Mymichigan Medical Center- Sault

Summary Statement of Deficiencies D2001 ENROLLMENT CFR(s): 493.801(a)(1)(2)(i) The laboratory must-- (1) Notify HHS of the approved program or programs in which it chooses to participate to meet proficiency testing requirements of this subpart. (2)(i) Designate the program(s) to be used for each specialty, subspecialty, and analyte or test to determine compliance with this subpart if the laboratory participates in more than one proficiency testing program approved by CMS; This STANDARD is not met as evidenced by: . Based on record review and correspondence with General Supervisor #1, the laboratory failed to designate the program used for compliance when it enrolled in two programs for compatibility testing for 2 (second and third events of 2022) consecutive events receiving unsatisfactory results. Findings include: 1. A review of the laboratory's proficiency testing information reported to CMS revealed the laboratory was enrolled in two compatibility testing programs and one of the programs noted unsatisfactory performance in the second and third events of 2022. The laboratory had not designated one program used to monitor proficiency testing performance compliance. 2. A review of the laboratory's compliance history revealed a lack of proficiency testing desk review performed due to the two consecutive unsatisfactory events. 3. An email received on 7/1/24 at 2:54 pm from General Supervisor #1 confirmed the laboratory had not previously designated which program for compatibility testing was to be used for compliance monitoring. 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 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 -- 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 record review and interview, the laboratory failed to successfully participate in proficiency testing for compatibility testing. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on record review and interview with General Supervisor #1, the laboratory failed to achieve satisfactory results in compatibility proficiency testing for two (second and third events of 2022) consecutive testing events. Findings include: 1. A review of the laboratory's proficiency testing records revealed the following scores for compatibility testing: a. 2022 Second event, 80% b. 2022 Third event, 80% 2. An interview on 6/26/24 at 12:12 pm with General Supervisor #1 confirmed the laboratory had not obtained satisfactory results for the two events listed above in compatibility testing. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: . Based on observation and interviews, the laboratory failed to follow its venipuncture blood specimen collection procedures for one patient specimen collection observed. Findings include: 1. The surveyor observed Phlebotomist #1 performing venipuncture utilizing a butterfly needle on a patient in the Emergency Room at 11:00 am on 06/25 -- 2 of 4 -- /2024. The blood collection began with a blue top sodium citrate vacutainer, followed by a gold top serum separator vacutainer, another blue top sodium citrate vacutainer, a green top lithium heparin vacutainer, and finally, two purple top EDTA vacutainers consecutively. The first blue vacutainer tube was discarded. 2. An interview with Phlebotomist #1 at 11:05 am on 06/25/2024 indicated a blue top vacutainer is initially used as a primer to ensure adequate blood flow for all vacutainers. 3. A review of the laboratory's "Specimen Collection: Venipuncture" procedure revealed a section stating, "To avoid possible test result error due to cross contamination from tube additives, the recommended order of draw is: 1. Blood culture bottle 2. Coagulation (sodium citrate) tube (eg, blue top) 3. Serum tube with or without clot activator, with or without gel (eg, red top) 4. Heparin tube with or without gel plasma separator (eg, green top) 5. EDTA (eg, lavender top) 6. Glycolic inhibitor (eg, grey top)" Based on interview with GS1 and GS2 at 12:12 pm on 06/25/2024, it was confirmed that the venipuncture observed did not align with the laboratory policy. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) 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 direct observation and interviews the laboratory failed to include expiration dates on labels for two bottles of decolorizer in microbiology and 12 chemistry controls observed. Findings include: 1. The surveyor observed one aliquot of decolorizer in Microbiology on 06/25/2024 at 2:15 pm which did not include the expiration date on the label as well as no expiration date on parent container label. 2. The surveyor observed 12 Chemistry Controls (LIST) on 06/26/2024 at 9:28 am, did not include the expiration date on the label: a. Liquichek Unassayed Chemistry Control (Human) levels one and two with an open date of "6/25." b. Liquichek Urine Chemistry Control levels one and two with an open date of "6/16" and "6/20" respectively. c. Liquichek Immunology Control level one with an open date of "4/22 /24." d. Liquichek Ethanol/Ammonia Control levels one and three with an open date of "6/22." e. Liquichek Spinal Fluid Control levels one and two with an open date of "5/29" and "5/31" respectively. f. MAS Bilirubin Liquid Assayed Bilirubin controls levels one, two, and three with the open date of "5/20/24." 