Utica Park Clinic-Family Medical

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and from the proficiency testing provider. The laboratory was found out of compliance with the following CLIA Conditions: 493.803; D2016: Successful Participation 493.1407; D6000: Laboratory Director, Moderate Complexity D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the CASPER 0155D report and API (American Proficiency Institute) Performance Summaries and Comparative Evaluation records, the laboratory failed to successfully participate in a 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 -- proficiency testing program for two of two consecutive testing events in the specialty of Hematology for the analyte HCT (Hematocrit), resulting in unsuccessful performance. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the CASPER 0155D report and API (American Proficiency Institute) Performance Summaries and Comparative Evaluation records, the laboratory failed to achieve satisfactory performance for the analyte Hematocrit for two consecutive testing events in 2025. Findings include: (1) A review of the CASPER 0155D report identified the following unsatisfactory scores for Hematocrit: (a) First Event 2025 - 60% (b) Second Event 2025 - 40% (2) A review of the Performance Summaries and Comparative Evaluation records from API (American Proficiency Testing) for 2025 confirmed the above findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the CASPER 0155D report and API (American Proficiency Institute) Performance Summaries and Comparative Evaluation records, the laboratory director failed to provide overall management and direction for two consecutive testing events in 2025, resulting in unsuccessful performance. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the CASPER 0155D report and API (American Proficiency Institute) Performance Summaries and Comparative Evaluation records, the laboratory director failed to ensure successful performance in an HHS approved proficiency testing program for the analyte Hematocrit in two consecutive testing events in 2025. Refer to D2130. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 05/22/2025. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director at the conclusion of the survey. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of written policies and procedures and interview with the laboratory director, the written policy did not define the frequency of the assessments for the clinical consultant based on the position responsibilities for one of one clinical consultant. Findings include: (1) A review of the competency assessment policy titled, "Competency Assessment for Clinical Consultant" identified it did not define the frequency of the assessments; (2) Interview with the laboratory director on 05/22 /2025 at 11:05 am confirmed that although the competencies based on the position responsibilities of the clincal consultant had been performed annually, the policy did not define the frequency of assessments. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: 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 -- Based on a review of records and interview with the laboratory director, the laboratory failed to review and evaluate proficiency testing results to identify biases for one of four Hematology proficiency testing events reviewed in 2024 and 2025. Findings include: (1) A review of Hematology proficiency testing records for 2024 (first, second, and third events), and 2025 (first event) identified the following biases (biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency testing program) for one of four events: (a) Third 2024 Event: (i) RDW- CV (Hem-3S)(x10E9E/L)**- five of five results exhibited positive biases: (aa) Sample HSY-11 - SDI of 2.0 (bb) Sample HSY-12 - SDI of 2.3 (cc) Sample HSY-13 - SDI of 2.3 (dd) Sample HSY-14 - SDI of 2.4 (ee) Sample HSY-15 - SDI of 2.4 (2) There was no evidence in the records to prove the biases had been identified and addressed; (3) The records were reviewed with the technical consultant who stated on 05/22/2025 at 10:30 am, the biases had not been addressed. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 a review of records, manufacturer's instructions, and interview with the laboratory director, the laboratory failed to ensure the room temperature, relative humidity, and refrigerator temperatures had been documented as observed during the review period of June 2024 through May 2025. Findings include: I. RT (ROOM TEMPERATURE) AND RH (RELATIVE HUMIDITY): (1) On 05/22/2025 at 08:55 am the laboratory director stated the laboratory performed CBC (Complete Blood Count) using the Medonic M-Series analyzer; (2) A review of the operator's manual titled, "Medonic M-series User's Manual" under Section 2: "Installation/Operating Environment" required an operating temperature range of 18 to 32 degrees C (Centigrade) and a maximum of 80% RH; (3) A review of the daily logs from June 2024 through May 2025 identified RT and RH readings had not been recorded as follows: (a) Room Temperatures (three of 12 months): (i) January 2025 - 31 of 31 days (ii) February 2025 - 28 of 28 days (iii) March 2025 - 31 of 31 days (b) Relative Humidity (one of 12 months): (i) March 2025 - 31 of 31 days (4) The records were reviewed with the laboratory director who stated on 05/22/2025 at 11:20 am, the RT and RH readings had not been documented as stated above. II. REFRIGERATOR TEMPERATURE: (1) Observation of the laboratory on 05/22/2025 at 10:45 am, identified three bottles of Boule Con-Diff quality control materials (lot #22503-01, lot #22503-02, and lot #22503-01) stored in the refrigerator with a manufacturer's storage requirement of 2-8 degrees Centigrade (C); (2) A review of temperature logs from June 2024 through May 2025 identified the refrigerator temperature had not been recorded for two of 12 months as follows: (a) February 2025 - 28 of 28 days (days1 through day 28) (b) March 2025 - 31 of 31 days (days 1 through day 31) (3) Interview with the laboratory director on 05/22/2025 at 11:20 am confirmed the refrigerator temperatures had not been documented as performed as stated above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 09/14/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director at the conclusion of the survey. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory director, the laboratory failed to ensure a proficiency testing attestation statement had been signed by the laboratory director for one of six events reviewed during 2021, 2022, and to date in 2023. Findings include: (1) A review of the third 2021; first, second, and third 2022; and first and second 2023 Hematology proficiency testing records identified the following for one of six events: (a) Second 2022 Event - The attestation statement had not been signed by the laboratory director. (2) The findings were reviewed with the laboratory director who stated on 09/14/2023 at 10:45 am, the attestation statement had not been signed by the laboratory director. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory director, the laboratory failed to verify the accuracy of testing when the proficiency testing program did not evaluate submitted results for one of six events reviewed during 2021, 2022, and to date in 2023. Findings include: (1) A review of the third 2021; first, second, and third 2022; and first and second 2023 Hematology proficiency testing records identified the following analytes had not been evaluated by the proficiency testing program for the First 2022 Event for five of five samples (HEM-01, HEM-02, HEM-03, HEM-04, and HEM-05): (a) %Granulocytes (b) Hematocrit (c) Hemoglobin (d) %Lymphocytes (e) MCH (Mean Corpuscular Hemoglobin) (f) MCHC (Mean Corpuscular Hemoglobin Concentration) (g) MCV (Mean Corpuscular Volume) (h) %Monocytes/Mids (i) Platelet Count (j) Red Cell Count (k) White Cell Count (2) A review of the records identified no evidence verifying the laboratory had performed a self-evaluation of the non-graded results utilizing the participant data summary; (3) The records were reviewed with the laboratory director who stated on 09/14/2023 at 10:45 am, the laboratory had not performed a self-evaluation of the non-graded results. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a review of policy and procedure manual and interview with the laboratory director, the laboratory failed to ensure the procedure manual had been approved and signed by the laboratory director. Findings include: (1) On 09/14/2023 at 09:15 am, the laboratory director stated CBC (Complete Blood Count) test was performed using the Medonic M Series hematology analyzer; (2) A review of the "Policy & Procedures 21st" manual identified no evidence it had been signed as approved by the laboratory director. Examples of policies and procedures contained in the manuals were listed as follows: (a) "Policy 11.0 - CBC"; (b) "Policy 13.4 - Criteria for Repeating CBC's"; (c) "Policy 40.1 - CBC Reportable Range"; (d) "Policy 40.5 - CBC New Lot Verification: (3) The manual was reviewed with the laboratory director who stated on 09/14/2023 at 09:50 am, the policy and procedure manual had not been approved and signed by the laboratory director. D5409 PROCEDURE MANUAL CFR(s): 493.1251(e) The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance as described in 493.1105(a)(2). -- 2 of 5 -- This STANDARD is not met as evidenced by: Based on a review of the procedure manual and interview with the laboratory director, the laboratory failed to ensure that a procedure no longer in use, had been indicated as discontinued, with the date of discontinuance. Findings include: (1) On 09/14/2023 at 11:05 am, the laboratory director verified CBC testing was performed using the Medonic M analyzer; (2) The surveyor reviewed the procedure manual, and identified a procedure titled "CBC Policy", which was used for the Medonic CA670 analyzer; (3) Interview with the laboratory director on 09/14/2023 at 11:05 am, confirmed the procedure was no longer being used because the Medonic CA 620 was no longer in use. 