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Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 a review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records and staff interview, the testing personnel and the laboratory director/designee failed to sign one of eight attestation statements from 2023, 2024, and 2025. The findings include: 1. A review of eight of the laboratory's API PT testing events in 2023, 2024 and 2025 revealed that the testing personnel and the laboratory director/designee failed to sign an attestation statement for API 2023 Event 3. 2. The office manager and assistant office manager confirmed the survey findings in an interview on 11/25/2025 at 1:45 p.m. . 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: Based on a review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records and staff interviews, the laboratory failed to review and evaluate PT results for four of eight testing events in 2023, 2024, and 2025. The findings include: 1. A review of the laboratory ' s API PT records revealed no documented evaluation or review for the following events: - 2024 Hematology 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 -- /Coagulation Event 2 - 2024 Hematology/Coagulation Event 3 - 2025 Hematology /Coagulation Event 1 - 2025 Hematology/Coagulation Event 2 2. The office manager and assistant office manager confirmed the survey findings during an interview on 11 /25/2025 at 1:45 p.m. . D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 laboratory observation, a review of quality control (QC) package inserts, QC instrument printouts, and staff interviews, the laboratory failed to ensure that they did not use hematology controls for complete blood count (CBC) testing past their expiration date for two of five lot numbers that were in use in 2025. This deficiency is a repeat deficiency identified in the previous survey conducted on 06/14/2023. The findings include: 1. Observation of the laboratory revealed a Sysmex XP-300 hematology analyzer (Serial Number: A2587) and Eightcheck-3WP Xtra QC material used for patient CBC testing. 2. A review of the QC package inserts revealed the following lot numbers used in 2025. - Lot 4303 Expiration 02/05/2025 - Lot 5021 Expiration 04/30/2025 - Lot 5105 Expiration 07/23/2025 - Lot 5189 Expiration 10/15 /2025 - Lot 5273 Expiration 01/07/2026 3. A review of the Sysmex XP-300 instrument QC printouts revealed that the laboratory used the following QC lot numbers past their expiration dates: - Lot 5021, Expiration 04/30/2025, used until 05 /07/2025, 7 days past expiration. - Lot 5189, Expiration 10/15/2025, used until 11/09 /2025, 24 days past expiration. 4. The office manager and assistant office manager confirmed the survey findings during an interview on 11/25/2025 at 1:45 p.m. -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on observation of the laboratory, lack of the laboratory records, and interview with the office manager, the laboratory failed to retain the complete blood count (CBC) quality control (QC) manufacturer assay sheets and sysmex maintenance records in 2021 (12 of 12 months) and 2022 (10 of 12 months). The findings include: 1) Observation of the laboratory on 6/14/23 at 8:15 am revealed three levels of Eightcheck-3WP Xtra (Lot: 3080) stabilized human erythrocytes in use for quality control of a Sysmex XP-300 analyzer (SN: A2587). 2) Review of laboratory records revealed the following: -Quality control (QC) manufacturer assay sheets for Eightcheck-3WP Xtra could not be provided for 2021 and 2022. -Sysmex XP-300 Maintenance Logs for analyzer SN: A2587 could not be provided by the laboratory for all of 2021 and 10 of 12 months for 2022. 3) Interview with the office manager on 6/14/23 at 12:30 pm confirmed the following: -The laboratory failed to retain the manufacturer assay sheets for historical CBC control lots used in 2021 and 2022. -The laboratory failed to retain the Sysmex XP-300 maintenance logs for all of 2021 and January through October of 2022. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality assurance plan, review of the laboratory's quality assurance records, and interview with the office manager, the laboratory failed to follow their quality assurance policy for monthly chart reviews of complete blood count (CBC) testing in 2023. The findings include: 1. Review of the laboratory's quality assessment plan states the laboratory will complete monthly chart reviews for CBC errors and discrepancies. 2. Review of the laboratory's monthly chart review log revealed no documentation of completed chart reviews for CBC errors and discrepancies for January through May of 2023. 3. Interview on 06/14/23 at 12:30 pm with the office manager confirmed the laboratory failed to complete chart reviews for CBC errors and discrepancies from the beginning of 2023 to the date of the survey. 