Orion Laboratories, Llc

Summary Statement of Deficiencies 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: No deficiency details available. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful 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 2 -- This STANDARD is not met as evidenced by: No deficiency details available. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: An on-site follow-up survey was performed as Orion Laboratories, LLC, CLIA ID 19D2168465, on December 17, 2024. Based on review of the laboratory's personnel training records, performance specification records, and interview with personnel, the Laboratory Director failed to ensure three (3) of three (3) Testing Personnel had complete training documentation for blood bank (ABO type and antibody screen) testing. Findings: 1. In interview on December 17, 2024 at 9:35 am, the Laboratory Manager stated the laboratory brought on blood bank ABO type and antibody screen testing after their previous inspection. 2. Review of the laboratory's performance specification records for the blood bank testing revealed the Laboratory Director approved the laboratory's studies on September 24, 2024. 3. Review of training records revealed hands-on training, quality control and antibody screening were not included. The laboratory had documentation of a written test for Testing Personnel 2 and Testing Personnel 3 prior to patient testing. 4. In interview on December 17, 2024 at 5:00 pm, the Laboratory Manager confirmed she did not have training records for herself or complete training records for Testing Personnel 2 and 3. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Complaint survey (LA00069894) was performed at Orion Laboratories, LLC, CLIA ID 19D2168465, on February 2, 2024. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard deficiencies were cited. D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, complaint form, and interview with personnel, the laboratory failed to document complaints and problems reported to the laboratory. Findings: 1. Review of the laboratory's "Complaint Investigation Policy" revealed for customer complaints the Chief Operating Officer is to be notified immediately. "If the Chief Operations Officer is not immediately available, document complainant name, facility and call back number. Notify complainant that issue will be investigated and resolved. Personnel taking phone call will complete a 'Complaint Documentation Form,' (found in Orion Laboratories Dropbox), upon receiving complaint. the form includes documentation for the problem, investigation,

Summary Statement of Deficiencies D0000 A recertification survey was performed on September 26-28, 2022 at Orion Laboratories, LLC - CLIA ID # 19D2168465. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manual and interview with personnel, the laboratory failed to have a complete policy and procedure manual. Findings: 1. Review of the laboratory's procedure manual revealed the laboratory did not include detailed instructions for the the following laboratory practices: a) New lot rollover of coagulation reagents to include step by step instructions for verifying new reagents as well as criteria of qualification for "normal donors" to be utilized in reference interval studies. b) Process for documentation of manual cell counts to include duplicate testing of patient and quality control as well as frequency of quality control performance. c) Step by Step processed for staining of slides to be utilized for manual cell differentials and/or peripheral blood smear review, as well as stain acceptability and stability of staining reagents. 2. In interview on September 27, 2022 at 2:40 pm, the Laboratory Manager and Technical Consultant confirmed the laboratory policy and procedure manuals did not specifically address the above laboratory processes. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 11 -- Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: I. Based on observation during the laboratory tour, review of manufacturer instructions and instrument printouts of patient hematology testing as well as interview with laboratory personnel, the laboratory failed to follow manufacturer's instructions and laboratory procedure for flags appearing on Complete Blood Counts (CBC) for three (3) of three (3) patients reviewed. Findings: 1. Direct observation during the laboratory tour on September 26, 2023 at 10:30am revealed the laboratory use of a Sysmex XN-1000 for hematology analysis. 