Michigan United Physicians

Summary Statement of Deficiencies 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 Laboratory Director, the laboratory failed to have a test request for testing performed by the laboratory for 9 (Patients PLC21-06886, PLC21-06175, PLS21-02585, PLS21-02268, PLS21-01571, PLC21- 01139, PLS22-01580, PLS22-01062, and PLC22-00397) of 9 patient test records reviewed. Findings include: 1. A review of patient test records revealed the following patients had cytology and histopathology microscopic examinations (professional component) performed by the laboratory: a. PLC21-06886 had testing performed 10 /07/2021. b. PLC21-06175 had testing performed 09/08/2021. c. PLS21-02585 had testing performed 08/12/2021. d. PLS21-02268 had testing performed 06/28/2021. e. PLS21-01571 had testing performed 04/22/2021. f. PLC21-01139 had testing performed 02/11/2021. g. PLS22-01580 had testing performed 05/18/2022. h. PLS22- 01062 had testing performed 04/05/2022. i. PLC22-00397 had testing performed 01/21 /2022. 2. A review of the test requests for the patients listed above on 6/14/22 revealed to be for the reference laboratory and were test requests for the specimen grossing and processing part (technical component) of cytology and histopathology testing performed by the reference laboratory. 3. The surveyor requested the test requests for the patients listed above for the professional component performed by the laboratory on 6/14/22 at 10:35 am and they were not made available. 4. An interview on 6/14/22 at 10:35 am with the Laboratory Director revealed if the "professional" or "global" boxes on the test request form were to be checked, the reference laboratory performing the specimen grossing and processing would also perform the professional component. The Laboratory Director confirmed the laboratory did not have test requests for the testing performed by the laboratory for the patients listed above. 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 D5633 CYTOLOGY CFR(s): 493.1274(d)(1) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(1) The technical supervisor establishes a maximum workload limit for each individual who performs primary screening. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and interview it was determined that the laboratory failed to follow written policies and procedures to ensure that maximum workload limits were established for one of one Technical Supervisor in 2019, 2020 and to the date of the survey in 2021. Findings include: 1. The laboratory failed to follow the procedure titled WORK LOAD LIMITS FOR NON GYNECOLOGICAL CYTOLOGY SPECIMENS which stated: "Work load limits with maximum will be established and adjusted based on volume, need and individual capability." 2. The Survey Team requested and the laboratory failed to provide maximum workload limits based on individual capabilities for one of one Technical Supervisor in 2019, 2020, and to the date of the survey in 2021. Technical Supervisor included: -Laboratory Director/Technical Supervisor 3. During an interview on May 24, 2021 at 4:40 PM these findings were confirmed by the Laboratory Director/Technical Supervisor. D5637 CYTOLOGY CFR(s): 493.1274(d)(1)(ii) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(1)(ii) Each individual's workload limit is reassessed at least every 6 months and adjusted when necessary. 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: Based on review of laboratory policies and procedures, lack of laboratory records and interview it was determined that the laboratory failed to follow written policies and procedures to reassess a maximum workload limit at least every six months for one of one Technical Supervisors in 2019, 2020 and to the date of the survey in 2021. Cross refer to D5633 Findings include: 1. The laboratory failed to follow the procedure WORK LOAD LIMITS FOR NON GYNECOLOGICAL CYTOLOGY SPECIMENS which stated: "On a daily biannual basis, work load limits will be established for pathologist." 