Initial Comments:
Based on the findings of an on site unannounced Medicare recertification survey completed on 4/12/19, Shore Family Health Care 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 4/12/19, Shore Family Health Care 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 observation and staff (EMP) interview, the clinic failed to ensure that patient use scales were calibrated and maintained in safe operating condition, at least yearly, for three (3) of three (3) scales located within the clinic and available for patient use.
Findings Included:
During a tour of the clinic on 4/11/19 at approximately 10:00 a.m. the following scales failed to show that they were calibrated and/or maintained to be in safe operating condition within the past twelve months:
- "Tanita WB10a" [name brand] scale located directly outside of treatment room. The scale had a sticker attached that stated the next inspection was "due 11/2017". The clinic could not provide any documentation to show the scale had been inspected within the past 12 months.
- "Health Ometer" [name brand baby scale] located inside treatment room. The scale had a sticker attached that stated "PM [preventative maintenance] due 10/18 [October 2018] last done 10/17 [October 2017]. The clinic could not provide any documentation to show the scale had been inspected within the past 12 months.
- "Detecto" [name brand] located inside the laboratory room. The scale did not have a sticker that showed the last inspection date. The clinic could not provide any documentation to show the scale had been inspected within the past 12 months.
An interview with EMP1 and EMP2 on 4/11/19 at approximately 11:00 confirmed the above findings stating "we had scales brought over from another office recently". Additionally EMP1 revealed that the scales should have been inspected and calibrated "yearly".
Plan of Correction:The Clarion Hospital Bio Med Tech was notified that the three scales noted in the deficiency were in need of inspection and calibration. The calibration and inspection was completed on 4/24/2019 by the Clarion Hospital Bio Med Tech. The scales have been added to the list of PM equipment. Calibration and inspection will continue to be on an annual basis.
491.6(b)(2) STANDARD
MAINTENANCE
Name - Component - 00
Drugs and biologicals are appropriately stored; and
Observations:
Based on clinic policy and procedure, direct observations, and staff (EMP) interview, the facility failed to maintain a preventative maintenance program to ensure expired medications and supplies were not available for use. Additionally, the clinic failed to follow clinic policy and procedure for the logging and monitoring of sample medications stored in the clinic.
Findings Included:
During a tour of the clinic's patient treatment rooms on 4/11/19 at approximately 10:00 a.m., the following expired medications and supplies were discovered:
- six (6) "Max V" culture swabs with an expiration date of 12/18
- six (6) vials of Ceftriaxone [Antibiotic medication] 250mg [milligram] with an expiration date of 11/1/18
- two (2) vials of Decadron [steroid medication] 10mg/ml [milliliter] with an expiration date of 3/30/19
- two (2) vials of Adrenalin [medication for emergency life support] 1mg/ml with an expiration of 1/31/19
An interview with EMP1 and EMP2 on 4/11/19 at approximately 10:20 a.m. confirmed the above findings and verified all expiration dates.
Agency policy and procedure, reviewed on 4/11/19 at approximately 1:00 p.m. revealed " ... SAMPLE MEDICATIONS ... POLICY: All medication samples shall be logged in/out and appropriately monitored ... This will permit timely identification of patients in the even of a recall of medications. ... GUIDELINES: 1. The top portion of the Sample Medication Log Sheet ... shall be completed when a new medication is received in the office. 2. The person receiving the samples should be the one responsible for obtaining the receipt and filling it out properly. The copies of the receipts should be kept in a file in the med room. ... 5. The following should be completed: b) The patient's name, date, lot number, expiration date, and number dispensed shall be recorded on the Sample Medication Log Sheet. ... ."
During a tour of the clinic's sample medication room on 4/11/19 at approximately 10:30 a.m., This surveyor observed approximately 100 boxes of various sample medication in cardboard boxes and mesh containers on the floor of the room. An interview with EMP1 and EMP2 at approximately 10:30 a.m. revealed that these were sample medications that "were not logged in yet". When asked if one of these boxes of medications were to be used to provide sample medications to patients, would the clinic have a way to track this medication [since it has not been logged in yet], EMP1 stated "no".
Also a random selection of three (3) previously logged sample medications revealed the following discrepancies:
Janumet [medication to treat diabetes] 50/500: The physical count was 8 boxes, the clinic log revealed 14 boxes.