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 and interview with the laboratory director, the laboratory failed to ensure collection tubes were stored as required in 16 of 16 patient rooms. Findings include: BLOOD COLLECTION TUBES (1) On 09/14/2023 at 09:58 am, observation of the patient room #9 identified the following examples of blood collection tubes, stored in the room: (a) BD Vacuette K2 EDTA 7.2 mg tubes - 27 tubes of lot #2347070; storage requirement of 4-25 degrees C (Centigrade); (b) BD Vacutainer SST tubes - 8 tubes of lot #2326098; storage requirement of 4-25 degrees C; (c) BD Vacutainer PST Gel Lithium Heparin tubes - 14 tubes of lot #2321412; storage requirement of 4-25 degrees C; (2) On 09/14/2023 at 09:58 am, observation of the patient room #10 identified the following examples of blood collection tubes, stored in the room: (a) BD Vacutainer K2 EDTA 7.2 mg tubes - 9 tubes of lot #2347070; storage requirement of 4-25 degrees C (Centigrade); (b) BD Vacutainer SST tubes - 11 tubes of lot #2326098; storage requirement of 4-25 degrees C; (c) BD Vacutainer PST Gel Lithium Heparin tubes - 10 tubes of lot #2321412; storage requirement of 4-25 degrees C; (3) Interview with the laboratory director 09/14/2023 at 09:58 am confirmed the laboratory was not monitoring the temperature of the patient rooms. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview with the laboratory director, the laboratory failed -- 3 of 5 -- to ensure expired supplies were not available for use. Findings include: (1) Observation of the laboratory 09/14/2023 at 09:15 am, identified the following expired collection tubes were available for use: (a) 31 BD Vacutainer buffered sodium citrate 0.109M, 3.2% tubes, lot 2321334, expired 08/31/2023. (2) Interview with the laboratory director on 09/14/2023 at 09:17 am confirmed the collection tubes were available for use. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory director, the laboratory failed to demonstrate the performance specifications for one of one replacement analyzer. Findings include: (1) On 09/14/2023 at 09:15 am, the laboratory director stated the following: (a) The laboratory began using the Medonic M Series hematology analyzer to perform CBC (Complete Blood Count) on 08/24/2021; (b) The laboratory received the Medonic M Series hematology analyzer (serial number 25112) from a sister laboratory as a replacement for the Medonic CA 620 hematology analyzer. (2) A review of records from August 2021 to the current date identified no evidence the performance specifications (i.e., accuracy, precision, reportable range) had been demonstrated on the replacement analyzer; (3) The findings were reviewed with the laboratory director who stated on 09/14/2023 at 10:00 am, the laboratory had not demonstrated the performance specifications for the replacement analyzer. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory director, the laboratory failed to ensure patient test reports included included the name of the laboratory location and the performing location for three of three patient testing reports reviewed. Findings Include: (1) On 09/14/2023 at 11:45 am, the laboratory director stated CBC testing was performed on the Medonic M analyzer; (2) A review of three patient reports (testing performed on 07/10/2023, 09/05/2023, 09/08/2023) identified -- 4 of 5 -- they did not include the name and address of the laboratory location where testing was performed for three of three patient reports: (a) The facility name was not on the reports. (b) The performing location was not on the reports. (3) The findings were reviewed with the laboratory director who stated on 09/14/2023 at 11:45 am; the name and address of the performing location was not on the patient reports. -- 5 of 5 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 08/18/2021. The findings were reviewed with the laboratory director at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory director, the laboratory failed to following the manufacturer's instructions for specimen transport and storage for 3 of 3 patient specimens. Findings include: (1) On 08/18/20201 at 10:20 am, the laboratory director stated the following to the surveyor: (a) The laboratory performed COVID-19 testing using the following instrument: (i) Sofia 2 Flu + SARS Antigen FIA (Fluorescent Immunoassay) - qualitative detection of nucleocapsid protein from influenza A and influenza B, and SARS-CoV-2 from direct nasal swabs. (2) The surveyor reviewed the manufacturer's product insert titled, "Sofia 2 Flu + SARS Antigen FIA". Under the section titled, "USING SOFIA 2" the manufacturer stated, "Warning: Results must not be interpreted past 30 minutes after inoculation. Using the Sofia 2 past this time may result in false results"; (3) The surveyor reviewed 3 test reports for patients tested between 08/11/2021 and 08/16/2021 and identified the following: (a) Patient Report #1 -Specimen collection date and time (08/11/20201 at 03:08 pm) was after the result date and time (08/11/2021 at 01:13 pm); (b) Patient Report #2 - Specimen collection date and time (08/13/20201 at 02:12 pm) was after the result date and time (08/13/2021 at 12:17 pm); (c) Patient Report #3 - Specimen collection date and time (08/16/20201 at 11:01 am) was after the result date and time (08/11/2021 at 09:06 am). (4) The surveyor was not able to determine if the 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 -- had been interpreted within the 30 minutes after inoculation since the specimen collection date and time was after the results date and time; (5) The surveyor reviewed the records with the laboratory director. The laboratory director stated on 08/18/2021 at 12:50 pm the laboratory could not prove the results had been interpreted within 30 minutes after inoculation as indicated above. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory director, the laboratory failed to perform calibration procedures as required by the manufacturer. Findings include: (1) On 08/18/20201 at 10:15 am, the laboratory director stated to the surveyor CBC (Complete Blood Count) testing was performed using the Medonic CA-620 analyzer; (2) The surveyor reviewed the manufacturer's instructions, contained in the operator's manual which were as follows: (a) Section 10.4 titled, "Calibration through a Certified Calibrator" described the step- by-step procedure for calibration of the Medonic CA-620 analyzer and stated, "Recommended calibration periods is twice a year with a "Hematology Blood Calibrator" certified by Boule. Good laboratory practice involves regular daily checks with blood controls to assure the analyzer and reagents are fully functional. Calibration procedures are carried out to minimize any possible drift caused by tolerances in reagents, environment-changes or instrument."; (3) The surveyor reviewed records from 07/13/2019 through 07/14/2021. There was no evidence the calibration procedure had been performed between 07/13/2019 and 12/31/2020; (4) The surveyor reviewed the findings with the laboratory director who stated on 08/18 /2021 at 12:15 pm, the calibration procedure had not been performed as indicated above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 05/30/19. The laboratory was found out of compliance with the following CLIA regulation: 493.1421: D6033: Testing Personnel, Moderate Complexity The findings were reviewed with the laboratory director at the conclusion of the survey. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory director, the laboratory failed to ensure proficiency testing samples were tested by personnel who routinely performed patient testing. Findings include: PART-TIME TESTING PERSON (1) At the beginning of the survey, the surveyor reviewed the Laboratory Personnel Report (Form CMS-209) completed prior to the survey. The form listed 4 testing persons (Testing person #1, testing person #2, testing person #3, and testing person #4) as performing the moderate complexity testing in the laboratory; (2) The laboratory director stated to the surveyor the moderate complexity laboratory testing performed was CBC (Complete Blood Count) (i.e. WBC (White Blood Count), RBC (Red Blood Count), Hemoglobin, Hematocrit, Platelet Count, etc.) testing using the Medonic CA620 hematology analyzer; (3) The surveyor then reviewed Hematology proficiency testing records for the Third 2017 Event; the First, Second and Third 2018 Events; and the First 2019 Event and identified testing person #4 had not performed proficiency testing in 5 of the 5 Hematology proficiency testing events; (4) The surveyor asked the laboratory director if testing person #4 had been trained to perform CBC testing. The laboratory director stated to the surveyor, testing person #4 had been trained and would fill in and perform patient testing if the laboratory was short- Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- staffed; (5) The surveyor reviewed the findings with the laboratory director, who stated to the surveyor the laboratory failed to ensure proficiency testing had been performed by all testing persons who performed patient testing. FLOAT TESTING PERSON (1) The surveyor reviewed patient test records (i.e. Specimen Log Sheets) from October 2017 through March 2019 and identified initials of an individual who performed patient testing, but who had not been listed on the Laboratory Personnel Form (Testing person #5); (2) The surveyor reviewed proficiency testing records again but could not locate documentation that proved testing person #5 had analyzed proficiency testing samples in 5 of the 5 events; (3) The surveyor asked the laboratory director if testing person #5 performed patient CBC testing. The laboratory director stated to the surveyor, testing person #5 was a float testing person who would fill in whenever the laboratory was short-staffed; (4) The surveyor reviewed the findings with the laboratory director who stated to the surveyor the laboratory failed to ensure proficiency testing had been performed by all testing persons who performed patient testing. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory director, the laboratory failed to take