2. The Survey Team requested and the laboratory failed to provide records of a workload reassessment at least every six months for one of one Technical Supervisors in 2019, 2020 and to the date of the survey in 2021. 3. During an interview on May 24, 2021 at 4:40 PM these findings were confirmed by the Laboratory Director/Technical Supervisor. D5657 CYTOLOGY CFR(s): 493.1274(e)(5) (e) The laboratory must establish and follow written policies and procedures that ensure the following: (e)(5) The report contains narrative descriptive nomenclature for all results. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures and interview it was determined that the laboratory failed to establish written policies and procedures for the system of narrative descriptive nomenclature used by the laboratory to report nongynecologic cytology test results. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to define the criteria used and the system of narrative descriptive nomenclature used by the laboratory to report nongynecologic cytology test results. 2. During an interview on May 24, 2021 at 4:40 PM these findings were confirmed by the Laboratory Director /Technical Supervisor. D9999 By agreement between ASCT Services, Inc. and CMS, information provided for CMS's completion of CMS Form 670 are ASCT Services, Inc. averages only. This information is confidential and proprietary to ASCT Services, Inc., is exempt under the Freedom of Information Act (5 U.S.C. 552 et seq.), and shall be used for federal government purposes only. -- 2 of 2 --

Summary Statement of Deficiencies 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: A. Based on review of laboratory policies and procedures, records and interview, it was determined that the laboratory failed to follow written policies and procedure to ensure the specimen source was documented on the final reports from 3/6/2017 to date of the survey in 2018. Findings include: 1. The Survey Team reviewed the procedure titled "REQUISITION AND REPORT GUIDELINES", which stated: "Each case is examined to confirm completeness and accuracy of specimens submitted and preparation received." 2. The Survey Team reviewed 145 final cytology test reports from 3/6/2017 to 2/8/2018. One-hundred-forty-five (145) of the 145 final reports did not accurately indicate the specimen source. a. The specimen source listed on the 145 final reports was "urine". The specimen source on the corresponding test requisition for the 145 specimens was "bladder washings". Reports include: PLC17- 01073 PLC17-04977 PLC17-01074 PLC17-05086 PLC17-01157 PLC17-05181 PLC17-01158 PLC17-05182 PLC17-01176 PLC17-05183 PLC17-01179 PLC17- 05230 PLC17-01256 PLC17-05315 PLC17-01257 PLC17-05440 PLC17-01258 PLC17-05441 PLC17-01259 PLC17-05589 PLC17-01373 PLC17-05650 PLC17- 01374 PLC17-05651 PLC17-01375 PLC17-05652 PLC17-01402 PLC17-05753 PLC17-01447 PLC17-05754 PLC17-01489 PLC17-05885 PLC17-01546 PLC17- 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 -- 05886 PLC17-01575 PLC17-05993 PLC17-01584 PLC17-06544 PLC17-01585 PLC17-06783 PLC17-01586 PLC17-06784 PLC17-01642 PLC17-06785 PLC17- 01643 PLC17-06786 PLC17-01730 PLC17-06787 PLC17-02168 PLC17-06838 PLC17-02169 PLC17-06863 PLC17-02170 PLC17-07483 PLC17-02190 PLC17- 07484 PLC17-02191 PLC17-07517 PLC17-02192 PLC17-07519 PLC17-02237 PLC17-07661 PLC17-02254 PLC17-07703 PLC17-02300 PLC17-07794 PLC17- 02301 PLC17-07795 PLC17-02333 PLC17-07828 PLC17-02335 PLC17-07902 PLC17-02363 PLC17-08126 PLC17-02400 PLC17-08127 PLC17-02454 PLC17- 08165 PLC17-02546 PLC17-08205 PLC17-02686 PLC17-08256 PLC17-02758 PLC17-08319 PLC17-02759 PLC17-08319 PLC17-02822 PLC17-08377 PLC17- 02837 PLC17-08421 PLC17-02995 