Luis E Alvarez, Md, Apmc

Summary Statement of Deficiencies D0000 A Recertification survey was performed on October 20, 2025 at Luis E. Alvarez, MD, CLIA ID # 19D2164782. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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 applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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: I. Based on observation, review of manufacturer's storage requirements and the laboratory's temperature records, as well as interview with personnel, the laboratory failed to define acceptable room temperature limits within the manufacturers' required ranges for one (1) of one (1) rooms where Histopathology supplies were stored. Findings: 1. Observation by surveyor during the laboratory tour on October 20, 2025 at 10:05 a.m. revealed the laboratory stored the following supplies in Room 2: a) Histology Connections Differential Rapid Blood Stain, Solution A - Manufacturer's storage requirements 15-30 degrees Celsius. b) Histology Connections Differential Rapid Blood Stain, Solution B - Manufacturer's storage requirements 15-30 degrees Celsius. c) Histology Connections Alcian Blue Stain Solution, 1% w/v, pH 2.5 - Manufacturer's storage requirements 15-30 degrees Celsius. d) Bouin's fluid tissue fixative - Manufacturer's storage requirements 15-30 degrees Celsius. 2. Review of the laboratory's temperature log for Room 2 revealed the laboratory defined the 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 -- acceptable room temperature limits as 55-80 degrees Fahrenheit (12.8-26.7 degrees Celsius) which exceeded the manufacturers' lower temperature limits 3. In interview on October 20, 2025 at 12 p.m., Testing Personnel 1 confirmed the acceptable room temperature limits defined by the laboratory exceeded the manufacturers' lower temperature limits as identified above. II. Based on observation, review of the manufacturer's operating requirements and laboratory temperature records, as well as interview with personnel, the laboratory failed to monitor the room temperature and humidity for one (1) of two (2) rooms where Histopathology testing was performed. Findings: 1. Observation by surveyor during the laboratory tour on October 20, 2025 at 10:05 a.m. revealed the following instruments utilized for Histopathology testing in Room 1: a) Dakewe DP360 Slide Stainer - Manufacturer's operating temperature 15- 40 degrees Celsius, manufacturer's operating humidity 10-85%. b) Thermoscientific HistoStar - Manufacturer's operating temperature 17-27 degrees Celsius, manufacturer's operating humidity maximum 80%. 2. Review of the laboratory's temperature and humidity records revealed no documentation of room temperature and /or humidity monitoring for Room 1. 3. In interview on October 20, 2025 at 12 p.m., Testing Personnel 1 confirmed the laboratory did not monitor the room temperature and humidity of Room 1 as identified above. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) (b)(1)(i) 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. (b)(1)(ii) 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 maintenance records and interview with personnel, the laboratory failed to document weekly maintenance for Histopathology stains as required by the laboratory for thirty-eight (38) of thirty-eight (38) weeks reviewed. Findings: 1. Review of the laboratory's policy "Routine Microtomy and Staining Procedure" section "Quality Control" revealed the following: *"Stainer - Day of Use" - "The containers will be dumped out and cleaned once weekly." 2. Review of the laboratory's maintenance logs from January 2025 through September 2025 revealed the laboratory did not document weekly maintenance of the stain containers. 3. In interview on October 20, 2025 at 11:26 a.m., Testing Personnel 1 stated she performed weekly maintenance but did not document it as identified above. D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) (e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and stain logs as well as interview with personnel, the laboratory failed to document all quality control (QC) procedures for nine (9) of nine (9) months reviewed. Findings: 1. Review of the laboratory's policy "Routine Microtomy and Staining Procedure" section "Procedure" revealed "each -- 2 of 3 -- working day a control slide must be stained and reviewed by the Pathologist or Pathology Laboratory Manager." 2. Review of the laboratory's staining logs for Hematoxylin and Eosin (H&E), Alcian Blue/Periodic Acid-Schiff (PAS), and Diff- Quik revealed the laboratory did not document the reagent lot numbers and expiration dates in use for staining slides. 3. In interview on October 20, 2025 at 10:10 a.m., Testing Personnel 1 confirmed she did not document the lot numbers and expiration dates of reagents as identified above. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results; This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Findings: 1. The laboratory failed to define acceptable room temperature limits within the manufacturers' required ranges for one (1) of one (1) rooms where Histopathology supplies were stored. Refer to D5413 I. 2. The laboratory failed to monitor the room temperature and humidity for one (1) of two (2) rooms where Histopathology testing was performed. Refer to D5413 II. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and interview with personnel, the Laboratory Director failed to ensure a complete quality control program was established to assure the quality of laboratory testing results. Refer to D5609. D6023 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(6) (e)(6) 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 observation, record review, and interview with personnel, the Laboratory Director failed to ensure that the laboratory performed required maintenance. Refer to D5433. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Recertification survey was performed on October 12, 2023 at Luis E. Alvarez, MD, CLIA ID # 19D2164782. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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: Based on record review and interview with laboratory personnel, the Laboratory Director failed to provide overall management and direction to the laboratory. Refer to D6171. 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 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 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 -- 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: Based on review of the laboratory's CMS 209 form (Laboratory Personnel Report), personnel records, and patient test records; as well as interview with personnel, the laboratory failed to ensure histopathology gross examinations performed by delegated -- 2 of 3 -- testing personnel was reviewed by a Technical Supervisor. Findings: 1. Review of the laboratory's CMS 209 form (Laboratory Personnel Report) revealed Personnel 2 was listed as the only testing personnel. 2. Review of personnel records for Personnel 2 revealed she held an associate degree in laboratory science. 3. Review of patient test records revealed Personnel 2 performs gross examinations on histopathology specimens. 4. In interview on October 12, 2023 at 10:36 a.m., the Laboratory Director stated she does not review all gross examinations performed by Personnel 2 within 24 hours. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An Initial survey was performed on April 19, 2022 at Luis E. Alvarez, MD, APMC, CLIA ID # 19D2164782. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 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: I. Based on review of the laboratory's policies, temperature and humidity logs, and interview with personnel, the laboratory failed to monitor the room temperature and humidity of the laboratory for one (1) of twelve (12) months reviewed in 2021. Findings: 1. Review of the laboratory's "Temperature and Humidity Limits" policy revealed "Ambient temperature of the laboratory shall be recorded daily. Ambient humidity levels will be recorded daily." 2. Review of the laboratory's room temperature and humidity logs for 2021 revealed the laboratory did not document the room temperature and humidity for January 2021. 3. In interview on April 19, 2022 at 12:56 pm, the Testing Personnel stated she could not find the room temperature and humidity log for January 2021. II. Based on review of the laboratory's policies, temperature and humidity logs, and interview with personnel, the laboratory failed to define the room humidity limits. Findings: 1. Review of the laboratory's "Temperature and Humidity Limits"policy revealed "Ambient humidity levels will be recorded daily. Humidity range shall be within 25-80%." The current Laboratory Director 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 -- approved the policy on October 29, 2021. 2. Review of the laboratory's temperature and humidity logs for 2020 revealed the laboratory's acceptable humidity range was 25-80%; however, beginning in March 2021, the laboratory's acceptable humidity range was listed as 10-80%. The laboratory's policy was not updated to reflect the change that was made to the humidity logs. 3. In interview on April 19, 2022 at 11:39 am, the Testing Personnel confirmed the laboratory's temperature and humidity policy did not include the change to the laboratory's humidity limits. D5785