Prime Med

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) 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 reviews of the Medonic M-Series Hematology maintenance records, the Medonic M-Series User's manual, and an interview with the Laboratory Manager (LM), the laboratory failed to perform the six-month maintenance, as recommended by the manufacturer. There was no documentation the laboratory performed four out of four semi-annual cleaning procedures due in 2024-2025. The findings include: 1. A review of the Hematology maintenance records revealed the Medonic M-Series had no documentation for the six-month maintenance during the 22 months reviewed from 2024-2025. 2. A review of the Medonic M- Series User's manual revealed on page 66, "Section 8: Cleaning, Maintenance and Transport...Six Month Cleaning procedure". 3. The LM confirmed the above findings during the exit conference on 11-05-2025 at 1: 00 PM. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) (a )Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (a)(1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (a)(2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (a)(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 (a) (2)(ii) Including the number, type, and concentration of calibration materials, as well 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 -- as acceptable limits for and the frequency of calibration; and (a)(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 reviews of the Medonic M-Series User's manual, the Medonic M-Series Hematology calibration records and an interview with the Laboratory Manager (LM), the laboratory failed to perform calibration at least every six months, as required by the manufacturer. There was no record of one of two calibrations due in 2025. The findings include: 1. A review of the Medonic M- Series User's manual revealed on page 59, in Section 7: Calibration, the manufacturer's recommendation to perform calibration at least every six months. 2. A review of the Hematology calibration records revealed the Medonic M-Series had no evidence of calibration due September 2025. 3. The LM confirmed the above findings during the exit conference on 11-05- 2025 at 1:00 PM. -- 2 of 2 --

Summary Statement of Deficiencies 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 the Medonic M Series Hematology analyzer calibration records, the Medonic User's Manual and an interview with the Laboratory Director, the laboratory failed to perform and document quality controls (QC) following calibration as per manufacturer's instructions. This was noted for two out of three calibrations performed from March 2022 to the date of the current survey, 12/12/2023. The findings include: 1. A review of the Medonic Hematology records revealed calibrations and QC as follows: A) Calibration 09/27/2022 at 13:35 PM. No evidence of QC following the calibration was available for review. B) Calibration 02/22/2023 at 13:42 PM. No evidence of QC following the calibration was available for review. 2. A review of the Medonic M Series User's Manual on page 62 in the Calibration Section revealed, "...17. It is recommended to run controls after calibration to verify that all parameters have been calibrated correctly. ...". 3. During an interview on 12/12 /2023 at 12:00 PM, the above findings were reviewed and confirmed with the Laboratory Director. 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 -- 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 a final patient report and an intereview with the Laboratory Director, the laboratory failed to include all required information on test reports. This was noted for one out of one patient reports reviewed from the date of the last survey, 3/17/2022, to the date of the current survey, 12/12/2023. The findings include: 1. A review of a final patient test report for a Complete Blood Count (CBC) run on the Medonic M Series revealed only the address of the facility's sister site in Dothan, Alabama. No evidence of the physical address of the facility performing the CBC was available for review. 2. During an interview on 12/12/2023 at 12:00 PM, the Laboratory Director confirmed the above findings. 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 a review of Personnel records, a review of Proficiency Testing (PT) records, and an interview with the Laboratory Director, the Technical consultant failed to assess competency of non waived Testing Personnel for the Medonic M Series Hematology analyzer annually. This was noted for one out three Testing Personnel previously qualified since the date of the last survey, 3/17/2022. The findings include: 1. A review of Personnel records revealed Testing Personnel #1 to have competency assessments dated 6/28/2022 and 6/30/2023. The aforementioned documents only assessed competency for the BioFire respiratory panel. 2. A review of Proficiency Testing records revealed Testing Personnel #1 participated in three out of four Hematology PT events reviewed. 2. During an interview on 12/12/2023 at 12:00 PM, the Laboratory Director confirmed Testing Personnel #1 did perform patient testing on the Medonic. The Laboratory Director confirmed the absence of a competency assessment for the Medonic. -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a review of proficiency testing records, and interviews with the Laboratory Director, the surveyor determined the laboratory failed to enroll in proficiency testing (PT) with an HHS (Health and Human Services)-approved PT provider for regulated tests for the first two events in 2020 and the first two events in 2021. This affected two of three Microbiology PT survey events in 2020, and two of three Hematology and Microbiology PT survey events in 2021. The findings include: 1. During the entrance tour at 9:00 AM on 3/17/2022 the Laboratory Director stated moderate- complexity testing included a Molecular Respiratory Pathogen Panel performed on the BioFire Film Array (in use since the previous survey on 6/18/2019), and CBC's (Complete Blood Counts) performed on the Medonic M Series Hematology analyzer (in use for patient testing since 3/16/2021.) 