American Clinical Solutions Llc

Summary Statement of Deficiencies D0000 An unannounced complaint survey for complaint number 2021008611, was conducted 08/02/21 to 08/06/21 at American Clinical Solutions LLC. The laboratory was not in compliance with 42 CFR 493, Requirements for Clinical Laboratories. The following Conditions were not met: D5200 - 493.1230 General Laboratory Systems D5300 - 493.1240 Preanalytic Systems D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and staff interview the laboratory failed to have a system in place to document all reported complaints and failed to have a mechanism for determining investigation of complaints received from patients. (See D5205) D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- Based on record review and Staff interviews the laboratory failed to document and investigate complaints that came from patients from 08/20/20 to 08/03/21. Findings included: On 08/02/21 at 1:22 PM., the Laboratory Supervisor reported that a letter was received from Patient #1 on 04/23/21, and Patient #1 had also called the laboratory (date unknown). The Laboratory Supervisor stated "I can't discuss patient results with the patient. We only discuss this with the doctor, and the doctor never contacted us." The Laboratory Supervisor stated that the letter was placed in a book and no action was taken. Review of the letter from Patient #1 revealed a complaint that stated "...The only drug which should have been detected was hydrocodone, which is the only opiate I regularly use. I can't imagine what may have happened in your lab that was so wrong, unless it was just unintended carelessness ...Believe what you will, but I have never taken, or thought about taking the other drugs which tested positive on what was supposed to be my swab/saliva test. I can't tell you how stressful this has been. I now have to go to a pain management facility for treatment..." On 08 /02/21 at 12:45 PM., the Laboratory Supervisor and the Laboratory's Clinical Laboratory Improvement Amendment (CLIA) Specialist were informed of a discrepancy found on Patient #1's requisition, which indicated a source type of oral, but had an accessioning label and test result report indicating "Urine Drug Test". The Laboratory Supervisor stated, "I don't know what could have happened. It's impossible that this wasn't urine." The Laboratory Supervisor and CLIA Specialist reported that they needed to look into this to determine what occurred. Follow-up interview with the Laboratory Supervisor on 08/02/21 at 4:39 PM confirmed that the laboratory never follows up on any concerns that were not from a doctor's office. The Laboratory Supervisor stated that she was just informed that day of Patient #1's letter and had not seen it prior to this. She stated that even if she had seen it sooner, she would not have taken any action on it as they do not speak to or follow-up on any complaints from patients and that it was a strict policy to not speak to patients. The Laboratory Supervisor stated that the Toxicologist was responsible for responding to the complaints received by the laboratory. Interview on 08/02/21 at 4:42 PM with the Toxicologist revealed she did not know anything about the letter from Patient #1. The Toxicologist confirmed that she only received and responded to complaints that were from physicians. On 08/03/21 at 9:13 AM, a log or other documentation of complaints received from patients from 08/20/20 to current was requested from the Laboratory Supervisor. Electronic correspondence (email) and telephonic communication with the Laboratory Supervisor from 08/03/2021 to 08/05/21 revealed no documentation of complaints from patients was provided. The Laboratory Supervisor provided a document from the receptionist protocol via email on 08/03/21 at 12:42 PM. Review of the document titled "Phone System" updated on 01/02/19 revealed a yellow highlighted section on the bottom stating: "***IMPORTANT*** do not give information to patients. ALWAYS re-direct patient calls back to the physician." Record review of the laboratory's undated "Complaints Protocol" policy and procedure revealed "The purpose of this procedure is to outline the process to receive, evaluate and make decisions on complaints and internal

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at American Clinical Solutions LLC on 07/08/20. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on observations, record review, and interview with the Technical Supervisor the laboratory failed to install their Beckman Coulter Olympus AU 640 Chemistry analyzer with the space requirements for 2 (2018-2020) out of 2 years. Findings Included: Observations of the Olympus AU 640 on 07/08/20 at 7:00 PM revealed that the Chemistry Analyzer was 12 inches away from the back wall. Review of the manufacturer's instruction (MI) of the Beckman Coulter Olympus AU 640 Chemistry analyzer revealed, "Installation Space Requirements: As shown in the figure below, this system requires space around it for safe installation." A review of the figure revealed a minimum distance of 20 inches was required from the back of the machine. Interview on 07/08/20 at 7:00 PM with the Technical Supervisor confirmed that the Chemistry analyzer was not installed per the manufacturer's instructions. Photographic evidence was obtained. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and 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 -- test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on record review and interview with the Technical Supervisor the laboratory did not follow manufacturer's instructions (MI) and keep the Beckman Coulter Olympus AU 640 Chemistry analyzer in the required humidity range for 21 (November 2018) out of 22 (October 2018-July 2020) months reviewed. Findings Included: Review of MI for the Beckman Coulter Olympus AU 640 Chemistry analyzer revealed that the "humidity must be between 40 and 80% RH with no condensation." The MI also stated that "Temperature and humidity fluctuations must be within the specified range(s), otherwise the system cannot produce reliable data." Review of the Humidity record revealed humidity was not in the 40-80% range on the following days: July 2020 - 5/5 out of range, June 2020 - 22/22 out of range, May 2020 - 20/20 out of range, April 2020 - 22/22 out of range, March 2020 - 22/22 out of range, February 2020 - 22/22 out of range, January 2020 - 22/22 out of range, December 2019 - 21/21 out of range, November 2019 - 20/20 out of range, October 2019 - 18/23 out of range, September 2019 - 10/20 out of range, August 2019 - 1/22 out of range, July 2019 - 2/22 out of range, June 2019 - 3/20 out of range, May 2019 - 13/22 out of range, April 2019 - 16/22 out of range, March 2019 - 14/21 out of range, February 2019 - 3/20 out of range, January 2019 - 17/22 out of range, December 2018 - 9/20 out of range, November 2018 - 0/21 out of range, and October 2018 - 1/23 out of range. Interview on 07/08/20 at 7:00 PM with the Technical Supervisor confirmed that the aforementioned dates were not in the 40-80% humidity range. -- 2 of 2 --