2. Review of the laboratory's policy revealed the laboratory policy aligns with the manufacturer instructions for flags appearing on complete blood count (CBC) result: a) instrument Platelet (Plt) flag of *Plt Distribution (Dist)* requires the laboratory to "scan for platelet morphology" b) instrument Red Blood Cell (RBC) flag of *Dimorphic* and *RBC Abnormal Distribution (Abn Dist)* requires the laboratory to "Scan for RBC Morphology" 3. Review of patient testing directly from XN-1000 on September 26, 2022 at 2:25pm revealed the laboratory failed to follow the manufacturer instructions and laboratory policy for flagging for the following two (2) patients reviewed: Sample ID: 2209230096 performed September 24, 2022 - Plt Dist with no scan for plt morphology Sample ID: 2209230029 performed September 23, 2022 - Dimorphic & RBC Abn Dist flags with no scan for RBC morphology performed. 4. Interview with with testing personnel and laboratory manager on September 26, 2023 at 3pm confirmed the patients identified above were reported without microscopic review confirming Sysmex instrument flags. II. Based on observation during laboratory tour, review of manufacturer instructions, patient results and quality control as well as interview with personnel, the laboratory failed to perform Prothrombin Time Test (PT) within four (4) hours of collection as required by manufacturer for ten (10) of seventeen (17) patients reviewed. Findings: 1. Observation by surveyor during the laboratory tour on September 26, 2022 at 9:58 am revealed the laboratory utilizes Sysmex CA660 Coagulation analyzer for Prothrombin Time (PT) testing. 2. Review of the Sysmex CA660 operator's manual under specimen storage revealed for PT testing "samples should be analyzed within four (4) hours of collection". 3. Review of patient records for PT testing from June 15, 2022 - June 30, 2022 revealed the following ten (10) of seventeen (17) patients reviewed were not tested within four (4) hours of collection as required by the manufacturer: a) Patient P9987195 collected on June 15, 2022 at 9:30 am and received at 04:52 pm - exceeding the four (4) hours required by manufacturer by three (3) hour twenty two (22) minutes b) Patient P9986288 collected on June 16, 2022 at 1:40 pm and received on June 17, 2022 at 10: 02 am - exceeding the four (4) hours required by manufacturer by sixteen (16) hour twenty two (22) minutes c) Patient P9987324 collected on June 17, 2022 at 8:32 am and received at 07:01 pm - exceeding the four (4) hours required by manufacturer by six (6) hour twenty nine (29) minutes d) Patient P9987411 collected on June 16, 2022 at 3:00 pm and received on June 17, 2022 at 11:03 am - exceeding the four (4) hours required by manufacturer by sixteen (16) hour three (3) minutes e) Patient P9987435 collected on June 17, 2022 at 11:50 am and received at 07:08 pm - exceeding the four (4) hours required by manufacturer by three (3) hour eighteen (18) minutes f) Patient P9987437 collected on June 17, 2022 at 11:56 am and received at 06:59 pm - exceeding the four (4) hours required by manufacturer by three (3) hour three (3) -- 2 of 11 -- minutes g) Patient P9987601 collected on June 20, 2022 at 12:04 pm and received at 05:48 pm - exceeding the four (4) hours required by manufacturer by one (1) hour forty four (44) minutes h) Patient P9981198 collected on June 20, 2022 at 12:41 pm and received at 05:51 pm - exceeding the four (4) hours required by manufacturer by one (1) hour ten (10) minutes i) Patient P9986491 collected on June 21, 2022 at 10:36 am and received at 04:32 pm - exceeding the four (4) hours required by manufacturer by one (1) hour fifty six (56) minutes j) Patient P9987195 collected on June 15, 2022 at 9:30 am and received at 04:52 pm - exceeding the four (4) hours required by manufacturer by three (3) hour fifty two (52) minutes 5. In interview on September 28, 2022 at 02:57 pm, the technical consultant stated the laboratory should not perform testing outside of the timeframe of the manufacturer and that samples should have been poured off the cells if the four hour stability of the manufacturer was exceeded. The technical consultant confirmed there was no policy or documentation to verify this process. 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 observation, review of manufacturer instructions and calibration records as well as interview with personnel, the laboratory failed to perform calibration every 6 months as required by the manufacturer for the Sysmex XN-1000 analyzer for 2021- 2022. Findings: 1. Observation by the surveyor during the laboratory tour on September 26, 2022 at 10:20am revealed the laboratory utilized the Sysmex XN-1000 Hematology analyzer for the testing of Complete Blood Counts (CBC). 