Sierra Vista Pathology Pc

Summary Statement of Deficiencies D5637 CYTOLOGY CFR(s): 493.1274(d)(1)(ii) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(1)(ii) Each individual's workload limit is reassessed at least every 6 months and adjusted when necessary. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures and interview with the facility personnel, the laboratory failed to establish written policies and procedures to reassess and adjust, when necessary, a maximum workload limit at least every six months for the Technical Supervisors who perform primary screening of non-gynecologic cytology specimens. Findings include: 1. The laboratory performs the microscopic examination on non-gynecological cytology specimens, with an approximate annual test volume of 1,564. 2. No documentation was presented for review during the survey conducted on February 27, 2023 to indicate the laboratory established written policies and procedures to detail how the Technical Supervisors' workload limits would be reassessed at least every six months and adjusted when necessary. 3. The facility personnel interviewed on 2/27/2023 at 1:35pm confirmed the laboratory failed to establish policies and procedures as indicated above. D5645 CYTOLOGY CFR(s): 493.1274(d)(3) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(3) The laboratory must maintain records of the total number of slides examined by each individual during each 24-hour period and the number of hours spent examining slides in the 24-hour period irrespective of the site or 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 4 -- This STANDARD is not met as evidenced by: Based on review of established laboratory policies and procedures, lack of records for daily workload limits and interview with the facility personnel, the laboratory failed to follow established policies with regard to documenting the time spent by each individual examining cytology specimens in a 24-hour period. Finding include: 1. The laboratory performs testing on non-gynecological cytology specimens, with an approximate annual test volume of 1,564. 2. The laboratory's policy titled, "Non-Gyn Cytology Workload Policy" states, "Maximum 100 slides in an 8-hour workday (12.5 slides/hr). Workload includes slides, not cases (for Non-Gyn and QC). Pathologist and /or cytologist are to follow the Non-Gyn Cytology Workload Procedure at Sierra Vista Pathology. Said personnel is not to exceed a maximum of 100 slides in an 8-hour workday (12.5 slides/hr). This is set in place to prevent fatigue." 3. No documentation was presented for review during the survey conducted on February 27, 2023 to indicate the laboratory maintained records of the total number of slides examined by each individual during each 24-hour period and the number of hours spent examining slides in the 24-hour period irrespective of the site or laboratory. 4. The laboratory failed to monitor and document daily workload limits of the total number of cytology slides examined by each individual from 2021, 2022 and through the date of the survey, February 27, 2023. 5. The facility personnel interviewed on 2/27/2023 at 1: 30pm confirmed that the cytology technical supervisor was not documenting the time spent examining slides during each 24-hour period during 2021 through the date of the survey. D6133 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(c)(6) In cytology, the technical supervisor or the individual qualified under 439.1449(k)(2), if responsible for screening cytology slide preparations, must document the number of cytology slides screened in 24 hours and the number of hours devoted during each 24- hour period to screening cytology slides. This STANDARD is not met as evidenced by: Based on review of laboratory polices and procedures, lack of laboratory daily workload records and interview with the facilty personnel, two out of two Technical Supervisors performing primary screening of cytology specimen slides failed to document the number of slides screened and the number of hours devoted to screening slides during each 24-hour period in 2021, 2022 and to the date of the survey in 2023. Findings include: 1. The laboratory failed to provide records of the total number of slides screened for two out of two Technical Supervisors who screen cytology specimen slides during each 24-hour period in 2021, 2022 and to the date of the survey performed on February 27, 2023. 2. The CMS-209, Laboratory Personnel Form presented for review during the survey listed two Technical Supervisors who examine cytology slides. 3. The facility personnel interviewed on February 27, 2023 at 1:30pm confirmed each Technical Supervisor failed to monitor and record the number of cytology slides screened in 24 hours and the number of hours devoted during each 24-hour period to screening cytology slides. D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of -- 2 of 4 -- osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: -- 3 of 4 -- Based on the education documentation presented for review during the survey for one testing personnel (TP-3) and interview with the facility personnel, the laboratory failed to ensure that testing personnel have the required education qualifications prior to testing patients' specimens. Findings include: 1. The laboratory performs approximately 16,014 patient tests annually under the specialty of Pathology. 2. During the survey performed on February 27, 2023, the CMS-209, Laboratory Personnel form submitted for review listed a total of three testing personnel who perform the gross examination on patient specimens. Testing Personnel (TP-3) began patient testing on June 20, 2022. 3. No documentation was presented for review during the survey to indicate that TP-3 referenced above met the required qualifications under 493.1489 for Testing Personnel who perform high complexity testing. 4. The education credentials presented for review for TP-3 failed to include evidence of at least 60 semester hours from an accredited institution that include 24 semester hours of science courses including six semester hours of chemistry; six semester hours of biology; and twelve semester hours of chemistry, biology, or medical technology in any combination. 5. The facility personnel interviewed on 2/27 /2023 at 1:10pm acknowledged that the testing personnel stated above lacked the appropriate education documentation for the complexity of testing performed by the laboratory. -- 4 of 4 --

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on direct inspection of histopathology stain reagents and interview with the facility personnel, the laboratory failed to properly label stain reagents used in conjunction with patient testing. Findings include: 1. The laboratory performs the Hematoxylin & Eosin (H&E) stain on histopathology specimens and performs approximately 17,817 patient tests annually. 2. Direct inspection of the stain reagents, Hema-Diff Solution 3: Thiazine Dye and Hema-Diff Solution 2: Xanthene Dye, revealed the containers were missing the lot number and expiration date for each reagent component. 3. The facility personnel confirmed that the reagent containers indicated above were not labeled with the current lot number and expiration date at the time of the survey. 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 --