3. A record review of laboratory policy for reagent labeling was requested and confirmed policy "Medical Supply Storage, Handling, & Verification" for labeling reagents under section "Storage and Handling" under the section "Medical Supplies" on page 1 and 2: #1. "Are stored and handled as defined by the laboratory and following the manufacturer's instructions. #2. "Used within their indicated expiration date for patient testing." #5. "Reagents, calibrators, controls, stains, chemicals, and solutions are properly labeled as applicable and appropriate with the following elements. d. Expiration date" 4. Interview with Testing Personnel #6 at 9:28 am on 06/26/2024 confirmed that reagents and controls were not labeled as indicated by the laboratory policy. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) -- 3 of 4 -- (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Director, the laboratory failed to perform and document immunohistochemical stain positive and negative reactivity each time of use for 2 (June 2022 to June 2024) of 2 years reviewed. Findings include: 1. A review patient test records revealed the following patients had testing using immunohistochemistry staining without documentation of positive and negative reactivity of controls each time of use: a. Pathology Patient #3 with testing performed on 5/2/22. b. Pathology Patient #5 with testing performed on 5/28/24. c. Pathology Patient #7 with testing performed on 5/17/24. 2. An interview on 6/24/24 at 2:22 pm with the Laboratory Director confirmed the laboratory had not been recording positive and negative reactivity of the immunohistochemical stains used. -- 4 of 4 --

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) 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, record review, and interview with General Supervisor #2 (GS2), the laboratory failed to ensure reagents were labeled with an expiration date for 2 of 7 inking bottles observed in the grossing area. Findings include: 1. During a tour of the laboratory on 4/25/2022 at 7:58 am, the surveyor observed 2 of 7 inking bottles in use with no expiration date on the bottle as follows: a. Cancer Diagnostic, Inc. (CDI) - black ink b. Biochemical (BBC) Path-Mark 2. A review of the laboratory's "Policy for Labeling, Storing, Preparing, Evaluating, and Tracking Laboratory Reagent" in step 2 "Labeling" "All reagents prepared or opened within the laboratory must be labeled with the following information when applicable: A. Preparation/opened date and time if appropriate B. Expiration date C. Reagent identity, including lot number, strength, titer, and/or concentration D. Initials of person preparing/opening the reagent E. Precautionary or other miscellaneous information" 3. An interview on 4/25/2022 at 7:58 am, GS2 confirmed the 2 of 7 open inking bottles did not have an expiration date recorded on the bottle. 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 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 -- deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: . A. Based on observation and interview with General Supervisor #2 (GS2), the laboratory failed to ensure tissue marking dyes did not exceed their expiration date for 5 of 5 tissue marking dyes observed. Findings include: 1. During a tour of the laboratory on 4/25/2022 at 7:58 am, the surveyor observed the following Cancer Diagnostics, Inc. (CDI) tissue marking dyes had exceeded their expiration dates: black, yellow, green, red, and orange with an expiration date of 09/30/2021. 2. An interview on 4/25/2022 at 7:58 am, GS2 confirmed the CDI tissue marking dyes in use had exceeded their expiration dates. B. Based on observation and interview with General Supervisor #2 (GS2), the laboratory failed to ensure blood specimen collection tubes did not exceed their expiration date for 3 tubes (2 navy top and 1 red top) within 1 of 3 phlebotomy mobile trays observed. Findings include: 1. The surveyor observed 3 phlebotomy trays in the specimen collection area and found 2 navy top tubes with the expiration date of 2/28/22 and 12/31/21 along with a red top microtainer with the expiration date of 8/31/21 in one of the trays on 4/25/22 at 8:05 am. 2. A review of the laboratory's "Policy for Labeling, Storing, Preparing, Evaluating, and Tracking Laboratory Reagents" revealed a section stating, "Expired reagents or solutions will not be used except for in extenuating circumstances with the approval of a Chief Tech or Laboratory Director; and, providing quality control passes." 3. An interview on 4/25/22 at 8:06 am with GS2 confirmed the tubes exceeded their expiration date and were present in the phlebotomy tray. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: . Based on record review and interview with General Supervisor #2 (GS2), the laboratory failed to perform and document the monthly maintenance on the Sysmex CS-2500 coagulation instrument for 12 (February - March and May-November 2021 and January-March 2022) of 24 months reviewed. Findings include: 1. A record review of the monthly Sysmex "CS-2500" maintenance log revealed for 12 of 24 months in 2021 and 2022 there was a lack of documentation of the monthly clean filters as follows: a. 2021 - lack of documentation for February - March and May - November b. 2022 - lack of documentation for January - March 2. An interview on 4 /25/2022 at 1:18 pm, GS2 confirmed the laboratory failed to perform and document the monthly maintenance as written on the log sheet. 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 -- 2 of 5 -- 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 record review and interview with Testing Personnel #4 (TP4), the laboratory failed to perform a negative control at least every day of patient testing for its red blood cell unit ABO Rh typing and patient ABO Rh and antibody screens for 2 (April 2020 to April 2022) of 2 years reviewed. Findings include: 1. A review of the laboratory's quality control documentation for their manual tube method testing revealed the laboratory recorded only positive reactions and there was a lack of documentation of quality control performed to show the laboratory was able to obtain negative results for its ABO Rh and antibody screen testing each day of patient testing. 2. A review of the laboratory's "Blood Bank Quality Control (Daily)" stating, "This quality control program is to be used for the daily quality control evaluation of routine blood bank reagents. Laboratories must ensure that serologic test reagents are suitably reactive each day of use. A good quality control procedure will monitor procedures, reagents and equipment.", "Commercial quality control material (corQC) is used to evaluate the performance of any reagents associated with manual tube blood typing and tube/gel antibody screening. Manual quality control will be required each day of patient testing using these methods. Various reagents are used to evaluate the performance of reagents associated with less frequently used blood bank testing. Individual procedures identify necessary quality control needs in these instances." and "Control tolerance limits: All reagents must show reactivity pertinent to patient testing or unit retypes." 3. An interview on 4/26/22 at 8:45 am with TP4 confirmed the laboratory is not performing negative controls for its manual tube method for ABO Rh and antibody screen testing. 4. A review of patient records revealed 249 patients had tube typing, 157 cord blood patients had tube typing, 27 patients had antibody screens performed by the tube method, and 34 patients had anti-human globulin (AHG) crossmatches performed by tube method since April 2020. 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 record review and interview with Testing Personnel #18 (TP18), the laboratory failed to identify the name and address of the laboratory performing the Immunohistochemical Evaluation on the patients final report for 1 (M000178076) of 7 patients reviewed. Findings include: 1. Record review revealed for 1 (M000178076) of 7 patients reviewed, the name and address of the laboratory performing the Immunohistochemical Evaluation ( CK7, Pan CK, CD31, CD34, and CD68) was not present on the patients final report in the electronic medical records (EMR). 2. During -- 3 of 5 -- the interview on 4/26/2022 at 9:36 am, TP18 confirmed the name and address of the testing laboratory was not present on the patient's final report in the EMR. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: . Based on record review and interview with General Supervisor #3 (GS3), the laboratory failed to make sure the competency assessment contained the 6 minimal procedures for evaluation for 2 (April 2020 to April 2022) of 2 years reviewed. Findings include: 1. Review of the Point-of-Care competency assessment for Rupture of Membranes (ROM) Plus test revealed the assessment did not contain the following procedures which constitutes part of the minimal requirements for assessment as follows: a. Monitoring the recording and reporting of patient test results. b. Review of test results, worksheets, quality control records, proficiency testing results, and preventive maintenance. c. Direct observation of performance of instrument maintenance and function checks. d. Assessment of problem solving skills. 2. Review of the competency assessments for 2 of 2 years revealed for 17 testing personnel in the Point-of-Care location the competency assessments were lacking the above procedures and evaluations by the GS3. 3. During the interview on 4/26/2022 at approximately 10:15 am, GS3 confirmed the competency assessments did not contain all 6 procedures. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: . Based on record review and interview with General Supervisor #3 (GS3), the laboratory failed to ensure the testing personnel met the qualification requirements at 493.1423. Findings include: 1. The laboratory failed to ensure testing personnel was qualified. Refer to D6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at -- 4 of 5 -- least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: . Based on record review and interview with General Supervisor #3 (GS3), the laboratory failed to ensure testing personnel were qualified for 1 (Testing Personnel #30 [TP30]) of 17 testing personnel listed on the CMS-209 form. Findings include: 1. A review of the laboratory's personnel records revealed a lack of qualification documentation for TP30 performing the Point-of-Care moderate complexity testing. 2. The surveyor requested qualification documentation for TP30 to show they were qualified to perform moderate complexity testing on 4/26/2022 at 10:15 am and it was not made available. 3. The laboratory was provided 7 days to supply documentation and it was not made available. . -- 5 of 5 --

Summary Statement of Deficiencies D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on record review and interview with General Supervisor #2 (GS2), the laboratory failed to follow procedures to verify the criteria for acceptability of Beckman Coulter iQ 200 ELITE microscopic urinalysis analyzer controls for 2 (October 2018 to October 2020) of 2 years. Findings include: 1. A review of the laboratory's established "Automated Urinalysis testing on the iRICELL iChem VELOCITY + iQ 200 ELITE" procedure revealed a section stating, "Parallel testing: Parallel testing between the old shipment or lot number and the new shipment or lot number of iQ control ensures that the system is operating within acceptable criteria. Run a new lot of control in parallel with the old lot so that approximately 5-10 values are obtained before placing the new control lot into service." 2. The surveyor requested documentation of the parallel testing for new lots or shipments of quality control material for the iQ 200 ELITE analyzer on 10/12/20 at 11:13 am and they were not made available. 3. An interview on 10/12/20 at 11:13 am with GS2 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 -- confirmed the laboratory did not verify the criteria for acceptability of controls for the Beckman Coulter iQ 200 ELITE analyzer. 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, record review, and interview with General Supervisor #1 (GS1), the laboratory failed to perform a comparison of the iQ 200 ELITE microscopic urinalysis analyzer and the manual microscopic urine sediment methods at least twice annually for 2 (October 2018 to October 2020) of 2 years reviewed. Findings include: 1. During a tour of the laboratory on 10/12/20 at 8:08 am, the surveyor observed a Beckman Coulter iQ 200 ELITE microscopic urinalysis analyzer and an Olympus BH-2 microscope in the urinalysis section of the laboratory. 2. A review of the laboratory's test menu revealed the laboratory performs urine sediment examinations with both automated and manual methods. 3. The surveyor requested documentation of the performance of comparison testing for both automated and manual methods on 10/12/20 at 11:13 am and it was not made available. 4. An interview on 10/14/20 at 9:18 am with GS1 confirmed the laboratory did not perform comparison testing at least twice annually for both automated and manual microscopic urinalysis testing. 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 record review and interviews with General Supervisor #1 (GS1) and General Supervisor #2 (GS2), the laboratory failed to provide patients receiving COVID-19 testing with the authorized fact sheets required for interpretation of results for 5 (May 2020 to October 2020) of 5 months reviewed. Findings include: 1. During a tour of the COVID-19 collection site on 10/13/20 at 10:32 am, the surveyor observed a provider giving a document titled "Exposure Guidelines" to patients during test collection. 2. A review of the "Exposure Guidelines" revealed the document did not contain the authorized fact sheets for COVID-19 testing. 3. An interview on 10/13 /20 at 10:32 am with GS1 and GS2 revealed the laboratory does not give patients authorized fact sheets for COVID-19 testing. 4. A review of the laboratory's test menu -- 2 of 4 -- revealed it performs three methods for COVID-19 testing: a. Abbott ID NOW b. BD MAX BD BioGX SARS-CoV-2 c. Quidel Sofia SARS antigen FIA 5. A review of the laboratory's Abbott ID NOW manufacturer instructions for use revealed a section titled "Conditions of Authorization" stating, "Authorized laboratories using your product will include with test result reports, all authorized Fact Sheets. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media." 6. A review of the laboratory's BD BioGX SARS-CoV-2 Reagents for BD MAX system manufacturer instructions for use revealed a section titled "Conditions of Authorization" stating, "Authorized laboratories using the BioGX SARS-CoV-2 Reagents for BD MAX System will include with test result reports of the BioGX SARS-CoV-2 Reagents for BD MAX System test, all authorized Fact Sheets. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media. 7. A review of the laboratory's SOFIA SARS Antigen FIA manufacturer instructions for use revealed a section titled "Conditions of Authorization for the Laboratory" stating, "Authorized laboratories using your product will include with test result reports, all authorized Fact Sheets. