Ear Nose & Throat Associates Of Manatee Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Ear, Nose, & Throat Associates of Manatee PA on 02/23/22. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and interview with the Licensed Practical Nurse (LPN), the laboratory failed to verify the accuracy of thyroid fine needle aspiration (FNA) adequacy assessment testing twice a year for 6 out of 6 Testing Personnel (#A - # F) for 2 out of 2 years (2020 - 2021) reviewed. Findings Included: Upon review of the policy for peer review, titled "Policy for Determination of Adequacy" adopted on 4/15 /21 and most recently signed and reviewed by the laboratory director on 10/1/21 revealed: Determination of Adequacy: Every six months the laboratory director will review the first 5 specimens of the month, for a total of 30 patients to determine adequacy. Record review revealed no peer review records for Testing Personnel, #A, #B, #C, #D, #E, and #F, for 2020 and 2021. On 02/23/22 at 10:35 AM, the LPN stated that the outside laboratory reviewed referred patient slides for diagnosis and not adequacy. The LPN confirmed that the peer review had not been performed for Testing Personnel, #A -#F, for 2020 or 2021. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Ear, Nose, & Throat Associates of Manatee PA on 10/16/19. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with the Laboratory Manager the laboratory failed to record the temperature where specimens were stored for 6 months. Findings Included: Observation, during a tour of the laboratory on 10/16/19 at 9:00 AM, revealed a small refrigerator with patient specimens. Closer observation revealed no thermometer in the refrigerator. Review of temperature charts revealed no temperatures were recorded for the small refrigerator. On 10/16/19 at 10:20 AM, the Laboratory Manager reported that the refrigerator had been in service for 6 months and confirmed that the temperatures had not been recorded. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on record review and interview with the Laboratory Manager the laboratory failed to document daily microscope cleaning and failed to have preventative maintenance documented since 01/17/18. Findings Included: Review of the Microscope Cleaning Log revealed the following instructions: Please wipe down the microscope face plate at the end of each day that it has been used and replace the cover. Then log in the date and your initials. Review of Microscope Cleaning Log entries revealed the cleaning was performed 08/10/18, 12/06/18, and 09/24/19. Review of the "...Stain Adequacy Chart" revealed testing was performed on 79 days in 2019 and no log was present to indicate how many days testing was performed in 2018. Review of maintenance records revealed no documentation of a yearly preventative maintenance performed on the microscope. Interview on 10/16/19 at 10: 40 AM with the Laboratory Manager confirmed that the daily microscope cleaning was not documented and that the microscope preventative maintenance had not been performed. -- 2 of 2 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and interview with the Office Manager, the laboratory failed to verify the accuracy of testing twice a year by only conducting peer reviews once in 2017. Findings Included: Review of peer reviews revealed that in 2017 the only peer review performed was on 11/17/17. During an interview on 01/17/18 at 1:00 PM the Office Manager confirmed that there was only 1 peer review conducted in 2017. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --