Birmingham Royal Oak Medical Group

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 record review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, it was determined the laboratory failed to successfully participate in a CMS-approved proficiency testing program for the hematology analyte: White Blood Cell Differential. Findings include: Review of the CMS database and the API proficiency testing reports revealed the laboratory failed to achieve satisfactory performance for the hematology analyte: White Blood Cell Differential. Refer to D2123 and D2130. D2123 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(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: . Based on review of the CMS database and review of the American Proficiency Institute (API) final proficiency testing reports, it was determined the laboratory failed to participate in the hematology analyte, White Blood Cell Differential for 2 (1st and 3rd events 2020) of 3 testing events. Findings include: 1. A review of the CMS database and review of the API final proficiency testing reports revealed the laboratory attained the following scores for the hematology analyte: White Blood Cell Differential: PT Event Score 1st event of 2020 0% 3rd event of 2020 0% 2. A review of API proficiency testing reports revealed the laboratory failed to participate in proficiency testing for the hematology analyte: White Blood Cell Differential. D2130 HEMATOLOGY 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 the American Proficiency Institute (API) proficiency testing reports, the laboratory failed to participate and achieve satisfactory performance for 2 (1st and 3rd events 2020) of 3 testing events for the hematology analyte: White Blood Cell Differential. Findings include: For the hematology analyte: White Blood Cell Differential the following scores were attatined: Hematology PT Event Score 1st event 2020 0% 3rd event 2020 0% -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: . Based on record review and interview, the laboratory failed to enroll in a proficiency testing program for one (2018) of two years reviewed in the speciality of hematology for the analytes: white blood cell differential, red blood cell count, hematocrit, hemoglobin, white blood cell count, and platelets. Findings include: 1. On December 5, 2018 at 10:37 AM, record review of the CMS database and the American Proficiency Institute (API) proficiency testing documents revealed there was no documentation to show the laboratory was enrolled in a proficiency testing program in 2018. 2. During the interview on December 5, 2018 at 10:37 AM, testing personnel #1 as listed on the CMS-209 confirmed the laboratory was not enrolled in a proficiency testing program for the speciality of hematology in 2018. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or 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 -- examining specimens. This STANDARD is not met as evidenced by: . Based on procedure review and interview, the laboratory failed to establish and follow written procedures for the hematology testing. Findings include: 1. On December 5, 2018 at 9:20 AM, review of the "Procedure Manual " revealed the laboratory did not have procedures for the following: a. Operating, maintenance, normal ranges, panic value, instrument generated flag procedures for the Sysmex XP- 300 hematology analyzer b. Quality Control, new lot assessment, troubleshooting, and end of lot procedures for the Sysmex XP-300 hematology analyzer. c. Competency procedures d. Proficiency Testing procedures e. Temperature - room, refrigerator, humidity monitoring, and