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 of the laboratory, review of manufacturer's user manual, reagent package instructions, lack of documentation and interviews with the office manager, the laboratory failed to monitor the ambient temperature and relative humidity in the areas where the complete blood count (CBC) instrument and reagents were being used and stored for patient testing and refrigerator temperature for quality control (QC) material in 2021, 2022, and 2023. The findings include: 1. Observation of the laboratory on 6/14/23 at 8:15 am revealed the following: - Sysmex XP-300 CBC instrument (SN: A2587) in use for patient CBC testing. - Sysmex Stromatolyser-WH reagent (Lot: Y2006) used by the Sysmex XP-300 stored in ambient conditions in a storage room. - Three levels of Eightcheck-3WP Xtra QC (Lot: 3080) material stored in a Frigidaire refrigerator. 2. Review of the XP-300 Instructions for Use section titled "14.1 Specifications" revealed an operating ambient temperature range of 15 - 30 degrees Celsius (C) and a relative humidity range of 30% to 85%. 3. Review of reagent package instructions revealed the following: - Storage range for Sysmex Stromatolyser-WH reagent is between 2 - 35 degrees Celsius (C). - Storage range for Eightcheck-3WP Xtra QC material is 2 - 8 degrees Celsius (C). 4. There were no records for monitoring of refrigerator temperature, ambient temperature, or relative humidity for surveyor review. 5. Interview with the office manager on 06/14/23 at 12: 30 pm confirmed the laboratory failed to monitor refrigerator temperature, ambient temperature, or relative humidity in the areas where the Sysmex XP- 300 CBC instrument and reagents were stored and used for patient testing in 2021, 2022, and 2023. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) -- 2 of 4 -- Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of manufacturer instructions for use, and interview with the office manager, the laboratory failed to label three of three controls observed on the date of the survey (6/14/23) with corrected expiration date after the controls were opened for use. The findings include: 1. Observation of the laboratory on 6/14/23 at 8:15 am revealed three levels of Eightcheck-3WP (Lot: 3080) in use for performing quality control on the Sysmex XP-300 complete blood count (CBC) instrument. The controls were not labeled with an open date or corrected expiration date. 2. Review of the Sysmex XP-300 instructions for use in Section 9.2 "Quality Control" revealed Eightcheck-3WP controls are to be stored at 2-8 degrees Celsius (C) and states "After opening, the product is stable for 7 days if returned to the refrigerator promptly after use". 3. Interview with with the office manager on 6/14/23 at 12:30 pm confirmed the laboratory controls in use had expiration dates that changed after opening and the laboratory failed to label the controls with the corrected expiration dates for three of three controls observed. 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 review of instrument quality control (QC) printouts, review of patient test reports, and interview with the office manager, the laboratory failed to ensure controls were not used past their expiration date from 4/6/23 to 4/9/23 with a total of eight patient's results reported during the period the expired controls were in use. The findings include: 1. Review of the Sysmex XP-300 instrument (SN: A2587) QC printouts revealed three levels of Eightcheck-3WP Xtra (Lot: 2361) controls with an expiration date of 4/5/23 were used for daily QC from 4/6/23 to 4/9/23. 2. Review of patient test reports revealed a total of 8 patient complete blood counts (CBC's) were reported 4/6/23 to 4/9/23. 3. Interview with the office manager on 6/14/23 at 12:30 pm confirmed the laboratory failed to ensure controls were not used past their expiration date from 4/6/23 to 4/9/23 with patient testing performed. 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. -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on review of the Sysmex XP-300 instructions for use, review of maintenance records, and interview with the office manager, the laboratory failed to perform and document maintenance per manufacturer's requirements in 2022 and 2023. The findings include: 1. A review of the Sysmex XP-300 instructions for use in section 12.1 "Maintenance schedule" revealed the following: - Weekly: Clean SRV tray. - Every month: Clean TD and Clean waste chamber. 2. A review of the XP-300 Maintenance Logs revealed weekly maintenance was not recorded for 21 of 28 weeks reviewed and monthly maintenance was not recorded for 1 of 7 months reviewed. 3. An interview on 6/14/23 at 12:30 pm with the office manager confirmed the laboratory failed to perform and document maintenance checks for the Sysmex XP- 300 System as required by the manufacturer for 2022 and 2023. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of the laboratory's personnel report (CMS form 209), testing personnel competency assessments, and interview with the office manager, the technical consultant failed to evaluate annual competency for one of three testing personnel performing complete blood count (CBC) patient testing in 2022. The findings include: 1. Review of CMS form 209 revealed three testing personnel (TP1, TP2, and TP3). 2. Review of the laboratory's testing personnel competency assessments revealed one of three annual competencies(for TP3) were not performed in 2022. 3. Interview with the office manager on 6/14/23 at 12:30 pm confirmed TP3 was performing CBC patient testing in 2022 and the technical consultant failed to document competency assessment for TP3 in 2022. -- 4 of 4 --

