Comprehensive Surgical Care Of Reno-Tahoe,Llc

Summary Statement of Deficiencies D5803 TEST REPORT CFR(s): 493.1291(b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. This STANDARD is not met as evidenced by: No deficiency details available. D5821 TEST REPORT CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: No deficiency details available. D6028 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(10) 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 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 -- director must-- (e)(10) Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart; This STANDARD is not met as evidenced by: No deficiency details available. 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: No deficiency details available. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: No deficiency details available. 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: No deficiency details available. D6048 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(ii) The procedures for evaluation of the competency of the staff must include, but are not limited to monitoring the recording and reporting of test results. This STANDARD is not met as evidenced by: No deficiency details available. -- 2 of 3 -- D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: No deficiency details available. -- 3 of 3 --

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on August 21, 2024. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the the Individualized Quality Control Plan (IQCP), a review of the laboratory's control logs, a review of the i-Stat print outs, a review of patient test results, and an interview with the technical consultant, the laboratory failed to perform quality control (QC) for the Activated Clotting Time (ACT) testing on the i-Stat as directed to ensure accurate test performance. Findings include: 1. The director approved IQCP plan for ACT testing on the i-Stat indicated that two levels of an external quality control were to be run with "each new lot, each new shipment, every 30 days after the lot/shipment is in use, and after any system maintenance 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 6 -- software upgrades (CLEW)." The laboratory failed to document any QC results on the control logs between February 29, 2024 and August 20, 2024. 2. A review of the IQCP for ACT testing on the i-Stat found that the initial IQCP studies were performed between January 25, 2024 through March 6, 2024. 3. A review of the laboratory control logs, found control lots 261161 (Level 1) and 271160 (Level 2), and cartridge lot R23349 were used between January 25, 2024 and February 29, 2024. IQCP QC results between February 29, 2024 and March 6, 2024 were not documented on the control logs. 4. Control results for control lots 261165 (Level 1) and 271165 (Level 2), and cartridge lot R24089 were documented on August 20, 2024. 5. A review of the i-Stat print outs from March 2024 through May 2024, found that there were no print outs available for controls after March 6, 2024. The cartridge lot number documented on the i-Stat print out was 460R233190181. The remaining print outs were for electronic simulator runs on March 22, 2024 and May 15, 2024. 6. A review of patient results found that patients had been tested on May 15, 2024 and June 12, 2024, using cartridge lot 436R233490181. No control results were documented on these days or for the initial use of cartridge lot 436R233490181. 7. These findings were confirmed in an interview with the technical consultant on August 21, 2024 at approximately 11: 30 AM. The laboratory performs approximately 600 hematology tests annually. D5781