Comprehensive Cancer Center, La Quinta

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on the surveyor's review of the College of American Pathologists (CAP) proficiency testing (PT) records and interviews with the technical consultant (TC) and testing personnel (TP), it was determined that the laboratory failed to attain at least 80 percent of the acceptable score in Routine Chemistry for the Lactate Dehydrogenase (LDH) and Total Bilirubin (TBil) analytes. The findings include: 1. The surveyor reviewed the PT records wherein CAP reported an unsatisfactory score of the following: a. 0% unsatisfactory score for LDH analyte for the second event of 2024 (Q2-2024) due to absence of response (CAP code 42). b. 60% unsatisfactory score for TBil analyte for the third event of 2025 (Q3-2025). 2. The TC and TP affirmed by interviews on March 25, 2026, at approximately 9:40 a.m. that the laboratory obtained the unsatisfactory PT scores for the LDH and TBil analytes as mentioned in statement #1. 3. According to the laboratory's testing declaration form (Lab-144) submitted on the day of the survey, the laboratory performed approximately 657 LDH and 1,167 TBil patient test samples annually including the time when the laboratory received the unsatisfactory proficiency testing scores. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 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 -- through 493.1236. This STANDARD is not met as evidenced by: Based on the lack of the laboratory's policy and procedure for quality assessment and interviews with the testing personnel-1 (TP1) and testing personnel-2 (TP2), it was determined that the laboratory failed to follow their established and approved policy and procedure for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the general laboratory systems. The findings include: 1. The laboratory failed to follow their established and approved policy and procedure for the quality assessment specific to personnel competency. In addition, the competency assessment documentation for both TP1 and TP2 were missed for the years 2024 and 2025. 2. No

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on observation, review of the laboratory's written policies and procedures, and interview with the laboratory staff, it was determined that the laboratory failed to ensure that written procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. The findings included: a. Review of the laboratory written policies and procedures (P&P) , there were no current laboratory director's signature to indicated that the laboratory's P&P were approved, signed, and dated before use. b. The laboratory staff affirmed (01/04/2018 @ 12:20 pm) that no current laboratory director's approval, signatures and dated were noted for written P&P. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory quality control records, and interview with the laboratory staff, it was determined that the laboratory failed to 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, and failed to document all control procedures performed. the findings included: a. The laboratory performed routine chemistry and CBC (complete blood cell counts) and released patient test results reports. b. By interview and observation, no evidence of a qualified personnel's verification of daily quality control shown. c. The laboratory staff affirmed (1/04/2018 @ 11: 35 am) no signature daily but monthly. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(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, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, 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: Based on review of the laboratory records, and interview with the laboratory staff, it was determined that the laboratory director failed to be responsible for the overall operation, including, but is not limited to the following, reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. The findings include: See D-5407 and D-5441 D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require