Huron Medical Center Pc

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with the technical consultant, the laboratory failed to follow its biohazardous safety procedures while performing blood specimen collection for one of one observed specimen collections. Findings include: 1. The surveyor observed collection personnel #1 on 1/6/25 at 11:05 am perform a blood specimen collection off of a peripherally inserted central catheter (PICC). After flushing the line and wasting 10 mL of blood, collection personnel #1 pulled off a syringe of blood, added a needle to the end of the syringe, and stabbed the top of a lavender-top vacutainer blood collection tube. Once the tube was filled, the needle was recapped. 2. A review of the laboratory's "General Laboratory Policies Safety" policy revealed a section titled "Avoiding Needle Sticks" stating, "Sticking yourself with a contaminated needle is a most serious hazard. It almost always happens when the worker goes to recap the needle after using it." 3. A review of the laboratory's "Venipuncture" policy revealed a section stating, "Never recap the needle." 4. An interview on 1/6/25 with the technical consultant confirmed collection personnel #1 had not followed safety procedures. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, 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 -- when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with the technical consultant, the laboratory failed to establish a specimen labeling policy for two (January 2023 to January 2025) of two years reviewed. Findings include: 1. The surveyor observed Collection Personnel #2 on 1/6/25 at 11:05 am entering the laboratory with a lavender- top blood tube that had not been labeled with patient information. Collection Personnel #2 proceeded to label the tube prior to performing a Complete Blood Count. 2. A review of the laboratory's policies and procedures revealed a lack of specimens labeling policy. 3. An interview on 1/6/25 at 1:03 pm with the technical consultant confirmed the laboratory had not established a specimen labeling policy. -- 2 of 2 --

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant, the laboratory failed to verify the accuracy of its hematology testing for analytes the American Proficiency Institute had not assigned a score for 1 (2021 2nd Event) of 4 testing events reviewed. Findings include: 1. A review of the laboratory's American Proficiency Institute (API) testing results revealed the laboratory received results of "Not Graded" for the second event in 2021 for basophil and lymphocyte percentage. 2. The surveyor requested verification of accuracy for the basophil and lymphocyte percentage on 12/7/22 at 9:36 am and it was not made available. 3. A review of the laboratory's "Profiency Testing" policy on 12/7/22 revealed a section stating, "If there are any results that are marked with a ? or # sign, they will be evaluated in the same manner as a failing score." 4. An interview on 12/7/22 at 9:36 am with the Technical Consultant revealed the basophil and lymphocyte percentages with not graded results had not been evaluated. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Consultant #1 (TC1), the laboratory failed to rotate proficiency testing samples among all testing personnel routinely performing patient testing for 6 (1 event in 2021, 3 events in 2020, and 2 events in 2019) of 6 testing events reviewed. Findings include: 1. Review of the laboratory's CMS-209 form revealed it had 7 testing personnel for moderate complexity testing. 2. A review of the laboratory's American Proficiency Institute (API) proficiency testing attestations revealed Testing Personnel #1 performed testing for all specimens in the following proficiency testing events: a. 2021 Hematology /Coagulation 1st Event b. 2020 Hematology/Coagulation 3rd Event c. 2020 Hematology/Coagulation 2nd Event d. 2020 Hematology/Coagulation 1st Event e. 2019 Hematology/Coagulation 3rd Event f. 2019 Hematology/Coagulation 2nd Event 3. An interview on 6/14/21 at 12:12 pm with TC1 confirmed the laboratory did not rotate its proficiency testing specimens among its routine testing staff. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. 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 -- (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Consultant #1 (TC1), the laboratory failed to monitor the temperature for the refrigerator storing hematology quality control materials for 1 week (6/8/21 to 6/14/21) in June 2021. Findings include: 1. A review of the laboratory's temperature monitoring logs revealed a lack of documentation of temperature monitoring for the refrigerator storing hematology quality control materials since 6/7/21. 2. A review of the laboratory's "Table of Expected Values" for the hematology quality control materials revealed a section showing the temperature range for storage was 2-8 degrees Celsius. 3. An interview on 6/14/21 at 12:05 am with TC1 confirmed the laboratory had not recorded temperatures for the refrigerator since 6/7/21. 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 with Technical Consultant #1 (TC1), the laboratory failed to obtain accuracy performance specifications within manufacturer ranges for the Beckman Coulter DxH 520 hematology analyzer for 1 (percent basophils) of 21 total whole blood parameters. Findings include: 1. A review of the laboratory's verification of performance specifications for the Beckman Coulter DxH 520 hematology analyzer revealed the method comparison for percent basophil (BA%) had a bias percentage of -30.2%. 2. A review of the laboratory's copy of the Beckman Coulter System Overview Performance revealed a section titled "Method Comparison" stating, "Accuracy was assessed using a minimum of 40 morphologically normal samples collected into K2 or K3EDTA, stored at operational temperature, and analyzed within 8 hours of collection on the DxH 520 and a comparator. Results with system messages were excluded. The mean difference was calculated according to CLSI EP09-A3. Mean difference results should be within the limits defined below." and "BA% measuring range 0.00 to 100.00 bias or percent bias range plus or minus 1% to plus or minus 10%." 3. An interview on 6/14/21 at 10:48 am with TC1 confirmed the accuracy for BA% did not meet the manufacturer specifications and the laboratory director did not address the discrepancy. -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Consultant #1 (TC1), the laboratory failed to retain all daily Abbott Cell-Dyn 1800 background count records for two (May 2017 to May 2019) of two years reviewed. Findings include: 1. Record review revealed the daily background counts were not maintained for two years as follows: a. Patient testing on 08/23/18 b. Patient testing on 11/20/18 2. On May 30, 2019 at 11:00 AM, TC1 acknowledged the background counts had not been maintained for at least two years. 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- . Based on record review and interview with Technical Consultant #1 (TC1), the laboratory failed to perform the hematology complete blood cell count (CBC) quality control each day of patient testing for two (#5 and #6) of nine patient charts audited. Findings include: 1. Review of the daily CBC quality control records revealed the laboratory did not run at least two different levels of controls on the day of patient testing as follows: a. 24 patients had CBC testing on 08/23/18 - no controls run b. 26 patients had CBC testing on 11/20/18 - no controls run 2. During the interview on May 30, 2019 at 11:00 am, TC1 acknowledged that at least two different levels of controls had not been performed and documented on the days of patient testing. -- 2 of 2 --