Pathology Group Of La-Cypress Pointe Surgical Hosp

Summary Statement of Deficiencies D0000 A Recertification survey was performed at Pathology Group of LA-Cypress Pointe Surgical Hospital, CLIA ID 19D2052850, on November 26, 2024. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, manufacturer's manual, maintenance records, and interview with personnel, the laboratory failed to perform the annual maintenance for the cryostat per the manufacturer's requirements in 2023. Findings: 1. In interview on November 26, 2024 at 1:05 pm, the Compliance Personnel stated the laboratory replaced their old Leica 1850 cryostat on November 14, 2024. 2. Review of the laboratory's "Cryostat Maintenance and Decontamination" policy under the "Annually" section revealed "Preventative maintenance as required by the manufacturer." 3. Review of the Leica 1850 Cryostat manual revealed "have the instrument inspected by a qualified service engineer authorized by us once a year." 4. Review of the laboratory's maintenance records revealed the laboratory did not have 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 -- the annual preventative maintenance (PM) performed for the cryostat in 2023. 5. In interview on November 26, 2024 at 2:05 pm, the Compliance Personnel confirmed the laboratory did not have the 2023 annual PM for the cryostat performed. D6095 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(6) The laboratory director must ensure the establishment and maintenance of acceptable levels of analytical performance for each test system. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, maintenance records, manufacturer's manual, and interview with personnel, the Laboratory Director failed to ensure maintenance procedures were followed to ensure acceptable levels of test performance. Refer to D5433. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Recertification survey was performed on June 10, 2021 at Pathology Group of LA- Cypress Pointe Surgical Hospital, CLIA ID # 19D2052850. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation by surveyor and interview with personnel, the laboratory failed to ensure laboratory supplies did not exceed their expiration dates. Findings: 1. Observation by surveyor during the laboratory tour on June 10, 2021 at 9:46 am revealed the following expired items: a) BD Vacutainer ACD Solution B blood collection tube, Lot 9065714, Expiration date: 2021-03-31, Quantity: four (4) tubes 2. In interview on June 10, 2021 at 9:46 am, the laboratory's Compliance Officer confirmed the identified items were expired. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. 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 2 -- Based on observation by surveyor and interview with personnel, the Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Refer to D5417. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure policies and procedures were maintained for assessing personnel competency. Refer to D6127. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of policies, personnel records and interview with personnel, the Technical Supervisor failed to ensure semi-annual competency assessment was performed for one (1) of four (4) testing personnel reviewed. Findings: 1. Review of the laboratory's "Pathologist Competency Assessment" form revealed "This competency evaluation is performed once upon hire, within 6 months, and annually." 2. Review of personnel records revealed the laboratory hired four (4) testing personnel since their previous survey in 2018. 3. Review of personnel records for Testing Personnel 1 revealed the laboratory did not have documentation of a semi-annual competency assessment due December 2020. The laboratory's semi-annual competency assessment for Testing Personnel 1 showed an assessment of "patient test performance, test results, logs, problem solving skills, and reporting issues" on "6/9 /20," which was the same date as his initial training documents. 4. In interview on June 10, 2021 at 10:19 am, the laboratory's Compliance Officer stated she did not realize the same case from the initial training was pulled for the six (6) month assessment for Testing Personnel 1. The Compliance Officer confirmed the laboratory did not have a documented semi-annual competency assessment for Testing Personnel 1. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Certification Survey was performed on October 24, 2018 at Pathology Group of Louisiana-Cypress Pointe Surgical Hospital, CLIA ID # 19D2052850. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to establish and follow written policies and procedures to assess competency for testing personnel. Findings: 1. Review of the laboratory's CMS-209 form (Laboratory Personnel Report) revealed the following fifteen (15) personnel serve as testing personnel: Personnel 1-15 2. Review of the laboratory's policy and procedure manual revealed the laboratory did not include the following six (6) procedures as a minimal requirement for assessing the competency of all personnel performing laboratory testing: a) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b) Monitoring the recording and reporting or test results. c) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records. d) Direct observation of performance of instrument maintenance and function checks. e) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. f) Assessment of problem solving skills. 3. In interview on October 24, 2018 at 9:55 am, Personnel 16 stated the laboratory did not have a policy to assess testing 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 -- personnel. Personnel 16 further stated she thought it was not required since doctors are performing the testing. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure policies and procedures were established for assessing personnel competency, and whenever necessary, identify needs for remedial training or continuing education to improve skills. Refer to D5209. -- 2 of 2 --