2. Review of the Sysmex XN-1000 manual revealed "Initial calibration is performed during installation by the Sysmex representative. Following installation calibration, the operator is requested to verify the instrument calibration every 6 months or on an 'as needed' basis and maintain good QC practices, to ensure the accuracy of the system." Further review of the laboratory procedure revealed that calibration procedures are to be performed every six months or any time a major component or maintenance is performed. 3. Review of the calibration records for 2021 - 2022 revealed the laboratory performed calibration in February only for years 2021 and 2022. 4. In interview on September 27, 2022 at 3:15pm, the laboratory manager confirmed the laboratory only performed calibrations for the Sysmex XN-1000 once for both 2021 and 2022, and that the second calibration was not performed. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the -- 3 of 11 -- 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 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 observation by surveyor, review of policies, manufacturer's instrument manual, calibration records, and interview with personnel, the laboratory failed to perform calibration verification procedures for Thyroid Peroxidase Antibody (aTPO) at least every six (6) months per manufacturer requirements during 2021 - 2022. Findings: 1. Observation by surveyor during the laboratory tour on September 24, 2022 at 10:20 am revealed the laboratory utilizes the Siemens Atellica for chemistry testing to include Thyroid Peroxidase Antibody (aTPO). 2. Review of the Atellica instrument calibration records revealed the routine calibration contained only 2 calibration points. Further review of calibration records revealed the laboratory performed no additional calibration for aTPO including 3 or more calibration points covering the reportable range for 2021 and 2022. 3. In interview on September 27, 2021 at 2:49 pm, the Laboratory Manager stated the laboratory performs calibration verification for analytes with 2 calibration points but had missed aTPO as an analyte requiring calibration verification. The laboratory manager confirmed the laboratory did not perform calibration verification for aTPO in 2021-2022. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation during laboratory tour, review of laboratory policies, quality control records and patient test records, as well as interview with laboratory personnel, the laboratory failed to perform two (2) levels of controls prior to patient testing for parathyroid hormone (PTH) testing for two (2) of nineteen (19) days reviewed over two months of patient testing. Findings: 1. Observation by surveyor -- 4 of 11 -- during laboratory tour on September 26, 2022 at 10:26 am revealed the laboratory utilizes the Siemens Atellica with BioRad Immunoassay quality control. 2. Review of the laboratory's quality control policy for chemistry testing revealed the laboratory is to perform two (2) levels of quality controls within acceptable range prior to patient testing for chemistry testing performed on the Siemens Atellica, including PTH. 3. Review of patient testing and PTH quality control records for February 2022 and August 2022 revealed the laboratory did not perform two (2) levels of controls for the following two (2) out of nineteen (19) days reviewed: Sample ID: 2208080155 performed August 09, 2022: Controls Level 1 and Level 2 not performed within 24 hours Sample ID: 2202100018 performed February 10, 2022: Controls Level 1 and Level 2 not performed within 24 hours 4. In interview on September 27, 2022 at 3:30 pm, the laboratory manager confirmed the above patients were tested without 2 levels of quality control prior to patient testing. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory procedure, test menu, Quality Control (QC) and patient records, and interview with personnel, the laboratory failed to document external reactive and non-reactive controls for Rapid Plasma Reagin (RPR) patient testing for thirteen (13) of forty eight (48) days reviewed. Findings: 1. Review of the test menu provided to the surveyor by laboratory staff revealed the laboratory performed manual Rapid Plasma Reagin (RPR) patient testing. 2. Review of the laboratory's Quality Control Procedures revealed "External Quality Controls are performed each day of use, prior to or parallel with patient testing." 