Pain & Spine Center

Summary Statement of Deficiencies D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) 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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Review of quality control records, policies and procedures, patient test records and interview of facility personnel during the on-site revisit conducted on May 28, 2019 found this deficiency remains uncorrected. The laboratory director failed to ensure that the quality control program had been established and maintained. (See D5217, D5441 and D5481) 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 D0000 As a result of the CLIA recertification inspection, the laboratory is not in compliance with the following Conditions of Participation required for certification in the CLIA program at 42 CFR part 493: D5022 - 42 C.F.R. 493.1213 Condition: Toxicology; D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director; D6108 - 42 C.F.R. 493.1447 Condition: Laboratories performing high complexity testing; technical supervisor; D6141 - 42 C.F.R. 493.1459 Condition: Laboratories performing high complexity testing; general supervisor; D6168 - 42 C.F.R. 493.1487 Condition: Laboratories performing high complexity testing; testing personnel; D5022 TOXICOLOGY CFR(s): 493.1213 If the laboratory provides services in the subspecialty of Toxicology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on surveyor observations, temperature records, quality control policies and procedures, quality control records, patient records, and interview with facility personnel, the laboratory failed to meet the requirements for certification in the specialty of Toxicology. The findings included: 1. The laboratory failed to establish and follow procedures for assessing accuracy of analytes twice annually that were reported in quantitative values for 8 of 8 assays. Refer to D5217. 2. The laboratory failed to store specimens at the appropriate temperature prior to testing for 129 of 129 dates reviewed. Refer to D5311. 3. The laboratory failed to monitor the accuracy and precision of quality control materials over time. Refer to D5441. 4. The laboratory failed to ensure that the results of quality control materials were within acceptable limits prior to reporting patient results. Refer to D5481. 5. The laboratory failed to take and document