Northlakes Community Clinic

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory verification records and procedures for one of one new analyzer and interview with the two technical consultants, the laboratory did not document evaluation of the Diesse MINI-CUBE ESR (Erythrocyte Sedimentation Rate) analyzer precision or reference interval (normal range) and did not evaluate the full reportable range prior to reporting patient results starting in July 2023. Findings include: 1. Review of the verification records for the Diesse MINI-CUBE ESR analyzer showed the laboratory director signed a summary sheet on January 4, 2023, referencing the laboratory's comparison studies between the MINI-CUBE and the ESR AutoPlus analyzers. The summary sheet and attached comparison study showed no evaluation of precision or the reference interval for the analyzer. The comparison study included samples with results between 5 and 50 mm/hour. 2. The laboratory procedure, 'Diesse MINI-CUBE ESR Automated Method', stated the laboratory's reportable range was 0 - 140 mm/hour. 3. Interview with the two technical consultants on August 14, 2024, at 10:30 AM confirmed the verification records did not include precision data or show the director evaluated precision for the Diesse MINI-CUBE ESR analyzer and did not show evaluation of reference intervals. Further interview confirmed the laboratory had not evaluated the full reportable range prior to starting patient testing. 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 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 laboratory information system (LIS) patient reports, Clinical Laboratory Improvement Amendments (CLIA) Application for Certification Form CMS-116 and interview with the testing personnel, staff A, the test report did not include the correct testing address. Findings include: 1. Review of LIS test report for patient 1 showed laboratory testing was performed at "NORTHLAKES COMMUNITY CLINIC HAYWARD BACK OFFICE TEST". Further review showed the address for the testing performed at was 11128 N. State Hwy 77, Hayward, WI 54843. 2. Review of the CLIA Form CMS-116 showed the address of the laboratory as 15954 Rivers Edge Drive, Hayward, WI 54843. 3. Interview with staff A on November 15, 2022, at 10:30 AM confirmed the laboratory's address is 15954 Rivers Edge Drive, Hayward, WI 54843, and testing was started at this address on May 20, 2021. Further interview confirmed the test report did not include the correct testing address. 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 3 -- 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 8:30 AM 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. 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 the Center for Medicare and Medicaid Services (CMS) Form 209 "Laboratory Personnel Report" and personnel records, and interview with the regional laboratory manager, the technical consultant did not document testing personnel competency for three of three testing personnel in 2019. Findings include: 1. Review of the CMS Form 209 shows four testing personnel employed in the laboratory. 2. Review of personnel records showed three of the four identified testing personnel were performing testing during 2019. Review of competency records in 2019 showed no evidence of competency evaluation of staff A, B, or C in 2019. 3. -- 2 of 3 -- Interview with the regional laboratory manager on December 3, 2020 at 9:00 AM confirmed staff A, B, and C were performing testing in 2019 and confirmed the technical consultant did not document competency of testing personnel in 2019. -- 3 of 3 --

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 procedures and interview with the technical consultant, four out of five laboratory procedures reviewed do not include dates of initial use. Findings include: 1. Review of five laboratory procedures revealed four procedures that did not include the effective date or any indication of the date of initial use: *Cell Dyn Emerald *Clinitek Procedure *Streck ESR Procedure, Automated Method (ESR, Erythrocyte Sedimentation Rate) *Vaginal Wet Prep 2. Interview with the technical consultant, staff C, on November 7, 2018 at 11:00 AM confirmed the procedures did not include a date of initial use. This is a repeat deficiency previously cited on September 19, 2014. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor observation of blood collection tubes and interview with the technical consultant, the red top Vacuette tubes available for use in the phlebotomy area were past their May 17, 2018 expiration date. Findings include: 1. Observation of blood collection tubes in the phlebotomy area on November 7, 2018 at 11:15 AM 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 -- revealed all red top Vacuette tubes observed showed an expiration date of 2018-05-17 (May 17, 2018). 2. Interview with the technical consultant, staff C, on November 7, 2018 at 11:15 AM confirmed the red top Vacuette tubes had exceeded the expiration date after May 17, 2018 and were still in use. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with the technical consultant the laboratory did not verify that the manufacturer's reference intervals for the Emerald hematology analyzer, including age and sex specific ranges, were appropriate for the laboratory's patient population before using the analyzer for patient testing. Findings include: 1. Review of the laboratory's studies of performance specifications for the Emerald hematology analyzer showed no evaluation of the manufacturer's or other published reference ranges. 2. Interview with the technical consultant, staff C, on November 7, 2018 at 10:30 AM confirmed the laboratory did not verify the reference ranges for the Emerald hematology analyzer were appropriate for their patient population. Further interview revealed the Emerald hematology analyzer has been used for patient testing since September 7, 2018. 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, the test report does not indicate the address of the laboratory where the test was performed for testing performed at this laboratory. Findings include: 1. Review of patient test reports for tests performed in this laboratory 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, staff C, on November 7, 2018 at 11:30 AM confirmed the address of the testing laboratory is not indicated on the Centricity test report for testing performed at this laboratory. -- 2 of 4 -- D6026 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(8) 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)(8) Ensure that reports of test results include pertinent information required for interpretation. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory procedures and interview with the technical consultant, the laboratory director has not ensured that reference ranges for hematology reports are appropriate for interpretation based on the patient age and sex. Findings include: 1. Review of laboratory procedures shows hematology reference ranges are not age and sex specific. 2. Interview with the technical consultant, staff C, on November 7, 2018 at 11:00 AM, confirmed the laboratory does not provide age and sex specific reference ranges for the appropriate interpretation of hematology test results. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) 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)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based on surveyor review of the laboratory procedure manual and interview with testing personnel, the director has approved two procedures for microscopic urinalysis testing with different sample preparation instructions. Findings include: 1. The procedure manual includes a cover sheet signed by the laboratory director in 2017 and 2018 showing approval of the entire procedure manual. 2. Review of the procedure manual reveals two procedures that include instructions for microscopic urine evaluation. Neither procedure shows a discontinuation date. The "Clinitek Procedure" shows 9 mL (milliliters) of supernatant is removed from a centrifuged 10 mL sample; the sediment is mixed in the resulting 1 mL of supernatant. The "Routine Urinalysis Visual Method" procedure shows 9.5 mL of supernatant is removed from a centrifuged 10 mL sample; the sediment is mixed with the resulting 0.5 mL of supernatant. 3. Interview with the technical consultant, staff C, on November 7, 2018 at 11:00 AM confirms use of the two urinalysis procedures would produce different results and that the director did not ensure the instructions in the procedure manual are consistent for microscopic urine evaluation. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the -- 3 of 4 -- 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 personnel records and interview with the technical consultant, two testing personnel do not have credentials available showing they meet the qualification requirements for moderate complexity testing personnel. Findings include: 1. Two of four testing personnel do not have credentials showing they meet the qualification requirements for moderate complexity testing. See D6065. 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 personnel records and interview with the technical consultant, two out of four testing personnel do not have documented evidence showing they meet the qualification requirements to perform moderate complexity testing. Findings include: 1. Review of personnel records showed no evidence of credentials for staff A or staff B. 2. Interview with the technical consultant, staff C, on November 7, 2018 at 9:15 AM revealed the laboratory has four testing personnel. Further interview confirmed Staff A and B perform moderate complexity testing and confirmed documented credentials were not available showing staff A or B meet the minimum requirements for moderate complexity testing personnel. -- 4 of 4 --