Palo Alto Medical Foundation

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 the surveyors' observation during the laboratory tour and interviews with the technical supervisor (TS) and testing personnel (TP), the laboratory failed to label reagents and solutions for preparation and expiration dates in throughout the laboratory. The findings included: 1. Based on the surveyor's observation during the laboratory's tour on March 13, 2024, at approximately 3:46 p.m..; no opening, preparation, or expiration date labels were used or documented for the reagents and solutions (ex: bleach. methanol, lens cleaner, diluents and distilled water). 2. The TS and TP affirmed in an interview conducted 3/13/2024, at approximately 3:46 p.m. that the reagents and solutions mentioned in statement 1 were not labeled with the opening, preparation, and expiration dates or documented. 3. Based on the laboratory's annual testing declaration submitted at the time of the survey, the laboratory analyzed approximately 1,717,041 test samples. D5815 TEST REPORT CFR(s): 493.1291(h) When the laboratory cannot report patient test results within its established time frames, the laboratory must determine, based on the urgency of the patient test(s) requested, the need to notify the appropriate individual(s) of the delayed 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 -- This STANDARD is not met as evidenced by: Based on review of laboratory's policies and procedures, patient test records review from March 13, 2024, and interview with the technical supervisor (TS); it was determined that the laboratory failed to have a policy for turn-around time (TAT) for all tests performed in the laboratory. 1. The laboratory failed to provide TAT of testing for six (6) out of six (6) randomly chosen patients at the time of the survey (March 13, 2024). The laboratory did not provide a TAT policy which may adversely impact patient management. 2. The laboratory TS on March 13, 2024, at approximately 4:10 p.m. affirmed that the laboratory did not have a TAT policy to notify any delay on testing to the health care providers. 3. The laboratory's testing declaration form, signed by the laboratory director on 3/8/2024, stated that the laboratory performs 1,717,041 tests annually. D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) The laboratory director must ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's records and interviews with the laboratory's technical supervisor (TS) and testing personnel (TP) on March 13, 2024; it was determined that the laboratory director is cited herein due to failure to ensure that several aspects of the preanalytic and analytic phases of the laboratory testing were monitored. See D5415 and D5815. -- 2 of 2 --

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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 observation of the Siemens Vista 500 chemistry analyzers (serial numbers DV330692 and DV370130), reviews of Event 3, 2017, proficiency testing reports from CMS (report 155D, Individual Laboratory Profile) and CAP (College of American Pathologists), laboratory proficiency testing records, and patients test records; and interview with laboratory personnel, the laboratory failed to attain a score of at least 80%, constituting unsatisfactory testing for Chloride (Cl). Findings included: a. CMS and CAP reported the score of 40% based on 3 unacceptable results out of 5: PT sample Lab result Mean result ---------------------------------------------------------------- CHM -12 95 101.7 CHM -13 107 116.3 CHM -14 95 101.6 b. Laboratory personnel, including the Technical Consultant, affirmed (4/24/19 at 5pm) the aforementioned findings; and thus unsatisfactory testing for Chloride. c. The reliability and quality of results reported could not be assured when testing was unsatisfactory. Based on the stated annual test volume, the laboratory reported approximately 5,986 Cl results each month during the timeframe October - December 2017. A few examples selected at random are as follows: Date (patients tested) one example ID -------------------------------------------------------- 10/21/17 (65) ... ... ... ..... 55665364 10 /22/17 ( 9) ... ... ... ......56327060 10/23/17 (209) ... ... ... .....56014145 . . D2109 TOXICOLOGY CFR(s): 493.845(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte 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 -- in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on observation of the Siemens Vista 500 chemistry analyzers for toxicology testing, reviews of Event 2, 2017, proficiency testing reports from CMS (report 155D, Individual Laboratory Profile) and CAP (College of American Pathologists), laboratory proficiency testing records, and patients test records; and interview with laboratory personnel, the laboratory failed to attain a score of at least 80%, constituting unsatisfactory testing for Gentamicin. Findings included: a. CMS and CAP reported the score of 60% based on 2 unacceptable results out of 5: PT sample Lab result Acceptable ------------------------------------------------ CHM - 09 10.1 2.3 - 3.9 CHM - 10 3.2 7.3 - 12.2 b. Laboratory personnel, including the Technical Consultant, affirmed (4/24/19 at 5pm) the aforementioned findings; and thus unsatisfactory testing for Gentamicin. c. The reliability and quality of results reported could not be assured when testing was unsatisfactory. Based on the stated annual test volume, the laboratory reported approximately 8 results for Gentamicin during the timeframe June - August 2017. 