Office Laboratory Associates

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 laboratory's policy and procedure, American Proficiency Institute (API) proficiency testing (PT) records, and an interview with the medical laboratory technician (MLT); it was determined that the laboratory failed to attain at least 80 percent of the acceptable score in Routine Chemistry for the Sodium (Na), Magnesium (Mg), Potassium (K), and Uric Acid (UA) analytes. The findings include: 1. The surveyor reviewed the PT records wherein API reported unsatisfactory scores for Na, Mg, K, and UA analytes. The results were as follows: a. Na PT analyte in second event of 2023 (Q2-2023), Overall score: 60% Specimen Reported Expected CH-06 *137 128 - 136 CH-07 149 142 - 151 CH-08 *132 122 - 130 CH-09 156 150 - 159 CH-10 145 138 - 147 b. Mg PT analyte in first event of 2025 (Q1-2025), Overall score: 60% Specimen Reported Expected CH-01 2.5 2.2 - 3.1 CH-02 *2.3 1.5 - 2.2 CH-03 4.3 3.5 - 4.8 CH-04 *2.3 1.2 - 1.8 CH-05 2.0 1.8 - 2.6 c. K PT analyte in the second event of 2025 (Q2-2025), Overall score: 60% Specimen Reported Expected CH-06 2.7 2.3 - 3.0 CH-07 *6.2 5.4 - 6.1 CH-08 3.9 3.4 - 4.1 CH-09 5.2 4.5 - 5.2 CH- 10 *7.9 6.7 - 7.4 d. UA PT analyte in second event of 2025 (Q2-2025), Overall score: 20% Specimen Reported Expected CH-06 2.5 1.9 - 2.5 CH-07 *9.9 7.9 - 9.8 CH-08 *5.3 4.1 - 5.2 CH-09 *8.4 6.3 - 7.8 CH-10 13.6 9.9 - 12.2 Legend: * = unsatisfactory score reported 2. The MLT affirmed by an interview on September 10, 2025, at approximately 10:10 a.m. that the laboratory obtained the unsatisfactory PT scores from the API program 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 annually performed and reported approximately 17,160 patient test samples for 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 -- Routine Chemistry that included the Na, Mg, K, and UA analytes during the time the laboratory received unsatisfactory proficiency testing scores. Thus, the accuracy and reliability of patient test reported cannot be determined. D2121 HEMATOLOGY CFR(s): 493.851(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 American Proficiency Institute (API) proficiency testing (PT) records, and an interview with the medical laboratory technician (MLT), it was determined that the laboratory failed to attain at least 80 percent of the acceptable response resulting to an unsatisfactory performance for the Hematology third event in 2024 (Q3-2024) for the White Blood Cell (WBC) automated differential test. The findings include: 1. API reported a 47% score for the WBC automated differential test for Q3-2024 event. Further review of the quality assessment documentation showed that this score was negatively impacted by the 40% score for Granulocytes, 40% score in Lymphocytes, and 60% score for Monocytes. 2. The MLT affirmed by an interview on September 10, 2025, at approximately 10:10 a.m. that the laboratory obtained the PT scores mentioned in statement #1. 3. According to the laboratory testing declaration submitted on the day of the survey, the laboratory performed approximately 5,725 samples annually for Hematology that included the WBC automated differential test in the Cell Blood Count panel. Thus, the reliability and quality of Hematology patient results reported could not be assured at the time when the laboratory obtained unsatisfactory scores. 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 the surveyor's review of five patient records, personnel competency documentation, and an interview with the medical laboratory technician (MLT); as specified in the personnel requirements in subpart M, it was determined that the laboratory failed to perform competency assessment for all personnel involved in patient testing. The findings include: 1. Review of the personnel competency records revealed that the technical consultant failed to fulfill the responsibility of conducting an annual assessment for all testing personnel. Instead, the MLT performed the competency for the laboratory assistant for the years 2023 and 2024 making it invalid. 2. The MLT does not qualify as a technical consultant under 493.1411 regulation to perform competency assessment. 3.Five records were randomly selected and reviewed by the surveyor. All results were released by the testing personnel whose competency was invalid. Thus, the quality and reliability of patient samples processed and reported could not be assured. 4. According to the testing declaration form submitted at the time of the survey, the laboratory reported and performed approximately 24,735 -- 2 of 4 -- patient samples annually for the specialty of Chemistry and Hematology including the time when competency assessment for one of the testing personnel was invalid. 