3. Review of the Quality Control (QC) and patient records from July 2022 through September 2022 revealed the laboratory did not document external reactive and non-reactive controls each day of patient testing for the following thirteen (13) of forty eight (48) testing days reviewed: a) July 1, 2022: 5 patients performed with no quality control documented b) July 6, 2022: 4 patients performed with no quality control documented c) July 7, 2022: 3 patients performed with no quality control documented d) July 8, 2022: 4 patients performed with no quality control documented e) July 11, 2022: 2 patients performed with no quality control documented f) July 21, 2022: 1 patient performed with no quality control documented g) July 22, 2022: 1 patient performed with no quality control documented h) July 27, 2022: 1 patient performed with no quality control documented i) August 1, 2022: 1 patient performed with no quality control documented j) August 8, 2022: 3 patients performed with no quality control documented k) August 15, 2022: 2 patients performed with no quality control documented l) August 20, 2022: 1 patient performed with no quality control documented m) August 24, 2022: 1 patient performed with no quality control documented 4. In interview on September 27, 2022 at 1:20 pm, the laboratory manager confirmed the laboratory external reactive and non- reactive controls was not documented for the above identified patients. The laboratory manager also stated all manual tests have quality control performed with patient testing, but the quality control is recorded in the LIS. -- 5 of 11 -- D5451 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(iii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Test procedures producing graded or titered results include a negative control material and a control material with graded or titered reactivity, respectively; 493.1256 (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control and patient testing records as well as interview with laboratory personnel, the laboratory failed to include a titered control for reactive RPR testing for one (1) of thirteen (13) patients. Findings: 1. Review of the laboratory's policy for RPR testing revealed additional titer quality control required for any reactive patient RPR. 2. Review of RPR patient test records from July - September 2022 revealed the laboratory failed to perform a negative and a known titered control for the following one (1) of thirteen (13) reactive RPR tests performed: Patient 2207140201 performed on July 15, 2022. 3. Interview with the laboratory manager and technical consultant on September 27, 2022 at 2pm confirmed the above reactive RPR did not have titer quality control documented with patient testing. D5543 HEMATOLOGY CFR(s): 493.1269(a)(d) (a) For manual cell counts performed using a hemocytometer-- (a)(1) One control material must be tested each 8 hours of operation; and (a)(2) Patient specimens and control materials must be tested in duplicate. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: I. Based on review of laboratory policy, patient and quality control records as well as interview with laboratory personnel, the laboratory failed to perform quality control every 8 hours of patient testing for manual cell counts. Findings: 1. Review of the laboratory procedure manual for manual cell counts revealed quality control (QC) to be performed every 8 hours of patient testing for all cell counts performed with a hemocytometer. 2. Review of patient testing and quality control records from April 2021 - July 2021 revealed the following three (3) of twenty (20) patients perfomed without QC every 8 hours: a) P9942728 b) P994744 c) P36692 3. Interview with the technical consultant on September 26, 2022 at 2pm confirmed the above identified patients did not have documented quality control performed within 8 hours of patient testing. II. Based on review of laboratory poilcy, patient and quality control records as well as interview with laboratory personnel, the laboratory failed to perform quality control and patient testing for manual cell using a hemocytometer in duplicate. Findings: 1. Review of the laboratory policy revealed performance of testing by hemocytometer procedure did not specify a required frequency of duplicate counts. 2. Review of patient testing and quality control records from April 2021 - July 2021 revealed the following three (3) of twenty (20) patients perfomed by hemocytometer were not counted in duplicate: a) P9942728 b) P994744 c) P36692 3. Interview with the technical consultant on September 26, 2022 at 2pm revealed the laboratory does perform counts in duplicate, but the duplicate count is documented outside of the LIS. -- 6 of 11 -- The technical consultant confirmed the LIS does not reflect duplicate count of quality control or patient testing. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on observation during laboratory tour, review of laboratory policies and records, as well as interview with personnel, the laboratory failed to perform instrument comparison testing of two (2) Atellica instruments at least twice annually. Findings: 1. Observation by surveyor during the laboratory tour on September 26, 2022 at 10 am revealed the laboratory utilizes the following two (2) Siemens Atellica instruments (930 &1300) for a variety of patient testing. 2. Review of the laboratory's records revealed the laboratory performed instrument correlations in September of 2022, but did not have documentation of comparison of the two Atellica analyzers for the first half of 2022. 3. In interview on September 27, 2022 at 10:33 am the technical consultant confirmed the laboratory did not perform the instrument correlations of the Atellicas twice in 2022. D5785