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media." 8. An interview with the GS1 and GS2 on 10 /15/2020 at 10:00 am confirmed the laboratory had not been distributing the authorized Fact Sheets to patients according to the manufacturer's instructions. ***This is a repeat deficiency from the 3/1/16 recertification survey*** D6047 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b(8)(i) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. This STANDARD is not met as evidenced by: . Based on record review and interview with General Supervisor #1 (GS1), the Technical Consultant failed to ensure direct observations of patient test performance were evaluated during testing personnel competency assessments for Testing Personnel #14. Findings include: 1. A review of testing personnel competency assessments revealed a lack of documentation of direct observations for Testing Personnel #14 performed on 2/20/20 for the following departments: a. Hematology b. Coagulation c. Urinalysis d. Chemistry e. Serology 2. A review of the laboratory's established "Personnel" procedure revealed a section stating, "The Laboratory Co- Directors and Laboratory Leads are responsible for assigning employees in their department various tasks to measure competence. these tasks may include written tests, proficiency testing survey specimens, or completing a physical task such as performing tests on instruments." 3. An interview on 10/13/20 at 8:48 am with GS1 confirmed the competency assessment for Testing Personnel #14 did not have documentation of the observation of patient test performance. D6048 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(ii) The procedures for evaluation of the competency of the staff must include, but are not limited to monitoring the recording and reporting of test results. -- 3 of 4 -- This STANDARD is not met as evidenced by: . Based on record review and interview with General Supervisor #2 (GS2), the Technical Consultant failed to evaluate the recording and reporting of results in competency assessments for personnel performing the ROM PLUS fetal fibronectin test kit for 2 (October 2018 to October 2020) of 2 years reviewed. Findings include: 1. A review of ROM PLUS fetal fibronectin testing personnel competency assessments revealed a lack of documentation of the evaluation of recording and reporting of test results from October 2018 to October 2020. 2. An interview on 10/13/20 at 10:10 am with GS2 confirmed the Technical Consultant did not evaluate the recording and reporting of test results during competency assessments. -- 4 of 4 --

Summary Statement of Deficiencies 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 record review and interview, the laboratory failed to perform and evaluate the performance specifications for the loaner Cytyc ThinPrep 2000 Cytology Processor and the laboratories primary Cytyc ThinPrep 2000 Cytology Processor when returned from preventive maintenance before being put into use. Findings include: 1. On February 28, at 11:35 a.m., record review revealed an invoice showing the laboratory received a loaner Cytyc ThinPrep 2000 Cytology Processor on May 19, 2017 for use while the laboratories primary instrument was having preventive maintenance performed. 2. On February 28, 2018 at 11:35 a.m. when queried, testing personnel #8 and #9 as listed on the CMS-209 were not able to provide the surveyor with documentation to show the loaner instrument and the serviced instrument had performance specifications evaluated and documented prior to being put into use. 3. During the interview on February 28, at 11:35 a.m., testing personnel #8 and #9 confirmed the performance specifications were not performed and documented prior to use. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) 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 -- For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to perform and document the weekly maintenance for the hematology XE 5000 instrument for nine (June-August 2016 and May, August, October, and November 2017) of 24 months reviewed. Findings include: 1. On February 28, 2018 at 12:45 p.m., record review of the "Sysmex XE-5000 SN A2893 Maintenance Log" revealed there is one task to be performed weekly - Power Down IPU. 2. On February 28, 2018 at 12:45 p.m., record review of the Sysmex XE-5000 Maintenance Log revealed the laboratory failed to perform and document the weekly maintenance task for nine of 24 months reviewed in 2016, 2017, and 2018 as follows: a. one of four weeks not performed - July 2016, May-June, August, and November 2017 b. two of four weeks not performed - June and August 2016 and October 2017 c. three of four weeks not performed - September 2016 3. During the interview on February 28, 2018 at 12:45 p.m., technical consultant #1 as listed on the CMS-209 confirmed the weekly maintenance was not performed as required by the manufacturer. ***Repeat Deficiency from June 26, 2012 and February 26, 2014 surveys*** -- 2 of 2 --