2. A review of laboratory records revealed no documentation of proficiency testing. At approximately 9:20 AM on 3/17/2022 the Laboratory Director explained most of the laboratory records were retained electronically, and only the Clinic Administrator had access to the PT records. 3. At approximately 2:00 PM on 3/17/2022 the surveyor was provided two surveys, as follows: A) WSLH (Wisconsin State Laboratory of Hygiene) Proficiency Testing Off- Schedule Set A Hematology PT performed on 10/20/2021, and B) API (American Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- Proficiency Institute) Remedial PT Event 72R for BioFire testing performed on 9/1 /2021 4. At approximately 2:10 PM on 3/17/2022, the surveyor requested the rest of the PT records, including BioFire PT (Event 3-2019, Events 1, 2 and 3-2020) and the 2021 PT for Hematology and Microbiology. The Laboratory Director explained there were no records for 2019 since these were already packed away. The Director further stated she noticed she had not received any PT scores in July 2021, and after investigation determined Administration had failed to place the API PT order for 2021; only API Event 3-2021 surveys were available when the order was received by API in August 2021. In addition, the Laboratory Director ordered remedial or off- cycle PT surveys from other PT providers. [Only the records for the two remedial surveys listed in #3 above were available on the day of the survey.] 5. On 3/21/2022 at 7:52 AM the laboratory submitted via e-mail the following surveys for moderate- complexity testing: A) API 2020-Event #3-Microbiology performed on 10/13/2020 B) API 2020-Event #3 SARS-CoV2 performed on 11/3/2020 C) API 2021-Event #3- Microbiology performed on 9/29/2021 D) API 2021-Event #3-Hematology performed on 11/12/2021 E) AAFP (American Academy of Family Physicians) Reinstatement PT for Virology performed 9/2 - 9/3/2021 F) API 2022-Event #1-Microbiology performed on 2/18/2022 6. On 3/30/2022 the surveyor reviewed the above records and noted no 2020-Event #1 and #2 PT surveys for Microbiology (performed on the BioFire). The surveyor further noted the CMS (Center for Medicare and Medicaid Services) CASPER Report 0096D Proficiency Testing Scores report listed no scoring for Event #1 and #2 in 2020; this indicated the laboratory failed to order Microbiology PT in early 2020. [A review of BioFire Quality Control records revealed the instrument was in use for patient testing in 2020 for all months except February, May and August.] 7. In a phone interview on 3/30/2022 at 1:00 PM, the surveyor asked the Laboratory Director about Microbiology PT for 2020. The Laboratory Director stated she submitted to CLIA everything the Administrator had e-mailed to her. The Director stated she knew the laboratory was performing patient testing despite some BioFire reagent supply shortages in 2020, however the laboratory did not notify her about any problems regarding PT. The Director stated she may have noted a lack of PT and written this up in QA (Quality Assessment) reports. The surveyor stated none of this documentation was provided during the survey, and noted the laboratory failed to order PT Event #1 and #2 surveys in 2020 and 2021. . D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on a lack of proficiency testing records on the day of the survey, and interviews with the Laboratory Director, the laboratory failed to retain PT records in a format allowing review by the surveyor during the survey period. This affected six of eight PT records from Event #3-2019 thru Event #1-2022. The findings include: 1. During the entrance tour at 9:00 AM on 3/17/2022 the Laboratory Director stated moderate- complexity testing included a Molecular Respiratory Pathogen Panel performed on the BioFire Film Array (in use since the previous survey on 6/18/2019), and CBC's (Complete Blood Counts) performed on the Medonic M Series Hematology analyzer (in use for patient testing since 3/16/2021.) 2. A review of laboratory records revealed no documentation of proficiency testing. At approximately 9:20 AM on 3/17/2022 the Laboratory Director explained most of the laboratory records were retained electronically, and only the Clinic Administrator had access to the PT records. 3. At -- 2 of 9 -- approximately 2:00 PM on 3/17/2022 the surveyor was provided two surveys, as follows: A) WSLH (Wisconsin State Laboratory of Hygiene) Proficiency Testing Off- Schedule Set A Hematology PT performed on 10/20/2021, and B) API (American Proficiency Institute) Remedial PT Event 72R for BioFire testing performed on 9/1 /2021 4. At approximately 2:10 PM on 3/17/2022, the surveyor requested the rest of the PT records, including Microbiology PT (Event 3-2019, Events 1, 2 and 3-2020) and the 2021 PT for Hematology and Microbiology. The Laboratory Director explained there were no records for 2019 since these were already packed away. The surveyor explained the 2019-Event #3 survey results were not reviewed during the previous CLIA survey on 6/18/2019, and the laboratory should have retained the results for review during this CLIA survey. 