Cobb & Douglas Public Health

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on March 11, 2021. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory policy and procedure manual (SOP) and staff interview, the laboratory failed to have a written policies and procedure for all tests performed by the laboratory as required. Findings include: 1. SOP review revealed the lack of a policy and procedure for quality control (QC) for KOH (Potassium Hydroxide) and Wet Prep (Wet Preparation) testing. 2. An interview in the conference room with Staff #11 (CMS 209 for Marietta Center Clinic) on 3/11/2021 at approximately 12:15 p.m. confirmed the lack of the aforementioned QC policy and procedure. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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 qualitative procedure, include a negative and positive control material; (g) 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 laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on laboratory document review and staff interview, the laboratory failed to document all quality control (QC) procedures as required. Findings include: 1. Laboratory document review revealed the lack of QC documentation for KOH (Potassium Hydroxide) and Wet Prep (Wet Preparation) for all 4 clinics -- Marietta Center, Acworth-Kennesaw, Smyrna, and Douglas -- for the following time periods: 2018 -- July through December;2019, 2020, and 2021 thus far. 2. An interview with Staff #11 (CMS 209 for Marietta Center Clinic) on 3/11/1021 in the conference room at approximately 11:30 p.m. confirmed the lack of QC for KOH and Wet Prep for the aformentioned time periods. 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 lab report reviews and staff interview, the laboratory failed to include all the required information on the in-house laboratory test reports. Findings include: 1. Review of the in-house patient reports #193506, #260969, and #1129489 reveals the lack of referance range, units of measurement, and the health department's address where the test was performed. 2. Interview with Staff #11 (CMS 209 for Marietta Center Clinic) in the conference room on March 11, 2021, at approximately 1:30 p.m. confirmed the lack of the aforementioned data. -- 2 of 2 --

Summary Statement of Deficiencies D0000 `A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on June 6, 2018. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 testing personnel (TP) document review and staff interview, the laboratory failed to employ a qualified individual to perform the duties and responsibilities of technical consultant (TC) due to lack of education documentation. Findings include: Refer to 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 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 -- 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 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 testing personnel (TP) document review and staff interview, the laboratory failed to employ a qualified individual to perform the duties and responsibilities of technical consultant (TC) due to lack of education documentation. Findings include: 1. TP document review revealed the TP performing the duties and responsibilities of TC was unqualified due to lack of education documentation. 2. This individual was performing the duties of TC for the following Cobb and Douglas Public Health facilities: Douglasville, East Cobb, Smyrna, Marietta, and Acworth/Kennesaw. 2. An interview with Staff #3 (CMS 209 -- Cobb/Douglas Health Department/Adult Health) on 6/6/2018, in a conference room at the Acworth/Kennesaw location at approximately 2 p.m. confirmed the TP performing the duties and responsibilities of TC was unqualified due to lack of education documentation. -- 2 of 2 --