Oakleaf Clinics Sc

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 surveyor review of a Centers for Medicare and Medicaid Services (CMS) Form 116 'Application for Certification' and laboratory procedures and interview with the Technical Consultant, the current laboratory director had not approved, signed, and dated four of four random procedures reviewed since assuming the role of laboratory director on April 29, 2024. Findings include: 1. Review of a CMS Form 116 submitted by the laboratory to the State CLIA office showed the laboratory requested a laboratory director change to a pathologist (Staff A) effective April 29, 2024. 2. Review of four random laboratory procedures (Troponin, Urine Microscopics, Vitros XT3400 Chemistry, and Affinion II ACR) showed no evidence of approval by Staff A. 3. Interview with the Technical Consultant on July 19, 2024, at 1:30 PM confirmed Staff A had not approved, signed, and dated the laboratory procedures since assuming the role of laboratory director on April 29, 2024. 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 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 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 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 surveyor review of the federal Certification and Survey Provider Enhancement Reports (CASPER) Proficiency Testing (PT) and the Wisconsin State Laboratory of Hygiene (WSLH) Proficiency Testing (PT) records, the laboratory failed to successfully participate in PT for the White Blood Cell (WBC) Differential (Diff) analyte in the Specialty of Hematology for events 2020-2 and 2020-3. See D2130 D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- 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 surveyor review of the federal Certification and Survey Provider Enhancement Reports (CASPER) Proficiency Testing (PT) and the Wisconsin State Laboratory of Hygiene (WSLH) Proficiency Testing (PT) records, the laboratory failed to successfully participate in PT for the White Blood Cell (WBC) Differential (Diff) analyte in the Specialty of Hematology for events 2020-2 and 2020-3. Findings include: 1. Review of PT records in the CASPER reporting system showed that the laboratory failed two consecutive PT events for the WBC Diff analyte in the Specialty of Hematology: Event 2020-2, score 53% and Event 2020-3, score 50% 2. Surveyor review of the WSLH PT evaluation reports on November 17, 2020 confirmed the failed PT scores for the WBC Diff analyte. This results in a failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events which is an unsuccessful PT performance. -- 2 of 2 --

Summary Statement of Deficiencies D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory quality control records, manufacturer's package insert instructions, and interview with the laboratory supervisor the laboratory does not use an elevated serum bilirubin control for monitoring the abnormal range of neonatal bilirubin testing. The laboratory also does not use an elevated serum glucose control to check the clinically relevant range for high glucose results. Item #1 Findings include: 1. Review of laboratory quality control (QC) records for the bilirubin assay show that two levels of QC are performed on a daily basis. The current in use lot of Bio-Rad Liquid Assayed Multiqual QC had the following QC ranges: Level 1: 0.469-0.840 mg/dL Level 2: 2.81-3.38 mg/dL 2. Review of QC records for the bilirubin assay show that an elevated serum based bilirubin control for monitoring the abnormal range of neonatal bilirubin's is not assayed when performing neonatal bilirubin testing. 3. Interview with the laboratory supervisor on May 30, 2018 at 12:15 PM confirms that an elevated serum based bilirubin control is not used to monitor the abnormal range of neonatal bilirubin's. Item #2 Findings include: 1. Review of laboratory QC records for the glucose assay show that two levels of QC are performed on a daily basis. The current in use lot of Bio-Rad Liquid Assayed Multiqual QC had the following QC ranges: Level 1: 48.3- 60.7 mg/dL Level 2: 101-119 mg/dL 2. Review of the manufacturer's package insert 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 -- instructions state QC should check the clinically relevant range. 3. Interview with the laboratory supervisor on May 30, 2018 at 12:15 PM confirms that glucose quality control does not cover the clinically relevant range for elevated glucose testing. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on laboratory record review and interview with the laboratory supervisor, the laboratory director has designated in writing responsibilities to an individual who is not a qualified technical consultant to perform those duties. Findings include: 1. The laboratory director may delegate to a technical consultant, in writing, the responsibilities in : 493.1407(e)(3), (4), (5), (6), (7), (11), (12), and (13). 2. The laboratory director has written delegation to an individual that is not a qualified technical consultant to perform those responsibilities. 3. Interview with the laboratory supervisor on May 30, 2018 at 11:30 AM confirms that the laboratory director has not delegated responsibilities in writing to a qualified technical consultant to perform the responsibilities in 493.1407(e)(3), (4), (5), (6), (7), (11), (12), and (13). -- 2 of 2 --