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 observation of the Stago Compact coagulation analyzer, reviews of Event 2, 2018, proficiency testing reports from CMS (report 155D, Individual Laboratory Profile) and CAP (College of American Pathologists), laboratory proficiency testing records, and patients test records; and interview with laboratory personnel, the laboratory failed to attain scores of at least 80%, constituting unsatisfactory testing for PT and PTT (Prothrombin Time; Partial Thromboplastin Time). Findings included: a. CMS and CAP reported scores of 20% for both PT and PTT based on 4 unacceptable results out of 5 for each analyte. b. Laboratory personnel, including the Technical Consultant, affirmed (4/24/19 at 5pm) the aforementioned findings; and thus unsatisfactory testing for PT and PTT. c. The reliability and quality of results reported could not be assured when testing was unsatisfactory. Based on the stated annual tests volumes, for the timeframe May - August 2018, the laboratory reported approximately 2,085 PT and 416 PTT results. Examples include the following: Date (patients tested) one example ID --------------------------------------------------- 5/25/18 (6) ... ... ... ... ..... F1609545 5/26/18 (2) ... ... ... ... ......51333048 D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on -- 2 of 4 -- proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on observation of the Stago Compact coagulation analyzer, reviews of Event 2, 2017, proficiency testing reports from CAP (College of American Pathologists) and patients test records;the lack of laboratory proficiency testing records, and interview with laboratory personnel, the laboratory failed to participate for Fibrinogen, constituting unsatisfactory testing. Findings included: a. For 5 of 5 samples shipped on 5/15/17 for evaluation on 7/10/17, CAP received no results from the laboratory and reported Code 11 based on the laboratory's response, "Unable to analyze". b. The laboratory was unable to provide for review records documenting problems with instrument, reagents or control materials that prevented testing of Fibrinogen from date of receipt of the CAP samples in May 2017 to deadline date for reporting in July 2017. c. Test records revealed patients specimen were tested for Fibrinogen during the timeframe May - July 2017: Month (patients tested) Date/ one example ID ------------------------------------------------------- May 2017 (3) ...............5/25/17... 54869108 June 2017 (9) ................6/21/17...59580725 July 2017 (13) ...............7/20 /17...56081659 d. Laboratory personnel, including the Technical Consultant, affirmed (4/24/19 at 5pm) the aforementioned findings constituting the failure to participate in proficiency testing, resulting in a score of 0% for Fibrinogen and thus, unsatisfactory testing. c. The reliability and quality of results reported could not be assured in the absence of participating in proficiency testing. During the timeframe May - August 2017, the laboratory reported 25 Fibrinogen results. . D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on observation of two Siemens Vista 500 analyzers for chemistry, endocrinology, and toxicology; review of laboratory records verifying test -- 3 of 4 -- calibrations, the lack of documents, and interview with laboratory personnel, the laboratory failed to perform calibration verification procedures at least once every 6 months in 2018 to 2019. Findings included: a. Laboratory records reviewed on 4/24 /19 documented calibrations were verified for each anlyzer as follows: Vista 500 -A Vista 500 - B -------------------- -------------------- June 2017 December 2017 December 2017 January 2018 June 2018 March 2018 August 2018* June 2018 March 2019 August 2018* April 2019 b. The laboratory was unable to provide for review documents verifying each analyzer's calibrations at least once within 6 months after August 2018 (*). c. Laboratory personnel, including the Technical Consultant, affirmed (4/24/19 at 5:30pm) the aforementioned lack of laboratory records; and thus, the laboratory's failure to verify calibrations at least once every 6 months after August 2018. d. The reliability and quality of results reported could not be assured in the absence of timely verifications of instrument calibrations. Based on the stated annual tests volumes, for the timeframe September 2018 - February/March 2019, the laboratory reported the approximate test volumes as follows: Results ----------- Chemistry ....... .... 656,786 Endocrinology .. .. 22,416 Toxicology ................. 759 . D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on observation of two Siemens Vista 500 analyzers for chemistry, endocrinology, and toxicology testing, patients tests records and instruments records reviewed on 4/24/19, the lack of laboratory records, and interview with laboratory personnel, it was determined that the laboratory failed to twice a year evaluate and define the relationship between test results for both analyzers. Findings included: a. The second Vista 500 (B) had been put into routine use after February 2017; however, the laboratory failed to provide for review records comparing it's results to the first Vista 500 (A) a second time in 2017. b. Laboratory personnel, including the Technical Consultant, affirmed (4/24/19 at 6pm) the aforementioned lack of records; and thus the failure to twice a year evaluate and define the relationship between test results for both analyzers. c. The reliability and quality of results between analyzers used interchangeably could not be assured in the absence of comparative studies. Based on the stated annual tests volumes, the laboratory in 2017 reported the following estimated test volumes: Routine chemistry ........1,125,920 Endocrinology ................. 38,429 Toxicology .........................1,302 -- 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 Hematology constituting unsuccessful PT performance. (See D2130) 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 -- D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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, Prothrombin time (PT), resulting in an "initial" (first) unsuccessful performances. 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, PT, as follows: 2018 Q2 2018 Q3 PT 20% 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, PT. 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, PT, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performance. (See D2016 and D2130) -- 2 of 2 --