5. As the interview continued on 3/17 /2022, the Director further stated Administration had failed to place the API PT order for 2021; only API Event 3-2021 surveys were available and performed by the laboratory. In addition, the Laboratory Director ordered remedial or off-cycle PT surveys from other PT providers. Only the records for the two remedial surveys listed in #3 above were available on the day of the survey; no other PT records were available for review. . 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 through 493.1236. This STANDARD is not met as evidenced by: Based on a review of proficiency testing and personnel records, the Quality Assessment [QA] Plan and an interview with the Laboratory Director, the laboratory failed to follow their procedures to monitor, assess and correct problems identified in the laboratory processes and procedures. The findings include: I) Proficiency Testing 1. A review of the Quality Assessment Plan under "Proficiency Testing"(PT), on page 9 of 13 revealed, "...Standards ...All regulated analytes are enrolled in an approved PT program. ... All documentation is kept on file for at least two years. ...". 2. A review of proficiency testing records revealed the laboratory failed to enroll in proficiency testing (PT) with an HHS (Health and Human Services)-approved PT provider for regulated tests for the first two events in 2020 (Microbiology) and the first two events (Hematology and Microbiology) in 2021. (Refer to D2000.) The laboratory further failed to implement a system to retain PT records for six of eight survey events (Event #3-2019 thru Event #1-2022) in a format allowing review of the records during the on- site CLIA survey. (Refer to D3037.) 3. During an interview at approximately 9:20 AM on 3/17/2022 the Laboratory Director explained most of the laboratory records were retained electronically, and only the Clinic Administrator had access to the PT records. During a later interview at 2:10 PM, the Laboratory Director confirmed Administration had failed to order 2021 PT until August 2021, by which time only 2021-Event 3 was available. The surveyor further confirmed via the CMS (Center for Medicare and Medicaid Services) CASPER Report 0096D Proficiency Testing Scores report which had no scores for Event #1 and #2 in 2020, indicating the laboratory failed to order Microbiology PT in early 2020. During a phone interview on 3/30/2022 at 1:00 PM the Laboratory failed to forward any PT for these events, and did not notify her of any problems. II) Personnel 1. A review of the Quality Assessment Plan under "Personnel", on page 3 of 13 revealed, "...Standards ... Each personnel file shall -- 3 of 9 -- contain: ...Documentation of highest level of education ... Documentation of new hire training...". The surveyor also noted under "

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 Laboratory Personnel Report for CLIA (CMS form #209), a review of the personnel and proficiency testing records, a review of the Quality Assessment Plan (8.0 Proficiency Testing) and quality assurance records, and an on- site interview with the representative for the laboratory and the Laboratory Director, via the telephone, the surveyor determined the laboratory failed to ensure the proficiency testing samples were tested on a rotational basis by all personnel who routinely perform patient testing. This affected five of five proficiency testing events. The findings include: 1. The Laboratory Personnel Report, signed by the Laboratory Director, included three testing personnel (one new personnel, since the previous survey in August of 2017. 2. A review of the personnel records revealed Testing Personnel (TP) #1 and #2 had previously qualified to perform moderate complexity testing and were trained in March of 2017. Further review revealed TP #1 and TP #2 were competent to perform testing in the laboratory, including the Bioray Film Array analyzer for respiratory panels. This is the only non-waived testing performed at the laboratory. 3. A review of the API (American Proficiency Institute) proficiency testing records revealed TP #1 had signed the attestation statements (indicating she was the testing personnel) for Event #3, 2017; all three events for 2018, and Event #1, 2019 for Molecular Bacteriology and Virology testing, performed on the Bioray. 4. In an interview on June 18, 2019 at 12:50 PM, with the Laboratory Director (via telephone) and a representative for the laboratory, who was on-site for the survey process, the surveyor inquired why testing personnel #1 had been the only participant with the proficiency testing. The Laboratory Director confirmed TP #1 had performed 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 -- all of the proficiency testing. The Laboratory Director stated it was discussed with TP #1 the need to rotate the proficiency testing, as late as yesterday (June 17). There was no documentation of this discussion. The Laboratory Director further stated TP #2 was a nurse, who performed patient testing. The representative, sent by the Laboratory Director to be onsite for the survey process, confirmed the nurse, TP #2, did perform testing on patient samples and was trained to do so. 5. A review of the quality assurance records revealed a note, dated 8/30/18: "...need to rotate testing staff." 