Northlakes Community Clinic

Summary Statement of Deficiencies D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on surveyor review of testing logs and competence evaluations and interview with a Technical Consultant (Staff A), the technical consultant did not evaluate one of two testing personnel for competence in performing urine microscopic testing at this laboratory. Findings include: 1. Review of urinalysis testing logs showed Staff A evaluated and reported four patient samples in May 2024 (one sample each on May 14 and 15 and two samples on May 28, 2024). 2. Review of competence evaluation records showed no documented competence evaluation of urine microscopy performance for Staff A at this laboratory. 3. Interview with Staff A on August 14, 2024, at 1:15 PM confirmed they had performed urine microscopic testing without evaluation of competence at this laboratory. 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 D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Item 1: Based on surveyor review of proficiency testing records and interview with testing personnel, staff A, the laboratory did not verify the accuracy of microscopic urinalysis testing twice annually in 2021. Findings include: 1. Review of proficiency testing records showed a proficiency testing order for Wisconsin State Laboratory of Hygiene (WSLH) Provider Performed Microscopy (PPM) module on May 17, 2021, to include KOH Preparation, skin and vaginal source, Wet preparation and Urine Sediment. 2. Review of proficiency testing records showed an evaluation of accuracy for microscopic urinalysis in the second event of 2021 for WSLH. Further review showed no evaluation of microscopic urinalysis a second time in 2021. 3. Interview with staff A on November 15, 2022, at 8:30 AM confirmed the laboratory had not verified the accuracy of the test twice annually in 2021. Item 2: Based on surveyor review of proficiency testing records and interview with testing personnel, staff A, the laboratory did not verify the accuracy of potassium hydroxide (KOH) or vaginal wet mount testing twice annually in 2021. Findings include: 1. Review of proficiency testing records showed a proficiency testing order for Wisconsin State Laboratory of Hygiene (WSLH) Provider Performed Microscopy (PPM) module on May 17, 2021, to include KOH Preparation, skin and vaginal source, Wet preparation and Urine Sediment. 2. Review of proficiency testing records showed an evaluation of accuracy for KOH and vaginal wet mount testing in the second event of 2021 for WSLH. Further review showed no evaluation of KOH and vaginal wet mount testing a second time in 2021. 3. Interview with staff A on November 15, 2022, at 8:30 AM confirmed the laboratory had not verified the accuracy of the tests twice annually in 2021. 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 D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on surveyor review of the Centers for Medicare and Medicaid Services (CMS) Form 209 "Laboratory Personnel Report" and academic credentials, and interview with the regional laboratory manager, the laboratory did not have a technical consultant who met the qualification requirements of 493.1411 of this subpart for the last four months. Findings include: 1. The assigned technical consultant does not hold the minimum academic credentials to meet the qualification requirements for technical consultant. See D6035. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty 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 2 -- subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Based on surveyor review of the Centers for Medicare and Medicaid Services (CMS) Form 209 "Laboratory Personnel Report" and academic credentials, and interview with the regional laboratory manager, the technical consultant who has been in the role for the last four months did not hold academic credentials that met the qualification requirements for a technical consultant. Findings include: 1. Review of the CMS Form 209 showed the laboratory identified staff A as the technical consultant for the laboratory. 2. Review of academic credentials showed the highest academic credential held by staff A was an Associate's Degree in medical laboratory science. 3. Interview with the regional laboratory manager, staff A, on December 3, 2020 at 12:45 PM confirmed their academic credentials did not meet the requirements for the technical consultant position. Further interview confirmed staff A has been in the technical consultant role for four months. -- 2 of 2 --

Summary Statement of Deficiencies D5409 PROCEDURE MANUAL CFR(s): 493.1251(e) The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance as described in 493.1105(a)(2). This STANDARD is not met as evidenced by: Based on surveyor review of laboratory procedures and interview with the technical consultant, the laboratory's procedure for microscopic urinalysis does not include a date of initial use in this laboratory. Findings include: 1. Review of the laboratory's procedure manual revealed the "Clinitek Procedure" includes instructions for the microscopic portion of the urinalysis exam. The procedure did not include a date of initial use. 2. Interview with the technical consultant on November 7, 2018 at 1:30 PM confirmed the procedure did not include a date of initial use. 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: Based on surveyor review of test reports and interview with the technical consultant, 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 -- the test report does not indicate the address of the laboratory location where the test was performed. Findings include: 1. Review of patient test reports in the Centricity electronic medical record showed no indication of the address of the laboratory where testing was performed. 2. Interview with the technical consultant on November 7, 2018 at 1:30 PM confirmed the address of the testing laboratory is not indicated on the Centricity test report. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on surveyor review of the Centers for Medicare and Medicaid Services (CMS) Form CMS-209 titled "Laboratory Personnel Report (CLIA)" and personnel records, and interview with the technical consultant, one of four testing personnel does not have credentials available showing they meet the qualification requirements for moderate complexity testing personnel. Findings include: 1. One of four testing personnel does not have credentials showing they meet the qualification requirements for moderate complexity testing. See D 6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on surveyor review of the Centers for Medicare and Medicaid Services (CMS) Form CMS-209 title "Laboratory Personnel Report (CLIA)" and personnel records, and interview with the technical consultant, one of four testing personnel does not have documented evidence showing they meet the qualification requirements to perform moderate complexity testing. Findings include: 1. Review of Form CMS-209 titled "Laboratory Personnel Report (CLIA)" shows staff A is one of four testing personnel in this lab. 2. Review of personnel records showed no evidence of credentials for staff A. 3. Interview with the technical consultant on November 7, 2018 at 1:00 PM confirmed documented credentials were not available showing staff A meets the minimum requirements for moderate complexity testing personnel. -- 2 of 2 --