Dr Jessica Pagana-Defazio Fpc

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manual, American Proficiency Institute (API) proficiency testing (PT) records and interview with the laboratory director (LD), the LD/designee and testing personnel (TP) failed to sign 11 of 18 API PT attestation statement documents for chemistry, hematology, and microbiology testing performed in 2021 and 2022. Findings Include: 1. The Office Lab Proficiency procedure states, "When surveys are received: Laboratory Director/Designee must sign the survey form." 2. On the day of the survey, 06/13/2023 at 10:15 am, the following 11 of 18 API PT attestation statements reviewed were not signed by the LD or designee in 2021 and 2022. - Miscellaneous Chemistry: - 2021 Event #2 - 2022 Event #1 - 2022 Event # 2 -Chemistry Core: - 2021 Event # 3 - 2022 Event # 2 - Microbiology: - 2022 Event # 1 - 2022 Event #2 - 2022 Event # 3 - Hematology /Coagulation - 2021 Event # 3 - 2022 Event # 1 - 2022 Event #2 3. The following 2 of 18 API PT attestations reviewed were not signed by TP that performed the testing: - Chemistry Core - 2021 Event # 3 - 2022 Event # 2 4. The LD confirmed the findings above on 06/13/2023 around 11:00 am. D6048 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(ii) The procedures for evaluation of the competency of the staff must include, but are not limited to monitoring the recording and reporting of test results. 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 -- This STANDARD is not met as evidenced by: Based on review of competency assessment records, and interview with the laboratory director (LD), the technical consultant (TC) failed to provide documentation for the monitoring of recording and reporting of test results for 1 of 4 testing personnel (TP) that performed complete blood cell counts (CBC) from 07/09/2022 to the date of survey. Findings include: 1. On the day of the survey, 06/13/2023 at 09:00 am, the competency assessment records revealed that the TC failed to document the monitoring of the recording and reporting of test results for 1 of 4 TP (CMS 209 TP #1) that performed CBC testing on the Cell-Dyn Emerald hematology analyzer from 07/09/2022 to 06/13/2023. 2. The LD confirmed the findings above on 06/13/2023 around 11:00 am. -- 2 of 2 --

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory 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 observation and interview with the laboratory director (LD), the laboratory failed to document maintenance for 1 of 1 refrigerator thermometer in 2021. Findings include: 1. On the day of survey, 05/26/2021, Observation of laboratory revealed, a Fisher Brand Traceable thermometer's on the laboratory refrigerator was due for service on April 17, 2021. 2. The laboratory could not provide documentation of service performed on the thermometer from April 17, 2021 to June 8, 2021. 2. The LD confirmed the finding above at the summation on 06/08/2021 around 2:10 pm. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory 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 laboratory tour, review of the Unico Power Spin Centrifuge Manuel and interview with the Laboratory Director, the laboratory failed to perform RPM (revolution per minute) function checks on the Unico Power Spin Centrifuge from April 2017 to the date of survey. Findings include: 1. Unico Power Spin Centrifuge Manuel, under the Calibartion section states, "It is recommended that your centrifuge's RPM be calibrated at least every 6 months". 2. On the day of survey, 11/09/2018, the labortaory was unable to provide documentation of RPM checks performed on the Unico Power Spin Centrifuge every 6 months. 3. The Unico Power Spin Centrifuge is used to spin chemistry specimen: - In 2017, 35,752 specimen were analyzed. - In 2018, (01/01/2018 to 10/31/2018) 34,310 specimen were analyzed. 4. The LD confirmed the findings above on 11/09/2018 around 9:00 am. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit 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 -- of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of Ace Alera calibration verification records and interview with the Labortaory Director (LD), the laboratory failed to perform calibration verification (CV) on the Ace Alera chemistry analyzer according to manufacturer's instructions in 2018. Findings include: 1. on the day of survey, 11/09/2018, according to the the Ace Alera's manufacturer's instructions, calibration verification criteria should be performed at least every six months. The laboratory last performed CV on 1/24/2018 and was due to be performed by 07/24/2018. The labortaory was unable to provide documentation of a CV performed before 07/24/2018. 2. In 2018 - 31,699 specimen were analyzed on the Ace Alera. 3. The LD confirmed the findings above on 11/09 /2018 around 09:55 am. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on testing personnel (TP) competency assessment record review and interview with the Laboratory Director (LD), the laboratory technical consultant (the LD) failed to assess the competency assessment of 2 of 4 TP for each analyzer (Ace Alera, Tosoh AIA 360 and Cell Dyn Emerald CBC) they perform testing on from 2017 to the date of survey. Findings include: 1. On the day of survey, 11/09/2018, review of competency assessment records revealed, CLIA's 6 points of competency is only assessed for testing personnel's 6 month competency and 1st yearly competency. 2. Thereafter, the LD performs a "Performance Appraisal" yearly, which does not cover all 6 points of CLIA's competency assessment and does not assess TP (2 of 4) for each analyzer (Ace Alera, Tosoh AIA 360 and Cell Dyn Emerald CBC) they perform testing on. 3. The LD confirmed the findings above on 11/09/2018 around 8:45 am. -- 2 of 2 --