Michigan Adult & Child Medicine

Summary Statement of Deficiencies D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

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 the Office Manager (OM), the Laboratory Director (LD) failed to attest to the routine integration of the hematology proficiency testing samples into the patient workload for 1 (3rd event 2019) of 2 events reviewed for 2 years. Findings include: 1. Record review of the Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing documents, the Laboratory Director (LD) failed to sign the attestation statement sheet for the 3rd event in 2019 of 2 events reviewed for 2 years. 2. An interview on 8/24/2021 at 10:26 am, the OM confirmed the LD did not sign the attestation statement sheet. D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: . Based on record review and interview with the Office Manager (OM), the laboratory failed to have a written request for patient testing from an authorized person for 1 (#13) of 14 patient charts audited. Findings include: 1. Record review revealed for 1 (#13) of 14 patient charts audited the laboratory did not have a written request for laboratory testing by an authorized person for the potassium hydroxide (KOH) and the 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 -- wet mount testing completed on 7/14/2020. 2. An interview on 8/24/2021 at 11:50 am, the OM confirmed the patients paper chart did not contain a written order for the KOH and wet mount testing. D5777 COMPARISON OF TEST RESULTS CFR(s): 493.1281(b)(c) (b) The laboratory must have a system to identify and assess patient test results that appear inconsistent with the following relevant criteria, when available: (b)(1) Patient age. (b)(2) Sex. (b)(3) Diagnosis or pertinent clinical data. (b)(4) Distribution of patient test results. (b)(5) Relationship with other test parameters. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: . Based on record review and interview with the Office Manager (OM), the laboratory failed to document the comparison studies for the sampling of the patient specimens in the open mode versus the closed mode on the Beckman Coulter Act diff hematology analyzer for 2 (August 2019 to August 2021) of 2 years of testing. Findings included: 1. Record review revealed the laboratory lacked the documentation to show comparison studies were performed and documented twice a year for 2 (August 2019 to August 2021) of 2 years of testing. 2. An interview on 8/24/2021 at 9: 55 am, the OM confirmed the laboratory failed to perform and document the comparison studies twice a year. D5803 TEST REPORT CFR(s): 493.1291(b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. This STANDARD is not met as evidenced by: . Based on record review and interview with the Office Manager (OM), the laboratory failed to have the final potassium hydroxide (KOH) and wet mount testing results maintained as part of the patient's paper chart for 1 (#13) of 14 patient charts reviewed. Findings include: 1. A record review for 1 (#13) of 14 patient charts reviewed revealed a lack of documentation in the patient's paper chart for the KOH and wet mount specimen tested on 7/14/2020. 2. An interview on 8/24/2021 at 11:50 am, the OM confirmed the patient's final KOH and wet mount testing results was not maintained in the patient's paper chart. 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 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: . Based on review of the CMS database and review of the Wisconsin State Laboratory of Hygiene (WSLH) final proficiency testing reports, it was determined that the laboratory failed to successfully participate in a CMS approved proficiency testing program for the specialty of hematology for 2 (events 2 and 3 of 2019) of 3 testing events. Findings include: Review of the CMS database and the WSLH proficiency testing reports showed unsatisfactory performance for two of three proficiency testing events for the specialty of hematology. Refer to D2130 and D2131. . D2130 HEMATOLOGY 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 -- CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on review of the CMS database and review of the Wisconsin State Laboratory of Hygiene (WSLH) final proficiency testing reports, it was determined that the laboratory failed to satisfactory performance for the hematology analytes red blood cells (RBC) and hematocrit (HCT) for 2 (events 2 and 3 of 2019) of 3 testing events. Findings include: Unsatisfactory performance for two out of three consecutive PT events constituting unsuccessful performance for RBC, and HCT. RBC PT Event Score 2nd event 2019 40% 3rd event 2019 0% HCT PT Event Score 2nd event 2019 60% 3rd event 2019 0% D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance 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 review of the CMS database and review of the Wisconsin State Laboratory of Hygiene (WSLH) final proficiency testing reports, it was determined that the laboratory failed to satisfactory performance for the specialty of hematology for 2 (events 2 and 3 of 2019) of 3 testing events. Findings include: Unsatisfactory performance for two out of three consecutive PT events constituting unsuccessful performance for the specialty of hematology. Specialty of Hematology PT Event Score 2nd event 2019 75% 3rd event 2019 48% -- 2 of 2 --