PLC17-08422 PLC17-03591 PLC17-08423 PLC17-03641 PLC17-08541 PLC17-03690 PLC17-08542 PLC17-03695 PLC17- 08566 PLC17-03715 PLC17-08609 PLC17-03752 PLC17-08660 PLC17-03818 PLC17-08661 PLC17-03819 PLC17-08720 PLC17-03836 PLC17-08738 PLC17- 04277 PLC17-08754 PLC17-04317 PLC18-00011 PLC17-04363 PLC18-00012 PLC17-04364 PLC18-00013 PLC17-04365 PLC18-00056 PLC17-04366 PLC18- 00072 PLC17-04445 PLC18-00195 PLC17-04484 PLC18-00196 PLC17-04485 PLC18-00197 PLC17-04486 PLC18-00663 PLC17-04521 PLC18-00665 PLC17- 04522 PLC18-00676 PLC17-04564 PLC18-00712 PLC17-04565 PLC18-00713 PLC17-04567 PLC18-00826 PLC17-04597 PLC18-00827 PLC17-04920 PLC18- 00873 PLC17-04921 3. During an interview on 02/13/2018 at 9:15 AM, the Laboratory Director/Technical Supervisor confirmed that the 145 final reports did not list the specimen source accurately. B. Based on review of laboratory policies and procedures, records and interview, it was determined that the laboratory failed to follow written policies and procedure to ensure the clinical history appeared on the final reports from 3/6/2017 to date of the survey in 2018. Findings include: 1. The Survey Team reviewed the procedure titled "CLINICAL CORRELATION" which stated: "The required information and other pertinent information should be included in the clinical history section of the pathology report in a clear, concise and organized manner." 2. The Survey Team reviewed 145 final cytology test reports from 3/6/2017 to 2/8/2018. One-hundred-thirty-nine (139) of 145 final reports did not document any clinical history. Reports include: PLC17-01073 PLC17-05181 PLC17-01074 PLC17- 05182 PLC17-01157 PLC17-05183 PLC17-01158 PLC17-05230 PLC17-01257 PLC17-05315 PLC17-01258 PLC17-05441 PLC17-01259 PLC17-05589 PLC17- 01373 PLC17-05650 PLC17-01374 PLC17-05651 PLC17-01375 PLC17-05652 PLC17-01402 PLC17-05753 PLC17-01447 PLC17-05754 PLC17-01489 PLC17- 05885 PLC17-01546 PLC17-05886 PLC17-01575 PLC17-05993 PLC17-01584 PLC17-06544 PLC17-01585 PLC17-06783 PLC17-01642 PLC17-06784 PLC17- 01643 PLC17-06785 PLC17-01730 PLC17-06786 PLC17-02168 PLC17-06787 PLC17-02169 PLC17-06838 PLC17-02170 PLC17-06863 PLC17-02190 PLC17- 07483 PLC17-02191 PLC17-07484 PLC17-02192 PLC17-07517 PLC17-02237 PLC17-07519 PLC17-02254 PLC17-07661 PLC17-02300 PLC17-07703 PLC17- 02301 PLC17-07794 PLC17-02333 PLC17-07795 PLC17-02335 PLC17-07828 PLC17-02363 PLC17-07902 PLC17-02400 PLC17-08126 PLC17-02454 PLC17- 08127 PLC17-02546 PLC17-08165 PLC17-02686 PLC17-08205 PLC17-02758 PLC17-08256 PLC17-02759 PLC17-08319 PLC17-02822 PLC17-08319 PLC17- 02837 PLC17-08377 PLC17-02995 PLC17-08421 PLC17-03641 PLC17-08422 PLC17-03690 PLC17-08423 PLC17-03695 PLC17-08541 PLC17-03715 PLC17- 08542 PLC17-03752 PLC17-08566 PLC17-03818 PLC17-08609 PLC17-03819 PLC17-08660 PLC17-03836 PLC17-08661 PLC17-04277 PLC17-08720 PLC17- 04317 PLC17-08738 PLC17-04363 PLC17-08754 PLC17-04364 PLC18-00011 PLC17-04365 PLC18-00012 PLC17-04366 PLC18-00013 PLC17-04445 PLC18- 00056 PLC17-04484 PLC18-00072 PLC17-04485 PLC18-00195 PLC17-04486 -- 2 of 3 -- PLC18-00196 PLC17-04521 PLC18-00197 PLC17-04522 PLC18-00663 PLC17- 04564 PLC18-00665 PLC17-04565 PLC18-00676 PLC17-04567 PLC18-00712 PLC17-04597 PLC18-00713 PLC17-04920 PLC18-00826 PLC17-04921 PLC18- 00827 PLC17-04977 PLC18-00873 PLC17-05086 3. During an interview, on 02/13 /2018 at 9:15 AM, the Laboratory Director/Technical Supervisor confirmed that the 139 final reports did not document the clinical history which had been provided on the test requisition. D9999 By agreement between ASCT Services, Inc. and CMS, information provided for CMS's completion of CMS Form 670 are ASCT Services, Inc. averages only. This information is confidential and proprietary to ASCT Services, Inc., is exempt under the Freedom of Information Act (5 U.S.C. 552 et seq.), and shall be used for federal government purposes only. -- 3 of 3 --