Karmanos Cancer Institute - Lapeer

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: . Based on record review and interview with the Manager of Clinic Operations, the laboratory failed to establish and follow written competency assessment policies for 2 of 2 Technical Consultants (TC1, TC2) as listed on the CMS-209 per CLIA regulation 493.1235. Findings include: 1. A review of the laboratory personnel documentation revealed a lack of competency assessments for the following: a. No competency assessments were conducted for TC1 for the years 2023, 2024 and 2025. b. No competency assessments were conducted for TC2 since promotion into new role in April 2024. c. The surveyor requested the missing documentation listed above at 10: 30 am from TC2 and was unable to provide documents. 2. A review of the laboratory's personnel competency policies revealed the policy did not include assessments for Technical Consultants. 3. An interview with the Manager of Clinic Operations on 04/14/2025 at 10:45 am confirmed the lack of documentation listed above; and stated that the laboratory TC (Technical Consultant) competency assessments are conducted every 2 years; however it is not indicated in the laboratory policy. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: . Based on record review and interview with the Supervisor of Operations (SO), the laboratory failed to have the white binder that housed the policies and procedures approved, signed, and dated by the Laboratory Director for 22 (June 2021 to March 2023) of 22 months of operation in use. Findings include: 1. A record review of the white binder that housed the laboratory's policies and procedures revealed the Laboratory Director never approved, signed, and dated the policies and procedures in use for 22 (June 2021 to March 2023) of 22 months in use. 2. An interview on 3/22/23 at 11:02 am, the SO confirmed the policies and procedures in the white binder were not approved, signed, and dated by the Laboratory Director. 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. 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 record review and interview with the Supervisor of Operations (SO), the laboratory failed to perform the hematology calibration procedures at least every 6 months for 1 (second event in 2022) of 5 events reviewed. Findings include: 1. Record review of the calibration documents for the hematology Horiba Medical ABX Micros 60 hematology analyzer revealed the laboratory did not have any documentation to show the calibration procedure was performed for 1 (second event in 2022) of 5 events reviewed. 2. When queried on 3/22/2023 at 11:59 am, the SO stated the facility was having trouble with the purchasing order to receive the calibration material in a timely manner. 3. An interview on 3/22/2023 at 11:59 am, the SO confirmed the calibration verification was not performed for the 2nd event in 2022. ***Repeat Deficiency from the 12/13/2016 survey*** D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #1, the laboratory failed to establish policies and procedures to assess the competency of their three technical consultants listed on the CMS-209 form for 2 (June 2019 to June 2021) of 2 years reviewed. Findings include: 1. A review of the laboratory's competency records revealed a lack of competency documentation for the following personnel: a. Technical Consultant #1 b. Technical Consultant #2 c. Technical Consultant #3 2. An interview with Testing Personnel #1 on 6/2/21 at 9:49 am revealed the laboratory did not have policies and procedures for the assessment of consultant competency and has not performed competency assessments for the personnel listed above. ***This is a repeated deficiency from the 6/17/19 and 12/13/16 recertification surveys*** D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the 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 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 -- 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 record review and interview with Testing Personnel #1 and #2, the laboratory failed to perform calibration on the Horiba ABX micros 60 hematology analyzer at least every 6 months for 1 (September 2019) of 4 calibration events reviewed. Findings include: 1. A review of the laboratory's calibration records for the Horiba ABX micros 60 hematology analyzer for Complete Blood Count (CBC) testing revealed a lack of documentation of a calibration performed in September 2019, after the previous calibration performed on 3/5/19. 2. A review of the laboratory's policy titled "Quality Assurance for Micros 60 Analyzer" revealed a section stating, "calibration is performed every six months and as necessary. Keep all printouts and file in folder labeled same." 3. An interview on 6/2/21 at 10:21 am with Testing Personnel #1 and #2 confirmed the laboratory did not have documentation of performing calibration for September 2019. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #1 and #2 (TP1 and TP2), the Laboratory Director (LD) and TP failed to attest to the routine integration of the hematology proficiency testing samples into the patient workload for 6 (2nd and 3rd events 2017, 1st-3rd events 2018 and the 1st event of 2019) of 6 events reviewed. Findings include: 1. Record review of the American Proficiency Institute (API) hematology proficiency testing documents revealed the attestation statement sheet was not signed by the LD and TP for 6 of 6 events in 2017 - 2019. 2. During the interview on June 17, 2019 at 10:45 am, TP1 and TP2 acknowledged the attestation statement sheets were not signed. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- the PT event. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #1 and #2 (TP1 and TP2), the laboratory failed to 1) retain the original proficiency testing (PT) program report forms for 2 (3rd event 2017 and 2018) of 6 events reviewed and 2) the instrument printouts for 1 (3rd event 2017) of 6 events reviewed for the hematology PT. Findings include: 1. Record review of the American Proficiency Institute (API) final PT documents revealed the laboratory did not retain the original proficiency testing program report forms and the instrument printouts as follows: a. original PT program report forms - 3rd event 2017 and 2018 b. original instrument printouts - 3rd event 2017 2. During the interview on June 17, 2019 at 10:45 am, TP1 and TP2 acknowledge the original PT program report forms and the hematology instrument printouts was not available to the surveyor. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: . Based on procedure review, record review, and interview with Testing Personnel #1 and #2 (TP1 and TP2), the laboratory failed to ensure competency policies were followed for 14 (#1 - #14) of 14 TP performing the moderately complex hematology complete blood cell count testing. Findings include: 1. Review of the "Personnel Competency Policy/Procedure" in the CLIA manual revealed competency is to be completed, initially, at 6 months, and annually thereafter. 2. Record review of the TP competency assessments revealed the following: a. No initial competency - TP5 b. No 6 month competency - TP4 and TP11 c. no annually competency in 2017 - TP7 and TP12 c. no annual competency in 2018 - TP1 - TP3, TP5 - TP9, and TP11 - TP14 d. no annual competency in 2019 - TP2 - TP4, TP6, TP8 - TP9, and TP12 - TP14 3. During the interview on June 17, 2019 at 9:28 am, TP1 and TP2 acknowledged the competency assessments had not been performed or documented as stated in the policy. ***Repeat Deficiency from the 12/03/16 survey*** D5785