6. The section, titled 8.0 Proficiency Testing of the Quality Assessment Plan, included the following: "...The laboratory test PT samples using the same procedure /methodologies used for patient testing and qualified testing personnel test the PT specimens on rotational schedule..." D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of Quality Control (QC) and Quality Assurance (QA) records, a review of the policy and procedure manual, and an interview with the on-site technical representative, sent by the Laboratory Director (LD) to assist with the survey process, and a telephone interview with the LD, the surveyor determined the laboratory failed to test an external positive and negative with each lot number or shipment of reagent packs for respiratory panels, prior to testing patients specimens and reporting the results. The laboratory's manual contained two QC plans, which were contradictory. Although, the laboratory indicated in an IQCP (Individualized Quality Control Plan), the external positive and negative controls would be tested with each change and shipment of reagent packs, the laboratory failed to test both controls on the same day or within the same timeframes of using the reagent packs for patient testing. The findings include: 1. The laboratory's policy and procedure manual contained two QC plans, which were contradictory. a) A review of the manual revealed instructions under Quality Control, for QC testing on the Biofire to test a positive and negative control with the reagent pack number and/or shipment; and to verify external and internal control results are acceptable, prior to patient testing with the reagent lot, shipment, and following month. b) Further review of the policies and procedures revealed an IQCP with the following instructions for quality control testing: "...daily (Internal), + (positive)/= (negative) with change and shipment of lot per manufacturer's recommendations..." 2. A review of the QC records revealed the following: a) In 2017, the laboratory tested external positive and negative controls: April 14 (lot #471717), June 22 (lot #534117), Aug 25 (lot#595617), and November 27 (lot #678317). On December 19, the laboratory staff documented a positive external control was run with reagent lot #650017, but a negative was not tested until December 26 for this lot number of reagent. b) On January 24, 2018 the staff documented an external negative control was tested for lot number 778017, and the positive was tested on January 25, 2018. c) On February 27, 2018, the staff -- 2 of 5 -- documented an external positive control was tested for lot number 815218, but the negative was not run until March 7. d) On April 30, 2018, the staff documented an external positive control was run for lot number 889818, but the negative was not run until May 1, 2018. e) On November 28, 2018, the staff documented two negative external controls were run with lot number 256618. f) On March 6, 2019, the staff documented a negative control was run with lot number 441319. Using this same lot number of reagent packs, the laboratory documented a positive external control was run on April 15 and a negative was run on April 16. 3. A review of the QA notes revealed the same technical representative, on-site for the survey, documented that no positive quality control was tested for new lot number, started 3/6/19, and was unable to locate the instrument printout for documentation. On the QA note for 2/20/18 - 3/12 /18, the staff documented no patients were recalled and no harm to patients. There was no documentation of which patients were potentially affected or what might have been the clinical significance to the patients. There was no documentation of assessment by the clinicians for these patients, whose specimens were tested with reagent packs which quality control had not been appropriately verified. 4. At 12:06 PM on June 18, 2019, the laboratory representative stated the staff had been testing the quality control with each shipment of reagents, which usually coincided with each lot number. At 12: 29 PM, the representative stated she assumed no patients were done on January 24, 2018, because the QC was tested at 5:10 PM, and the office closes at 5:00 (PM). The surveyor inquired of the meaning of "no patients recalled." The laboratory representative stated this statement means no patients were called back to perform a re- test. At this time, the surveyor asked the staff to verify how many patients were tested between December 19-26, 2017; January 24 -25, 2018, February 27 - March 7, 2018; April 30 - May 1, 2018; November 28, 2018 (two negative controls were tested) - February 25, 2019 (when negative and positive external controls were tested); and March 6 - April 16, 2019. 5. In a telephone interview on 6/18/2019 at 12:50 PM, the LD confirmed the contradiction in the policies. The LD stated "In my world, everything is external unless I said internal. In the lab manual, I should have marked out, monthly. We changed that." The LD also stated the staff had pulled the patients' charts (which patients were not identified), and because of the patients' clinical histories, the patients had not been re-called for re-testing. The LD director confirmed there was no documentation of patient remediation in QA notes or otherwise. Again, the surveyor asked about the time frames given above to verify the patient testing. The on-site representative stated no patients were tested. The surveyor asked again, specifically about the instance in November when two negative controls were tested. The on-site representative stated she would have to check. 6. Further review of the QA reports revealed the laboratory's random chart reviews and checklists. The random patient chart reviews for February 1 - 7, 11, 12 19, 26, and 28 of 2018 indicated no problems were identified. The QA checklists indicated no problems were identified by the lab in the category, titled: QC performed per requirements, based on manufacturer's recommendations, CLIA requirements and lab policies.