Nexium [medication to treat reflux]: The physical count was 11 boxes, the clinic log revealed four (4) boxes.
Tylenol liquid [medication to treat pain or fever]: The physical count was 40 boxes, the clinic log revealed 48 boxes.
EMP1 and EMP2 confirmed the above findings on 4/11/19 at approximately 10:40 a.m. by verifying the above medication counts.
Plan of Correction:All supplies that expire will be labeled when they are received into the office with an expiration date in sharpie.
Staff that stock patient care supplies will receive education on supply, medication monitoring and expiration dates on 5/02/2019 by the lead office nurse. Staff receiving the education will sign an in-service sheet indicating their participation in the education. Any staff not present for the staff meeting will be provided one-on-one education by the manager of the department upon their return.
Medications shall not be stored in areas where patients have access to them. Staff nurses will conduct an audit and rotation of stock in supply areas and exam rooms assigned to them for outdated supplies/medications and complete the Supply Audit Storage Tool weekly beginning on 5/10/2019 and continuing indefinitely. The checklist will be submitted to the lead office nurse for review. The lead office nurse will conduct monthly audits of all supply areas and exam rooms beginning on May 6, 2019 and continue indefinitely using the Fire, Safety and Quality Assurance Checklist. Health Services of Clarion, Inc., Clinical Coordinator will conduct an audit quarterly beginning on June 3, 2019, these will continue for a period of one year and then will be completed semi-annual continuing indefinitely. Any supplies found during the course of an audit will be immediately disposed of.
Staff nurses will focus on dating a multi-dose vial, after opening, with the new expiration date, 28 days (utilizing available stickers) unless otherwise stipulated by the manufacture. An assigned staff nurse will conduct a weekly audit and rotation of stock of the medication area using the Medication Storage Audit Tool. The tool will be submitted to the lead office nurse for review. The lead office nurse will conduct monthly audits of the medication area beginning on May 6, 2019 and continue indefinitely using the Fire, Safety and Quality Assurance Checklist. Health Services of Clarion, Inc., Clinical Coordinator will conduct and audit quarterly beginning on June 3, 2019, these will continue for a period of one year and then will be completed semi-annual continuing indefinitely.
Beginning on 4/29/19, continuing indefinitely, medications and supplies used for emergency life support will be opened at least once per month to check for appropriate and outdated supplies by an assigned staff nurse. This monthly review will be documented on the Emergency Medical Pack/ER Cart Checklist form. The staff nurse will submit a copy of the completed Emergency Medical Pack/ER Cart Checklist to the lead staff nurse to review. The lead staff nurse will conduct quarterly audits beginning on May 6, 2019 using the Fire, Safety and Quality Assurance Checklist continuing indefinitely.
On 4/15/19 a staff nurse was assigned to complete an audit of the medication samples. The staff nurse will use the current medication log and the sample medications will be inventoried and labeled with expiration dates in black marker and logged into the medication log by 5/15/19. When receiving samples the person receiving the samples will ensure that a receipt is included. Once the designated staff nurse receives the samples and the receipt the samples will be dated for expiration and logged into the medication log, the inventory stock count updated and the inventory rotated as needed. At the end of each business day the designated staff nurse will inspect the medication sample room and ensure that all samples received for the day have been logged in, dated, and placed on the shelf. The staff nurse will use the Daily/Weekly Medication Room Inspection Audit Tool. At the end of each week the lead staff nurse will inspect the medication sample room and verify that all sample medications received that week have been properly stored using the Daily/Weekly Medication Room Inspection Audit Tool. Expired medications will be logged out and sent to the Clarion Hospital Pharmacy for disposal. The receipt will be placed in a file in the sample medication room and kept for a period of one year from the date of receipt. Medication Sample sign out slips will be located in the medication sample room. When staff that are licensed and who are permitted to distribute medication samples are distributing sample medications, a sign out slip will be completed and placed into the bin placed on the counter. The slips will then be collected at the end of each day and logged into the medication sample log. Each week the designated staff nurse will complete and audit of the sample medication log in comparison to the sign out slips. At the end of each week the staff nurse will review the week's audit with the lead staff nurse continuing indefinitely.
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