Summary Statement of Deficiencies 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 the laboratory procedure manual, employee personnel records for 2018 and 2019, and interview with the laboratory supervisor, the laboratory failed to have a procedure to include all six criteria for assessing personnel competency. The findings include: 1) Review of the laboratory procedure manual revealed the following six criteria were not included in the procedure and competency documentation: direct observation of routine patient test performance; monitoring the recording and reporting of test results; review of intermediate test results or worksheets, quality control records, proficiency testing results and preventative maintenance records; direct observation of performance of instrument maintenance and function checks; assessment of test performance through previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and assessment of problem solving skills. 2) Review of the 2018 and 2019 employee personnel records revealed no documentation of competency assessment for the six required criteria for 15 out of 15 testing personnel. 3) Interview on November 25, 2019 at 12:30 p.m. with the laboratory supervisor confirmed the testing personnel competency procedure did not include the six criteria for testing personnel competency assessment required by the Centers for Medicare and Medicaid Services (CMS). D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies 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 the Complete Blood Count (CBC) Proficiency Testing (PT) records for 2016 and 2017 and upon interview with the primary testing person, determined the PT samples were not tested by twelve of thirteen testing personnel as listed on the Laboratory Personnel Report Form 209. The findings include: 1. A review of the CBC PT records for 2016 and 2017 revealed only one of thirteen testing personnel's signature on the attestation sheets. 2. An interview with the CBC primary testing person at approximately 9:30 a.m. on February 27, 2018 confirmed she was the only person of thirteen, listed on the Laboratory Personnel Report Form, who tested the proficiency testing samples for 2016 and 2017. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- the PT event. This STANDARD is not met as evidenced by: Based on review of the complete blood count (cbc) proficiency testing (PT) attestation records in 2016-17 and an interview with the primary testing person determined the laboratory director failed to ensure that all PT attestation statements are signed during 2016 and 2017. The findings include: 1. Review of the 2016 1st-3rd events and 2017 1st-3rd events PT records for cbc for the specialty of hematology revealed the laboratory director did not sign the attestation statements for testing persons during the 2016 2nd event and 2017 1st & 3rd events. 2. Interview with the primary testing person on February 27, 2018, at approximately 9:50 AM confirmed that the director failed to attest/sign attestation statements during the 2016 2nd event and 2017 1st & 3rd events. 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 review of laboratory refrigerator temperature logs, and interview with the primary testing person determined the laboratory failed to document laboratory refrigerator temperature, have an acceptable temperature criteria listed on log sheets and were not reviewed for 2016, 2017 and 2018. Findings include: 1. Review of laboratory refrigerator temperature log for 2016 revealed no documentation for temperature in March 4,10,15,16,23,24,31, April 1,7,12,21,22,23,25,28,29,30, May 1- 3,5,6,9,11,13,20,21,25,26,31, June "Biohazard frig" 1-14,23, "Vaccine frig" 4,10,18- 31, July 23, August 14,19,28-30, September 4,6,10-13,16-19,23-25, October 1- 4,6,10,17,20-22, November 3,8,11, and December 18,20-22,25-30 2016. 2 .Review of lab refrigerator temperature log for 2017 revealed no documentation for temperature in January 1-4,10,22-26,30-31, March 17,26-30, April 4-6,10-12,19,20,26-28, May 1,11,12,27,28, June 2,26,31, August 10,11, September 17,19-22,26-28, October 5,6,14,15,18-20,31, November 1,19,20,24-26, December 7,8. 2017. 3. Review of lab refrigerator temperature log for 2018 revealed no documentation for temperature in February 22, 23 2018. 4. Review of laboratory refrigerator temperature log for 2016 revealed no acceptable temperature criteria listed on log sheets for January-April and December, and April-July in 2017. 5. Review of the laboratory refrigerator temperature logs for 2016, 2017 and 2018 revealed the laboratory refrigerator temperature logs were not signed off indicating no review was done 2016, 2017 and 2018. 6. Interview with the primary testing person on February 27th at 11:00AM confirmed the laboratory failed to consistently document the laboratory refrigerator temperatures, have acceptable temperature criteria listed and were not reviewed in 2016, 2017 and 2018. D6018 LABORATORY DIRECTOR RESPONSIBILITIES -- 2 of 3 -- 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