Wellness Club, The

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a lack of proficiency testing (PT) records and an interview with testing personnel 1 (TP1) on 9/13/2024, the laboratory failed to enroll in proficiency testing since opening on 10/01/2023. The findings include: 1. A lack of PT records identified that the laboratory failed to enroll and participate in PT for all analytes performed by the laboratory since opening on 10/01/2023. The analytes include: prostate specific antigen and total testosterone. 2. An interview with TP1 on 9/13/2024 at 9:13 am confirmed that the laboratory failed to enroll and participate in PT for all analytes since opening on 10/01/2023. 3. The laboratory projects performing 300 tests annually. 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 test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- 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 a lack of laboratory temperature logs and an interview with testing personnel 1 (TP1) on 9/13/2024, the laboratory failed to establish and monitor the testing temperature and humidity and storage temperature for reagents since opening on 10/01/2023. The findings include: 1. A lack of the laboratory temperature logs identified the laboratory failed to establish and monitor testing temperature and humidity per the NanoEntek FREND manufacturer requirements. 2. A lack of the laboratory temperature logs identified the laboratory failed to establish and monitor reagent storage temperature per the NanoEntek FREND manufacturer requirements. 3. An interview with TP1 on 9/13/2024 at 9:13 am confirmed that the laboratory failed to monitor temperatures and humidity since opening on 10/01/2023. 4. The laboratory projects performing 300 tests annually. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of instrument manuals, a lack of maintenance logs and an interview with testing personnel 1 (TP1) on 9/13/2024, the laboratory failed to perform function checks as required by the NanoEntek FREND manufacturer. The findings include: 1. A review of the NanoEntek FREND user manual identified that the Q.C. Check is to be performed daily to verify the performance of the analyzer. 2. A lack of maintenance logs for the NanoEntek FREND identified that the laboratory failed to perform the required performance verification using the Q.C. Check daily since opening in 10/01/2023. 3. An interview with TP1 on 9/13/2024 at 9:10 am confirmed the above finding. 4. The laboratory projects performing 300 tests annually. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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 quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a lack of Quality Control (QC) records and an interview with testing personnel 1 (TP1) on 9/13/2024, the laboratory failed to successfully perform two levels of QC each day of use on the NanoEntek FREND since opening on 10/01/2023. The findings include: 1. A lack of QC documents for the NanoEntek FREND for 2023 -- 2 of 7 -- and 2024 identified that the laboratory failed to perform two levels of external QC for each analyte everyday of testing in 2023 and 2024. 2. An interview with TP1 on 9/13 /2024 at 9:10 am confirmed the above finding. 3. The laboratory projects performing 300 tests annually. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid (CMS) personnel form 209, lack of Proficiency Testing (PT) documents, a lack of documentation, and an interview with testing personnel 1 on 9/13/2024, the laboratory director failed to ensure that new instrument verifications were performed, that testing personnel had training and were competent to provide accurate and reliable patient results, that PT was ordered and performed, that testing personnel had policies and procedures to follow, and that the laboratory had a quality assurance plan. See D6013, D6015, D6120, D6121, D6129 and D6131. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on a review of the NanoEntek FREND instrument verification and an interview with testing personnel 1 (TP1) on 9/13/2024, the laboratory director failed to ensure that the verification of instrument performance specifications were adequate. The findings include: 1. A review of the new instrument verification of the NanoEntek FREND identified that the laboratory director failed to review and approve the verification results for accuracy, precision, and reportable range to ensure that they were adequate before beginning patient testing. 2. An interview with TP1 on 9/13 /2024 at 8:44 am confirmed that the laboratory director failed to review and approve the verification. 3. The laboratory projects performing 300 tests annually. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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 -- 3 of 7 -- director must-- (e)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on a lack of Proficiency Testing (PT) records and an interview with testing personnel 1 (TP1) on 9/13/2024, the laboratory director failed to ensure that the laboratory was enrolled in PT for all testing performed since opening on 10/01/2024. The findings include: 1. A lack of PT records identified that the laboratory failed to enroll and participate in PT for prostate specific antigen and total testosterone. See D2000 2. An interview with TP1 on 9/13/2024 at 9:13 am confirmed the above finding. 3. The laboratory projects performing 300 tests annually. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a lack of quality control (QC) documentation and an interview with testing personnel 1 (TP1) on 9/13/2024, the laboratory director failed to ensure that the laboratory had an acceptable QC plan that testing personnel were following. The findings include: 1. A lack of a QC policy and QC documentation for prostate specific antigen (PSA) and total testosterone testing identified that the laboratory failed to perform and document acceptable QC since opening on 10/01/2023. See D5447 2. An interview with TP1 on 9/13/2024 at 9:10 am confirmed the above finding. 3. The laboratory projects performing 300 tests annually. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a lack of laboratory policies and procedures and an interview with testing personnel 1 (TP1) on 9/13/2024, the laboratory director failed to establish a quality assurance (QA) plan for the laboratory to follow. The findings include: 1. A lack of laboratory policies and procedures identified that the laboratory failed to establish and follow a QA plan for general laboratory systems that included assessing specimen identification and integrity, personnel competencies and proficiency testing performance. 2. A lack of laboratory policies and procedures identified that the -- 4 of 7 -- laboratory failed to establish and follow a QA plan for preanalytic laboratory systems that included assessing specimen handling and collection problems, and inadequate specimen preparation. 3. A lack of laboratory policies identified that the laboratory failed to establish a QA policy for analytic systems to monitor and assess test procedures, equipment maintenance, verification of method performance, calibration verification, control procedures and