Summary Statement of Deficiencies D0000 AN INITIAL CERTIFICATION SURVEY was conducted on October 26-28, 2020 at Orion Laboratories, LLC - CLIA 19D2168465. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on review of Proficiency Testing records and the laboratory's test list, as well as interview with personnel, the laboratory failed to enroll in an approved program to establish and maintain the accuracy of White Blood Cell differential (WBC Diff) and Human Chorionic Gonadotropin (HCG) testing. Findings: 1. Review of the annual test volumes provided by the laboratory revealed the laboratory performs Manual Differentials (WBC Diff) and serum HCG testing. 2. Review of proficiency testing records for 2020 revealed the laboratory did not enroll or participate in WBC Diff or serum HCG in any testing events. 3. Interview with technical consultants on October 26, 2020 at 10:30am confirmed the laboratory was not enrolled for WBC Diff or serum HCG for 2020 proficiency testing. 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. 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 -- This STANDARD is not met as evidenced by: Based on RPR maintenance record review and interview with personnel, the laboratory failed to retain monthly maitenance Rapid Plasma Reagin (RPR) for at least two (2) years for six (6) of six (6) months reviewed. Findings: 1. Review of the ASI RPR Test Kit manufacturer instructions revealed detailed instructions to "perform accuracy check on the needle" prior to dispensing 0.05 ml of antigen suspension for the assay protocol. Further review of the manufacturer instructions for assay protocol state to "rotate at 100 +/- 5 rpm for 8 minutes". 2. Review of the laboratory's RPR policy revealed no detailed instructions for documentation of needle accuracy check or verification of rotator RPM checks. 3. Review of patient testing records for RPRs revealed fifty-one (51) patients were tested from April 2020-October 2020 with no documentation of needle accuracy or RPM verification. 4. In interview on October 27, 2020 at 11:22 am, the Technical Consultant and Testing Personnel stated needle accuracy is performed on each new bottle of antigen suspension and rotator RPM is verified monthly. The Technical Consultant confirmed the policy does not specify maintenance frequency or how this should be documented. Not retain RPR maintenance 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 review of proficiency testing records and interview with personnel, the laboratory failed to verify the accuracy of Hemoglobin (Hgb) A1C at least twice annually. Findings: 1. Review of the laboratory's annual test volumes provided to surveyor revealed the laboratory performs Hgb A1C on the Siemens's Atellica 930. 2. Review of the laboratory's proficiency testing records for 2020 revealed the laboratory did not enroll or participate in HgbA1c to verify the accuracy of testing. 3. In interview on October 26, 2020 at 10:25am the Technical Consultant confirmed the laboratory did not enroll in HgbA1c for 2020 PT but would update enrollment for 2021. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's collection protocol and interview with personnel, the laboratory failed to establish detailed written instructions for providers to maintain the integrity of blood samples. Findings: 1. Direct observation of specimen processing on October 27, 2020 at 9:55am revealed the laboratory receives blood specimens transported between 2-8 degrees Celsius and no greater than 48 hours from collection. 2. Review of the laboratory's Blood Collection Protocol available to providers -- 2 of 4 -- revealed the laboratory did not include specific instructions for transportation or acceptable stability and temperature requirements of blood samples referenced to the laboratory for testing. 3. In interview with Technical Consultants and Laboratory Manager on October 27, 2020 at 1pm, personnel confirmed the Blood Collection Protocol was missing the temperature requirements and stability accepted by the laboratory like the other sample types received. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) 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)