after an emergency room visit, health maintenance tracking by patient and scanning outside results to an external order to improve the ability of staff members in locating results timely. Education on refrigerator/freezer data loggers followed the meeting. Areas of improvement identified were staff assistance in review of open and closed records. A continuation meeting for 2018 program evaluation will be completed by 1/11/2019.
The Director of Operations will ensure the education on the Annual program evaluation and policy review will occur for a new employee upon hire during the orientation period, and then be reviewed annually and will occur January of each program year.
491.11(d) STANDARD
EVALUATION FINDINGS & ACTION TAKEN
Name - Component - 00
The clinic ... staff considers the findings of the evaluation and takes corrective action if necessary.
Observations:
Based on review of clinic documentation and interview with staff (EMP), the surveyor was not able to assess if the clinic evaluated on an annual basis whether the RHC (rural health clinic) considered the findings of an annual evaluation and took corrective actions.
Findings included:
Annual program evaluations were not found for any year but 2017. The surveyor was not able to assess if the clinic evaluated on an annual basis whether the RHC (rural health clinic) considered the findings of an annual evaluation and took corrective actions.
Review on 11/28/18 at approximately 3:50 p.m., of document from clinic's manual read "Annual Program Evaluation Policy...It will be the task of the committee to determine whether there was appropriate utilization of clinic services by patients, whether organizational policies and procedures were followed and to provide recommendations for implementation any required changes."
During interview on 11/29/18 12:30 p.m., EMP 8 and EMP 9 confirmed finding and that documentation of prior annual program evaluations were not found at time of survey. EMP 8 assured surveyor they had been done and corrective actions would be implemented.
Plan of Correction:J0086
To come into compliance with this policy the clinic conducted a partial program evaluation on 12/7/2018 with Davidsville Rural Health Clinic staff members, one member of the community, Director of Operations and the Director of Clinical Services and a non-clinic healthcare provider. Information presented at this meeting included the annual volume of patients by provider, utilization of clinic services, review of policies, annual wellness visit report, efficiency of closing encounters by providers, transition of care- follow-up calls made to patients after an emergency room visit, health maintenance tracking by patient and scanning outside results to an external order to improve the ability of staff members in locating results timely. Education on refrigerator/freezer data loggers followed the meeting. Areas of improvement identified were staff assistance in review of open and closed records, increase percentage of transition of care follow-up visits and annual wellness visits. A continuation meeting for 2018 program evaluation will be completed by 1/11/2019 and include appropriate utilization of clinic services by patients, specifics of when policies and procedures were not followed, and provide recommendations for follow-up with monitoring assistance.
The Director of Operations will ensure the education on the Annual program evaluation and policy review will occur for a new employee upon hire during the orientation period, and then be reviewed annually and will occur January of each program year.
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