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 the deficiencies given, the laboratory director is herein cited for failure to ensure that the systems for the preanalytic, analytic, and postanalytic phases of the laboratory were monitored and followed to provide quality laboratory services. The findings include: 1. Personnel competency. See D5209 2. Failure of technical consultant to provide technical and scientific oversight. See D6036 3. Technical consultant responsibilities and qualifications. See D6064 D6036 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413 The technical consultant is responsible for the technical and scientific oversight of the laboratory. The technical consultant is not required to be onsite at all times testing is performed; however, he or she must be available to the laboratory on an as needed basis to provide consultation, as specified in paragraph (a) of this section. This STANDARD is not met as evidenced by: Based on the surveyor's findings on September 10, 2025, and an interview with medical laboratory technician; the technical consultant is herein cited for deficient practice in failure to provide technical and scientific oversight of the laboratory. The findings include: 1. Unsatisfactory proficiency testing score for Routine Chemistry. See D2087 2. Unsatisfactory proficiency testing score for Hematology. See D2121 D6064 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(a) Each individual performing moderate complexity testing must-- (a) possess a current license issued by the State in which the laboratory is located, if such licensing is required; and This STANDARD is not met as evidenced by: Based on surveyor's review of five randomly selected patient testing records, testing personnel records, and an interview with the medical laboratory technician (MLT); it was determined that the laboratory failed to ensure that the testing personnel -- 3 of 4 -- performing patient testing on all analytes possessed an appropriate current license issued by the State of California. The findings include: 1. The laboratory had two testing personnel performing moderate complexity testing, one was an MLT, while the other was a laboratory assistant who did not hold a current license issued by the State of California, wherein the laboratory is located. The laboratory performed patient testing for Routine Chemistry, Endocrinology, and Hematology. 2. On September 10, 2025 at approximately 9:10 a.m., the MLT affirmed by interview that the laboratory assistant listed in the CMS-209 and Lab-116 performed and reported moderate complexity tests. 3. The quality and reliability of patient tests reported cannot be assured. 4. According to the laboratory testing declaration form (Lab-144) submitted at the time of survey, the laboratory processed and reported approximately 24,735 samples annually for Routine Chemistry, Endocrinology, and Hematology. -- 4 of 4 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the specialty of Routine Chemistry constituting unsuccessful PT performance. (See D2096) 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 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, Bilirubin, Total (BILI, Total), resulting in an "initial" (first) unsuccessful performance. The findings include: a. The laboratory failed to maintain successful performance with the PT program by failing to obtain a score of 80% of acceptable responses in two out of three consecutive PT events for the analyte, BILI, Total, as follows: 2021 Q2 2021 Q3 BILI, Total 40% 60% Q2 = Second Testing Event Q3 = Third Testing Event b. Failure to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT resulted in an initial unsuccessful performance for the analyte, BILI, Total. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See D6016) D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analyte, BILI, Total, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in an unsuccessful PT performance. (see D2016 and D2096) -- 2 of 2 --

Summary Statement of Deficiencies D2121 HEMATOLOGY CFR(s): 493.851(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 review of the laboratory's American Proficiency Institute (API) testing records, five (5) random patients sampling, and interview with the testing personnel; it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Erythrocyte Count on the third event of 2020 (Q3-2020). The findings included: 1. The API proficiency program gave an unsatisfactory score of 40% for Red Blood Cell Count (RBC) for Q3-2020. 2. Based on the laboratory's annual testing declaration submitted on the day of the survey February 18, 2021, the laboratory analyzed and reported approximately 1,768 Complete Blood Count which included RBC, during the time the laboratory had unsatisfactory proficiency testing results. 3. The technical supervisors confirmed on 2/18/2021 at approximately 11:45 a. m. that the laboratory received the above proficiency score of 40% for Erythrocyte Count (RBC) described in 1. D6074 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(5) Each individual performing moderate complexity testing must be capable of identifying problems that may adversely affect test performance or reporting of test results and either must correct the problems or immediately notify the technical consultant, clinical consultant or director. 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 review of the laboratory's American Proficiency Institute testing records for the third event of 2020 and interview with the testing person, it was determined that the testing personnel failed to identify problems that may adversely affect test performance or reporting of test results and either must correct the problems or immediately notify the technical consultant, clinical consultant or director (See D 2121). -- 2 of 2 --