Summary Statement of Deficiencies D6108 LABORATORY TECHNICAL SUPERVISOR CFR(s): 493.1447 The laboratory must have a technical supervisor who meets the qualification requirements of 493.1449 of this subpart and provides technical supervision in accordance with 493.1451 of this subpart. This CONDITION is not met as evidenced by: Based on record review and interview with the Laboratory Manager the Technical Supervisor failed to ensure employee competency evaluations were being performed and failed to identify unqualified Testing personnel (See D6120). D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (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 record review and interview with the Laboratory Manager the Technical Supervisor failed to perform competency evaluations on 7 (#A,#B,#D,#E,#F,#Gand #H) out of 9 Testing personnel and performed competencies on 3 (#J-#L) out of 3 Testing personnel that were not qualified to perform high complexity testing. Findings Included: Review of the CMS 209 revealed 2 Technical Supervisors listed (Testing Person #B) and the Laboratory Director. Testing Person #B was also listed as the only 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 -- General Supervisor. Competency Evaluations were not found for 2017 for Testing Personnel #A, #B, #D, #E, #F, #G, and #H. No competency evaluations were found in 2018 for Testing Person #H. Competency evaluations for the unqualified Testing Personnel #J, #K, and #L were done on 09/21/18 and signed off by Testing Person #H. During an interview on 09/25/18 at 3:45 PM the Laboratory Manager confirmed that there were no other competency evaluations on the aforementioned staff. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview with the Laboratory Manager the laboratory failed to have licensed personnel performing high complexity testing (See D6170) and failed to have qualified testing personnel (See D6171). D6170 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(a) Each individual performing high complexity testing must possess a current license issued by the State in which the laboratory is located, if such licensing is required. This STANDARD is not met as evidenced by: Based on record review and interview with the Laboratory Manager the laboratory failed to ensure 3 (#K, #L, and #M) out of 13 Testing Personnel had a State of Florida Clinical Laboratory Personnel license. Findings Included: Rule 64B3-2.003(19), Florida Administrative Code requires Testing Personnel who work in an Independent Laboratory be licensed by the Board. Review of the CMS 209 revealed Testing Personnel #K, #L, and #M did not have a State of Florida Clinical Laboratory Personnel license. During an interview on 09/25/18 at 3:45 PM the Laboratory Manager confirmed that Testing Personnel #K. #L, and #M did not have a State of Florida Clinical Laboratory Personnel license. D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) 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 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; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of -- 2 of 4 -- biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on record review and interview with the Laboratory Manager the laboratory failed to have 2 (#K and #M) out of 13 Testing personnel to be qualified to perform high complexity testing. Findings Included: Review of employee competencies conducted on 09/21/18 for Testing Personnel #K and #M revealed that they were deemed competent and signed off to prepare stock solutions , prepare mobile phase solutions, perform daily, weekly, and monthly maintenance of the instruments, diluting specimens, doing pH, making standards, and making controls. Testing Person #K has a GED and Testing Person #M does not have a GED or a High School diploma. During an interview on 10/01/18 via email at 10:08 AM the Laboratory Manager confirmed the education of #K and #M. During an interview on 09/25/18 at 3:45 PM the Laboratory Manager revealed that Testing Person #K and #M were -- 3 of 4 -- originally hired for specimen processing and they were not aware that the pH testing strips were high complexity and that making the stock, controls, standards, and maintenance were part of the analytic systems process. Rule 64B3-2.003(19), Florida Administrative Code states "Manual Pretesting procedures means collecting and labeling specimens; initially separating specimens by centrifugation prior to testing; receiving specimens and requisitions, processing, sorting, accessioning, prior to testing and delivering specimens to the appropriate testing sites; specimen processing for storage and shipping to a reference laboratory; routine hematology and microbiology slide preparation from a primary sample; loading automated stainers; loading specimens onto automated sampling or processing systems; cytopreparatory staining, measuring and alioquoting specimens; and direct primary inoculation of microbiology cultures; Placement of specimens onto an automated instrument or system is considered a manual pretesting duty, provided it does not include any activity that initiates the analytic process." Testing Personnel #K and #M are not qualified to be high complexiy Testing Personnel. -- 4 of 4 --